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-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.
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 post-procedure. 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±9.8 years, 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. (Figure 1)
Conclusion:
PFA using the BiB-PFA-system under conscious sedation is safe, feasible, and well tolerated, enabling streamlined workflows with high patient satisfaction.
Figure 1: Changes in Patient-Reported Pain, Anxiety, Dyspnea Satisfaction and Recommendation
Values are displayed in medians.
