Abstract 13663: 90-day Safety and Performance Outcomes With a Novel Extravascular ICD Lead

Introduction: Long-term transvenous implantable cardioverter defibrillator (ICD) leads have many pitfalls. There is in development a novel extravascular (EV) ICD lead for sensing and defibrillation of ventricular tachyarrhythmias (VT/VF) utilizing commercially available DF-4 ICD pulse generators. We evaluate here 90-day safety and performance outcomes for delivery, stability, sensing, and defibrillation using this prototype EV lead. Methods: 18 patients scheduled to undergo de novo or replacement ICD were enrolled in a prospective, nonrandomized study (SECURE-EV STUDY). Each subject was simultaneously implanted with EV ICD lead (AtaCor, SanClemente, CA) attached to a commercially available ICD pulse generator. Study lead was delivered with a designed tool into left parasternal anterior mediastinum via a selected 4th, 5th or 6th intercostal space. Over 90 days pts were evaluated intermittently for defibrillation energy requirements, matched sensing events between both devices, stability of lead position and adverse events. Results: 16/18 of enrolled subjects received study device. Lead failed implant in 2 due to (1) intercostal ossification and (1) mediastinal adhesions. Prior to 30-days, 4 subjects were withdrawn from study due to pneumothorax, wound dehiscence, death unrelated to IV-ICD implantation and early elective lead removal. Over 90-days of simultaneous sensing, 4 events of VT/VF in 3 pts were detected by both devices. There was 1 AF discrimination error & 1 atrial oversensing event detected by both devices. There were 4 events of non-cardiac noise in 4 pts detected by EV-ICD only. 1 event of Twave oversensing was detected by TV-ICD. 23 conversion tests in 13 subjects were performed at energy (26 to 30 J delivered, 1 tested with 35J) at 30- and 90-day visits, with successful conversion in all 23. Mean time between fibrillation detection and shock delivery was 10.7 seconds. Conclusion: This study showed feasibility of sensing and defibrillating induced VT/VF with intercostal placed prototype extravascular ICD lead. Findings with ICD lead was consistent across 4 commercially available ICDs. Simultaneous sensing of VT/VF in ambulatory pts was matched. Non-cardiac inappropriate sensing with EV-ICD lead is being addressed in new prototype.