B-PO05-088 SINGLE-SHOT LATTICE TIP CATHETER FOR PULMONARY VEIN ISOLATION WITH PULSED FIELD ABLATION

Abstract

Pulsed-field ablation (PFA) is a nonthermal energy with potential safety advantages for pulmonary vein isolation (PVI). To examine a novel PFA system that includes an expandable over-the-wire multielectrode lattice tip catheter and electroanatomical mapping system (EAM) for single-shot PVI. This system includes an 8F over-the-wire compressible lattice tip catheter that expands to a dimeter of up to 34mm for antral PVI (Sphere PVI™, Affera Inc., Figure) and an EAM system (Prism-1™). PFA is applied from six elements surrounding the equator using a biphasic waveform of microsecond scale (5 secs per application). In 8 swine, the superior vena cava (SVC) and right superior pulmonary vain (RSPV) were targeted for isolation (entrance and exit block). Animals were survived for 3 wks (n=4) and 24 hrs (n=4) for evaluation of temporal lesion durability and tissue effects. Pre and post contrast venography evaluated vessel diameter. In 8 animals, the catheter was positioned in an antral venous position and 2-3 applications (total PFA time 10-15sec) produced successful isolation. All targeted veins remained isolated in all animals. The Figure shows a representative example of 3-week post ablation voltage maps demonstrating chronic wide isolation of the SVC and RSPV. Contrast venography showed no changes in RSPV diameter (P=NS), and phrenic nerve function remained intact. Histopathological analysis demonstrated well demarcated lesions comprised of collagen. In this pre-clinical study, a single-shot lattice PFA catheter produced rapid, antral and durable PVI.