title: Evaluation of early complications related to De Novo cardioverter defibrillator implantation insights from the Ontario ICD database.
abstract: OBJECTIVE
  This study examined the predictors of early complications after defibrillator implantation.
  
  
  BACKGROUND
  Although implantable cardioverter-defibrillators are widely used, predictors of procedural complications and the consequences of these events have not been determined.
  
  
  METHODS
  In a prospective, multicenter, population-based clinical outcomes registry of all newly implanted defibrillator patients at 18 centers in Ontario, Canada, we examined 45-day complications and all-cause mortality from February 2007 to May 2009. Complications were determined longitudinally and were categorized as direct implant-related or indirect events.
  
  
  RESULTS
  Among 3,340 patients (mean age 63.8 +/- 12.5 years, 78.5% men), major complications occurred in 4.1% of de novo procedures. Compared with those undergoing a single-chamber device, implantation of a cardiac resynchronization defibrillator (adjusted hazard ratio [HR]: 2.17, 95% confidence interval [CI]: 1.38 to 3.43, p < 0.001) or dual-chamber device (adjusted HR: 1.82, 95% CI: 1.19 to 2.79, p = 0.006) was associated with increased risk of major complications. Major complications were increased in women (adjusted HR: 1.49, 95% CI: 1.02 to 2.16, p = 0.037) and when left ventricular end-systolic dimension exceeded 45 mm (adjusted HR: 1.54, 95% CI: 1.08 to 2.20, p = 0.018). Major complications (excluding death) occurring early after defibrillator implantation were associated with increased adjusted risk of subsequent death up to 180 days after defibrillator implant (adjusted HR: 3.70, 95% CI: 1.64 to 8.33, p = 0.002). Direct implant-related complications were associated with increased risk of early death (adjusted HR: 24.89, p = 0.01), whereas indirect clinical complications conferred increased risk of near-term death (adjusted HR: 12.35, p < 0.001) after defibrillator implantation.
  
  
  CONCLUSIONS
  Complications after de novo defibrillator implantation were strongly associated with device type. Major complications were associated with increased risk of mortality.
authors.affiliation: Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada; Toronto General Hospital, Toronto, Ontario, Canada. dlee@ices.on.ca
authors.forename: Douglas S
authors.initials: DS
authors.lastname: Lee
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Krahn
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Healey
authors.forename: David
authors.initials: D
authors.lastname: Birnie
authors.forename: Eugene
authors.initials: E
authors.lastname: Crystal
authors.forename: Paul
authors.initials: P
authors.lastname: Dorian
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Simpson
authors.forename: Yaariv
authors.initials: Y
authors.lastname: Khaykin
authors.forename: Douglas
authors.initials: D
authors.lastname: Cameron
authors.forename: Amir
authors.initials: A
authors.lastname: Janmohamed
authors.forename: Raymond
authors.initials: R
authors.lastname: Yee
authors.forename: Peter C
authors.initials: PC
authors.lastname: Austin
authors.forename: Zhongliang
authors.initials: Z
authors.lastname: Chen
authors.forename: Judy
authors.initials: J
authors.lastname: Hardy
authors.forename: Jack V
authors.initials: JV
authors.lastname: Tu
mesh_terms: D000368:Aged; D002423:Cause of Death; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009864:Ontario; D012042:Registries; D012307:Risk Factors; D016896:Treatment Outcome