title: Update on small-diameter implantable cardioverter-defibrillator leads performance.
abstract: BACKGROUND
  The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long-term follow-up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medical's Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA).
  
  
  METHODS
  Since 1996, all ICD system implantations at the Leiden University Medical Center, the Netherlands, are registered. For this study, data up to February 2011 on 396 Sprint Fidelis leads (follow-up 3.4 ± 1.5 years), 165 8-French (F) Riata leads (follow-up 4.6 ± 2.6 years), and 30 7-F Riata leads (follow-up 2.9 ± 1.3 years) were compared with a benchmark cohort of 1,602 ICD leads (follow-up 3.4 ± 2.7 years) and assessed for the occurrence of lead failure and cardiac perforation.
  
  
  RESULTS
  During follow-up, the yearly lead failure rate of the Sprint Fidelis lead, 7-F Riata lead, 8-F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] 2.4-5.7, P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI 1.0-18.0, P < 0.05) for the 7-F Riata lead. One cardiac perforation was observed (3.3%) in the 7-F Riata group versus none in the 8-F Riata and Sprint Fidelis lead population.
  
  
  CONCLUSIONS
  The current update demonstrates that the risk of lead failure during long-term follow-up is significantly increased for both the Sprint Fidelis and the 7-F Riata lead in comparison to the benchmark cohort. Only one cardiac perforation occurred.
authors.affiliation: Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Johannes B
authors.initials: JB
authors.lastname: van Rees
authors.forename: Guido H
authors.initials: GH
authors.lastname: van Welsenes
authors.forename: C Jan Willem
authors.initials: CJ
authors.lastname: Borleffs
authors.forename: Joep
authors.initials: J
authors.lastname: Thijssen
authors.forename: Enno T
authors.initials: ET
authors.lastname: van der Velde
authors.forename: Ernst E
authors.initials: EE
authors.lastname: van der Wall
authors.forename: Lieselot
authors.initials: L
authors.lastname: van Erven
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Schalij
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D004567:Electrodes, Implanted / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D006335:Heart Injuries / Q000453:epidemiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D011183:Postoperative Complications / Q000453:epidemiology*; D015995:Prevalence; D012307:Risk Factors