Catheter Ablation -> Atrial Fibrillation & Atrial Flutter: -> Clinical Trials / Outcomes D-PO01 - Featured Poster Session (ID 11) Poster

D-PO01-126 - Safety Of A Combined Radiofrequency + Pulsed Field Ablation Approach To Pulmonary Vein Isolation In A First-in-human Clinical Trial (ID 928)

Abstract

Background: Thermal ablation of AF has both efficacy and safety limitations. For the former, large thermal footprint RF catheters allow facile creation of contiguous lesions. But safety concerns, like esophageal damage, remain with all thermal ablation systems. Conversely, pulse field ablation (PFA) may alleviate this concern by virtue of its preferential effect on myocardium. Recently a focal lattice-tip ablation system was designed to deliver either RF or PF energy.
Objective: To assess the safety of combined RF/PF-based PVI in a first in human trial (NCT04141007).
Methods: After ICE-guided transseptal, PVI was performed with the lattice catheter,the compatiblemapping system and RF & PF generators (Sphere-9,Prism-1, HexaGen and HexaPulse; Affera Inc). Toggling between energy sources, encircling PVI lesions were with RFA anteriorly (Tmax 73°C; 5 sec) and PFA posteriorly (3-5 sec). Post-procedure endoscopy (EGD) and brain MRI (DWI and FLAIR) were within 1 wk and 48 hrs, respectively.
Results: The 24-pt PAF cohort (age 53.5±10; 54% male) underwent successful PVI using 19.2±4.5 anterior RF and 26.4±10.2 posterior PF lesions - the latter often delivered directly atop the esophagus. There were no pericardial effusions, or phrenic paresis/palsy. In 2 of 24 pts with EGDs, there were minor mucosal thermal effects - both traceable to RF lesions, and absent on repeat EGD 1 wk later. Brain MRIs in 20 of 20 pts showed no lesions. There were 2 vascular injuries unrelated to the study catheter.
Conclusion: These data highlight the safety of combined RF/PF ablation for PVI. This RF/PF approach capitalizes on the strengths of both energies: the safety of PFA and the years of experience with RFA.
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