Background
Pulsed field ablation (PFA) has emerged as a non-thermal energy source enabling efficient and tissue-selective pulmonary vein isolation (PVI). The novel balloon-in-basket (BiB) system integrates real-time electroanatomic mapping and contact-sensing to streamline ablation workflows. However, data from real-world clinical practice remain limited.
Purpose
To evaluate procedural performance, acute safety, and feasibility of the BiB PFA system in consecutive atrial fibrillation (AF) patients treated in a high-volume electrophysiology center.
Methods
This prospective registry included the first 100 consecutive patients undergoing PVI using the BiB PFA system between 01/2024 and 10/2025. The initial 30 patients were enrolled in the VOLT CE Mark trial, and 25 additional patients participated in the VOLT-AF IDE trial. In the CE Mark cohort, electroanatomic mapping of the left atrium was performed using an additional multipolar mapping catheter, whereas in subsequent cases, mapping was performed solely using the BiB system. Baseline, procedural, and safety data were analyzed descriptively. All patients were clinically monitored and followed for safety until hospital discharge, typically 1–2 days post-procedure. Additional linear or extra-pulmonary ablations were performed at operator discretion.
Results
Patients were 68 [62–76] years old; 41 % were female, 51 % had paroxysmal and 49 % persistent AF. The median CHA₂DS₂-VA score was 2 [1–4], left-ventricular ejection fraction 55 [54–58] %, left-atrial volume index 38 [28–48] mL/m², and body-mass index 27.2 [24.8–29.4] kg/m². Median procedure duration was 59 [48–71] min, left-atrial dwell time 46 [28–59] min, and fluoroscopy time 8.2 [6.1–10.6] min; contrast use was 40 [40–50] mL. All pulmonary veins were successfully isolated, with first-shot isolation achieved in 100 % of PVs using a median of 4 applications per vein. Posterior wall ablation was performed in 41 %, anterior line in 5 %, CTI line in 3 %, and SVC isolation in 6 % of cases, all with confirmed bidirectional block or successful isolation. No major periprocedural complications occurred (0 % tamponade, stroke/TIA, or phrenic nerve palsy). One groin complication (1 %) was managed successfully by interventional coil embolisation. Same-day discharge was achieved in 8 % of patients; however, a substantially higher proportion could have been discharged safely, with the rate limited only by institutional policies rather than clinical constraints.
Conclusion
In this initial 100-patient real-world experience, the BiB PFA system enabled rapid, effective, and safe PVI with consistent first-shot success. The absence of major complications and the feasibility of broad same-day discharge highlight its favorable safety and workflow profile in contemporary AF ablation practice.
