Pulsed field ablation (PFA) is as effective for the treatment of paroxysmal atrial fibrillation (AFib) as radiofrequency or cryoballoon ablation, according to new research presented at ESC Congress 2023, the annual meeting of the European Society of Cardiology. The analysis was simultaneously published in the New England Journal of Medicine.[1]
The ADVENT trial included nearly 700 patients with paroxysmal AFib treated at one of 30 U.S. facilities. A few study participants at each facility were treated with PFA to ensure operators gained experience with the technology. All other patients were randomized to either undergo PFA (305 patients) or conventional thermal ablation, which was delivered in the form of radiofrequency ablation (167 patients) or cryoballoon ablation (135 patients).
All PFA patients were treated with the Farapulse PFA system by Boston Scientific, which received CE mark approval in 2021 and is not yet fully approved by the U.S. Food and Drug Administration (FDA).
Overall, PFA was linked to a success rate of 73.3%, comparable to the 71.3% seen in the thermal ablation group. This met the trial’s predetermined criteria for noninferiority.
The study’s primary safety endpoint was the composite of acute and chronic device- and procedure-related adverse events after seven days in addition to pulmonary vein stenosis or esophageal fistula in the first 12 moths after implantation. This was seen in 2.1% of PFA patients and 1.5% of thermal ablation patients, which also met the trial’s predetermined criteria for noninferiority.
“The ADVENT trial showed that PFA is as effective and safe as conventional thermal ablation to treat paroxysmal AFib,” principal investigator Vivek Reddy, MD, an electrophysiologist with the Icahn School of Medicine at Mount Sinai, said in a prepared statement.
Reddy also detailed some of the other differences between the two treatment methods.
“Procedure times were faster for PFA than thermal ablation, but there was more X-ray exposure with PFA,” he added.
The ADVENT trial was fully funded by Boston Scientific, which aims to use these results to help the Farapulse system gain FDA approval.
Read the full New England Journal of Medicine study here.
Additional ESC Congress 2023 coverage is available here, here, here and here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.