WEDNESDAY, Jan. 19, 2005 (HealthDayNews) -- New research has convinced Medicare officials that doubling or tripling the use of implantable defibrillators to treat heart failure is economically justifiable.
The study found the death rate of patients who had an implanted defibrillator, which delivers an electric shock to keep the heart beating, was 23 percent lower than for those given drug treatment.
The findings appear in the Jan. 20 issue of the New England Journal of Medicine.
As a result, the Centers for Medicare and Medicaid Services (CMS) has announced it will greatly expand the number of defibrillator implants it will pay for. Some 500,000 Americans, mostly elderly, will now be eligible, and about 30,000 to 40,000 implants are expected each year, federal officials said.
The new rule will take effect "in a week or two," said Dr. Sean Tunis, chief medical officer of CMS. Medicare will require doctors to enter data on each patient in a national registry that will make it possible to track the results of the procedure, he said.
The study results make it imperative for anyone diagnosed with congestive heart failure, in which the heart progressively loses the ability to pump blood, to become aware of an often unfamiliar measure of cardiac performance called ejection fraction, said Dr. Alan Kadish, associate director of the Northwestern Cardiovascular Institute, who wrote an accompanying editorial in the journal.
Ejection fraction is the percentage of blood pumped during each beat of the heart. The ejection fraction of a healthy heart is about 67 percent. While several factors will be involved in each decision on whether to implant a defibrillator, such as the presence of other illnesses, the basic rule is that someone with an ejection fraction of 30 or lower will be eligible for a defibrillator, Kadish said.
"Until the current study, we haven't had a clear and simple message," he said. "Now the clear and simple message is that if the ejection fraction is 30 percent or less, you should strongly consider having a defibrillator implanted. The message to the public is that if you have been told you have heart disease, know your ejection fraction and ask your doctor what to do about it."
One unexpected result of the study is to emphasize the importance of asking about drug treatment, said study leader Dr. Gust H. Bardy, director of the Seattle Institute for Cardiac Research.
The trial compared use of an implantable defibrillator to treatment with amiodarone (Cordarone), a drug "widely used and presumed to be of value" for heart failure, Bardy said. The study results showed that amiodarone was no more effective than a placebo, and that it appeared to worsen the risk of death for some patients, he said.
"Patients should appreciate that if they have heart failure they should not only ask doctors if they are candidates for implantable defibrillators but also about other therapies, including drugs," he said.
Perhaps the best-known American recipient of an implanted defibrillator is Vice President Dick Cheney, who received one after having a mild heart attack. The defibrillators that Medicare will finance are less complex than the one given Cheney, but still cost upward of $40,000, Kadish said.
That expense is regarded as cost-effective, but not because it reduces the overall cost of caring for a patient, Kadish said. Instead, it is based on the assessment that money should be spent on a treatment if it costs no more than $30,000 to $40,000 per year of life saved. Implanted defibrillators meet that criterion, he said.
The American Heart Association offers an overview on defibrillators.