PO-05-054 CHRONIC (90 DAY) SAFETY AND PERFORMANCE OUTCOMES WITH A NOVEL EXTRAVASCULAR ICD LEAD

A novel extravascular (EV) ICD lead (AtaCor Medical, San Clemente, CA) is under development for sensing and defibrillation of ventricular tachyarrhythmias (VF) using DF-4 compatible pulse generator (PG) connected to the placed in anterior mediastinum through an intercostal space. The purpose this analysis characterize 90-Day safety performance a EV-ICD commercially available PG. Subjects (n=18) enrolled non-randomized, single-center SECURE EV Study (NCT05099289) were concurrently implanted with two systems (see Figure 1): (1) Research System investigational tunneled subcutaneously lateral pocket and; (2) standard Permanent TV-ICD left pectoral programmed according care. “recording only” mode store events without risk delivering therapy. Detection zone programming was matched between allow comparison stored events. Systems remained up 90 days. test induced VF conversion submaximal energy performed at 30- 90-day study visits confirm appropriate chronic defibrillation. Lead implant procedure successful 16/18 subjects. median follow-up duration days (mean = 71 days). Twelve (12) subjects completed visit per protocol 4 exited early due to: pneumothorax (day 5); wound dehiscence 22); elective removal understand (41), viral death (unrelated on day 33). Twenty-two (22) tests 13 (26 30 J delivered) and/or visits, all 22 (100%). One 1 subject acute heart failure symptoms maximum (35 delivered defibrillation) clinically limiting number potential rescue shocks. Sensing detection by 23 episodes left, parasternal inserted via space safe effective automatically detecting VT/VF after implantation.