Pacemaker, Defibrillator Reliability Can Be Improved

While the devices have gotten better, they still malfunction, studies find

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By Ed Edelson
HealthDay Reporter

TUESDAY, April 25, 2006 (HealthDay News) -- The reliability of implanted cardiac pacemakers and defibrillators is getting better, but there's still room for improvement, two new studies find.

Reliability is an important issue for the hundreds of thousands of Americans walking around with either a pacemaker -- designed to keep the heart beating regularly -- or a defibrillator -- a device that delivers a shock to restart a malfunctioning heart.

One study examined data supplied by device manufacturers to the U.S. Food and Drug Administration from 1990 to 2002, a period when 2.25 million pacemakers and 415,780 defibrillators were implanted in Americans. During that time, 8,834 pacemakers and 8,489 defibrillators were removed because they malfunctioned. The higher percentage rate of defibrillator malfunction was predictable because they are more complex devices than pacemakers, said study author Dr. William H. Maisel, director of the pacemaker and device service at Beth Israel Deaconess Medical Center, in Boston.

The second study, which reviewed data from three registries from North America, Denmark and the United Kingdom, found similar malfunction rates. But the important information concerns the changes over time, and "the results are mixed," said Maisel, who authored the second study as well.

"Data from both of these studies suggest that pacemaker reliability has improved considerably since the 1980s, and that it continued to improve in the 1990s," Maisel said. "Defibrillator reliability decreased from 1998 to 2002, when there was an increase in the number and rate of malfunctions, but then declined again down to the lowest levels in the past decade."

The results of both studies appear in the April 26 issue of the Journal of the American Medical Association.

The results, he said, "suggest that an ongoing monitoring of device performance is needed. Industry needs to be reporting device performance in a more timely fashion, informing physicians and patients of malfunction."

At the same time, people who have the devices implanted need to have "a more realistic expectation of device performance," Maisel said.

However, one factor to consider when an implanted defibrillator acts up is the possibility of complications when replacement surgery is done, according to another report in the same issue of the journal.

Data on 533 patients who underwent replacement surgery found that 43 of them -- 8.1 percent -- had complications in the following three months. Two patients died of infections after surgery.

"Before this, there was very little information about the risk of having a replacement operation done," said study leader Dr. Andrew D. Krahn, a professor of cardiology at the University of Western Ontario. "The high complication rate we reported indicates that when a decision is made on leaving things alone or intervening, the risk of intervening is higher than expected."

The reliability of pacemakers and defibrillators became headline news last year, first when the Guidant Corp. issued an alert saying that about 28,000 pacemakers had defects that could make them malfunction, then when it was revealed that the company had decided not to issue alerts about life-threatening defects in some of its implanted defibrillators. The U.S. Food and Drug Administration then said it would strengthen its oversight of such heart devices.

Before that recent publicity about device malfunctions, "if you had asked physicians or patients what they thought the chance was of device malfunction, they would have been wrong by a factor of 100," Maisel said. "They thought the devices were 100 times more reliable than they really are."

His study found the annual replacement rate for pacemakers in the United States due to malfunction was 4.6 per 1,000 implants. For defibrillators, the rate was 20.7 per 1,000 implants. The annual replacement rate for pacemakers decreased steadily over the years, while the defibrillator replacement rate decreased from 1993 to 1996, and then rose sharply. More than half the defibrillator malfunctions occurred in the last three years of the study.

There were 30 deaths attributed to device failure from 1990 to 2002 among pacemaker patients and 31 among the much smaller number of defibrillator patients.

"It's important that patients understand what the expected reliability of these devices is, so they can make informed decisions," Maisel said. "Manufacturers should provide this information. It is being done better than it was. In the last six months, industry has started providing more information. We are moving in the right direction, but it still could be better."

Dr. Bruce L. Wilkoff is director of cardiac and tachyarrhythmia devices at the Cleveland Clinic, and wrote an accompanying editorial in the journal. The studies "should enable clinicians and patients to make better informed decisions about these devices," he said.

In an interview, Wilkoff focused on the positive side of the new studies.

"From the 1980s to now, malfunction rates have come down," Wilkoff said. "These are not perfect, and we know that there are going to be failure rates. Despite all of it, these devices, despite all the flaws, they do the job. People live longer and feel better because of them."

Wilkoff acknowledged that most doctors had not informed their patients about the risk of device failure, "but some patients did not want to know," he said.

"I don't think there is any problem of manufacturers being honest with you," Wilkoff said. "I'm excited that we put this information out there so doctors and patients can know about it. This is a dramatic therapy that saves lives. It's not perfect, but it is improving."

More information

To learn more about the devices, visit the National Library of Medicine.

SOURCES: William H. Maisel, M.D., director, pacemaker and device service, Beth Israel Deaconess Medical Center, Boston; Bruce L. Wilkoff, M.D., director, cardiac and tachyarrhythmia devices, Cleveland Clinic; Andrew D. Krahn, M.D., professor, cardiology, University of Western Ontario, London, Ontario, Canada; April 26, 2006, Journal of the American Medical Association

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