2026-04-18T06:07:53Zhttps://recercat.cat/oai/request
oai:recercat.cat:2445/2227192025-12-04T19:07:45Zcom_2072_1057col_2072_478858col_2072_478917col_2072_478921
RECERCAT author Knops, Reinoud E. author Lloyd, Michael S. author Roberts, Paul R. author Wright, David J. author Boersma, Lucas V. A. author Doshi, Rahul author Friedman, Paul A. author Neuzil, Petr author Blomstroem Lundqvist, Madelene Carina author Bongiorni, Maria Grazia author Burke, Martin C. author Gras, Daniel author Kutalek, Steven P. author Amin, Anish K. author Fu, Eugene Y. author Epstein, Laurence M. author Tolosana, José M. (José María) author Callahan, Thomas D. author Aasbo, Johan D. author Augostini, Ralph author Manyam, Harish author Nair, Devi G. author Mondesert, Blandine author Su, Wilber W. author Pepper, Chris author Miller, Marc A. author Grammes, Jon author Saleh, Karim author Marquie, Christelle author Merchant, Faisal M. author Cha, Yong-Mei author Cunnington, Colin author Frankel, David S. author West, Julie author Matznick, Elizabeth author Swackhamer, Bryan author Brisben, Amy J. author Weinstock, Jonathan author Stein, Kenneth M. author Reddy, Vivek Y. author Mont Girbau, Lluís author the MODULAR ATP Investigators 2025-07-31T10:45:21Z2025-07-31T10:45:21Z2024-10-172025-07-31T10:45:21Z 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 communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure. Conclusions The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months cc-by-nc-nd (c) Massachusetts Medical Society, 2024 http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess Desfibril·ladors cardioversors implantables Arrítmia Implantable cardioverter-defibrillators Arrhythmia A Modular Communicative Leadless Pacing-Defibrillator System info:eu-repo/semantics/article info:eu-repo/semantics/acceptedVersion