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Physicians caught in a spot with heart-device recalls

Cardiologists want more information about device problems, but they fear being bombarded with random data.

By Kevin B. O'Reilly, amednews staff. Aug. 22/29, 2005.

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This year's flurry of heart-device recalls by the industry's leading manufacturers have left cardiologists looking for more useful information about problems as well as advice on how to communicate with their patients.

"You can always have a random failure in a random device," said Anne Curtis, MD, cardiology chief at the University of South Florida, Tampa. "But when do you go from a random problem to pattern? And when you see a pattern, what's the right response to it?"

Dr. Curtis is president of the Washington, D.C.-based Heart Rhythm Society, which has convened a 12-member task force that includes two FDA officials to study the matter. The group is also hosting a Sept. 16 conference to examine how to improve device manufacturers' communication with physicians and heart specialists' communication with their patients.

The moves come in response to widespread concern among physicians, patients, politicians and regulators about the circumstances surrounding recent recalls.

Last month, No. 2 heart-device manufacturer Guidant Corp. recalled 18,000 of its pacemakers for potential leak failures. This was preceded in May by recalls of 88,000 of Guidant's implantable cardioverter defibrillators. Joshua Oukrup, a 21-year-old with hypertrophic cardiomyopathy, died in March while bicycling because his Guidant Ventak Prizm 2 DR Model 1861 ICD short-circuited and failed to send a life-saving shock.

His cardiologist, Barry Maron, MD, discovered that Guidant had reported similar trouble with the device to the FDA's adverse-events database before fixing the problem in April 2002. Dr. Maron met with Guidant and urged company officials to go public, but he said they refused.