title: Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To determine the complication rate associated with ICD generator replacement for the current ICD advisories.
  
  
  METHODS
  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.
  
  
  METHODS
  Complications associated with elective ICD generator replacement for current device advisories.
  
  
  RESULTS
  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 2 patients after extraction for pocket infection. Minor complications occurred in 12 patients (2.3%). There were 3 (0.1%) advisory-related device malfunctions reported, without clinical consequences.
  
  
  CONCLUSIONS
  ICD generator replacement in patients with advisory devices is associated with a substantial rate of complications, including death. These complications need to be considered in the development of guidelines determining the appropriate treatment of patients with advisory devices.
authors.affiliation: Division of Cardiology, Department of Medicine, University of Western Ontario, London.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Gould
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Krahn
mesh_terms: D000368:Aged; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D018795:Device Approval; D004868:Equipment Failure; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012086:Reoperation; D012306:Risk