Key result
EAM guidance shows no benefit over fluoroscopy alone for durable PVI in pulsed-field ablation.
Why the study?
Data on long-term durability of PVI with newer PFA platforms and the incremental value of electroanatomic mapping guidance remain limited.
Does fluoroscopy plus electroanatomic mapping guidance improve pulmonary vein isolation durability compared to fluoroscopy alone in patients with atrial fibrillation undergoing balloon-in-basket pulsed-field ablation?
RCT (n=96)
Patients and endpoint adjudication blinded; operators not blinded
1:1 using a centralized, web-based system with a computer-generated permuted block sequence stratified by AF type
No
Does fluoroscopy plus electroanatomic mapping guidance improve pulmonary vein isolation durability compared to fluoroscopy alone in patients with atrial fibrillation undergoing balloon-in-basket pulsed-field ablation?
Absolute Event Rate: 88.4% vs 95.3%
p-value: p=0.43
A standardized balloon-in-basket PFA workflow achieves high chronic PVI durability, and adding electroanatomic mapping guidance does not significantly improve procedural or durability outcomes compared to fluoroscopy alone.
Fluoroscopy-only workflow suffices for high-durability PVI with balloon-in-basket PFA; confirms no added benefit from electroanatomic mapping in this RCT.
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.
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Muñoz et al. (2026) conducted an RCT in Paroxysmal or persistent atrial fibrillation (n=96). Fluoroscopy plus electroanatomic mapping (EAM) guidance for balloon-in-basket PFA vs. Fluoroscopy-only guidance for balloon-in-basket PFA was evaluated on Proportion of patients with all pulmonary veins durably isolated >30 days after index procedure (p=0.43). Electroanatomic mapping guidance did not significantly improve the proportion of patients with all pulmonary veins durably isolated compared to fluoroscopy alone (88.4% vs 95.3%, p=0.43) following balloon-in-basket pulsed-field ablation.
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