Acute human defibrillation performance of a subcutaneous implantable cardioverter-defibrillator with an additional coil electrode

Abstract

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. The purpose of this study was to acutely assess the defibrillation efficacy of parallel and transverse configurations in patients receiving an S-ICD. 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. 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. 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.