title: Long-Term Evaluation of Biotronik Linox and Linox(smart) Implantable Cardioverter Defibrillator Leads.
abstract: Expert consensus holds that post-market, systematic surveillance of ICD leads is essential to ensure confirmation of adequate lead performance. GALAXY (NCT00836589) and CELESTIAL (NCT00810264) are ongoing multicenter, prospective, non-randomized registries conducted to confirm the long-term safety and reliability of Biotronik leads.
  
  
  
  ICD and CRT-D patients are followed for Linox and Linox(smart) ICD lead performance and safety for 5 years post-implant. All procedural and system-related adverse events (AEs) were assessed at each follow-up, along with lead electrical parameters. An independent CEC of EPs adjudicated AEs to determine AE category and lead relatedness. The analysis used categories of lead observations per ISO 5841-2 (Third edition). A total of 3,933 leads were implanted in 3,840 patients (73.0% male, mean age 67.0 ± 12.2 years) at 146 US centers. The estimated cumulative survival probability was 96.3% at 5 years after implant for Linox leads and 96.6% at 4 years after implant for Linox(smart) leads. A comparison of the Linox and Linox(smart) survival functions did not find evidence of a difference (P = 0.2155). The most common AEs were oversensing (23, 0.58%), conductor fracture (14, 0.36%), failure to capture (13, 0.33%), lead dislodgement (12, 0.31%), insulation breach (10, 0.25%), and abnormal pacing impedance (8, 0.20%).
  
  
  
  Linox and Linox(smart) ICD leads are safe, reliable and infrequently associated with lead-related AEs. Additionally, estimated cumulative survival probability is clinically acceptable and well within industry standards. Ongoing data collection will confirm the longer-term safety and performance of the Linox family of ICD leads.
authors.affiliation: University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Good
authors.affiliation: University Hospitals of Cleveland, Cleveland, Ohio, USA.
authors.forename: Ivan
authors.initials: I
authors.lastname: Cakulev
authors.affiliation: Steward St. Elizabeth's Medical Center, Brighton, MA, USA.
authors.forename: Michael V
authors.initials: MV
authors.lastname: Orlov
authors.affiliation: Emory University, Atlanta, Georgia, USA.
authors.forename: David
authors.initials: D
authors.lastname: Hirsh
authors.affiliation: Biotronik, Lake Oswego, Oregon, USA.
authors.forename: John
authors.initials: J
authors.lastname: Simeles
authors.affiliation: Biotronik, Lake Oswego, Oregon, USA.
authors.forename: Kelly
authors.initials: K
authors.lastname: Mohr
authors.affiliation: Biotronik, Lake Oswego, Oregon, USA.
authors.forename: Phil
authors.initials: P
authors.lastname: Moll
authors.affiliation: Emory University and Atlanta VA Medical Center, Atlanta, Georgia, USA.
authors.forename: Heather
authors.initials: H
authors.lastname: Bloom
mesh_terms: D000368:Aged; D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D017147:Defibrillators, Implantable; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012042:Registries; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D016277:Ventricular Function, Left
keywords: Biotronik; Linox lead; Performance; adverse event; cardiac resynchronization therapy; implantable cardioverter defibrillator; lead; reliability; survival