title: Biventricular defibrillator patients have higher complication rates after revision of recalled leads.
abstract: BACKGROUND
  Since the 2009 revised advisory statement regarding Sprint Fidelis® Defibrillator Lead failure rates (Medtronic Inc., Minneapolis, MN, USA), there has been a significant increase in revision of these leads. We sought to establish the frequency of major procedural complications and determine what patient characteristics were associated with these outcomes.
  
  
  METHODS
  We retrospectively reviewed the charts of 621 patients with Fidelis® leads being followed in the University of Pittsburgh Medical Center through January 1, 2010. The population was then examined for rates of lead malfunction, revision, and complication.
  
  
  RESULTS
  The average time from implantation of Fidelis® lead to endpoint was 32 ± 16 months. Overall lead survival rates were 89% at 41 months and were lower in biventricular implantable cardioverter defibrillator (BiVICD) as compared to standard implantable cardioverter defibrillator patients (log rank P = 0.053). Prophylactic revisions increased dramatically during 2009 (9.4% vs 1.4%, P < 0.001). Among the 131 patients who underwent revision during the entire time of follow-up, 11 patients had postoperative complications (8.5%). The only significant variable found between patients who did and did not have complications was the presence of a BiVICD (81.8 vs 48.7%, P = 0.036). Of the 40 total patients who underwent lead extraction, all three complications occurred in patients with BiVICDs.
  
  
  CONCLUSIONS
  The number of prophylactic Fidelis® lead revisions has increased dramatically since 2008, and procedure-related complications have been higher than anticipated. Major procedural complication rates are greater among patients with BiVICDs. Overall, lead extraction does not appear to increase procedural risk as compared to abandonment.
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
authors.forename: Genevieve E
authors.initials: GE
authors.lastname: Brumberg
authors.forename: Bahaa
authors.initials: B
authors.lastname: Kaseer
authors.forename: Hemal
authors.initials: H
authors.lastname: Shah
authors.forename: Samir
authors.initials: S
authors.lastname: Saba
authors.forename: Sandeep
authors.initials: S
authors.lastname: Jain
mesh_terms: D000368:Aged; D058409:Cardiac Resynchronization Therapy Devices / Q000706:statistics & numerical data; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D020878:Device Removal / Q000706:statistics & numerical data*; D004567:Electrodes, Implanted / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D006352:Heart Ventricles / Q000601:surgery; D006801:Humans; D008297:Male; D010414:Pennsylvania / Q000453:epidemiology; D011183:Postoperative Complications / Q000453:epidemiology*; D015995:Prevalence; D019919:Prosthesis Implantation / Q000706:statistics & numerical data*; D012086:Reoperation / Q000706:statistics & numerical data; D018570:Risk Assessment; D057053:Safety-Based Medical Device Withdrawals