FIRST-IN-HUMAN EXPERIENCE OF HIGH ENERGY ELECTROPULSE PULSED FIELD ABLATION: ACUTE RESULTS FOR PULMONARY VEINS AND POSTERIOR WALL ISOLATION.

Abstract

Background: Different iterations of catheter and energy delivery system configurations are evolving for pulsed field ablation (PFA); however, some have used large and complex catheters, required large sheaths and had a recognised risk of haemolysis.

Objective: To evaluate the acute safety and efficacy of a custom designed 8F variable loop multielectrode mapping and PFA catheter with contact sensing.

Methods: This acute feasibility study recruited 30 patients undergoing de novo ablation of paroxysmal or persistent atrial fibrillation (AF). The ElectroPulse Study is a first-in-human, non-randomised, prospective study of a novel PFA system that utilizes an 8F 10-electrode variable loop steerable mapping and ablation catheter with 2800V biphasic bipolar waveform. All patients had pulmonary vein (PV) and posterior wall isolation (PWI) using the PFA system. The main outcomes were the acute success of PV/PWI and peri-procedural serious adverse events.

Results: Complete PV/PWI was successfully achieved in all 30 patients with 59.7±7.2 applications. Total procedural time was 113.6±26.3 mins with fluoroscopy time of 8.0±5.5 mins and LA dwell time of 78.7±18.6 mins. There was no esophageal injury, phrenic nerve palsy, clinical stroke or death. Brain MRI detected 2 new but transient silent cerebral lesions. Two patients (6.7%) had vascular access complications. Although there were changes in the biomarkers for hemolysis, none of the patient experienced clinical hemolysis or related acute kidney injury.

Conclusion: This first-in-human study demonstrated that PFA using a novel variable loop catheter with a contact sensing system safely achieved 100% acute PVI/PWI with safety profile comparable to existing PFA systems.