"Awake and Ablated": First experience with a balloon-in-basket PFA system without propofol

Pulsed field ablation (PFA) is a novel technique for pulmonary vein isolation (PVI) in atrial fibrillation, offering myocardial selectivity and a favorable safety profile. The balloon-in-basket (BiB)-PFA system enables circumferential PVI with optimized tissue contact. PFA is typically performed under deep sedation or general anesthesia, increasing procedural risk and logistical burden.

This study evaluated the safety, feasibility, and patient experience of BiB-PVI under conscious sedation, keeping patients awake and avoiding routine use of propofol.

Consecutive patients undergoing de novo PVI were prospectively enrolled. Conscious sedation included fentanyl, midazolam, metamizole, and lidocaine; propofol was used for direct-current cardioversion only. Patient experience was assessed via structured questionnaires at 3 time points: during ablation and 1 hour and 1 day after the procedure. Pain, dyspnea, and anxiety were rated on numeric rating scales (0-10); satisfaction and recommendation were rated on visual analog scales (0%-100%).

14 patients (86% male; age 70.6 ± 9.8 years; BMI 27.7 ± 3.7 kg/m²) were included. Procedure duration was 54.5 minutes (38.3, 60.8); LA dwell time was 23 minutes (19.5, 34.8). 2.5 PFA applications (2.0, 4.0) were delivered per vein (left superior pulmonary vein 2.5; left inferior pulmonary vein 2.5; right inferior pulmonary vein 2.5; right superior pulmonary vein 2.5). Additional ablation strategies were performed owing to the interventionist's preference. No escalation to deep sedation was required. Pain was 6.5 (4.3, 8.0), decreasing to 2.0 after ablation and on day 1 (P = .002/.001). Dyspnea and anxiety remained low. Satisfaction reached 95% (90, 100) and recommendation 100% (90, 100), remaining high throughout follow-up.

PFA using the BiB-PFA system under conscious sedation is safe, feasible, and well tolerated, enabling streamlined workflows with high patient satisfaction.