title: Outcome of advisory implantable cardioverter-defibrillator replacement: one-year follow-up.
abstract: BACKGROUND
  Implantable cardioverter defibrillator (ICD) generator advisories present management dilemmas for physicians regarding competing risks of ICD failure and replacement-related complications. There is currently a paucity of long-term data concerning the complications associated with advisory ICD replacement.
  
  
  OBJECTIVE
  In a large multicenter advisory ICD generator replacement cohort followed for 12 months, we aimed to assess replacement-related complications by performing a case-control determination of complication risk factors to identify characteristics that could assist with advisory ICD replacement decision making.
  
  
  METHODS
  Twelve large ICD implanting centers reviewed the 1-year follow-up outcome of advisory ICDs replaced between October 2004 and October 2005. The complication cohort was characterized and compared in a nested case-control analysis with age- and gender-matched controls without complications from the same replacement population.
  
  
  RESULTS
  At the 12 participating institutions, 451 of 2635 advisory ICD devices were replaced (17.1%). Over 355 +/- 204 days of follow-up, there were 41 (9.1%) complications; 27 (5.9%) required reoperation and included two deaths. There were 14 minor complications (3.1%). Multivariate analysis demonstrated that the number of previous pocket procedures was associated with an increase in complications and that combined consultant and fellow operators was associated with a decrease in complications compared with a single operator alone.
  
  
  CONCLUSIONS
  Complications from advisory ICD generator replacement are frequent and include infection and, rarely, death. The risk of replacement is increased in patients with multiple previous pocket procedures.
authors.affiliation: University of Western Ontario, London, Ontario, Canada.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Gould
authors.forename: Lorne J
authors.initials: LJ
authors.lastname: Gula
authors.forename: Jean
authors.initials: J
authors.lastname: Champagne
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Healey
authors.forename: Doug
authors.initials: D
authors.lastname: Cameron
authors.forename: Christophers
authors.initials: C
authors.lastname: Simpson
authors.forename: Bernard
authors.initials: B
authors.lastname: Thibault
authors.forename: Arnold
authors.initials: A
authors.lastname: Pinter
authors.forename: Stanley
authors.initials: S
authors.lastname: Tung
authors.forename: Laurence
authors.initials: L
authors.lastname: Sterns
authors.forename: David
authors.initials: D
authors.lastname: Birnie
authors.forename: Derek
authors.initials: D
authors.lastname: Exner
authors.forename: Ratika
authors.initials: R
authors.lastname: Parkash
authors.forename: Allan C
authors.initials: AC
authors.lastname: Skanes
authors.forename: Raymond
authors.initials: R
authors.lastname: Yee
authors.forename: George J
authors.initials: GJ
authors.lastname: Klein
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Krahn
mesh_terms: D000368:Aged; D002170:Canada / Q000453:epidemiology; D017147:Defibrillators, Implantable; D004554:Electric Countershock / Q000295:instrumentation*; D004868:Equipment Failure / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology / Q000601:surgery*; D019919:Prosthesis Implantation / Q000009:adverse effects*; D012086:Reoperation / Q000379:methods / Q000706:statistics & numerical data; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D017180:Tachycardia, Ventricular / Q000628:therapy*; D013997:Time Factors