Feasibility of a fluoroscopy-only visualization method using a balloon-in-basket PFA catheter in a real-world cohort

Background

Cardiac ablation is a well-understood procedure to improve arrhythmia-free survival and decrease atrial fibrillation (AF)-related comorbidities. However, the resource demands of a "standard" ablation in first-world countries, with advanced catheters, 3D-electroanatomic mapping (3D-EAM) systems, and anesthesia support, are often beyond the reach of healthcare providers in the developing world. A fluoroscopy-only visualization approach, without the use of 3D-EAM, can alleviate some of these demands. However, the feasibility of this approach in pulsed-field ablation (PFA) procedures has not been well quantified.

Purpose

The objective of this analysis was to assess the feasibility of a fluoroscopy-only visualization approach using a balloon-in-basket PFA catheter in a real-world cohort.

Methods

Acute, observational data was obtained from 581 cases by 169 operators at 95 European centers, from March to October 2025. The Volt PFA Catheter was used in all procedures; whereas the mapping workflow and ablation approach were at operator discretion. A fluoroscopy-only visualization approach (FO) without a 3D-EAM system was used in 15 cases; the remainder (n=566) used the EnSite 3D mapping system (EAM). Due to the difference in sample size, qualitative trends were assessed, and statistical significance was not evaluated.

Results

The most common indication for ablation was de novo paroxysmal AF (PAF) (n=11/15 FO, n=429/566 EAM), followed by de novo persistent AF (PsAF) (n=4/15 FO, n=113/566 EAM). The remaining EAM procedures were redo PAF (15/566), redo PsAF (8/566), and atrial flutter (1/566). First-pass isolation, defined as isolation on first check after ablation of each set of PVs, was achieved in 80% of FO and 93% of EAM cases; acute success was achieved in 100% of FO and 99.5% of EAM cases. A safety event occurred in 0% of FO cases and 0.7% of EAM cases. The procedure time for FO and EAM subjects was 55.4±15.4 and 61.6±23.2 minutes, respectively. Fluoroscopy was used for 12.7±7.4 min in 100% of FO cases and 11.1±6.6 min in 95.9% of EAM cases. ICE was used in 17.5% of EAM cases. PVI time for FO and EAM subjects was similar (20.0±13.8 vs 22.9±10.2 min, respectively).

Deep sedation with propofol was used in 80% of FO subjects (12/15) and 40.8% (231/566) of EAM subjects; general anesthesia was used in 13.3% (2/15) and 45.9% (260/566) of subjects, respectively, with the remainder of cases using conscious sedation (1/15 FO, 75/566 EAM). The total number of PFA applications for FO and EAM subjects was 15.6±6.2 and 17.4±7.5, respectively, with 7.0±3.6 and 7.6±5.1 applications outside of the PVs, respectively. Non-PV ablation targets are summarized in Table 1.

Conclusion

Fluoroscopy-only-guided pulsed-field ablation demonstrated similar safety, efficacy, and efficiency as 3D-EAM-guided cases in a real-world cohort, supporting the feasibility of this visualization approach in catheter ablation for AF with the Volt PFA system.