Long-term performance of a novel communicating antitachycardia pacing–enabled leadless pacemaker and subcutaneous implantable cardioverter-defibrillator system: A comprehensive preclinical study

• Published in: Heart rhythm Vol. 19; no. 5; pp. 837 - 846
• Main Authors: Breeman, Karel T.N., Swackhamer, Bryan, Brisben, Amy J., Quast, Anne-Floor B.E., Carter, Nathan, Shuros, Allan, Soltis, Brian, Koop, Brendan E., Burke, Martin C., Wilde, Arthur A.M., Tjong, Fleur V.Y., Knops, Reinoud E.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2022
• Subjects: Animals; Antitachycardia pacing; Cardiac Pacing, Artificial; Defibrillators, Implantable; Dogs; Humans; Leadless pacemaker; Modular therapy; Pacemaker, Artificial; Subcutaneous ICD; Treatment Outcome; Wireless communication; Wireless communication; Antitachycardia pacing; Modular therapy; Leadless pacemaker; Subcutaneous ICD
• ISSN: 1547-5271; 1556-3871; 1556-3871
• DOI: 10.1016/j.hrthm.2022.01.024

Subcutaneous implantable cardioverter-defibrillators (S-ICDs) and leadless pacemakers (LPs) are intended to diminish transvenous lead–related complications. However, S-ICDs do not deliver antibradycardia pacing or antitachycardia pacing, and currently, there is no commercially available coordinated leadless option for patients with defibrillator and (expected) pacing needs. We evaluated the performance, safety, and potential replacement strategies of a novel modular cardiac rhythm management (mCRM) system, a wirelessly communicating antitachycardia pacing–enabled LP and S-ICD in a preclinical model. LP implantation was attempted in 68 canine subjects, and in 38 an S-ICD was implanted as well. Animals were evaluated serially up to 18 months. At all evaluations, communication thresholds (CTs) between the devices, LP electrical parameters, and system-related complications were assessed. Different replacement strategies were tested. The LP was successfully implanted in 67 of 68 (98.5%) and the concomitant S-ICD in 38 of 38 (100%). mCRM communication was successful in 1022 of 1024 evaluations (99.8%). The mean CT was 2.2 ± 0.7 V at implantation and stable afterward (18 months: 1.8 ± 0.7 V). In multivariable analysis, larger LP-to-S-ICD angle and dorsal posture were associated with higher CTs. At implantation, the mean pacing capture threshold, impedance, and R-wave amplitude were 0.3 ± 0.1 V, 898.4 ± 198.9 Ω, and 26.4 ± 8.2 mV. The mean pacing capture threshold remained stable and impedance and R-wave amplitudes were within acceptable ranges throughout (0.7 ± 0.4 V, 619.1 ± 90.6 Ω, and 20.1 ± 8.4 mV at 18 months). Different replacement strategies seem feasible. This first mCRM system demonstrated excellent performance up to 18 months in a preclinical model.