title: The Canadian experience with Durata and Riata ST Optim defibrillator leads: a report from the Canadian Heart Rhythm Society Device Committee.
abstract: BACKGROUND
  The St. Jude Medical Riata family of implantable cardioverter-defibrillator (ICD) leads has demonstrated a high rate of externalized conductors and electrical failure.
  
  
  OBJECTIVE
  Given similar design elements of Durata to Riata, the purpose of this study was to assess the rates of failure of the Riata ST Optim and Durata lead families in Canada.
  
  
  METHODS
  All Canadian ICD-implanting centers were invited to submit follow-up information on all Optim-coated ICD leads implanted. Electrical failure was defined as a rapid change in impedance or pacing capture threshold leading to lead revision, or oversensing due to noise. Externalized conductors were defined as appearance of conductor wires outside the lead body. Systematic fluoroscopic screening for externalized conductors was not performed.
  
  
  RESULTS
  As of December 1, 2012, 15 of 25 centers provided data on 3981 leads (44% of those sold in Canada during the same timeframe): 3477 Durata and 504 Riata ST Optim leads. The most common model numbers were 7122 (1516 leads [38%]), 7121 (707 leads [18%]), and 7120 (622 leads [16%]). Mean follow-up duration from implant to December 1, 2012, was 4.47 ± 0.48 years for Riata ST Optim leads and 2.00 ± 1.10 years for Durata leads. The annual rate of lead failure was 0.27% per year for Riata ST Optim leads and 0.24% per year for Durata leads. No instances of externalized conductors were identified in the failed leads. No deaths were attributed to lead failure; however, 2 patients experienced inappropriate shocks due to lead failure.
  
  
  CONCLUSIONS
  The overall electrical failure rates of the Riata ST Optim and Durata leads appear to be low, and no instances of externalized conductors were observed.
authors: University of British Columbia, Vancouver, British Columbia, Canada.
authors: Matthew T
authors: MT
authors: Bennett
authors: Andrew C T
authors: AC
authors: Ha
authors: Derek V
authors: DV
authors: Exner
authors: Stanley K K
authors: SK
authors: Tung
authors: Ratika
authors: R
authors: Parkash
authors: Sean
authors: S
authors: Connors
authors: Benoit
authors: B
authors: Coutu
authors: Eugene
authors: E
authors: Crystal
authors: Jean
authors: J
authors: Champagne
authors: Francois
authors: F
authors: Philippon
authors: Raymond
authors: R
authors: Yee
authors: Elizabeth A
authors: EA
authors: Stephenson
authors: Pablo B
authors: PB
authors: Nery
authors: Vidal
authors: V
authors: Essebag
authors: Shubhayan
authors: S
authors: Sanatani
authors: Damian
authors: D
authors: Redfearn
authors: Andrew D
authors: AD
authors: Krahn
authors: Jeffrey S
authors: JS
authors: Healey
mesh_terms: D001145:Arrhythmias, Cardiac / Q000628:therapy*; D002170:Canada; D020099:Coated Materials, Biocompatible; D017147:Defibrillators, Implantable; D017097:Electric Impedance; D004867:Equipment Design; D004868:Equipment Failure; D006801:Humans; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors
chemical_list: D020099:Coated Materials, Biocompatible
keywords: Advisory; CHRS; Canadian Heart Rhythm Society; Defibrillator; Durata; ICD; Implantable cardioverter-defibrillator; Lead failure; Riata; implantable cardioverter-defibrillator