Newswise — Implantable cardioverter-defibrillator (ICD) generator replacement in Canadian patients with devices that were recalled was associated with an 8 percent rate of complications, according to a study in the April 26 issue of JAMA.
Potential and actual ICD malfunctions caused by failure of generator components, once made public, are known as ICD advisories. ICD advisories potentially affect a large number of patients, according to background information in the article. These advisories or recalls stem from unanticipated failures of ICD generator components that potentially place the patient at risk and are recognized after commercial release and clinical use. Few data are available to guide physicians in the appropriateness of their response to risk imposed by these advisories or to quantify the complication rate associated with ICD generator replacement.
Paul A. Gould, M.B.B.S., Ph.D., and Andrew D. Krahn, M.D., of the University of Western Ontario, London, quantified the complications arising from ICD device replacement resulting directly from the current device advisories. The study included 17 ICD implanting centers in Canada, which were surveyed to assess complication rates as a result of generator replacements because of ICD advisories from October 2004 to October 2005.
During the period of the survey, 2,915 patients had recall devices, including 533 (18.3 percent) patients who underwent elective replacement of an advisory device at an average of 26.5 months after initial ICD implant. Complications directly attributable to elective advisory device replacement occurred in 43 patients (8.1 percent) during an average of 2.7 months' follow-up. Twelve of these were minor complications (2.3 percent). The incidence of major complications was 5.8 percent. Two patients died after ICD replacement led to infection requiring system extraction (0.38 percent of all replacements).
"In conclusion, ICD generator replacement in patients with advisory devices is associated with a substantial risk of complications, including death. These risks need to be considered in the development of guidelines to determine the appropriate treatment of patients with advisory devices," the authors write.(JAMA. 2006;295:1907-1911. )
Editor's Note: This study was unfunded and independently performed. Dr. Krahn reported receiving consulting fees and research funding from Medtronic and Guidant.
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