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

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.