First-in-human experience of high-energy ElectroPulse pulsed field ablation: Acute results for pulmonary veins and posterior wall isolation

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 recognized risk of hemolysis.

OBJECTIVE: The purpose of this study was 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, nonrandomized, prospective study of a novel PFA system that utilizes an 8F, 10-electrode variable loop steerable mapping and ablation catheter with 2800-V biphasic bipolar waveform. All patients had pulmonary vein isolation (PVI) and posterior wall isolation (PWI) using the PFA system. The main outcomes were the acute success of PV/PWI and periprocedural serious adverse events.

RESULTS: Complete PVI/PWI was successfully achieved in all 30 patients using 59.7 ± 7.2 applications. Total procedural time was 113.6 ± 26.3 minutes, fluoroscopy time 8.0 ± 5.5 minutes, and left atrial dwell time 78.7 ± 18.6 minutes. There was no esophageal injury, phrenic nerve palsy, clinical stroke, or death. Brain magnetic resonance imaging 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 patients 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.