Pulsed Field Ablation Shows Promise in Treating Persistent Atrial Fibrillation

Pulsed field ablation (PFA) technology provides a promising treatment option for patients with persistent atrial fibrillation (PerAF), a study sponsored by Boston Scientific found. The ADVANTAGE AF trial, the first large multicenter study of its kind, established that using a Pentaspline PFA catheter to treat PerAF patients with pulmonary vein isolation (PVI) plus posterior wall ablation (PWA) achieved safety and effectiveness goals, according to results published recently in JACC Journals.

Study Design and Results

The ADVANTAGE AF trial enrolled 355 patients across 43 medical centers, with 249 patients completing the treatment protocol. All patients received PVI plus PWA using the FARAWAVE pentaspline PFA catheter system, developed by Boston Scientific.

The primary safety endpoint showed a remarkably low adverse event rate of 2.3%, well below the prespecified performance goal of 12%. Notably, the trial reported no pericardial tamponade, stroke, pulmonary vein stenosis, or esophageal fistula—complications that can occur with traditional thermal-based ablation procedures.

The primary effectiveness outcome was 63.5% in one year, significantly exceeding the predefined performance goal of 40%. When focusing on freedom from symptomatic recurrence, the success rate reached an impressive 85.3%.

Quality of life (QoL) metrics showed substantial improvements following treatment. The score on the QoL questionnaire improved from 62.4 at baseline to 91.1 at 12 months, while the EQ-5D-5L score increased from 76.1 to 85.2, representing statistically significant enhancements in patient wellbeing.

The Technology Behind the Results

PFA represents a paradigm shift in cardiac ablation technology. Unlike traditional ablation methods that use radiofrequency or cryoablation to create scar tissue that blocks abnormal electrical signals, PFA uses non-thermal electric fields to create microscopic pores in cell membranes.

This mechanism appears particularly effective for cardiac tissue while sparing surrounding structures like the esophagus, which can be damaged during thermal ablation procedures.

Learning Curve and Operator Experience

One of the most striking findings from the study was the impact of operator experience on outcomes. Analysis showed a marked difference in success rates between early and later cases, with approximately a 20-percentage point improvement after operators completed their first three procedures.

Most operators (67%) had no prior experience using the pentaspline PFA catheter before participating in the trial, highlighting the technology’s relative ease of adoption despite the observed learning curve.

Atrial Arrhythmia Burden

The study also assessed post-ablation residual atrial arrhythmia (AA) burden, a measure of the percentage of time patients spend in arrhythmia. Results showed that 80.1% of patients achieved a residual AA burden of less than 10%—a threshold with better QoL scores and lower healthcare utilization in this PerAF population.

Future Implications

The ADVANTAGE AF trial results suggest that PFA technology may address some of the limitations of conventional thermal ablation approaches for PerAF. Its favorable safety profile, particularly regarding esophageal injury, may allow for more extensive PWA without increasing procedural risk.

However, researchers caution that longer-term follow-up is needed to fully understand the long-term outcomes. A second phase of the ADVANTAGE AF trial is underway, incorporating implantable cardiac monitors for more comprehensive rhythm monitoring.

Limitations and Perspective

The researchers acknowledge several limitations of their study, including its single-arm, non-randomized design. Without a direct comparison group, it remains difficult to determine whether PFA is superior to conventional thermal ablation techniques for PerAF. Additionally, the study size is too small to clarify the risk for rare adverse events.

Despite these limitations, experts view the ADVANTAGE AF results as an important step forward in atrial fibrillation treatment. The combination of high efficacy, excellent safety profile, and significant QoL improvements positions PFA as a promising option for the millions of people worldwide suffering from PerAF.

“PFA is advancing rapidly, and studies like ADVANTAGE AF will help pave the way,” said Dr. Harlan Krumholz on the April 29, 2025, episode of the JACC Deep Dive podcast. “But continuing rigorous study, especially with longer follow-up, randomized comparisons, and extended monitoring, will be essential to fully understand the role in managing persistent AF.”

Source:

Reddy VY, et al. J Am Coll Cardiol. 2025 May 6;85(17):1664-1678. doi: 10.1016/j.jacc.2025.03.515. PMID: 40306839.