Acute safety and procedural characteristics of conscious and deep sedation to general anesthesia workflows with novel balloon-based PFA system

Abstract Background There is an increasing desire to perform cardiac ablation procedures with decreased general anesthesia requirements, however, there is a perceived risk of skeletal muscle recruitment (SMR) during pulsed field ablation (PFA). This has largely presented the opportunity to adopt PFA into conscious or deep sedation workflows. Purpose This analysis was performed to demonstrate the feasibility, safety, and effectiveness of pulmonary vein isolation (PVI) with the novel balloon-in-basket Volt™ PFA catheter under conscious or deep sedation workflows. Methods The Volt CE Mark Study (NCT06106594) is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study. Enrollment of 150 paroxysmal (PAF) and persistent AF (PsAF) subjects occurred between November 2023 and March 2024 at 11 sites worldwide. Subjects underwent de novo PVI with the Volt PFA catheter under a form of anesthesia at the physician’s discretion, including general anesthesia (GA) or conscious sedation/deep sedation (CS/DS). Acute data is reported regarding procedure characteristics, PVI success, and safety by anesthesia use. Results Of the 150 enrolled, 146 subjects underwent ablation procedures; 62.3% (91/146) underwent ablation under GA (mean age 63.6 ± 10 years, 63.7% male, 80.2% PAF) and 37.7% (55/146) underwent ablation under CS/DS (mean age 64.8 ± 10.1 years, 61.8% male, 54.5% PAF). The average procedure time including protocol-mandated 20-minute waiting period, pre- and post-procedure phrenic nerve stimulation, and voltage mapping was 102.1 ± 34.2 minutes with an average 40.5 ± 22.2 minutes of Volt PFA catheter left atrial (LA) dwell time for those with GA and 97.5 ± 31.0 minutes with an average 37.6 ± 17.7 minutes of LA dwell time for CS/DS, respectively. The average total PFA applications was 18.5 ± 6.8 applications/patient with an average of 4.9 applications/vein for subjects under GA and 16.1 ± 2.5 applications/patient with an average of 4.7 applications/vein for subjects under CS/DS (p=0.0028). Acute success, defined as PVI confirmed via entrance block at end of 20-minute waiting period after no more than the maximum allowed therapy applications, was achieved in 98.9% (90/91) and 98.2% (54/55) of GA subjects and CS/DS subjects, respectively (p=0.7171). A primary safety endpoint event was observed in 1.1% (1/91) of subjects under GA and in 5.5% (3/55) of subjects under CS/DS (p=0.1502). Primary safety events included 1 vascular access complication under GA and 1 cardiac tamponade, 1 pneumonia, and 1 vascular access complication under CS/DS. Of note, there were no adverse events associated with SMR or patient movement during procedures with CS/DS. Conclusion Acute data from the Volt CE Mark study demonstrate that PFA procedures with the Volt PFA catheter in subjects under deep or conscious sedation are feasible and result in safety rates and procedural outcomes that do not significantly differ compared to procedures with general anesthesia.