TY - JOUR
T1 - Acute human defibrillation performance of a subcutaneous implantable cardioverter-defibrillator with an additional coil electrode
AU - Yap, Sing-Chien
AU - Oosterwerff, Erik F. J.
AU - Boersma, Lucas V. A.
AU - van der Stuijt, Willeke
AU - Lenssen, Anneke
AU - Hahn, Stephen J.
AU - Knops, Reinoud E.
N1 - Funding Information: This clinical study was sponsored and funded by Boston Scientific International SA, Belgium ( ClinicalTrials.gov identifier NCT03802110 ; EUDAMED (European Database on Medical Devices): CIV-NL-18-11-026204. Publisher Copyright: © 2023 Heart Rhythm Society
PY - 2023/12
Y1 - 2023/12
N2 - Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) delivers 80 J shocks from an 8 cm left-parasternal coil to a 59 cm3 left lateral pulse generator (PG). A system that defibrillates with lower energy could significantly reduce PG size. Computer modeling and animal studies suggested that a second shock coil either parallel to the left-parasternal coil or transverse from the xiphoid to the PG pocket would significantly reduce the defibrillation threshold. Objective: The purpose of this study was to acutely assess the defibrillation efficacy of parallel and transverse configurations in patients receiving an S-ICD. Methods: Testing was performed in patients receiving a conventional S-ICD system. Success at 65 J was required before investigational testing. A second electrode was temporarily inserted from the xiphoid incision connected to the PG with an investigational Y-adapter. Phase 1 (n = 11) tested the parallel configuration. Phase 2 (n = 21) tested both parallel and transverse configurations in random order. Results: This study enrolled 35 patients (28 males (80%); mean age 51 ± 17 years; left ventricular ejection fraction 40% ± 15%; body mass index 26 ± 4 kg/m2; prior myocardial infarction 46%; congestive heart failure 49%; cardiomyopathy 63%). Compared to the conventional S-ICD system, mean shock impedance decreased for both parallel (69 ± 15 Ω vs 86 ± 20 Ω; n = 33; P < .001) and transverse (56 ± 14 Ω vs 81 ± 21 Ω; n = 20; P < .001) configurations. Shock success rates at 20, 30, and 40 J were 55%, 79%, 97%, and 25%, 70%, 90% for parallel and transverse configurations, respectively. Defibrillation threshold testing was well tolerated with no serious adverse events. Conclusion: Adding a second shock coil, particularly in the parallel configuration, significantly reduced the impedance and had a high likelihood of defibrillation success at energies ≤40 J. This may enable the development of a smaller S-ICD.
AB - Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) delivers 80 J shocks from an 8 cm left-parasternal coil to a 59 cm3 left lateral pulse generator (PG). A system that defibrillates with lower energy could significantly reduce PG size. Computer modeling and animal studies suggested that a second shock coil either parallel to the left-parasternal coil or transverse from the xiphoid to the PG pocket would significantly reduce the defibrillation threshold. Objective: The purpose of this study was to acutely assess the defibrillation efficacy of parallel and transverse configurations in patients receiving an S-ICD. Methods: Testing was performed in patients receiving a conventional S-ICD system. Success at 65 J was required before investigational testing. A second electrode was temporarily inserted from the xiphoid incision connected to the PG with an investigational Y-adapter. Phase 1 (n = 11) tested the parallel configuration. Phase 2 (n = 21) tested both parallel and transverse configurations in random order. Results: This study enrolled 35 patients (28 males (80%); mean age 51 ± 17 years; left ventricular ejection fraction 40% ± 15%; body mass index 26 ± 4 kg/m2; prior myocardial infarction 46%; congestive heart failure 49%; cardiomyopathy 63%). Compared to the conventional S-ICD system, mean shock impedance decreased for both parallel (69 ± 15 Ω vs 86 ± 20 Ω; n = 33; P < .001) and transverse (56 ± 14 Ω vs 81 ± 21 Ω; n = 20; P < .001) configurations. Shock success rates at 20, 30, and 40 J were 55%, 79%, 97%, and 25%, 70%, 90% for parallel and transverse configurations, respectively. Defibrillation threshold testing was well tolerated with no serious adverse events. Conclusion: Adding a second shock coil, particularly in the parallel configuration, significantly reduced the impedance and had a high likelihood of defibrillation success at energies ≤40 J. This may enable the development of a smaller S-ICD.
KW - Defibrillation
KW - Electrodes
KW - Human
KW - Implantable cardioverter-defibrillator
KW - Subcutaneous
UR - http://www.scopus.com/inward/record.url?scp=85170412189&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.hrthm.2023.08.009
DO - https://doi.org/10.1016/j.hrthm.2023.08.009
M3 - Article
C2 - 37579867
SN - 1547-5271
VL - 20
SP - 1649
EP - 1656
JO - Heart Rhythm
JF - Heart Rhythm
IS - 12
ER -