Durability of pulmonary vein isolation and feasibility and safety of additional intrapulmonary vein sleeve ablation by means of a circular pulsed-field ablation catheter. The PVI-PVA study.

BackgroundPulmonary vein isolation (PVI) constitutes the established strategy for atrial fibrillation (AF) ablation. With the advent of PV stenosis risk-free pulsed field ablation (PFA), we explored the feasibility and safety of additional ablation within PV sleeves (PVA). Moreover, we assessed the durability of PVI through PFA in a deep sedation setting, comparing a 3D Electroanatomical Mapping (3D-EAM)-based navigation approach with the standard fluoroscopy-based one. MethodsIn this single-center, first-in-human study (NCT07035288), 40 AF patients underwent first time PFA-based PVI+PVA (4 additional applications inside the PVs) between November 2024 and April 2025 using a circular array PFA catheter (PulseSelect, Medtronic, Minneapolis, MN), randomized to either 3D-EAM-based (Carto3 prime, J&J, Irvine, CA) or fluoroscopy-based navigation, in a propofol-based deep sedation setting. Rate of conversion from 3D-EAM to fluoroscopy-based navigation was recorded. First-pass isolation was assessed immediately post-ablation. Venography and 3D-EAM were performed at remapping at 2 to 3 months after the index procedure. ResultsNo major procedure-related adverse events were noted, as well as no acute kidney injury, significant hemolysis or phrenic nerve palsy. First-pass isolation was successfully achieved in 95% of patients (3D-EAM: 95%, fluoroscopy: 95%, p=NS) and in 98.7% of PVs. Venography performed at remapping revealed no PV stenosis. PVI durability per patient was 92.5% (3D-EAM: 90%, fluoroscopy: 95%, p=NS) and per vein was 97.5% (3D-EAM: 97.5%, fluoroscopy: 97.5%, p=NS between navigation methods). Half of 3D-EAM cases were converted to fluoroscopy due to map shift. ConclusionsPFA-based PVA is safe. Catheter performance, as depicted by 97.5% durable PVI, was such that adding a 3D-EAM system was not associated with improved efficacy and exhibited high conversion rate to fluoroscopy-based navigation in a deep sedation setting. Categories: electrophysiology Special Sections: Original article Randomized clinical trial: NCT07035288