Work

The efficiency and safety of zero-exchange workflows in pulsed field ablation: Comprehensive insights from the DISRUPT-AF registry

Year: 2025

Type: article

Abstract: Background Pulsed field ablation (PFA) has revolutionized catheter ablation procedures in terms of safety, efficiency, and efficacy. Streamlined zero-exchange workflows with therapy sheath integrated transseptal puncture (TSP) devices may offer further improvements. However, the impact of device exchanges on real-world PFA procedures remains unknown. Objective Describe and quantify procedural characteristics associated with different PFA workflows. Methods The DISRUPT-AF registry (NCT06335082) is an observational, prospective, study assessing clinical experience with the pentaspline PFA system in the United States. Procedures are performed as per standard-of-care, where specific workflows and left atrial (LA) access devices were not mandated. Results A total of 873 cases (mean age, 68.0 ±11.4 years; 38.6% female) with 62 unique operators across 20 centers were assessed. Of these, 10.1%, 63.1%, and 26.8% reported "0"-, "1-2"-, and "3+"-exchanges, respectively. Regardless of AF subtype, zero-exchange workflows were associated with significantly shorter and more consistent TSP times (0:5.7±4.2min; 1-2:15.3±7.3min; 3+:19.2±9.3min; p<0.001), LA dwell times (0:26.9±10.2min; 1-2:36.8±13.2min; 3+:50.8±17.8min; p<0.001), and relative procedure times (0:100%; 1-2:152.7%; 3+:209.4%; p<0.001), when compared to 1-2 and 3+-exchange procedures. Despite this increased efficiency, there were no differences in TSP success rates, PFA lesion count, acute pulmonary vein isolation rates, and procedural complication rates between the three workflows. Conclusion The adoption of zero-exchange workflows enabled by therapy sheath integrated TSP devices results in significant improvements in procedural efficiency and predictability without compromising patient safety or acute outcomes.

Source: Heart Rhythm O2

DOI: 10.1016/j.hroo.2025.07.014