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