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

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: This first mCRM system demonstrated excellent performance up to 18 months in a preclinical model.