Extravascular ICD (EV ICD System) meets global pivotal clinical trial's safety and effectiveness endpoints

Findings from the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study were presented as late-breaking science at the European Society of Cardiology (ESC) Congress 2022 in Barcelona and simultaneously published in The New England Journal of Medicine. Worldwide, the EV ICD system is investigational and not yet approved for sale or distribution.

Study Results: Effectiveness: In the study, the device's effectiveness in delivering defibrillation therapy at implant was 98.7% (298 of 302 patients), surpassing the prespecified performance goal of 88%. These results reflect a greater defibrillation efficacy for the EV ICD than historical transvenous ICD studies; comparable efficacy to the subcutaneous ICD despite EV ICD's smaller device size; and a predicted increase in longevity compared to the subcutaneous ICD. Additionally, all discrete spontaneous arrhythmias were successfully treated (18 of 18, 100%).Further, the efficacy of ATP – which paces the heart to interrupt and terminate a dangerous rhythm, potentially avoiding a defibrillation shock – in the EV ICD study was comparable to ATP efficacy in transvenous defibrillators. In total, 33 shocks were avoided by having ATP programmed "on."

Study Results: Safety: The study also exceeded its safety endpoint: at six months, 92.6% of patients (Kaplan-Meier estimate) were free from major system and/or procedure-related major complications such as hospitalization, system revision, or death (compared to the performance goal of 79%; p<0.001). there were no major intraprocedural complications, nor any unique complications observed related to the ev icd procedure or system (compared to transvenous and subcutaneous icds). at six months, 25 major complications were observed in 23 of 316 patients who underwent an implant attempt (7.3%). twenty-nine patients experienced inappropriate shocks (9.7%, average 10.6 months follow up), most commonly due to p-wave oversensing, which was more frequent in patients implanted early in the study and less frequent among patients implanted later in the study.

The EV ICD Pivotal study is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study that assessed the safety and effectiveness of the Medtronic EV ICD system for patients at risk of sudden cardiac death. The EV ICD Pivotal study enrolled 356 patients at 46 sites in 17 countries in North America, Europe, the Middle East, Asia, Australia and New Zealand. Medtronic has received FDA approval for a Continued Access Study while the agency reviews the company's EV ICD pre-market application.

See-"Efficacy and Safety of an Extravascular Implantable Cardioverter–Defibrillator"-Paul Friedman, M.D., Francis Murgatroyd, F.R.C.P., Lucas V.A. Boersma, M.D. et al., for the Extravascular ICD Pivotal Study Investigators. August 28, 2022 .OI: 10.1056/NEJMoa2206485.