학술논문
Acute human defibrillation performance of a subcutaneous implantable cardioverter-defibrillator with an additional coil electrode.
Document Type
Academic Journal
Author
Yap SC; Department of Cardiology, Thorax Center, Cardiovascular Institute, Erasmus Medisch Centrum, Rotterdam, The Netherlands. Electronic address: s.c.yap@erasmusmc.nl.; Oosterwerff EFJ; Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands.; Boersma LVA; Department of Cardiology, St Antonious Ziekenhuis, Nieuwegein, The Netherlands; Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.; van der Stuijt W; Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.; Lenssen A; Boston Scientific, Amsterdam, The Netherlands.; Hahn SJ; Boston Scientific CRM, St. Paul, Minnesota.; Knops RE; Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Source
Publisher: Elsevier Country of Publication: United States NLM ID: 101200317 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1556-3871 (Electronic) Linking ISSN: 15475271 NLM ISO Abbreviation: Heart Rhythm Subsets: MEDLINE
Subject
Language
English
Abstract
Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) delivers 80 J shocks from an 8 cm left-parasternal coil to a 59 cm 3 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.
(Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
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/m
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.
(Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)