Studies determine patient risk from ICD replacement

May 18, 2006

BOSTON--Physicians should weigh the risks of replacing implantable cardioverter defibrillators (ICDs) after recalls and advisories issued by device manufacturers against the theoretic risk of device failure, according to two studies presented today at HEART RHYTHM 2006, the Heart Rhythm Society's 27th Annual Scientific Sessions. A third study found that safety advisories did not increase feelings of anxiety, depression or fear of death in patients.

A study, "Complication Risk with Pulse Generator Change: Implications When Reacting to a Device Advisory or Recall," conducted at the Mayo Clinic from 2000-2005 looked at the complication rate in 732 ICD replacements, 570 due to elective replacements (i.e., expected battery depletion) and 162 in response to recalls or advisories. Researchers found that nine complications out of the 732 replacements (1.24 percent) occurred in patients. Complications included infection and hematoma.

"These findings allow me to accurately and honestly talk to patients about the risk of complications when they hear about recalls," said lead author David L. Hayes, M.D., professor of medicine at the Mayo Clinic College of Medicine in Rochester, MN.

A similar study, "Replacement of Device Advisory ICDs is Associated with Significant Complications Including Death: Report from the Canadian Heart Rhythm Society Device Advisory Working Group," examined the complication rate for ICD replacements at 17 medical centers across Canada. Of the 533 ICD replacements performed from October 2004 to October 2005, complications occurred in 43 patients (8.1 percent). The replacements led to minor complications such as infection and hematoma conservatively managed in 12 cases, and major complications requiring re-operation in 31 patients including 10 patients requiring device extraction (1.9%). Two deaths resulted from the extractions.

"The risk of complications was much higher than we anticipated," said lead author Paul Gould, MBBS, PhD from the University of Western Ontario in London, Ontario, Canada. "Given the relatively high complication rate, physicians need to seriously consider if device replacement potentially puts the patient at risk."

Another study, "Impact of ICD Recall on Patients' Anxiety, Depression and Quality of Life," presented today at the meeting found that ICD recalls did not seem to cause feelings of unease or anger in patients. Researchers at Mount Sinai Medical Center in New York distributed questionnaires to 96 patients, 53 of whom had heart devices that had been recalled and 43 with devices that had not been recalled. The patients were evenly divided among men and women, and device manufacturer. When asked about their emotional status and to gauge their overall quality of life, the study found no significant differences among the two groups.

"The findings may be a reflection of good communication between physicians and their patients, which likely helped in reducing patients' concerns about ICD recalls," said lead author Manish Undavia, M.D., electrophysiology fellow at Mt. Sinai School of Medicine.

To help physicians determine the risks of ICD replacement, investigators at Virginia Commonwealth University Medical Center and Duke University developed a decision analysis model. Their decision modeling study, "Recalled Pacemakers and ICDs: A Decision Analysis Model to Guide Management," was presented today at the meeting.

"For physicians trying to manage recalls, there was no clear consensus about the risks and benefits of device replacement," said Mitesh S. Amin, M.D., lead author and resident in the department of internal medicine at Virginia Commonwealth University Medical Center. "We hope this model will be used at other medical centers to help guide decisions about replacing devices."

The study concluded that the risks of replacing ICDs are not insignificant and should only be considered when patients are at a high risk of death from device malfunction.

Session details:


IMPACT OF ICD RECALL ON PATIENTS' ANXIETY, DEPRESSION, AND QUALITY OF LIFE [May 18, 2006, 9:00 a.m. - Noon, Poster Session #2, Exhibit Hall]

RECALLED PACEMAKERS AND ICDS: A DECISION ANALYSIS MODEL TO GUIDE MANAGEMENT [Thursday, May 18, 2006, 8:00 a.m. - 9:30 a.m., Session #AB04, Room 204AB]

HEART RHYTHM 2006 takes place May 17-20 at the Boston Convention and Exhibition Center in Boston. The meeting is the most comprehensive educational event on heart rhythm disorders, offering over 400 educational opportunities in multiple formats and over 125 innovative products and services for the heart rhythm management field. The world's most renowned scientists and physicians will present a wide range of heart rhythm topics including advances in statins, cardiac resynchronization therapy, catheter ablation, cardiac pacing and heart failure and the latest technology, including state-of-the-art pacemakers and defibrillators.

For more information, please visit the Heart Rhythm Society website at
About Heart Rhythm Society
The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of over 4,300 physicians and associated professionals in over 65 countries around the world.

Editor's Note: Please contact Rebecca Leaf at 202-745-5051 or to receive complimentary registration to attend HEART RHYTHM 2006.

The Reis Group

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