September 5, 2026EP Europace0 citationsOpen Access
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
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Key Result
Pulmonary vein isolation using a balloon-in-basket pulsed-field ablation catheter achieved 91.9% per-patient durability, with comparable results between fluoroscopy-only and EAM guidance.
Key Points
- To evaluate chronic pulmonary vein isolation durability using a balloon-in-basket pulsed-field ablation catheter and compare fluoroscopy-only versus electroanatomic mapping workflows.
- In a prospective, single-center randomized trial, 96 patients with paroxysmal or persistent atrial fibrillation underwent de novo pulmonary vein isolation (PVI).
- Participants were randomized 1:1 to either a fluoroscopy-only workflow or a fluoroscopy plus electroanatomic mapping (EAM) workflow.
- Invasive remapping was systematically conducted >30 days post-procedure (median 41 days) to assess vein isolation durability and safety events.
- Systematic remapping in 86 patients demonstrated overall per-vein durability of 97.4% (341/350) and per-patient complete durability of 91.9% (79/86).
- Median fluoroscopy time was 3.4 minutes [IQR 2.4–4.6] across 15 [IQR 13–16] applications, with durability and remapping parameters remaining comparable between fluoroscopy-only and EAM guidance.
- Zero major adverse events occurred within 30 days of the index or remapping procedures.
Study Design
Type
RCT (n=96)
Randomization
1:1
Multicenter
No
Structured PICO
Does fluoroscopy plus electroanatomic mapping improve pulmonary vein isolation durability compared to fluoroscopy alone in patients with atrial fibrillation undergoing pulsed-field ablation?
P
Population
96 patients with paroxysmal or persistent atrial fibrillation undergoing de novo PVI with a balloon-in-basket PFA catheter, followed for a median of 41 days.
I
Intervention
Fluoroscopy plus electroanatomic mapping (EAM) workflow for pulmonary vein isolation with a balloon-in-basket pulsed-field ablation catheter
C
Comparator
Fluoroscopy-only workflow for pulmonary vein isolation with a balloon-in-basket pulsed-field ablation catheter
O
Outcome
Dual primary efficacy endpoint: proportion of pulmonary veins (PVs) and of patients with all PVs durably isolated assessed by systematic invasive remapping >30 days after index proceduresurrogate
Balloon-in-basket pulsed-field ablation achieves high pulmonary vein isolation durability, and adding electroanatomic mapping to fluoroscopy does not improve procedural or durability outcomes compared to fluoroscopy alone.
Abstract
Abstract 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.
Cite This Study
Muñoz et al. (2026) conducted an RCT in paroxysmal or persistent atrial fibrillation (n=96). Fluoroscopy plus electroanatomic mapping (EAM) workflow vs. Fluoroscopy-only workflow was evaluated on proportion of pulmonary veins (PVs) and of patients with all PVs durably isolated. Pulmonary vein isolation using a balloon-in-basket pulsed-field ablation catheter achieved 91.9% per-patient durability, with comparable results between fluoroscopy-only and EAM guidance.