Acute defibrillation performance of a novel, non-transvenous shock pathway in adult ICD indicated patients

Objectives: The purpose of this study was to evaluate the efficacy of a totally subcutaneous, anteroposterior defibrillation shock pathway using a long time-constant shock waveform that emulates a proposed device having approximately twice the capacitance and thus twice the available energy of traditional transvenous devices. Background: A non-transvenous defibrillation system potentially offers advantages over a transvenous system including simplification of the implant procedure and reduction of the impact of device complications by eliminating the need to place a lead within the heart. Previous non-transvenous defibrillation efficacy studies have been reported using anterolateral and anterior-anterior shock vectors. An external anteroposterior shock vector has demonstrated superior efficacy compared to anterolateral shock vectors but a prospective study on an anteroposterior shock vector with implanted electrodes has not been previously reported. Methods: The non-transvenous shock vector consisted of an anterior low pectorally-placed active can emulator electrode and a posterior subcutaneous coil electrode. The shock waveform was a biphasic with 50% tilt per phase and a time constant of decay of 12 ms. Defibrillation efficacy was characterized using a step-down defibrillation threshold protocol (35 J, 25 J, 15 J). Results: A total of 33 patients with standard ICD indications were enrolled in the study with 32 fully completing the protocol. The patient population was 69% male, with a mean age of 59 ± 12 years. Mean ejection fraction was 27 ± 12%. Of the 32 patients tested, 26 patients (81%) were successfully defibrillated at 35 J or less, 18 patients were defibrillated at 25 J or less and 9 patients were successfully defibrillated at 15 J. Conclusions: Defibrillation using a long time-constant waveform delivered through an anteroposterior non-transvenous pathway including a pectoral active can emulator electrode and a posterior subcutaneous coil electrode is feasible with over 80% of patients defibrillated successfully using 35 J or less.