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
G Boriani, G Molon, S Nardi, G Mitacchione, D Ricciardi, E Chieffo, R Mantovan, L Bontempi, M Ziacchi, E Casali, M CasellaAbstract
Introduction
Pulmonary vein isolation (PVI) is an established treatment for symptomatic atrial fibrillation (AF). Over the past decade, single-shot technologies have simplified ablation workflows, with cryoballoon (CB) representing the standard "anatomical approach." Recently, pulsed field ablation (PFA) has emerged as a non-thermal alternative designed to selectively ablate myocardial tissue while minimizing collateral injury. The PulseSelect system is a PFA technology specifically designed for PVI, with growing clinical experience supporting its safety and efficacy.
Purpose
In this analysis, acute and one-year outcomes of PulseSelect PFA and fourth-generation cryoballoon (CB4) ablation, both performed in the same medium-volume centers as part of routine clinical practice, were compared.
Methods
A total of 254 consecutive patients undergoing first-time PVI were included: 121 treated with PulseSelect and 133 with CB4, across 10 Italian centers between January 2024 and February 2025. Baseline clinical and echocardiographic data were prospectively collected. Procedural workflow, anesthesia type, procedure duration, fluoroscopy time, and periprocedural complications were analyzed. Follow-up included scheduled clinical visits and 12-month monitoring to assess arrhythmia recurrence, evaluated using Kaplan–Meier survival analysis.
Results
Among 254 patients, 28.3% were women, with a mean age of 62±9 years; and paroxysmal AF accounted for 76.4% of cases. Baseline clinical and echocardiographic characteristics were comparable between the two groups. General anesthesia was used in the majority of PulseSelect procedures (81.3%); whereas CB4 ablations used general anesthesia in only 16.5% of the cases. Mean procedure duration was significantly shorter with PulseSelect (59 ± 17 min) compared with CB4 (77 ± 32 min, p < 0.001), while fluoroscopy and dwell times were similar. No acute complications occurred in the PulseSelect group. In contrast, three transient phrenic nerve palsies were observed with CB4 (all resolved before discharge). At 12 months, arrhythmia recurrence was comparable between groups (15.0% (95% CI: 6.4% - 32.8%) PulseSelect vs. 17.4% (95% CI: 8.6% - 33.4%) CB4, p= 0.46), confirming high efficacy for both single-shot ablation modalities (Figure 1).
Conclusions
Both PulseSelect PFA and cryoballoon ablation provided excellent acute safety and efficacy in this real-world multicenter experience. The two single-shot technologies differ mainly in procedural workflow, with shorter ablation times for PulseSelect but different anesthetic requirements influencing total lab time. Long-term outcomes confirmed durable rhythm control with both systems. As both ablation systems are safe and effective, the choice between PFA and CB4 will likely depend on operator preference, patient characteristics, and local organizational factors such as anesthesia and device availability.Figure 1