CI-452764-4 OUTCOMES IN PATIENTS WITH HIGH BODY MASS INDEX USING A NOVEL INTERCOSTAL 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) has been tested in subjects with body mass indexes (BMI) up to 35 kg/m2. Since habitus can affect effectiveness, it was deemed important assess this new high BMI (HBMI). The purpose analysis initial safety performance outcomes obese (BMI ≥ 30 kg/m2) compared non-obese < kg/m2). Thirty=six (36) human were enrolled two non-randomized, single-center studies (PASS PULL EV-ICD, NCT0509928 SECURE EV, NCT05099289) identical acute testing protocols. Subjects implanted an investigational EV-ICD lead, inserted through intercostal space at the left sternal margin into anterior mediastinum, fixated fascial plane along parasternum. then tunneled subcutaneously a lateral pocket (n=30) or pectoral (n=6). Leads connected DF-4 compatible pulse generators testing. Defibrillation started Joules (J) stepped down 10 J increments following conversion success 5 failure. Automatic detection algorithms relied upon first shock unless manual commanded shocks necessary due suspected undersensing. For analysis, cohort split subgroups low (n=23) (n=13) differences related habitus. Low (LBMI) HBMI, similar by gender (22% vs 23% female), age (mean 57 yrs 60 yrs) mean LVEF (39% 37%), respectively. Median time placement (11.5 min 10.3 min), as lowest energy required induced VF midaxillary (LBMI = 16.4 HBMI 16.2 J). Sensing 100% appropriate both groups, time-to-therapy 10.1 s 11.5 s). In limited size cohort, serious adverse events device procedure indifferent 2 (9%) 0). left, parasternal EV via safe effective automatically sensing, detecting defibrillating VT/VF subjects.