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.