Geographic analysis of workflow variability in PFA procedures

Background/Intro Cardiac ablation procedure workflows to treat atrial fibrillation (AF) vary by operator and geography and may be influenced by country-specific reimbursement policies. However, systematic quantification of these differences—especially for newly approved and commercialized technologies—remains limited. Purpose The objective of this analysis was to compare real-world procedural characteristics of a novel PFA technology by geographical location to identify differences in workflows. Methods Acute, observational data was collected from 1409 cases at 221 institutions from Mar 2025 to Feb 2026 following initial commercial release of the Volt PFA system. Results, including acute effectiveness and procedural efficiency, were compared between cases performed in the US (n=105) and Europe (n=1304). Results The most common indication for ablation was de novo paroxysmal AF (62.9% in US, 75.7% in Europe), followed by de novo persistent AF (26.7% in US, 19.6% in Europe). Acute outcomes were similar, with first-pass isolation achieved in 94.5% of US cases and 95.4% of Europe cases and acute success in 100% and 99.5% of cases, respectively (p=1.0000, p=0.6071, respectively). Of cases performed in the US, 86.7% were under general anesthesia compared to 45.0% in Europe (p<0.0001), followed by deep sedation with propofol, used in 12.4% of US cases and 35.9% of Europe cases (p<0.0001). Intracardiac echocardiography (ICE) was used in 100% of cases in the US, to visualize transseptal puncture (100% of cases) and confirm catheter-tissue contact (87.4% of cases). In contrast, ICE was used in only 15.5% of cases in Europe (p<0.0001), to visualize transseptal puncture (15.2% of cases) and to confirm contact (6.5% of cases). Fluoroscopy was used in 73.3% of US cases and 97.2% of Europe cases (p<0.0001). In both geographies, EnSite X was used in a majority of cases (97.1% in the US; 95.9% in Europe), although the primary catheter used for electroanatomical mapping and model creation varied significantly (HD Grid X in 73.5% of US cases; Volt in 94.6% of Europe cases, p<0.0001). Efficiency metrics are summarized in Table 1. Conclusion This analysis of real-world, observational data using a novel balloon-in-basket PFA system demonstrates the high acute efficacy of the system regardless of geography or workflow. There were significant differences in workflows by geography, including anesthesia type, ICE use, and mapping catheter selection. These differences are likely partially attributed to differences in reimbursement policies between regions as adjunct imaging modalities are not reimbursed in Europe. Overall, these findings provide insight that this novel technology accommodates a variety of workflows while maintaining consistently high success rates.