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A recent study found that approximately one in five cardiac defibrillators malfunctions 10 years after initial implantation, increasing the risk of death and other serious adverse events in patients with the devices.

According to researchers, the electrical wires—or leads—connecting the defibrillator device to the heart are prone to malfunction and, in fact, pose a greater risk for patients than the battery failures that prompted the recall of thousands of devices in 2005.

Patients whose device malfunctions because of a faulty lead may suffer increased anxiety, additional medical costs to remove, replace, or repair the device, and in some cases death, said the researchers.

The Research

The study involved 990 patients who were implanted with their first cardiac defibrillator between 1992 and 2005 and showed that the leads failed in 148 cases, or 15 percent. Women and healthier patients expected to live longer faced the greatest risk of failure.

“These data emphasize that lead failure may become a prominent concern. The high incidence of lead complications in these patients should be considered at the time of implantation,” said Thomas Kleemann, lead researcher and German electrophysiologist.

Cardiac defibrillators are used to deliver electrical shocks to the heart to restore normal rhythm. The devices, which cost at least $30,000, are implanted in about 70,000 patients each year in the United States.

Medtronic and Boston Scientific manufacturer the widely used devices. In recent years, various models have been recalled for defects including battery failure.

(Article source: Boston.com)

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