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Heart Device Recipients Often Not Aware of Recalls
Date:5/15/2008

Some not clear on risks of problems, two surveys find

THURSDAY, May 15 (HealthDay News) -- Two new surveys suggest that many heart patients with implanted devices aren't aware of recent recalls and don't understand the dangers they might face.

The surveys are small, but they point to a lack of understanding among both doctors and patients about heart disease and the devices used to treat it, said Dr. Bruce Wilkoff, director of cardiac and tachyarrhythmia devices at Cleveland Clinic.

"There are fundamental problems with even the physician's understanding of the situation and an appropriate focus on accurate information," said Wilkoff, who is familiar with the surveys.

Recent recalls of implanted defibrillators have forced some patients to have them removed. The devices deliver jolts to the heart that reset its electrical system when needed.

One of the new surveys found that almost one in five heart patients didn't know about recent recalls of their devices.

The findings, expected to be released at the Heart Rhythm Society's annual meeting, in San Francisco, came in a survey of 61 randomly selected patients at the University of Maryland and the Baltimore VA Medical Center. They were asked about recalls between October 2006 and April 2007.

Eighteen percent didn't know about any pacemaker or defibrillator recall. About half learned about them through the media, and only 24 percent heard through their doctor.

More than half said they'd be very worried if their device was recalled.

"We need to do a little better of a job and find better means of talking to our patients," said survey lead author Dr. Timm-Michael Dickfeld, director of electrophysiology at the Baltimore VA Medical Center. "They seem to like to have the physicians talk to them more, and explain these things more, and not leave it up to the media or the TV to inform them."

A second survey, by doctors at the University of Oklahoma, asked 165 patients with a variety of heart devices whether they'd want them removed if there was a recall or safety advisory.

Just 5 percent said they'd want the device removed immediately if there was a "recall," and 2.5 percent said they'd want it taken out if there was a "safety advisory."

The patients gave a variety of answers when asked what they thought the chances were that they'd experience a device recall, with 31 percent thinking it was one in 100,000.

Dr. Andrea Russo, an electrophysiologist at the University of Pennsylvania, said the results of the Maryland survey suggest that officials should stop using the word "recall" in favor of "safety device."

"The term 'recall' implies that the device will fail dramatically and the failure will be potentially 'life-threatening,' with the term implying that it should be 'taken out,'" she said. The reality, according to her, may be different.

"The types of failures may vary dramatically, and the outcome following 'failure' is also quite variable and not necessarily life-threatening," she said.

More information

Learn more about implanted defibrillators from the American Heart Association.



SOURCES: Bruce Wilkoff, M.D., director, cardiac and tachyarrhythmia devices, Cleveland Clinic; Timm-Michael Dickfeld, M.D., Ph.D., director, electrophysiology, Baltimore VA Medical Center, and assistant professor, University of Maryland; Andrea Russo, M.D., electrophysiologist, University of Pennsylvania, Philadelphia; May 15, 2008, presentation, Heart Rhythm Society's annual meeting, San Francisco


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