Key result
Atrial fibrillation ablation with the PulseSelect circular PFA catheter achieved acute pulmonary vein isolation in 99.6% of patients, with a major complication rate of 0.76%.
Why the study?
The PulseSelect circular pulsed field ablation catheter showed excellent safety in its pivotal trial, but real-world evidence regarding its early adoption and implementation remains scarce.
Observational (n=520)
Yes
Real-world experience with the PulseSelect circular PFA catheter demonstrates high acute efficacy for pulmonary vein isolation and an excellent safety profile with major complications under 1%.
Supports PFA safety in real-world AF ablation; leaves open randomized confirmation of effectiveness.
BACKGROUND: The PulseSelect™ circular pulsed field ablation (PFA) catheter demonstrated excellent safety in its pivotal trial, but real-world evidence on its early adoption and implementation remains scarce. OBJECTIVE: To report the first multicentre, real-world experience of atrial fibrillation (AF) ablation with the PulseSelect circular PFA catheter, focusing on procedural characteristics, metrics, safety and short-term clinical outcomes. METHODS: This observational study included the first 520 consecutive patients undergoing AF ablation with the PulseSelect catheter across five Spanish centres. Patient and procedural characteristics, safety (major complications), acute pulmonary vein isolation (PVI) rate and arrhythmia recurrence during follow-up were recorded. RESULTS: Acute PVI was achieved in 518/520 patients (99.6%). Procedures were performed under deep sedation (52.7%) or general anaesthesia (47.3%), without anaesthesia-related complications. Mean procedural time was 69.95 min, with a learning curve plateauing after the first 8-10 cases. Same-day or < 24 h discharge occurred in 95.4%. Major complications occurred in four patients (0.76%); no deaths or clinically evident haemolysis were observed. Electroanatomical mapping (EAM) was used in a minority of cases (3.65%); when used, there was 100% concordance between post-ablation maps and PulseSelect catheter recordings in confirming PVI. During a mean follow-up of 10.8 ± 5 months, arrhythmia recurrence after the 3-month blanking period occurred in 16.2% of patients. After one year of follow-up, arrhythmic recurrence was observed in 52/220 (23.63%) patients. CONCLUSIONS: In the first large real-world series, AF ablation with the PulseSelect circular PFA catheter without routine use of EAM was feasible, safe, and effective, with major complications < 1% and short hospitalisation. These findings support rapid and safe implementation of this technology in clinical practice, with flexibility regarding anaesthesia modality.
No takes yet. Share an insight, caveat, or question.
Ballesteros et al. (2026) conducted an observational in Atrial fibrillation (n=520). PulseSelect circular pulsed field ablation (PFA) catheter was evaluated on Acute pulmonary vein isolation (PVI). Atrial fibrillation ablation with the PulseSelect circular PFA catheter achieved acute pulmonary vein isolation in 99.6% of patients, with a major complication rate of 0.76%.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:
More from Journal of Interventional Cardiac Electrophysiology