Pulmonary Vein Isolation Durability in a Randomized Trial comparing Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-in-basket Pulsed-field Ablation.

BACKGROUND: Data on long-term durability of pulmonary vein isolation (PVI) with newer pulsed field ablation (PFA) platforms and incremental value of electroanatomic mapping (EAM) guidance remain limited. This study evaluated chronic PVI durability following ablation with a balloon-in-basket PFA catheter and compared outcomes of fluoroscopy-only versus fluoroscopy plus EAM workflows. METHODS: In this prospective, single-center trial, consecutive patients with paroxysmal or persistent atrial fibrillation (AF) underwent de novo PVI with a balloon-in-basket PFA catheter. Patients were randomized 1:1 to fluoroscopy-only or fluoroscopy plus EAM workflow. Systematic invasive remapping was planned >30 days after the index procedure. The dual primary efficacy endpoint was the proportion of pulmonary veins (PVs) and of patients with all PVs durably isolated. The prespecified secondary endpoint was the comparison of procedural characteristics and PVI durability between workflows. Safety outcomes included major adverse events within 30 days of index or remapping procedures. RESULTS: Ninety-six patients (67.4 ± 9.2 years, 44.8% female, 57.3% with paroxysmal AF) underwent index ablation. Fluoroscopy time and number of applications were 3.4 [2.4-4.6] minutes and 15 [13-16], respectively. Systematic remapping was performed in 86 patients at a median of 41 days, with per-vein and per-patient durability of 341/350 (97.4%), and 79/86 (91.9%) respectively. PVI durability and chronic remapping parameters were comparable between guidance strategies. No major adverse events occurred. CONCLUSION: A standardized balloon-in-basket PFA workflow for PVI achieved high PVI durability. EAM guidance did not confer additional procedural or durability benefit over fluoroscopy-only guidance.