AB-452675-2 PULMONARY VEIN ISOLATION USING A NOVEL MAP-AND-ABLATE SPHERICAL ARRAY PULSED FIELD ABLATION CATHETER: THE PULSE-EU PAROXYSMAL AF COHORT

Abstract

Despite the promise of pulsed field ablation (PFA), there is much about the biophysics of this novel energy technology that remains to be understood. Preclinical studies have shown that close electrode-tissue proximity increases the likelihood of achieving transmural PFA lesions by maximizing the electric field penetration into the target tissue. The current single-shot PFA catheters are capable of performing pulmonary vein isolation (PVI), but cannot reliably confirm tissue contact. To report the clinical outcomes using a novel Map-and-Ablate spherical array multielectrode catheter that is able to verify tissue contact and deliver single-shot PFA. In the first-in-human PULSE-EU study, paroxysmal AF pts underwent PVI using the spherical array PFA catheter (Globe; Kardium Inc., Canada) using a 16Fr deflectable sheath under general anesthesia and ICE-guidance. Using a custom mapping system integrated with the PFA catheter (GPS; Kardium Inc.) the array catheter rendered contact and voltage anatomic maps. The spherical array was positioned at each PV ostia and PF applications (1.7 kV/lesion, ungated, micro-second scale pulses) were delivered after verifying tissue contact (Figure). Follow-up included post-procedure EGD and plans for protocol-mandated invasive remapping at 2-3 mo after the index procedure. A total of 24 pts (age 59.9±10.8 years; gender women-37.5%; LA 42.5±3.7 mm; LVEF 62.6±8.0%%) underwent PVI with a total procedure duration of 71.5±22.9 min. All PVs (96 of 96 PVs) were acutely isolated, typically with a single application. There were no acute reconnections. The total pulse delivery time and LA catheter dwell time were 42.2±7.6 sec and 36.8±13.7 min, respectively. There were no serious procedure or device related adverse events including no stroke/TIA, pericardial effusion, phrenic nerve injury, or esophageal complications. One patient had pericarditis which was treated medically. Post-procedure EGD revealed no thermal injury in 21 of 21 pts. PV remapping has thus far been performed in 6 pts, and revealed durable PVI in all 24 of 24 (100%) PVs. [Remapping data on the remaining cohort will be available by May 2023.] In this first-in-human PULSE-EU clinical study, the spherical array PFA catheter was able to render atrial anatomy, isolate PVs (with initial data indicating 100% durability), and perform pre-/post- electrical mapping.