Geographic variation in sedation workflows: quantifying the impact of regional sedation regulations in pulsed field ablation procedures with a novel balloon-in-basket PFA system

Background

There has been great interest in utilizing conscious and deep sedation in PFA procedures to minimize additional personnel support and associated costs. Previous publications have shown that a novel balloon-in-basket PFA system is safe and effective, regardless of anesthesia choice. However, there is a need to quantify workflows in a real-world cohort.

Purpose

The objective of this analysis was to compare sedation workflows in real-world cases using a balloon-in-basket PFA catheter.

Methods

Acute, observational data was collected from 1304 cases performed using the Volt PFA System at 77 European centers from March 2025 to Feb 2026. Ablation and procedural workflows, including sedation, were per operator’s discretion. Outcomes were compared between countries where an electrophysiologist can administer propofol (EP, n=412) and those where propofol must be administered by anesthesia personnel (AP, n=892).

Results

The most common indication for ablation was de novo paroxysmal AF (PAF) (69.9% of EP cases, 78.4% of AP cases), followed by de novo persistent AF (PsAF) (23.5% EP, 17.8% AP), redo PAF (3.6% EP, 2.2% AP), redo PsAF (2.9% EP, 1.5% AP), and atrial flutter (0% EP, 0.1% AP). First-pass isolation was achieved in 90.2% of EP cases and in 98.1% of AP cases (p<0.0001), with acute success rates of 99.5% in EP cases and 99.6% AP cases (p=1.000). A safety event was reported in 1 EP case (0.24%, 1 instance of phrenic weakening) and in 4 AP cases (0.45%, 1 instance each of pericardial effusion and cardiac tamponade; 2 cases of ST elevation).

In EP cases, the most common sedation workflow was deep sedation with propofol, used in 72.6% (299/412) of cases. In contrast, the most common sedation workflow in AP cases was general anesthesia, used in 59.6% of cases (532/892) (Table 1). The change in workflow selection over time is shown in Figure 1; notably, in EP countries, there was a trend towards greater selection of a deep sedation with propofol workflow over time. The inverse of this trend was observed in AP countries, with a trend towards greater use of conscious sedation without propofol over time.

Cases were shorter in AP compared to EP cases, with total procedure times of 59.3±23.1 and 63.1±23.1 min (p=0.0088), respectively. More PFA applications were delivered in AP than EP cases (17.5±8.3 vs 15.9±5.5 (p<0.0001), respectively), with significantly more non-PV ablation performed (23.8% (212/892) vs 10.9% (45/412) (p<0.0001), respectively).

Conclusion

This analysis shows that the Volt PFA system is safe and effective regardless of anesthesia workflow choice in a real-world cohort. Sedation workflow trends over time following initial commercial release of the system showed a trend towards selection of a workflow that required less additional personnel support where possible. Further understanding of this trend with physician preference surveys and quantification of site-specific guidelines is warranted.