title: Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: a report from the Canadian Heart Rhythm Society Device Advisory Committee.
abstract: BACKGROUND
  The Medtronic Sprint Fidelis family of leads has recently been the subject of a widespread advisory. Lead failure rates are estimated at 2.3% at 30 months, 2.6 times the failure rate of the reference Medtronic 6947 lead.
  
  
  OBJECTIVE
  The purpose of this study was to contact pediatric and adult implantable cardioverter-defibrillator (ICD) implant centers across Canada to determine the short-term response to the October 15, 2007 Medtronic Fidelis lead advisory.
  
  
  METHODS
  All centers completed an 11-part survey to assess the frequency and presentation of lead failure, operator characteristics, and center's response.
  
  
  RESULTS
  Lead failure was noted in 80 (1.29%) of 6,181 patients at 21.0 months, with inappropriate shocks experienced in 45 (56%) of the 80 patients (overall risk 0.73%). No deaths were attributed to lead failure. Sensing was the primary form of failure, seen in 60 leads (75%), with pacing failure in 10 (13%), and high-voltage failure in 15 (19%). Assessment of the previous routine ICD interrogation prior to the advisory or lead failure demonstrated evidence of altered lead performance in only 8 (10%) of the 80 leads. Inappropriate shocks typically were multiple (median 7, range 1-122), with a single shock seen in only 5 patients. Lead failure was noted in 18 of 23 centers, representing 89.8% of leads implanted, with at least one failure noted in 15 of 16 centers that implanted more than 200 leads. Forty-seven of the 135 operators in the 23 institutions implanted the 80 leads that subsequently failed. Only 16 operators were involved in more than a single lead that subsequently failed; seven operators participated in three or more leads that subsequently failed. Seven centers planned to replace leads in most pacing-dependent patients, and two centers planned to replace leads in patients unable to hear the alert tone.
  
  
  CONCLUSIONS
  This national experience suggests a Fidelis lead failure rate of 1.29% at 21 months, most often presenting with multiple inappropriate shocks without evidence of impending failure from routine lead follow-up. Lead failure did not appear to cluster around specific operators or around high-volume or low-volume implant centers.
authors.affiliation: London Health Sciences Center, University Campus, 339 Windermere Road, London, Ontario, Canada N6A 5A5. akrahn@uwo.ca
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Krahn
authors.forename: Jean
authors.initials: J
authors.lastname: Champagne
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Healey
authors.forename: Doug
authors.initials: D
authors.lastname: Cameron
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Simpson
authors.forename: Bernard
authors.initials: B
authors.lastname: Thibault
authors.forename: Iqwal
authors.initials: I
authors.lastname: Mangat
authors.forename: Stanley
authors.initials: S
authors.lastname: Tung
authors.forename: Laurence
authors.initials: L
authors.lastname: Sterns
authors.forename: David H
authors.initials: DH
authors.lastname: Birnie
authors.forename: Derek V
authors.initials: DV
authors.lastname: Exner
authors.forename: Ratika
authors.initials: R
authors.lastname: Parkash
authors.forename: Soori
authors.initials: S
authors.lastname: Sivakumaran
authors.forename: Ted
authors.initials: T
authors.lastname: Davies
authors.forename: Benoit
authors.initials: B
authors.lastname: Coutu
authors.forename: Eugene
authors.initials: E
authors.lastname: Crystal
authors.forename: Kevin
authors.initials: K
authors.lastname: Wolfe
authors.forename: Atul
authors.initials: A
authors.lastname: Verma
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Stephenson
authors.forename: Shubhayan
authors.initials: S
authors.lastname: Sanatani
authors.forename: Robert
authors.initials: R
authors.lastname: Gow
authors.forename: Sean
authors.initials: S
authors.lastname: Connors
authors.forename: Felix Ayala
authors.initials: FA
authors.lastname: Paredes
authors.forename: Vidal
authors.initials: V
authors.lastname: Essebag
mesh_terms: D026683:Advisory Committees; D002170:Canada; D017147:Defibrillators, Implantable; D004868:Equipment Failure / Q000706:statistics & numerical data; D006306:Health Surveys; D006801:Humans; D012955:Societies, Medical