A Modular Communicative Leadless Pacing–Defibrillator System

作者：Reinoud E. Knops, Michael S. Lloyd, Paul R. Roberts, David J. Wright, Lucas V.A. Boersma, Rahul N. Doshi, Paul A. Friedman, Petr Neužil, Carina Blomström‐Lundqvist, Maria Grazia Bongiorni, Martin C. Burke, Daniel Gras, Steven P. Kutalek, Anish K. Amin, Eugene Y. Fu, Laurence M. Epstein, José Marı́a Tolosana, Thomas Callahan, Johan D. Aasbo, Ralph Augostini, Harish Manyam, Devi G. Nair, Blandine Mondésert, Wilber Su, Chris Pepper, Marc A. Miller, Jon A. Grammes, Karim Saleh, Christelle Marquié, Faisal M. Merchant, Yong‐Mei Cha, Colin Cunnington, David S. Frankel, Julie West, Elizabeth Matznick, Bryan Swackhamer, Amy Brisben, Jonathan Weinstock, Kenneth M. Steín, Vivek Y. Reddy, Lluı́s Mont · 发表于：New England Journal of Medicine · 年份：2024 · DOI：10.1056/nejmoa2401807 · 被引用次数：83 · 研究领域：Cardiac pacing and defibrillation studies、Cardiac electrophysiology and arrhythmias、Transplantation: Methods and Outcomes

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown. METHODS: We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system. The safety end point was freedom from leadless pacemaker-related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%). RESULTS: We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker-related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of com...