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

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.

We aimed to describe and quantify procedural characteristics associated with different PFA workflows.

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.

A total of 873 cases (mean age, 68.0 ± 11.4 years; 38.6% women) 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 atrial fibrillation subtype, zero-exchange workflows were associated with significantly shorter and more consistent TSP times (0:5.7 ± 4.2 min; 1-2:15.3 ± 7.3 min; 3+:19.2 ± 9.3 min; P <0.001), left atrium dwell times (0:26.9 ± 10.2 min; 1-2:36.8 ± 13.2 min; 3+:50.8 ± 17.8 min; P < .001), and relative procedure times (0: 100%; 1-2: 152.7%; 3+: 209.4%; P < .001), when compared with 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 3 workflows.

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.