21 CFR 870.2600 - Signal isolation system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Signal isolation system. 870.2600 Section 870.2600...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2600 Signal isolation system. (a) Identification. A signal isolation system is a device that electrically isolates the patient...

21 CFR 870.2600 - Signal isolation system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Signal isolation system. 870.2600 Section 870.2600...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2600 Signal isolation system. (a) Identification. A signal isolation system is a device that electrically isolates the patient...

21 CFR 870.2340 - Electrocardiograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electrocardiograph. 870.2340 Section 870.2340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2340 Electrocardiograph. (a...

21 CFR 870.2320 - Ballistocardiograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ballistocardiograph. 870.2320 Section 870.2320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2320 Ballistocardiograph...

21 CFR 870.2400 - Vectorcardiograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vectorcardiograph. 870.2400 Section 870.2400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2400 Vectorcardiograph. (a...

21 CFR 870.2320 - Ballistocardiograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ballistocardiograph. 870.2320 Section 870.2320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2320 Ballistocardiograph...

21 CFR 870.2340 - Electrocardiograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Electrocardiograph. 870.2340 Section 870.2340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2340 Electrocardiograph. (a...

21 CFR 870.2400 - Vectorcardiograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vectorcardiograph. 870.2400 Section 870.2400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2400 Vectorcardiograph. (a...

21 CFR 870.2360 - Electrocardiograph electrode.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electrocardiograph electrode. 870.2360 Section 870.2360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2360 Electrocardiograph...

21 CFR 870.2675 - Oscillometer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Oscillometer. 870.2675 Section 870.2675 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2675 Oscillometer. (a) Identification. An...

21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

Code of Federal Regulations, 2012 CFR

2012-04-01

... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra...

21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

Code of Federal Regulations, 2013 CFR

2013-04-01

... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra...

21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

Code of Federal Regulations, 2014 CFR

2014-04-01

... System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. Implantable intra...

21 CFR 870.2360 - Electrocardiograph electrode.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Electrocardiograph electrode. 870.2360 Section 870.2360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2360 Electrocardiograph...

21 CFR 870.2675 - Oscillometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Oscillometer. 870.2675 Section 870.2675 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2675 Oscillometer. (a) Identification. An...

21 CFR 870.2750 - Impedance phlebograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Impedance phlebograph. 870.2750 Section 870.2750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2750 Impedance phlebograph...

21 CFR 870.2770 - Impedance plethysmograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Impedance plethysmograph. 870.2770 Section 870.2770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2770 Impedance...

21 CFR 870.2350 - Electrocardiograph lead switching adaptor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electrocardiograph lead switching adaptor. 870.2350 Section 870.2350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2350...

21 CFR 870.2370 - Electrocardiograph surface electrode tester.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electrocardiograph surface electrode tester. 870.2370 Section 870.2370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2370...

21 CFR 870.2840 - Apex cardiographic transducer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Apex cardiographic transducer. 870.2840 Section 870.2840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2840 Apex...

21 CFR 870.2310 - Apex cardiograph (vibrocardiograph).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Apex cardiograph (vibrocardiograph). 870.2310 Section 870.2310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2310 Apex...

21 CFR 870.2890 - Vessel occlusion transducer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vessel occlusion transducer. 870.2890 Section 870.2890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2890 Vessel occlusion...

21 CFR 870.2920 - Telephone electrocardiograph transmitter and receiver.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Telephone electrocardiograph transmitter and receiver. 870.2920 Section 870.2920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices...

21 CFR 870.2780 - Hydraulic, pneumatic, or photoelectric plethysmographs.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hydraulic, pneumatic, or photoelectric plethysmographs. 870.2780 Section 870.2780 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices...

21 CFR 870.2700 - Oximeter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Oximeter. 870.2700 Section 870.2700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2700 Oximeter. (a) Identification. An oximeter is...

21 CFR 870.2600 - Signal isolation system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Signal isolation system. 870.2600 Section 870.2600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2600 Signal isolation...

21 CFR 870.2350 - Electrocardiograph lead switching adaptor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Electrocardiograph lead switching adaptor. 870.2350 Section 870.2350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2350...

21 CFR 870.2310 - Apex cardiograph (vibrocardiograph).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Apex cardiograph (vibrocardiograph). 870.2310 Section 870.2310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2310 Apex...

21 CFR 870.2920 - Telephone electrocardiograph transmitter and receiver.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Telephone electrocardiograph transmitter and receiver. 870.2920 Section 870.2920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices...

21 CFR 870.2600 - Signal isolation system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Signal isolation system. 870.2600 Section 870.2600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2600 Signal isolation...

21 CFR 870.2890 - Vessel occlusion transducer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vessel occlusion transducer. 870.2890 Section 870.2890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2890 Vessel occlusion...

21 CFR 870.2370 - Electrocardiograph surface electrode tester.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Electrocardiograph surface electrode tester. 870.2370 Section 870.2370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2370...

21 CFR 870.2780 - Hydraulic, pneumatic, or photoelectric plethysmographs.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hydraulic, pneumatic, or photoelectric plethysmographs. 870.2780 Section 870.2780 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices...

21 CFR 870.2840 - Apex cardiographic transducer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Apex cardiographic transducer. 870.2840 Section 870.2840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2840 Apex...

21 CFR 870.2700 - Oximeter.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Oximeter. 870.2700 Section 870.2700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2700 Oximeter. (a) Identification. An oximeter is...

21 CFR 870.2710 - Ear oximeter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear oximeter. 870.2710 Section 870.2710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2710 Ear oximeter. (a) Identification. An ear...

21 CFR 870.2050 - Biopotential amplifier and signal conditioner.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Biopotential amplifier and signal conditioner. 870.2050 Section 870.2050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2050...

21 CFR 870.2800 - Medical magnetic tape recorder.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical magnetic tape recorder. 870.2800 Section 870.2800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2800 Medical...

21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable Intra-aneurysm Pressure Measurement System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices...

21 CFR 870.2810 - Paper chart recorder.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Paper chart recorder. 870.2810 Section 870.2810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2810 Paper chart recorder...

21 CFR 870.2640 - Portable leakage current alarm.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Portable leakage current alarm. 870.2640 Section 870.2640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2640 Portable...

21 CFR 870.2860 - Heart sound transducer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Heart sound transducer. 870.2860 Section 870.2860...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2860 Heart sound transducer. (a) Identification. A heart sound transducer is an external transducer that exhibits a change in...

21 CFR 870.2060 - Transducer signal amplifier and conditioner.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Transducer signal amplifier and conditioner. 870.2060 Section 870.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2060...

21 CFR 870.2060 - Transducer signal amplifier and conditioner.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Transducer signal amplifier and conditioner. 870.2060 Section 870.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2060...

21 CFR 870.2060 - Transducer signal amplifier and conditioner.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Transducer signal amplifier and conditioner. 870.2060 Section 870.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2060...

21 CFR 870.2060 - Transducer signal amplifier and conditioner.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Transducer signal amplifier and conditioner. 870.2060 Section 870.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2060...

21 CFR 870.2120 - Extravascular blood flow probe.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Extravascular blood flow probe. 870.2120 Section 870.2120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2120 Extravascular...

21 CFR 870.2640 - Portable leakage current alarm.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Portable leakage current alarm. 870.2640 Section 870.2640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2640 Portable...

21 CFR 870.2050 - Biopotential amplifier and signal conditioner.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Biopotential amplifier and signal conditioner. 870.2050 Section 870.2050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2050...

21 CFR 870.2870 - Catheter tip pressure transducer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Catheter tip pressure transducer. 870.2870 Section 870.2870 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2870 Catheter tip...

21 CFR 870.2850 - Extravascular blood pressure transducer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Extravascular blood pressure transducer. 870.2850 Section 870.2850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2850 Extravascular...

21 CFR 870.2810 - Paper chart recorder.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Paper chart recorder. 870.2810 Section 870.2810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2810 Paper chart recorder...

21 CFR 870.2800 - Medical magnetic tape recorder.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical magnetic tape recorder. 870.2800 Section 870.2800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2800 Medical...

21 CFR 870.2060 - Transducer signal amplifier and conditioner.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Transducer signal amplifier and conditioner. 870.2060 Section 870.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2060...

21 CFR 870.2710 - Ear oximeter.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear oximeter. 870.2710 Section 870.2710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2710 Ear oximeter. (a) Identification. An ear...

21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable Intra-aneurysm Pressure Measurement System. 870.2855 Section 870.2855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices...

21 CFR 870.2860 - Heart sound transducer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Heart sound transducer. 870.2860 Section 870.2860...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2860 Heart sound transducer. (a) Identification. A heart sound transducer is an external transducer that exhibits a change in...

21 CFR 870.2860 - Heart sound transducer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Heart sound transducer. 870.2860 Section 870.2860...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2860 Heart sound transducer. (a) Identification. A heart sound transducer is an external transducer that exhibits a change in...

21 CFR 870.2860 - Heart sound transducer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Heart sound transducer. 870.2860 Section 870.2860...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2860 Heart sound transducer. (a) Identification. A heart sound transducer is an external transducer that exhibits a change in...

21 CFR 870.2860 - Heart sound transducer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Heart sound transducer. 870.2860 Section 870.2860...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2860 Heart sound transducer. (a) Identification. A heart sound transducer is an external transducer that exhibits a change in...

21 CFR 870.2900 - Patient transducer and electrode cable (including connector).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Patient transducer and electrode cable (including connector). 870.2900 Section 870.2900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices...

21 CFR 870.2450 - Medical cathode-ray tube display.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical cathode-ray tube display. 870.2450 Section 870.2450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2450 Medical...

21 CFR 870.2450 - Medical cathode-ray tube display.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical cathode-ray tube display. 870.2450 Section 870.2450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2450 Medical...

21 CFR 870.2900 - Patient transducer and electrode cable (including connector).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Patient transducer and electrode cable (including connector). 870.2900 Section 870.2900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices...

21 CFR 870.2910 - Radiofrequency physiological signal transmitter and receiver.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Radiofrequency physiological signal transmitter and receiver. 870.2910 Section 870.2910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring...

21 CFR 870.2910 - Radiofrequency physiological signal transmitter and receiver.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiofrequency physiological signal transmitter and receiver. 870.2910 Section 870.2910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring...

Optical multichannel monitoring of skin blood pulsations for cardiovascular assessment

NASA Astrophysics Data System (ADS)

Spigulis, Janis; Erts, Renars; Ozols, Maris

2004-07-01

Time resolved detection and analysis of the skin back-scattered optical signals (reflection photoplethysmography or PPG) provide rich information on skin blood volume pulsations and can serve for cardiovascular assessment. The multichannel PPG concept has been developed and clinically verified in this work. Simultaneous data flow from several body locations allows to study the heartbeat pulse wave propagation in real time and to evaluate the vascular resistance. Portable two- and four-channel PPG monitoring devices and special software have been designed for real-time data acquisition and processing. The multi-channel devices were successfully applied for cardiovascular fitness tests and for early detection of arterial occlusions.

Translation in cardiovascular stents and occluders: From biostable to fully degradable

PubMed Central

Huang, Yingying; Wong, Yee Shan; Ng, Herr Cheun Anthony; Boey, Freddy Y. C.

2017-01-01

Abstract Cardiovascular disease is a major cause of morbidity and mortality, especially in developed countries. Most academic research efforts in cardiovascular disease management focus on pharmacological interventions, or are concerned with discovering new disease markers for diagnosis and monitoring. Nonpharmacological interventions with therapeutic devices, conversely, are driven largely by novel materials and device design. Examples of such devices include coronary stents, heart valves, ventricular assist devices, and occluders for septal defects. Until recently, development of such devices remained largely with medical device companies. We trace the materials evolution story in two of these devices (stents and occluders), while also highlighting academic contributions, including our own, to the evolution story. Specifically, it addresses not only our successes, but also the challenges facing the translatability of concepts generated via academic research. PMID:29313029

Community Engagement to Optimize the Use of Web-Based and Wearable Technology in a Cardiovascular Health and Needs Assessment Study: A Mixed Methods Approach.

PubMed

Yingling, Leah R; Brooks, Alyssa T; Wallen, Gwenyth R; Peters-Lawrence, Marlene; McClurkin, Michael; Cooper-McCann, Rebecca; Wiley, Kenneth L; Mitchell, Valerie; Saygbe, Johnetta N; Johnson, Twanda D; Curry, Rev Kendrick E; Johnson, Allan A; Graham, Avis P; Graham, Lennox A; Powell-Wiley, Tiffany M

2016-04-25

Resource-limited communities in Washington, D.C. have high rates of obesity-related cardiovascular disease in addition to inadequate physical activity (PA) facilities and limited Internet access. Engaging community members in the design and implementation of studies to address these health disparities is essential to the success of community-based PA interventions. The objective of the study was to use qualitative and quantitative methods to evaluate the feasibility and acceptability of PA-monitoring wristbands and Web-based technology by predominantly African American, church-based populations in resource-limited Washington, D.C. neighborhoods. To address cardiovascular health in at-risk populations in Washington, D.C., we joined community leaders to establish a community advisory board, the D.C. Cardiovascular Health and Obesity Collaborative (D.C. CHOC). As their first initiative, the Washington, D.C. Cardiovascular Health and Needs Assessment intends to evaluate cardiovascular health, social determinants of health, and PA-monitoring technologies. At the recommendation of D.C. CHOC members, we conducted a focus group and piloted the proposed PA-monitoring system with community members representing churches that would be targeted by the Cardiovascular Health and Needs Assessment. Participants (n=8) agreed to wear a PA-monitoring wristband for two weeks and to log cardiovascular health factors on a secure Internet account. Wristbands collected accelerometer-based data that participants uploaded to a wireless hub at their church. Participants agreed to return after two weeks to participate in a moderated focus group to share experiences using this technology. Feasibility was measured by Internet account usage, wristband utilization, and objective PA data. Acceptability was evaluated through thematic analysis of verbatim focus group transcripts. Study participants (5 males, 3 females) were African American and age 28-70 years. Participant wristbands recorded data on 10.1±1.6 days. Two participants logged cardiovascular health factors on the website. Focus group transcripts revealed that participants felt positively about incorporating the device into their church-based populations, given improvements were made to device training, hub accessibility, and device feedback. PA-monitoring wristbands for objectively measuring PA appear to be a feasible and acceptable technology in Washington, D.C., resource-limited communities. User preferences include immediate device feedback, hands-on device training, explicit instructions, improved central hub accessibility, and designation of a church member as a trained point-of-contact. When implementing technology-based interventions in resource-limited communities, engaging the targeted community may aid in early identification of issues, suggestions, and preferences. ClinicalTrials.gov NCT01927783; https://clinicaltrials.gov/ct2/show/NCT01927783 (Archived by WebCite at http://www.webcitation.org/6f8wL117u).

ISHNE/EHRA expert consensus on remote monitoring of cardiovascular implantable electronic devices (CIEDs).

PubMed

Dubner, Sergio; Auricchio, Angelo; Steinberg, Jonathan S; Vardas, Panos; Stone, Peter; Brugada, Josep; Piotrowicz, Ryszard; Hayes, David L; Kirchhof, Paulus; Breithardt, Günter; Zareba, Wojciech; Schuger, Claudio; Aktas, Mehmet K; Chudzik, Michal; Mittal, Suneet; Varma, Niraj

2012-02-01

We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices (CIEDs) with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers (IPGs), implantable cardioverter-defibrillators (ICDs), devices for cardiac resynchronization therapy (CRT) (both, with and without defibrillation properties), loop recorders, and haemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology (ISHNE) and the European Heart Rhythm Association (EHRA) combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.

Cardiovascular fitness strengthening using portable device.

PubMed

Alqudah, Hamzah; Kai Cao; Tao Zhang; Haddad, Azzam; Su, Steven; Celler, Branko; Nguyen, Hung T

2016-08-01

The paper describes a reliable and valid Portable Exercise Monitoring system developed using TI eZ430-Chronos watch, which can control the exercise intensity through audio stimulation in order to increase the Cardiovascular fitness strengthening.

Remote monitoring of cardiovascular implanted electronic devices: a paradigm shift for the 21st century.

PubMed

Cronin, Edmond M; Varma, Niraj

2012-07-01

Traditional follow-up of cardiac implantable electronic devices involves the intermittent download of largely nonactionable data. Remote monitoring represents a paradigm shift from episodic office-based follow-up to continuous monitoring of device performance and patient and disease state. This lessens device clinical burden and may also lead to cost savings, although data on economic impact are only beginning to emerge. Remote monitoring technology has the potential to improve the outcomes through earlier detection of arrhythmias and compromised device integrity, and possibly predict heart failure hospitalizations through integration of heart failure diagnostics and hemodynamic monitors. Remote monitoring platforms are also huge databases of patients and devices, offering unprecedented opportunities to investigate real-world outcomes. Here, the current status of the field is described and future directions are predicted.

Optical noninvasive monitoring of skin blood pulsations

NASA Astrophysics Data System (ADS)

Spigulis, Janis

2005-04-01

Time-resolved detection and analysis of skin backscattered optical signals (remission photoplethysmography or PPG) provide rich information on skin blood volume pulsations and can serve for reliable cardiovascular assessment. Single- and multiple-channel PPG concepts are discussed. Simultaneous data flow from several locations on the human body allows us to study heartbeat pulse-wave propagation in real time and to evaluate vascular resistance. Portable single-, dual-, and four-channel PPG monitoring devices with special software have been designed for real-time data acquisition and processing. The prototype devices have been clinically studied, and their potential for monitoring heart arrhythmias, drug-efficiency tests, steady-state cardiovascular assessment, body fitness control, and express diagnostics of the arterial occlusions has been confirmed.

Remote Monitoring of Cardiac Implantable Electronic Devices.

PubMed

Cheung, Christopher C; Deyell, Marc W

2018-01-08

Over the past decade, technological advancements have transformed the delivery of care for arrhythmia patients. From early transtelephonic monitoring to new devices capable of wireless and cellular transmission, remote monitoring has revolutionized device care. In this article, we review the current evolution and evidence for remote monitoring in patients with cardiac implantable electronic devices. From passive transmission of device diagnostics, to active transmission of patient- and device-triggered alerts, remote monitoring can shorten the time to diagnosis and treatment. Studies have shown that remote monitoring can reduce hospitalization and emergency room visits, and improve survival. Remote monitoring can also reduce the health care costs, while providing increased access to patients living in rural or marginalized communities. Unfortunately, as many as two-thirds of patients with remote monitoring-capable devices do not use, or are not offered, this feature. Current guidelines recommend remote monitoring and interrogation, combined with annual in-person evaluation in all cardiac device patients. Remote monitoring should be considered in all eligible device patients and should be considered standard of care. Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Remote monitoring for active cardiovascular implantable electronic devices: a European survey.

PubMed

Halimi, Franck; Cantù, Francesco

2010-12-01

This survey sampled today's European practices in the use of remote monitoring (RM) for the follow-up of active cardiovascular implantable electronic devices. Eighty-five per cent of the responding centres are currently using RM. For the majority, RM is expected to increase importantly within 5 years, and it has already led to a new organization of care based on dedicated allied professionals and/or the creation of RM units. There are still major limitations for the development of RM, such as ethical and legal aspects, reimbursement issues, and the lack of specific national- and European-updated guidelines which need to be informed.

Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink).

PubMed

Brachmann, Johannes; Böhm, Michael; Rybak, Karin; Klein, Gunnar; Butter, Christian; Klemm, Hanno; Schomburg, Rolf; Siebermair, Johannes; Israel, Carsten; Sinha, Anil-Martin; Drexler, Helmut

2011-07-01

The Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink (OptiLink HF) study is designed to investigate whether OptiVol fluid status monitoring with an automatically generated wireless CareAlert notification via the CareLink Network can reduce all-cause death and cardiovascular hospitalizations in an HF population, compared with standard clinical assessment. Methods Patients with newly implanted or replacement cardioverter-defibrillator devices with or without cardiac resynchronization therapy, who have chronic HF in New York Heart Association class II or III and a left ventricular ejection fraction ≤35% will be eligible to participate. Following device implantation, patients are randomized to either OptiVol fluid status monitoring through CareAlert notification or regular care (OptiLink 'on' vs. 'off'). The primary endpoint is a composite of all-cause death or cardiovascular hospitalization. It is estimated that 1000 patients will be required to demonstrate superiority of the intervention group to reduce the primary outcome by 30% with 80% power. The OptiLink HF study is designed to investigate whether early detection of congestion reduces mortality and cardiovascular hospitalization in patients with chronic HF. The study is expected to close recruitment in September 2012 and to report first results in May 2014.

The role of nanotechnology and nano and micro-electronics in monitoring and control of cardiovascular diseases and neurological disorders

NASA Astrophysics Data System (ADS)

Varadan, Vijay K.

2007-04-01

Nanotechnology has been broadly defined as the one for not only the creation of functional materials and devices as well as systems through control of matter at the scale of 1-100 nm, but also the exploitation of novel properties and phenomena at the same scale. Growing needs in the point-of-care (POC) that is an increasing market for improving patient's quality of life, are driving the development of nanotechnologies for diagnosis and treatment of various life threatening diseases. This paper addresses the recent development of nanodiagnostic sensors and nanotherapeutic devices with functionalized carbon nanotube and/or nanowire on a flexible organic thin film electronics to monitor and control of the three leading diseases namely 1) neurodegenerative diseases, 2) cardiovascular diseases, and 3) diabetes and metabolic diseases. The sensors developed include implantable and biocompatible devices, light weight wearable devices in wrist-watches, hats, shoes and clothes. The nanotherapeutics devices include nanobased drug delivery system. Many of these sensors are integrated with the wireless systems for the remote physiological monitoring. The author's research team has also developed a wireless neural probe using nanowires and nanotubes for monitoring and control of Parkinson's disease. Light weight and compact EEG, EOG and EMG monitoring system in a hat developed is capable of monitoring real time epileptic patients and patients with neurological and movement disorders using the Internet and cellular network. Physicians could be able to monitor these signals in realtime using portable computers or cell phones and will give early warning signal if these signals cross a pre-determined threshold level. In addition the potential impact of nanotechnology for applications in medicine is that, the devices can be designed to interact with cells and tissues at the molecular level, which allows high degree of functionality. Devices engineered at nanometer scale imply a controlled manipulation of individual molecules and atoms that can interact with the human body at sub-cellular level. The recent progress in microelectronics and nanosensors crates very powerful tools for the early detection and diagnosis. The nanowire integrated potassium and dopamine sensors are ideal for the monitoring and control of many cardiovascular diseases and neurological disorders. Selected movies illustrating the applications of nanodevices to patients will be shown at the talk.

Expert panel consensus recommendations for home blood pressure monitoring in Asia: the Hope Asia Network.

PubMed

Park, Sungha; Buranakitjaroen, Peera; Chen, Chen-Huan; Chia, Yook-Chin; Divinagracia, Romeo; Hoshide, Satoshi; Shin, Jinho; Siddique, Saulat; Sison, Jorge; Soenarta, Arieska Ann; Sogunuru, Guru Prasad; Tay, Jam Chin; Turana, Yuda; Wang, Ji-Guang; Zhang, Yuqing; Kario, Kazuomi

2018-04-01

Hypertension is the leading cause of mortality throughout Asia. Home blood pressure monitoring has the potential to improve hypertension control and is a useful adjunct to conventional office blood pressure measurements due to its diagnostic accuracy and prognostic value in predicting cardiovascular outcomes. At present, there are no region-specific guidelines addressing the use of home blood pressure monitoring in Asia. Therefore, an expert panel was convened to address the use of home blood pressure monitoring and develop key recommendations to help guide clinical practice throughout the Asia region. The resulting recommendations support the use of home blood pressure monitoring with a validated device as an accurate adjunct for diagnosing hypertension and predicting cardiovascular outcome. Diagnosis and treatment of hypertension should still be guided by conventional office/clinic blood pressure measurements. The expert panel encourages the incorporation of home blood pressure monitoring into local clinical guidelines and offers practical recommendations to ensure continuity of care where a validated home blood pressure device is not available.

Mobile Health Advances in Physical Activity, Fitness, and Atrial Fibrillation: Moving Hearts.

PubMed

McConnell, Michael V; Turakhia, Mintu P; Harrington, Robert A; King, Abby C; Ashley, Euan A

2018-06-12

The growing recognition that "health" takes place outside of the hospital and clinic, plus recent advances in mobile and wearable devices, have propelled the field of mobile health (mHealth). Cardiovascular disease and prevention are major opportunities for mHealth, as mobile devices can monitor key physiological signals (e.g., physical activity, heart rate and rhythm) for promoting healthy behaviors, detecting disease, and aid in ongoing care. In this review, the authors provide an update on cardiovascular mHealth by highlighting recent progress and challenges with mobile and wearable devices for assessing and promoting physical activity and fitness, and for monitoring heart rate and rhythm for the detection and management of atrial fibrillation. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink)

PubMed Central

Brachmann, Johannes; Böhm, Michael; Rybak, Karin; Klein, Gunnar; Butter, Christian; Klemm, Hanno; Schomburg, Rolf; Siebermair, Johannes; Israel, Carsten; Sinha, Anil-Martin; Drexler, Helmut

2011-01-01

Aims The Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink (OptiLink HF) study is designed to investigate whether OptiVol fluid status monitoring with an automatically generated wireless CareAlert notification via the CareLink Network can reduce all-cause death and cardiovascular hospitalizations in an HF population, compared with standard clinical assessment. Methods Patients with newly implanted or replacement cardioverter-defibrillator devices with or without cardiac resynchronization therapy, who have chronic HF in New York Heart Association class II or III and a left ventricular ejection fraction ≤35% will be eligible to participate. Following device implantation, patients are randomized to either OptiVol fluid status monitoring through CareAlert notification or regular care (OptiLink ‘on' vs. ‘off'). The primary endpoint is a composite of all-cause death or cardiovascular hospitalization. It is estimated that 1000 patients will be required to demonstrate superiority of the intervention group to reduce the primary outcome by 30% with 80% power. Conclusion The OptiLink HF study is designed to investigate whether early detection of congestion reduces mortality and cardiovascular hospitalization in patients with chronic HF. The study is expected to close recruitment in September 2012 and to report first results in May 2014. ClinicalTrials.gov Identifier: NCT00769457 PMID:21555324

Engineering studies of vectorcardiographs in blood pressure measuring systems, appendix 2

NASA Technical Reports Server (NTRS)

Mark, R. G.

1975-01-01

The development of a cardiovascular monitoring system to noninvasively monitor the blood pressure and heart rate using pulse wave velocity was described. The following topics were covered: (1) pulse wave velocity as a measure of arterial blood pressure, (2) diastolic blood pressure and pulse wave velocity in humans, (3) transducer development for blood pressure measuring device, and (4) cardiovascular monitoring system. It was found, in experiments on dogs, that the pulse wave velocity is linearly related to diastolic blood pressure over a wide range of blood pressure and in the presence of many physiological perturbations. A similar relationship was observed in normal, young human males over a moderate range of pressures. Past methods for monitoring blood pressure and a new method based on pulse wave velocity determination were described. Two systems were tested: a Doppler ultrasonic transducer and a photoelectric plethysmograph. A cardiovascular monitoring system was described, including operating instructions.

Live long and prosper: potentials of low-cost consumer devices for the prevention of cardiovascular diseases.

PubMed

Meyer, Jochen; Hein, Andreas

2013-01-01

Cardiovascular diseases (CVD) are one of the major causes of death worldwide. Personal behavior such as physical activity considerably influences the risk of incurring a CVD. In the last years numerous products such as pedometers have become available on the mass market that allow monitoring relevant behaviors and vital parameters. These devices are sufficiently precise, affordable, and easy to use. While today they are mostly lifestyle oriented they also have considerable potential for health and prevention. Our goal is to investigate how recent low-cost devices can be used in real-life settings for the prevention of CVD, and whether using these devices has an advantage over subjective self-assessment. We also examine whether it is feasible to use multiple of such devices in parallel. We observe whether and how persons are willing and able to use multiple devices in their daily lives. We compare the devices' measurements with subjective self-assessment. We make use of existing low-cost consumer devices to monitor a user's behavior. By mapping the devices' features with pre-defined prevention goals we ensure that the system collects meaningful data that can be used to monitor the individual's behavior. We conducted a user study with 10 healthy adults to measure usability and to identify problems with sensor use in real life. The participants used the devices' original portals to monitor their behavior. The subjects (age range 35-75) used an off-the-shelf pedometer and a sports watch for 4 weeks. The participants responded in principle positively to the use of the devices. Analyzing the sensor data, we found that the users had some difficulties in operating the devices. We also found that the participants' self-assessment of their health behavior was too optimistic compared to the monitored data. They rated the usability of the overall system with 71 of up to 100 points in the "System Usability Scale". Our study indicates that today's devices are suitable for a long term monitoring of health for the prevention of CVD. Using the devices provides more precise data than a subjective self-assessment. However usability and acceptance of the systems are still major topics.

Adherence with physical activity monitoring wearable devices in a community-based population: observations from the Washington, D.C., Cardiovascular Health and Needs Assessment.

PubMed

Yingling, Leah R; Mitchell, Valerie; Ayers, Colby R; Peters-Lawrence, Marlene; Wallen, Gwenyth R; Brooks, Alyssa T; Troendle, James F; Adu-Brimpong, Joel; Thomas, Samantha; Henry, JaWanna; Saygbe, Johnetta N; Sampson, Dana M; Johnson, Allan A; Graham, Avis P; Graham, Lennox A; Wiley, Kenneth L; Powell-Wiley, Tiffany

2017-12-01

Wearable mobile health (mHealth) technologies offer approaches for targeting physical activity (PA) in resource-limited, community-based interventions. We sought to explore user characteristics of PA tracking, wearable technology among a community-based population within a health and needs assessment. In 2014-2015, we conducted the Washington, D.C., Cardiovascular Health and Needs Assessment in predominantly African-American churches among communities with higher obesity rates and lower household incomes. Participants received a mHealth PA monitor and wirelessly uploaded PA data weekly to church data collection hubs. Participants (n = 99) were 59 ± 12 years, 79% female, and 99% African-American, with a mean body mass index of 33 ± 7 kg/m 2 . Eighty-one percent of participants uploaded PA data to the hub and were termed "PA device users." Though PA device users were more likely to report lower household incomes, no differences existed between device users and non-users for device ownership or technology fluency. Findings suggest that mHealth systems with a wearable device and data collection hub may feasibly target PA in resource-limited communities.

Wireless Monitoring for Patients with Cardiovascular Diseases and Parkinson's Disease.

PubMed

Kefaliakos, Antonios; Pliakos, Ioannis; Charalampidou, Martha; Diomidous, Marianna

2016-01-01

The use of applications for mobile devices and wireless sensors is common for the sector of telemedicine. Recently various studies and systems were developed in order to help patients suffering from severe diseases such as cardiovascular diseases and Parkinson's disease. They present a challenge for the sector because such systems demand the flow of accurate data in real time and the use of specialized sensors. In this review will be presented some very interesting applications developed for patients with cardiovascular diseases and Parkinson's disease.

Development of the Internet-Enabled System for Exercise Telerehabilitation and Cardiovascular Training.

PubMed

Dedov, Vadim N; Dedova, Irina V

2015-07-01

Sustained exercise training could significantly improve patient rehabilitation and management of noncommunicable diseases in the community. This study aimed to develop a universal telecare system for delivery of exercise rehabilitation and cardiovascular training services at home. An innovative bilateral leg training device was equipped with an electronic system for the ongoing measurement of training activities with the device. A single-item parameter reflecting the intensity of training was monitored using several modern telecommunication technologies. According to the application protocol, eight volunteers first tried the device for 30-60 min to determine their personal training capacity. Then, they were provided with equipment to use at home for 4 weeks. Adherence to daily training was assessed by the number of training days per week, training intensity, and duration of training sessions. The system provided reliable recording of training activities with the device using (1) long-term data logging without an ongoing connection to the computer, (2) wireless monitoring and recording of training activities on a stand-alone computer, and (3) a secure cloud-based monitoring over the Internet connection using electronic devices, including smartphones. Overall analysis of recordings and phone feedbacks to participants took only approximately 5 h for the duration of study. This study, although of a pilot nature, described the comprehensive exercise telerehabilitation system integrating mobile training equipment with personalized training protocols and remote monitoring. A single-item electronic parameter of the system usage facilitated time-effective data management. Wireless connection allowed various locations of device application and several monitoring arrangements ranging from real-time monitoring to long-term recording of exercise activities. A cloud-based software platform enabled management of multiple users at distance. Implementation of this model may facilitate both accessibility and availability of personalized exercise telerehabilitation services. Further studies would validate it in the clinical and healthcare environment.

Optical multichannel sensing of skin blood pulsations

NASA Astrophysics Data System (ADS)

Spigulis, Janis; Erts, Renars; Kukulis, Indulis; Ozols, Maris; Prieditis, Karlis

2004-09-01

Time resolved detection and analysis of the skin back-scattered optical signals (reflection photoplethysmography or PPG) provide information on skin blood volume pulsations and can serve for cardiovascular assessment. The multi-channel PPG concept has been developed and clinically verified in this study. Portable two- and four-channel PPG monitoring devices have been designed for real-time data acquisition and processing. The multi-channel devices were successfully applied for cardiovascular fitness tests and for early detection of arterial occlusions in extremities. The optically measured heartbeat pulse wave propagation made possible to estimate relative arterial resistances for numerous patients and healthy volunteers.

Labview Based ECG Patient Monitoring System for Cardiovascular Patient Using SMTP Technology.

PubMed

Singh, Om Prakash; Mekonnen, Dawit; Malarvili, M B

2015-01-01

This paper leads to developing a Labview based ECG patient monitoring system for cardiovascular patient using Simple Mail Transfer Protocol technology. The designed device has been divided into three parts. First part is ECG amplifier circuit, built using instrumentation amplifier (AD620) followed by signal conditioning circuit with the operation amplifier (lm741). Secondly, the DAQ card is used to convert the analog signal into digital form for the further process. Furthermore, the data has been processed in Labview where the digital filter techniques have been implemented to remove the noise from the acquired signal. After processing, the algorithm was developed to calculate the heart rate and to analyze the arrhythmia condition. Finally, SMTP technology has been added in our work to make device more communicative and much more cost-effective solution in telemedicine technology which has been key-problem to realize the telediagnosis and monitoring of ECG signals. The technology also can be easily implemented over already existing Internet.

Labview Based ECG Patient Monitoring System for Cardiovascular Patient Using SMTP Technology

PubMed Central

Singh, Om Prakash; Mekonnen, Dawit; Malarvili, M. B.

2015-01-01

This paper leads to developing a Labview based ECG patient monitoring system for cardiovascular patient using Simple Mail Transfer Protocol technology. The designed device has been divided into three parts. First part is ECG amplifier circuit, built using instrumentation amplifier (AD620) followed by signal conditioning circuit with the operation amplifier (lm741). Secondly, the DAQ card is used to convert the analog signal into digital form for the further process. Furthermore, the data has been processed in Labview where the digital filter techniques have been implemented to remove the noise from the acquired signal. After processing, the algorithm was developed to calculate the heart rate and to analyze the arrhythmia condition. Finally, SMTP technology has been added in our work to make device more communicative and much more cost-effective solution in telemedicine technology which has been key-problem to realize the telediagnosis and monitoring of ECG signals. The technology also can be easily implemented over already existing Internet. PMID:27006940

Remote monitoring of heart failure: benefits for therapeutic decision making.

PubMed

Martirosyan, Mihran; Caliskan, Kadir; Theuns, Dominic A M J; Szili-Torok, Tamas

2017-07-01

Chronic heart failure is a cardiovascular disorder with high prevalence and incidence worldwide. The course of heart failure is characterized by periods of stability and instability. Decompensation of heart failure is associated with frequent and prolonged hospitalizations and it worsens the prognosis for the disease and increases cardiovascular mortality among affected patients. It is therefore important to monitor these patients carefully to reveal changes in their condition. Remote monitoring has been designed to facilitate an early detection of adverse events and to minimize regular follow-up visits for heart failure patients. Several new devices have been developed and introduced to the daily practice of cardiology departments worldwide. Areas covered: Currently, special tools and techniques are available to perform remote monitoring. Concurrently there are a number of modern cardiac implantable electronic devices that incorporate a remote monitoring function. All the techniques that have a remote monitoring function are discussed in this paper in detail. All the major studies on this subject have been selected for review of the recent data on remote monitoring of HF patients and demonstrate the role of remote monitoring in the therapeutic decision making for heart failure patients. Expert commentary: Remote monitoring represents a novel intensified follow-up strategy of heart failure management. Overall, theoretically, remote monitoring may play a crucial role in the early detection of heart failure progression and may improve the outcome of patients.

Optical non-invasive monitoring of skin blood pulsations

NASA Astrophysics Data System (ADS)

Spīgulis, Jānis

2005-08-01

Time resolved detection and analysis of the skin backscattered optical signals (remission photoplethysmography or PPG) provide rich information on skin blood volume pulsations and can serve for reliable cardiovascular assessment. The single- and multi-channel PPG concepts are discussed in this work. Simultaneous data flow from several body locations allows one to study the heartbeat pulse wave propagation in real time and evaluate the vascular resistance. Portable single-, dual- and four-channel PPG monitoring devices with special software have been designed for real-time data acquisition and processing. The clinical studies confirmed their potential in the monitoring of heart arrhythmias, drug tests, steady-state cardiovascular assessment, body fitness control, and express diagnostics of the arterial occlusions.

A review on remote monitoring technology applied to implantable electronic cardiovascular devices.

PubMed

Costa, Paulo Dias; Rodrigues, Pedro Pereira; Reis, António Hipólito; Costa-Pereira, Altamiro

2010-12-01

Implantable electronic cardiovascular devices (IECD) include a broad spectrum of devices that have the ability to maintain rhythm, provide cardiac resynchronization therapy, and/or prevent sudden cardiac death. The incidence of bradyarrhythmias and other cardiac problems led to a broader use of IECD, which turned traditional follow-up into an extremely heavy burden for healthcare systems to support. Our aim was to assess the impact of remote monitoring on the follow-up of patients with IECD. We performed a review through PubMed using a specific query. The paper selection process included a three-step approach in which title, abstract, and cross-references were analyzed. Studies were then selected using previously defined inclusion criteria and analyzed according to the country of origin of the study, year, and journal of publication; type of study; and main issues covered. Twenty articles were included in this review. Eighty percent of the selected papers addressed clinical issues, from which 94% referred clinical events identification, clinical stability, time savings, or physician satisfaction as advantages, whereas 38% referred disadvantages that included both legal and technical issues. Forty-five percent of the papers referred patient issues, from which 89% presented advantages, focusing on patient acceptance/satisfaction, and patient time-savings. The main downsides were technical issues but patient privacy was also addressed. All the papers dealing with economic issues (20%) referred both advantages and disadvantages equally. Remote monitoring is presently a safe technology, widely accepted by patients and physicians, for its convenience, reassurance, and diagnostic potential. This review summarizes the principles of remote IECD monitoring presenting the current state-of-the-art. Patient safety and device interaction, applicability of current technology, and limitations of remote IECD monitoring are also addressed. The use of remote monitor should consider the selection of patients, the type of disease, and centers' availability to receive, interpret and respond to device alerts. Before remote IECD monitoring can be routinely used, technical, procedure, and ethical/legal issues should be addressed.

Patient perspective on remote monitoring of cardiovascular implantable electronic devices: rationale and design of the REMOTE-CIED study.

PubMed

Versteeg, H; Pedersen, S S; Mastenbroek, M H; Redekop, W K; Schwab, J O; Mabo, P; Meine, M

2014-10-01

Remote patient monitoring is a safe and effective alternative for the in-clinic follow-up of patients with cardiovascular implantable electronic devices (CIEDs). However, evidence on the patient perspective on remote monitoring is scarce and inconsistent. The primary objective of the REMOTE-CIED study is to evaluate the influence of remote patient monitoring versus in-clinic follow-up on patient-reported outcomes. Secondary objectives are to: 1) identify subgroups of patients who may not be satisfied with remote monitoring; and 2) investigate the cost-effectiveness of remote monitoring. The REMOTE-CIED study is an international randomised controlled study that will include 900 consecutive heart failure patients implanted with an implantable cardioverter defibrillator (ICD) compatible with the Boston Scientific LATITUDE® Remote Patient Management system at participating centres in five European countries. Patients will be randomised to remote monitoring or in-clinic follow-up. The In-Clinic group will visit the outpatient clinic every 3-6 months, according to standard practice. The Remote Monitoring group only visits the outpatient clinic at 12 and 24 months post-implantation, other check-ups are performed remotely. Patients are asked to complete questionnaires at five time points during the 2-year follow-up. The REMOTE-CIED study will provide insight into the patient perspective on remote monitoring in ICD patients, which could help to support patient-centred care in the future.

Wearable photoplethysmography device prototype for wireless cardiovascular monitoring

NASA Astrophysics Data System (ADS)

Kviesis-Kipge, E.; Grabovskis, A.; Marcinkevics, Z.; Mecnika, V.; Rubenis, O.

2014-05-01

The aim of the study was to develop a prototype system of the smart garment for real time telemetric monitoring of human cardiovascular activity. Two types of photoplethysmography (PPG) sensors for low noise and artefact free signal recording from various sites of the human body that were suitable for integration into smart textile were investigated. The reflectance sensors with single and multiple photodiodes based on "pulse-duration-based signal conversion" signal acquisition principle were designed and evaluated. The technical parameters of the system were measured both on bench and in vivo. Overall, both types of PPG sensors showed acceptable signal quality SNR 86.56±3.00 dB, dynamic range 89.84 dB. However, in-vivo condition tests revealed lower noise and higher accuracy achieved by applying the multiple photodiodes sensor. We concluded that the proposed PPG device prototype is simple and reliable, and therefore, can be utilized in low-cost smart garments.

Cardiac or Other Implantable Electronic Devices and Sleep-disordered Breathing – Implications for Diagnosis and Therapy

PubMed Central

Bitter, Thomas; Gutleben, Klaus-Jürgen; Horstkotte, Dieter; Oldenburg, Olaf

2014-01-01

Sleep-disordered breathing (SDB) is of growing interest in cardiology because SDB is a highly prevalent comorbidity in patients with a variety of cardiovascular diseases. The prevalence of SDB is particularly high in patients with cardiac dysrhythmias and/or heart failure. In this setting, many patients now have implantable cardiac devices, such as pacemakers, implantable cardioverter-defibrillators or implanted cardiac resynchronisation therapy devices (CRT). Treatment of SDB using implantable cardiac devices has been studied previously, with atrial pacing and CRT being shown not to bring about satisfactory results in SDB care. The latest generations of these devices have the capacity to determine transthoracic impedance, to detect and quantify breathing efforts and to identify SDB. The capability of implantable cardiac devices to detect SDB is of potential importance for patients with cardiovascular disease, allowing screening for SDB, monitoring of the course of SDB in relation to cardiac status, and documenting of the effects of treatment. PMID:26835077

Cardiac or Other Implantable Electronic Devices and Sleep-disordered Breathing - Implications for Diagnosis and Therapy.

PubMed

Fox, Henrik; Bitter, Thomas; Gutleben, Klaus-Jürgen; Horstkotte, Dieter; Oldenburg, Olaf

2014-08-01

Sleep-disordered breathing (SDB) is of growing interest in cardiology because SDB is a highly prevalent comorbidity in patients with a variety of cardiovascular diseases. The prevalence of SDB is particularly high in patients with cardiac dysrhythmias and/or heart failure. In this setting, many patients now have implantable cardiac devices, such as pacemakers, implantable cardioverter-defibrillators or implanted cardiac resynchronisation therapy devices (CRT). Treatment of SDB using implantable cardiac devices has been studied previously, with atrial pacing and CRT being shown not to bring about satisfactory results in SDB care. The latest generations of these devices have the capacity to determine transthoracic impedance, to detect and quantify breathing efforts and to identify SDB. The capability of implantable cardiac devices to detect SDB is of potential importance for patients with cardiovascular disease, allowing screening for SDB, monitoring of the course of SDB in relation to cardiac status, and documenting of the effects of treatment.

Emerging role of digital technology and remote monitoring in the care of cardiac patients.

PubMed

Banchs, Javier E; Scher, David Lee

2015-07-01

Current available mobile health technologies make possible earlier diagnosis and long-term monitoring of patients with cardiovascular diseases. Remote monitoring of patients with implantable devices and chronic diseases has resulted in better outcomes reducing health care costs and hospital admissions. New care models, which shift point of care to the outpatient setting and the patient's home, necessitate innovations in technology. Copyright © 2015 Elsevier Inc. All rights reserved.

Guidance on home blood pressure monitoring: A statement of the HOPE Asia Network.

PubMed

Kario, Kazuomi; Park, Sungha; Buranakitjaroen, Peera; Chia, Yook-Chin; Chen, Chen-Huan; Divinagracia, Romeo; Hoshide, Satoshi; Shin, Jinho; Siddique, Saulat; Sison, Jorge; Soenarta, Arieska Ann; Sogunuru, Guru Prasad; Tay, Jam Chin; Turana, Yuda; Wong, Lawrence; Zhang, Yuqing; Wang, Ji-Guang

2018-03-01

Hypertension is an important modifiable cardiovascular risk factor and a leading cause of death throughout Asia. Effective prevention and control of hypertension in the region remain a significant challenge despite the availability of several regional and international guidelines. Out-of-office measurement of blood pressure (BP), including home BP monitoring (HBPM), is an important hypertension management tool. Home BP is better than office BP for predicting cardiovascular risk and HBPM should be considered for all patients with office BP ≥ 130/85 mm Hg. It is important that HBPM is undertaken using a validated device and patients are educated about how to perform HBPM correctly. During antihypertensive therapy, monitoring of home BP control and variability is essential, especially in the morning. This is because HBPM can facilitate the choice of individualized optimal therapy. The evidence and practice points in this document are based on the Hypertension Cardiovascular Outcome Prevention and Evidence (HOPE) Asia Network expert panel consensus recommendations for HBPM in Asia. ©2018 Wiley Periodicals, Inc.

Research and Development of Information and Communication Technology-based Home Blood Pressure Monitoring from Morning to Nocturnal Hypertension.

PubMed

Kario, Kazuomi; Tomitani, Naoko; Matsumoto, Yuri; Hamasaki, Haruna; Okawara, Yukie; Kondo, Maiko; Nozue, Ryoko; Yamagata, Hiromi; Okura, Ayako; Hoshide, Satoshi

2016-01-01

Asians have specific characteristics of hypertension (HTN) and its relationship with cardiovascular disease. The morning surge in blood pressure (BP) in Asians is more extended, and the association slope between higher BP and the risk for cardiovascular events is steeper in this population than in whites. Thus, 24-hour BP control including at night and in the morning is especially important for Asian patients with HTN. There are 3 components of "perfect 24-hour BP control": the 24-hour BP level, adequate dipping of nocturnal BP (dipper type), and adequate BP variability such as the morning BP surge. The morning BP-guided approach using home BP monitoring (HBPM) is the first step toward perfect 24-hour BP control. After controlling morning HTN, nocturnal HTN is the second target. We have been developing HBPM that can measure nocturnal BP. First, we developed a semiautomatic HBPM device with the function of automatic fixed-interval BP measurement during sleep. In the J-HOP (Japan Morning Surge Home Blood Pressure) study, the largest nationwide home BP cohort, we successfully measured nocturnal home BP using this device with data memory, 3 times during sleep (2, 3, and 4 am), and found that nocturnal home BP is significantly correlated with organ damage independently of office and morning BP values. The second advance was the development of trigger nocturnal BP (TNP) monitoring with an added trigger function that initiates BP measurements when oxygen desaturation falls below a variable threshold continuously monitored by pulse oximetry. TNP can detect the specific nocturnal BP surges triggered by hypoxic episodes in patients with sleep apnea syndrome. We also added the lowest heart rate-trigger function to TNP to detect the "basal nocturnal BP," which is determined by the circulating volume and structural cardiovascular system without any increase in sympathetic tonus. This double TNP is a novel concept for evaluating the pathogenic pressor mechanism of nocturnal BP. These data are now collected using an information and communication technology (ICT)-based monitoring system. The BP variability includes different time-phase variability from the shortest beat-by-beat, positional, diurnal, day-by-day, visit-to-visit, seasonal, and the longest yearly changes. The synergistic resonance of each type of BP variability would produce great dynamic BP surges, which trigger cardiovascular events. Thus, in the future, the management of HTN based on the simultaneous assessment of the resonance of all of the BP variability phenotypes using a wearable "surge" BP monitoring device with an ICT-based data analysis system will contribute to the ultimate individualized medication for cardiovascular disease. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Plastics and cardiovascular health: phthalates may disrupt heart rate variability and cardiovascular reactivity.

PubMed

Jaimes, Rafael; Swiercz, Adam; Sherman, Meredith; Muselimyan, Narine; Marvar, Paul J; Posnack, Nikki Gillum

2017-11-01

Plastics have revolutionized medical device technology, transformed hematological care, and facilitated modern cardiology procedures. Despite these advances, studies have shown that phthalate chemicals migrate out of plastic products and that these chemicals are bioactive. Recent epidemiological and research studies have suggested that phthalate exposure adversely affects cardiovascular function. Our objective was to assess the safety and biocompatibility of phthalate chemicals and resolve the impact on cardiovascular and autonomic physiology. Adult mice were implanted with radiofrequency transmitters to monitor heart rate variability, blood pressure, and autonomic regulation in response to di-2-ethylhexyl-phthalate (DEHP) exposure. DEHP-treated animals displayed a decrease in heart rate variability (-17% SD of normal beat-to-beat intervals and -36% high-frequency power) and an exaggerated mean arterial pressure response to ganglionic blockade (31.5% via chlorisondamine). In response to a conditioned stressor, DEHP-treated animals displayed enhanced cardiovascular reactivity (-56% SD major axis Poincarè plot) and prolonged blood pressure recovery. Alterations in cardiac gene expression of endothelin-1, angiotensin-converting enzyme, and nitric oxide synthase may partly explain these cardiovascular alterations. This is the first study to show an association between phthalate chemicals that are used in medical devices with alterations in autonomic regulation, heart rate variability, and cardiovascular reactivity. Because changes in autonomic balance often precede clinical manifestations of hypertension, atherosclerosis, and conduction abnormalities, future studies are warranted to assess the downstream impact of plastic chemical exposure on end-organ function in sensitive patient populations. This study also highlights the importance of adopting safer biomaterials, chemicals, and/or surface coatings for use in medical devices. NEW & NOTEWORTHY Phthalates are widely used in the manufacturing of consumer and medical products. In the present study, di-2-ethylhexyl-phthalate exposure was associated with alterations in heart rate variability and cardiovascular reactivity. This highlights the importance of investigating the impact of phthalates on health and identifying suitable alternatives for medical device manufacturing. Copyright © 2017 the American Physiological Society.

A Device for Fetal Monitoring by Means of Control Over Cardiovascular Parameters Based on Acoustic Data

NASA Astrophysics Data System (ADS)

Khokhlova, L. A.; Seleznev, A. I.; Zhdanov, D. S.; Zemlyakov, I. Yu; Kiseleva, E. Yu

2016-01-01

The problem of monitoring fetal health is topical at the moment taking into account a reduction in the level of fertile-age women's health and changes in the concept of perinatal medicine with reconsideration of live birth criteria. Fetal heart rate monitoring is a valuable means of assessing fetal health during pregnancy. The routine clinical measurements are usually carried out by the means of ultrasound cardiotocography. Although the cardiotocography monitoring provides valuable information on the fetal health status, the high quality ultrasound devices are expensive, they are not available for home care use. The recommended number of measurement is also limited. The passive and fully non-invasive acoustic recording provides an alternative low-cost measurement method. The article describes a device for fetal and maternal health monitoring by analyzing the frequency and periodicity of heart beats by means of acoustic signal received on the maternal abdomen. Based on the usage of this device a phonocardiographic fetal telemedicine system, which will allow to reduce the antenatal fetal mortality rate significantly due to continuous monitoring over the state of fetus regardless of mother's location, can be built.

Portable microfluidic and smartphone-based devices for monitoring of cardiovascular diseases at the point of care.

PubMed

Hu, Jie; Cui, Xingye; Gong, Yan; Xu, Xiayu; Gao, Bin; Wen, Ting; Lu, Tian Jian; Xu, Feng

2016-01-01

Cardiovascular diseases (CVDs) are the main causes of morbidity and mortality in the world where about 4 in every 5 CVD deaths happen in low- and middle-income countries (LMICs). Most CVDs are preventable and curable, which is largely dependent on timely and effective interventions, including diagnosis, prognosis and therapeutic monitoring. However, these interventions are high-cost in high income countries and are usually lacking in LMICs. Thanks to the rapid development of microfluidics and nanotechnology, lots of portable analytical devices are developed for detection of CVDs at the point-of-care (POC). In the meantime, smartphone, as a versatile and powerful handheld tool, has been employed not only as a reader for microfluidic assays, but also as an analyzer for physiological indexes. In this review, we present a comprehensive introduction of the current status and potential development direction on POC diagnostics for CVDs. First of all, we introduce some main facts about CVDs and their standard diagnostic procedures and methods. Second, we discuss about both commercially available POC devices and developed prototypes for detection of CVDs via immunoassays. Subsequently, we report the advances in smartphone-based readout for microfluidic assays. Finally, we present some examples using smartphone, individually or combined with other components or devices, for CVD monitoring. We envision an integrated smartphone-based system capable of functioning blood tests, disease examination, and imaging will come in the future. Copyright © 2016 Elsevier Inc. All rights reserved.

Bioreactors as engineering support to treat cardiac muscle and vascular disease.

PubMed

Massai, Diana; Cerino, Giulia; Gallo, Diego; Pennella, Francesco; Deriu, Marco A; Rodriguez, Andres; Montevecchi, Franco M; Bignardi, Cristina; Audenino, Alberto; Morbiducci, Umberto

2013-01-01

Cardiovascular disease is the leading cause of morbidity and mortality in the Western World. The inability of fully differentiated, load-bearing cardiovascular tissues to in vivo regenerate and the limitations of the current treatment therapies greatly motivate the efforts of cardiovascular tissue engineering to become an effective clinical strategy for injured heart and vessels. For the effective production of organized and functional cardiovascular engineered constructs in vitro, a suitable dynamic environment is essential, and can be achieved and maintained within bioreactors. Bioreactors are technological devices that, while monitoring and controlling the culture environment and stimulating the construct, attempt to mimic the physiological milieu. In this study, a review of the current state of the art of bioreactor solutions for cardiovascular tissue engineering is presented, with emphasis on bioreactors and biophysical stimuli adopted for investigating the mechanisms influencing cardiovascular tissue development, and for eventually generating suitable cardiovascular tissue replacements.

Clinical and economic impact of remote monitoring on the follow-up of patients with implantable electronic cardiovascular devices: an observational study.

PubMed

Costa, Paulo Dias; Reis, A Hipólito; Rodrigues, Pedro P

2013-02-01

Traditional follow-up of patients with cardiovascular devices is still an activity that, in addition to serving an increasing population, requires a considerable amount of time and specialized human and technical resources. Our aim was to evaluate the applicability of the CareLink(®) (Medtronic, Minneapolis, MN) remote monitoring system as a complementary option to the follow-up of patients with implanted devices, between in-office visits. Evaluated outcomes included both clinical (event detection and time to diagnosis) and nonclinical (patient's satisfaction and economic costs) aspects. An observational, longitudinal, prospective study was conducted with patients from a Portuguese central hospital sampled by convenience during 1 week (43 patients). Data were collected in four moments: two in-office visits and two remote evaluations, reproducing 1 year of clinical follow-up. Data sources included health records, implant reports, initial demographic data collection, follow-up printouts, and a questionnaire. After selection criteria were verified, 15 patients (11 men [73%]) were included, 63.4±10.8 years old, representing 14.0±6.3 implant months. Clinically, 15 events were detected (9 by remote monitoring and 6 by patient-initiated activation), of which only 9 were symptomatic. We verified that remote monitoring could detect both symptomatic and asymptomatic events, whereas patient-initiated activation only detected symptomatic ones (p=0.028). Moreover, the mean diagnosis anticipation in patients with events was approximately 58 days (p<0.001). In nonclinical terms, we observed high or very high satisfaction (67% and 33%, respectively) with using remote monitoring technology, but still 8 patients (53%) stated they preferred in-office visits. Finally, the introduction of remote monitoring technology has the ability to reduce total follow-up costs for patients by 25%. We conclude that the use of this system constitutes a viable complementary option to the follow-up of patients with implantable devices, between in-office visits.

THE FUTURE OF MOBILE HEALTH APPLICATIONS AND DEVICES IN CARDIOVASCULAR HEALTH.

PubMed

Kelli, Heval Mohamed; Witbrodt, Bradley; Shah, Amit

2017-01-01

Mobile health (mHealth) is the utilisation of mobile technologies in healthcare and has particular relevance in improving lifestyle behaviours which may ultimately reduce cardiovascular disease risk. Various intervention studies for example integrate self-monitoring of diet and physical activity with text messaging systems to improve intermediate outcomes. Currently the future progress of mHealth technologies in formal diagnostic and therapeutic roles is pending and includes the need to validate and standardise accelerometer and heart rate data from various devices. Data also needs to be integrated from such devices into the medical record system to facilitate communication between providers and patients. Although short-term behaviour changes have been found with technologies such as Fitbit® (Fitbit, Inc., San Francisco, California, USA), whether such technologies/interventions lead to sustained behaviour change and reduced risk of myocardial infarction and death remains to be seen.

21 CFR 870.4500 - Cardiovascular surgical instruments.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiovascular surgical instruments. 870.4500... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4500 Cardiovascular surgical instruments. (a) Identification. Cardiovascular surgical instruments are surgical instruments that...

21 CFR 870.4500 - Cardiovascular surgical instruments.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiovascular surgical instruments. 870.4500... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4500 Cardiovascular surgical instruments. (a) Identification. Cardiovascular surgical instruments are surgical instruments that...

Detection of essential hypertension with physiological signals from wearable devices.

PubMed

Ghosh, Arindam; Torres, Juan Manuel Mayor; Danieli, Morena; Riccardi, Giuseppe

2015-08-01

Early detection of essential hypertension can support the prevention of cardiovascular disease, a leading cause of death. The traditional method of identification of hypertension involves periodic blood pressure measurement using brachial cuff-based measurement devices. While these devices are non-invasive, they require manual setup for each measurement and they are not suitable for continuous monitoring. Research has shown that physiological signals such as Heart Rate Variability, which is a measure of the cardiac autonomic activity, is correlated with blood pressure. Wearable devices capable of measuring physiological signals such as Heart Rate, Galvanic Skin Response, Skin Temperature have recently become ubiquitous. However, these signals are not accurate and are prone to noise due to different artifacts. In this paper a) we present a data collection protocol for continuous non-invasive monitoring of physiological signals from wearable devices; b) we implement signal processing techniques for signal estimation; c) we explore how the continuous monitoring of these physiological signals can be used to identify hypertensive patients; d) We conduct a pilot study with a group of normotensive and hypertensive patients to test our techniques. We show that physiological signals extracted from wearable devices can distinguish between these two groups with high accuracy.

Community-Based ECG Monitoring System for Patients with Cardiovascular Diseases.

PubMed

Lin, Bor-Shyh; Wong, Alice M; Tseng, Kevin C

2016-04-01

This study aims to develop a community-based electrocardiogram (ECG) monitoring system for cardiac outpatients to wirelessly detect heart rate, provide personalized healthcare, and enhance interactive social contact because of the prevalence of deaths from cardiovascular disease and the growing problem of aging in the world. The system not only strengthens the performance of the ECG monitoring system but also emphasizes the ergonomic design of wearable devices and user interfaces. In addition, it enables medical professionals to diagnose cardiac symptoms remotely and electronically manage medical reports and suggestions. The experimental result shows high performance of the dry electrode, even in dynamic conditions. The comparison result with different ECG healthcare systems shows the essential factors that the system should possess and the capability of the proposed system. Finally, a user survey was conducted based on the unified theory of acceptance and users of technology (UTAUT) model.

A fully automated health-care monitoring at home without attachment of any biological sensors and its clinical evaluation.

PubMed

Motoi, Kosuke; Ogawa, Mitsuhiro; Ueno, Hiroshi; Kuwae, Yutaka; Ikarashi, Akira; Yuji, Tadahiko; Higashi, Yuji; Tanaka, Shinobu; Fujimoto, Toshiro; Asanoi, Hidetsugu; Yamakoshi, Ken-ichi

2009-01-01

Daily monitoring of health condition is important for an effective scheme for early diagnosis, treatment and prevention of lifestyle-related diseases such as adiposis, diabetes, cardiovascular diseases and other diseases. Commercially available devices for health care monitoring at home are cumbersome in terms of self-attachment of biological sensors and self-operation of the devices. From this viewpoint, we have been developing a non-conscious physiological monitor installed in a bath, a lavatory, and a bed for home health care and evaluated its measurement accuracy by simultaneous recordings of a biological sensors directly attached to the body surface. In order to investigate its applicability to health condition monitoring, we have further developed a new monitoring system which can automatically monitor and store the health condition data. In this study, by evaluation on 3 patients with cardiac infarct or sleep apnea syndrome, patients' health condition such as body and excretion weight in the toilet and apnea and hypopnea during sleeping were successfully monitored, indicating that the system appears useful for monitoring the health condition during daily living.

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

PubMed

Bates, Katherine E; Vetter, Victoria L; Li, Jennifer S; Cummins, Susan; Aguel, Fernando; Almond, Christopher; Dubin, Anne M; Elia, Josephine; Finkle, John; Hausner, Elizabeth A; Joseph, Francesca; Karkowsky, Abraham M; Killeen, Matthew; Lemacks, Jodi; Mathis, Lisa; McMahon, Ann W; Pinnow, Ellen; Rodriguez, Ignacio; Stockbridge, Norman L; Stockwell, Margaret; Tassinari, Melissa; Krucoff, Mitchell W

2012-10-01

Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to designing clinical trials. This article summarizes the discussions that occurred at a Cardiac Safety Research Consortium-sponsored Think Tank convened on December 10, 2010, where members from academia, industry, and regulatory agencies discussed important issues regarding pediatric cardiovascular safety of medications and cardiovascular devices. Pediatric drug and device development may use adult data but often requires additional preclinical and clinical testing to characterize effects on cardiac function and development. Challenges in preclinical trials include identifying appropriate animal models, clinically relevant efficacy end points, and methods to monitor cardiovascular safety. Pediatric clinical trials have different ethical concerns from adult trials, including consideration of the subjects' families. Clinical trial design in pediatrics should assess risks and benefits as well as incorporate input from families. Postmarketing surveillance, mandated by federal law, plays an important role in both drug and device safety assessment and becomes crucial in the pediatric population because of the limitations of premarketing pediatric studies. Solutions for this wide array of issues will require collaboration between academia, industry, and government as well as creativity in pediatric study design. Formation of various epidemiologic tools including registries to describe outcomes of pediatric cardiac disease and its treatment as well as cardiac effects of noncardiovascular medications, should inform preclinical and clinical development and improve benefit-risk assessments for the patients. The discussions in this article summarize areas of emerging consensus and other areas in which consensus remains elusive and provide suggestions for additional research to further our knowledge and understanding of this topic. Copyright © 2012 Mosby, Inc. All rights reserved.

77 FR 48160 - Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

...] Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request for Comments... Cardiovascular Devices 30-Day Notices and Annual Reports.'' This public workshop will be cosponsored with... approval applications (PMAs), 30-day notices and annual reports, specifically for cardiovascular devices...

75 FR 47819 - Workshop on Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-09

...] Workshop on Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices AGENCY... (AAP), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and... Development of Pediatric Cardiovascular Devices.'' The topic to be discussed is pediatric cardiovascular...

75 FR 5335 - Workshop on Pediatric Neurological and Neurocognitive Assessments for Cardiovascular Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-02

...] Workshop on Pediatric Neurological and Neurocognitive Assessments for Cardiovascular Devices; Public... Neurocognitive Assessments for Cardiovascular Devices.'' The purpose of the public workshop is to solicit... various neurological and neurocognitive assessments for pediatric patients implanted with cardiovascular...

[Telemetry in the clinical setting].

PubMed

Hilbel, Thomas; Helms, Thomas M; Mikus, Gerd; Katus, Hugo A; Zugck, Christian

2008-09-01

Telemetric cardiac monitoring was invented in 1949 by Norman J Holter. Its clinical use started in the early 1960s. In the hospital, biotelemetry allows early mobilization of patients with cardiovascular risk and addresses the need for arrhythmia or oxygen saturation monitoring. Nowadays telemetry either uses vendor-specific UHF band broadcasting or the digital ISM band (Industrial, Scientific, and Medical Band) standardized Wi-Fi network technology. Modern telemetry radio transmitters can measure and send multiple physiological parameters like multi-channel ECG, NIPB and oxygen saturation. The continuous measurement of oxygen saturation is mandatory for the remote monitoring of patients with cardiac pacemakers. Real 12-lead ECG systems with diagnostic quality are an advantage for monitoring patients with chest pain syndromes or in drug testing wards. Modern systems are light-weight and deliver a maximum of carrying comfort due to optimized cable design. Important for the system selection is a sophisticated detection algorithm with a maximum reduction of artifacts. Home-monitoring of implantable cardiac devices with telemetric functionalities are becoming popular because it allows remote diagnosis of proper device functionality and also optimization of the device settings. Continuous real-time monitoring at home for patients with chronic disease may be possible in the future using Digital Video Broadcasting Terrestrial (DVB-T) technology in Europe, but is currently not yet available.

Noninvasive Hemodynamic Measurements During Neurosurgical Procedures in Sitting Position.

PubMed

Schramm, Patrick; Tzanova, Irene; Gööck, Tilman; Hagen, Frank; Schmidtmann, Irene; Engelhard, Kristin; Pestel, Gunther

2017-07-01

Neurosurgical procedures in sitting position need advanced cardiovascular monitoring. Transesophageal echocardiography (TEE) to measure cardiac output (CO)/cardiac index (CI) and stroke volume (SV), and invasive arterial blood pressure measurements for systolic (ABPsys), diastolic (ABPdiast) and mean arterial pressure (MAP) are established monitoring technologies for these kind of procedures. A noninvasive device for continuous monitoring of blood pressure and CO based on a modified Penaz technique (volume-clamp method) was introduced recently. In the present study the noninvasive blood pressure measurements were compared with invasive arterial blood pressure monitoring, and the noninvasive CO monitoring to TEE measurements. Measurements of blood pressure and CO were performed in 35 patients before/after giving a fluid bolus and a change from supine to sitting position, start of surgery, and repositioning from sitting to supine at the end of surgery. Data pairs from the noninvasive device (Nexfin HD) versus arterial line measurements (ABPsys, ABPdiast, MAP) and versus TEE (CO, CI, SV) were compared using Bland-Altman analysis and percentage error. All parameters compared (CO, CI, SV, ABPsys, ABPdiast, MAP) showed a large bias and wide limits of agreement. Percentage error was above 30% for all parameters except ABPsys. The noninvasive device based on a modified Penaz technique cannot replace arterial blood pressure monitoring or TEE in anesthetized patients undergoing neurosurgery in sitting position.

Sticker-type ECG/PPG concurrent monitoring system hybrid integration of CMOS SoC and organic sensor device.

PubMed

Yongsu Lee; Hyeonwoo Lee; Seunghyup Yoo; Hoi-Jun Yoo

2016-08-01

The sticker-type sensor system is proposed targeting ECG/PPG concurrent monitoring for cardiovascular diseases. The stickers are composed of two types: Hub and Sensor-node (SN) sticker. Low-power CMOS SoC for measuring ECG and PPG signal is hybrid integrated with organic light emitting diodes (OLEDs) and organic photo detector (OPD). The sticker has only 2g weight and only consumes 141μW. The optical calibration loop is adopted for maintaining SNR of PPG signal higher than 30dB. The pulse arrival time (PAT) and SpO2 value can be extracted from various body parts and verified comparing with the reference device from 20 people in-vivo experiments.

A Wearable and Highly Sensitive Graphene Strain Sensor for Precise Home-Based Pulse Wave Monitoring.

PubMed

Yang, Tingting; Jiang, Xin; Zhong, Yujia; Zhao, Xuanliang; Lin, Shuyuan; Li, Jing; Li, Xinming; Xu, Jianlong; Li, Zhihong; Zhu, Hongwei

2017-07-28

Profuse medical information about cardiovascular properties can be gathered from pulse waveforms. Therefore, it is desirable to design a smart pulse monitoring device to achieve noninvasive and real-time acquisition of cardiovascular parameters. The majority of current pulse sensors are usually bulky or insufficient in sensitivity. In this work, a graphene-based skin-like sensor is explored for pulse wave sensing with features of easy use and wearing comfort. Moreover, the adjustment of the substrate stiffness and interfacial bonding accomplish the optimal balance between sensor linearity and signal sensitivity, as well as measurement of the beat-to-beat radial arterial pulse. Compared with the existing bulky and nonportable clinical instruments, this highly sensitive and soft sensing patch not only provides primary sensor interface to human skin, but also can objectively and accurately detect the subtle pulse signal variations in a real-time fashion, such as pulse waveforms with different ages, pre- and post-exercise, thus presenting a promising solution to home-based pulse monitoring.

21 CFR 870.3535 - Intra-aortic balloon and control system

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3535 Intra-aortic... consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning...

21 CFR 870.3535 - Intra-aortic balloon and control system

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3535 Intra-aortic... consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning...

Remote management of heart failure using implantable electronic devices

PubMed Central

Morgan, John M.; Kitt, Sue; Gill, Jas; McComb, Janet M.; Ng, Ghulam Andre; Raftery, James; Roderick, Paul; Seed, Alison; Williams, Simon G.; Witte, Klaus K.; Wright, David Jay; Harris, Scott; Cowie, Martin R.

2017-01-01

Abstract Aims Remote management of heart failure using implantable electronic devices (REM-HF) aimed to assess the clinical and cost-effectiveness of remote monitoring (RM) of heart failure in patients with cardiac implanted electronic devices (CIEDs). Methods and results Between 29 September 2011 and 31 March 2014, we randomly assigned 1650 patients with heart failure and a CIED to active RM or usual care (UC). The active RM pathway included formalized remote follow-up protocols, and UC was standard practice in nine recruiting centres in England. The primary endpoint in the time to event analysis was the 1st event of death from any cause or unplanned hospitalization for cardiovascular reasons. Secondary endpoints included death from any cause, death from cardiovascular reasons, death from cardiovascular reasons and unplanned cardiovascular hospitalization, unplanned cardiovascular hospitalization, and unplanned hospitalization. REM-HF is registered with ISRCTN (96536028). The mean age of the population was 70 years (range 23–98); 86% were male. Patients were followed for a median of 2.8 years (range 0–4.3 years) completing on 31 January 2016. Patient adherence was high with a drop out of 4.3% over the course of the study. The incidence of the primary endpoint did not differ significantly between active RM and UC groups, which occurred in 42.4 and 40.8% of patients, respectively [hazard ratio 1.01; 95% confidence interval (CI) 0.87–1.18; P = 0.87]. There were no significant differences between the two groups with respect to any of the secondary endpoints or the time to the primary endpoint components. Conclusion Among patients with heart failure and a CIED, RM using weekly downloads and a formalized follow up approach does not improve outcomes. PMID:28575235

Monitors Enable Medication Management in Patients' Homes

NASA Technical Reports Server (NTRS)

2014-01-01

Glenn Research Center awarded SBIR funding to ZIN Technologies to develop a platform that could incorporate sensors quantifying an astronaut’s health status and then communicate with the ground. ZIN created a device, developed the system further, and then formed Cleveland-based FlexLife Health to commercialize the technology. Today it is part of an anti-coagulation management system for people with cardiovascular disease.

2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care: Endorsed by the American Heart Assocation, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention.

PubMed

Rihal, Charanjit S; Naidu, Srihari S; Givertz, Michael M; Szeto, Wilson Y; Burke, James A; Kapur, Navin K; Kern, Morton; Garratt, Kirk N; Goldstein, James A; Dimas, Vivian; Tu, Thomas

2015-05-19

Although historically the intra-aortic balloon pump has been the only mechanical circulatory support device available to clinicians, a number of new devices have become commercially available and have entered clinical practice. These include axial flow pumps, such as Impella(®); left atrial to femoral artery bypass pumps, specifically the TandemHeart; and new devices for institution of extracorporeal membrane oxygenation. These devices differ significantly in their hemodynamic effects, insertion, monitoring, and clinical applicability. This document reviews the physiologic impact on the circulation of these devices and their use in specific clinical situations. These situations include patients undergoing high-risk percutaneous coronary intervention, those presenting with cardiogenic shock, and acute decompensated heart failure. Specialized uses for right-sided support and in pediatric populations are discussed and the clinical utility of mechanical circulatory support devices is reviewed, as are the American College of Cardiology/American Heart Association clinical practice guidelines. Copyright © 2015 The Society for Cardiovascular Angiography and Interventions, The American College of Cardiology Foundation, The Heart Failure Society of America, and The Society for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care (Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie D'intervention).

PubMed

Rihal, Charanjit S; Naidu, Srihari S; Givertz, Michael M; Szeto, Wilson Y; Burke, James A; Kapur, Navin K; Kern, Morton; Garratt, Kirk N; Goldstein, James A; Dimas, Vivian; Tu, Thomas

2015-06-01

Although historically the intra-aortic balloon pump has been the only mechanical circulatory support device available to clinicians, a number of new devices have become commercially available and have entered clinical practice. These include axial flow pumps, such as Impella®; left atrial to femoral artery bypass pumps, specifically the TandemHeart; and new devices for institution of extracorporeal membrane oxygenation. These devices differ significantly in their hemodynamic effects, insertion, monitoring, and clinical applicability. This document reviews the physiologic impact on the circulation of these devices and their use in specific clinical situations. These situations include patients undergoing high-risk percutaneous coronary intervention, those presenting with cardiogenic shock, and acute decompensated heart failure. Specialized uses for right-sided support and in pediatric populations are discussed and the clinical utility of mechanical circulatory support devices is reviewed, as are the American College of Cardiology/American Heart Association clinical practice guidelines. © 2015 by The Society for Cardiovascular Angiography and Interventions, The American College of Cardiology Foundation, The Heart Failure Society of America, and The Society for Thoracic Surgery.

Transcranial Doppler monitoring during stenting of the carotid bifurcation: evaluation of two different distal protection devices in preventing embolization.

PubMed

Rubartelli, Paolo; Brusa, Giulia; Arrigo, Alessandro; Abbadessa, Francesco; Giachero, Corinna; Vischi, Massimo; Ricca, Maria Maddalena; Ottonello, Gian Andrea

2006-08-01

To compare the efficacy of 2 emboli protection devices in preventing embolization during carotid artery stenting (CAS). The GuardWire distal occlusion system (n=19) and the distal FilterWire EX (n=12) were compared in 31 consecutive patients (24 men; mean age 71+/-10 years) monitored with transcranial Doppler for microembolic signals before, during, and after CAS. The choice of the protection device was based on availability and on the patency of the contralateral carotid artery. The baseline characteristics were similar in the patients treated under protection from either device. Placement and retrieval of the protection device, stenting, and postdilation were technically successful in all patients. Two patients suffered a transient ischemic attack shortly after the procedure; no other adverse cardiovascular events occurred at 30 days. Compared to the GuardWire, the use of the FilterWire was associated with more microembolic signals during stent deployment (77.4+/-33.5 versus 1.07+/-1.94, p<0.0001), postdilation (63.9+/-21.0 versus 2.06+/-2.58, p<0.0001), and retrieval of the protection device (21.4+/-15.4 versus 10.9+/-8.3, p=0.051). Consequently, the total amount of microembolic signals during the procedure was higher when the filter device was employed (183.0+/-42.1 versus 31.7+/-12.0, p<0.0001). The distal occlusion device appears to be more effective than the filter in reducing distal embolization detected by transcranial Doppler monitoring.

Real-time monitoring of cardiovascular function in rhesus macaques infected with Zaire ebolavirus.

PubMed

Kortepeter, Mark G; Lawler, James V; Honko, Anna; Bray, Mike; Johnson, Joshua C; Purcell, Bret K; Olinger, Gene G; Rivard, Robert; Hepburn, Matthew J; Hensley, Lisa E

2011-11-01

Nine rhesus macaques were implanted with multisensor telemetry devices and internal jugular vein catheters before being infected with Zaire ebolavirus. All animals developed viremia, fever, a hemorrhagic rash, and typical changes of Ebola hemorrhagic fever in clinical laboratory tests. Three macaques unexpectedly survived this usually lethal disease, making it possible to compare physiological parameters in lethally challenged animals and survivors. After the onset of fever, lethal illness was characterized by a decline in mean arterial blood pressure, an increase in pulse and respiratory rate, lactic acidosis, and renal failure. Survivors showed less pronounced change in these parameters. Four macaques were randomized to receive supplemental volumes of intravenous normal saline when they became hypotensive. Although those animals had less severe renal compromise, no apparent survival benefit was observed. This is the first report of continuous physiologic monitoring in filovirus-infected nonhuman primates and the first to attempt cardiovascular support with intravenous fluids.

An ultra low power ECG signal processor design for cardiovascular disease detection.

PubMed

Jain, Sanjeev Kumar; Bhaumik, Basabi

2015-08-01

This paper presents an ultra low power ASIC design based on a new cardiovascular disease diagnostic algorithm. This new algorithm based on forward search is designed for real time ECG signal processing. The algorithm is evaluated for Physionet PTB database from the point of view of cardiovascular disease diagnosis. The failed detection rate of QRS complex peak detection of our algorithm ranges from 0.07% to 0.26% for multi lead ECG signal. The ASIC is designed using 130-nm CMOS low leakage process technology. The area of ASIC is 1.21 mm(2). This ASIC consumes only 96 nW at an operating frequency of 1 kHz with a supply voltage of 0.9 V. Due to ultra low power consumption, our proposed ASIC design is most suitable for energy efficient wearable ECG monitoring devices.

21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

Code of Federal Regulations, 2014 CFR

2014-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4200... mounting bracket or system-priming equipment. (b) Classification. (1) Class I. The device is classified as...

21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

Code of Federal Regulations, 2012 CFR

2012-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4200... mounting bracket or system-priming equipment. (b) Classification. (1) Class I. The device is classified as...

21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

Code of Federal Regulations, 2013 CFR

2013-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4200... mounting bracket or system-priming equipment. (b) Classification. (1) Class I. The device is classified as...

21 CFR 870.4380 - Cardiopulmonary bypass pump speed control.

Code of Federal Regulations, 2012 CFR

2012-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4380... device used that incorporates an electrical system or a mechanical system, or both, and is used to...

21 CFR 870.4380 - Cardiopulmonary bypass pump speed control.

Code of Federal Regulations, 2014 CFR

2014-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4380... device used that incorporates an electrical system or a mechanical system, or both, and is used to...

21 CFR 870.4380 - Cardiopulmonary bypass pump speed control.

Code of Federal Regulations, 2013 CFR

2013-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4380... device used that incorporates an electrical system or a mechanical system, or both, and is used to...

Cost-effectiveness of workplace wellness to prevent cardiovascular events among U.S. firefighters.

PubMed

Patterson, P Daniel; Smith, Kenneth J; Hostler, David

2016-11-21

The leading cause of death among firefighters in the United States (U.S.) is cardiovascular events (CVEs) such as sudden cardiac arrest and myocardial infarction. This study compared the cost-effectiveness of three strategies to prevent CVEs among firefighters. We used a cost-effectiveness analysis model with published observational and clinical data, and cost quotes for physiologic monitoring devices to determine the cost-effectiveness of three CVE prevention strategies. We adopted the fire department administrator perspective and varied parameter estimates in one-way and two-way sensitivity analyses. A wellness-fitness program prevented 10% of CVEs, for an event rate of 0.9% at $1440 over 10-years, or an incremental cost-effectiveness ratio of $1.44 million per CVE prevented compared to no program. In one-way sensitivity analyses, monitoring was favored if costs were < $116/year. In two-way sensitivity analyses, monitoring was not favored if cost was ≥ $399/year. A wellness-fitness program was not favored if its preventive relative risk was >0.928. Wellness-fitness programs may be a cost-effective solution to preventing CVE among firefighters compared to real-time physiologic monitoring or doing nothing.

Conformable amplified lead zirconate titanate sensors with enhanced piezoelectric response for cutaneous pressure monitoring.

PubMed

Dagdeviren, Canan; Su, Yewang; Joe, Pauline; Yona, Raissa; Liu, Yuhao; Kim, Yun-Soung; Huang, YongAn; Damadoran, Anoop R; Xia, Jing; Martin, Lane W; Huang, Yonggang; Rogers, John A

2014-08-05

The ability to measure subtle changes in arterial pressure using devices mounted on the skin can be valuable for monitoring vital signs in emergency care, detecting the early onset of cardiovascular disease and continuously assessing health status. Conventional technologies are well suited for use in traditional clinical settings, but cannot be easily adapted for sustained use during daily activities. Here we introduce a conformal device that avoids these limitations. Ultrathin inorganic piezoelectric and semiconductor materials on elastomer substrates enable amplified, low hysteresis measurements of pressure on the skin, with high levels of sensitivity (~0.005 Pa) and fast response times (~0.1 ms). Experimental and theoretical studies reveal enhanced piezoelectric responses in lead zirconate titanate that follow from integration on soft supports as well as engineering behaviours of the associated devices. Calibrated measurements of pressure variations of blood flow in near-surface arteries demonstrate capabilities for measuring radial artery augmentation index and pulse pressure velocity.

Noninvasive and continuous blood pressure measurement via superficial temporal artery tonometry.

PubMed

Canning, Julia; Helbert, Kendall; Iashin, Grigoriy; Matthews, Jonathan; Yang, Jason; Delano, Margaret K; Sodini, Charles G; Quan Zhang

2016-08-01

The measurement of blood pressure is an important cardiovascular health assessment, yet the current set of methodologies is limited in resolution, repeatability, accuracy, simplicity, and safety. This paper presents the design and prototype implementation of a novel and easy-to-use medical device for noninvasive and continuous blood pressure monitoring through tonometry at the superficial temporal artery (STA). The device features a stable form factor inspired by over-ear headphones that adjusts easily from person to person using a combination prismatic and rotational joint. A stepper motor and pressure sensor, built into the device, apply a controlled force to flatten the artery and measure the wearer's blood pressure. The design is fully wireless, using Bluetooth communication to connect to a custom control and monitoring interface on the user's laptop that allows for easy calibration and real-time measurement. Preliminary testing of the device showed a percentage error from a blood pressure cuff mean arterial pressure measurement of 7.7% (7.0 mmHg). This was also compared to a Nexfin vascular unloading device, which showed a percentage error from the blood pressure cuff of 7.3% (6.6 mmHg).

Method and apparatus for monitoring dynamic cardiovascular function using n-dimensional representatives of critical functions

NASA Technical Reports Server (NTRS)

Syroid, Noah (Inventor); Westinskow, Dwayne (Inventor); Agutter, James (Inventor); Albert, Robert (Inventor); Strayer, David (Inventor); Wachter, S. Blake (Inventor); Drews, Frank (Inventor)

2010-01-01

A method, system, apparatus and device for the monitoring, diagnosis and evaluation of the state of a dynamic pulmonary system is disclosed. This method and system provides the processing means for receiving sensed and/or simulated data, converting such data into a displayable object format and displaying such objects in a manner such that the interrelationships between the respective variables can be correlated and identified by a user. This invention provides for the rapid cognitive grasp of the overall state of a pulmonary critical function with respect to a dynamic system.

Is hypertension the fate of aortic coarctation patients treated with Cheatham Platinum (CP) stent?

PubMed

Baykan, Ali; Demiraldi, Ayse G; Tasci, Onur; Pamukcu, Ozge; Sunkak, Suleyman; Uzum, Kazım; Sezer, Sadettin; Narin, Nazmi

2018-04-01

The aim of this study is to address the presence of hypertension and risk for cardiovascular diseases in patients with Coarctation of the Aorta (CoA) who were treated with endovascular stent placement. Twenty patients (mean age: 14.2 ± 3.9 years) who were treated with stent and 20 age- and sex-matched controls were included to the study. Structure and functions of left ventricle were assessed by echocardiography. Carotid intima media (CIM) thickness was measured by using sonography as a marker for detecting cardiovascular risk. As indirect marker of arterial stiffness, pulse wave velocity, and augmentation index were recorded by ambulatory blood pressure monitorization/arteriography device. By ambulatory blood pressure monitorization, 24 h and daytime systolic and mean arterial pressure values were found to be significantly higher in patient group. Based on percentile values, 15% and 5% of patients were pre-hypertensive and hypertensive, respectively. Pulse wave velocity and cardiac output values were found to be significantly higher than control group. CIM thickness was also found to be significantly higher in patient group when compared to controls. It was shown that hypertension incidence as demonstrated by ambulatory blood pressure monitorization and risk for cardiovascular diseases as indicated by CIM thickness and Pulse wave velocity were higher than those in healthy population even after CoA is corrected. © 2017, Wiley Periodicals, Inc.

Android based self-diagnostic electrocardiogram system for mobile healthcare.

PubMed

Choo, Kan-Yeep; Ling, Huo-Chong; Lo, Yew-Chiong; Yap, Zuo-Han; Pua, Jun-Sheng; Phan, Raphael C-W; Goh, Vik-Tor

2015-01-01

Cardiovascular diseases are the most common cause of death worldwide and are characterized by arrhythmia (i.e. irregular rhythm of heartbeat). Arrhythmia occasionally happens under certain conditions, such as stress. Therefore, it is difficult to be diagnosed using electrocardiogram (ECG) devices available in hospitals for just a few minutes. Constant diagnosis and monitoring of heartbeat is required to reduce death caused by cardiovascular diseases. Mobile healthcare system has emerged as a potential solution to assist patients in monitoring their own heart condition, especially those who are isolated from the reference hospital. This paper proposes a self-diagnostic electrocardiogram system for mobile healthcare that has the capability to perform a real-time ECG diagnostic. The self-diagnostic capability of a real-time ECG signal is achieved by implementing a detrended fluctuation analysis (DFA) method. The result obtained from DFA is used to display the patient's health condition on a smartphone anytime and anywhere. If the health condition is critical, the system will alert the patient and his medical practitioner for further diagnosis. Experimental results verified the validity of the developed ECG diagnostic application on a smartphone. The proposed system can potentially reduce death caused by cardiovascular diseases by alerting the patient possibly undergoing a heart attack.

Cost efficiency and reimbursement of remote monitoring: a US perspective.

PubMed

Slotwiner, David; Wilkoff, Bruce

2013-06-01

Demographic and technological changes are driving increased utilization of cardiac implantable electronic devices (CIEDs) remote monitoring. In the USA, fee-for-service model of healthcare delivery, services rendered are valued based upon time, intensity, and technical or practice expense costs. As a consequence of this perspective, and to contain spending, Medicare has grouped physician services into families. Spending within each family of services must, by law, remain budget neutral. Cardiac implantable electronic devices monitoring services, remote and in-person, are grouped into one family. As the volume of services within this family increases, the individual encounters are destined to be discounted into ever decreasing portions. However, if the value of remote monitoring is demonstrated to extend beyond the previous boundaries of in-person interrogations, a rational request can be made to reconsider the relative value of remote monitoring. Outcome data supporting the value-added benefits of remote monitoring are rapidly accumulating, including (i) patient convenience, with reduced use of office services, (ii) equal safety compared with in-person evaluation, (iii) shorter detection time to actionable events (arrhythmias, cardiovascular disease progression, and device malfunction), (iv) reduced length of stay for hospitalizations, (v) reduced inappropriate shocks, (vi) increased battery longevity, and (vii) a relative reduction in the risk of death. Fully automatic wireless technology, only recently widely implemented, will add considerable clinical efficiencies and further increase the value of remote monitoring. The U.S. challenge will be to appropriately define the relative value of CIEDs remote monitoring now that outcome data have demonstrated its value extends beyond in-person interrogation.

21 CFR 870.1210 - Continuous flush catheter.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1210 Continuous flush catheter. (a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system...

21 CFR 870.1210 - Continuous flush catheter.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1210 Continuous flush catheter. (a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system...

21 CFR 870.1210 - Continuous flush catheter.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1210 Continuous flush catheter. (a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system...

21 CFR 870.3300 - Vascular embolization device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vascular embolization device. 870.3300 Section 870.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3300 Vascular embolization...

21 CFR 870.3300 - Vascular embolization device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vascular embolization device. 870.3300 Section 870.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3300 Vascular embolization...

REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study.

PubMed

Tajstra, Mateusz; Sokal, Adam; Gwóźdź, Arkadiusz; Wilczek, Marcin; Gacek, Adam; Wojciechowski, Konrad; Gadula-Gacek, Elżbieta; Adamowicz-Czoch, Elżbieta; Chłosta-Niepiekło, Katarzyna; Milewski, Krzysztof; Rozentryt, Piotr; Kalarus, Zbigniew; Gąsior, Mariusz; Poloński, Lech

2017-07-01

The number of patients with heart failure implantable cardiac electronic devices (CIEDs) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow-up is crucial. Remote monitoring (RM) has been widely put into practice in the management of CIEDs but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of RM in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate (RESULT) study is to evaluate the impact of RM on the clinical status of patients with ICDs or CRT-Ds using an integrated platform. Six hundred consecutive patients with ICDs or CRT-Ds implanted will be prospectively randomized to either a traditional or RM-based follow-up model. The primary clinical endpoint will be a composite of all-cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from RM devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: NCT02409225). © 2016 Wiley Periodicals, Inc.

First results from experiments performed with the ESA Anthrorack during the D-2 Spacelab mission.

PubMed

Kuipers, A

1996-06-01

In 1993 four astronauts performed physiological experiments on the payload "Anthrorack" during the second German Spacelab mission D-2. The Anthrorack set-up is a Spacelab double rack developed under the management of the European Space Agency. It consists of an ECHO machine, a respiratory monitoring system (gas analyzer with flow meter), a blood centrifuge, an ergometer, a finger blood pressure device, ECG, body impedance measurement device and a respiratory inductance plethysmograph. Experiment-specific equipment was used as well. Nineteen investigators performed experiments in the cardiovascular, pulmonary, fluid-renal and nutritional physiology area. Results on central venous pressure, ocular pressure, vascular resistance, cardiac output, tissue thickness and orthostatic intolerance are presented in the cardiovascular area. In the pulmonary area first results are mentioned on O2 transport perfusion and ventilation distribution and breathing pattern. From the fluid-renal experiments, data from diuresis, sodium excretion and hormonal determinations are given. Finally results from glucose metabolism and nitrogen turnover experiments are presented.

First results from experiments performed with the ESA Anthrorack during the D-2 spacelab mission

NASA Astrophysics Data System (ADS)

Kuipers, A.

1996-06-01

In 1993 four astronauts performed physiological experiments on the payload "Anthrorack" during the second German Spacelab mission D-2. The Anthrorack set-up is a Spacelab double rack developed under the management of the European Space Agency. It consists of an ECHO machine, a respiratory monitoring system (gas analyzer with flow meter), a blood centrifuge, an ergometer, a finger blood pressure device, ECG, body impedance measurement device and a respiratory inductance plethysmograph. Experiment-specific equipment was used as well. Nineteen investigators performed experiments in the cardiovascular, pulmonary, fluid-renal and nutritional physiology area. Results on central venous pressure, ocular pressure, vascular resistance, cardiac output, tissue thickness and orthostatic intolerance are presented in the cardiovascular area. In the pulmonary area first results are mentioned on O 2 transport perfusion and ventilation distribution and breathing pattern. From the fluid-renal experiments, data from diuresis, sodium excretion and hormonal determinations are given. Finally results from glucose metabolism and nitrogen turnover experiments are presented.

Smartphone-based Continuous Blood Pressure Measurement Using Pulse Transit Time.

PubMed

Gholamhosseini, Hamid; Meintjes, Andries; Baig, Mirza; Linden, Maria

2016-01-01

The increasing availability of low cost and easy to use personalized medical monitoring devices has opened the door for new and innovative methods of health monitoring to emerge. Cuff-less and continuous methods of measuring blood pressure are particularly attractive as blood pressure is one of the most important measurements of long term cardiovascular health. Current methods of noninvasive blood pressure measurement are based on inflation and deflation of a cuff with some effects on arteries where blood pressure is being measured. This inflation can also cause patient discomfort and alter the measurement results. In this work, a mobile application was developed to collate the PhotoPlethysmoGramm (PPG) waveform provided by a pulse oximeter and the electrocardiogram (ECG) for calculating the pulse transit time. This information is then indirectly related to the user's systolic blood pressure. The developed application successfully connects to the PPG and ECG monitoring devices using Bluetooth wireless connection and stores the data onto an online server. The pulse transit time is estimated in real time and the user's systolic blood pressure can be estimated after the system has been calibrated. The synchronization between the two devices was found to pose a challenge to this method of continuous blood pressure monitoring. However, the implemented continuous blood pressure monitoring system effectively serves as a proof of concept. This combined with the massive benefits that an accurate and robust continuous blood pressure monitoring system would provide indicates that it is certainly worthwhile to further develop this system.

21 CFR 870.3545 - Ventricular bypass (assist) device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ventricular bypass (assist) device. 870.3545 Section 870.3545 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3545 Ventricular...

21 CFR 870.3545 - Ventricular bypass (assist) device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ventricular bypass (assist) device. 870.3545 Section 870.3545 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3545 Ventricular...

mHealth in Cardiovascular Health Care.

PubMed

Chow, Clara K; Ariyarathna, Nilshan; Islam, Sheikh Mohammed Shariful; Thiagalingam, Aravinda; Redfern, Julie

2016-08-01

Mobile health (mHealth) has been defined as medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices and personal digital assistants. Cardiovascular mHealth is, arguably, leading the mHealth space, through innovation, research and implementation, and especially in the areas of prevention, cardiac rehabilitation and education. mHealth includes simple strategies, such as the use of short message service (SMS) or text messages in successful short-term smoking-cessation, weight loss and diabetes management programs. The recent Australian Tobacco, Exercise and Diet Messages (TEXT ME) randomised clinical trial addressed multiple cardiovascular risk factors. mHealth can also involve more complex strategies, such as smart phone applications (apps), global positioning systems (GPS) and Bluetooth technologies. Although many apps could be considered suitable for primary prevention, they are largely unregulated and most are not evidence-based. Some have been well-developed, such as the Food Switch app and an iPhone electrocardiogram (ECG) system. The "explosion" of apps has driven initiatives such as the Mobile Applications Rating Scale (MARS). More recently, the use of sensors to monitor and provide feedback to patients and healthcare providers is being explored. With almost two billion people currently owning a Smartphone, and 50% of adults (globally) predicted to own one by 2018, mHealth provides the prospect of delivering efficient, affordable healthcare services to widespread populations both locally and globally. In particular, it has the potential to reduce socioeconomic disparity and alleviate the burden of cardiovascular disease. There is now a need to rethink traditional health service structures and bioengineering capacity, to ensure mHealth systems are also safe, secure and robust. Copyright © 2016 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

Recurrence of stroke caused by nocturnal hypoxia-induced blood pressure surge in a young adult male with severe obstructive sleep apnea syndrome.

PubMed

Yoshida, Tetsuro; Kuwabara, Mitsuo; Hoshide, Satoshi; Kario, Kazuomi

2016-03-01

Obstructive sleep apnea syndrome (OSAS) causes resistant hypertension and a hypopnea-related nocturnal blood pressure (BP) surge. This could lead to an increase of not only the nocturnal BP level but also nocturnal BP variability, both of which increase an individual's cardiovascular risk. We recently developed a trigger sleep BP monitoring method that initiates BP measurement when an individual's oxygen desaturation falls below a variable threshold, and we demonstrated that it can detect a BP surge during apnea episodes. We here report the case of a 36-year-old man with severe OSAS who experienced the recurrence of stroke due to nocturnal hypoxia and a nocturnal BP surge measured by this trigger sleep BP monitoring device. A nocturnal BP surge during sleep in OSAS patients could be a strong trigger of cardiovascular events. Copyright © 2016 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

Rationale and design for the Asia BP@Home study on home blood pressure control status in 12 Asian countries and regions.

PubMed

Kario, Kazuomi; Tomitani, Naoko; Buranakitjaroen, Peera; Chen, Chen-Huan; Chia, Yook-Chin; Divinagracia, Romeo; Park, Sungha; Shin, Jinho; Siddique, Saulat; Sison, Jorge; Soenarta, Arieska Ann; Sogunuru, Guru Prasad; Tay, Jam Chin; Turana, Yuda; Wang, Ji-Guang; Wong, Lawrence; Zhang, Yuqing; Wanthong, Sirisawat; Hoshide, Satoshi; Kanegae, Hiroshi

2018-01-01

Home blood pressure (BP) monitoring is endorsed in multiple guidelines as a valuable adjunct to office BP measurements for the diagnosis and management of hypertension. In many countries throughout Asia, physicians are yet to appreciate the significant contribution of BP variability to cardiovascular events. Furthermore, data from Japanese cohort studies have shown that there is a strong association between morning BP surge and cardiovascular events, suggesting that Asians in general may benefit from more effective control of morning BP. We designed the Asia BP@Home study to investigate the distribution of hypertension subtypes, including white-coat hypertension, masked morning hypertension, and well-controlled and uncontrolled hypertension. The study will also investigate the determinants of home BP control status evaluated by the same validated home BP monitoring device and the same standardized method of home BP measurement among 1600 or more medicated patients with hypertension from 12 countries/regions across Asia. ©2017 Wiley Periodicals, Inc.

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.3460 - Endovascular Suturing System.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endovascular Suturing System. 870.3460 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3460 Endovascular Suturing System. (a) Identification. An endovascular suturing system is a medical device intended to provide...

21 CFR 870.3460 - Endovascular Suturing System.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endovascular Suturing System. 870.3460 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3460 Endovascular Suturing System. (a) Identification. An endovascular suturing system is a medical device intended to provide...

21 CFR 870.1290 - Steerable catheter control system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Steerable catheter control system. 870.1290... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1290 Steerable catheter control system. (a) Identification. A steerable catheter control system is a device that is...

21 CFR 870.1290 - Steerable catheter control system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Steerable catheter control system. 870.1290... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1290 Steerable catheter control system. (a) Identification. A steerable catheter control system is a device that is...

21 CFR 870.3460 - Endovascular Suturing System.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endovascular Suturing System. 870.3460 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3460 Endovascular Suturing System. (a) Identification. An endovascular suturing system is a medical device intended to provide...

21 CFR 870.1290 - Steerable catheter control system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Steerable catheter control system. 870.1290... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1290 Steerable catheter control system. (a) Identification. A steerable catheter control system is a device that is...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more of...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more of...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to noninvasively change one or more of...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to noninvasively change one or more of...

21 CFR 870.5325 - Defibrillator tester.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Defibrillator tester. 870.5325 Section 870.5325...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5325 Defibrillator tester. (a) Identification. A defibrillator tester is a device that is connected to the output of a...

21 CFR 870.5325 - Defibrillator tester.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Defibrillator tester. 870.5325 Section 870.5325...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5325 Defibrillator tester. (a) Identification. A defibrillator tester is a device that is connected to the output of a...

21 CFR 870.5325 - Defibrillator tester.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Defibrillator tester. 870.5325 Section 870.5325...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5325 Defibrillator tester. (a) Identification. A defibrillator tester is a device that is connected to the output of a...

21 CFR 870.5325 - Defibrillator tester.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Defibrillator tester. 870.5325 Section 870.5325...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5325 Defibrillator tester. (a) Identification. A defibrillator tester is a device that is connected to the output of a...

21 CFR 870.5325 - Defibrillator tester.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Defibrillator tester. 870.5325 Section 870.5325...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5325 Defibrillator tester. (a) Identification. A defibrillator tester is a device that is connected to the output of a...

21 CFR 870.1800 - Withdrawal-infusion pump.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Withdrawal-infusion pump. 870.1800 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1800 Withdrawal-infusion pump. (a) Identification. A withdrawal-infusion pump is a device designed to inject accurately drugs...

Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience

PubMed Central

Gee, Adrian P.; Richman, Sara; Durett, April; McKenna, David; Traverse, Jay; Henry, Timothy; Fisk, Diann; Pepine, Carl; Bloom, Jeannette; Willerson, James; Prater, Karen; Zhao, David; Koç, Jane Reese; Ellis, Steven; Taylor, Doris; Cogle, Christopher; Moyé, Lemuel; Simari, Robert; Skarlatos, Sonia

2013-01-01

Background Aims Multi-center cellular therapy clinical trials require the establishment and implementation of standardized cell processing protocols and associated quality control mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods Standardized cell preparations, consisting of autologous bone marrow mononuclear cells, prepared using the Sepax device were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central quality control program that included product evaluation by the CCTRN biorepositories. Results Data from the first 60 procedures demonstrate that uniform products, that met all release criteria, could be manufactured at all five sites within 7 hours of receipt of the bone marrow. Uniformity was facilitated by use of the automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized quality control. Conclusions Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training, and quality control. PMID:20524773

Cost–consequence analysis of daily continuous remote monitoring of implantable cardiac defibrillator and resynchronization devices in the UK

PubMed Central

Burri, Haran; Sticherling, Christian; Wright, David; Makino, Koji; Smala, Antje; Tilden, Dominic

2013-01-01

Aims The need for ongoing and lifelong follow-up (FU) of patients with cardiac implantable electric devices (CIED) requires significant resources. Remote CIED management has been established as a safe alternative to conventional periodical in-office FU (CFU). An economic model compares the long-term cost and consequences of using daily Home Monitoring® (HM) instead of CFU. Methods and results A cost–consequence evaluation comparing HM vs. CFU was performed using a Markov cohort model and data relating to events and costs identified via a systematic review of the literature. The model is conservative, without assuming a reduction of cardiovascular events by HM such as decompensated heart failure or mortality, or considering cost savings such as for transportation. Also cost savings due to an improved timing of elective device replacement, and fewer FU visits needed in patients near device replacement are not considered. Over 10 years, HM is predicted to be cost neutral at about GBP 11 500 per patient in either treatment arm, with all costs for the initial investment into HM and fees for ongoing remote monitoring included. Fewer inappropriate shocks (−51%) reduce the need for replacing devices for battery exhaustion (−7%); the number of FU visits is predicted to be halved by HM. Conclusion From a UK National Health Service perspective, HM is cost neutral over 10 years. This is mainly accomplished by reducing the number of battery charges and inappropriate shocks, resulting in fewer device replacements, and by reducing the number of in-clinic FU visits. PMID:23599169

Cost-consequence analysis of daily continuous remote monitoring of implantable cardiac defibrillator and resynchronization devices in the UK.

PubMed

Burri, Haran; Sticherling, Christian; Wright, David; Makino, Koji; Smala, Antje; Tilden, Dominic

2013-11-01

The need for ongoing and lifelong follow-up (FU) of patients with cardiac implantable electric devices (CIED) requires significant resources. Remote CIED management has been established as a safe alternative to conventional periodical in-office FU (CFU). An economic model compares the long-term cost and consequences of using daily Home Monitoring® (HM) instead of CFU. A cost-consequence evaluation comparing HM vs. CFU was performed using a Markov cohort model and data relating to events and costs identified via a systematic review of the literature. The model is conservative, without assuming a reduction of cardiovascular events by HM such as decompensated heart failure or mortality, or considering cost savings such as for transportation. Also cost savings due to an improved timing of elective device replacement, and fewer FU visits needed in patients near device replacement are not considered. Over 10 years, HM is predicted to be cost neutral at about GBP 11 500 per patient in either treatment arm, with all costs for the initial investment into HM and fees for ongoing remote monitoring included. Fewer inappropriate shocks (-51%) reduce the need for replacing devices for battery exhaustion (-7%); the number of FU visits is predicted to be halved by HM. From a UK National Health Service perspective, HM is cost neutral over 10 years. This is mainly accomplished by reducing the number of battery charges and inappropriate shocks, resulting in fewer device replacements, and by reducing the number of in-clinic FU visits.

Validation protocols for blood pressure-measuring devices: status quo and development needs.

PubMed

Beime, Beate; Deutsch, Cornelia; Gomez, Timothy; Zwingers, Thomas; Mengden, Thomas; Bramlage, Peter

2016-02-01

Hypertension is a major risk factor for cardiovascular morbidity and mortality. Therefore, blood pressure self-measuring devices have emerged as valuable tools in patient care and the accuracy of these instruments is of fundamental importance. For this reason, several validation procedures for assessing the efficacy of blood pressure monitoring devices have been developed, including protocols by the Association for the Advancement of Medical Instrumentation, the British Hypertension Society, the German Hypertension League (Prüfsiegelprotokoll), and the International Protocol of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. In the past, most of the protocols have been reviewed and modified because of experiences gained during the validation studies carried out. However, each shows distinct differences, that is number and characteristics of patients required, blood pressure ranges, and the length of the validation procedure, which may result in unique advantages and/or limitations associated with their use. The continued standardization and evolution of these guidelines is essential to ensure the efficacy of blood pressure-measuring devices marketed for clinical and home use. Here, we aimed to compare four currently used validation protocols and to initiate a discussion on potential future improvements.

21 CFR 870.5900 - Thermal regulating system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Thermal regulating system. 870.5900 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5900 Thermal regulating system. (a) Identification. A thermal regulating system is an external system consisting of a device that...

21 CFR 870.5900 - Thermal regulating system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Thermal regulating system. 870.5900 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5900 Thermal regulating system. (a) Identification. A thermal regulating system is an external system consisting of a device that...

21 CFR 870.5900 - Thermal regulating system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Thermal regulating system. 870.5900 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5900 Thermal regulating system. (a) Identification. A thermal regulating system is an external system consisting of a device that...

21 CFR 870.5900 - Thermal regulating system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Thermal regulating system. 870.5900 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5900 Thermal regulating system. (a) Identification. A thermal regulating system is an external system consisting of a device that...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

Utilizing Smartphone-Based Machine Learning in Medical Monitor Data Collection: Seven Segment Digit Recognition

PubMed Central

Shenoy, Varun N.; Aalami, Oliver O.

2017-01-01

Biometric measurements captured from medical devices, such as blood pressure gauges, glucose monitors, and weighing scales, are essential to tracking a patient’s health. Trends in these measurements can accurately track diabetes, cardiovascular issues, and assist medication management for patients. Currently, patients record their results and date of measurement in a physical notebook. It may be weeks before a doctor sees a patient’s records and can assess the health of the patient. With a predicted 6.8 billion smartphones in the world by 20221, health monitoring platforms, such as Apple’s HealthKit2, can be leveraged to provide the right care at the right time. This research presents a mobile application that enables users to capture medical monitor data and send it to their doctor swiftly. A key contribution of this paper is a robust engine that can recognize digits from medical monitors with an accuracy of 98.2%. PMID:29854226

Utilizing Smartphone-Based Machine Learning in Medical Monitor Data Collection: Seven Segment Digit Recognition.

PubMed

Shenoy, Varun N; Aalami, Oliver O

2017-01-01

Biometric measurements captured from medical devices, such as blood pressure gauges, glucose monitors, and weighing scales, are essential to tracking a patient's health. Trends in these measurements can accurately track diabetes, cardiovascular issues, and assist medication management for patients. Currently, patients record their results and date of measurement in a physical notebook. It may be weeks before a doctor sees a patient's records and can assess the health of the patient. With a predicted 6.8 billion smartphones in the world by 2022 1 , health monitoring platforms, such as Apple's HealthKit 2 , can be leveraged to provide the right care at the right time. This research presents a mobile application that enables users to capture medical monitor data and send it to their doctor swiftly. A key contribution of this paper is a robust engine that can recognize digits from medical monitors with an accuracy of 98.2%.

A non-contact capacitance based electrocardiograph and associated heart-rate detection using enhanced Fourier interpolation method.

PubMed

Kumar Thakur, Rupak; Anoop, C S

2015-08-01

Cardio-vascular health monitoring has gained considerable attention in the recent years. Principle of non-contact capacitive electrocardiograph (ECG) and its applicability as a valuable, low-cost, easy-to-use scheme for cardio-vascular health monitoring has been demonstrated in some recent research papers. In this paper, we develop a complete non-contact ECG system using a suitable front-end electronic circuit and a heart-rate (HR) measurement unit using enhanced Fourier interpolation technique. The front-end electronic circuit is realized using low-cost, readily available components and the proposed HR measurement unit is designed to achieve fairly accurate results. The entire system has been extensively tested to verify its efficacy and test results show that the developed system can estimate HR with an accuracy of ±2 beats. Detailed tests have been conducted to validate the performance of the system for different cloth thicknesses of the subject. Some basic tests which illustrate the application of the proposed system for heart-rate variability estimation has been conducted and results reported. The developed system can be used as a portable, reliable, long-term cardiac health monitoring device and can be extended to human drowsiness detection.

Measurement and monitoring of electrocardiogram belt tension in premature infants for assessment of respiratory function

PubMed Central

Ciaccio, Edward J; Hiatt, Mark; Hegyi, Thomas; Drzewiecki, Gary M

2007-01-01

Background Monitoring of the electrocardiogram (ECG) in premature infants with conventional adhesive-backed electrodes can harm their sensitive skin. Use of an electrode belt prevents skin irritation, but the effect of belt pressure on respiratory function is unknown. A strain gauge sensor is described which measures applied belt tension. Method The device frame was comprised of an aluminum housing and slide to minimize the device weight. Velcro tabs connected housing and slide to opposite tabs located at the electrode belt ends. The slide was connected to a leaf spring, to which were bonded two piezoresistive transducers in a half-bridge circuit configuration. The device was tested for linearity and calibrated. The effect on infant respiratory function of constant belt tension in the normal range (30 g–90 g) was determined. Results The mechanical response to a step input was second order (fn = 401 Hz, ζ = 0.08). The relationship between applied tension and output voltage was linear in the range 25–225 gm of applied tension (r2 = 0.99). Measured device sensitivity was 2.18 mV/gm tension using a 5 V bridge excitation voltage. When belt tension was increased in the normal range from 30 gm to 90 gm, there was no significant change in heart rate and most respiratory functions during monitoring. At an intermediate level of tension of 50 gm, pulmonary resistance and work of breathing significantly decreased. Conclusion The mechanical and electrical design of a device for monitoring electrocardiogram electrode belt tension is described. Within the typical range of application tension, cardiovascular and respiratory function are not substantially negatively affected by electrode belt force. PMID:17445262

Measurement and monitoring of electrocardiogram belt tension in premature infants for assessment of respiratory function.

PubMed

Ciaccio, Edward J; Hiatt, Mark; Hegyi, Thomas; Drzewiecki, Gary M

2007-04-19

Monitoring of the electrocardiogram (ECG) in premature infants with conventional adhesive-backed electrodes can harm their sensitive skin. Use of an electrode belt prevents skin irritation, but the effect of belt pressure on respiratory function is unknown. A strain gauge sensor is described which measures applied belt tension. The device frame was comprised of an aluminum housing and slide to minimize the device weight. Velcro tabs connected housing and slide to opposite tabs located at the electrode belt ends. The slide was connected to a leaf spring, to which were bonded two piezoresistive transducers in a half-bridge circuit configuration. The device was tested for linearity and calibrated. The effect on infant respiratory function of constant belt tension in the normal range (30 g-90 g) was determined. The mechanical response to a step input was second order (fn = 401 Hz, zeta = 0.08). The relationship between applied tension and output voltage was linear in the range 25-225 gm of applied tension (r2 = 0.99). Measured device sensitivity was 2.18 mV/gm tension using a 5 V bridge excitation voltage. When belt tension was increased in the normal range from 30 gm to 90 gm, there was no significant change in heart rate and most respiratory functions during monitoring. At an intermediate level of tension of 50 gm, pulmonary resistance and work of breathing significantly decreased. The mechanical and electrical design of a device for monitoring electrocardiogram electrode belt tension is described. Within the typical range of application tension, cardiovascular and respiratory function are not substantially negatively affected by electrode belt force.

21 CFR 870.4300 - Cardiopulmonary bypass gas control unit.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary bypass gas control unit. 870.4300... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4300 Cardiopulmonary bypass gas control unit. (a) Identification. A cardiopulmonary bypass gas control unit is a device used...

21 CFR 870.4300 - Cardiopulmonary bypass gas control unit.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary bypass gas control unit. 870.4300... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4300 Cardiopulmonary bypass gas control unit. (a) Identification. A cardiopulmonary bypass gas control unit is a device used...

21 CFR 870.3945 - Prosthetic heart valve sizer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Prosthetic heart valve sizer. 870.3945 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3945 Prosthetic heart valve sizer. (a) Identification. A prosthetic heart valve sizer is a device used to measure the size of the...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.1100 - Blood pressure alarm.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood pressure alarm. 870.1100 Section 870.1100...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1100 Blood pressure alarm. (a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure...

21 CFR 870.1140 - Venous blood pressure manometer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Venous blood pressure manometer. 870.1140 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1140 Venous blood pressure manometer. (a) Identification. A venous blood pressure manometer is a device attached to a venous...

21 CFR 870.1140 - Venous blood pressure manometer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Venous blood pressure manometer. 870.1140 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1140 Venous blood pressure manometer. (a) Identification. A venous blood pressure manometer is a device attached to a venous...

21 CFR 870.1120 - Blood pressure cuff.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic...

21 CFR 870.1140 - Venous blood pressure manometer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Venous blood pressure manometer. 870.1140 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1140 Venous blood pressure manometer. (a) Identification. A venous blood pressure manometer is a device attached to a venous...

21 CFR 870.1100 - Blood pressure alarm.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood pressure alarm. 870.1100 Section 870.1100...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1100 Blood pressure alarm. (a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure...

21 CFR 870.1120 - Blood pressure cuff.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic...

21 CFR 870.1120 - Blood pressure cuff.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic...

21 CFR 870.1100 - Blood pressure alarm.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood pressure alarm. 870.1100 Section 870.1100...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1100 Blood pressure alarm. (a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure...

21 CFR 870.1120 - Blood pressure cuff.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic...

21 CFR 870.1140 - Venous blood pressure manometer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Venous blood pressure manometer. 870.1140 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1140 Venous blood pressure manometer. (a) Identification. A venous blood pressure manometer is a device attached to a venous...

21 CFR 870.1100 - Blood pressure alarm.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure alarm. 870.1100 Section 870.1100...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1100 Blood pressure alarm. (a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3620 - Pacemaker lead adaptor.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor. (a) Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it...

21 CFR 870.3620 - Pacemaker lead adaptor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor. (a) Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it...

21 CFR 870.3620 - Pacemaker lead adaptor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor. (a) Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3620 - Pacemaker lead adaptor.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor. (a) Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3945 - Prosthetic heart valve sizer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Prosthetic heart valve sizer. 870.3945 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3945 Prosthetic heart valve sizer. (a) Identification. A prosthetic heart valve sizer is a device used to measure the size of the...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.3945 - Prosthetic heart valve sizer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prosthetic heart valve sizer. 870.3945 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3945 Prosthetic heart valve sizer. (a) Identification. A prosthetic heart valve sizer is a device used to measure the size of the...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.3945 - Prosthetic heart valve sizer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Prosthetic heart valve sizer. 870.3945 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3945 Prosthetic heart valve sizer. (a) Identification. A prosthetic heart valve sizer is a device used to measure the size of the...

21 CFR 870.3945 - Prosthetic heart valve sizer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Prosthetic heart valve sizer. 870.3945 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3945 Prosthetic heart valve sizer. (a) Identification. A prosthetic heart valve sizer is a device used to measure the size of the...

21 CFR 870.4885 - External vein stripper.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External vein stripper. 870.4885 Section 870.4885...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4885 External vein stripper. (a) Identification. An external vein stripper is an extravascular device used to remove a section of...

21 CFR 870.4885 - External vein stripper.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External vein stripper. 870.4885 Section 870.4885...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4885 External vein stripper. (a) Identification. An external vein stripper is an extravascular device used to remove a section of...

21 CFR 870.4885 - External vein stripper.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External vein stripper. 870.4885 Section 870.4885...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4885 External vein stripper. (a) Identification. An external vein stripper is an extravascular device used to remove a section of...

21 CFR 870.4885 - External vein stripper.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External vein stripper. 870.4885 Section 870.4885...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4885 External vein stripper. (a) Identification. An external vein stripper is an extravascular device used to remove a section of...

21 CFR 870.4885 - External vein stripper.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External vein stripper. 870.4885 Section 870.4885...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4885 External vein stripper. (a) Identification. An external vein stripper is an extravascular device used to remove a section of...

Central arterial pressure assessment with intensity POF sensor

NASA Astrophysics Data System (ADS)

Leitão, Cátia; Gonçalves, Steve; Antunes, Paulo; Bastos, José M.; Pinto, João. L.; André, Paulo

2015-09-01

The central pressure monitoring is considered a new key factor in hypertension assessment and cardiovascular prevention. In this work, it is presented the central arterial systolic pressure assessment with an intensity based POF sensor. The device was tested in four subjects, and stable pulse waves were obtained, allowing the calculation of the central pressure for all the subjects. The results shown that the sensor performs reliably, being a simple and low-cost solution to the intended application.

Hypertension Canada's 2018 Guidelines for Diagnosis, Risk Assessment, Prevention, and Treatment of Hypertension in Adults and Children.

PubMed

Nerenberg, Kara A; Zarnke, Kelly B; Leung, Alexander A; Dasgupta, Kaberi; Butalia, Sonia; McBrien, Kerry; Harris, Kevin C; Nakhla, Meranda; Cloutier, Lyne; Gelfer, Mark; Lamarre-Cliche, Maxime; Milot, Alain; Bolli, Peter; Tremblay, Guy; McLean, Donna; Padwal, Raj S; Tran, Karen C; Grover, Steven; Rabkin, Simon W; Moe, Gordon W; Howlett, Jonathan G; Lindsay, Patrice; Hill, Michael D; Sharma, Mike; Field, Thalia; Wein, Theodore H; Shoamanesh, Ashkan; Dresser, George K; Hamet, Pavel; Herman, Robert J; Burgess, Ellen; Gryn, Steven E; Grégoire, Jean C; Lewanczuk, Richard; Poirier, Luc; Campbell, Tavis S; Feldman, Ross D; Lavoie, Kim L; Tsuyuki, Ross T; Honos, George; Prebtani, Ally P H; Kline, Gregory; Schiffrin, Ernesto L; Don-Wauchope, Andrew; Tobe, Sheldon W; Gilbert, Richard E; Leiter, Lawrence A; Jones, Charlotte; Woo, Vincent; Hegele, Robert A; Selby, Peter; Pipe, Andrew; McFarlane, Philip A; Oh, Paul; Gupta, Milan; Bacon, Simon L; Kaczorowski, Janusz; Trudeau, Luc; Campbell, Norman R C; Hiremath, Swapnil; Roerecke, Michael; Arcand, Joanne; Ruzicka, Marcel; Prasad, G V Ramesh; Vallée, Michel; Edwards, Cedric; Sivapalan, Praveena; Penner, S Brian; Fournier, Anne; Benoit, Geneviève; Feber, Janusz; Dionne, Janis; Magee, Laura A; Logan, Alexander G; Côté, Anne-Marie; Rey, Evelyne; Firoz, Tabassum; Kuyper, Laura M; Gabor, Jonathan Y; Townsend, Raymond R; Rabi, Doreen M; Daskalopoulou, Stella S

2018-05-01

Hypertension Canada provides annually updated, evidence-based guidelines for the diagnosis, assessment, prevention, and treatment of hypertension in adults and children. This year, the adult and pediatric guidelines are combined in one document. The new 2018 pregnancy-specific hypertension guidelines are published separately. For 2018, 5 new guidelines are introduced, and 1 existing guideline on the blood pressure thresholds and targets in the setting of thrombolysis for acute ischemic stroke is revised. The use of validated wrist devices for the estimation of blood pressure in individuals with large arm circumference is now included. Guidance is provided for the follow-up measurements of blood pressure, with the use of standardized methods and electronic (oscillometric) upper arm devices in individuals with hypertension, and either ambulatory blood pressure monitoring or home blood pressure monitoring in individuals with white coat effect. We specify that all individuals with hypertension should have an assessment of global cardiovascular risk to promote health behaviours that lower blood pressure. Finally, an angiotensin receptor-neprilysin inhibitor combination should be used in place of either an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in individuals with heart failure (with ejection fraction < 40%) who are symptomatic despite appropriate doses of guideline-directed heart failure therapies. The specific evidence and rationale underlying each of these guidelines are discussed. Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry

PubMed Central

Ricci, Renato Pietro; Morichelli, Loredana; D'Onofrio, Antonio; Calò, Leonardo; Vaccari, Diego; Zanotto, Gabriele; Curnis, Antonio; Buja, Gianfranco; Rovai, Nicola; Gargaro, Alessio

2013-01-01

Aims The HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management. Methods and results The workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27% pacemakers, 27% single-chamber implantable cardioverter defibrillators (ICDs), 22% dual-chamber ICDs, 24% ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 ± 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51%): 2033 (82%) were detected during HM sessions; 438 (18%) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3% [confidence interval (CI), 82.5–86.0%] and 97.4% (CI, 96.5–98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1–14 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: +0.56 (CI, 0.53–0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0–107.0) min × health personnel/100 patients. Conclusion Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption. PMID:23362021

Current challenges for clinical trials of cardiovascular medical devices.

PubMed

Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

2014-07-15

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

A Systematic Review of Economic Evaluations of Pacemaker Telemonitoring Systems.

PubMed

López-Villegas, Antonio; Catalán-Matamoros, Daniel; Martín-Saborido, Carlos; Villegas-Tripiana, Irene; Robles-Musso, Emilio

2016-02-01

Over the last decade, telemedicine applied to pacemaker monitoring has undergone extraordinary growth. It is not known if telemonitoring is more or less efficient than conventional monitoring. The aim of this study was to carry out a systematic review analyzing the available evidence on resource use and health outcomes in both follow-up modalities. We searched 11 databases and included studies published up until November 2014. The inclusion criteria were: a) experimental or observational design; b) studies based on complete economic evaluations; c) patients with pacemakers, and d) telemonitoring compared with conventional hospital monitoring. Seven studies met the inclusion criteria, providing information on 2852 patients, with a mean age of 81 years. The main indication for device implantation was atrioventricular block. With telemonitoring, cardiovascular events were detected and treated 2 months earlier than with conventional monitoring, thus reducing length of hospital stay by 34% and reducing routine and emergency hospital visits as well. There were no significant intergroup differences in perceived quality of life or number of adverse events. The cost of telemonitoring was 60% lower than that of conventional hospital monitoring. Compared with conventional monitoring, cardiovascular events were detected earlier and the number or hospitalizations and hospital visits was reduced with pacemaker telemonitoring. In addition, the costs associated with follow-up were lower with telemonitoring. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

21 CFR 870.3535 - Intra-aortic balloon and control system

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Intra-aortic balloon and control system 870.3535... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3535 Intra-aortic balloon and control system (a) Identification. A intra-aortic balloon and control system is a device that...

21 CFR 870.3535 - Intra-aortic balloon and control system

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intra-aortic balloon and control system 870.3535... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3535 Intra-aortic balloon and control system (a) Identification. A intra-aortic balloon and control system is a device that...

78 FR 79300 - Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

... balloon and control system (IABP) devices when indicated for acute coronary syndrome, cardiac and non... and non-cardiac surgery, or complications of heart failure. The special controls for this device are.... FDA-2013-N-0581] Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems...

75 FR 18849 - Food and Drug Administration/National Heart Lung and Blood Institute/National Science Foundation...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-13

... cardiovascular diseases and therapies; Patient-specific modeling, including virtual surgical planning and... Workshop on Computer Methods for Cardiovascular Devices: The Integration of Nonclinical and Clinical Models... Workshop on Computer Methods for Cardiovascular Devices: The Integration of Nonclinical and Clinical Models...

21 CFR 870.1450 - Densitometer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Densitometer. 870.1450 Section 870.1450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1450 Densitometer. (a) Identification. A...

21 CFR 870.1340 - Catheter introducer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Catheter introducer. 870.1340 Section 870.1340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1340 Catheter introducer...

21 CFR 870.1250 - Percutaneous catheter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Percutaneous catheter. 870.1250 Section 870.1250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1250 Percutaneous catheter...

21 CFR 870.1270 - Intracavitary phonocatheter system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intracavitary phonocatheter system. 870.1270... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1270 Intracavitary phonocatheter system. (a) Identification. An intracavitary phonocatheter system is a system that includes a...

21 CFR 870.1270 - Intracavitary phonocatheter system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Intracavitary phonocatheter system. 870.1270... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1270 Intracavitary phonocatheter system. (a) Identification. An intracavitary phonocatheter system is a system that includes a...

21 CFR 870.1270 - Intracavitary phonocatheter system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Intracavitary phonocatheter system. 870.1270... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1270 Intracavitary phonocatheter system. (a) Identification. An intracavitary phonocatheter system is a system that includes a...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker programmers. 870.3700 Section 870.3700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers...

21 CFR 870.1250 - Percutaneous catheter.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Percutaneous catheter. 870.1250 Section 870.1250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1250 Percutaneous catheter...

21 CFR 870.1915 - Thermodilution probe.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Thermodilution probe. 870.1915 Section 870.1915 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1915 Thermodilution probe...

21 CFR 870.1340 - Catheter introducer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Catheter introducer. 870.1340 Section 870.1340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1340 Catheter introducer...

21 CFR 870.1450 - Densitometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Densitometer. 870.1450 Section 870.1450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1450 Densitometer. (a) Identification. A...

Cuffless and Continuous Blood Pressure Estimation from the Heart Sound Signals

PubMed Central

Peng, Rong-Chao; Yan, Wen-Rong; Zhang, Ning-Ling; Lin, Wan-Hua; Zhou, Xiao-Lin; Zhang, Yuan-Ting

2015-01-01

Cardiovascular disease, like hypertension, is one of the top killers of human life and early detection of cardiovascular disease is of great importance. However, traditional medical devices are often bulky and expensive, and unsuitable for home healthcare. In this paper, we proposed an easy and inexpensive technique to estimate continuous blood pressure from the heart sound signals acquired by the microphone of a smartphone. A cold-pressor experiment was performed in 32 healthy subjects, with a smartphone to acquire heart sound signals and with a commercial device to measure continuous blood pressure. The Fourier spectrum of the second heart sound and the blood pressure were regressed using a support vector machine, and the accuracy of the regression was evaluated using 10-fold cross-validation. Statistical analysis showed that the mean correlation coefficients between the predicted values from the regression model and the measured values from the commercial device were 0.707, 0.712, and 0.748 for systolic, diastolic, and mean blood pressure, respectively, and that the mean errors were less than 5 mmHg, with standard deviations less than 8 mmHg. These results suggest that this technique is of potential use for cuffless and continuous blood pressure monitoring and it has promising application in home healthcare services. PMID:26393591

Cuffless and Continuous Blood Pressure Estimation from the Heart Sound Signals.

PubMed

Peng, Rong-Chao; Yan, Wen-Rong; Zhang, Ning-Ling; Lin, Wan-Hua; Zhou, Xiao-Lin; Zhang, Yuan-Ting

2015-09-17

Cardiovascular disease, like hypertension, is one of the top killers of human life and early detection of cardiovascular disease is of great importance. However, traditional medical devices are often bulky and expensive, and unsuitable for home healthcare. In this paper, we proposed an easy and inexpensive technique to estimate continuous blood pressure from the heart sound signals acquired by the microphone of a smartphone. A cold-pressor experiment was performed in 32 healthy subjects, with a smartphone to acquire heart sound signals and with a commercial device to measure continuous blood pressure. The Fourier spectrum of the second heart sound and the blood pressure were regressed using a support vector machine, and the accuracy of the regression was evaluated using 10-fold cross-validation. Statistical analysis showed that the mean correlation coefficients between the predicted values from the regression model and the measured values from the commercial device were 0.707, 0.712, and 0.748 for systolic, diastolic, and mean blood pressure, respectively, and that the mean errors were less than 5 mmHg, with standard deviations less than 8 mmHg. These results suggest that this technique is of potential use for cuffless and continuous blood pressure monitoring and it has promising application in home healthcare services.

21 CFR 870.1380 - Catheter stylet.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Catheter stylet. 870.1380 Section 870.1380 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1380 Catheter stylet. (a...

21 CFR 870.1360 - Trace microsphere.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Trace microsphere. 870.1360 Section 870.1360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1360 Trace microsphere. (a...

21 CFR 870.1660 - Indicator injector.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Indicator injector. 870.1660 Section 870.1660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1660 Indicator injector. (a...

21 CFR 870.1230 - Fiberoptic oximeter catheter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Fiberoptic oximeter catheter. 870.1230 Section 870.1230 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1230 Fiberoptic oximeter...

21 CFR 870.1270 - Intracavitary phonocatheter system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Intracavitary phonocatheter system. 870.1270 Section 870.1270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1270 Intracavitary...

21 CFR 870.1280 - Steerable catheter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Steerable catheter. 870.1280 Section 870.1280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1280 Steerable catheter. (a...

21 CFR 870.1210 - Continuous flush catheter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Continuous flush catheter. 870.1210 Section 870.1210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1210 Continuous flush...

21 CFR 870.1300 - Catheter cannula.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Catheter cannula. 870.1300 Section 870.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1300 Catheter cannula. (a...

21 CFR 870.3450 - Vascular graft prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular graft...

21 CFR 870.1110 - Blood pressure computer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood pressure computer. 870.1110 Section 870.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1110 Blood pressure...

21 CFR 870.1660 - Indicator injector.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Indicator injector. 870.1660 Section 870.1660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1660 Indicator injector. (a...

21 CFR 870.1380 - Catheter stylet.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Catheter stylet. 870.1380 Section 870.1380 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1380 Catheter stylet. (a...

21 CFR 870.1230 - Fiberoptic oximeter catheter.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Fiberoptic oximeter catheter. 870.1230 Section 870.1230 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1230 Fiberoptic oximeter...

21 CFR 870.1300 - Catheter cannula.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Catheter cannula. 870.1300 Section 870.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1300 Catheter cannula. (a...

21 CFR 870.1210 - Continuous flush catheter.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Continuous flush catheter. 870.1210 Section 870.1210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1210 Continuous flush...

21 CFR 870.1280 - Steerable catheter.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Steerable catheter. 870.1280 Section 870.1280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1280 Steerable catheter. (a...

21 CFR 870.1800 - Withdrawal-infusion pump.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Withdrawal-infusion pump. 870.1800 Section 870.1800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1800 Withdrawal-infusion...

21 CFR 870.1270 - Intracavitary phonocatheter system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Intracavitary phonocatheter system. 870.1270 Section 870.1270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1270 Intracavitary...

21 CFR 870.1360 - Trace microsphere.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Trace microsphere. 870.1360 Section 870.1360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1360 Trace microsphere. (a...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a...

21 CFR 870.1350 - Catheter balloon repair kit.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Catheter balloon repair kit. 870.1350 Section 870.1350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1350 Catheter balloon...

21 CFR 870.1650 - Angiographic injector and syringe.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Angiographic injector and syringe. 870.1650 Section 870.1650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1650 Angiographic...

21 CFR 870.1240 - Flow-directed catheter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Flow-directed catheter. 870.1240 Section 870.1240 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1240 Flow-directed catheter...

21 CFR 870.1370 - Catheter tip occluder.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Catheter tip occluder. 870.1370 Section 870.1370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1370 Catheter tip occluder...

21 CFR 870.1290 - Steerable catheter control system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Steerable catheter control system. 870.1290 Section 870.1290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1290 Steerable...

21 CFR 870.1310 - Vessel dilator for percutaneous catheterization.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vessel dilator for percutaneous catheterization. 870.1310 Section 870.1310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1310...

21 CFR 870.3250 - Vascular clip.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vascular clip. 870.3250 Section 870.3250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3250 Vascular clip. (a) Identification. A vascular...

21 CFR 870.1390 - Trocar.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Trocar. 870.1390 Section 870.1390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1390 Trocar. (a) Identification. A trocar is a...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

21 CFR 870.1370 - Catheter tip occluder.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Catheter tip occluder. 870.1370 Section 870.1370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1370 Catheter tip occluder...

21 CFR 870.1650 - Angiographic injector and syringe.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Angiographic injector and syringe. 870.1650 Section 870.1650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1650 Angiographic...

21 CFR 870.1290 - Steerable catheter control system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Steerable catheter control system. 870.1290 Section 870.1290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1290 Steerable...

21 CFR 870.3640 - Indirect pacemaker generator function analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Indirect pacemaker generator function analyzer. 870.3640 Section 870.3640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3640...

21 CFR 870.1310 - Vessel dilator for percutaneous catheterization.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vessel dilator for percutaneous catheterization. 870.1310 Section 870.1310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1310...

21 CFR 870.1100 - Blood pressure alarm.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood pressure alarm. 870.1100 Section 870.1100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1100 Blood pressure alarm...

21 CFR 870.3620 - Pacemaker lead adaptor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor...

21 CFR 870.1435 - Single-function, preprogrammed diagnostic computer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Single-function, preprogrammed diagnostic computer. 870.1435 Section 870.1435 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1435...

21 CFR 870.1390 - Trocar.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Trocar. 870.1390 Section 870.1390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1390 Trocar. (a) Identification. A trocar is a...

21 CFR 870.1140 - Venous blood pressure manometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Venous blood pressure manometer. 870.1140 Section 870.1140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1140 Venous blood...

21 CFR 870.1240 - Flow-directed catheter.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Flow-directed catheter. 870.1240 Section 870.1240 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1240 Flow-directed catheter...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870.3650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker generator function analyzer. 870.3630 Section 870.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker...

21 CFR 870.3250 - Vascular clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vascular clip. 870.3250 Section 870.3250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3250 Vascular clip. (a) Identification. A vascular...

21 CFR 870.1350 - Catheter balloon repair kit.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Catheter balloon repair kit. 870.1350 Section 870.1350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1350 Catheter balloon...

21 CFR 870.1120 - Blood pressure cuff.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood pressure cuff. 870.1120 Section 870.1120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet...

21 CFR 870.1130 - Noninvasive blood pressure measurement system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Noninvasive blood pressure measurement system. 870.1130 Section 870.1130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1130...

A randomized, controlled trial of Veriset™ hemostatic patch in halting cardiovascular bleeding.

PubMed

Glineur, David; Hendrikx, Marc; Krievins, Dainis; Stradins, Peteris; Voss, Bernhard; Waldow, Thomas; Haenen, Luc; Oberhoffer, Martin; Ritchie, Caroline M

2018-01-01

Obtaining hemostasis during cardiovascular procedures can be a challenge, particularly around areas with a complex geometry or that are difficult to access. While several topical hemostats are currently on the market, most have caveats that limit their use in certain clinical scenarios such as pulsatile arterial bleeding. The aim of this study was to assess the effectiveness and safety of Veriset™ hemostatic patch in treating cardiovascular bleeding. Patients (N=90) scheduled for cardiac or vascular surgery at 12 European institutions were randomized 1:1 to treatment with either Veriset™ hemostatic patch (investigational device) or TachoSil ® (control). After application of the hemostat, according to manufacturer instructions for use, time to hemostasis was monitored. Follow-up occurred up to 90 days post-surgery. Median time to hemostasis was 1.5 min with Veriset™ hemostatic patch, compared to 3.0 min with TachoSil ® ( p <0.0001). Serious adverse events within 30 days post-surgery were experienced by 12/44 (27.3%) patients treated with Veriset™ hemostatic patch and 10/45 (22.2%) in the TachoSil ® group ( p =0.6295). None of these adverse events were device-related, and no reoperations for bleeding were required within 5 days post-surgery in either treatment group. This study reinforces the difference in minimum recommended application time between Veriset™ hemostatic patch and TachoSil ® (30 s versus 3 min respectively). When compared directly at 3 min, Veriset™ displayed no significant difference, showing similar hemostasis and safety profiles on the cardiovascular bleeding sites included in this study.

Effectiveness of a Self-monitoring Device for Urinary Sodium-to-Potassium Ratio on Dietary Improvement in Free-Living Adults: a Randomized Controlled Trial.

PubMed

Iwahori, Toshiyuki; Ueshima, Hirotsugu; Ohgami, Naoto; Yamashita, Hideyuki; Miyagawa, Naoko; Kondo, Keiko; Torii, Sayuki; Yoshita, Katsushi; Shiga, Toshikazu; Ohkubo, Takayoshi; Arima, Hisatomi; Miura, Katsuyuki

2018-01-05

Reducing the urinary sodium-to-potassium ratio is important for reducing both blood pressure and risk of cardiovascular disease. Among free-living Japanese individuals, we carried out a randomized trial to clarify the effect of lifestyle modification for lowering urinary sodium-to-potassium ratio using a self-monitoring device. This was an open, prospective, parallel randomized, controlled trial. Ninety-two individuals were recruited from Japanese volunteers. Participants were randomly allocated into intervention and control groups. A month-long dietary intervention on self-monitoring urinary sodium-to-potassium ratio was carried out using monitors (HEU-001F, OMRON Healthcare Co., Ltd., Kyoto, Japan). All participants had brief dietary education and received a leaflet as usual care. Monitors were handed out to the intervention group, but not to the control group. The intervention group was asked to measure at least one spot urine sodium-to-potassium ratio daily, and advised to lower their sodium-to-potassium ratio toward the target of less than 1. Outcomes included changes in 24-hour urinary sodium-to-potassium ratio, sodium excretion, potassium excretion, blood pressure, and body weight in both groups. Mean measurement frequency of monitoring was 2.8 times/day during the intervention. Changes in urinary sodium-to-potassium ratio were -0.55 in the intervention group and -0.06 in the control group (P = 0.088); respective sodium excretion changes were -18.5 mmol/24 hours and -8.7 mmol/24 hours (P = 0.528); and corresponding potassium excretion was 2.6 mmol/24 hours and -1.5 mmol/24 hours (P = 0.300). No significant reductions were observed in either blood pressure or body weight after the intervention. Providing the device to self-monitor a sodium-to-potassium ratio did not achieve the targeted reduction of the ratio in "pure self-management" settings, indicating further needs to study an effective method to enhance the synergetic effect of dietary programs and self-monitoring practice to achieve the reduction. However, we cannot deny the possibility of reducing sodium-to-potassium ratio using a self-monitoring device.

Recent Advances in Free-Living Physical Activity Monitoring: A Review

PubMed Central

Andre, David; Wolf, Donna L.

2007-01-01

It has become clear recently that the epidemic of type 2 diabetes sweeping the globe is associated with decreased levels of physical activity and an increase in obesity. Incorporating appropriate and sufficient physical activity into one's life is an essential component of achieving and maintaining a healthy weight and overall health, especially for those with type II diabetes mellitus. Regular physical activity can have a positive impact by lowering blood glucose, helping the body to be more efficient at using insulin. There are other substantial benefits for patients with diabetes, including prevention of cardiovascular disease, hyperlipidemia, hypertension, and obesity. Several complications of utilizing a self-care treatment methodology involving exercise include (1) patients may not know how much activity that they engage in and (2) health-care providers do not have objective measurements of how much activity their patients perform. However, several technological advances have brought a variety of activity monitoring devices to the market that can address these concerns. Ranging from simple pedometers to multisensor devices, the different technologies offer varying levels of accuracy, comfort, and reliability. The key notion is that by providing feedback to the patient, motivation can be increased and targets can be set and aimed toward. Although these devices are not specific to the treatment of diabetes, the importance of physical activity in treating the disease makes an understanding of these devices important. This article reviews these physical activity monitors and describes the advantages and disadvantages of each. PMID:19885145

Evidence and Perspectives on the 24-hour Management of Hypertension: Hemodynamic Biomarker-Initiated 'Anticipation Medicine' for Zero Cardiovascular Event.

PubMed

Kario, Kazuomi

There are notable differences between Asians and Westerners regarding hypertension (HTN) and the relationship between HTN and cardiovascular disease (CVD). Asians show greater morning surges in blood pressure (BP) and a steeper slope illustrating the link between higher BP and the risk of CVD events. It is thus particularly important for Asian hypertensives to achieve 24-h BP control, including morning and night-time control. There are three components of 'perfect 24-h BP control:' the 24-h BP level, nocturnal BP dipping, and BP variability (BPV), such as the morning BP surge that can be assessed by ambulatory BP monitoring. The morning BP-guided approach using home BP monitoring (HBPM) is the first step toward perfect 24-h BP control, followed by the control of nocturnal HTN. We have been developing new HBPM devices that can measure nocturnal BP. BPV includes different time-phase variability from the shortest beat-by-beat, positional, diurnal, day-by-day, visit-to-visit, seasonal, and yearly changes. The synergistic resonance of each type of BPV would produce a great dynamic BP surge (resonance hypothesis), which triggers a CVD event, especially in the high-risk patients with systemic hemodynamic atherothrombotic syndrome (SHATS). In the future, the innovative management of HTN based on the simultaneous assessment of the resonance of all of the BPV phenotypes using a beat by beat wearable 'surge' BP monitoring device (WSP) and an information and communication technology (ICT)-based data analysis system will produce a paradigm shift from 'dots' BP management to 'seamless' ultimate individualized 'anticipation medication' for reaching a zero CVD event rate. Copyright © 2016 The Author. Published by Elsevier Inc. All rights reserved.

Efficacy of intrathoracic impedance and remote monitoring in patients with an implantable device after the 2011 great East Japan earthquake.

PubMed

Suzuki, Hitoshi; Yamada, Shinya; Kamiyama, Yoshiyuki; Takeishi, Yasuchika

2014-01-01

Several studies have revealed that stress after catastrophic disasters can trigger cardiovascular events, however, little is known about its association with the occurrence of heart failure in past earthquakes. The objective of the present study was to determine whether the Great East Japan Earthquake on March 11, 2011, increased the incidence of worsening heart failure in chronic heart failure (CHF) patients with implantable devices. Furthermore, we examined whether intrathoracic impedance using remote monitoring was effective for the management of CHF.We enrolled 44 CHF patients (32 males, mean age 63 ± 12 years) with implantable devices that can check intrathoracic impedance using remote monitoring. We defined the worsening heart failure as accumulated impedance under reference impedance exceeding 60 ohms-days (fluid index threshold), and compared the incidence of worsening heart failure and arrhythmic events 30 days before and after March 11.Within the 30 days after March 11, 10 patients exceeded the threshold compared with only 2 patients in the preceding 30 days (P < 0.05). Although 9 patients using remote monitoring among the 10 patients with threshold crossings were not hospitalized, one patient without the system was hospitalized due to acute decompensated heart failure. On the contrary, arrhythmic events did not change between before and after March 11.Our results suggest that earthquake-induced stress causes an increased risk of worsening heart failure without changes in arrhythmia. Furthermore, intrathoracic impedance using remote monitoring may be a useful tool for the management of CHF in catastrophic disasters.

SenseMyHeart: A cloud service and API for wearable heart monitors.

PubMed

Pinto Silva, P M; Silva Cunha, J P

2015-01-01

In the era of ubiquitous computing, the growing adoption of wearable systems and body sensor networks is trailing the path for new research and software for cardiovascular intensity, energy expenditure and stress and fatigue detection through cardiovascular monitoring. Several systems have received clinical-certification and provide huge amounts of reliable heart-related data in a continuous basis. PhysioNet provides equally reliable open-source software tools for ECG processing and analysis that can be combined with these devices. However, this software remains difficult to use in a mobile environment and for researchers unfamiliar with Linux-based systems. In the present paper we present an approach that aims at tackling these limitations by developing a cloud service that provides an API for a PhysioNet-based pipeline for ECG processing and Heart Rate Variability measurement. We describe the proposed solution, along with its advantages and tradeoffs. We also present some client tools (windows and Android) and several projects where the developed cloud service has been used successfully as a standard for Heart Rate and Heart Rate Variability studies in different scenarios.

21 CFR 870.1670 - Syringe actuator for an injector.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Syringe actuator for an injector. 870.1670 Section 870.1670 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1670 Syringe...

21 CFR 870.3260 - Vena cava clip.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vena cava clip. 870.3260 Section 870.3260 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3260 Vena cava clip. (a) Identification. A vena...

21 CFR 870.1330 - Catheter guide wire.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Catheter guide wire. 870.1330 Section 870.1330...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1330 Catheter guide wire. (a) Identification. A catheter guide wire is a coiled wire that is designed to fit inside a...

21 CFR 870.1330 - Catheter guide wire.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Catheter guide wire. 870.1330 Section 870.1330...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1330 Catheter guide wire. (a) Identification. A catheter guide wire is a coiled wire that is designed to fit inside a...

21 CFR 870.1670 - Syringe actuator for an injector.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Syringe actuator for an injector. 870.1670 Section 870.1670 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1670 Syringe...

21 CFR 870.3260 - Vena cava clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vena cava clip. 870.3260 Section 870.3260 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3260 Vena cava clip. (a) Identification. A vena...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker repair or replacement material. 870.3710 Section 870.3710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker...

21 CFR 870.5150 - Embolectomy catheter.

Code of Federal Regulations, 2014 CFR

2014-04-01

... thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Embolectomy catheter. 870.5150 Section 870.5150...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5150 Embolectomy catheter...

21 CFR 870.5150 - Embolectomy catheter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Embolectomy catheter. 870.5150 Section 870.5150...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5150 Embolectomy catheter...

21 CFR 870.5150 - Embolectomy catheter.

Code of Federal Regulations, 2013 CFR

2013-04-01

... thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Embolectomy catheter. 870.5150 Section 870.5150...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5150 Embolectomy catheter...

21 CFR 870.5150 - Embolectomy catheter.

Code of Federal Regulations, 2012 CFR

2012-04-01

... thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Embolectomy catheter. 870.5150 Section 870.5150...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5150 Embolectomy catheter...

[Subcutaneous ureteral bypass devices as a treatment option for bilateral ureteral obstruction in a cat with ureterolithiasis].

PubMed

Heilmann, Romy M; Pashmakova, Medora; Lamb, Jodie H; Spaulding, Kathy A; Cook, Audrey K

2016-06-16

A 6-year-old female spayed Domestic Shorthair cat was presented with acute lethargy, dehydration, marked azotemia, metabolic acidosis, left-sided renomegaly, and bilateral hydronephrosis. Ureterolithiasis and ureteral obstruction were suspected based on further diagnostics including abdominal sonography. Medical treatment was not successful. Fluoroscopically guided antegrade pyelography confirmed the diagnosis of bilateral ureteral obstruction due to ureterolithiasis. Subcutaneous ureteral bypass (SUB) devices were placed bilaterally, followed by close patient monitoring. Frequent reassessment of patient parameters and blood work served to adjust the fluid needs of the patient and to ensure proper hydration, correction of azotemia at an appropriate rate, and cardiovascular stability. After significant improvement of all patient parameters within 5 days, the patient was discharged from the hospital. Treatment included a dietary change to reduce the risk of stone formation as well as a phosphorus binder. Clinical and clinicopathologic parameters were unchanged at the 1- and 4- and 7-month rechecks (consistent with IRIS CKD stage II-NP-AP0), and both SUB devices continued to provide unobstructed urine flow. Bilateral placement of subcutaneous ureteral bypass devices may be a safe and potentially effective treatment option for acute bilateral ureteral obstruction in cats with ureterolithiasis. Strict patient monitoring and patient-centered postoperative treatment decisions are crucial to successful treatment outcomes.

Diagnostic and therapeutic yield of a patient-controlled portable EEG device with dry electrodes for home-monitoring neurological outpatients-rationale and protocol of the HOMEONE pilot study.

PubMed

Neumann, Thomas; Baum, Anne Katrin; Baum, Ulrike; Deike, Renate; Feistner, Helmut; Hinrichs, Hermann; Stokes, Joseph; Robra, Bernt-Peter

2018-01-01

The HOME ONE study is part of the larger HOME project, which aims to provide evidence of diagnostic and therapeutic yield ("change of management") of a patient-controlled portable EEG device with dry electrodes for the purposes of EEG home-monitoring neurological outpatients. The HOME ONE study is the first step in the process of investigating whether outpatient EEG home-monitoring changes the diagnosis and treatment of patients in comparison to conventional EEG ("change of management"). Both EEG devices (conventional and portable) will be systematically compared via a two-phase intra-individual assessment.In the first phase (pilot study phase), both EEG devices will be used within neurologist practices (all other things being equal). This pilot study (involving 130 patients) will evaluate the technical usability and efficacy of the new portable dry electrode EEG recorder in comparison to conventional EEG devices. Judgements will be based on technical assessments and EEG record examinations of private practitioners and two experienced neurologists (percent of concordant readings and kappa values).The second phase (feasibility study phase) aims to assess patients' acceptability and feasibility of the EEG home-monitoring and will provide insights into the extent diagnostic and therapeutic yields can be expected.For this purpose, a conventional EEG will be recorded in neurologist practices. Thereafter, the practice staff will instruct the patients on how the portable EEG device functions. The patients will subsequently use the devices in their home environment.The evaluation will compare the before and after documented diagnostic findings and the therapeutic consequences of the private practitioners with those of two experienced neurologists. To the best of our knowledge, this will be the first study of its kind to examine new approaches to diagnosing unclear consciousness disorders or other disorders of the CNS or the cardiovascular system through the use of a patient-controlled portable EEG device with dry electrodes for the purpose of home-monitoring neurological outpatients. If the two phases of the HOME ONE study provide sufficient evidence of diagnostic and therapeutic yields, this would justify (indication-specific) full-scale randomized controlled trials or observational studies. DRKS DRKS00012685. Registered 9 August 2017, retrospectively registered.

Disease management: atrial fibrillation and home monitoring.

PubMed

Ricci, Renato Pietro

2013-06-01

Device-detected atrial fibrillation (AF) episodes predict poor clinical outcome regardless of symptoms. Potential benefits of remote monitoring are early arrhythmia detection and patient continuous monitoring. Several studies of device remote monitoring consistently demonstrated that AF represents the most common clinical alert and that detailed information on arrhythmia onset, duration, and burden as well as on the ventricular rate may be early available for clinical evaluation. Reaction time to AF alerts was very short in all series involving either pacemakers or defibrillators and action ability of AF alerts was very high. In the Home Guide Registry, in which 1650 patients were enrolled, AF was detected in 16.3% of patients and represented 36% of all cardiovascular events during the follow-up. Timely anticoagulation introduction in asymptomatic patients may impact on the stroke rate. According to the results of repeated Monte Carlo simulations based on a real population of 166 patients, daily monitoring may reduce the 2-year stroke risk by 9-18% with an absolute reduction of 0.2-0.6%, compared with conventional inter-visit intervals of 6-12 months. In the COMPAS trial, the incidence of hospitalizations for atrial arrhythmias and related stroke was significantly higher in the control group than in the remote monitoring group. Major questions will be addressed by the ongoing IMPACT trial in which a remote monitoring guided anticoagulation strategy based on AF detection will be compared with a physician-directed standard strategy. In patients with heart failure, AF early detection combined with other indexes may help prevent hospitalizations.

Dry Electrodes for ECG and Pulse Transit Time for Blood Pressure: A Wearable Sensor and Smartphone Communication Approach

NASA Astrophysics Data System (ADS)

Shyamkumar, Prashanth

Cardiovascular Diseases (CVDs) have been a major cause for deaths in both men and women in United States. Cerebrovascular Diseases like Strokes are known to have origins in CVDs as well. Moreover, nearly 18 Million Americans have a history of myocardial infarction and are currently undergoing cardiac rehabilitation. Consequently, CVDs are the highest costing disease groups and cost more than all types of cancer combined. However, significant cost reduction is possible through the effective use of the vast advances in embedded and pervasive electronic devices for healthcare. These devices can automate and move a significant portion of disease management to the patient's home through cyber connectivity, a concept known as point-of-care (POC) diagnostics and healthcare services. POC can minimize hospital visits and potentially avoid admission altogether with prognostic tools that give advanced notice of any abnormalities or chronic illnesses so that the treatment can be planned in advance. The POC concept requires continuous remote health monitoring. Therefore, the various sensors needed for comprehensive monitoring need to be worn daily and throughout the day. Moreover, true "roaming" capability is necessary so that it does not restrict the user's travel or his/her quotidian activities. Two biomedical signals namely, Electrocardiogram (ECG) and Blood Pressure are important diagnostic tests in assessing the cardiac health of a person. To that end, the research presented in this thesis: First , describes the development of a remote monitoring solution based on Bluetooth(TM), smartphones and cyber infrastructure for cardiac care called e-nanoflex. Second, Sensors for ECG that are compatible with everyday life style namely, (a) dry, gel-less vertically aligned gold nanowire electrodes, (b) dry textile-based conductive sensor electrodes to address the need for this technology to monitor cardiovascular diseases in women are tested with e-nanoflex and discussed. Third, non-invasive, cuff-less Blood pressure estimation based on Pulse Transit Time with multiple synchronized sensor nodes, is implemented with e-nanoflex and the results are discussed.

Improving hemodynamics of cardiovascular system under a novel intraventricular assist device support via modeling and simulations.

PubMed

Zhu, Shidong; Luo, Lin; Yang, Bibo; Li, Xinghui; Wang, Xiaohao

2017-12-01

Ventricular assist devices (LVADs) are increasingly recognized for supporting blood circulation in heart failure patients who are non-transplant eligible. Because of its volume, the traditional pulsatile device is not easy to implant intracorporeally. Continuous flow LVADs (CF-LVADs) reduce arterial pulsatility and only offer continuous flow, which is different from physiological flow, and may cause long-term complications in the cardiovascular system. The aim of this study was to design a new pulsatile assist device that overcomes this disadvantage, and to test this device in the cardiovascular system. Firstly, the input and output characteristics of the new device were tested in a simple cardiovascular mock system. A detailed mathematical model was established by fitting the experimental data. Secondly, the model was tested in four pathological cases, and was simulated and coupled with a fifth-order cardiovascular system and a new device model using Matlab software. Using assistance of the new device, we demonstrated that the left ventricle pressure, aortic pressure, and aortic flow of heart failure patients improved to the levels of a healthy individual. Especially, in state IV level heart failure patients, the systolic blood pressure increased from 81.34 mmHg to 132.1 mmHg, whereas the diastolic blood pressure increased from 54.28 mmHg to 78.7 mmHg. Cardiac output increased from 3.21 L/min to 5.16 L/min. The newly-developed assist device not only provided a physiological flow that was similar to healthy individuals, but also effectively improved the ability of the pathological ventricular volume. Finally, the effects of the new device on other hemodynamic parameters are discussed.

76 FR 43582 - Cardiovascular Devices; Classification of Electrocardiograph Electrodes

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2007-N-0092] (Formerly Docket No. 2007N-0308) Cardiovascular Devices; Classification of... amended as follows: [[Page 43585

Development of exercise devices to minimize musculoskeletal and cardiovascular deconditioning in microgravity

NASA Technical Reports Server (NTRS)

Schwandt, Douglas F.; Whalen, Robert T.; Watenpaugh, Donald E.; Parazynski, Scott E.; Hargens, Alan R.

1991-01-01

The paper describes three exercise devices, developed at the NASA-Ames Research Center, for maintaining musculoskeletal and cardiovascular fitness in astronauts during extended space flights. These devices represent the following exercise concepts: (1) exercise against LBNP, (2) instrumented dynamic interlimb resistance, and (3) multiple resistive exercise. The three devices complement each other to provide the aerobic and strength training exercises for different situations. All three devices permit eccentric, concentric, and isometric contractions for a variety of exercises.

2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care (Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention).

PubMed

Rihal, Charanjit S; Naidu, Srihari S; Givertz, Michael M; Szeto, Wilson Y; Burke, James A; Kapur, Navin K; Kern, Morton; Garratt, Kirk N; Goldstein, James A; Dimas, Vivian; Tu, Thomas

2015-06-01

Although historically the intra-aortic balloon pump has been the only mechanical circulatory support device available to clinicians, a number of new devices have become commercially available and have entered clinical practice. These include axial flow pumps, such as Impella(®); left atrial to femoral artery bypass pumps, specifically the TandemHeart; and new devices for institution of extracorporeal membrane oxygenation. These devices differ significantly in their hemodynamic effects, insertion, monitoring, and clinical applicability. This document reviews the physiologic impact on the circulation of these devices and their use in specific clinical situations. These situations include patients undergoing high-risk percutaneous coronary intervention, those presenting with cardiogenic shock, and acute decompensated heart failure. Specialized uses for right-sided support and in pediatric populations are discussed and the clinical utility of mechanical circulatory support devices is reviewed, as are the American College of Cardiology/American Heart Association clinical practice guidelines. Copyright © 2015. Published by Elsevier Inc.

A Novel Bioreactor System for the Assessment of Endothelialization on Deformable Surfaces

PubMed Central

Bachmann, Björn J.; Bernardi, Laura; Loosli, Christian; Marschewski, Julian; Perrini, Michela; Ehrbar, Martin; Ermanni, Paolo; Poulikakos, Dimos; Ferrari, Aldo; Mazza, Edoardo

2016-01-01

The generation of a living protective layer at the luminal surface of cardiovascular devices, composed of an autologous functional endothelium, represents the ideal solution to life-threatening, implant-related complications in cardiovascular patients. The initial evaluation of engineering strategies fostering endothelial cell adhesion and proliferation as well as the long-term tissue homeostasis requires in vitro testing in environmental model systems able to recapitulate the hemodynamic conditions experienced at the blood-to-device interface of implants as well as the substrate deformation. Here, we introduce the design and validation of a novel bioreactor system which enables the long-term conditioning of human endothelial cells interacting with artificial materials under dynamic combinations of flow-generated wall shear stress and wall deformation. The wall shear stress and wall deformation values obtained encompass both the physiological and supraphysiological range. They are determined through separate actuation systems which are controlled based on validated computational models. In addition, we demonstrate the good optical conductivity of the system permitting online monitoring of cell activities through live-cell imaging as well as standard biochemical post-processing. Altogether, the bioreactor system defines an unprecedented testing hub for potential strategies toward the endothelialization or re-endothelialization of target substrates. PMID:27941901

A device for rapid and quantitative measurement of cardiac myocyte contractility

NASA Astrophysics Data System (ADS)

Gaitas, Angelo; Malhotra, Ricky; Li, Tao; Herron, Todd; Jalife, José

2015-03-01

Cardiac contractility is the hallmark of cardiac function and is a predictor of healthy or diseased cardiac muscle. Despite advancements over the last two decades, the techniques and tools available to cardiovascular scientists are limited in their utility to accurately and reliably measure the amplitude and frequency of cardiomyocyte contractions. Isometric force measurements in the past have entailed cumbersome attachment of isolated and permeabilized cardiomyocytes to a force transducer followed by measurements of sarcomere lengths under conditions of submaximal and maximal Ca2+ activation. These techniques have the inherent disadvantages of being labor intensive and costly. We have engineered a micro-machined cantilever sensor with an embedded deflection-sensing element that, in preliminary experiments, has demonstrated to reliably measure cardiac cell contractions in real-time. Here, we describe this new bioengineering tool with applicability in the cardiovascular research field to effectively and reliably measure cardiac cell contractility in a quantitative manner. We measured contractility in both primary neonatal rat heart cardiomyocyte monolayers that demonstrated a beat frequency of 3 Hz as well as human embryonic stem cell-derived cardiomyocytes with a contractile frequency of about 1 Hz. We also employed the β-adrenergic agonist isoproterenol (100 nmol l-1) and observed that our cantilever demonstrated high sensitivity in detecting subtle changes in both chronotropic and inotropic responses of monolayers. This report describes the utility of our micro-device in both basic cardiovascular research as well as in small molecule drug discovery to monitor cardiac cell contractions.

Screening for obstructive sleep apnea syndrome in patients with type 2 diabetes mellitus: a prospective study on sensitivity of Berlin and STOP-Bang questionnaires.

PubMed

Westlake, Katerina; Plihalova, Andrea; Pretl, Martin; Lattova, Zuzana; Polak, Jan

2016-10-01

Obstructive sleep apnea (OSA) is highly prevalent in patients with Type 2 diabetes mellitus representing an additional risk factor for already increased cardiovascular mortality. As cardiovascular diseases are the main cause of death in this population, there is a need to identify patients with moderate to severe OSA indicated for treatment. We aimed to evaluate the performance of the Berlin, STOP, and STOP-Bang screening questionnaires in a population of patients with Type 2 diabetes mellitus. 294 consecutive patients with Type 2 diabetes mellitus filled in the questionnaires and underwent overnight home sleep monitoring using a type IV sleep monitor. Severe, moderate, and mild OSA was found in 31 (10%), 61 (21%), and 121 (41%) patients, respectively. The questionnaires showed a similar sensitivity and specificity for AHI ≥ 15: 0.69 and 0.50 for Berlin, 0.65 and 0.49 for STOP, and 0.59 and 0.68 for STOP-Bang. However, the performance of the STOP-Bang questionnaire was different in men vs. women, sensitivity being 0.74 vs. 0.29 (p < 0.05) and specificity 0.56 vs. 0.82 (p < 0.05). Even the best-performing Berlin questionnaire failed to identify 31% of patients with moderate to severe OSA as being at high risk of OSA, thus preventing them from receiving a correct diagnosis and treatment. Considering that patients with Type 2 diabetes mellitus are at high risk of cardiovascular mortality and also have a high prevalence of moderate to severe OSA, we find screening based on the questionnaires suboptimal and suggest that OSA screening should be performed using home sleep monitoring devices. Copyright © 2016 Elsevier B.V. All rights reserved.

Predictable And SuStainable Implementation Of National Cardiovascular Registries Infrastructure: A Think Tank Report from MDEpiNet

PubMed Central

Zeitler, Emily P.; Al-Khatib, Sana M.; Drozda, Joseph P.; Kessler, Larry G.; Kirtane, Ajay J.; Kong, David F.; Laschinger, John; Marinac-Dabic, Danica; Morice, Marie-Claude; Reed, Terrie; Sedrakyan, Art; Stein, Kenneth M.; Tcheng, James; Krucoff, Mitchell W.

2015-01-01

The Medical Device Epidemiological Network Initiative (MDEpiNet) is a public-private partnership between the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and participating partners. The Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) program is an MDEpiNet-sponsored program which aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle (TPLC). To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included four areas of cardiovascular medicine intended to cultivate interest in four MDEpiNet Disease Specific/Device Specific Working Groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the Working Groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program. PMID:26699602

Measurement of total hemoglobin reduces red cell transfusion in hospitalized patients undergoing cardiac surgery: a retrospective database analysis.

PubMed

Craver, Christopher; Belk, Kathy W; Myers, Gerard J

2018-01-01

Historically, perioperative hemoglobin monitoring has relied on calculated saturation, using blood gas devices that measure plasma hematocrit (Hct). Co-oximetry, which measures total hemoglobin (tHb), yields a more comprehensive assessment of hemodilution. The purpose of this study was to examine the association of tHb measurement by co-oximetry and Hct, using conductivity with red blood cell (RBC) transfusion, length of stay (LOS) and inpatient costs in patients having major cardiac surgery. A retrospective study was conducted on patients who underwent coronary artery bypass graft (CABG) and/or valve replacement (VR) procedures from January 2014 to June 2016, using MedAssets discharge data. The patient population was sub-divided by the measurement modality (tHb and Hct), using detailed billing records and Current Procedural Terminology coding. Cost was calculated using hospital-specific cost-to-charge ratios. Multivariable logistic regression was performed to identify significant drivers of RBC transfusion and resource utilization. The study population included 18,169 cardiovascular surgery patients. Hct-monitored patients accounted for 66% of the population and were more likely to have dual CABG and VR procedures (10.4% vs 8.9%, p=0.0069). After controlling for patient and hospital characteristics, as well as patient comorbidities, Hct-monitored patients had significantly higher RBC transfusion risk (OR=1.26, CI 1.15-1.38, p<0.0001), longer LOS (IRR=1.08, p<0.0001) and higher costs (IRR=1.15, p<0.0001) than tHb-monitored patients. RBC transfusions were a significant driver of LOS (IRR=1.25, p<0.0001) and cost (IRR=1.22, p<0.0001). tHb monitoring during cardiovascular surgery could offer a significant reduction in RBC transfusion, length of stay and hospital cost compared to Hct monitoring.

76 FR 47143 - Approval for Manufacturing Authority, Foreign-Trade Zone 153; Abbott Cardiovascular Systems, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

... Authority, Foreign-Trade Zone 153; Abbott Cardiovascular Systems, Inc., (Cardiovascular Devices), Riverside... of Abbott Cardiovascular Systems, Inc., within Sites 11-13 of FTZ 153, located in Riverside County... behalf of Abbott Cardiovascular Systems, Inc., as described in the application and Federal Register...

Effectiveness of a Self-monitoring Device for Urinary Sodium-to-Potassium Ratio on Dietary Improvement in Free-Living Adults: a Randomized Controlled Trial

PubMed Central

Ueshima, Hirotsugu; Ohgami, Naoto; Yamashita, Hideyuki; Miyagawa, Naoko; Kondo, Keiko; Torii, Sayuki; Yoshita, Katsushi; Shiga, Toshikazu; Ohkubo, Takayoshi; Arima, Hisatomi; Miura, Katsuyuki

2018-01-01

Background Reducing the urinary sodium-to-potassium ratio is important for reducing both blood pressure and risk of cardiovascular disease. Among free-living Japanese individuals, we carried out a randomized trial to clarify the effect of lifestyle modification for lowering urinary sodium-to-potassium ratio using a self-monitoring device. Methods This was an open, prospective, parallel randomized, controlled trial. Ninety-two individuals were recruited from Japanese volunteers. Participants were randomly allocated into intervention and control groups. A month-long dietary intervention on self-monitoring urinary sodium-to-potassium ratio was carried out using monitors (HEU-001F, OMRON Healthcare Co., Ltd., Kyoto, Japan). All participants had brief dietary education and received a leaflet as usual care. Monitors were handed out to the intervention group, but not to the control group. The intervention group was asked to measure at least one spot urine sodium-to-potassium ratio daily, and advised to lower their sodium-to-potassium ratio toward the target of less than 1. Outcomes included changes in 24-hour urinary sodium-to-potassium ratio, sodium excretion, potassium excretion, blood pressure, and body weight in both groups. Results Mean measurement frequency of monitoring was 2.8 times/day during the intervention. Changes in urinary sodium-to-potassium ratio were −0.55 in the intervention group and −0.06 in the control group (P = 0.088); respective sodium excretion changes were −18.5 mmol/24 hours and −8.7 mmol/24 hours (P = 0.528); and corresponding potassium excretion was 2.6 mmol/24 hours and −1.5 mmol/24 hours (P = 0.300). No significant reductions were observed in either blood pressure or body weight after the intervention. Conclusions Providing the device to self-monitor a sodium-to-potassium ratio did not achieve the targeted reduction of the ratio in “pure self-management” settings, indicating further needs to study an effective method to enhance the synergetic effect of dietary programs and self-monitoring practice to achieve the reduction. However, we cannot deny the possibility of reducing sodium-to-potassium ratio using a self-monitoring device. PMID:29093302

Comparision and analysis of top 10 exercise android Apps in mainland China.

PubMed

Wang, Yanling; Sun, Liu; Xu, Yahong; Xiao, Qian; Chang, Polun; Wu, Ying

2015-01-01

Medical guidelines highly recommend physical activity and aerobic exercise in the prevention of primary and secondary cardiovascular disease. The use of exercise-promoting application software may improve clinical outcomes for cardiovascular disease (CVD) patients. The study aimed to compare and analyze the functions of the top 10 exercise Android Apps which had more than 1,000,000 downloads from the main four Android App stores in mainland China. The results showed that most of these popular apps had pedometer, exercise plan preset, user data presentation, user encouragement and community sharing functions while a few of them had exercise video clips or animation support and wearable devices. Given these data, the conclusion is that these popular apps fulfill some of the functions recommended by medical guidelines, however, lack of some functions such as pre-exercise risk assessment, the exercise intensity recording, specific instructions by professionals, and monitoring functions for CVD patients.

Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial.

PubMed

Reddy, Vivek Y; Sievert, Horst; Halperin, Jonathan; Doshi, Shephal K; Buchbinder, Maurice; Neuzil, Petr; Huber, Kenneth; Whisenant, Brian; Kar, Saibal; Swarup, Vijay; Gordon, Nicole; Holmes, David

2014-11-19

While effective in preventing stroke in patients with atrial fibrillation (AF), warfarin is limited by a narrow therapeutic profile, a need for lifelong coagulation monitoring, and multiple drug and diet interactions. To determine whether a local strategy of mechanical left atrial appendage (LAA) closure was noninferior to warfarin. PROTECT AF was a multicenter, randomized (2:1), unblinded, Bayesian-designed study conducted at 59 hospitals of 707 patients with nonvalvular AF and at least 1 additional stroke risk factor (CHADS2 score ≥1). Enrollment occurred between February 2005 and June 2008 and included 4-year follow-up through October 2012. Noninferiority required a posterior probability greater than 97.5% and superiority a probability of 95% or greater; the noninferiority margin was a rate ratio of 2.0 comparing event rates between treatment groups. Left atrial appendage closure with the device (n = 463) or warfarin (n = 244; target international normalized ratio, 2-3). A composite efficacy end point including stroke, systemic embolism, and cardiovascular/unexplained death, analyzed by intention-to-treat. At a mean (SD) follow-up of 3.8 (1.7) years (2621 patient-years), there were 39 events among 463 patients (8.4%) in the device group for a primary event rate of 2.3 events per 100 patient-years, compared with 34 events among 244 patients (13.9%) for a primary event rate of 3.8 events per 100 patient-years with warfarin (rate ratio, 0.60; 95% credible interval, 0.41-1.05), meeting prespecified criteria for both noninferiority (posterior probability, >99.9%) and superiority (posterior probability, 96.0%). Patients in the device group demonstrated lower rates of both cardiovascular mortality (1.0 events per 100 patient-years for the device group [17/463 patients, 3.7%] vs 2.4 events per 100 patient-years with warfarin [22/244 patients, 9.0%]; hazard ratio [HR], 0.40; 95% CI, 0.21-0.75; P = .005) and all-cause mortality (3.2 events per 100 patient-years for the device group [57/466 patients, 12.3%] vs 4.8 events per 100 patient-years with warfarin [44/244 patients, 18.0%]; HR, 0.66; 95% CI, 0.45-0.98; P = .04). After 3.8 years of follow-up among patients with nonvalvular AF at elevated risk for stroke, percutaneous LAA closure met criteria for both noninferiority and superiority, compared with warfarin, for preventing the combined outcome of stroke, systemic embolism, and cardiovascular death, as well as superiority for cardiovascular and all-cause mortality. clinicaltrials.gov Identifier: NCT00129545.

FDA's perspectives on cardiovascular devices.

PubMed

Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

2009-06-01

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

Diurnal blood pressure changes.

PubMed

Asayama, Kei; Satoh, Michihiro; Kikuya, Masahiro

2018-05-23

The definition of diurnal blood pressure changes varies widely, which can be confusing. Short-term blood pressure variability during a 24-h period and the dipping status of diurnal blood pressure can be captured by ambulatory blood pressure monitoring, and these metrics are reported to have prognostic significance for cardiovascular complications. Morning blood pressure surge also indicates this risk, but its effect may be limited to populations with specific conditions. Meanwhile, the combined use of conventional office blood pressure and out-of-office blood pressure allows us to identify people with white-coat and masked hypertension. Current home devices can measure nocturnal blood pressure during sleep more conveniently than ambulatory monitoring; however, we should pay attention to blood pressure measurement conditions regardless of whether they are in a home, ambulatory, or office setting. The relatively poor reproducibility of diurnal blood pressure changes, including the nocturnal fall of blood pressure, is another underestimated issue to be addressed. Although information on diurnal blood pressure changes is expected to be used more effectively in the future, we should also keep in mind that blood pressure levels have remained central to the primary and secondary prevention of blood pressure-related cardiovascular diseases in clinical practice.

Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery.

PubMed

Tom, James

2016-01-01

The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias.

Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery

PubMed Central

Tom, James

2016-01-01

The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias. PMID:27269668

An electrocardiographic, molecular and biochemical approach to explore the cardioprotective effect of vasopressin and milrinone against phosphide toxicity in rats.

PubMed

Jafari, Abbas; Baghaei, Amir; Solgi, Reza; Baeeri, Maryam; Chamanara, Mohsen; Hassani, Shokoufeh; Gholami, Mahdi; Ostad, Seyed Nasser; Sharifzadeh, Moahmmad; Abdollahi, Mohammad

2015-06-01

The present study was conducted to identify the protective effect of vasopressin (AVP) and milrinone on cardiovascular function, mitochondrial complex activities, cellular ATP reserve, oxidative stress, and apoptosis in rats poisoned by aluminum phosphide (AlP). Rats were divided into five groups (n = 12) including control, AlP (12.5 mg/kg), AlP + AVP (2.0 Units/kg), AlP + milrinone (0.25 mg/kg) and AlP + AVP + milrinone. After treatment, the animals were connected to an electronic cardiovascular monitoring device to monitor electrocardiographic (ECG) parameter. Finally, oxidative stress biomarkers, mitochondrial complex activities, ADP/ATP ratio and apoptosis were evaluated on the heart tissues. Results indicated that AlP administration induced ECG abnormalities along with a decline in blood pressure and heart rate. AVP and milrinone significantly ameliorated these changes in all treated groups. Considerable protective effects on oxidative stress biomarkers, complex IV activity, ADP/ATP ratio and caspase-3 and -9 activities in treated groups were also found. These findings were supported by flow cytometry assay of cardiomyocytes. In conclusion, administration of AVP and milrinone, not only improve cardiovascular functions in AlP poisoned rats in the short time, but after a long time can also restore mitochondrial function and ATP level and reduce the oxidative damage, which prevent cardiomyocytes from entering the apoptotic phase. Copyright © 2015 Elsevier Ltd. All rights reserved.

A fabric wrist patch sensor for continuous and comprehensive monitoring of the cardiovascular system.

PubMed

Kwonjoon Lee; Kiseok Song; Taehwan Roh; Hoi-Jun Yoo

2016-08-01

The wrist patch-type ECG/APW sensor system is proposed for continuous and comprehensive monitoring of the patient's cardiovascular system. The wrist patch-type ECG/APW sensor system is consists of ECG/APW sensor, ECG/APW electrodes, and base station for real-time monitoring of the patient's status. The ECG/APW sensor and electrodes are composed of wrist patch, bandage-type ECG electrode and fabric APW electrode, respectively so that the patient's cardiovascular system can be continuously monitored in daily life with free hand-movement. Since the proposed wrist patchtype ECG/APW sensor simultaneously measures ECG/APW, the cardiac indicators, such as HR and PAT, can be extracted for comprehensive and accurate monitoring of the patient's cardiovascular system. The proposed wrist patch-type ECG/APW sensor system is successfully verified using the commercial PPG sensor (RP520) and demonstrated with the customized Android application on the smart phone.

Development of a wearable multi-frequency impedance cardiography device.

PubMed

Weyer, Sören; Menden, Tobias; Leicht, Lennart; Leonhardt, Steffen; Wartzek, Tobias

2015-02-01

Cardiovascular diseases as well as pulmonary oedema can be early diagnosed using vital signs and thoracic bio-impedance. By recording the electrocardiogram (ECG) and the impedance cardiogram (ICG), vital parameters are captured continuously. The aim of this study is the continuous monitoring of ECG and multi-frequency ICG by a mobile system. A mobile measuring system, based on 'low-power' ECG, ICG and an included radio transmission is described. Due to the high component integration, a board size of only 6.5 cm×5 cm could be realized. The measured data can be transmitted via Bluetooth and visualized on a portable monitor. By using energy-efficient hardware, the system can operate for up to 18 hs with a 3 V battery, continuously sending data via Bluetooth. Longer operating times can be realized by decreased transfer rates. The relative error of the impedance measurement was less than 1%. The ECG and ICG measurements allow an approximate calculation of the heart stroke volume. The ECG and the measured impedance showed a high correlation to commercial devices (r=0.83, p<0.05). In addition to commercial devices, the developed system allows a multi-frequency measurement of the thoracic impedance between 5-150 kHz.

21 CFR 870.3470 - Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Intracardiac patch or pledget made of... CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3470 Intracardiac patch or pledget made of... or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric...

21 CFR 870.3470 - Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Intracardiac patch or pledget made of... CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3470 Intracardiac patch or pledget made of... or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric...

21 CFR 870.3470 - Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or...

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intracardiac patch or pledget made of... CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3470 Intracardiac patch or pledget made of... or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric...

21 CFR 870.3470 - Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or...

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Intracardiac patch or pledget made of... CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3470 Intracardiac patch or pledget made of... or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric...

21 CFR 870.3470 - Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Intracardiac patch or pledget made of... CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3470 Intracardiac patch or pledget made of... or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric...

Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management

PubMed Central

Piette, John D.; List, Justin; Rana, Gurpreet K.; Townsend, Whitney; Striplin, Dana; Heisler, Michele

2015-01-01

We examined evidence on whether mobile health (mHealth) tools, including Interactive Voice Response (IVR) calls, short message service (SMS) or text messaging, and smartphones, can improve lifestyle behaviors and management related to cardiovascular diseases throughout the world. We conducted a state-of-the-art review and literature synthesis of peer-reviewed and grey literature published since 2004. The review prioritized randomized trials and studies focused on cardiovascular diseases and risk factors, but included other reports when they represented the best available evidence. The search emphasized reports on the potential benefits of mHealth interventions implemented in low- and middle-income countries (LMICs). IVR and SMS interventions can improve cardiovascular preventive care in developed countries by addressing risk factors including weight, smoking, and physical activity. IVR and SMS-based interventions for cardiovascular disease management also have shown benefits with respect to hypertension management, hospital readmissions, and diabetic glycemic control. Multi-modal interventions including web-based communication with clinicians and mHealth-enabled clinical monitoring with feedback also have shown benefits. The evidence regarding the potential benefits of interventions using smartphones and social media is still developing. Studies of mHealth interventions have been conducted in more than 30 LMICs, and evidence to date suggests that programs are feasible and may improve medication adherence and disease outcomes. Emerging evidence suggests that mHealth interventions may improve cardiovascular-related lifestyle behaviors and disease management. Next generation mHealth programs developed worldwide should be based on evidence-based behavioral theories and incorporate advances in artificial intelligence for adapting systems automatically to patients’ unique and changing needs. PMID:25690685

Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management

PubMed Central

Piette, John D.; List, Justin; Rana, Gurpreet K.; Townsend, Whitney; Striplin, Dana; Heisler, Michele

2016-01-01

We examined evidence on whether mobile health (mHealth) tools, including Interactive Voice Response (IVR) calls, short message service (SMS) or text messaging, and smartphones, can improve lifestyle behaviors and management related to cardiovascular diseases throughout the world. We conducted a state-of-the-art review and literature synthesis of peer-reviewed and grey literature published since 2004. The review prioritized randomized trials and studies focused on cardiovascular diseases and risk factors, but included other reports when they represented the best available evidence. The search emphasized reports on the potential benefits of mHealth interventions implemented in low- and middle-income countries (LMICs). IVR and SMS interventions can improve cardiovascular preventive care in developed countries by addressing risk factors including weight, smoking, and physical activity. IVR and SMS-based interventions for cardiovascular disease management also have shown benefits with respect to hypertension management, hospital readmissions, and diabetic glycemic control. Multi-modal interventions including web-based communication with clinicians and mHealth-enabled clinical monitoring with feedback also have shown benefits. The evidence regarding the potential benefits of interventions using smartphones and social media is still developing. Studies of mHealth interventions have been conducted in more than 30 LMICs, and evidence to date suggests that programs are feasible and may improve medication adherence and disease outcomes. Emerging evidence suggests that mHealth interventions may improve cardiovascular-related lifestyle behaviors and disease management. Next generation mHealth programs developed worldwide should be based on evidence-based behavioral theories and incorporate advances in artificial intelligence for adapting systems automatically to patients’ unique and changing needs. PMID:26596977

21 CFR 870.2100 - Cardiovascular blood flowmeter.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cardiovascular blood flowmeter. 870.2100 Section... Cardiovascular blood flowmeter. (a) Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow...

21 CFR 870.2100 - Cardiovascular blood flowmeter.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Cardiovascular blood flowmeter. 870.2100 Section... Cardiovascular blood flowmeter. (a) Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow...

21 CFR 870.2100 - Cardiovascular blood flowmeter.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Cardiovascular blood flowmeter. 870.2100 Section... Cardiovascular blood flowmeter. (a) Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow...

21 CFR 870.2100 - Cardiovascular blood flowmeter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiovascular blood flowmeter. 870.2100 Section... Cardiovascular blood flowmeter. (a) Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow...

Distal protection in cardiovascular medicine: current status.

PubMed

Ali, Onn Akbar; Bhindi, Ravinay; McMahon, Aisling C; Brieger, David; Kritharides, Leonard; Lowe, Harry C

2006-08-01

Iatrogenic and spontaneous downstream microembolization of atheromatous material is increasingly recognized as a source of cardiovascular morbidity and mortality. Devising ways of reducing this distal embolization using a variety of mechanical means--distal protection--is currently under intense and diverse investigation. This review therefore summarizes the present status of distal protection. It examines the problem of distal embolization, describes the available distal protection devices, reviews those areas of cardiovascular medicine where distal protection devices are being investigated, and discusses potential future developments.

Feedback from physical activity monitors is not compatible with current recommendations: A recalibration study.

PubMed

Thompson, Dylan; Batterham, Alan M; Peacock, Oliver J; Western, Max J; Booso, Rahuman

2016-10-01

Wearable devices to self-monitor physical activity have become popular with individuals and healthcare practitioners as a route to the prevention of chronic disease. It is not currently possible to reconcile feedback from these devices with activity recommendations because the guidelines refer to the amount of activity required on top of normal lifestyle activities (e.g., 150 minutes of moderate-to-vigorous intensity activity per week over-and-above normal moderate-to-vigorous lifestyle activities). The aim of this study was to recalibrate the feedback from self-monitoring. We pooled data from four studies conducted between 2006 and 2014 in patients and volunteers from the community that included both sophisticated measures of physical activity and 10-year risk for cardiovascular disease and type 2 diabetes (n=305). We determined the amount of moderate-to-vigorous intensity activity that corresponded to FAO/WHO/UNU guidance for a required PAL of 1.75 (Total Energy Expenditure/Basal Metabolic Rate). Our results show that, at the UK median PAL, total moderate-to-vigorous intensity physical activity will be around 735 minutes per week (~11% of waking time). We estimate that a 4% increase in moderate-to-vigorous intensity activity will achieve standardised guidance from FAO/WHO/UNU and will require ~1000 minutes of moderate-to-vigorous intensity activity per week. This study demonstrates that feedback from sophisticated wearable devices is incompatible with current physical activity recommendations. Without adjustment, people will erroneously form the view that they are exceeding recommendations by several fold. A more appropriate target from self-monitoring that accounts for normal moderate-to-vigorous lifestyle activities is ~1000 minutes per week, which represents ~15% of waking time. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Verification of a computational cardiovascular system model comparing the hemodynamics of a continuous flow to a synchronous valveless pulsatile flow left ventricular assist device.

PubMed

Gohean, Jeffrey R; George, Mitchell J; Pate, Thomas D; Kurusz, Mark; Longoria, Raul G; Smalling, Richard W

2013-01-01

The purpose of this investigation is to use a computational model to compare a synchronized valveless pulsatile left ventricular assist device with continuous flow left ventricular assist devices at the same level of device flow, and to verify the model with in vivo porcine data. A dynamic system model of the human cardiovascular system was developed to simulate the support of a healthy or failing native heart from a continuous flow left ventricular assist device or a synchronous pulsatile valveless dual-piston positive displacement pump. These results were compared with measurements made during in vivo porcine experiments. Results from the simulation model and from the in vivo counterpart show that the pulsatile pump provides higher cardiac output, left ventricular unloading, cardiac pulsatility, and aortic valve flow as compared with the continuous flow model at the same level of support. The dynamic system model developed for this investigation can effectively simulate human cardiovascular support by a synchronous pulsatile or continuous flow ventricular assist device.

Verification of a computational cardiovascular system model comparing the hemodynamics of a continuous flow to a synchronous valveless pulsatile flow left ventricular assist device

PubMed Central

Gohean, Jeffrey R.; George, Mitchell J.; Pate, Thomas D.; Kurusz, Mark; Longoria, Raul G.; Smalling, Richard W.

2012-01-01

The purpose of this investigation is to utilize a computational model to compare a synchronized valveless pulsatile left ventricular assist device to continuous flow left ventricular assist devices at the same level of device flow, and to verify the model with in vivo porcine data. A dynamic system model of the human cardiovascular system was developed to simulate support of a healthy or failing native heart from a continuous flow left ventricular assist device or a synchronous, pulsatile, valveless, dual piston positive displacement pump. These results were compared to measurements made during in vivo porcine experiments. Results from the simulation model and from the in vivo counterpart show that the pulsatile pump provides higher cardiac output, left ventricular unloading, cardiac pulsatility, and aortic valve flow as compared to the continuous flow model at the same level of support. The dynamic system model developed for this investigation can effectively simulate human cardiovascular support by a synchronous pulsatile or continuous flow ventricular assist device. PMID:23438771

SCCT guidelines on radiation dose and dose-optimization strategies in cardiovascular CT

PubMed Central

Halliburton, Sandra S.; Abbara, Suhny; Chen, Marcus Y.; Gentry, Ralph; Mahesh, Mahadevappa; Raff, Gilbert L.; Shaw, Leslee J.; Hausleiter, Jörg

2012-01-01

Over the last few years, computed tomography (CT) has developed into a standard clinical test for a variety of cardiovascular conditions. The emergence of cardiovascular CT during a period of dramatic increase in radiation exposure to the population from medical procedures and heightened concern about the subsequent potential cancer risk has led to intense scrutiny of the radiation burden of this new technique. This has hastened the development and implementation of dose reduction tools and prompted closer monitoring of patient dose. In an effort to aid the cardiovascular CT community in incorporating patient-centered radiation dose optimization and monitoring strategies into standard practice, the Society of Cardiovascular Computed Tomography has produced a guideline document to review available data and provide recommendations regarding interpretation of radiation dose indices and predictors of risk, appropriate use of scanner acquisition modes and settings, development of algorithms for dose optimization, and establishment of procedures for dose monitoring. PMID:21723512

Digitally enhanced recovery: Investigating the use of digital self-tracking for monitoring leisure time physical activity of cardiovascular disease (CVD) patients undergoing cardiac rehabilitation

PubMed Central

Auinger, Andreas; Riedl, René; Kindermann, Harald; Helfert, Markus; Ocenasek, Helmuth

2017-01-01

Research has shown that physical activity is essential in the prevention and treatment of chronic diseases like cardiovascular disease (CVD). Smart wearables (e.g., smartwatches) are increasingly used to foster and monitor human behaviour, including physical activity. However, despite this increased usage, little evidence is available on the effects of smart wearables in behaviour change. The little research which is available typically focuses on the behaviour of healthy individuals rather than patients. In this study, we investigate the effects of using smart wearables by patients undergoing cardiac rehabilitation. A field experiment involving 29 patients was designed and participants were either assigned to the study group (N = 13 patients who finished the study and used a self-tracking device) or the control group (N = 16 patients who finished the study and did not use a device). For both groups data about physiological performance during cardiac stress test was collected at the beginning (baseline), in the middle (in week 6, at the end of the rehabilitation in the organized rehabilitation setting), and at the end of the study (after 12 weeks, at the end of the rehabilitation, including the organized rehabilitation plus another 6 weeks of self-organized rehabilitation). Comparing the physiological performance of both groups, the data showed significant differences. The participants in the study group not only maintained the same performance level as during the midterm examination in week 6, they improved performance even further during the six weeks that followed. The results presented in this paper provide evidence for positive effects of digital self-tracking by patients undergoing cardiac rehabilitation on performance of the cardiovascular system. In this way, our study provides novel insight about the effects of the use of smart wearables by CVD patients. Our findings have implications for the design of self-management approaches in a patient rehabilitation setting. In essence, the use of smart wearables can prolong the success of the rehabilitation outside of the organized rehabilitation setting. PMID:29020079

Blood Pressure Out of the Office: Its Time Has Finally Come.

PubMed

Krakoff, Lawrence R

2016-03-01

The diagnosis of hypertension includes measurement of blood pressure out of the office by either 24-hour ambulatory monitoring or home blood pressure monitoring. These methods have led to recognition of "white coat hypertension" (WCH) and "masked hypertension" (MH). Research in the 1930s first demonstrated that blood pressures in the office were often far different from those out of the office, at a time when there was no effective treatment. International attention was focused on another imminent world war and a highly controversial election in the United States. Hypertension was not a priority for concern. From the 1950s onward: (i) epidemiology linked hypertension to risk of cardiovascular disease, (ii) effective and safe drugs for treatment of hypertension appeared, (iii) randomized clinical trials demonstrated that drug treatment of hypertension is highly effective for prevention of cardiovascular disease, and (iv) advances in technology led to development of small, portable devices for recording blood pressure noninvasively at home or during usual activities. Accurate measurement of blood pressure in "real life" is now necessary and feasible for appropriate diagnosis and assessment of treatment. Out-of-office blood pressure measurement is emerging as the standard of care for hypertension. © American Journal of Hypertension, Ltd 2015. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Flexible polymer transistors with high pressure sensitivity for application in electronic skin and health monitoring

NASA Astrophysics Data System (ADS)

Schwartz, Gregor; Tee, Benjamin C.-K.; Mei, Jianguo; Appleton, Anthony L.; Kim, Do Hwan; Wang, Huiliang; Bao, Zhenan

2013-05-01

Flexible pressure sensors are essential parts of an electronic skin to allow future biomedical prostheses and robots to naturally interact with humans and the environment. Mobile biomonitoring in long-term medical diagnostics is another attractive application for these sensors. Here we report the fabrication of flexible pressure-sensitive organic thin film transistors with a maximum sensitivity of 8.4 kPa-1, a fast response time of <10 ms, high stability over >15,000 cycles and a low power consumption of <1 mW. The combination of a microstructured polydimethylsiloxane dielectric and the high-mobility semiconducting polyisoindigobithiophene-siloxane in a monolithic transistor design enabled us to operate the devices in the subthreshold regime, where the capacitance change upon compression of the dielectric is strongly amplified. We demonstrate that our sensors can be used for non-invasive, high fidelity, continuous radial artery pulse wave monitoring, which may lead to the use of flexible pressure sensors in mobile health monitoring and remote diagnostics in cardiovascular medicine.

Flexible polymer transistors with high pressure sensitivity for application in electronic skin and health monitoring.

PubMed

Schwartz, Gregor; Tee, Benjamin C-K; Mei, Jianguo; Appleton, Anthony L; Kim, Do Hwan; Wang, Huiliang; Bao, Zhenan

2013-01-01

Flexible pressure sensors are essential parts of an electronic skin to allow future biomedical prostheses and robots to naturally interact with humans and the environment. Mobile biomonitoring in long-term medical diagnostics is another attractive application for these sensors. Here we report the fabrication of flexible pressure-sensitive organic thin film transistors with a maximum sensitivity of 8.4 kPa(-1), a fast response time of <10 ms, high stability over >15,000 cycles and a low power consumption of <1 mW. The combination of a microstructured polydimethylsiloxane dielectric and the high-mobility semiconducting polyisoindigobithiophene-siloxane in a monolithic transistor design enabled us to operate the devices in the subthreshold regime, where the capacitance change upon compression of the dielectric is strongly amplified. We demonstrate that our sensors can be used for non-invasive, high fidelity, continuous radial artery pulse wave monitoring, which may lead to the use of flexible pressure sensors in mobile health monitoring and remote diagnostics in cardiovascular medicine.

Measuring the arterial-induced skin vibration by geometrical moiré fringe

NASA Astrophysics Data System (ADS)

Chiu, Shih-Yung; Wang, Chun-Hsiung; Lee, Shu-Sheng; Wu, Wen-Jong; Hsu, Yu-Hsiang; Lee, Chih-Kung

2018-02-01

The demand for self-measured blood pressure self-monitoring device has much increased due to cardiovascular diseases have become leading causes of death for aging population. Currently, the primary non-invasive blood pressure monitoring method is cuff-based. It is well developed and accurate. However, the measuring process is not comfortable, and it cannot provide a continuous measurement. To overcome this problem, methods such as tonometry, volume clamp method, photoplethysmography, pulse wave velocity, and pulse transit time are reported. However, the limited accuracy hindered its application for diagnostics. To perform sequential blood pressure measurement with a high accuracy and long-term examination, we apply moiré interferometry to measure wrist skin vibration induced by radial artery. To achieve this goal, we developed a miniaturized device that can perform moiré interferometry around the wrist region. The 0.4-mm-pitched binary grating and tattoo sticker with 0.46 mm-pitched stripe pattern are used to perform geometric moiré. We demonstrated that the sensitivity and accuracy of this integrated system were sufficient to monitor arterialinduced skin vibration non-invasively. Our developed system was validated with ECG signals collected by a commercial system. According to our studies from measurement, the repeatability of wrist pulsation measurement was achieved with an accuracy of 99.1% in heart rate. A good repeatability of wrist pulse measurement was achieved. Simulations and experiments are both conducted in this paper and prove of geometrical moiré method a suitable technique for arterial-induced skin vibration monitoring.

Use of paravascular admittance waveforms to monitor relative change in arterial blood pressure

NASA Astrophysics Data System (ADS)

Zielinski, Todd M.; Hettrick, Doug; Cho, Yong

2010-04-01

Non-invasive methods to monitor ambulatory blood pressure often have limitations that can affect measurement accuracy and patient adherence [1]. Minimally invasive measurement of a relative blood pressure surrogate with an implantable device may provide a useful chronic diagnostic and monitoring tool. We assessed a technique that uses electrocardiogram and paravascular admittance waveform morphology analysis to one, measure a time duration (vascular tone index, VTI in milliseconds) change from the electrocardiogram R-wave to admittance waveform peak and two, measure the admittance waveform minimum, maximum and magnitude as indicators of change in arterial compliance/distensibility or pulse pressure secondary to change in afterload. Methods: Five anesthetized domestic pigs (32 ± 4.2 kg) were used to study the effects of phenylephrine (1-5 ug/kg/min) on femoral artery pressure and admittance waveform morphology measured with a quadrapolar electrode array catheter placed next to the femoral artery to assess the relative change in arterial compliance due to change in peripheral vascular tone. Results: Statistical difference was observed (p < 0.05) comparing baseline VTI to phenylephrine VTI (246 ± .05 ms to 320 ± .07 ms) and baseline admittance waveform maximum to phenylephrine admittance waveform maximum (0.0148 ± .002 siemens to 0.0151 ± .002 siemens). Conclusion: Chronic minimally invasive admittance measurement techniques that monitor relative change in blood pressure may be suitable for implantable devices to detect progression of cardiovascular disease such as hypertension.

Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet).

PubMed

Zeitler, Emily P; Al-Khatib, Sana M; Drozda, Joseph P; Kessler, Larry G; Kirtane, Ajay J; Kong, David F; Laschinger, John; Marinac-Dabic, Danica; Morice, Marie-Claude; Reed, Terrie; Sedrakyan, Art; Stein, Kenneth M; Tcheng, James; Krucoff, Mitchell W

2016-01-01

The MDEpiNet is a public-private partnership between the US Food and Drug Administration's Center for Devices and Radiological Health and participating partners. The PASSION program is an MDEpiNet-sponsored program that aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle. To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included 4 areas of cardiovascular medicine intended to cultivate interest in 4 MDEpiNet disease-specific/device-specific working groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the working groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program. Copyright © 2015 Elsevier Inc. All rights reserved.

Utility of hand-held devices in diagnosis and triage of cardiovascular emergencies. Observations during implementation of a PACS-based system in an acute aortic syndrome (AAS) network.

PubMed

Matar, Ralph; Renapurkar, Rahul; Obuchowski, Nancy; Menon, Venu; Piraino, David; Schoenhagen, Paul

2015-01-01

Prompt diagnosis and early referral to specialized centers is critical for patients presenting with cardiovascular emergencies, including acute aortic syndromes (AAS). Prior data has suggested that mobile access to imaging studies with hand-held devices can accelerate diagnosis and management. We conducted a study to determine the diagnostic accuracy of a hand-held device compared to conventional dedicated work-stations for diagnosing a spectrum of cardiovascular emergencies, predominantly acute aortic pathology. This study included 104 cases who underwent computed tomography (CT)-scan during "on-call'' hours between January, 2013 and August, 2014 for suspected AAS. Assessment was performed on a hand-held device independently by two readers using an iPhone5 connected via secure connection to web-based PACS servers. The subsequent interpretation from a dedicated workstation coupled with the diagnosis at the time of discharge was used as the reference standard for determining the presence or absence of an acute abnormality. Sensitivity and Specificity were calculated on a per patient basis. Readers' sensitivity and specificity using the hand-held device to diagnose acute chest pathology were calculated. Hand-held device evaluation was determined to have a sensitivity of 85.2% and a specificity of 98.6% by reader A and a sensitivity of 96.3% and specificity of 100% by reader B. Of 103 cases interpreted by both readers, the readers agreed about the diagnosis in 98 cases (95.1%). This study demonstrates that hand-held devices can be a potential useful tool to assist in diagnosis and triage of patients presenting with cardiovascular emergencies. Further studies are needed to assess the impact of screen size and resolution. Copyright © 2015 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management.

PubMed

Piette, John D; List, Justin; Rana, Gurpreet K; Townsend, Whitney; Striplin, Dana; Heisler, Michele

2015-11-24

We examined evidence on whether mobile health (mHealth) tools, including interactive voice response calls, short message service, or text messaging, and smartphones, can improve lifestyle behaviors and management related to cardiovascular diseases throughout the world. We conducted a state-of-the-art review and literature synthesis of peer-reviewed and gray literature published since 2004. The review prioritized randomized trials and studies focused on cardiovascular diseases and risk factors, but included other reports when they represented the best available evidence. The search emphasized reports on the potential benefits of mHealth interventions implemented in low- and middle-income countries. Interactive voice response and short message service interventions can improve cardiovascular preventive care in developed countries by addressing risk factors including weight, smoking, and physical activity. Interactive voice response and short message service-based interventions for cardiovascular disease management also have shown benefits with respect to hypertension management, hospital readmissions, and diabetic glycemic control. Multimodal interventions including Web-based communication with clinicians and mHealth-enabled clinical monitoring with feedback also have shown benefits. The evidence regarding the potential benefits of interventions using smartphones and social media is still developing. Studies of mHealth interventions have been conducted in >30 low- and middle-income countries, and evidence to date suggests that programs are feasible and may improve medication adherence and disease outcomes. Emerging evidence suggests that mHealth interventions may improve cardiovascular-related lifestyle behaviors and disease management. Next-generation mHealth programs developed worldwide should be based on evidence-based behavioral theories and incorporate advances in artificial intelligence for adapting systems automatically to patients' unique and changing needs. © 2015 American Heart Association, Inc.

Design and implementation of a smartphone-based portable ultrasound pulsed-wave Doppler device for blood flow measurement.

PubMed

Huang, Chih-Chung; Lee, Po-Yang; Chen, Pay-Yu; Liu, Ting-Yu

2012-01-01

Blood flow measurement using Doppler ultrasound has become a useful tool for diagnosing cardiovascular diseases and as a physiological monitor. Recently, pocket-sized ultrasound scanners have been introduced for portable diagnosis. The present paper reports the implementation of a portable ultrasound pulsed-wave (PW) Doppler flowmeter using a smartphone. A 10-MHz ultrasonic surface transducer was designed for the dynamic monitoring of blood flow velocity. The directional baseband Doppler shift signals were obtained using a portable analog circuit system. After hardware processing, the Doppler signals were fed directly to a smartphone for Doppler spectrogram analysis and display in real time. To the best of our knowledge, this is the first report of the use of this system for medical ultrasound Doppler signal processing. A Couette flow phantom, consisting of two parallel disks with a 2-mm gap, was used to evaluate and calibrate the device. Doppler spectrograms of porcine blood flow were measured using this stand-alone portable device under the pulsatile condition. Subsequently, in vivo portable system verification was performed by measuring the arterial blood flow of a rat and comparing the results with the measurement from a commercial ultrasound duplex scanner. All of the results demonstrated the potential for using a smartphone as a novel embedded system for portable medical ultrasound applications. © 2012 IEEE

Real-time prediction of acute cardiovascular events using hardware-implemented Bayesian networks.

PubMed

Tylman, Wojciech; Waszyrowski, Tomasz; Napieralski, Andrzej; Kamiński, Marek; Trafidło, Tamara; Kulesza, Zbigniew; Kotas, Rafał; Marciniak, Paweł; Tomala, Radosław; Wenerski, Maciej

2016-02-01

This paper presents a decision support system that aims to estimate a patient׳s general condition and detect situations which pose an immediate danger to the patient׳s health or life. The use of this system might be especially important in places such as accident and emergency departments or admission wards, where a small medical team has to take care of many patients in various general conditions. Particular stress is laid on cardiovascular and pulmonary conditions, including those leading to sudden cardiac arrest. The proposed system is a stand-alone microprocessor-based device that works in conjunction with a standard vital signs monitor, which provides input signals such as temperature, blood pressure, pulseoxymetry, ECG, and ICG. The signals are preprocessed and analysed by a set of artificial intelligence algorithms, the core of which is based on Bayesian networks. The paper focuses on the construction and evaluation of the Bayesian network, both its structure and numerical specification. Copyright © 2015 Elsevier Ltd. All rights reserved.

Diagnosis and Treatment of the Cardiovascular Consequences of Fabry Disease.

PubMed

Baig, S; Vijapurapu, R; Alharbi, F; Nordin, S; Kozor, R; Moon, J; Bembi, B; Geberhiwot, T; Steeds, R P

2018-06-06

Fabry Disease (FD) has been a diagnostic challenge since it was first recognised in 1898, with patients traditionally suffering from considerable delay before a diagnosis is made. Cardiac involvement is the current leading cause of death in FD. A combination of improved enzyme assays, availability of genetic profiling, together with more organised clinical services for rare diseases, has led to a rapid growth in the prevalence of FD. The earlier and more frequent diagnosis of asymptomatic individuals before development of the phenotype has focussed attention on early detection of organ involvement and closer monitoring of disease progression. The high cost of enzyme replacement therapy at a time of constraint within many health economies moreover, has challenged clinicians to target treatment effectively. This article provides an outline of FD for the general physician and summarises the aetiology and pathology of FD, the cardiovascular (CV) consequences thereof, modalities used in diagnosis, and then discusses current indications for treatment, including pharmacotherapy and device implantation.

Ambulatory blood pressure and cardiovascular events in chronic kidney disease

PubMed Central

Agarwal, Rajiv

2007-01-01

Purpose of review Hypertension is an important risk factor for adverse cardiovascular and renal outcomes particularly in patients with chronic kidney disease. This review compares blood pressure measurements obtained in the clinic with those obtained outside the clinic to predict cardiovascular and renal injury and outcomes. Recent findings Data are accumulating that suggest that ambulatory blood pressure monitoring is a superior prognostic marker compared to blood pressures obtained in the clinic. Use of ambulatory blood pressure monitoring can detect white coat hypertension and masked hypertension which results in less misclassification of blood pressures. Ambulatory blood pressure monitoring is a marker of cardiovascular end points in CKD. Non dipping is associated with proteinuria and lower GFR. Although non-dipping is associated with more ESRD and cardiovascular events, adjustment for other risk factors removes the prognostic significance of non-dipping. For patients with CKD, not on dialysis, 24 hour ambulatory BP of <125/75 mm Hg, daytime ambulatory of <130/85 mm Hg and nighttime ambulatory BP of <110/70 mm Hg appear to be reasonable goal BP targets. In the management of hypertension in patients with CKD, control of hypertension is important. Ambulatory BP monitoring may be useful to assign more aggressive treatment to patients with masked hypertension and withdraw antihypertensive therapy in patients with white-coat hypertension. Summary Ambulatory blood pressure monitoring can refine cardiovascular and renal risk assessment in all stages of chronic kidney disease. The independent prognostic role of non-dipping is unclear. PMID:17868791

Prognostic Significance of Blood Pressure Variability on Beat-to-Beat Monitoring After Transient Ischemic Attack and Stroke.

PubMed

Webb, Alastair J S; Mazzucco, Sara; Li, Linxin; Rothwell, Peter M

2018-01-01

Visit-to-visit and day-to-day blood pressure (BP) variability (BPV) predict an increased risk of cardiovascular events but only reflect 1 form of BPV. Beat-to-beat BPV can be rapidly assessed and might also be predictive. In consecutive patients within 6 weeks of transient ischemic attack or nondisabling stroke (Oxford Vascular Study), BPV (coefficient of variation) was measured beat-to-beat for 5 minutes (Finometer), day-to-day for 1 week on home monitoring (3 readings, 3× daily), and on awake ambulatory BP monitoring. BPV after 1-month standard treatment was related (Cox proportional hazards) to recurrent stroke and cardiovascular events for 2 to 5 years, adjusted for mean systolic BP. Among 520 patients, 26 had inadequate beat-to-beat recordings, and 22 patients were in atrial fibrillation. Four hundred five patients had all forms of monitoring. Beat-to-beat BPV predicted recurrent stroke and cardiovascular events independently of mean systolic BP (hazard ratio per group SD, stroke: 1.47 [1.12-1.91]; P =0.005; cardiovascular events: 1.41 [1.08-1.83]; P =0.01), including after adjustment for age and sex (stroke: 1.47 [1.12-1.92]; P =0.005) and all risk factors (1.40 [1.00-1.94]; P =0.047). Day-to-day BPV was less strongly associated with stroke (adjusted hazard ratio, 1.29 [0.97-1.71]; P =0.08) but similarly with cardiovascular events (1.41 [1.09-1.83]; P =0.009). BPV on awake ambulatory BP monitoring was nonpredictive (stroke: 0.89 [0.59-1.35]; P =0.59; cardiovascular events: 1.08 [0.77-1.52]; P =0.65). Despite a weak correlation ( r =0.119; P =0.02), beat-to-beat BPV was associated with risk of recurrent stroke independently of day-to-day BPV (1.41 [1.05-1.90]; P =0.02). Beat-to-beat BPV predicted recurrent stroke and cardiovascular events, independently of mean systolic BP and risk factors but short-term BPV on ambulatory BP monitoring did not. Beat-to-beat BPV may be a useful additional marker of cardiovascular risk. © 2017 The Authors.

Portable two-channel PPG cardiovascular sensor device

NASA Astrophysics Data System (ADS)

Spigulis, Janis; Erts, Renars; Ozols, Maris

2003-10-01

A portable sensor device for simultaneous detection and processing of skin-remitted optical signals from any two sites of the body has been developed and tested. The photoplethysmography (PPG) principle was applied to follow the dilatation and contraction of skin blood vessels during the cardiac cycle. The newly developed two-channel approach allows to estimate the vascular blood flow resistance by analysis of time shifts between the PPG pulses detected at different body sites. Potential of the sensor device for express-assessment of human cardio-vascular condition and for body fitness tests has been demonstrated.

Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.

PubMed

Fraser, Alan G; Daubert, Jean-Claude; Van de Werf, Frans; Estes, N A Mark; Smith, Sidney C; Krucoff, Mitchell W; Vardas, Panos E; Komajda, Michel

2011-07-01

The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.

The use of imaging for electrophysiological and devices procedures: a report from the first European Heart Rhythm Association Policy Conference, jointly organized with the European Association of Cardiovascular Imaging (EACVI), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology.

PubMed

Blomström Lundqvist, Carina; Auricchio, Angelo; Brugada, Josep; Boriani, Giuseppe; Bremerich, Jens; Cabrera, Jose Angel; Frank, Herbert; Gutberlet, Matthias; Heidbuchel, Hein; Kuck, Karl-Heinz; Lancellotti, Patrizio; Rademakers, Frank; Winkels, Gerard; Wolpert, Christian; Vardas, Panos E

2013-07-01

Implantations of cardiac devices therapies and ablation procedures frequently depend on accurate and reliable imaging modalities for pre-procedural assessments, intra-procedural guidance, detection of complications, and the follow-up of patients. An understanding of echocardiography, cardiovascular magnetic resonance imaging, nuclear cardiology, X-ray computed tomography, positron emission tomography, and vascular ultrasound is indispensable for cardiologists, electrophysiologists as well as radiologists, and it is currently recommended that physicians should be trained in several imaging modalities. There are, however, no current guidelines or recommendations by electrophysiologists, cardiac imaging specialists, and radiologists, on the appropriate use of cardiovascular imaging for selected patient indications, which needs to be addressed. A Policy Conference on the use of imaging in electrophysiology and device management, with representatives from different expert areas of radiology and electrophysiology and commercial developers of imaging and device technologies, was therefore jointly organized by European Heart Rhythm Association (EHRA), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology (ESCR). The objectives were to assess the state of the level of evidence and a first step towards a consensus document for currently employed imaging techniques to guide future clinical use, to elucidate the issue of reimbursement structures and health economy, and finally to define the need for appropriate educational programmes to ensure clinical competence for electrophysiologists, imaging specialists, and radiologists.

76 FR 53851 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2011-N-0505] Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent... preamendments device: Cardiovascular permanent pacemaker electrode. The document was published with an incorrect...

Development of an Integrated Countermeasure Device for Long Duration Space Flight and Exploration Missions

NASA Technical Reports Server (NTRS)

Lee, S. M. C.; Streeper, T.; Spiering, B. A.; Loehr, J. A.; Guilliams, M. E.; Bloomberg, J. J.; Mulavara, A. P.; Cavanagh, P. R.; Lang, T.

2010-01-01

Musculoskeletal, cardiovascular, and sensorimotor deconditioning have been observed consistently in astronauts and cosmonauts following long-duration spaceflight. Studies in bed rest, a spaceflight analog, have shown that high intensity resistive or aerobic exercise attenuates or prevents musculoskeletal and cardiovascular deconditioning, respectively, but complete protection has not been achieved during spaceflight. Exercise countermeasure hardware used during earlier International Space Station (ISS) missions included a cycle ergometer, a treadmill, and the interim resistive exercise device (iRED). Effectiveness of the countermeasures may have been diminished by limited loading characteristics of the iRED as well as speed restrictions and subject harness discomfort during treadmill exercise. The Advanced Resistive Exercise Device (ARED) and the second generation treadmill were designed to address many of the limitations of their predecessors, and anecdotal reports from ISS crews suggest that their conditioning is better preserved since the new hardware was delivered in 2009. However, several countermeasure devices to protect different physiologic systems will not be practical during exploration missions when the available volume and mass will be severely restricted. The combined countermeasure device (CCD) integrates a suite of hardware into one device intended to prevent spaceflight-induced musculoskeletal, cardiovascular, and sensorimotor deconditioning. The CCD includes pneumatic loading devices with attached cables for resistive exercise, a cycle for aerobic exercise, and a 6 degree of freedom motion platform for balance training. In a proof of concept test, ambulatory untrained subjects increased muscle strength (58%) as well as aerobic capacity (26%) after 12-weeks of exercise training with the CCD (without balance training), improvements comparable to those observed with traditional exercise training. These preliminary results suggest that this CCD can concurrently improve musculoskeletal and cardiovascular conditioning in ambulatory subjects, but further work is required to validate its use as countermeasure to spaceflight-induced deconditioning.

Continuous glucose monitoring in acute coronary syndrome.

PubMed

Rodríguez-Quintanilla, Karina Alejandra; Lavalle-González, Fernando Javier; Mancillas-Adame, Leonardo Guadalupe; Zapata-Garrido, Alfonso Javier; Villarreal-Pérez, Jesús Zacarías; Tamez-Pérez, Héctor Eloy

2013-01-01

Diabetes mellitus is an independent risk factor for cardiovascular disease. To compare the efficacy of devices for continuous glucose monitoring and capillary glucose monitoring in hospitalized patients with acute coronary syndrome using the following parameters: time to achieve normoglycemia, period of time in normoglycemia, and episodes of hypoglycemia. We performed a pilot, non-randomized, unblinded clinical trial that included 16 patients with acute coronary artery syndrome, a capillary or venous blood glucose ≥ 140 mg/dl, and treatment with a continuous infusion of fast acting human insulin. These patients were randomized into 2 groups: a conventional group, in which capillary measurement and recording as well as insulin adjustment were made every 4h, and an intervention group, in which measurement and recording as well as insulin adjustment were made every hour with a subcutaneous continuous monitoring system. Student's t-test was applied for mean differences and the X(2) test for qualitative variables. We observed a statistically significant difference in the mean time for achieving normoglycemia, favoring the conventional group with a P = 0.02. Continuous monitoring systems are as useful as capillary monitoring for achieving normoglycemia. Copyright © 2012 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

Validation of Heart Rate Monitor Polar RS800 for Heart Rate Variability Analysis During Exercise.

PubMed

Hernando, David; Garatachea, Nuria; Almeida, Rute; Casajús, Jose A; Bailón, Raquel

2018-03-01

Hernando, D, Garatachea, N, Almeida, R, Casajús, JA, and Bailón, R. Validation of heart rate monitor Polar RS800 for heart rate variability analysis during exercise. J Strength Cond Res 32(3): 716-725, 2018-Heart rate variability (HRV) analysis during exercise is an interesting noninvasive tool to measure the cardiovascular response to the stress of exercise. Wearable heart rate monitors are a comfortable option to measure interbeat (RR) intervals while doing physical activities. It is necessary to evaluate the agreement between HRV parameters derived from the RR series recorded by wearable devices and those derived from an electrocardiogram (ECG) during dynamic exercise of low to high intensity. Twenty-three male volunteers performed an exercise stress test on a cycle ergometer. Subjects wore a Polar RS800 device, whereas ECG was also recorded simultaneously to extract the reference RR intervals. A time-frequency spectral analysis was performed to extract the instantaneous mean heart rate (HRM), and the power of low-frequency (PLF) and high-frequency (PHF) components, the latter centered on the respiratory frequency. Analysis was done in intervals of different exercise intensity based on oxygen consumption. Linear correlation, reliability, and agreement were computed in each interval. The agreement between the RR series obtained from the Polar device and from the ECG is high throughout the whole test although the shorter the RR is, the more differences there are. Both methods are interchangeable when analyzing HRV at rest. At high exercise intensity, HRM and PLF still presented a high correlation (ρ > 0.8) and excellent reliability and agreement indices (above 0.9). However, the PHF measurements from the Polar showed reliability and agreement coefficients around 0.5 or lower when the level of the exercise increases (for levels of O2 above 60%).

Pediatric Home Sleep Apnea Testing

PubMed Central

Tan, Hui-Leng; Kheirandish-Gozal, Leila

2015-01-01

Pediatric OSA can result in significant neurocognitive, behavioral, cardiovascular, and metabolic morbidities. Prompt diagnosis and treatment are, therefore, of paramount importance. The current gold standard for diagnosis of OSA in children is in-laboratory polysomnography (PSG). Home sleep apnea testing has been considered as an alternative as it is potentially more cost effective, convenient, and accessible. This review concentrates mainly on the use of type 2 and 3 portable monitoring devices. The current evidence on the feasibility and diagnostic accuracy of home testing in the diagnosis of pediatric OSA was examined. Overall, the evidence in children is limited. Feasibility studies that have been performed have on the whole shown good results, with several reporting > 90% of their home recordings as meeting predetermined quality criteria regarding signal artifact and minimum recording time. The limited data comparing type 2 studies with in-laboratory PSG have shown no significant differences in respiratory parameters. The results pertaining to diagnostic accuracy of type 3 home sleep apnea testing devices are conflicting. Although more research is needed, home testing with at least a type 3 portable monitor offers a viable alternative in the diagnosis of otherwise healthy children with moderate to severe OSA, particularly in settings where access to polysomnography is scarce or unavailable. Of note, since most studies have been performed in habitually snoring healthy children, home sleep apnea testing may not be applicable to children with other comorbid conditions. In particular, CO2 monitoring is important in children in whom there is concern regarding nocturnal hypoventilation, such as children with neuromuscular disease, underlying lung disease, or obesity hypoventilation, and most home testing devices do not include a transcutaneous or end-tidal CO2 channel. PMID:26270608

Existential Threat or Dissociative Response? Examining Defensive Avoidance of Point-of-Care Testing Devices Through a Terror Management Theory Framework.

PubMed

Dunne, Simon; Gallagher, Pamela; Matthews, Anne

2015-01-01

Using a terror management theory framework, this study investigated if providing mortality reminders or self-esteem threats would lead participants to exhibit avoidant responses toward a point-of-care testing device for cardiovascular disease risk and if the nature of the device served to diminish the existential threat of cardiovascular disease. One hundred and twelve participants aged 40-55 years completed an experimental questionnaire. Findings indicated that participants were not existentially threatened by established terror management methodologies, potentially because of cross-cultural variability toward such methodologies. Highly positive appraisals of the device also suggest that similar technologies may beneficially affect the uptake of screening behaviors.

Objective cardiovascular assessment in the neonatal intensive care unit.

PubMed

Dempsey, Eugene M; El-Khuffash, Afif Faisal

2018-01-01

Traditionally, cardiovascular well-being was essentially based on whether the mean blood pressure was above or below a certain value. However, this singular crude method of assessment provides limited insight into overall cardiovascular well-being. Echocardiography has become increasingly used and incorporated into clinical care. New objective modality assessments of cardiovascular status continue to evolve and are being evaluated and incorporated into clinical care. In this review article, we will discuss some of the recent advances in objective assessment of cardiovascular well-being, including the concept of multimodal monitoring. Sophisticated haemodynamic monitoring systems are being developed, including mechanisms of data acquisition and analysis. Their incorporation into clinical care represents an exciting next stage in the management of the infant with cardiovascular compromise. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

78 FR 1162 - Cardiovascular Devices; Reclassification of External Cardiac Compressor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... safety and electromagnetic compatibility; For devices containing software, software verification... electromagnetic compatibility; For devices containing software, software verification, validation, and hazard... electrical components, appropriate analysis and testing must validate electrical safety and electromagnetic...

Blood pressure monitoring: theory and practice. European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability Teaching Course Proceedings.

PubMed

Stergiou, George S; Palatini, Paolo; Asmar, Roland; Bilo, Grzegorz; de la Sierra, Alejandro; Head, Geoff; Kario, Kazuomi; Mihailidou, Anastasia; Wang, Jiguang; Mancia, Giuseppe; O'Brien, Eoin; Parati, Gianfranco

2018-02-01

The European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and Cardiovascular Variability organized a Teaching Course on 'Blood Pressure Monitoring: Theory and Practice' during the 2017 ESH Meeting in Milan, Italy. This course performed by 11 international BP monitoring experts covered key topics of BP monitoring, including office BP measurement, ambulatory BP monitoring, home BP monitoring, ambulatory versus home BP, white-coat and masked hypertension, cuff use, and BP variability. This article presents a summary of the proceedings of the ESH BP Monitoring Teaching Course, including essential information, practical issues, and recommendations on the clinical application of BP monitoring methods, aiming to the optimal management of patients with suspected or diagnosed hypertension.

Wireless device monitoring systems and monitoring devices, and associated methods

DOE Office of Scientific and Technical Information (OSTI.GOV)

McCown, Steven H; Derr, Kurt W; Rohde, Kenneth W

Wireless device monitoring systems and monitoring devices include a communications module for receiving wireless communications of a wireless device. Processing circuitry is coupled with the communications module and configured to process the wireless communications to determine whether the wireless device is authorized or unauthorized to be present at the monitored area based on identification information of the wireless device. Methods of monitoring for the presence and identity of wireless devices are also provided.

A Computational Model for Thrombus Formation in Response to Cardiovascular Implantable Devices

NASA Astrophysics Data System (ADS)

Horn, John; Ortega, Jason; Maitland, Duncan

2014-11-01

Cardiovascular implantable devices elicit complex physiological responses within blood. Notably, alterations in blood flow dynamics and interactions between blood proteins and biomaterial surface chemistry may lead to the formation of thrombus. For some devices, such as stents and heart valves, this is an adverse outcome. For other devices, such as embolic aneurysm treatments, efficient blood clot formation is desired. Thus a method to study how biomedical devices induce thrombosis is paramount to device development and optimization. A multiscale, multiphysics computational model is developed to predict thrombus formation within the vasculature. The model consists of a set of convection-diffusion-reaction partial differential equations for blood protein constituents involved in the progression of the clotting cascades. This model is used to study thrombus production from endovascular devices with the goal of optimizing the device design to generate the desired clotting response. This work was performed in part under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344.

Point-of-Care Technologies for Precision Cardiovascular Care and Clinical Research

PubMed Central

King, Kevin; Grazette, Luanda P.; Paltoo, Dina N.; McDevitt, John T.; Sia, Samuel K.; Barrett, Paddy M.; Apple, Fred S.; Gurbel, Paul A.; Weissleder, Ralph; Leeds, Hilary; Iturriaga, Erin J.; Rao, Anupama; Adhikari, Bishow; Desvigne-Nickens, Patrice; Galis, Zorina S.; Libby, Peter

2016-01-01

Point-of-care technologies (POC or POCT) are enabling innovative cardiovascular diagnostics that promise to improve patient care across diverse clinical settings. The National Heart, Lung, and Blood Institute convened a working group to discuss POCT in cardiovascular medicine. The multidisciplinary working group, which included clinicians, scientists, engineers, device manufacturers, regulatory officials, and program staff, reviewed the state of the POCT field; discussed opportunities for POCT to improve cardiovascular care, realize the promise of precision medicine, and advance the clinical research enterprise; and identified barriers facing translation and integration of POCT with existing clinical systems. A POCT development roadmap emerged to guide multidisciplinary teams of biomarker scientists, technologists, health care providers, and clinical trialists as they: 1) formulate needs assessments; 2) define device design specifications; 3) develop component technologies and integrated systems; 4) perform iterative pilot testing; and 5) conduct rigorous prospective clinical testing to ensure that POCT solutions have substantial effects on cardiovascular care. PMID:26977455

Assessing the feasibility of using uniaxial accelerometers with an online support platform in the delivery of a community-based exercise referral scheme.

PubMed

Hawkins, Jemma L; Oliver, Emily J; Wyatt-Williams, Jeannie; Scale, Elaine; van Woerden, Hugo C

2014-10-01

Exercise referral schemes are established within community-based health care; however, they have been criticized for failing to evidence long-term behavior change relative to usual care. As such, recent reviews have called for refinement of their delivery with a focus on embedded strategies targeting client motivation. This research letter presents findings from an initial pilot trial conducted within Wales' National Exercise Referral Scheme (NERS), examining the feasibility of using validated physical activity monitoring devices and an accompanying online platform within standard scheme delivery. 30 individuals referred to generic or cardiovascular pathways were offered the system; of these 17 agreed to participate. Common reasons for declining were clustered into lack of technology literacy or access, condition severity, or fear of costs associated with losing the device. Analysis of follow-up interviews after 4 weeks of use indicated that while participants found the monitoring devices practical and informative, only a minority (n = 4) were using the system in full. Crucially, the system element most aligned with contemporary theories of motivation (the online portal) was not used as expected. In addition, feedback from exercise referral professionals indicated that there were demands for support from clients, which might be mitigated by more effective independent system use. Recommendations for larger scale trials using similar systems include consideration of targeted patient groups, equity of access, and providing adequate technological support that is currently beyond the capacity of the NERS system. © The Author(s) 2014.

Micro-electromechanical film bulk acoustic sensor for plasma and whole blood coagulation monitoring.

PubMed

Chen, Da; Song, Shuren; Ma, Jilong; Zhang, Zhen; Wang, Peng; Liu, Weihui; Guo, Qiuquan

2017-05-15

Monitoring blood coagulation is an important issue in the surgeries and the treatment of cardiovascular diseases. In this work, we reported a novel strategy for the blood coagulation monitoring based on a micro-electromechanical film bulk acoustic resonator. The resonator was excited by a lateral electric field and operated under the shear mode with a frequency of 1.9GHz. According to the apparent step-ladder curves of the frequency response to the change of blood viscoelasticity, the coagulation time (prothrombin time) and the coagulation kinetics were measured with the sample consumption of only 1μl. The procoagulant activity of thromboplastin and the anticoagulant effect of heparin on the blood coagulation process were illustrated exemplarily. The measured prothrombin times showed a good linear correlation with R 2 =0.99969 and a consistency with the coefficient of variation less than 5% compared with the commercial coagulometer. The proposed film bulk acoustic sensor, which has the advantages of small size, light weight, low cost, simple operation and little sample consumption, is a promising device for miniaturized, online and automated analytical system for routine diagnostics of hemostatic status and personal health monitoring. Copyright © 2017 Elsevier B.V. All rights reserved.

“We can’t get along without each other”: Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety

PubMed Central

Lehoux, Pascale; Ducey, Ariel; Easty, Anthony; Ross, Sue; Bell, Chaim; Trbovich, Patricia

2017-01-01

Objectives Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed. Design A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team. Results Twenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as “symbiotic”, but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness. Conclusions Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and should govern interaction with representatives, or support their staff in this regard. PMID:28358886

Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments.

PubMed

Wild, Claudia; Erdös, Judit; Zechmeister, Ingrid

2014-11-04

European medical device regulation is under scrutiny and will be re-regulated with stricter rules concerning requirements for clinical evidence for high-risk medical devices. It is the aim of this study to analyse the differences between Europe and USA in dealing with risks and benefits of new cardio-vascular devices. Since no information is available on clinical data used by the Notified Body for CE-marking, data from Austrian pre-reimbursement assessments close to European market approval were used as proxy and compared with clinical data available at time of market approval by FDA in the USA. 10 cardio-vascular interventions with 27 newly CE approved medical devices were analysed. The time lag between market authorisation in Europe and in the USA is 3 to 7 years. Only 7 CE-marked devices also hold a FDA market approval, 7 further devices are in FDA approved ongoing efficacy trials. For 4 of the CE-marked devices the FDA market application or the approval-trial was either suspended due to efficacy or safety concerns or the approval was denied. Evidence available at time of CE-marking are most often case-series or small feasibility RCTs, while large RCTs and only in rare cases prospective cohort studies are the basis of FDA approvals. Additionally, the FDA often requires post-approval studies for high-risk devices. Market authorisation based on mature clinical data deriving from larger RCTs and longer follow-ups do not only change the perspective on the risk-benefit ratio, but also secures real patient benefit and safety and assures payers of investing only in truly innovative devices.

"We can't get along without each other": Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety.

PubMed

Gagliardi, Anna R; Lehoux, Pascale; Ducey, Ariel; Easty, Anthony; Ross, Sue; Bell, Chaim; Trbovich, Patricia; Urbach, David R

2017-01-01

Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed. A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team. Twenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as "symbiotic", but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness. Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and should govern interaction with representatives, or support their staff in this regard.

Self-Powered Real-Time Arterial Pulse Monitoring Using Ultrathin Epidermal Piezoelectric Sensors.

PubMed

Park, Dae Yong; Joe, Daniel J; Kim, Dong Hyun; Park, Hyewon; Han, Jae Hyun; Jeong, Chang Kyu; Park, Hyelim; Park, Jung Gyu; Joung, Boyoung; Lee, Keon Jae

2017-10-01

Continuous monitoring of an arterial pulse using a pressure sensor attached on the epidermis is an important technology for detecting the early onset of cardiovascular disease and assessing personal health status. Conventional pulse sensors have the capability of detecting human biosignals, but have significant drawbacks of power consumption issues that limit sustainable operation of wearable medical devices. Here, a self-powered piezoelectric pulse sensor is demonstrated to enable in vivo measurement of radial/carotid pulse signals in near-surface arteries. The inorganic piezoelectric sensor on an ultrathin plastic achieves conformal contact with the complex texture of the rugged skin, which allows to respond to the tiny pulse changes arising on the surface of epidermis. Experimental studies provide characteristics of the sensor with a sensitivity (≈0.018 kPa -1 ), response time (≈60 ms), and good mechanical stability. Wireless transmission of detected arterial pressure signals to a smart phone demonstrates the possibility of self-powered and real-time pulse monitoring system. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

ActivityAware: An App for Real-Time Daily Activity Level Monitoring on the Amulet Wrist-Worn Device.

PubMed

Boateng, George; Batsis, John A; Halter, Ryan; Kotz, David

2017-03-01

Physical activity helps reduce the risk of cardiovascular disease, hypertension and obesity. The ability to monitor a person's daily activity level can inform self-management of physical activity and related interventions. For older adults with obesity, the importance of regular, physical activity is critical to reduce the risk of long-term disability. In this work, we present ActivityAware , an application on the Amulet wrist-worn device that measures daily activity levels (sedentary, moderate and vigorous) of individuals, continuously and in real-time. The app implements an activity-level detection model, continuously collects acceleration data on the Amulet, classifies the current activity level, updates the day's accumulated time spent at that activity level, logs the data for later analysis, and displays the results on the screen. We developed an activity-level detection model using a Support Vector Machine (SVM). We trained our classifiers using data from a user study, where subjects performed the following physical activities: sit, stand, lay down, walk and run. With 10-fold cross validation and leave-one-subject-out (LOSO) cross validation, we obtained preliminary results that suggest accuracies up to 98%, for n=14 subjects. Testing the ActivityAware app revealed a projected battery life of up to 4 weeks before needing to recharge. The results are promising, indicating that the app may be used for activity-level monitoring, and eventually for the development of interventions that could improve the health of individuals.

Profiling wrist pulse from skin surface by Advanced Vibrometer Interferometer Device

NASA Astrophysics Data System (ADS)

Lee, Hao-Xiang; Lee, Shu-Sheng; Hsu, Yu-Hsiang; Lee, Chih-Kung

2017-02-01

With global trends in population aging, the need to decrease and prevent the onset of cardiovascular disease has drawn a great attention. The traditional cuff-based upper arm sphygmomanometer is still the standard method to retrieve blood pressure information for diagnostics. However, this method is not easy to be adapted by patients and is not comfortable enough to perform a long term monitoring process. In order to correlate the beating profile of the arterial pulse on the wrist skin, an Advanced Vibrometer Interferometer Device (AVID) is adopted in this study to measure the vibration amplitude of skin and compare it with blood pressure measured from the upper arm. The AVID system can measure vibration and remove the directional ambiguity by using circular polarization interferometer technique with two orthogonal polarized light beams. The displacement resolution of the system is nearly 1.0 nm and the accuracy is experimentally verified. Using an optical method to quantify wrist pule, it provides a means to perform cuff-less, noninvasive and continuous measurement. In this paper, the correlations between the amplitude of skin vibration and the actual blood pressure is studied. The success of this method could potentially set the foundation of blood pressure monitor system based on optical approaches.

Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research.

PubMed

Pickering, Thomas G; Hall, John E; Appel, Lawrence J; Falkner, Bonita E; Graves, John; Hill, Martha N; Jones, Daniel W; Kurtz, Theodore; Sheps, Sheldon G; Roccella, Edward J

2005-01-01

Accurate measurement of blood pressure is essential to classify individuals, to ascertain blood pressure-related risk, and to guide management. The auscultatory technique with a trained observer and mercury sphygmomanometer continues to be the method of choice for measurement in the office, using the first and fifth phases of the Korotkoff sounds, including in pregnant women. The use of mercury is declining, and alternatives are needed. Aneroid devices are suitable, but they require frequent calibration. Hybrid devices that use electronic transducers instead of mercury have promise. The oscillometric method can be used for office measurement, but only devices independently validated according to standard protocols should be used, and individual calibration is recommended. They have the advantage of being able to take multiple measurements. Proper training of observers, positioning of the patient, and selection of cuff size are all essential. It is increasingly recognized that office measurements correlate poorly with blood pressure measured in other settings, and that they can be supplemented by self-measured readings taken with validated devices at home. There is increasing evidence that home readings predict cardiovascular events and are particularly useful for monitoring the effects of treatment. Twenty-four-hour ambulatory monitoring gives a better prediction of risk than office measurements and is useful for diagnosing white-coat hypertension. There is increasing evidence that a failure of blood pressure to fall during the night may be associated with increased risk. In obese patients and children, the use of an appropriate cuff size is of paramount importance.

Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research.

PubMed

Pickering, Thomas G; Hall, John E; Appel, Lawrence J; Falkner, Bonita E; Graves, John; Hill, Martha N; Jones, Daniel W; Kurtz, Theodore; Sheps, Sheldon G; Roccella, Edward J

2005-02-08

Accurate measurement of blood pressure is essential to classify individuals, to ascertain blood pressure-related risk, and to guide management. The auscultatory technique with a trained observer and mercury sphygmomanometer continues to be the method of choice for measurement in the office, using the first and fifth phases of the Korotkoff sounds, including in pregnant women. The use of mercury is declining, and alternatives are needed. Aneroid devices are suitable, but they require frequent calibration. Hybrid devices that use electronic transducers instead of mercury have promise. The oscillometric method can be used for office measurement, but only devices independently validated according to standard protocols should be used, and individual calibration is recommended. They have the advantage of being able to take multiple measurements. Proper training of observers, positioning of the patient, and selection of cuff size are all essential. It is increasingly recognized that office measurements correlate poorly with blood pressure measured in other settings, and that they can be supplemented by self-measured readings taken with validated devices at home. There is increasing evidence that home readings predict cardiovascular events and are particularly useful for monitoring the effects of treatment. Twenty-four-hour ambulatory monitoring gives a better prediction of risk than office measurements and is useful for diagnosing white-coat hypertension. There is increasing evidence that a failure of blood pressure to fall during the night may be associated with increased risk. In obese patients and children, the use of an appropriate cuff size is of paramount importance.

The Future of Adult Cardiac Assist Devices: Novel Systems and Mechanical Circulatory Support Strategies

PubMed Central

Bartoli, Carlo R.; Dowling, Robert D.

2011-01-01

Synopsis The recent, widespread success of mechanical circulatory support has ushered in a new era of cardiovascular medicine in which numerous implantable devices exist to treat advanced heart failure. As cardiac assist devices gain prevalence in the clinical management of cardiovascular disease, it is increasingly important to raise awareness of novel device systems, the unique mechanisms by which they function, and implications for patient management. In this article, we present state-of-the-art devices that are currently under development or in clinical trials. Devices are categorized as Standard Full-Support (HeartMate III, CorAide, Evaheart LVAS), Less-Invasive Full-Support (MVAD), Partial-Support (CircuLite Synergy Pocket Micro-Pump, Reitan Catheter Pump, Procyrion CAD, C-Pulse, Symphony Counterpulsation Device) Right Ventricular Assist Device (RVAD; DexAide, Impella RD Recover, Impella RP), and Total Artificial Heart (TAH; CardioWest, AbioCor II, Continuous-Flow TAH, Continuous-Flow BiVAD). Implantation strategy, mechanism of action, durability, efficacy, hemocompatibility, and human factors such as quality of life during device support are considered. The feasibility of novel strategies for unloading the failing heart is examined. PMID:22062206

Wireless device monitoring methods, wireless device monitoring systems, and articles of manufacture

DOEpatents

McCown, Steven H [Rigby, ID; Derr, Kurt W [Idaho Falls, ID; Rohde, Kenneth W [Idaho Falls, ID

2012-05-08

Wireless device monitoring methods, wireless device monitoring systems, and articles of manufacture are described. According to one embodiment, a wireless device monitoring method includes accessing device configuration information of a wireless device present at a secure area, wherein the device configuration information comprises information regarding a configuration of the wireless device, accessing stored information corresponding to the wireless device, wherein the stored information comprises information regarding the configuration of the wireless device, comparing the device configuration information with the stored information, and indicating the wireless device as one of authorized and unauthorized for presence at the secure area using the comparing.

Cardiovascular and metabolic monitoring of children and adolescents on antipsychotic treatment: A cross-sectional descriptive study.

PubMed

de la Torre Villalobos, Miquel; Martin-López, Luis Miguel; Fernández Sanmartín, María Isabel; Pujals Altes, Elena; Gasque Llopis, Silvia; Batlle Vila, Santiago; Pérez-Solá, Victor; Novo Navarro, Patricia; Gómez Simón, Isabel; Fresno González, Cristina; Camprodon Rosanas, Ester; Bulbena Vilarrasa, Antonio

Cardiovascular and metabolic monitoring of patients on antipsychotic medication is essential. This becomes more important in those of paediatric age, as they are more vulnerable, and also because prescriptions of this kind of drugs are still increasing. To evaluate the monitoring of cardiovascular and metabolic risk factors in a group of children and young people on antipsychotic medication. A descriptive cross-sectional study was conducted in which a group of 220 patients aged 8-17 years, diagnosed with a mental disorder and on antipsychotic treatment. They were compared to a control group of 199 asthmatic patients not exposed to antipsychotic drugs. Data was extracted from the computerised clinical history ECAP in 2013. The mean age of the children was 12 years (8-17). Risperidone (67%) was the most frequent treatment. The recording of Body Mass Index (BMI) and blood pressure (AP) was 50% in Mental Disorder (MD) patients. A higher number of cardiovascular monitoring physical parameters (weight, height, BMI and BP) were observed in the MD group compared to the control Asthma control group. Altogether, more physical parameters than biochemistry parameters were recorded. This study shows that the recording of cardiovascular parameters and metabolic studies needs to be improved in children and adolescents on treatment with antipsychotics. Copyright © 2016 SEP y SEPB. Publicado por Elsevier España, S.L.U. All rights reserved.

Advanced Tracers in PET Imaging of Cardiovascular Disease

PubMed Central

Zhang, Wei; Wu, Hua; Liu, Gang

2014-01-01

Cardiovascular disease is the leading cause of death worldwide. Molecular imaging with targeted tracers by positron emission tomography (PET) allows for the noninvasive detection and characterization of biological changes at the molecular level, leading to earlier disease detection, objective monitoring of therapies, and better prognostication of cardiovascular diseases progression. Here we review, the current role of PET in cardiovascular disease, with emphasize on tracers developed for PET imaging of cardiovascular diseases. PMID:25389529

33 CFR 154.525 - Monitoring devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Monitoring devices. 154.525... Monitoring devices. The COTP may require the facility to install monitoring devices if the installation of monitoring devices at the facility would significantly limit the size of a discharge of oil or hazardous...

Electrical treatment of atrial arrhythmias in heart failure patients implanted with a dual defibrillator CRT device. Results from the TRADE-HF study.

PubMed

Botto, Giovanni Luca; Padeletti, Luigi; Covino, Gregorio; Pieragnoli, Paolo; Liccardo, Mattia; Mariconti, Barbara; Favale, Stefano; Molon, Giulio; De Filippo, Paolo; Bolognese, Leonardo; Landolina, Maurizio; Raciti, Giovanni; Boriani, Giuseppe

2017-06-01

Ventricular and atrial arrhythmias commonly occur in heart failure patients and are a significant source of symptoms, morbidity and mortality. Some specific generators referred to as dual defibrillators, Dual CRT-Ds, have the ability to treat atrial and ventricular arrhythmias. TRADE-HF is a prospective two-arm randomized study aimed at assessing the benefits of complete automatic management of atrial arrhythmias in patients implanted with a dual CRT-D. Primary objective of the TRADE-HF study was to document reduction of unplanned hospital admission for cardiac reasons or death for cardiovascular causes or progression to permanent AF, by comparing fully-automatic device driven therapy for atrial tachycardia or fibrillation (AT/AF) to an in-hospital approach for treatment of symptomatic AT/AF. Randomized Patients were followed every 6months for 3years to assess the primary objective. Four-hundred-twenty patients have been enrolled in the study. At the end of the study 30 subjects died for cardiovascular causes, 60 had at least one hospitalization for cardiovascular causes and 14 developed permanent AF. Eighty-seven patients experienced a composite event. Hazard Ratio for device-managed automatic therapy arm compared to traditional was 0.987 (95% CI: 0.684-1.503; p=0.951). The primary endpoint analysis resulted in no difference between the device managed and in-hospital treatment arm. The TRADE-HF study failed to demonstrate a reduction in the composite of unplanned hospitalizations for cardiovascular causes or death for cardiovascular causes or progression to permanent AF using automatic atrial therapy compared to a traditional approach including hospitalization for symptomatic episodes and/or in-hospital treatment of AT/AF. Copyright © 2017 Elsevier B.V. All rights reserved.

Remote monitoring of left ventricular assist device parameters after HeartAssist-5 implantation.

PubMed

Pektok, Erman; Demirozu, Zumrut Tuba; Arat, Nurcan; Yildiz, Omer; Oklu, Emine; Eker, Deniz; Ece, Ferah; Ciftci, Cavlan; Yazicioglu, Nuran; Bayindir, Osman; Kucukaksu, Deniz Suha

2013-09-01

Although several left ventricular assist devices (LVADs) have been used widely, remote monitoring of LVAD parameters has been available only recently. We present our remote monitoring experience with an axial-flow LVAD (HeartAssist-5, MicroMed Cardiovascular, Inc., Houston, TX, USA). Five consecutive patients who were implanted a HeartAssist-5 LVAD because of end-stage heart failure due to ischemic (n=4) or idiopathic (n=1) cardiomyopathy, and discharged from hospital between December 2011 and January 2013 were analyzed. The data (pump speed, pump flow, power consumption) obtained from clinical visits and remote monitoring were studied. During a median follow-up of 253 (range: 80-394) days, fine tuning of LVADs was performed at clinical visits. All patients are doing well and are in New York Heart Association Class-I/II. A total of 39 alarms were received from three patients. One patient was hospitalized for suspected thrombosis and was subjected to physical examinations as well as laboratory and echocardiographic evaluations; however, no evidence of thrombus washout or pump thrombus was found. The patient was treated conservatively. Remaining alarms were due to insufficient water intake and were resolved by increased water consumption at night and summer times, and fine tuning of pump speed. No alarms were received from the remaining two patients. We believe that remote monitoring is a useful technology for early detection and treatment of serious problems occurring out of hospital thereby improving patient care. Future developments may ease troubleshooting, provide more data from the patient and the pump, and eventually increase physician and patient satisfaction. Despite all potential clinical benefits, remote monitoring should be taken as a supplement to rather than a substitute for routine clinical visits for patient follow-up. © 2013 Wiley Periodicals, Inc. and International Center for Artificial Organs and Transplantation.

Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: A randomised, controlled clinical trial.

PubMed

Bravo-Escobar, Raquel; González-Represas, Alicia; Gómez-González, Adela María; Montiel-Trujillo, Angel; Aguilar-Jimenez, Rafael; Carrasco-Ruíz, Rosa; Salinas-Sánchez, Pablo

2017-02-20

Previous studies have documented the feasibility of home-based cardiac rehabilitation programmes in low-risk patients with ischemic heart disease, but a similar solution needs to be found for patients at moderate cardiovascular risk. The objective of this study was to analyse the effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic cardiopathology at moderate cardiovascular risk. A randomised, controlled clinical trial was designed wherein 28 patients with stable coronary artery disease at moderate cardiovascular risk, who met the selection criteria for this study, participated. Of these, 14 were assigned to the group undergoing traditional cardiac rehabilitation in hospital (control group) and 14 were assigned to the home-based mixed surveillance programme (experimental group). The patients in the experimental group went to the cardiac rehabilitation unit once a week and exercised at home, which was monitored with a remote electrocardiographic monitoring device (NUUBO®). The in-home exercises comprised of walking at 70% of heart rate reserve during the first month, and 80% during the second month, for 1 h per day at a frequency of 5 to 7 days per week. A two-way repeated measures analysis of variance (ANOVA) was performed to evaluate the effects of time (before and after intervention) and time-group interaction regarding exercise capacity, risk profile, cardiovascular complications, and quality of life. No significant differences were observed between the traditional cardiac rehabilitation group and the home-based with mixed surveillance group for exercise time and METS achieved during the exertion test, and the recovery rate in the first minute (which increased in both groups after the intervention). The only difference between the two groups was for quality of life scores (10.93 [IC95%: 17.251, 3.334, p = 0.007] vs -4.314 [IC95%: -11.414, 2.787; p = 0.206]). No serious heart-related complications were recorded during the cardiac rehabilitation programme. The home-based cardiac rehabilitation programme with mixed surveillance appears to be as effective and safe as the traditional model in patients with ischemic heart disease who are at moderate cardiovascular risk. However, the cardiac rehabilitation programmes carried out in hospital seems to have better results in improving the quality of life. Retrospectively registered NCT02796404 (May 23, 2016).

ARED (Advanced-Resistive Exercise Device) Update

NASA Technical Reports Server (NTRS)

Ploutz-Snyder, Lori

2009-01-01

This viewgraph presentation describes ARED which is a new hardware exercise device for use on the International Space Station. Astronaut physiological adaptations, muscle parameters, and cardiovascular parameters are also reviewed.

Influence of Exposure Error and Effect Modification by Socioeconomic Status on the Association of Acute Cardiovascular Mortality with Particulate Matter in Phoenix

EPA Science Inventory

Using ZIP code-level mortality data, the association of cardiovascular mortality with PM_2.5 and PM_10-2.5,measured at a central monitoring site, was determined for three populations at different distances from the monitoring site but with similar numbers of d...

77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... Administration (FDA) is classifying the endovascular suturing system into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance..., or FDA issues an order finding the device to be substantially equivalent, in accordance with section...

21 CFR 868.2375 - Breathing frequency monitor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Breathing frequency monitor. 868.2375 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2375 Breathing frequency monitor. (a) Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient...

Successes and future outlook for microfluidics-based cardiovascular drug discovery.

PubMed

Skommer, Joanna; Wlodkowic, Donald

2015-03-01

The greatest advantage of using microfluidics as a platform for the assessment of cardiovascular drug action is its ability to finely regulate fluid flow conditions, including flow rate, shear stress and pulsatile flow. At the same time, microfluidics provide means for modifying the vessel geometry (bifurcations, stenoses, complex networks), the type of surface of the vessel walls, and for patterning cells in 3D tissue-like architecture, including generation of lumen walls lined with cells and heart-on-a-chip structures for mimicking ventricular cardiomyocyte physiology. In addition, owing to the small volume of required specimens, microfluidics is ideally suited to clinical situations whereby monitoring of drug dosing or efficacy needs to be coupled with minimal phlebotomy-related drug loss. In this review, the authors highlight potential applications for the currently existing and emerging technologies and offer several suggestions on how to close the development cycle of microfluidic devices for cardiovascular drug discovery. The ultimate goal in microfluidics research for drug discovery is to develop 'human-on-a-chip' systems, whereby several organ cultures, including the vasculature and the heart, can mimic complex interactions between the organs and body systems. This would provide in vivo-like pharmacokinetics and pharmacodynamics for drug ADMET assessment. At present, however, the great variety of available designs does not go hand in hand with their use by the pharmaceutical community.

Method and Apparatus for Monitoring of Daily Activity in Terms of Ground Reaction Forces

NASA Technical Reports Server (NTRS)

Whalen, Robert T. (Inventor); Breit, Gregory A. (Inventor)

2001-01-01

A device to record and analyze habitual daily activity in terms of the history of gait-related musculoskeletal loading is disclosed. The device consists of a pressure-sensing insole placed into the shoe or embedded in a shoe sole, which detects contact of the foot with the ground. The sensor is coupled to a portable battery-powered digital data logger clipped to the shoe or worn around the ankle or waist. During the course of normal daily activity, the system maintains a record of time-of-occurrence of all non-spurious foot-down and lift-off events. Off line, these data are filtered and converted to a history of foot-ground contact times, from which measures of cumulative musculoskeletal loading, average walking- and running-specific gait speed, total time spent walking and running, total number of walking steps and running steps, and total gait-related energy expenditure are estimated from empirical regressions of various gait parameters to the contact time reciprocal. Data are available as cumulative values or as daily averages by menu selection. The data provided by this device are useful for assessment of musculoskeletal and cardiovascular health and risk factors associated with habitual patterns of daily activity.

21 CFR 868.2450 - Lung water monitor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2450 Lung water monitor. (a) Identification. A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient's lung by... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Lung water monitor. 868.2450 Section 868.2450 Food...

21 CFR 868.2450 - Lung water monitor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Lung water monitor. 868.2450 Section 868.2450 Food... DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2450 Lung water monitor. (a) Identification. A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient's lung by...

21 CFR 868.2450 - Lung water monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Lung water monitor. 868.2450 Section 868.2450 Food... DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2450 Lung water monitor. (a) Identification. A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient's lung by...

21 CFR 868.2450 - Lung water monitor.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Lung water monitor. 868.2450 Section 868.2450 Food... DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2450 Lung water monitor. (a) Identification. A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient's lung by...

21 CFR 868.2450 - Lung water monitor.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Lung water monitor. 868.2450 Section 868.2450 Food... DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2450 Lung water monitor. (a) Identification. A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient's lung by...

Toward flexible and wearable human-interactive health-monitoring devices.

PubMed

Takei, Kuniharu; Honda, Wataru; Harada, Shingo; Arie, Takayuki; Akita, Seiji

2015-03-11

This Progress Report introduces flexible wearable health-monitoring devices that interact with a person by detecting from and stimulating the body. Interactive health-monitoring devices should be highly flexible and attach to the body without awareness like a bandage. This type of wearable health-monitoring device will realize a new class of electronics, which will be applicable not only to health monitoring, but also to other electrical devices. However, to realize wearable health-monitoring devices, many obstacles must be overcome to economically form the active electrical components on a flexible substrate using macroscale fabrication processes. In particular, health-monitoring sensors and curing functions need to be integrated. Here recent developments and advancements toward flexible health-monitoring devices are presented, including conceptual designs of human-interactive devices. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

21 CFR 882.5500 - Lesion temperature monitor.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Lesion temperature monitor. 882.5500 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5500 Lesion temperature monitor. (a) Identification. A lesion temperature monitor is a device used to monitor the tissue...

21 CFR 882.5500 - Lesion temperature monitor.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Lesion temperature monitor. 882.5500 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5500 Lesion temperature monitor. (a) Identification. A lesion temperature monitor is a device used to monitor the tissue...

21 CFR 882.5500 - Lesion temperature monitor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Lesion temperature monitor. 882.5500 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5500 Lesion temperature monitor. (a) Identification. A lesion temperature monitor is a device used to monitor the tissue...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

40 CFR 60.343 - Monitoring of emissions and operations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... device for the continuous measurement of the pressure loss of the gas stream through the scrubber. The monitoring device must be accurate within ±250 pascals (one inch of water). (2) A monitoring device for continuous measurement of the scrubbing liquid supply pressure to the control device. The monitoring device...

21 CFR 868.2025 - Ultrasonic air embolism monitor.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ultrasonic air embolism monitor. 868.2025 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2025 Ultrasonic air embolism monitor. (a) Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in...

21 CFR 868.2025 - Ultrasonic air embolism monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ultrasonic air embolism monitor. 868.2025 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2025 Ultrasonic air embolism monitor. (a) Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in...

21 CFR 868.2025 - Ultrasonic air embolism monitor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ultrasonic air embolism monitor. 868.2025 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2025 Ultrasonic air embolism monitor. (a) Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in...

21 CFR 868.2600 - Airway pressure monitor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Airway pressure monitor. 868.2600 Section 868.2600...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2600 Airway pressure monitor. (a) Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway...

Short-Term Repeatability of Noninvasive Aortic Pulse Wave Velocity Assessment: Comparison Between Methods and Devices.

PubMed

Grillo, Andrea; Parati, Gianfranco; Rovina, Matteo; Moretti, Francesco; Salvi, Lucia; Gao, Lan; Baldi, Corrado; Sorropago, Giovanni; Faini, Andrea; Millasseau, Sandrine C; Scalise, Filippo; Carretta, Renzo; Salvi, Paolo

2017-12-08

Aortic pulse wave velocity (PWV) is an indirect index of arterial stiffness and an independent cardiovascular risk factor. Consistency of PWV assessment over time is thus an essential feature for its clinical application. However, studies providing a comparative estimate of the reproducibility of PWV across different noninvasive devices are lacking, especially in the elderly and in individuals at high cardiovascular risk. Aimed at filling this gap, short-term repeatability of PWV, estimated with 6 different devices (Complior Analyse, PulsePen-ETT, PulsePen-ET, SphygmoCor Px/Vx, BPLab, and Mobil-O-Graph), was evaluated in 102 high cardiovascular risk patients hospitalized for suspected coronary artery disease (72 males, 65 ± 13 years). PWV was measured in a single session twice, at 15-minute interval, and its reproducibility was assessed though coefficient of variation (CV), coefficient of repeatability, and intraclass correlation coefficient. The CV of PWV, measured with any of these devices, was <10%. Repeatability was higher with cuff-based methods (BPLab: CV = 5.5% and Mobil-O-Graph: CV = 3.4%) than with devices measuring carotid-femoral PWV (Complior: CV = 8.2%; PulsePen-TT: CV = 8.0%; PulsePen-ETT: CV = 5.8%; and SphygmoCor: CV = 9.5%). In the latter group, PWV repeatability was lower in subjects with higher carotid-femoral PWV. The differences in PWV between repeated measurements, except for the Mobil-O-Graph, did not depend on short-term variations of mean blood pressure or heart rate. Our study shows that the short-term repeatability of PWV measures is good but not homogenous across different devices and at different PWV values. These findings, obtained in patients at high cardiovascular risk, may be relevant when evaluating the prognostic importance of PWV. © American Journal of Hypertension, Ltd 2017. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Global cardiovascular device innovation: Japan-USA synergies: Harmonization by Doing (HBD) program, a consortium of regulatory agencies, medical device industry, and academic institutions.

PubMed

Uchida, Takahiro; Ikeno, Fumiaki; Ikeda, Koji; Suzuki, Yuka; Todaka, Koji; Yokoi, Hiroyoshi; Thompson, Gary; Krucoff, Mitchel; Saito, Shigeru

2013-01-01

Global medical devices have become more popular, but investment money for medical device development is not easily available in the market. Worldwide health-care budget constraints mean that efficient medical device development has become essential. To achieve efficient development, globalization is a key to success. Spending large amounts of money in different regions for medical device development is no longer feasible. In order to streamline processes of global medical device development, an academic, governmental, and industrial consortium, called the Harmonization by Doing program, has been set up. The program has been operating between Japan and the USA since 2003. The program has 4 working groups: (1) Global Cardiovascular Device Trials; (2) Study on Post-Market Registry; (3) Clinical Trials; and (4) Infrastructure and Methodology Regulatory Convergence and Communication. Each working group has as its goals the achievement of speedy and efficient medical device development in Japan and the USA. The program has held multiple international meetings to deal with obstacles against efficient medical device development. This kind of program is very important to deliver novel medical devices. Involvement of physicians in this type of activity is also very helpful to achieve these goals.

Real-time Magnetic Resonance Imaging Guidance for Cardiovascular Procedures

PubMed Central

Horvath, Keith A.; Li, Ming; Mazilu, Dumitru; Guttman, Michael A.; McVeigh, Elliot R.

2008-01-01

Magnetic resonance imaging (MRI) of the cardiovascular system has proven to be an invaluable diagnostic tool. Given the ability to allow for real-time imaging, MRI guidance of intraoperative procedures can provide superb visualization which can facilitate a variety of interventions and minimize the trauma of the operations as well. In addition to the anatomic detail, MRI can provide intraoperative assessment of organ and device function. Instruments and devices can be marked to enhance visualization and tracking. All of which is an advance over standard x-ray or ultrasonic imaging. PMID:18395633

Extracorporeal Membrane Oxygenation in Drug Overdose: A Clinical Case Series

PubMed Central

Vignesh, C.; Kumar, Madhan; Venkataraman, Ramesh; Rajagopal, Senthilkumar; Ramakrishnan, Nagarajan; Abraham, Babu K.

2018-01-01

Overdose of cardiovascular medications such as beta blockers and calcium channel blockers cause impaired cardiac contractility, vasoplegia, and/or rhythm disturbances. In addition to conventional management of limiting absorption, increasing elimination and hemodynamic support intravenous (IV) calcium infusion, hyperinsulinemia-euglycemia therapy, glucagon infusion, and IV lipid emulsion have been tried. Extracorporeal circulatory assist device support has been reported as a rescue therapy in overdose refractory to maximal medical therapy. We report three patients with cardiovascular medication overdose presenting with profound cardiovascular instability refractory to medical therapy. Venoarterial extracorporeal membrane oxygenation support (VA ECMO) was initiated to provide hemodynamic support. Despite the occurrence of device-associated complications, the outcome was good and all patients survived. VA ECMO may be considered in patients with severe refractory shock due to cardiotoxic medication overdose. PMID:29531453

Extracorporeal Membrane Oxygenation in Drug Overdose: A Clinical Case Series.

PubMed

Vignesh, C; Kumar, Madhan; Venkataraman, Ramesh; Rajagopal, Senthilkumar; Ramakrishnan, Nagarajan; Abraham, Babu K

2018-02-01

Overdose of cardiovascular medications such as beta blockers and calcium channel blockers cause impaired cardiac contractility, vasoplegia, and/or rhythm disturbances. In addition to conventional management of limiting absorption, increasing elimination and hemodynamic support intravenous (IV) calcium infusion, hyperinsulinemia-euglycemia therapy, glucagon infusion, and IV lipid emulsion have been tried. Extracorporeal circulatory assist device support has been reported as a rescue therapy in overdose refractory to maximal medical therapy. We report three patients with cardiovascular medication overdose presenting with profound cardiovascular instability refractory to medical therapy. Venoarterial extracorporeal membrane oxygenation support (VA ECMO) was initiated to provide hemodynamic support. Despite the occurrence of device-associated complications, the outcome was good and all patients survived. VA ECMO may be considered in patients with severe refractory shock due to cardiotoxic medication overdose.

From Microscale Devices to 3D Printing: Advances in Fabrication of 3D Cardiovascular Tissues

PubMed Central

Borovjagin, Anton V.; Ogle, Brenda; Berry, Joel; Zhang, Jianyi

2016-01-01

Current strategies for engineering cardiovascular cells and tissues have yielded a variety of sophisticated tools for studying disease mechanisms, for development of drug therapies, and for fabrication of tissue equivalents that may have application in future clinical use. These efforts are motivated by the need to extend traditional two-dimensional (2D) cell culture systems into 3D to more accurately replicate in vivo cell and tissue function of cardiovascular structures. Developments in microscale devices and bioprinted 3D tissues are beginning to supplant traditional 2D cell cultures and pre-clinical animal studies that have historically been the standard for drug and tissue development. These new approaches lend themselves to patient-specific diagnostics, therapeutics, and tissue regeneration. The emergence of these technologies also carries technical challenges to be met before traditional cell culture and animal testing become obsolete. Successful development and validation of 3D human tissue constructs will provide powerful new paradigms for more cost effective and timely translation of cardiovascular tissue equivalents. PMID:28057791

Surface Acoustic Wave Monitor for Deposition and Analysis of Ultra-Thin Films

NASA Technical Reports Server (NTRS)

Hines, Jacqueline H. (Inventor)

2015-01-01

A surface acoustic wave (SAW) based thin film deposition monitor device and system for monitoring the deposition of ultra-thin films and nanomaterials and the analysis thereof is characterized by acoustic wave device embodiments that include differential delay line device designs, and which can optionally have integral reference devices fabricated on the same substrate as the sensing device, or on a separate device in thermal contact with the film monitoring/analysis device, in order to provide inherently temperature compensated measurements. These deposition monitor and analysis devices can include inherent temperature compensation, higher sensitivity to surface interactions than quartz crystal microbalance (QCM) devices, and the ability to operate at extreme temperatures.

21 CFR 868.2600 - Airway pressure monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Airway pressure monitor. 868.2600 Section 868.2600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2600 Airway pressure monitor. (a) Identification. An airway pressure monitor is a devic...

78 FR 79304 - Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

... diabeticorum; Venous diseases, including the following: Prophylaxis of deep vein thrombophlebitis, edema (e.g..., edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic...

Impact of remote monitoring on the management of arrhythmias in patients with implantable cardioverter-defibrillator.

PubMed

Marcantoni, Lina; Toselli, Tiziano; Urso, Giulia; Pratola, Claudio; Ceconi, Claudio; Bertini, Matteo

2015-11-01

In the last decade, there has been an exponential increase in cardioverter-defibrillator (ICD) implants. Remote monitoring systems, allow daily follow-ups of patients with ICD. To evaluate the impact of remote monitoring on the management of cardiovascular events associated with supraventricular and ventricular arrhythmias during long-term follow-up. A total of 207 patients undergoing ICD implantation/replacement were enrolled: 79 patients received remote monitoring systems and were followed up every 12 months, and 128 patients were followed up conventionally every 6 months. All patients were followed up and monitored for the occurrence of supraventricular and ventricular arrhythmia-related cardiovascular events (ICD shocks and/or hospitalizations). During a median follow-up of 842 days (interquartile range 476-1288 days), 32 (15.5%) patients experienced supraventricular arrhythmia-related events and 51 (24.6%) patients experienced ventricular arrhythmia-related events. Remote monitoring had a significant role in the reduction of supraventricular arrhythmia-related events, but it had no effect on ventricular arrhythmia-related events. In multivariable analysis, remote monitoring remained as an independent protective factor, reducing the risk of supraventricular arrhythmia-related events of 67% [hazard ratio, 0.33; 95% confidence interval (CI), 0.13-0.82; P = 0.017]. Remote monitoring systems improved outcomes in patients with supraventricular arrhythmias by reducing the risk of cardiovascular events, but no benefits were observed in patients with ventricular arrhythmias.

The Role of Central Blood Pressure Monitoring in the Management of Hypertension.

PubMed

Ochoa, Adrian; Patarroyo-Aponte, Gabriel; Rahman, Mahboob

2018-04-19

Central blood pressure is a novel predictor of cardiovascular risk that can be measured in the clinical setting using currently available technology. This paper will review current available methods of central blood pressure monitoring as well as its impact in cardiac and renal disease. Both aortic and carotid systolic blood pressure are independently associated with cardiovascular mortality and serious cardiac events. Furthermore, studies show that systolic aortic blood pressure has been shown to be superior predictor of cardiovascular as compared to brachial blood pressure. Inhibitors of the renin angiotensin axis may have a beneficial effect on central blood pressure; however, long term studies evaluating the impact of lowering central blood pressure on clinical outcomes are lacking. Central blood pressure is a good predictor of cardiovascular risk. As more studies emerge demonstrating the value of central blood pressure as a therapeutic target, it is possible that targeting central blood pressure may become an important part of the armamentarium to lower cardiovascular risk.

Stroke Volume estimation using aortic pressure measurements and aortic cross sectional area: Proof of concept.

PubMed

Kamoi, S; Pretty, C G; Chiew, Y S; Pironet, A; Davidson, S; Desaive, T; Shaw, G M; Chase, J G

2015-08-01

Accurate Stroke Volume (SV) monitoring is essential for patient with cardiovascular dysfunction patients. However, direct SV measurements are not clinically feasible due to the highly invasive nature of measurement devices. Current devices for indirect monitoring of SV are shown to be inaccurate during sudden hemodynamic changes. This paper presents a novel SV estimation using readily available aortic pressure measurements and aortic cross sectional area, using data from a porcine experiment where medical interventions such as fluid replacement, dobutamine infusions, and recruitment maneuvers induced SV changes in a pig with circulatory shock. Measurement of left ventricular volume, proximal aortic pressure, and descending aortic pressure waveforms were made simultaneously during the experiment. From measured data, proximal aortic pressure was separated into reservoir and excess pressures. Beat-to-beat aortic characteristic impedance values were calculated using both aortic pressure measurements and an estimate of the aortic cross sectional area. SV was estimated using the calculated aortic characteristic impedance and excess component of the proximal aorta. The median difference between directly measured SV and estimated SV was -1.4ml with 95% limit of agreement +/- 6.6ml. This method demonstrates that SV can be accurately captured beat-to-beat during sudden changes in hemodynamic state. This novel SV estimation could enable improved cardiac and circulatory treatment in the critical care environment by titrating treatment to the effect on SV.

Using an electronic activity monitor system as an intervention modality: A systematic review.

PubMed

Lewis, Zakkoyya H; Lyons, Elizabeth J; Jarvis, Jessica M; Baillargeon, Jacques

2015-06-24

Obesity is a growing global health concern that may lead to cardiovascular disease, type II diabetes, and cancer. Several systematic reviews have shown that technology is successful in combating obesity through increased physical activity, but there is no known review on interventions that use an electronic activity monitor system (EAMS). EAMSs are defined as a wearable device that objectively measures lifestyle physical activity and can provide feedback, beyond the display of basic activity count information, via the monitor display or through a partnering application to elicit continual self-monitoring of activity behavior. These devices improve upon standard pedometers because they have the ability to provide visual feedback on activity progression, verbal encouragement, and social comparison. This systematic review aimed to synthesize the efficacy and feasibility results of EAMSs within published physical activity interventions. Electronic databases and journal references were searched for relevant articles. Data sources included CINAHL, Cochrane CENTRAL, Medline Ovid, PsycINFO, and clinicaltrials.gov. Out of the 1,574 retrieved, 11 articles met the inclusion criteria. These articles were reviewed for quality and content based on a risk of bias tool and intervention components. Most articles were determined to be of medium quality while two were of low quality, and one of high quality. Significant pre-post improvements in the EAMS group were found in five of nine studies for physical activity and in four of five studies for weight. One found a significant increase in physical activity and two studies found significant weight loss in the intervention group compared with the comparator group. The EAMS interventions appear to be feasible with most studies reporting continual wear of the device during waking hours and a higher retention rate of participants in the EAMS groups. These studies provide preliminary evidence suggesting that EAMS can increase physical activity and decrease weight significantly, but their efficacy compared to other interventions has not yet been demonstrated. More high-quality randomized controlled trials are needed to evaluate the overall effect of EAMS, examine which EAMS features are most effective, and determine which populations are most receptive to an EAMS.

An intelligent telecardiology system using a wearable and wireless ECG to detect atrial fibrillation.

PubMed

Lin, Chin-Teng; Chang, Kuan-Cheng; Lin, Chun-Ling; Chiang, Chia-Cheng; Lu, Shao-Wei; Chang, Shih-Sheng; Lin, Bor-Shyh; Liang, Hsin-Yueh; Chen, Ray-Jade; Lee, Yuan-Teh; Ko, Li-Wei

2010-05-01

This study presents a novel wireless, ambulatory, real-time, and autoalarm intelligent telecardiology system to improve healthcare for cardiovascular disease, which is one of the most prevalent and costly health problems in the world. This system consists of a lightweight and power-saving wireless ECG device equipped with a built-in automatic warning expert system. This device is connected to a mobile and ubiquitous real-time display platform. The acquired ECG signals are instantaneously transmitted to mobile devices, such as netbooks or mobile phones through Bluetooth, and then, processed by the expert system. An alert signal is sent to the remote database server, which can be accessed by an Internet browser, once an abnormal ECG is detected. The current version of the expert system can identify five types of abnormal cardiac rhythms in real-time, including sinus tachycardia, sinus bradycardia, wide QRS complex, atrial fibrillation (AF), and cardiac asystole, which is very important for both the subjects who are being monitored and the healthcare personnel tracking cardiac-rhythm disorders. The proposed system also activates an emergency medical alarm system when problems occur. Clinical testing reveals that the proposed system is approximately 94% accurate, with high sensitivity, specificity, and positive prediction rates for ten normal subjects and 20 AF patients. We believe that in the future a business-card-like ECG device, accompanied with a mobile phone, can make universal cardiac protection service possible.

[Wireless device for monitoring the patients with chronic disease].

PubMed

Ciorap, R; Zaharia, D; Corciovă, C; Ungureanu, Monica; Lupu, R; Stan, A

2008-01-01

Remote monitoring of chronic diseases can improve health outcomes and potentially lower health care costs. The high number of the patients, suffering of chronically diseases, who wish to stay at home rather then in a hospital increasing the need of homecare monitoring and have lead to a high demand of wearable medical devices. Also, extended patient monitoring during normal activity has become a very important target. In this paper are presented the design of the wireless monitoring devices based on ultra low power circuits, high storage memory flash, bluetooth communication and the firmware for the management of the monitoring device. The monitoring device is built using an ultra low power microcontroller (MSP430 from Texas Instruments) that offers the advantage of high integration of some circuits. The custom made electronic boards used for biosignal acquisition are also included modules for storage device (SD/MMC card) with FAT32 file system and Bluetooth device for short-range communication used for data transmission between monitoring device and PC or PDA. The work was focused on design and implementation of an ultra low power wearable device able to acquire patient vital parameters, causing minimal discomfort and allowing high mobility. The proposed wireless device could be used as a warning system for monitoring during normal activity.

An object-oriented, knowledge-based system for cardiovascular rehabilitation--phase II.

PubMed Central

Ryder, R. M.; Inamdar, B.

1995-01-01

The Heart Monitor is an object-oriented, knowledge-based system designed to support the clinical activities of cardiovascular (CV) rehabilitation. The original concept was developed as part of graduate research completed in 1992. This paper describes the second generation system which is being implemented in collaboration with a local heart rehabilitation program. The PC UNIX-based system supports an extensive patient database organized by clinical areas. In addition, a knowledge base is employed to monitor patient status. Rule-based automated reasoning is employed to assess risk factors contraindicative to exercise therapy and to monitor administrative and statutory requirements. PMID:8563285

Remote maintenance monitoring system

NASA Technical Reports Server (NTRS)

Simpkins, Lorenz G. (Inventor); Owens, Richard C. (Inventor); Rochette, Donn A. (Inventor)

1992-01-01

A remote maintenance monitoring system retrofits to a given hardware device with a sensor implant which gathers and captures failure data from the hardware device, without interfering with its operation. Failure data is continuously obtained from predetermined critical points within the hardware device, and is analyzed with a diagnostic expert system, which isolates failure origin to a particular component within the hardware device. For example, monitoring of a computer-based device may include monitoring of parity error data therefrom, as well as monitoring power supply fluctuations therein, so that parity error and power supply anomaly data may be used to trace the failure origin to a particular plane or power supply within the computer-based device. A plurality of sensor implants may be rerofit to corresponding plural devices comprising a distributed large-scale system. Transparent interface of the sensors to the devices precludes operative interference with the distributed network. Retrofit capability of the sensors permits monitoring of even older devices having no built-in testing technology. Continuous real time monitoring of a distributed network of such devices, coupled with diagnostic expert system analysis thereof, permits capture and analysis of even intermittent failures, thereby facilitating maintenance of the monitored large-scale system.

Optimization in Cardiovascular Modeling

NASA Astrophysics Data System (ADS)

Marsden, Alison L.

2014-01-01

Fluid mechanics plays a key role in the development, progression, and treatment of cardiovascular disease. Advances in imaging methods and patient-specific modeling now reveal increasingly detailed information about blood flow patterns in health and disease. Building on these tools, there is now an opportunity to couple blood flow simulation with optimization algorithms to improve the design of surgeries and devices, incorporating more information about the flow physics in the design process to augment current medical knowledge. In doing so, a major challenge is the need for efficient optimization tools that are appropriate for unsteady fluid mechanics problems, particularly for the optimization of complex patient-specific models in the presence of uncertainty. This article reviews the state of the art in optimization tools for virtual surgery, device design, and model parameter identification in cardiovascular flow and mechanobiology applications. In particular, it reviews trade-offs between traditional gradient-based methods and derivative-free approaches, as well as the need to incorporate uncertainties. Key future challenges are outlined, which extend to the incorporation of biological response and the customization of surgeries and devices for individual patients.

Second-Degree Atrioventricular Block Occurring After Tooth Extraction.

PubMed

Kamatani, Takaaki; Akizuki, Ayako; Kondo, Seiji; Shirota, Tatsuo

Although cardiac arrhythmias are occasionally associated with dental extractions and dental anesthesia, atrioventricular block is rarely seen during dental procedures. We report a rare case of type I second-degree atrioventricular block (Wenckebach phenomenon) occurring after bilateral extraction of impacted mandibular third molars under general anesthesia in a 16-year-old Japanese girl. Under consultation with a cardiovascular physician, we carefully monitored the patient's vital signs postoperatively, including blood pressure, oxygen saturation, and electrocardiogram, using a bedside monitor. Her postoperative course was uneventful. A 12-lead electrocardiogram the following day revealed no abnormality. In this case, we hypothesize that extubation of the nasotracheal tube or oral/pharyngeal suction might have triggered a vagal reflex that caused type I second-degree atrioventricular block. Our experience indicates that standard cardiovascular monitoring should be used for patients undergoing dental treatment under general anesthesia, even for young, healthy patients, to prevent and detect cardiovascular emergencies.

Orbital atherectomy: device evolution and clinical data.

PubMed

Staniloae, Cezar S; Korabathina, Ravikiran

2014-05-01

A number of atherectomy devices were developed in the last few years. Among them, the DiamondBack 360° Peripheral Orbital Atherectomy System (Cardiovascular Systems, Inc) was specifically designed to work in severely calcified plaque. This article reviews the history, mechanism of action, evolution, clinical data, and future applications of this particular atherectomy device.

A mock heart engineered with helical aramid fibers for in vitro cardiovascular device testing.

PubMed

Jansen-Park, So-Hyun; Hsu, Po-Lin; Müller, Indra; Steinseifer, Ulrich; Abel, Dirk; Autschbach, Rüdiger; Rossaint, Rolf; Schmitz-Rode, Thomas

2017-04-01

Mock heart circulation loops (MHCLs) serve as in-vitro platforms to investigate the physiological interaction between circulatory systems and cardiovascular devices. A mock heart (MH) engineered with silicone walls and helical aramid fibers, to mimic the complex contraction of a natural heart, has been developed to advance the MHCL previously developed in our group. A mock aorta with an anatomical shape enables the evaluation of a cannulation method for ventricular assist devices (VADs) and investigation of the usage of clinical measurement systems like pressure-volume catheters. Ventricle and aorta molds were produced based on MRI data and cast with silicone. Aramid fibers were layered in the silicone ventricle to reproduce ventricle torsion. A rotating hollow shaft was connected to the apex enabling the rotation of the MH and the connection of a VAD. Silicone wall thickness, aramid fiber angle and fiber pitch were varied to generate different MH models. All MH models were placed in a tank filled with variable amounts of water and air simulating the compliance. In this work, physiological ventricular torsion angles (15°-26°) and physiological pressure-volume loops were achieved. This MHCL can serve as a comprehensive testing platform for cardiovascular devices, such as artificial heart valves and cannulation of VADs.

21 CFR 886.1510 - Eye movement monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Eye movement monitor. 886.1510 Section 886.1510...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1510 Eye movement monitor. (a) Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record...

21 CFR 886.1510 - Eye movement monitor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Eye movement monitor. 886.1510 Section 886.1510...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1510 Eye movement monitor. (a) Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record...

30 CFR 77.211-1 - Continuous methane monitoring device; installation and operation; automatic deenergization of...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Continuous methane monitoring device... Installations § 77.211-1 Continuous methane monitoring device; installation and operation; automatic deenergization of electric equipment. Continuous methane monitoring devices shall be set to deenergize...

30 CFR 77.211-1 - Continuous methane monitoring device; installation and operation; automatic deenergization of...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Continuous methane monitoring device... Installations § 77.211-1 Continuous methane monitoring device; installation and operation; automatic deenergization of electric equipment. Continuous methane monitoring devices shall be set to deenergize...

A stretchable and flexible system for skin-mounted measurement of motion tracking and physiological signals.

PubMed

Pinghung Wei; Raj, Milan; Yung-Yu Hsu; Morey, Briana; DePetrillo, Paolo; McGrane, Bryan; Xianyan Wang; Lin, Monica; Keen, Bryan; Papakyrikos, Cole; Lowe, Jared; Ghaffari, Roozbeh

2014-01-01

In this paper, we present a stretchable wearable system capable of i) measuring multiple physiological parameters and ii) transmitting data via radio frequency to a smart phone. The electrical architecture consists of ultra thin sensors (<; 20 μm thick) and a conformal network of associated active and passive electronics in a mesh-like geometry that can mechanically couple with the curvilinear surfaces of the human body. Spring-like metal interconnects between individual chips on board the device allow the system to accommodate strains approaching ~30% A representative example of a smart patch that measures movement and electromyography (EMG) signals highlights the utility of this new class of medical skin-mounted system in monitoring a broad range of neuromuscular and cardiovascular diseases.

Perioperative Interrogation of St. Jude Cardiovascular Implantable Electronic Devices: A Guide for Anesthesiologists.

PubMed

Cronin, Brett; Essandoh, Michael K

2018-04-01

Feelings of trepidation or uncertainty regarding cardiovascular implantable electronic devices (CIEDs) in the perioperative period can often be mitigated by a thorough knowledge of societal recommendations, recommended management options, and familiarity with CIEDs. Given that effective interpretation of an interrogation report is vital to determining perioperative management options and applying societal recommendations, the creation and interpretation of St. Jude CIED interrogation reports are discussed. In an effort to increase the familiarity with St. Jude transvenous CIEDs amongst anesthesiologists, basic programming of a St. Jude pacemaker and implantable cardioverter defibrillator (ICD) also are described. Published by Elsevier Inc.

Shared performance monitor in a multiprocessor system

DOEpatents

Chiu, George; Gara, Alan G; Salapura, Valentina

2014-12-02

A performance monitoring unit (PMU) and method for monitoring performance of events occurring in a multiprocessor system. The multiprocessor system comprises a plurality of processor devices units, each processor device for generating signals representing occurrences of events in the processor device, and, a single shared counter resource for performance monitoring. The performance monitor unit is shared by all processor cores in the multiprocessor system. The PMU is further programmed to monitor event signals issued from non-processor devices.

Cardiovascular drugs and dental considerations.

PubMed

Wynn, R L

2000-07-01

This paper provides current information on the pharmacologic management of cardiovascular diseases. It also describes the drugs used to treat five common cardiovascular disorders--heart failure, coronary artery disease, atrial fibrillation, hypertension, and unstable angina--and lists their dental implications. This information can be used to monitor patients for potential adverse drug reactions and drug interactions and to provide an information base for medical consultation.

A Comparison and Calibration of a Wrist-Worn Blood Pressure Monitor for Patient Management: Assessing the Reliability of Innovative Blood Pressure Devices

PubMed Central

Melville, Sarah; Teskey, Robert; Philip, Shona; Simpson, Jeremy A; Lutchmedial, Sohrab

2018-01-01

Background Clinical guidelines recommend monitoring of blood pressure at home using an automatic blood pressure device for the management of hypertension. Devices are not often calibrated against direct blood pressure measures, leaving health care providers and patients with less reliable information than is possible with current technology. Rigorous assessments of medical devices are necessary for establishing clinical utility. Objective The purpose of our study was 2-fold: (1) to assess the validity and perform iterative calibration of indirect blood pressure measurements by a noninvasive wrist cuff blood pressure device in direct comparison with simultaneously recorded peripheral and central intra-arterial blood pressure measurements and (2) to assess the validity of the measurements thereafter of the noninvasive wrist cuff blood pressure device in comparison with measurements by a noninvasive upper arm blood pressure device to the Canadian hypertension guidelines. Methods The cloud-based blood pressure algorithms for an oscillometric wrist cuff device were iteratively calibrated to direct pressure measures in 20 consented patient participants. We then assessed measurement validity of the device, using Bland-Altman analysis during routine cardiovascular catheterization. Results The precalibrated absolute mean difference between direct intra-arterial to wrist cuff pressure measurements were 10.8 (SD 9.7) for systolic and 16.1 (SD 6.3) for diastolic. The postcalibrated absolute mean difference was 7.2 (SD 5.1) for systolic and 4.3 (SD 3.3) for diastolic pressures. This is an improvement in accuracy of 33% systolic and 73% diastolic with a 48% reduction in the variability for both measures. Furthermore, the wrist cuff device demonstrated similar sensitivity in measuring high blood pressure compared with the direct intra-arterial method. The device, when calibrated to direct aortic pressures, demonstrated the potential to reduce a treatment gap in high blood pressure measurements. Conclusions The systolic pressure measurements of the wrist cuff have been iteratively calibrated using gold standard central (ascending aortic) pressure. This improves the accuracy of the indirect measures and potentially reduces the treatment gap. Devices that undergo auscultatory (indirect) calibration for licensing can be greatly improved by additional iterative calibration via intra-arterial (direct) measures of blood pressure. Further clinical trials with repeated use of the device over time are needed to assess the reliability of the device in accordance with current and evolving guidelines for informed decision making in the management of hypertension. Trial Registration ClinicalTrials.gov NCT03015363; https://clinicaltrials.gov/ct2/show/NCT03015363 (Archived by WebCite at http://www.webcitation.org/6xPZgseYS) PMID:29695375

Study of nanosensor systems for hypertension associated cerebrovascular and cardiovascular disorders

NASA Astrophysics Data System (ADS)

Ramasamy, Mouli; Varadan, Vijay K.

2015-04-01

Hypertension and hypertension associated cerebrovascular and cardiovascular diseases are on a rise. At-least 970 million people in the world and Seventy percent of the American adults are affected by high blood pressure, also known as hypertension. Even though blood pressure monitoring systems are readily available, the number of people being affected has been increasing. Most of the blood pressure monitoring systems require cumbersome approaches. Even the noninvasive techniques have not lowered the number of people affected nor did at-least increase the user base of these systems. Uncontrolled or untreated hypertension may lead to various cerebrovascular disorders including stroke, hypertensive crisis, lacunar infarcts intracerebral damage, microaneurysm, and cardiovascular disorders including heart failure, myocardial infraction, and ischemic heart disease. Hypertension is rated as the one of the most important causes of premature death in spite of the technical advances in biomedical technology. This paper briefs a review of the widely adopted blood pressure monitoring methods, research techniques, and finally, proposes a concept of implementing nanosensors and wireless communication for real time non-invasive blood pressure monitoring.

The selected reaction monitoring/multiple reaction monitoring-based mass spectrometry approach for the accurate quantitation of proteins: clinical applications in the cardiovascular diseases.

PubMed

Gianazza, Erica; Tremoli, Elena; Banfi, Cristina

2014-12-01

Selected reaction monitoring, also known as multiple reaction monitoring, is a powerful targeted mass spectrometry approach for a confident quantitation of proteins/peptides in complex biological samples. In recent years, its optimization and application have become pivotal and of great interest in clinical research to derive useful outcomes for patient care. Thus, selected reaction monitoring/multiple reaction monitoring is now used as a highly sensitive and selective method for the evaluation of protein abundances and biomarker verification with potential applications in medical screening. This review describes technical aspects for the development of a robust multiplex assay and discussing its recent applications in cardiovascular proteomics: verification of promising disease candidates to select only the highest quality peptides/proteins for a preclinical validation, as well as quantitation of protein isoforms and post-translational modifications.

An underwater blood pressure measuring device.

PubMed

Sieber, Arne; Kuch, Benjamin; L'abbate, Antonio; Wagner, Matthias; Dario, Paolo; Bedini, Remo

2008-09-01

Measurement of arterial blood pressure is an important vital sign for monitoring the circulation. However, up to now no instrument has been available that enables the measurement of blood pressure underwater. The present paper details a novel, oscillometric, automatic digital blood pressure (BP) measurement device especially designed for this purpose. It consists mainly of analogue and digital electronics in a lexan housing that is rated to a depth of up to 200 metres' sea water, a cuff and a solenoid for inflation of the cuff with air supplied from a scuba tank. An integrated differential pressure sensor, exposed to the same ambient pressure as the cuff, allows accurate BP measurement. Calculation of systolic and diastolic pressures is based on the analysis of pressure oscillations recorded during the deflation. In hyperbaric chamber tests to pressures up to 405 kPa, BP measurements taken with the prototype were comparable to those obtained with established manual and automated methods. Swimming pool tests confirmed the correct functioning of the system underwater. The quality of the recorded pressure oscillations was very good even at 10 metres' fresh water, and allowed determination of diastolic and systolic pressure values. Based on these results we envisage that this device will lead to a better understanding of human cardiovascular physiology in underwater and hyperbaric environments.

76 FR 64223 - Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-17

... arrhythmias; and 4. Micro/macro shocks--Uncontrolled leakage currents or patient auxiliary currents can cause...); Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, Inc. 128 S. Ct. 999 (2008)). If this...

From Microscale Devices to 3D Printing: Advances in Fabrication of 3D Cardiovascular Tissues.

PubMed

Borovjagin, Anton V; Ogle, Brenda M; Berry, Joel L; Zhang, Jianyi

2017-01-06

Current strategies for engineering cardiovascular cells and tissues have yielded a variety of sophisticated tools for studying disease mechanisms, for development of drug therapies, and for fabrication of tissue equivalents that may have application in future clinical use. These efforts are motivated by the need to extend traditional 2-dimensional (2D) cell culture systems into 3D to more accurately replicate in vivo cell and tissue function of cardiovascular structures. Developments in microscale devices and bioprinted 3D tissues are beginning to supplant traditional 2D cell cultures and preclinical animal studies that have historically been the standard for drug and tissue development. These new approaches lend themselves to patient-specific diagnostics, therapeutics, and tissue regeneration. The emergence of these technologies also carries technical challenges to be met before traditional cell culture and animal testing become obsolete. Successful development and validation of 3D human tissue constructs will provide powerful new paradigms for more cost effective and timely translation of cardiovascular tissue equivalents. © 2017 American Heart Association, Inc.