What is the clinical evidence from this study?

Study design: Observational. Population: Female patients with paroxysmal atrial fibrillation undergoing de novo pulmonary vein isolation (n=1001). Intervention: Pentaspline pulsed-field ablation (PFA) vs. Conventional thermal ablation (radiofrequency and cryoablation). Primary outcome: Freedom from atrial fibrillation (AF) recurrence at 1-year follow-up after 90-day blanking period (OR 5.5 for complications (thermal vs PFA), 95% CI 95% CI 1.3–23.5 for complications OR, p=0.0227 for complications difference between PFA and thermal ablation).

What does this research mean for the field?

In women with paroxysmal atrial fibrillation, pulsed-field ablation significantly reduces procedural time and complication rates compared to thermal ablation, while maintaining comparable 1-year freedom from atrial fibrillation. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

Evaluate the efficacy and safety of pulsed field ablation versus thermal ablation methods in women with atrial fibrillation.

February 14, 2026Open Access

De Novo Pulmonary Vein Isolation by Means of Pulsed Field Versus Conventional Thermal Ablation of Paroxysmal Atrial Fibrillation in Women: Safety, Efficiency, and Efficacy

Key Result

Pulsed-field ablation reduced procedural time to median 60 minutes and complications to 0.9% versus 4.6% with thermal ablation, with comparable 1-year AF freedom rates (86.8% vs 83.9%) in women with paroxysmal AF.

Key Points

Evaluate the efficacy and safety of pulsed field ablation versus thermal ablation methods in women with atrial fibrillation.
Cohort of female patients undergoing pulmonary vein isolation for atrial fibrillation
Comparison of pulsed field ablation to thermal ablation technologies (radiofrequency and cryoablation)
Propensity score matching to balance characteristics among groups
Pulsed field ablation had significantly shorter skin-to-skin time compared to thermal methods
Overall complication rate was lower with pulsed field ablation (0.9%) than with thermal ablation (4.6%)
At one-year follow-up, freedom from atrial fibrillation was similar across all groups

Study Design

Type

Observational (n=1,001)

Multicenter

Yes

Structured PICO

Does pulsed-field ablation improve freedom from atrial arrhythmia recurrence and reduce complications compared to conventional thermal ablation in female patients with paroxysmal atrial fibrillation?

Population

1,001 female patients with paroxysmal atrial fibrillation undergoing de novo pulmonary vein isolation, mean age 63±10 years, mean LVEF 60.8±6%, enrolled across 20 Italian centers.

Intervention

Pentaspline pulsed-field ablation (PFA) system (FARAWAVE) for pulmonary vein isolation.

Comparator

Conventional thermal ablation systems (radiofrequency ablation or cryoablation) for pulmonary vein isolation.

Outcome

Freedom from atrial arrhythmia recurrence at 1-year follow-up.composite

In female patients with paroxysmal AF, pulsed-field ablation demonstrated similar 1-year efficacy but significantly shorter procedural times and fewer complications compared to conventional thermal ablation.

Main Result

Effect estimate: OR 5.5 for complications (thermal vs PFA) (95% CI 95% CI 1.3–23.5 for complications OR)

Absolute Event Rate: 86.8% vs 83.9%

p-value: p=0.0227 for complications difference between PFA and thermal ablation

Limitations

Non-randomized design
Potential underdetection of asymptomatic AF recurrences due to monitoring method
Analysis limited to female patients only, no male comparison
Small number of safety events limits power to detect differences
No data on pulmonary vein reconnections after ablation
Findings may not generalize to women of other racial/ethnic groups

Abstract

Background Women are frequently underrepresented in studies investigating atrial fibrillation (AF) ablation. We evaluated the acute efficacy, safety, and mid‐term outcomes of de novo paroxysmal AF ablation in female patients using a pentaspline pulsed‐field ablation (PFA) versus thermal‐based technologies. Methods In a cohort of consecutive female patients with paroxysmal AF undergoing de novo pulmonary vein isolation, enrolled in the ATHENA‐CHARISMA (Advanced Technologies For Successful Ablation of AF in Clinical Practice ‐ Catheter Ablation of Arrhythmias With High‐DensityMapping System in the Real WorldPractice) registries, thermal ablation systems (radiofrequency or cryoablation) were compared to the PFA by means of a propensity score matching (ratio 1:1:1). Results One‐thousand one female patients (mean age 63±10 years, mean left ventricular ejection fraction 60.8±6%) were included: 376 (37.6%) underwent cryoablation ablation, 342 (34.2%) radiofrequency ablation, and 283 (28.3%) PFA. Propensity score matching yielded 684 patients (228 per group). The PFA group had significantly shorter skin‐to‐skin time (60 50–75 minutes) compared with both radiofrequency (120 90–145 minutes, P <0.001) and cryoablation (75 60–100 minutes, P <0.001), while fluoroscopy time was similar among groups (15 11–21 minutes for PFA, 14 10–20 minutes for cryoablation, P =0.599 versus PFA and 14 9–20 minutes for radiofrequency, P =0.454 versus PFA). Overall complication rate was 3.4% and it was significantly higher after thermal ablation than PFA (4.6% versus 0.9%, OR, 5.5, 95% CI, 1.3–23.5, P =0.0227). During a median follow‐up of 413 277–589 days, 139 (20.3%) patients experienced AF recurrence. The Kaplan–Meier estimated freedom from AF at 1‐year follow‐up was 86.8% with PFA, 84.6% with cryoablation, and 83.3% with radiofrequency (log‐rank P value: 0.839). Conclusions Among this cohort of female patients, de novo paroxysmal AF using a pentaspline PFA system demonstrated significantly shorter procedural times, and a lower complication rate compared with thermal ablation systems. One‐year follow‐up revealed comparable rates of AF freedom across all ablation modalities. Registration ATHENA (Advanced Technologies For Successful Ablation of AF in Clinical Practice). URL: http://clinicaltrials.gov/ ; Unique identifier: NCT05617456. CHARISMA (Catheter Ablation of Arrhythmias With High‐Density Mapping System in the Real World Practice). URL: http://clinicaltrials.gov/ ; Unique Identifier: NCT03793998.

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Cite This Study

Ribatti et al. (Thu,) conducted a observational in Female patients with paroxysmal atrial fibrillation undergoing de novo pulmonary vein isolation (n=1,001). Pentaspline pulsed-field ablation (PFA) vs. Conventional thermal ablation (radiofrequency and cryoablation) was evaluated on Freedom from atrial fibrillation (AF) recurrence at 1-year follow-up after 90-day blanking period (OR 5.5 for complications (thermal vs PFA), 95% CI 95% CI 1.3–23.5 for complications OR, p=0.0227 for complications difference between PFA and thermal ablation). Pulsed-field ablation reduced procedural time to median 60 minutes and complications to 0.9% versus 4.6% with thermal ablation, with comparable 1-year AF freedom rates (86.8% vs 83.9%) in women with paroxysmal AF.

synapsesocial.com/papers/699011a12ccff479cfe58730 https://doi.org/https://doi.org/10.1161/jaha.125.041873

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