title: Recurrent implantable cardioverter-defibrillator replacement is associated with an increasing risk of pocket-related complications.
abstract: BACKGROUND
  Despite beneficial effects of implantable cardioverter-defibrillator (ICD) therapy, limited service life results in replacement within the majority of patients. Data concerning the effect of replacement procedures on the occurrence of pocket-related adverse events are scarce. In this study, the requirement for pocket-related surgical re-interventions following ICD treatment and the effect of device replacement were evaluated.
  
  
  METHODS
  From 1992 to 2008, 2,415 patients receiving an ICD at the Leiden University Medical Center were analyzed. Pocket-related complications requiring surgical re-intervention following ICD implantation or replacement were noted. Elective device replacement, lead failure, and device malfunction were not considered pocket-related complications.
  
  
  RESULTS
  A total of 3,161 ICDs were included in the analysis. In total, 145 surgical re-interventions were required in 122 (3.9%) ICDs implanted in 114 (4.7%) unique patients. Three-year cumulative incidence for first surgical re-intervention in all ICDs was 4.7% (95% confidence interval [CI] 3.9-5.5%). Replacement ICDs exhibited a doubled requirement for surgical re-intervention (rate ratio 2.2, 95% CI 1.5-3.0). Compared to first implanted ICDs, the occurrence of surgical re-intervention in replacements was 2.5 (95% CI 1.6-3.7) times higher for infectious and 1.7 (95% CI 0.9-3.0) for noninfectious causes. Subdivision by the number of ICD replacements showed an increase in the annual risk for surgical re-intervention, ranging from 1.5% (95% CI 1.2-1.9%) for the first, to 8.1% (95% CI 1.7-18.3%) for the fourth implanted ICD.
  
  
  CONCLUSIONS
  ICD replacement is associated with a doubled risk for pocket-related surgical re-interventions. Furthermore, the need for re-intervention increases with every consecutive replacement.
authors.affiliation: Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: C Jan Willem
authors.initials: CJ
authors.lastname: Borleffs
authors.forename: Joep
authors.initials: J
authors.lastname: Thijssen
authors.forename: Mihály K
authors.initials: MK
authors.lastname: de Bie
authors.forename: Johannes B
authors.initials: JB
authors.lastname: van Rees
authors.forename: Guido H
authors.initials: GH
authors.lastname: van Welsenes
authors.forename: Lieselot
authors.initials: L
authors.lastname: van Erven
authors.forename: Jeroen J
authors.initials: JJ
authors.lastname: Bax
authors.forename: Suzanne C
authors.initials: SC
authors.lastname: Cannegieter
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Schalij
mesh_terms: D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal; D004868:Equipment Failure; D005260:Female; D005548:Foreign-Body Migration; D006406:Hematoma / Q000209:etiology; D006801:Humans; D007239:Infections / Q000209:etiology; D008297:Male; D008875:Middle Aged; D003668:Pressure Ulcer / Q000209:etiology; D012086:Reoperation