title: The Number of Recalled Leads is Highly Predictive of Lead Failure: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS").
abstract: OBJECTIVE
  The purpose of this study was to determine if implantation of multiple recalled defibrillator leads is associated with an increased risk of lead failure.
  
  
  BACKGROUND
  The authors of the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS") have previously reported a relationship between recalled lead status, lead failure, and patient mortality. This substudy analyzes the relationship in a smaller subset of patients who received more than one recalled lead. The specific effects of having one or more recalled leads have not been previously examined.
  
  
  METHODS
  This study analyzed lead failure and mortality of 3802 patients in PAIDLESS and compared outcomes with respect to the number of recalled leads received. PAIDLESS includes all patients at Winthrop University Hospital who underwent defibrillator lead implantation between February 1, 1996 and December 31, 2011. Patients with no recalled ICD leads, one recalled ICD lead, and two recalled ICD leads were compared using the Kaplan-Meier method and log-rank test. Sidak adjustment method was used to correct for multiple comparisons. All calculations were performed using SAS 9.4. P-values <.05 were considered statistically significant.
  
  
  RESULTS
  This study included 4078 total ICD leads implanted during the trial period. There were 2400 leads (59%) in the no recalled leads category, 1620 leads (40%) in the one recalled lead category, and 58 leads (1%) in the two recalled leads category. No patient received more than two recalled leads. Of the leads categorized in the two recalled leads group, 12 experienced lead failures (21%), which was significantly higher (P<.001) than in the no recalled leads group (60 failures, 2.5%) and one recalled lead group (81 failures; 5%). Multivariable Cox's regression analysis found a total of six significant predictive variables for lead failure including the number of recalled leads (P<.001 for one and two recalled leads group).
  
  
  CONCLUSIONS
  The number of recalled leads is highly predictive of lead failure. Lead-based multivariable Cox's regression analysis produced a total of six predictive variable categories for lead failure, one of which was the number of recalled leads. Kaplan-Meier analysis showed that the leads in the two recalled leads category failed faster than both the no recalled lead and one recalled lead groups. The greater the number of recalled leads to which patients are exposed, the greater the risk of lead failure.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Kersten
authors.forename: Jinju
authors.initials: J
authors.lastname: Yi
authors.forename: Alyssa M
authors.initials: AM
authors.lastname: Feldman
authors.forename: Kunal
authors.initials: K
authors.lastname: Brahmbhatt
authors.forename: Wilbur J
authors.initials: WJ
authors.lastname: Asheld
authors.forename: Joseph
authors.initials: J
authors.lastname: Germano
authors.forename: Shahidul
authors.initials: S
authors.lastname: Islam
authors.affiliation: Director of Electrophysiology, Winthrop University Hospital, 222 Jericho Turnpike, Mineola, NY 11501 USA. tcohen@winthrop.org.
authors.forename: Todd J
authors.initials: TJ
authors.lastname: Cohen
mesh_terms: D000368:Aged; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000145:classification / Q000706:statistics & numerical data; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis / Q000379:methods / Q000706:statistics & numerical data; D005260:Female; D006331:Heart Diseases / Q000628:therapy; D006801:Humans; D008297:Male; D057052:Medical Device Recalls; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects / Q000145:classification / Q000706:statistics & numerical data; D014481:United States