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A new FDA ruling dramatically raises the number of people who could benefit from implantable cardioverter defibrillators (ICDs) like the one placed in Vice President Dick Cheney last year. Recent research shows that implanted defibrillators cut the risk of dying by one-third in heart attack survivors left with moderately weakened heart function.
"If you've had a heart attack and you have suppressed heart function, you should discuss with your physician whether you are a candidate for one of these devices," said FDA medical officer Dr. Helen Barold in an interview.
Experts say the sophisticated devices could protect the lives of at least 3 million heart attack survivors. A major heart attack or several smaller ones can weaken the heart, placing one at greater risk of cardiac arrest later. The advanced implanted defibrillators constantly check for abnormal beats and shock the heart back into rhythm in case of cardiac arrest.
"I call this having an emergency room in your chest because the ICD, in effect, functions like that," says Dr. Douglas Zipes, who played an important role in its ' invention. "The ICD monitors the heartbeat, and if the heartbeat gets too slow, the ICD paces it to go faster. If the heartbeat gets too fast, the ICD delivers a shock, a defibrillation, to make the heart go slower."
Under previous FDA guidelines, relatively few patients were eligible to receive an ICD in the United States. Based on the new findings, as many as 400,000 people more a year might qualify, according to Dr. Barold.
The FDA also advised physicians that defibrillator candidates do not require invasive testing when the catheter is advanced inside the heart to trigger an irregular beat.
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