Defibrillator Vest Calms Irregular Heartbeats
First external device to control arrhythmia gets OK
THURSDAY, Jan.3, 2002 (HealthDayNews) -- People with serious heart conditions may now have an alternative to surgically implanted pacemakers and other electronic regulators.
The U.S. Food and Drug Administration (FDA) has approved a vest-like heart monitor/defibrillator that detects and treats arrhythmia, or abnormal heart rhythms, in people at risk for cardiac arrest.
A product of Lifecor Inc. of Pittsburgh, it's the first device worn outside the body. In life-threatening situations, the defibrillator delivers an electrical shock to restore normal heart rhythm. A belt-like device worn around the chest and touching the skin, the device is connected to a monitor and an alarm worn at the waist.
Here's what the vest looks like.
The FDA "approval represents a significant advance in defibrillator technology. It means patients may now opt for a wearable defibrillator if they are not suitable candidates for an implanted defibrillator, or do not want one," says FDA Acting Principal Deputy Commissioner Dr. Bernard A. Schwetz.
Once a week, the patient connects the monitor to an external modem, and sends the data to a doctor's computer for review.
In clinical trials, 289 patients at 16 medical centers in the United States and Europe were fitted with the defibrillator vest. All were either awaiting heart transplants or had recently had a heart attack or a coronary bypass operation. The patients wore the defibrillator for an average of 20 hours a day for approximately three months.
The device was 71 percent successful in treating sudden cardiac arrests. This translated into a successful jolt of electrical current in five cardiac arrests. The vest also failed twice, but researchers ascribe this to electrodes being improperly attached to the patients' chests.
For good information on arrhythmia, see The Scripps Memorial Hospital Regional Cardiac Arrhythmia Center, part of the Scripps Memorial Hospital at La Jolla, Calif.