PO-623-08 FIRST-IN-HUMAN CLINICAL EXPERIENCE OF A NOVEL CONFORMABLE "SINGLE-SHOT" PULSED FIELD ABLATION CATHETER FOR PULMONARY VEIN ISOLATION

Abstract

Pulsed field ablation (PFA) has safety and procedural workflow advantages over conventional thermal ablation. Most “single-shot” PFA catheters are either not linked to mapping systems, require serial re-positioning or cannot easily accommodate varying PV anatomies. Recently, a novel 8-Fr single-shot large lattice PFA catheter that can conform to anatomies has been developed. In a first-in-human single-arm trial (NCT05144503, NCT05115214) of PAF ablation, we assessed the acute safety and efficacy of PVI using this single-shot PFA catheter. The 8Fr PFA catheter (SpherePVI; Affera Inc) has a large compressible/conformable lattice framework (expandable up to 34 mm diameter), and consists of 6 sections that are independently and sequentially energized for ablation. Under general anesthesia and after ICE-guided transseptal puncture, an 8.5 Fr deflectable sheath (Agilis, Abbott Inc) was used in concert with the PFA catheter and custom mapping system (Prism-1, Affera Inc) to quickly render the PV anatomy. Then the catheter was serially positioned at the ostium of each PV, and a PFA generator (HexaPULSE; Affera Inc) delivered biphasic pulse trains (5 sec per application; 1.3-2.0 kV [±]); goal of 1-3 lesions per PV. Post-procedure endoscopy (EGD) and brain MRI occurred within 24-72 hours. At 3 centers (5 operators), a total of 30 pts (age 57.6 ± 9.3 yrs; M / F = 15 / 15) underwent PVI. Mapping time to render the LA-PV anatomy was 5.7±3.2 min (range 1.3 - 13.1). PVI was acutely successful in all 30 pts: 122 of 122 (100%) PVs were acutely isolated using 2.4±0.4 applications/vein (10.0±1.6 applications/pt). The PVI duration time (transpired from 1st to last lesion) was 8.2±5.5 min (range 3.3 - 29.8). The total LA catheter dwell time for the PFA catheter was 12.9±7.6 min (range 5.0 - 36.0). Fluoroscopy time was 4.8±4.1 min. There were no serious adverse events - including no esophageal fistula, stroke/TIA, phrenic injury or tamponade. EGD in 18 pts revealed no thermal lesions, and brain MRI revealed acute lesions in 2 of 21 (9.5%) pts. PVI using the conformable “single-shot” PFA catheter was acutely successful and safe. Further studies should assess lesion durability and large multicenter clinical outcomes.View Large Image Figure ViewerDownload Hi-res image Download (PPT)