From trial to practice: early multicenter real-world experience with the circular pulsed field ablation catheter.

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.