TY - JOUR
T1 - Acute and 3-Month Performance of a Communicating Leadless Antitachycardia Pacemaker and Subcutaneous Implantable Defibrillator
AU - Tjong, Fleur V.Y.
AU - Brouwer, Tom F.
AU - Koop, Brendan
AU - Soltis, Brian
AU - Shuros, Allan
AU - Schmidt, Brian
AU - Swackhamer, Bryan
AU - Quast, Anne Floor E.B.
AU - Wilde, Arthur A.M.
AU - Burke, Martin C.
AU - Knops, Reinoud E.
PY - 2017/12/26
Y1 - 2017/12/26
N2 - Objectives The primary objective was to assess the acute and 3-month performance of the modular antitachycardia pacing (ATP)-enabled leadless pacemaker (LP) and subcutaneous implantable cardioverter-defibrillator (S-ICD) system, particularly device–device communication and ATP delivery. Background Transvenous pacemakers and implantable cardioverter-defibrillators (ICDs) have considerable rates of lead complications. We examined the next step in multicomponent leadless cardiac rhythm management: feasibility of pacing (including ATP) by a LP, commanded by an implanted S-ICD through wireless, intrabody, device–device communication. Methods The combined modular cardiac rhythm management therapy system of the LP and S-ICD prototypes was evaluated in 3 animal models (ovine, porcine, and canine) both in acute and chronic (90 days) experiments. LP performance, S-ICD to LP communication, S-ICD and LP rhythm discrimination, and ATP delivery triggered by the S-ICD were tested. Results The LP and S-ICD were successfully implanted in 98% of the animals (39 of 40). Of the 39 animals, 23 were followed up for 90 days post-implant. LP performance was adequate and exhibited appropriate VVI behavior during the 90 days of follow-up in all tested animals. Unidirectional communication between the S-ICD and LP was successful in 99% (398 of 401) of attempts, resulting in 100% ATP delivery by the LP (10 beats at 81% of the coupling interval). Adequate S-ICD sensing was observed during normal sinus rhythm, LP pacing, and ventricular tachycardia/ventricular fibrillation. Conclusions This study presents the preclinical acute and chronic performance of the combined function of an ATP-enabled LP and S-ICD. Appropriate VVI functionality, successful wireless device–device communication, and ATP delivery were demonstrated by the LP. Clinical studies on safety and performance are needed.
AB - Objectives The primary objective was to assess the acute and 3-month performance of the modular antitachycardia pacing (ATP)-enabled leadless pacemaker (LP) and subcutaneous implantable cardioverter-defibrillator (S-ICD) system, particularly device–device communication and ATP delivery. Background Transvenous pacemakers and implantable cardioverter-defibrillators (ICDs) have considerable rates of lead complications. We examined the next step in multicomponent leadless cardiac rhythm management: feasibility of pacing (including ATP) by a LP, commanded by an implanted S-ICD through wireless, intrabody, device–device communication. Methods The combined modular cardiac rhythm management therapy system of the LP and S-ICD prototypes was evaluated in 3 animal models (ovine, porcine, and canine) both in acute and chronic (90 days) experiments. LP performance, S-ICD to LP communication, S-ICD and LP rhythm discrimination, and ATP delivery triggered by the S-ICD were tested. Results The LP and S-ICD were successfully implanted in 98% of the animals (39 of 40). Of the 39 animals, 23 were followed up for 90 days post-implant. LP performance was adequate and exhibited appropriate VVI behavior during the 90 days of follow-up in all tested animals. Unidirectional communication between the S-ICD and LP was successful in 99% (398 of 401) of attempts, resulting in 100% ATP delivery by the LP (10 beats at 81% of the coupling interval). Adequate S-ICD sensing was observed during normal sinus rhythm, LP pacing, and ventricular tachycardia/ventricular fibrillation. Conclusions This study presents the preclinical acute and chronic performance of the combined function of an ATP-enabled LP and S-ICD. Appropriate VVI functionality, successful wireless device–device communication, and ATP delivery were demonstrated by the LP. Clinical studies on safety and performance are needed.
KW - ATP
KW - S-ICD
KW - leadless pacemaker
KW - modular therapy
KW - wireless communication
UR - http://www.scopus.com/inward/record.url?scp=85020026508&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.jacep.2017.04.002
DO - https://doi.org/10.1016/j.jacep.2017.04.002
M3 - Article
C2 - 29759829
SN - 2405-500X
VL - 3
SP - 1487
EP - 1498
JO - JACC: Clinical Electrophysiology
JF - JACC: Clinical Electrophysiology
IS - 13
ER -