ATLANTA — Ill-conceived Food and Drug Administration recalls and safety alerts involving implantable cardioverter defibrillators have created needless hysteria in a large population of patients, Dr. Mina K. Chung asserted at the annual meeting of the American College of Cardiology.
Her study of the 1,664 patients who received an ICD at the Cleveland Clinic Foundation between August 1996 and May 2004 showed that 44% of them had a device subject to an FDA class I, II, or III recall or a manufacturer's safety alert.
Overall mortality in the ICD recipients during a mean 3.9 years of follow-up was 31%. The key finding was that mortality was not significantly different in patients with or without a device warning or recall. Nor was mortality significantly increased even in patients whose ICD was subject to a class I recall, reserved for device problems deemed by the FDA to be potentially life threatening, added Dr. Chung, an electrophysiologist at the clinic.
It's important to keep a sense of perspective about ICD malfunctions, she continued, citing the case of the Medtronic Marquis ICD recall that affected 87,000 patients.
The recall was triggered by a risk of ICD malfunction estimated at 0.2%–1.5%, with the lesser figure probably being more accurate. That's a very modest risk in a generally sick patient population having close to 10% annual mortality even with an ICD in place, especially in light of the finding in the Cleveland Clinic series that ICD recalls and safety alerts had no impact on mortality. Yet a substantial number of patients requested device removal as a result of the Marquis recall.
“All mechanical-electrical devices have some rate of failure. For this type of very sophisticated device to have a failure rate of 1% or less is an incredible engineering accomplishment. We can't expect this kind of therapy to make us immortal,” the cardiologist said.
Session moderator Dr. Douglas P. Zipes hailed Dr. Chung's study as “a very important observation. “I find your data extremely reassuring, particularly in this time of hysteria over the recalls,” commented Dr. Zipes, professor of medicine at Indiana University, Indianapolis, and a former ACC president.
He added that he has heard of patients who refused an ICD implantation because of a much-publicized 1% or so device failure risk—even though their risk of sudden arrhythmic death without a device was much greater.
Dr. Zipes is a consultant to Medtronic. Dr. Chung has received honoraria from Medtronic and Guidant for speaking at educational seminars.