title: Complications associated with revision of Sprint Fidelis leads: report from the Canadian Heart Rhythm Society Device Advisory Committee.
abstract: BACKGROUND
  It has been observed that replacement of an implantable cardioverter-defibrillator generator in response to a device advisory may be associated with a substantial rate of complications, including death. The risk of lead revision in response to a lead advisory has not been determined previously.
  
  
  RESULTS
  Twenty-five implantable cardioverter-defibrillator implantation and follow-up centers from the Canadian Heart Rhythm Society Device Advisory Committee were surveyed to assess complication rates as a result of lead revisions due to the Sprint Fidelis advisory issued in October 2007. As of June 1, 2009, there had been 310 lead failures found in 6237 Sprint Fidelis leads in Canada (4.97%) over a follow-up of 40 months. There were 469 leads to be revised, 66% for confirmed fracture. Of the patients who underwent revision, 95% had a new lead inserted, whereas 4% had a pace/sense lead added. The lead was removed in 248 cases (53%), by simple traction in 61% and by laser lead extraction in 33%. Complications were encountered in 14.5% of the lead revisions; 7.25% of these were major, whereas 7.25% were minor. There were 2 deaths (0.43%). The overall risk of complications (19.8%) was greater in those who underwent lead removal at the time of revision than in those whose leads were abandoned (8.6%; P=0.0008).
  
  
  CONCLUSIONS
  The overall rate of major complications that arose from lead revision due to the Sprint Fidelis advisory was significant. This must be taken into account when lead revision is planned in those patients who have not yet demonstrated an abnormality in lead performance.
authors.affiliation: Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia. parkashr@cdha.nshealth.ca
authors.forename: Ratika
authors.initials: R
authors.lastname: Parkash
authors.forename: Eugene
authors.initials: E
authors.lastname: Crystal
authors.forename: Jamil
authors.initials: J
authors.lastname: Bashir
authors.forename: Christopher
authors.initials: C
authors.lastname: Simpson
authors.forename: David
authors.initials: D
authors.lastname: Birnie
authors.forename: Laurence
authors.initials: L
authors.lastname: Sterns
authors.forename: Derek
authors.initials: D
authors.lastname: Exner
authors.forename: Bernard
authors.initials: B
authors.lastname: Thibault
authors.forename: Sean
authors.initials: S
authors.lastname: Connors
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Healey
authors.forename: Jean
authors.initials: J
authors.lastname: Champagne
authors.forename: Doug
authors.initials: D
authors.lastname: Cameron
authors.forename: Iqwal
authors.initials: I
authors.lastname: Mangat
authors.forename: Atul
authors.initials: A
authors.lastname: Verma
authors.forename: Kevin
authors.initials: K
authors.lastname: Wolfe
authors.forename: Vidal
authors.initials: V
authors.lastname: Essebag
authors.forename: Teresa
authors.initials: T
authors.lastname: Kus
authors.forename: Felix
authors.initials: F
authors.lastname: Ayala-Paredes
authors.forename: Ted
authors.initials: T
authors.lastname: Davies
authors.forename: Shubhayan
authors.initials: S
authors.lastname: Sanatani
authors.forename: Robert
authors.initials: R
authors.lastname: Gow
authors.forename: Benoit
authors.initials: B
authors.lastname: Coutu
authors.forename: Soori
authors.initials: S
authors.lastname: Sivakumaran
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Stephenson
authors.forename: Andrew
authors.initials: A
authors.lastname: Krahn
mesh_terms: D026683:Advisory Committees / Q000592:standards*; D002170:Canada; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D018795:Device Approval / Q000592:standards*; D004567:Electrodes, Implanted / Q000592:standards; D004868:Equipment Failure; D005500:Follow-Up Studies; D006323:Heart Arrest / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D006339:Heart Rate; D006801:Humans; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D012955:Societies, Medical / Q000592:standards*