title: A Comparative Study of Defibrillator Leads at a Large-Volume Implanting Hospital: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS").
abstract: OBJECTIVE
  The purpose of the study was to examine survival in the implantable defibrillator subset of implanted leads at a large-volume implanting hospital.
  
  
  BACKGROUND
  Implantable lead survival has been the subject of many multicenter studies over the past decade. Fewer large implanting volume single-hospital studies have examined defibrillator lead failure as it relates to patient survival and lead construction.
  
  
  METHODS
  This investigator-initiated retrospective study examined defibrillator lead failure in those who underwent implantation of a defibrillator between February 1, 1996 and December 31, 2011. Lead failure was defined as: failure to capture/sense, abnormal pacing and/or defibrillator impedance, visual insulation defect or lead fracture, extracardiac stimulation, cardiac perforation, tricuspid valve entrapment, lead tip fracture and/or lead dislodgment. Patient characteristics, implant approach, lead manufacturers, lead models, recalled status, patient mortality, and core lead design elements were compared using methods that include Kaplan Meier analysis, univariate and multivariable Cox regression models.
  
  
  RESULTS
  A total of 4078 defibrillator leads were implanted in 3802 patients (74% male; n = 2812) with a mean age of 70 ± 13 years at Winthrop University Hospital. Lead manufacturers included: Medtronic: [n = 1834; 801 recalled]; St. Jude Medical: [n = 1707; 703 recalled]; Boston Scientific: [n = 537; 0 recalled]. Kaplan-Meier analysis adjusted for multiple comparisons revealed that both Boston Scientific's and St. Jude Medical's leads had better survival than Medtronic's leads (P<.001 and P=.01, respectively). Lead survival was comparable between Boston Scientific and St. Jude Medical (P=.80). A total of 153 leads failed (3.5% of all leads) during the study. There were 99 lead failures from Medtronic (5.4% failure rate); 56 were recalled Sprint Fidelis leads. There were 36 lead failures from St. Jude (2.1% failure rate); 20 were recalled Riata or Riata ST leads. There were 18 lead failures from Boston Scientific (3.35% failure rate); none were recalled. Kaplan Meier analysis also showed lead failure occurred sooner in the recalled leads (P=.01). A total of 1493 patients died during the study (mechanism of death was largely unknown). There was a significant increase in mortality in the recalled lead group as compared with non-recalled leads (P=.01), but no significant difference in survival when comparing recalled leads from Medtronic with St. Jude Medical (P=.67). A multivariable Cox regression model revealed younger age, history of percutaneous coronary intervention, baseline rhythm other than atrial fibrillation or atrial flutter, combination polyurethane and silicone lead insulation, a second defibrillation coil, and recalled lead status all contributed to lead failure.
  
  
  CONCLUSIONS
  This study demonstrated a significantly improved lead performance in the Boston Scientific and St. Jude leads as compared with Medtronic leads. Some lead construction variables (insulation and number of coils) also had a significant impact on lead failure, which was independent of the manufacturer. Recalled St. Jude leads performed better than recalled Medtronic leads in our study. Recalled St. Jude leads had no significant difference in lead failure when compared with the other manufacturer's non-recalled leads. Defibrillator recalled lead status was associated with an increased mortality as compared with non-recalled leads. This correlation was independent of the lead manufacturer and clinically significant even when considering known mortality risk factors. These results must be tempered by the largely unknown mechanism of death in these patients.
authors.affiliation: Winthrop University Hospital, 120 Mineola Boulevard, Suite 500, Mineola, NY 11501 USA. tcohen@winthrop.org.
authors.forename: Todd J
authors.initials: TJ
authors.lastname: Cohen
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.forename: Dhimesh
authors.initials: D
authors.lastname: Patel
mesh_terms: D000367:Age Factors; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000401:mortality / Q000628:therapy*; D017147:Defibrillators, Implantable / Q000009:adverse effects* / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D057052:Medical Device Recalls; D008875:Middle Aged; D015999:Multivariate Analysis; D065228:Non-Randomized Controlled Trials as Topic; D010138:Pacemaker, Artificial; D011474:Prosthesis Design / Q000295:instrumentation*; D011475:Prosthesis Failure; D012189:Retrospective Studies