Pulsed field ablation as first-line therapy for the treatment of atrial fibrillation: a FARADISE sub-analysis
I Garcia-Bolao, G Szeplaki, A Dello Russo, M Efremidis, N Szegedi, S Willems, H Haqqani, E Gandjbakhch, J Vijgen, M Fiala, P Balsam, A Bulava, M Gramlich, N Cielen, L BoersmaAbstract
Introduction
Pulsed field ablation (PFA) is an emerging treatment modality for patients with atrial fibrillation (AF). Patients are often treated with PFA after failing antiarrhythmic drug (AAD) therapy, but limited information is available regarding the safety and clinical outcomes of patients who receive PFA as a first-line therapy, prior to AAD treatment. FARADISE is a global registry that captures real-world clinical outcomes, and this one-year sub-analysis focuses on patients who received PFA as first-line therapy.
Purpose
To assess safety and long-term outcomes of AF patients who received PFA prior to AAD treatment (first-line therapy) compared to patients with a history of AAD treatment.
Methods
The prospective, non-randomized, global FARADISE registry (NCT05501873) enrolled patients clinically indicated for a PFA procedure and were treated per hospital standard-of-care. Safety and clinical effectiveness were assessed in de novo patients treated with the pentaspline PFA catheter as first-line therapy, compared to those with a history of AAD use. Clinical effectiveness was defined as freedom from arrhythmia recurrence, repeat procedure, or cardioversion.
Results
The FARADISE registry treated 1158 patients, including 462 de novo patients receiving PFA as first-line therapy and 581 de novo patients receiving PFA after previous AAD treatment. Paroxysmal AF indication was similar between the first-line therapy cohort and patients with prior AAD use (66.9% vs. 66.3%, p=0.84), while the first-line therapy cohort was modestly younger (63±11 years vs. 64±10 years, p=0.03). BMI, CHA2DS2-VASc, and coronary artery disease history were comparable between groups. In the first-line therapy cohort, 3D mapping was used more frequently (14.5% vs. 9.3%, p=0.01), while skin-to-skin procedure time (50 [39-67] minutes vs. 50 [40-67] minutes, p=0.28) was similar to those with prior AAD use. First-line patients experienced serious adverse events at a rate of 1.1%, compared to 1.9% in those with prior AAD use (p=0.32). Clinical effectiveness at 12 months was consistent in first-line therapy patients compared to patients with a history of AAD use (76% vs 79%, p=0.28, Figure 1).
Conclusions
Clinical effectiveness was similarly favorable between subjects receiving PFA as first-line therapy compared to those with a history of AAD treatment. The low rate of serious adverse events reinforces the strong safety profile of pentaspline PFA catheter ablation, supporting a role as an initial strategy for managing AF without AAD treatment.Garcia-Bolao et al Figure 1