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  Tiny Heart Devices Reduce Death Rate, but Cost Is Concern


By: Gina Kolata
New York Times, March 20, 2002

   

Researchers have found that they can sharply reduce the death rate in high-risk heart attack patients with small but costly devices that are tucked under the skin of the chest and can avert potentially fatal heart rhythms.

The devices, implantable defibrillators, sense when the heart's rhythm is going awry and administer a small electric shock to the heart to bring its fluttering rhythm back to normal, preventing sudden death. The new study found that the device was effective in patients whose hearts were so damaged from heart attacks that they could no longer pump blood effectively.

Implantable defibrillators are routinely used for a relatively small group of patients who, like Vice President Dick Cheney, have demonstrable heart-rhythm disturbances. The new study showed that the devices are effective in a much larger group of people who have had serious heart attacks that placed them at risk for heart-rhythm disturbances, but may not have had such problems yet.

The device costs about $20,000, though, and the operation to insert it, another $10,000. With 400,000 new patients a year who could benefit, and an additional three million patients who have already had serious heart attacks who could be helped, some doctors wonder who is going to pay.

Dr. Douglas Zipes, president of the American College of Cardiology, said he and other physicians were bracing for a surge of calls from patients who would want the device.

"It's a difficult situation," Dr. Zipes said. "We're looking at changes that could easily rupture the health care budget."

The study, which was reported yesterday at the annual meeting of the American College of Cardiology and will be published tomorrow in The New England Journal of Medicine, found that after an average of 20 months, 19.8 percent of those patients who did not have the devices died, compared with 14.2 percent of those who had them, a 30 percent difference in the death rate.

"There's no question — it's a big effect," said Dr. David Faxon, the president of the American Heart Association. "It's very significant. It offers hope for a large group of patients who have a very bad outlook. Before, we didn't have a good therapy for them."

For now, insurers and Medicare pay for limited use of the defibrillators in those patients who already have heart arrhythmias.

But use of the device in the wider group is under expedited review at the Food and Drug Administration, according to Dr. Arthur Moss of the University of Rochester Medical Center, who directed the study.

The study was paid for by the device's manufacturer, the Guidant Corporation. Dr. Moss said that the investigators insisted on autonomy, that they did not hold stock in the company, nor were they speakers for Guidant.

"What are we going to do when the phones start ringing off the hook?" asked Dr. Michael Lauer, a cardiologist at the Cleveland Clinic Foundation who directs clinical research in the department of cardiovascular medicine there.

Even the specialists who implant the devices, electrophysiologists, are in short supply. Dr. Zipes, an electrophysiologist, said that at least twice as many doctors like himself would be needed to handle the patient load.

It is, said medical specialists, a portent of issues to come and it raises questions about the cost of medicine for which society has, as yet, no answers.

"This is only one example of many that we will be seeing in the coming years where there are very, very effective and very, very expensive new treatments," said Dr. Alan Garber, an internist and economist at Stanford University. "Does that mean we should put the brakes on this procedure? The broader question is, Can we as a society afford to pay?"

In this case, much of the cost burden is likely to fall on Medicare, because most people with serious heart attacks are elderly. But that adds enormous costs to a publicly financed program with a fixed amount of money to spend.

Dr. Sean Tunis, who directs the coverage and analysis group for the Centers for Medicare and Medicaid Services, a federal agency that runs the programs, said that Medicare was likely to consider national coverage for the new use of implantable defibrillators. Medicare, he said, pays for technologies that are "clinically effective."

So far, cost has not been a factor in Medicare decisions, Dr. Tunis said, though Medicare is not legally prevented from considering it. But, he noted, Medicare's budget is fixed.

"As money for some particular service is increased, it may be that it causes a reduction in payments for other services," he said. "It is not necessarily that the pie expands."

Dr. Moss said that all 1,232 patients in the study had a heart-pumping function that was less than half of normal; they were also already being treated with the only drugs known to prolong their lives, beta- blockers and angiotensin converting enzyme inhibitors, also known as ace inhibitors. But neither addressed the arrhythmia problem.

"The heart fails in one of two ways," Dr. Moss said. "There can be a disastrous electrical catastrophe, an arrhythmia leading to sudden death. Or it can dwindle away," with increasingly feeble blood-pumping efforts, causing a slow death from heart failure.

"Up until now, the only treatment was for the mechanical problem — that's what beta blockers and ace inhibitors did," Dr. Moss said.

Some cardiologists are asking if the price for defibrillators might fall with wider use. Dr. Zipes said that one way to lower the price might be for manufacturers to make simpler devices, "a Volkswagen rather than a Rolls-Royce," he said.

But Dr. Garber said the devices were inherently costly.

"They represent extremely sophisticated technology that has to be completely reliable," he said. "I think they will remain expensive."

Dr. Faxon said it should be possible to identify heart attack patients who fit the study criteria but who are more likely than others to be helped by the devices. That might enable doctors to restrict defibrillators to a somewhat smaller group. But that requires more research and, for now, there is no way of choosing those who should — and those who should not — get defibrillators.

Dr. Zipes said he planned to implant defibrillators in patients who should be helped and argue with their insurers later.

"Very honestly, if it were I or my father or a loved one, I'd want them to get it," he said.


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