ATRIAL FIBRILLATION (AF) WITH A “SINGLE-SHOT” MAP-AND-ABLATE MULTIELECTRODE SPHERICAL ARRAY PULSED FIELD ABLATION CATHETER

Background: Pulsed field ablation (PFA) has been proven as a safe procedure with a multiple advantages over conventional thermal ablation modalities. Recently, a multielectrode spherical array catheter (Globe, Kardium Inc, Canada) capable of single-shot “mapping and ablation”, to deliver PFA.
Objective: To assess the acute safety and efficacy of AF ablation using this spherical array PFA catheter.
Methods: In a feasibility single-arm trial ICE-guided transseptal puncture was performed. Through  19 Fr deflectable sheath, the multielectrode spherical array PFA catheter  was advanced into the left atrium and deployed to its full spherical shape. Using the custom mapping system, the PFA catheter rendered anatomic maps. The PFA catheter was positioned at each PV ostium for PVI for paroxysmal AF patients plus box lesion for persistent AF ones .
Results: At a single center, a total 69 AF pts (38 with paroxysmal AF, 31 with persistent AF; age 62.3 ± 11.8 yrs; M / F = 41 /28; BMI 29.2± 3,8 LVEF 63 ± 7.6%; LA 40.8 ± 4,9 mm) all (69 pts) underwent PVI and for persistent AF 11 underwent posterior wall(PW) ablation and in 10 pts we performd mitral line. Using typically just one application per vein, PVI was acutely successful in 69 of 69 (100%) PVs , PW was isolated in 11 of 11 pts (100%) and mitral isthmus line was blocked in all 10 of 10 (100%) The total procedure time was 99±19 min. for paroxysmal AF and 111±23 min. for persistent AF. The total fluoroscopy time was 5,9 min.for paroxysmal AF and 6.5 min. for persistent AF. There were no safety events – including no esophageal fistula, stroke/TIA, phrenic injury or tamponade.
Conclusion: In this extended feasibility study, the “single-shot” map-and-ablate spherical array PFA catheter was able to safely and effectively isolate PVs with extension for posterior wall ablation and mitral isthmus line.