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

Background:Pulsed field ablation (PFA) is a novel technique for pulmonary vein isolation (PVI) in atrial fibrillation (AF), offering myocardial selectivity and a favorable safety profile.The balloon-inbasket (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. Objective:This study evaluated the safety, feasibility, and patient experience of BiB-PVI under conscious sedation-keeping patients awake and avoiding routine use of propofol. Methods: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 three time points: during ablation, 1-hour and 1-day postprocedure.Pain, dyspnea, and anxiety were rated on numeric rating scales(0-10); satisfaction and recommendation on visual analog scales (0-100 percent). Results:Fourteen patients (86% male, age 70.6±9.8years, BMI 27.7±3.7 kg/m2) were included.Procedure duration was 54.5 min (38.3;60.8); LA dwell time 23 min (19.5, 34.8).2.5 (2.0, 4.0) PFA-applications were delivered per vein (LSPV-2.5, LIPV-2.5,RIPV-2.5, RSPV-2.5).Additional ablation strategies were performed due to interventionist preference.No escalation to deep sedation was required.Pain was 6.5 (4.3, 8.0), decreasing to 2.0 post-ablation and on day-one (p = 0.002 / 0.001).Dyspnea and anxiety remained low.Satisfaction reached 95% (90, 100) and recommendation 100% (90, 100), remaining high throughout follow-up. Conclusion:PFA using the BiB-PFA-system under conscious sedation is safe, feasible, and well tolerated, enabling streamlined workflows with high patient satisfaction.