July 6, 2026Journal of Interventional Cardiac Electrophysiology0 citationsOpen Access
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
Key Result
PulseSelect pulsed field ablation resulted in a similar 12-month arrhythmia recurrence rate compared to fourth-generation cryoballoon ablation (17.4% vs. 15.0%, p=0.46) in patients undergoing first-time pulmonary vein isolation.
Key Points
- To compare the one-year outcomes of PulseSelect pulsed field ablation and cryoballoon ablation for pulmonary vein isolation in patients with atrial fibrillation.
- Multicenter analysis including 254 patients from 10 Italian centers
- 121 patients treated with PulseSelect PFA and 133 with cryoballoon ablation
- Assessment of procedural workflow, complications, and arrhythmia recurrence using Kaplan–Meier analysis.
- Average procedure duration was significantly shorter for PulseSelect (62.4 min) compared to cryoballoon (71.4 min; p = 0.005)
- No acute complications observed with PulseSelect; three transient phrenic nerve palsies with cryoballoon
- At 12 months, arrhythmia recurrence was 17.4% for PulseSelect and 15.0% for cryoballoon (p = 0.46)
Study Design
Type
Observational (n=254)
Multicenter
Yes
Structured PICO
Does PulseSelect PFA improve procedural outcomes and prevent arrhythmia recurrence compared to cryoballoon ablation in patients undergoing first-time PVI for atrial fibrillation?
P
Population
254 patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing first-time pulmonary vein isolation, followed for 12 months.
I
Intervention
PulseSelect pulsed field ablation (PFA) system (n=121)
C
Comparator
Fourth-generation cryoballoon (CB4) ablation (n=133)
O
Outcome
Arrhythmia recurrence at 12 monthshard clinical
In a real-world setting, PulseSelect PFA demonstrated comparable 1-year efficacy and safety to fourth-generation cryoballoon for first-time PVI, with shorter procedure times but higher use of general anesthesia.
Main Result
Absolute Event Rate: 17.4% vs 15%
p-value: p=0.46
Limitations
- Retrospective analysis of a prospectively collected real-world project, subject to inherent observational study limitations
- Potential temporal bias and residual confounding related to operator experience and learning curve effects, as PFA was newly introduced while cryoballoon was a mature technology
- Marked imbalance in anesthesia strategy between groups (general anesthesia vs. conscious sedation) which may have influenced procedural workflow and times
- Differences in procedural imaging strategies, such as the use of intracardiac echocardiography
- Small sample size
- Lack of standardized follow-up protocols and continuous rhythm monitoring across participating centers, potentially leading to undetected asymptomatic recurrences
- Radiation exposure assessed using fluoroscopy duration only, without dose-related parameters
- Analysis focused on time to first AF recurrence and did not account for total AF burden
Abstract
Abstract 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.