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.

Cardiac Arrhythmia Group and HonorHealth Research Institute Honor Health Scottsdale AZ

Cardiac Electrophysiology and Pacing Section Department of Cardiovascular Medicine Cleveland Clinic EP OH

Cardiac Electrophysiology Drexel University College of Medicine Philadelphia

Cardiac Electrophysiology Mount Sinai Fuster Heart Hospital New York NY

Cardiac Electrophysiology Northwell Health Manhasset NY

Cardiac Rhythm Management Boston Scientific St Paul MN

Clinical Cardiology Research University Hospital Southampton United Kingdom

CorVita Science Foundation Chicago IL

Departement de Cardiologie Hôpital Privé du Confluent Nantes France

Department of Cardiology Amsterdam UMC the Netherlands

Department of Cardiology Division of Cardiology European Georges Pompidou Hospital Paris France

Department of Cardiology Liverpool Heart and Chest Hospital United Kingdom

Department of Cardiology Na Homolce Hospital Prague Czechia

Department of Cardiology School of Medical Sciences Faculty of Medicine and Health Örebro University Örsebro and Uppsala University Sweden

Department of Cardiology St Antonius Hospital Nieuwegein Utrecht the Netherlands

Department of Cardiovascular Medicine Mayo Clinic Rochester MN

Heart Rhythm Clinic San Rossore Private Hospital Pisa Italy

Institut Clínic Cardiovascular Hospital Clínic Universitat de Barcelona Spain

Lexington Cardiology Baptist Health Lexington KY

Section of Cardiac Electrophysiology Department of Cardiology OhioHealth Riverside Methodist Hospital Columbus Ohio

Section of Cardiac Electrophysiology Emory University Atlanta GA

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