Safety, efficacy, and reliability evaluation of a novel small-diameter defibrillation lead: Global LEADR pivotal trial results
George H. Crossley, Prashanthan Sanders, Bert Hansky, Paolo De Filippo, Maully J. Shah, Morio Shoda, Surinder Kaur Khelae, Travis D. Richardson, François Philippon, John S. Zakaib, Hung‐Fat Tse, Darius P. Sholevar, Christoph Stellbrink, Rajeev K. Pathak, Goran Milašinović, Jason S. Chinitz, Bernice Tsang, Michael West, Brian Ramza, Xuebin Han, Babak Bozorgnia, Roberto Carta, Tessa Geelen, Adam Himes, Megan L Platner, Amy Thompson, Pamela Mason, Pamela K. 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, Pamela Mason, Travis Richardson, Gautham Kalahasty, Darius P. Sholevar, Timothy Smith
Abstract
BACKGROUND: Implantable cardioverter-defibrillators last longer, and interest in reliable leads with targeted lead placement is growing. The OmniaSecure defibrillation lead is a novel, small-diameter, catheter-delivered lead designed for targeted placement, based on the established SelectSecure SureScan MRI Model 3830 lumenless pacing lead platform. OBJECTIVE: This trial assessed safety and efficacy of the OmniaSecure defibrillation lead. METHODS: The worldwide LEADR pivotal clinical trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator, all of whom received the study lead. The primary efficacy end point was successful defibrillation at implantation per protocol. The primary safety end point was freedom from study lead-related major complications at 6 months. The primary efficacy and safety objectives were met if the lower bound of the 2-sided 95% credible interval was >88% and >90%, respectively. RESULTS: In total, 643 patients successfully received the study lead, and 505 patients have completed 12-month follow-up. The lead was placed in the desired right ventricular location in 99.5% of patients. Defibrillation testing at implantation was completed in 119 patients, with success in 97.5%. The Kaplan-Meier estimated freedom from study lead-related major complications was 97.1% at 6 and 12 months. The trial exceeded the primary efficacy and safety objective thresholds. There were zero study lead fractures and electrical performance was stable throughout the mean follow-up of 12.7 ± 4.8 months (mean ± SD). CONCLUSION: The OmniaSecure lead exceeded prespecified primary end point performance goals for safety and efficacy, demonstrating high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures.