George H. Crossley, Prashanthan Sanders, Bert Hansky, Paolo De Filippo, Maully J. Shah, Surinder Kaur Khelae, Travis D. Richardson, François Philippon, John S. Zakaib, Tessa Geelen, Katherin Arias, Baerbel Maus, Pamela Mason, Prashanthan Sanders, Rajeev Pathak, Prashanthan Sanders, Russell Allen Denman, Attila Mihalcz, Francois Philippon, Bernice Tsang, Glenn Sumner, Minglong Chen, Xiuebin Han, Xingbin Liu, Berit Thornvig Philbert, Pascal Defaye, Frederic Anselme, Christoph Stellbrink, Ngai-Yin Chan, Hung-Fat Tse, Paolo De Filippo, Kenji Ando, Kengo Kusano, Morio Shoda, Surinder Kaur Khelae, Pedro Miguel Lopes do Carmo, Goran Milasinovic, Elaine Boey, Ignasi Anguera Camos, Oscar Cano Pérez, Zachary Whinnett, Bryan Baranowski, Meir Friedman, Jay Dinerman, Robert Schaller, Babak Bozorgnia, John Zakaib, Jason Chinitz, Michael West, Brian Ramza, Robert Canby, Theodore Takata, Maully Shah, Marshall Winner, David Wilson, Pamela Mason, Travis Richardson, Gautham Kalahasty, Darius Sholevar, Timothy Smith
BACKGROUND: The LEADR (Lead Evaluation for Defibrillation and Reliability) trial evaluated the small-diameter (4.7F), lumenless, integrated bipolar OmniaSecure defibrillation lead. The trial exceeded primary safety and efficacy objective thresholds, demonstrating favorable efficacy at implant and a low rate of complications. Three-year term outcomes of the LEADR trial assessing the OmniaSecure lead are reported here. METHODS: The LEADR trial is a prospective, multicenter, single-arm clinical trial. Patients with an indication for de novo implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillator were implanted with the OmniaSecure lead in standard right ventricle locations and followed at prespecified intervals. The lead was evaluated for safety, efficacy, and reliability through final follow-up. RESULTS: There were 643/657 patients (97.9%) successfully implanted with the OmniaSecure lead with a mean follow-up of 32.4±9.1 months (26% female, 61.9±12.9 years). Pacing capture threshold, pacing impedance, and R-wave amplitudes remained stable throughout. There was a 96.5% freedom from major study lead-related complications at 3 years. At 3 years, 22.3% of patients received appropriate therapies, that is, shock and antitachycardia pacing, with a 75.4% antitachycardia pacing efficacy. Inappropriate shock rate was 2.7% and 5.9% at 1 and 3 years, respectively. CONCLUSIONS: The final results of the LEADR trial demonstrated 3-year term safety, efficacy, and reliability of the OmniaSecure lead, emphasizing the potential utility of this lead in a wide variety of patients.