PO-01-187 FEASIBILITY OF FLUOROLESS PULMONARY VEIN ISOLATION USING A SINGLE-SHOT CONFORMABLE PULSED FIELD ABLATION CATHETER

Abstract

Fluoroless pulmonary vein isolation (PVI) using point-by-point ablation catheters guided by electroanatomical mapping (EAM) systems is standard practice in many operators’ practice. While “single-shot” PVI tools have a streamlined procedural workflow, and with a safety profile enhanced by the emergence of pulsed field ablation (PFA) technology, these catheters have not been able to support a completely fluoroless workflow. A novel 8-Fr single-shot large lattice catheter with integrated magnetically-tracked EAM and PFA capabilities has been developed. To report for the first time the feasibility of performing single-shot PVI using a completely fluoroless approach. This 8 Fr PFA catheter (SpherePVI; Affera-Medtronic Inc) has a conformable large lattice framework that is expandable to 34 mm in diameter to permit “customization” to varying pulmonary vein anatomies (see Figure). It was delivered using an 8.5 Fr deflectable sheath (Agilis, Abbott Inc), and used with a custom EAM system (Prism-1; Affera-Medtronic Inc.) to render PV and left atrial anatomy. The PFA generator (HexaPULSE; Affera-Medtronic Inc) delivered biphasic waveforms (5 sec per application; 1.3-2.0 kV[±]); goal of 1-3 lesions per PV) from six elements situated circumferentially around the equatorial plane of the lattice. These cases conducted at a single center as part of a first-in-human study (NCT05115214): under general anesthesia, ICE was used to guide transeptal puncture and catheter positioning; fluoroscopy was initially used, followed by completely fluoroless ablation (using only ICE and EAM). The fluoroless cohort (n = 4 AF pts) was well matched with the control cohort (n = 5 AF pts) with similar baseline characteristics except for having more male patients (see Table). PVI was 100% successful in both groups. For PVI, both the number of PFA lesions delivered (16.3±0.5 vs 16.6±0.9 in the fluoroless and control groups, respectively) and the PVI ablation times (time only during lesion application; 1.6±0.0 min vs 1.6±0.1 min), and transpired time (defined as time transpiring between first to last lesion application; 8.3±1.1 min vs 9.6±2.2 min) were comparable. The total fluoroscopy time in the control group was 5.5±2.7 min. There were no serious adverse events in either group. This case series provides the proof-of-principle that fluoroless single-short PVI is feasible, safe and effective using a conformable large lattice PFA catheter.