Pulsed field ablation technique safe as first-time treatment for atrial fibrillation
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Key takeaways:
- Real-world data show pulsed field ablation was safe and associated with 1-year freedom from atrial fibrillation or flutter for 78% of patients.
- Longer-term data with more patients are needed.
In a real-world population, pulsed field ablation using a novel catheter was safe for most patients with atrial fibrillation in routine practice, with 78% free from AF at 1 year, registry data show.
Pulsed field ablation (PFA) is a novel AF ablation modality that has demonstrated preferential tissue ablation with no esophageal damage in early clinical trials, Vivek Y. Reddy, MD, director of cardiac arrhythmia services for The Mount Sinai Hospital and The Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai, told Healio. Using real-world data from the MANIFEST-PF Registry, Reddy and colleagues assessed the performance of a pentaspline PFA catheter (Farawave, Farapulse/Boston Scientific), including acute effectiveness and safety.
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“Initial first-in-human trials showed that pulsed field ablation was quite safe and a highly efficient procedure,” Reddy said in an interview. “It’s quite striking. The most optimized version has a high degree of durability. This translated to good clinical success — 1 year freedom from AF, atrial flutter and atrial tachycardia.”
In a retrospective study, researchers analyzed data from 1,568 patients who underwent PFA as a first-time AF ablation procedure across 24 centers (77 operators) between March 2021 and May 2022. The mean age of patients was 65 years; 35% were women and mean BMI was 28 kg/m2. Within the cohort, 65% of cases were paroxysmal AF; 32% were persistent AF and 3% were considered longstanding persistent cases; 12.8% of patients had atrial flutter and 14.4% had HF.
“These are the first 24 centers that started using the technology after CE Mark approval,” Reddy told Healio. “These operators were using this for the very first time, so the learning curve is captured with this experience, and that is very important.”
The primary effectiveness outcome was freedom from AF or atrial flutter after 3-month blanking period. Secondary outcomes included freedom from use of antiarrhythmic drugs or redo ablation procedures after the 3-month blanking period. Researchers also assessed acute and chronic major and minor adverse events.
The findings were presented at the European Heart Rhythm Association annual congress.
For the cohort, overall freedom from recurrence was 78% freedom from AF, atrial flutter and atrial tachycardia at 1 year. When stratified by AF type, efficacy was better for patients with paroxysmal AF (82%) vs. patients with persistent AF (71%), with the efficacy sensitive to pulmonary vein isolation durability, Reddy said.
“This behaved exactly as we suspected it would,” Reddy said. “Patients with persistent AF had a slightly lower success rate than those with paroxysmal AF.”
Freedom from arrhythmias, antiarrhythmic drugs and redo ablation procedures ranged 72% to 78%.
Major complications occurred in 1.6% of patients, the most common of which was pericardial tamponade (0.97%), according to the researchers. Minor complications occurred in 3.9% of patients, and most were vascular (3.3%).
“These data showed several things,” Reddy said “The technology was highly efficient. The median procedure time was only 1 hour. That is pretty extraordinary. Acutely, it was very effective; acute isolation of the veins was over 99%. It was also shown to be safe. There was no evidence of esophageal injury. There was one case of phrenic nerve injury among 1,500 patients.”
Reddy said researchers want to further analyze the registry data to compare outcomes by sex and further assess safety longer term. Two randomized trials, ADVENT, based in the U.S., and the ongoing BEAT-AF trial, based in Europe, will provide more information on the efficacy of PFA in the coming year, Reddy said.
Reference:
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Reddy VY, et al. Late-Breaking Science – Day 1. Presented at: EHRA: The Annual Congress of the European Heart Rhythm Association; April 16-18, 2023; Barcelona, Spain.
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