Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories

JAMA : the Journal of the American Medical Association
Paul A GouldCanadian Heart Rhythm Society Working Group on Device Advisories

Abstract

Recent implantable cardioverter-defibrillator (ICD) advisories and recalls have caused management dilemmas for physicians, particularly because there are no specific guidelines or data on outcomes from current management strategies. The risk of ICD generator replacement has not been assessed in this population. To determine the complication rate associated with ICD generator replacement for the current ICD advisories. Seventeen ICD implanting centers in Canada were surveyed to assess complication rates as a result of generator replacements because of ICD advisories from October 2004 to October 2005. Complications associated with elective ICD generator replacement for current device advisories. At the 17 surveyed centers, 2915 patients had recall devices, including 533 (18.3%) who had advisory ICDs replaced a mean (SD) of 26.5 (11.5) months after their initial implant. Of these patients, 66% had a secondary prevention ICD, and 45% had received a previous appropriate shock. During a mean (SD) of 2.7 (2.8) months' follow-up after ICD generator replacement, complications occurred in 43 patients (8.1%). Major complications attributable to advisory device replacement requiring reoperation occurred in 31 patients (5.8%), with death in...Continue Reading

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