Safety and performance of the novel balloon-in-basket pulsed field ablation system: initial 100-patient experience at a high-volume electrophysiology center
- 1Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany
- 2German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany
Abstract
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.
Graphical abstract:
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BibTeX
@article{tilz2026safety,
title = {{Safety and performance of the novel balloon-in-basket pulsed field ablation system: initial 100-patient experience at a high-volume electrophysiology center}},
author = {Roland Richard Tilz and Sascha Hatahet and Charlotte Eitel and Sorin Popescu and Roman Mamaev and Kohei Ukita and Mirco Küchler and Suzanne de Waha and Karl-Heinz Kuck and Jan-Per Wenzel},
journal = {Journal of Interventional Cardiac Electrophysiology},
year = {2026},
month = jun,
doi = {10.1007/s10840-026-02357-z},
url = {https://doi.org/10.1007/s10840-026-02357-z},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Safety and performance of the novel balloon-in-basket pulsed field ablation system: initial 100-patient experience at a high-volume electrophysiology center
AU - Roland Richard Tilz
AU - Sascha Hatahet
AU - Charlotte Eitel
AU - Sorin Popescu
AU - Roman Mamaev
AU - Kohei Ukita
AU - Mirco Küchler
AU - Suzanne de Waha
AU - Karl-Heinz Kuck
AU - Jan-Per Wenzel
PY - 2026
DA - 2026/06/03
JO - Journal of Interventional Cardiac Electrophysiology
DO - 10.1007/s10840-026-02357-z
UR - https://doi.org/10.1007/s10840-026-02357-z
AB - 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. Graphical abstract:
SN - 1383-875X
SN - 1572-8595
ER -