Evaluation of a Second-Generation Intercostal Extravascular ICD Lead with a Pectoral Pulse Generator for Sensing, Defibrillation and Anti-tachycardia Pacing.

Background: Intercostal EV-ICD leads may work better inn contact with the pericardium thereby directing pacing and defibrillation energy toward excitable myocytes. We report three-month safety and performance outcomes with a second-generation intercostal EV-ICD lead paired with standard, commercially available ICD pulse generators (PGs).

Methods: Subjects undergoing a transvenous ICD (TV-ICD) procedure received a concomitant intercostal EV-ICD lead system. The intercostal EV-ICD lead was connected sequentially to a PG in a left pectoral and then a left mid-axillary location. EV-ICD lead assessment included sensing and defibrillation of induced ventricular arrhythmias (IVA) and pacing capture. The intercostal EV-ICD system was followed in a "recording only" mode and the control TV-ICD system in "therapy delivery" mode to compare stored events. Devices were evaluated prior to hospital discharge, 2 weeks, 1 month, 2 months and 3 months post implant. Defibrillation testing was repeated prior to lead removal.

Results: 20/20(100%) were successfully implanted (median implant time of 9 minutes). Two major lead complications were reported over a mean of 82 days: (1) lead movement and (2) infection of both the TV-ICD and EV-ICD systems. Intraoperative pacing capture was achieved with the integrated bipolar configuration in 19 of 20 (95%) subjects. Pacing capture with the EV-ICD system was tolerated in all subjects, with over 90% feeling no pain after a one-month recovery from the procedure. Induced VF episodes were sensed in all subjects and defibrillated successfully in 17 of 17 patients (100%) with a left mid-axillary PG and 19 of 20 patients (95%) with a left pectoral PG. Sensing and defibrillation were successful in 18 of 18 (100%) tested prior to lead removal.

Conclusions: In this pilot experience with a second generation intercostal EV-ICD lead implantation, sensing and defibrillation of induced VF was successful when paired with a standard ICD PG from either a left midaxillary or pectoral pocket.

Study Identifier: NCT Number: NCT05791032, URL: https://clinicaltrials.gov/study/NCT05791032.