Pacemaker Study Stopped for Safety

Patients with Implanted Defibrillators Should Have Older-Style Pacemaker

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Dec. 20, 2002 -- Most heart patients who receive implantable defibrillators now also have their heart rhythms regulated with a pacemaker, but a new study finds that depending on the type of pacemaker, it might cause a worse effect on the heart with increased hospitalization, worsening heart failure, and death.

While no one questions the value of defibrillators like the one Vice President Dick Cheney received last year for patients with dangerously fast heart rhythms, the new research suggests that pacing the rhythm of two chambers of the heart instead of one is not needed in the vast majority of patients.

Researchers at the Cleveland Clinic stopped their study of these newer dual-chamber pacemaker-defibrillators early after determining that patients were dying much faster than those with the older single-chamber pacemakers. This newer type of pacemaker stimulates both chambers of the heart to not only fill the heart but pump blood out. A single-chamber pacemaker only stimulates the chamber that pumps blood out.

Their findings are published in the Dec. 25 issue of the Journal of the American Medical Association.

The study's lead researcher says patients who have the newer dual-chamber pacemaker-defibrillators should talk to their doctor about reprogramming the device so that the pacemaker function does not stimulate both chambers.

Bruce Wilkoff, MD, tells WebMD that fewer than 20% of patients who need defibrillators for irregular heart rhythms actually need pacemakers, which are primarily used to treat patients with slow heartbeats. Defibrillators sense abnormal heart rhythms and deliver an electric shock when such rhythms are determined to be dangerous. Dual-chamber pacemakers supply electrical impulses to both the upper and lower chambers of the heart.

"This year there were between 80,000 and 100,000 defibrillators implanted worldwide, and up to three-fourths of them were the dual-chamber devices and most are being programmed to the dual-pacing mode," he says.

The Cleveland Clinic study included 506 patients with heart disease or previous heart attacks who received the dual-chamber defibrillator-pacemakers. Half were programmed to stimulate the heart to pump at a rate of 70 beats per minute, and the other were programmed to have the pacemaker activated if the pumping capacity of the heart fell below 40 beats per minute, similar to a backup system for the pumping function of the heart should it fail.

One year after implantation, overall almost 84% of patients on the backup system survived and hospitalization from heart failure compared with only 74% of patients on the newer dual-chamber pacemaker.

Heart failure hospitalizations occurred more frequently in those patients who had the dual-chamber pacemaker with almost 23% at one year having been hospitalized for heart failure versus 13% in the group who had the older backup-type pacemaker.

The findings suggest that patients who need defibrillators might be better off with an older version of the device -- a single-chamber, backup pacemaker. The older model is much cheaper, costing anywhere from $2,000 to $9,000 less than the dual-chamber version. But Wilkoff says it is not yet clear whether the newer version offers other advantages to patients.

American Heart Association president Robert O. Bonow, MD, tells WebMD that the new findings will surprise a lot of physicians who believed that dual-chamber, pacing was better for all patients.

"This is reminiscent of the study that came out earlier this week showing that good, old, cheap diuretics may be just as good or better than the newer more expensive medications (for lowering blood pressure)," he says. "In this case, the simpler pacing method, which is easier to maintain and cheaper, may also be just as good or better."

Bonow agrees that patients with defibrillators need to talk to their physicians, and have their devices reprogrammed, if needed.

"I'm not saying they need to rush out and see their doctor tomorrow," he says. "But they should definitely discuss it at their next evaluation."

WebMD Health News


SOURCES: The Journal of the American Medical Association, Dec. 25, 2002 • Bruce Wilkoff, MD, director of cardiac pacing and tachyarrythmia devices, Cleveland Clinic • Robert O. Bonow, president, American Heart Association, Goldberg Professor of Medicine, Northwestern University Feinberg School of Medicine, chief of cardiology, Northwestern Memorial Hospital.
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