title: Prospective long-term evaluation of Optim-insulated (Riata ST Optim and Durata) implantable cardioverter-defibrillator leads.
abstract: BACKGROUND
  St Jude Medical Optim-insulated implantable cardioverter-defibrillator leads were designed to impart lubricity, strength, and abrasion resistance while maintaining flexibility and biostability. No long-term prospective follow-up data have been published.
  
  
  OBJECTIVE
  The objective of this study was to determine the rates of all-cause mechanical failure and its subtypes (conductor fracture, insulation abrasion, externalized conductors, and other mechanical failures) in a prospective cohort of Optim-insulated implantable cardioverter-defibrillator leads.
  
  
  METHODS
  St Jude Medical established 3 prospective registries and enrolled 11,016 leads implanted in 10,835 patients beginning in 2006. There was standardized baseline documentation, 6-monthly follow-up, adverse events reports (verified by expert staff using detailed algorithms), and documentation of lead revisions or inactivation, study withdrawal, and death. The Population Health Research Institute (McMaster University) was engaged to review database functions, adjudicate all potential mechanical lead failures, and conduct independent analyses of the data.
  
  
  RESULTS
  During a median follow-up of 3.2 years, there were 51 mechanical failures (0.46%), with 99.0% survival free of this outcome by 5 years of follow-up. Freedom from conductor fracture was identified in 99.4% and from all-cause abrasion in 99.8% of the leads, and there were no reports of externalized conductors. There were no significant differences in survival among Durata DF4, Durata DF1, and Riata ST Optim leads.
  
  
  CONCLUSIONS
  Over a mean follow-up of 3.2 years, Optim-insulated leads have low rates of all-cause mechanical failure and no observed externalized conductors. Independent analyses of these registries are designed to provide reliable long-term follow-up information and are ongoing.
authors.affiliation: Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: john.cairns@ubc.ca.
authors.forename: John A
authors.initials: JA
authors.lastname: Cairns
authors.affiliation: Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Epstein
authors.affiliation: Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: John
authors.initials: J
authors.lastname: Rickard
authors.affiliation: Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Connolly
authors.affiliation: Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Christopher
authors.initials: C
authors.lastname: Buller
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio.
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Wilkoff
authors.affiliation: Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Janice
authors.initials: J
authors.lastname: Pogue
authors.affiliation: Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Ellison
authors.initials: E
authors.lastname: Themeles
authors.affiliation: Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Jeff S
authors.initials: JS
authors.lastname: Healey
mesh_terms: D000328:Adult; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D016001:Confidence Intervals; D016208:Databases, Factual; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004567:Electrodes, Implanted; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D012042:Registries; D018570:Risk Assessment; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
keywords: ICD leads; Mechanical lead failure; Optim insulation; Prospective cohort study; Prospective registries