Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
Safety and performance of the novel balloon-in-basket pulsed field ablation system: initial 100-patient experience at a high-volume electrophysiology center.
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Tilz Roland Richard, Hatahet Sascha, Eitel Charlotte, Popescu Sorin, Mamaev Roman, Ukita Kohei, Küchler Mirco, de Waha Suzanne, Kuck Karl-Heinz, Wenzel Jan-Per
Аннотация
BACKGROUND: The balloon-in-basket(BiB) pulsed field ablation(PFA) system integrates real-time electroanatomic mapping and contact sensing to streamline workflows, but clinical experience remain limited. The aim was to descriptively evaluate procedural performance, acute safety, and feasibility of the BiB-PFA-system in consecutive atrial fibrillation(AF) patients treated at a high-volume electrophysiology center.
METHODS: This prospective study included the first 100 consecutive patients undergoing pulmonary vein isolation(PVI) with the BiB-PFA-system between 01/2024 and 10/2025. The initial 30 patients were part of VOLTTM-CE-Mark-study and 25 of VOLTTM-CE-Mark-extended-study. It included a 20-minute waiting periode, pre-/postablation left-atrial mapping and phrenic nerve pacing; subsequent procedures relied solely on BiB-PFA-system. Additional linear or extra-pulmonary ablations were performed at operator discretion. Follow-up(≥ 6 months) as per institutional standart was available in 52 patients.
RESULTS: Patients were 68[62;76] years old, 41% were female, and 47% had paroxysmal AF. Median procedure duration was 59[48.0;71.0] and BiB-dwell time 26.0[21.0; 37.5] min. For VOLT™-CE-Mark-study patients, procedure and BiB-dwell times were 72.5[67.3;85.0] and 25.0[21.0;28.2] min, compared with 48.5[36.5;59.0] and 23.5[18.3;36.3] min in non-study patients. All PVs were successfully isolated with 100% first-shot success using a median of 4 applications. Additional ablations included posterior wall(41%), anterior line(5%), CTI(3%), and SVC isolation(6%). One groin complication(1%) requirng intervention occured. Same-day discharge was conducted in 8%, limited primarily by institutional policy. Freedom from atrial tachyarrhythmia was 86% at median follow-up of 293[184;364]days.
CONCLUSION: The BiB-PFA system enabled PVI with consistent first-shot success and a low rate of periprocedural complications. Follow-up available in a subset of patients suggested favorable early rhythm outcomes.
TAKE HOME MESSAGE: • This study provides the first clinical experience with the BiB-PFA-system, characterizing procedural workflows and acute safety in routine practice • This study reports the first mid-term follow-up data for the BiB-PFA system, demonstrating an 86% freedom from atrial tachyarrhythmia after a 60-day blanking period at a median follow-up of 293 [184-364] days. • The integrated mapping-and-ablation design enabled efficient PVI with consistent first-shot success and short procedure times. • Ablation strategies beyond PVI-including posterior wall ablation, anterior line ablation, CTI ablation, and SVC isolation-were feasible and could be performed safely within the same workflow. • A low rate of periprocedural complications was observed in this cohort, including one vascular complication requiring intervention, supporting a favorable acute safety profile in a high-volume electrophysiology center.
METHODS: This prospective study included the first 100 consecutive patients undergoing pulmonary vein isolation(PVI) with the BiB-PFA-system between 01/2024 and 10/2025. The initial 30 patients were part of VOLTTM-CE-Mark-study and 25 of VOLTTM-CE-Mark-extended-study. It included a 20-minute waiting periode, pre-/postablation left-atrial mapping and phrenic nerve pacing; subsequent procedures relied solely on BiB-PFA-system. Additional linear or extra-pulmonary ablations were performed at operator discretion. Follow-up(≥ 6 months) as per institutional standart was available in 52 patients.
RESULTS: Patients were 68[62;76] years old, 41% were female, and 47% had paroxysmal AF. Median procedure duration was 59[48.0;71.0] and BiB-dwell time 26.0[21.0; 37.5] min. For VOLT™-CE-Mark-study patients, procedure and BiB-dwell times were 72.5[67.3;85.0] and 25.0[21.0;28.2] min, compared with 48.5[36.5;59.0] and 23.5[18.3;36.3] min in non-study patients. All PVs were successfully isolated with 100% first-shot success using a median of 4 applications. Additional ablations included posterior wall(41%), anterior line(5%), CTI(3%), and SVC isolation(6%). One groin complication(1%) requirng intervention occured. Same-day discharge was conducted in 8%, limited primarily by institutional policy. Freedom from atrial tachyarrhythmia was 86% at median follow-up of 293[184;364]days.
CONCLUSION: The BiB-PFA system enabled PVI with consistent first-shot success and a low rate of periprocedural complications. Follow-up available in a subset of patients suggested favorable early rhythm outcomes.
TAKE HOME MESSAGE: • This study provides the first clinical experience with the BiB-PFA-system, characterizing procedural workflows and acute safety in routine practice • This study reports the first mid-term follow-up data for the BiB-PFA system, demonstrating an 86% freedom from atrial tachyarrhythmia after a 60-day blanking period at a median follow-up of 293 [184-364] days. • The integrated mapping-and-ablation design enabled efficient PVI with consistent first-shot success and short procedure times. • Ablation strategies beyond PVI-including posterior wall ablation, anterior line ablation, CTI ablation, and SVC isolation-were feasible and could be performed safely within the same workflow. • A low rate of periprocedural complications was observed in this cohort, including one vascular complication requiring intervention, supporting a favorable acute safety profile in a high-volume electrophysiology center.