Efficacy and safety of a novel hexaspline pulsed field ablation system in patients with paroxysmal atrial fibrillation: the PLEASE-AF study

Europace. 2024 Jul 2;26(7):euae174. doi: 10.1093/europace/euae174.

Abstract

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

Methods and results: Patients underwent pulmonary vein (PV) isolation (PVI) by delivering different pulse intensities at the PV ostium (1800 V) and atrium (2000 V). 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-lead electrocardiogram and 24-h Holter examinations. The primary efficacy endpoint was 12-month freedom from any atrial arrhythmias lasting at least 30 s. 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 min, 63.0 ± 30.7 min, 169.7 ± 34.6 s, and 27.3 ± 10.1 min, 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.

Conclusion: 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.

Clinical trial registration: ClinicalTrials.gov Identifier: NCT05114954.

Keywords: Atrial fibrillation; Catheter ablation; Electrophysiology; Electroporation; Pulmonary vein isolation; Pulsed field ablation.

Publication types

  • Multicenter Study
  • Clinical Trial

MeSH terms

  • Action Potentials
  • Aged
  • Atrial Fibrillation* / diagnosis
  • Atrial Fibrillation* / physiopathology
  • Atrial Fibrillation* / surgery
  • Cardiac Catheters
  • Catheter Ablation* / adverse effects
  • Catheter Ablation* / methods
  • China
  • East Asian People
  • Electrocardiography, Ambulatory
  • Equipment Design
  • Female
  • Heart Rate
  • Humans
  • Male
  • Middle Aged
  • Pulmonary Veins* / physiopathology
  • Pulmonary Veins* / surgery
  • Recurrence
  • Time Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT05114954

Grants and funding