Journal of the American Heart Association · 2026
De Novo Pulmonary Vein Isolation by Means of Pulsed Field Versus Conventional Thermal Ablation of Paroxysmal Atrial Fibrillation in Women: Safety, Efficiency, and Efficacy.
Сравнительное исследованиеСтатьяНаблюдательное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Ribatti Valentina, Dello Russo Antonio, Riva Stefania, Malacrida Maurizio, Bianchi Stefano, Solimene Francesco, Iacopino Saverio, De Simone Antonio, Rossillo Antonio, Pelargonio Gemma, Zucchelli Giulio, Maggio Ruggero, Russo Maurizio, Pecora Domenico, Bertini Matteo, Bandino Stefano, Volpicelli Mario, Compagnucci Paolo, De Sanctis Valerio, Anselmino Matteo, Rordorf Roberto, Zingarini Gianluca, Rovaris Giovanni, Agus Elena, Themistoclakis Sakis, Mitacchione Gianfranco, Mea Roberta, Valeri Yari, Tondo Claudio, Casella Michela
Аннотация
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.
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.