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Heart device replacements pose risk

Bloomberg News / November 16, 2009

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SAN FRANCISCO - One in five patients were likely to be hospitalized for complications after heart devices and connecting wires made by Boston Scientific Corp., Medtronic Inc., and St. Jude Medical Inc. were replaced, researchers said yesterday.

Defibrillators and pacemakers are implanted to shock irregular heartbeats back into rhythm. The study evaluated patients in surgery to upgrade or change the devices and the wires, known as leads, connected to them. Doctors want to know the risks of replacements after a series of deaths and product recalls in 2006 and 2007, said Dr. Marye Gleva, a cardiologist at Washington University in St. Louis who was involved in the study.

About 15 percent of 713 patients who had surgery suffered serious infections or other complications after six months that required a hospital stay, the research found. Complications of all types occurred in 20.9 percent of cases. The researchers reported their findings at the American Heart Association meeting in Orlando, Fla.