March 9, 2004 (New Orleans) -- A tiny implantable defibrillator may be the best treatment for a broad range of patients with disabling heart failure -- saving lives when drugs alone can't do the job, says Gust H. Bardy, MD, president of the Seattle Institute for Cardiac Research.
And Bardy, who just completed overseeing the largest study ever of these devices, says he has the number to prove his point -- the devices commonly called ICDs reduced death by 23% compared with the best medical treatment. He unveiled those numbers at the American College of Cardiology Scientific Session 2004.
Heart failure often follows injury such as the scarring caused by heart attacks or damage caused by infections that attack heart muscle. Heart failure means the heart begins to pump less efficiently and gets larger and weaker, which causes the fatigue, breathlessness, and swelling that are hallmarks of heart failure.
New Candidates for ICDs
According the American Heart Association, about 5 million Americans are living with this condition, with 550,000 new cases diagnosed each year.
But one of the most dangerous complications of heart failure is sudden cardiac death, which is caused by an electrical failure in the heart that causes it to beat irregularly or suddenly stop beating. Defibrillators give an electric shock to the heart, helping to re-establish normal rhythms. ICDs are programmed to detect the irregular heartbeats that often precede sudden cardiac arrest. Perhaps the most famous recipient of an ICD is vice president Dick Cheney, who has a history of heart disease and who was implanted with an ICD shortly after taking office.
ICDs are often used in people who have a history of irregular heartbeats. In recent years, however, they have been implanted in patients who don't yet have arrhythmias but who are considered "at risk" because they have had heart attacks. And now, people with heart failure may be added to the list of patients who are eligible for ICD treatment.
But a big obstacle to ICD use is cost -- many models cost as much as $30,000, with physician and hospital fees on top of that. So researchers and payers, most notably Medicare and Medicaid, have been trying to decide which patients should get ICDs.
Bardy's new study suggests that heart failure patients, especially those who are sick but not completely disabled, are good candidates for ICDs. But he tells WebMD that expanding ICD coverage to include these patients could mean that as many as 1 million Americans could be implanted with ICDs.
Michael Cain, MD, president of the NASPE-Heart Rhythm Society and director of the cardiovascular division at Washington University in St. Louis, tells WebMD that he estimates "400,000 to 1.5 million people [with heart failure] could benefit from ICD implant."
Better Than Medication?
The new study enrolled more than 2,500 patients who were randomly chosen to receive either ICD, treatment with a drug used for arrhythmias called amiodarone, or dummy pills and then followed for almost four years. Bardy says the patients treated with amiodarone did no better than patients receiving dummy pills.
At a news conference, Bardy said the study was specifically designed to have a "broad public health impact" and he contended that results deliver that impact. But when asked about real-world economic impact of those results -- for example, if the Centers for Medicare and Medicaid would loosen current restrictions on Medicare reimbursement for ICDs, Bardy declined to comment.
Sidney C. Smith Jr., MD, professor of medicine and director of the Center for Cardiovascular Science and Medicine, tells WebMD that the results of the study may help the ICD proponents overcome the "resistance" from third-party payers. "My feeling is that the issue is science. When the science shows a patient benefit, cost should not be a barrier. So it may be that we need to find a way to produce cheaper ICDs." Smith was not involved in the study.