Long-Term Evaluation of Biotronik Linox and Linoxsmart Implantable Cardioverter Defibrillator Leads

Long‐Term Evaluation of Biotronik Linox Family of ICD Leads Introduction 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. Methods and Results ICD and CRT‐D patients are followed for Linox and Linoxsmart 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 Linoxsmart leads. A comparison of the Linox and Linoxsmart 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%). Conclusions Linox and Linoxsmart 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.