title: Do small (6.6 Fr.) active and passive fixation defibrillation leads perform as well as larger sized leads? A multi-centre analysis.
abstract: OBJECTIVE
  The 6.6 Fr. Sprint Fidelis lead family may allow multiple lead implantation procedures with reduced risk of venous obstruction.
  
  
  RESULTS
  Two prospective, historically controlled, multi-centre studies were conducted in Europe (80 patients) and Canada (79 patients). The purpose was to assess the ventricular lead-related adverse events (LRAEs) and performance of the small Models 6948 and 6949 defibrillation leads, respectively, in patients with a standard indication for an ICD implant. Safety was assessed by demonstrating equivalence of the LRAE free rate at 1 month to comparable but larger leads (Models 6942, 6943, 6944, 6947and 4074). Seventy-five of 80 patients with a 6948 lead (93.8%) remained free of LRAEs. Seventy-four out of 79 patients (93.7%) with the 6949 lead remained free of LRAEs. The 95% lower confidence bounds were above the critical difference limits. Thus, safety of the Sprint Fidelis((R)) leads is similar to that of larger leads. Electrical performance through 1-month follow-up proved to be acceptable in comparison with other established leads.
  
  
  CONCLUSIONS
  These multi-centre studies confirm that smaller defibrillation leads offer similar safety and efficacy features to widely used larger leads; they have low LRAE rates and defibrillation thresholds, while providing the advantage of a smaller introducer size and reduced venous obstruction.
authors.affiliation: Schüchtermann Klinik, Bad Rothenfelde, Germany. b.kuepper@elisabeth-essen.de
authors.forename: Bernhard
authors.initials: B
authors.lastname: Küpper
authors.forename: Raymond
authors.initials: R
authors.lastname: Yee
authors.forename: Gilles
authors.initials: G
authors.lastname: O'Hara
authors.forename: Chris S
authors.initials: CS
authors.lastname: Simpson
authors.forename: Paolo
authors.initials: P
authors.lastname: Della Bella
authors.forename: Martin
authors.initials: M
authors.lastname: Workel
authors.forename: Michael
authors.initials: M
authors.lastname: Hull
authors.forename: H
authors.initials: H
authors.lastname: Heuer
mesh_terms: D002170:Canada / Q000453:epidemiology; D018572:Disease-Free Survival; D004554:Electric Countershock / Q000295:instrumentation* / Q000379:methods / Q000706:statistics & numerical data*; D004567:Electrodes, Implanted / Q000145:classification / Q000706:statistics & numerical data*; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D015995:Prevalence; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D016896:Treatment Outcome; D014693:Ventricular Fibrillation / Q000453:epidemiology* / Q000517:prevention & control*