Acute human defibrillation performance of a subcutaneous implantable cardioverter-defibrillator with an additional coil electrode.
Heart Rhythm
; 20(12): 1649-1656, 2023 Dec.
Article
en En
| MEDLINE
| ID: mdl-37579867
ABSTRACT
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Desfibriladores Implantables
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Cardiomiopatías
Límite:
Adult
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Aged
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Heart Rhythm
Año:
2023
Tipo del documento:
Article