Efficacy and Safety of a Novel Hexaspline Pulsed Field Ablation System in Patients with Paroxysmal Atrial Fibrillation: The PLEASE-AF Study.

BACKGROUND: Pulsed field ablation (PFA) is an emerging non-thermal ablative modality demonstrating considerable promise for catheter ablation of atrial fibrillation (AF). However, these PFA trials have almost universally included only caucasian populations, with little data on its effect on other races/ethnicities.

OBJECTIVE: The PLEASE-AF trial sought to study 12-month efficacy and the safety of a multielectrode hexaspline PFA catheter in treating a predominatly Asian/Chinese population of patients with drug-refractory paroxysmal AF.

METHODS: Patients underwent pulmonary vein (PV) isolation by delivering different pulse intensities at the PV ostium (1800V) and atrium (2000V). Acute success was defined as no PV potentials and entrance/exit conduction block of all PVs after a 20-min waiting period. Follow-up at 3, 6, and 12 months included 12-ECG and 24-hour Holter examinations. The primary efficacy endpoint was 12-month freedom from any atrial arrhythmias lasting at least 30 seconds.

RESULTS: The cohort included 143 patients from 12 hospitals treated by 28 operators: age 60.2±10.0 years, 65.7% male, Asian/Chinese 100%, and left atrial diameter 36.6±4.9 mm. All PVs (565/565, 100%) were successfully isolated. The total procedure, catheter dwell, total PFA application, and total fluoroscopy times were 123.5±38.8 minutes, 63.0±30.7 minutes, 169.7±34.6 seconds and 27.3±10.1 minutes, respectively. The primary endpoint was observed in 124 of 143 patients (86.7%). One patient (0.7%) developed a small pericardial effusion 1-month post-procedure, not requiring intervention.

CONCLUSIONS: The novel hexaspline PFA catheter demonstrated universal acute PVI with an excellent safety profile and promising 12-month freedom from recurrent atrial arrhythmias in an Asian/Chinese population with paroxysmal AF.

REGISTRATION: URL: https://www.clinicaltrials.gov; unique identifier: NCT05114954.