One-Year Outcomes of the MODULAR ATP Trial: A Novel Leadless Pacemaker in Wireless Communication With a Subcutaneous Implantable Cardioverter Defibrillator
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: MODULAR antitachycardia pacing (ATP), a multicenter, international trial, assesses a modular cardiac rhythm management system: a subcutaneous implantable cardioverter defibrillator in wireless communication with a leadless pacemaker (LP) capable of pace-terminating ventricular tachycardia. METHODS: Enrolees had one or more clinical risk factors for ventricular tachycardia and did not require chronic pacing. Complications included prespecified major LP system- and procedure-related complications, and any complication related to the LP, subcutaneous implantable cardioverter defibrillator, implantation, or study protocol. Survival analysis was performed to identify complication-free rates, therapy delivery, and all-cause mortality. RESULTS: The 297 patients enrolled had an ejection fraction of 35±13%, 43% secondary prevention indications, and 59% with prior ventricular arrhythmias. Of 286 patients undergoing LP implantation (100% success), 251 patients completed 12-month follow-up. Mortality rate was 6%, with none related to the implant procedure. Median follow-up duration was 23.4 months (interquartile range, 17.9-28.1). The LP major complication-free rate was 97.2%, exceeding the performance goal. The overall LP+ subcutaneous implantable cardioverter defibrillator system-related complication-free rate was 88.5%. Appropriate tachyarrhythmia-therapy (ATP+shock) rates were 14.4%, and appropriate shock rates were 8.5%. Inappropriate total tachyarrhythmia therapy was 9.5% of which 8.5% were shocks. ATP was 67.3% successful in terminating ventricular arrhythmia episodes and accelerated ventricular arrhythmias in 10.1% of episodes. Overall therapy burden (ATP+shock) was 96/100 patient-years, of which 44/100 patient-years was for shock delivery. CONCLUSIONS: One-year outcomes of the first modular pacing-defibrillator system reveal low system and LP complication rates and good ATP efficacy rates, suggesting that the modular cardiac rhythm management is a viable alternative to single-chamber implantable cardioverter defibrillators using low-energy pacing capability without the need for transvenous leads. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov/; Unique identifier: NCT04798768.
Authors: Michael S. Lloyd, Vivek Y. Reddy, Paul Roberts, Rahul N. Doshi, David L. Wright, Lucas V.A. Boersma, Paul A. Friedman, Petr Neuzil, Carina Blomström-Lundqvist, Maria Grazia Bongiorni, Martin C. Burke, Daniel Gras, Steven P. Kutalek, Eloi Marijon, Jose María Tolosana, Anish K. Amin, Laurence M. Epstein, Johan D. Aasbo, Thomas D. Callahan, Amy J. Brisben, Julie West, Elizabeth Matznick, Benjamin Speakman, Tara N. Bachman, Lluís Mont, Reinoud E. Knops
Institutions: Emory University, University Hospital Southampton NHS Foundation Trust, University of Southampton, HonorHealth, Liverpool Heart and Chest Hospital, St. Antonius Ziekenhuis, Amsterdam University Medical Centers, Mayo Clinic, Na Homolce Hospital, Uppsala University, Örebro University, CorVita Science Foundation, Hôpital privé du Confluent, St. Mary Medical Center, Drexel University, Hôpital Européen Georges-Pompidou, Hospital Clínic de Barcelona, Universitat de Barcelona, OhioHealth, Riverside Methodist Hospital, Northwell Health, Central Baptist Hospital, Cleveland Clinic, Boston Scientific (United States)
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funder: Boston Scientific Corporation
OpenAlex ID: W4416185200