ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Friday, May 17, 1996 TAG: 9605170063
SECTION: NATIONAL/INTERNATIONAL PAGE: A-10 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Associated Press
The FDA on Thursday swiftly expanded the approved use of an implanted device that sends electrical jolts to an ailing heart after a study found the action could save thousands of lives annually.
Dr. Arthur J. Moss, professor of medicine at the University of Rochester, N.Y., School of Medicine and director of the study, said the implanted defibrillator can constantly monitor heart action in a patient at high risk of sudden cardiac death and quickly correct any threatening abnormal beat.
``People with this condition can be dead if they don't get outside help within four minutes,'' Moss said in an interview from a meeting in Seattle of the North American Society of Pacing and Electrophysiology, where he presented his study results.
He said often people with this condition keel over on the street and are dead long before any medical care is available. But with the automatic, implanted defibrillator, ``these people can be saved.''
Moss said the surgically implanted device sends strong surges of electrical energy to selected parts of the heart to force the organ into the proper rhythm. He said the effect is the same as with electrical paddles that emergency room physicians use to restart an arrested heart.
The implanted defibrillator had been approved previously for patients who had had at least one cardiac arrest or who had recurrent rapid heartbeat that had not responded to drugs.
Under the new approval, the device can now be put into patients who may have had a heart attack in the past but who are now without symptoms other than rapid or erratic heart rhythms detected on electrocardiograms. About 30 percent of patients in this group treated with traditional drugs die within two years of diagnosis.
Use of the implanted defibrillator, said the FDA, ``could save the lives of thousands of heart attack patients annually.''
Moss said about 500,000 Americans could benefit from the new use of the device. He said most of these are people who have had mild heart attacks that left them with cardiac muscle scars that affect the heartbeat for reasons not now understood.
``It is the unpredictability of the beat that is the reason for the defibrillator,'' said Moss. The device, he said, ensures that a patient will not die simply because his or her heartbeat sinks into a disorganized and inadequate pattern.
The FDA acted after evaluating a study directed by Moss that involved 95 patients treated with the implanted defibrillator and 101 treated with drugs. The patient group with the heart device experienced 15 deaths, while 39 patients on drugs died of heart attack.
LENGTH: Medium: 55 linesby CNB