Implantable cardioverter-defibrillators have higher malfunction rate than pacemakers

Although pacemakers and implantable cardioverter-defibrillators (ICDs) sustain and save many lives and have a low malfunction rate, their performance should be monitored, especially ICDs, which have a significantly higher malfunction rate than pacemakers, according to two studies in the April 26 issue of JAMA.

Pacemakers and ICDs are two of the most clinically significant and complex medical innovations of the past century. Yet, despite millions of implants worldwide and their increasingly frequent use, surprisingly little is known about their reliability and the rate at which they malfunction, according to background information in the article. Because pacemakers and ICDs represent "life-sustaining" therapies for many patients, the U.S. Food and Drug Administration (FDA) requires manufacturers to submit annual reports detailing the number of device implants and malfunctions that have occurred.

William H. Maisel, M.D., M.P.H., of Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, and colleagues from the U.S. FDA analyzed the manufacturer's pacemaker and ICD annual reports for the years 1990-2002 to determine the reported number, rate, and reasons for pacemaker and ICD malfunctions and to assess trends in their performance.

The researchers found that from 1990 to 2002, 2.25 million pacemakers and 415,780 ICDs were implanted in the United States. During this period, 17,323 devices (8,834 pacemakers and 8,489 ICDs) were explanted due to confirmed malfunction. The average annual total device malfunction replacement rate was 6.8 per 1,000 device implants. Overall, the annual average ICD malfunction replacement rate was significantly higher than the pacemaker malfunction replacement rate (20.7 vs. 4.6 replacements per 1,000 implants). Battery/capacitor abnormalities and electrical issues accounted for half of the total device failures. Sixty-one deaths (30 pacemaker patients, 31 ICD patients) were attributable to device ma

Contact: Bonnie Prescott
JAMA and Archives Journals

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