TY - JOUR
T1 - Long-term performance of a novel communicating antitachycardia pacing–enabled leadless pacemaker and subcutaneous implantable cardioverter-defibrillator system
T2 - A comprehensive preclinical study
AU - Breeman, Karel T. N.
AU - Swackhamer, Bryan
AU - Brisben, Amy J.
AU - Quast, Anne-Floor B. E.
AU - Carter, Nathan
AU - Shuros, Allan
AU - Soltis, Brian
AU - Koop, Brendan E.
AU - Burke, Martin C.
AU - Wilde, Arthur A. M.
AU - Tjong, Fleur V. Y.
AU - Knops, Reinoud E.
N1 - Funding Information: Funding Sources: This research was funded by Boston Scientific Corporation . Publisher Copyright: © 2022 Heart Rhythm Society
PY - 2022/5
Y1 - 2022/5
N2 - 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.
AB - 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.
KW - Antitachycardia pacing
KW - Leadless pacemaker
KW - Modular therapy
KW - Subcutaneous ICD
KW - Wireless communication
UR - http://www.scopus.com/inward/record.url?scp=85124516175&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.hrthm.2022.01.024
DO - https://doi.org/10.1016/j.hrthm.2022.01.024
M3 - Article
C2 - 35066181
SN - 1547-5271
VL - 19
SP - 837
EP - 846
JO - Heart Rhythm
JF - Heart Rhythm
IS - 5
ER -