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 — Posted Aug. 22, 2005
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.
"It's obvious that I was surprised they didn't," he said.
Guidant, which did not return repeated calls for comment, is not alone in its troubles. The No. 1 heart-device manufacturer, Minneapolis-based Medtronic, recalled 87,000 of its ICDs for a potential premature battery failure in February. By the end of May, 13,000 of those devices had been replaced.
At the Duke University Medical Center in Durham, N.C., 400 patients have the recalled Guidant ICDs implanted and 12 have the pacemakers, according to electrophysiology chief Roosevelt Gilliam III, MD.
"When you replace a device, there's an incumbent risk, infection being one of the larger ones," Dr. Gilliam said, explaining why he rarely advises patients to change models when even recalled devices are 99% effective.
"The unspoken risk," he said, "is that the device you put in may be no more reliable than one you've just taken out."
Some cardiologists are upset about Guidant's actions but unsure about what could be done.
"I think Guidant was in a situation where they continued to sell some devices when they knew they had a problem," said Robert Sorrentino, MD, a cardiac electrophysiologist at Augusta's Medical College of Georgia. "I think that showed poor judgment."
But, Dr. Sorrentino added, no heart-device can be 100% effective. "Anything made by the hand of man is not perfect," he said.