Single-shot ablation for AF: Real-world procedural and one-year outcomes with the newly adopted PulseSelect PFA compared with cryoballoon from the 1STOP project.

BACKGROUND

Pulmonary vein isolation (PVI) is an established treatment for symptomatic atrial fibrillation (AF). To date, cryoballoon (CB) ablation has been the most widely adopted single-shot approach, while pulsed field ablation (PFA) has emerged as a non-thermal alternative designed to preferentially ablate myocardial tissue and reduce collateral injury. PulseSelect™ is a CE-marked and FDA approved PFA system specifically developed for PVI. We compared acute and one-year outcomes of PulseSelect PFA versus fourth-generation cryoballoon (CB4) ablation in routine clinical practice.

METHODS

This multicenter analysis included 254 consecutive patients undergoing first-time PVI in 10 Italian medium-volume centers between January 2024 and February 2025: 121 treated with PulseSelect and 133 with CB4. Baseline clinical and echocardiographic characteristics were prospectively collected. Procedural workflow, anesthesia strategy, procedure duration, fluoroscopy time, and periprocedural complications were assessed. Follow-up consisted of scheduled visits with rhythm monitoring, and arrhythmia recurrence was evaluated using Kaplan-Meier analysis.

RESULTS

A total of 254 consecutive patients (mean age 62 ± 9 years, 28.3% women with paroxysmal AF in 76.4%) undergoing first-time PVI were included in the analysis: 133 treated with CB4 and 121 with PS PFA, with largely comparable baseline characteristics. General anesthesia was more frequently used with PulseSelect than with CB4 (74.4% vs. 16.5%). Mean skin-to-skin procedure duration was shorter with PulseSelect (62.4 ± 18 min) compared with CB4 (71.4 ± 30 min; p = 0.005), while fluoroscopy time was longer with PulseSelect. No acute complications occurred in the PulseSelect group; three transient phrenic nerve palsies were observed with CB4. At 12 months, no statistically significant difference in arrhythmia recurrence was observed between PulseSelect and CB4 (17.4% vs. 15.0%; p = 0.46).

CONCLUSIONS

In this real-world multicenter cohort, PulseSelect PFA and CB4 ablation showed excellent acute safety and no statistically significant differences in one-year arrhythmia recurrence were observed between the two treatment strategies.