One thousand cases of Pulsed-Field Ablation: Real-World insights
S Azevedo, R Almeida Carvalho, J Certo Pereira, I Coutinho Santos, R Montalvao, M Ines Soares, M Matias, D Gomes, D Matos, G Rodrigues, F Moscoso Costa, P Galvao Santos, P Carmo, D Cavaco, P Pulido AdragaoAbstract
Introduction
Pulmonary vein isolation (PVI) is the standard catheter-based treatment for atrial fibrillation (AF). Due to its safety profile and efficacy, pulsed field ablation (PFA), a non-thermal energy, has been increasingly adopted as the default strategy across many centers. We aimed to analyse the real-world efficacy and safety of PFA for the treatment of atrial arrhythmias in a tertiary high-volume center.
Methods
All patients undergoing PFA for atrial tachyarrhythmias (i.e., AF and atrial flutter [AFL]) between July 2022 and November 2025 were included in the registry. Baseline characteristics included age, sex, left atrial volume (LAVi), left ventricular ejection fraction and history of prior catheter ablation. Procedural metrics included procedure duration, fluoroscopy time, and use of general anesthesia/sedation. The outcome of interest was arrhythmia recurrence, defined as AFL/ AF documented on ECG, Holter or clinical records after a 3-months period. Safety endpoint encompassed periprocedural complications, including cardiac tamponade, stroke, vascular access complications, and death.
Results
A total of 1000 patients were included (mean age 64±11years, 62,5% male, LAVI 62±24, 51% paroxysmal AF, 15% atypical atrial flutter, 21% redo procedures). The PFA systems used were Farapulse (73%), Varipulse (18%), Volt (7%) and Affera (2%). Regarding ablation sets, most patients underwent PVI alone (58%) or combined with other lesions posterior wall isolation (32,6%), posterior mitral isthmus line (10,5%), anterior line (2,6%) and cavotricuspid isthmus isolation (5,3%). Mean procedure time was 75±26min, and fluoroscopy duration was 8.5±6min. A total of 748 procedures (75%) were performed under general anesthesia (GA), whereas the others were under sedation with remifentanil, dexmedetomidine and midazolam. Periprocedural complications were documented in 0.8% (2 tamponade, 2 vascular access). During a median follow-up of 10 months (IQR 6-14), a total of 13% suffered arrhythmia recurrence. Results were not different whether performed under GA or sedation. Efficacy was not significantly different when compared to our center and other high-volume center registries of AF ablation using thermal energies (RF or cryo).
Conclusion
In this comprehensive evaluation of 1000 PFA cases, the procedure showed a good efficacy and safety profile. PFA has become the standard catheter-based treatment of AF.1000 PFA