title: Canadian Registry of Implantable Electronic Device Outcomes: Surveillance of the Riata Lead Under Advisory.
abstract: The Riata lead under advisory has posed a unique clinical scenario where inside-out abrasion results in externalization of conductor cables, with a higher risk of electrical failure. We developed a comprehensive registry to assist with clinical management of this lead.
  
  
  
  This Canadian registry reports the findings of 3763 (74.2% of all Riata leads in Canada) Riata leads under advisory, with a mean follow-up time of 8.9±1.5 years. The overall electrical failure rate was 5.2% at 8 years, with no difference between 7-French and 8-French lead models. Cable externalization was found to be more common in the 8-French model (12.3% versus 5.2%, P<0.0001) and was associated with a higher risk of electrical failure. Predictors of electrical lead failure included cable externalization, higher left ventricular ejection fraction, younger age, higher body mass index, and a passive fixation lead. One patient died due to electrical failure, a further 2 patients survived an event where the device failed to deliver high-voltage therapy. Major complications because of lead extraction were higher when compared with lead abandonment, no difference among lead model observed. Two deaths occurred as a consequence of lead extraction, in the context of an underlying infection.
  
  
  
  The Riata lead under advisory has a steady electrical failure rate over time. There are identifiable predictors of lead failure that can assist with clinical decisions as to whether lead revision should be performed prophylactically.
authors.affiliation: For the author affiliations, please see the Appendix. Ratika.parkash@nshealth.ca.
authors.forename: Ratika
authors.initials: R
authors.lastname: Parkash
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Bernard
authors.initials: B
authors.lastname: Thibault
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Iqwal
authors.initials: I
authors.lastname: Mangat
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Benoit
authors.initials: B
authors.lastname: Coutu
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Matthew
authors.initials: M
authors.lastname: Bennett
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Healey
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Atul
authors.initials: A
authors.lastname: Verma
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Francois
authors.initials: F
authors.lastname: Philippon
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Roopinder
authors.initials: R
authors.lastname: Sandhu
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Douglas
authors.initials: D
authors.lastname: Cameron
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Felix
authors.initials: F
authors.lastname: Ayala-Paredes
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Laurence
authors.initials: L
authors.lastname: Sterns
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Vidal
authors.initials: V
authors.lastname: Essebag
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Teresa
authors.initials: T
authors.lastname: Kus
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Pablo
authors.initials: P
authors.lastname: Nery
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Stephenson
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Raymond
authors.initials: R
authors.lastname: Yee
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Derek
authors.initials: D
authors.lastname: Exner
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Satish
authors.initials: S
authors.lastname: Toal
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: David
authors.initials: D
authors.lastname: Birnie
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: George
authors.initials: G
authors.lastname: Wells
authors.affiliation: For the author affiliations, please see the Appendix.
authors.forename: Andrew
authors.initials: A
authors.lastname: Krahn
mesh_terms: D002170:Canada / Q000453:epidemiology; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal; D004567:Electrodes, Implanted; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011159:Population Surveillance; D012042:Registries; D012086:Reoperation; D012307:Risk Factors; D013997:Time Factors
keywords: catheter ablation; complications; electrophysiology; heart failure; implantable cardioverter-defibrillator