Pulsed field ablation (PFA) did not demonstrate superior efficacy to radiofrequency (RF) ablation in patients with drug-resistant, paroxysmal atrial fibrillation (AF) within the BEAT-PAROX-AF trial, from which late-breaking findings were presented at the European Society of Cardiology (ESC) congress (29 August–1 September, Madrid, Spain).
Explaining why the trial was carried out, principal Investigator Pierre Jaïs (L’Institut de Rythmologie et Modélisation Cardiaque, Bordeaux, France) said: “Pulmonary vein isolation [PVI] using thermal RF-based ablation is a widely accepted and established treatment for antiarrhythmic drug-resistant AF. However, PVI has evolved with the introduction of PFA, which is a faster, more straightforward nonthermal procedure that potentially offers more selective tissue targeting than thermal energy sources. Other trials have compared PFA with thermal energy sources with inconclusive results. We conducted the BEAT-PAROX-AF trial to directly compare PFA with advanced RF ablation in patients with antiarrhythmic drug-resistant symptomatic paroxysmal AF.”
BEAT-PAROX-AF was an open-label, randomised controlled superiority trial conducted at nine high-volume centres across France, Czechia, Germany, Austria and Belgium. Eligible patients were aged 18–80 years with symptomatic paroxysmal AF that was resistant to at least one antiarrhythmic drug, with a Class I or IIa indication for AF ablation as per ESC guidelines and effective oral anticoagulation for more than three weeks prior to the planned procedure. Patients were randomised 1:1 to PVI using either single-shot PFA or point-by-point RF ablation following the CLOSE protocol—a combination of ablation index (AI) and ≤6mm interlesion distance.
The primary endpoint was the single-procedure success rate after 12 months, defined as the absence of ≥30-second atrial arrhythmia recurrence, cardioversion, Class I/III antiarrhythmic drug resumption after a two-month blanking period, or any repeat ablation. For follow-up, participants were instructed to perform weekly self-recorded single-lead electrocardiograms (ECGs) and to capture recordings during symptomatic episodes using a mobile ECG system.
A total of 289 patients, who had a mean age of 63.5 years and 42% of whom were female, were analysed. The mean duration of drug-resistant AF was 39 months.
The primary endpoint—single-procedure success at 12 months—was high and similar between the procedure types, at 77.2% in the PFA group and 77.6% in the RF ablation group, with an adjusted difference of 0.9% (95% confidence interval [CI], –8.2 to 10.1; p=0.84). However, the mean total procedure duration was significantly shorter for PFA (56 vs 95 minutes), with an adjusted difference of −39 minutes (95% CI, −44 to −34).
Overall, the safety profile was excellent in both groups. Procedure-related serious adverse events Including unplanned or prolonged hospitalisations occurred in five patients (3.4%) in the PFA group and 11 patients (7.6%) in the RF ablation group. Complications appeared more frequently with RF ablation. One transient ischaemic attack was observed with PFA, while two tamponades percutaneously drained and two cases of pulmonary vein stenosis >70% were observed with RF ablation. Pulmonary vein stenosis >50% occurred in 12 patients and 15 patients, respectively, while no deaths, persistent phrenic palsy or stroke occurred.
“Both PFA and RF ablation using the CLOSE protocol showed excellent and similar efficacy,” Jaïs concluded. “Single-procedure success rates were comparable, although there appeared to be fewer complications and a shorter procedure time with PFA.”
