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

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Symptomatic atrial fibrillation (n=254). Intervention: PulseSelect pulsed field ablation (PFA) vs. Fourth-generation cryoballoon (CB4) ablation. Primary outcome: Arrhythmia recurrence at 12 months (defined as any documented episode of AF, AT, or AFL lasting ≥ 30 s beyond the blanking period) (p=0.46).

Q: What does this research mean for the field?

PulseSelect pulsed field ablation achieves similar one-year arrhythmia recurrence rates compared to fourth-generation cryoballoon ablation for pulmonary vein isolation, with shorter procedure durations and excellent acute safety. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Giuseppe Boriani; Giulio Molon; Stefano Nardi; Gianfranco Mitacchione; Danilo Ricciardi; E Chieffo; R MANTOVAN; L Bontempi; Cristian Martignani; Michela Casella; Edoardo Casali; Vincenzo Turco; Alessandro Costa; Luigi Argenziano; Matteo Ziacchi; Antonio Dello Russo

doi:10.1007/s10840-026-02392-w

July 4, 2026Journal of Interventional Cardiac ElectrophysiologyOpen 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

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Key result

PulseSelect PFA shows similar 12-month arrhythmia recurrence compared to fourth-generation cryoballoon ablation.

P=0.46
n=254

Why the study?

Pulsed field ablation has emerged as a non-thermal alternative to cryoballoon ablation for pulmonary vein isolation, but comparative real-world acute and one-year outcomes were needed.

Does pulsed field ablation prevent arrhythmia recurrence as effectively as cryoballoon ablation in patients undergoing first-time pulmonary vein isolation for symptomatic atrial fibrillation?

Study Design

Type

Observational (n=254)

Multicenter

Yes

Structured PICO

Does pulsed field ablation prevent arrhythmia recurrence as effectively as cryoballoon ablation in patients undergoing first-time pulmonary vein isolation for symptomatic 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

Pulsed field ablation (PulseSelect system) for single-shot pulmonary vein isolation

C

Comparator

Fourth-generation 28-mm cryoballoon (CB4) ablation

O

Outcome

Arrhythmia recurrence at 12 months (defined as any documented episode of atrial fibrillation, atrial tachycardia, or atrial flutter lasting ≥ 30 s beyond the blanking period)hard clinical

Main Result

Absolute Event Rate: 17.4% vs 15%

p-value: p=0.46

In a real-world setting, pulsed field ablation demonstrated comparable one-year efficacy and excellent acute safety compared to fourth-generation cryoballoon ablation for first-time pulmonary vein isolation.

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

Implication

Similar efficacy observed with PulseSelect PFA; should not yet change practice and leaves open need for randomized confirmation of procedural benefits.

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.

Discussion

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Cite This Study

Boriani et al. (2026) conducted an observational in Symptomatic atrial fibrillation (n=254). PulseSelect pulsed field ablation (PFA) vs. Fourth-generation cryoballoon (CB4) ablation was evaluated on Arrhythmia recurrence at 12 months (defined as any documented episode of AF, AT, or AFL lasting ≥ 30 s beyond the blanking period) (p=0.46). 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.

synapsesocial.com/papers/6a4b4578997070ff83b5b2c4 https://doi.org/10.1007/s10840-026-02392-w

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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

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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