title: Risk of Sprint Fidelis defibrillator lead failure is highly dependent on age.
abstract: BACKGROUND
  In 2007, Medtronic Sprint Fidelis defibrillator leads were taken off the market due to a high rate of lead failure. Current data do not allow for risk stratification of patients with regard to lead failure.
  
  
  OBJECTIVE
  We sought to determine predictors of Sprint Fidelis lead failure.
  
  
  METHODS
  Between 2004 and 2007, 269 Sprint Fidelis leads were implanted in 258 patients in our centre. Variables associated with lead failure were assessed by the Kaplan-Meier method and a Cox survival model.
  
  
  RESULTS
  During a median follow-up of 2.80 years (maximum 5.32), we observed 33 (12.3%) Sprint Fidelis lead failures (5-year survival, 65.6% ± 7.5%). In univariate analysis, age was the only predictor of lead failure (hazard ratio [HR] for 1-year increase 0.97; 95% confidence interval [CI] 0.95-0.99; p=0.009). Patients aged<62.5 years (median) had a significantly increased risk of lead failure compared with patients aged>62.5 years (HR 2.80; CI 1.30-6.02; p=0.009). Survival without Sprint Fidelis lead failure was 55.6% ± 10.4%) in patients aged<62.5 years (24/134 leads) vs 78.6% ± 8.8% in patients aged>62.5 years (9/135 leads). The annual incidence of lead failure in patients aged<62.5 years was 11.6% ± 4.9% during the fourth year after implantation and 22.9% ± 13.2% during the fifth year.
  
  
  CONCLUSIONS
  Overall, we found a higher rate of Sprint Fidelis lead dysfunction than previously described. Lead failure was much more frequent in younger patients. Our results emphasize the need for close follow-up of younger patients with Sprint Fidelis leads and suggest that, in these patients, the implantation of a new implantable cardioverter defibrillator lead at the time of generator replacement might be reasonable.
authors.affiliation: Service de rythmologie, hôpital cardiologique Louis-Pradel, hospices civils de Lyon, 59, boulevard Pinel, 69677 Bron cedex, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Girerd
authors.forename: Emilie
authors.initials: E
authors.lastname: Nonin
authors.forename: Julien
authors.initials: J
authors.lastname: Pinot
authors.forename: Elodie
authors.initials: E
authors.lastname: Morel
authors.forename: Carine
authors.initials: C
authors.lastname: Flys
authors.forename: Alina
authors.initials: A
authors.lastname: Scridon
authors.forename: Philippe
authors.initials: P
authors.lastname: Chevalier
mesh_terms: D017677:Age Distribution; D000368:Aged; D000375:Aging; D000465:Algorithms; D000704:Analysis of Variance; D001145:Arrhythmias, Cardiac / Q000628:therapy; D016001:Confidence Intervals; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors