Patients treated with pulsed-field ablation (PFA) for atrial fibrillation (AF) had a stroke or TIA rate nearly five times higher than those receiving radiofrequency ablation (RFA), according to a new single-center observational study — though the overall risk remains low.
Stroke / TIA rate — PFA
0.47%
10 events among 2,144 patients
Stroke / TIA rate — RFA
0.10%
2 events among 2,077 patients
Researchers at Beth Israel Deaconess Medical Center in Boston analyzed more than 4,200 consecutive AF ablation procedures performed between 2022 and 2026. They presented their findings at the European Heart Rhythm Association (EHRA) Congress 2026 in Paris — where late-breaking science on ablation techniques for atrial fibrillation management was a major theme.
Pulsed-field ablation has rapidly grown in popularity over the past several years, largely because it uses irreversible electroporation — a non-thermal mechanism — and offers shorter procedure times with a reduced risk of serious complications like esophageal injury, phrenic nerve paralysis, and pulmonary vein stenosis. But the new data suggest a more nuanced picture may be emerging. For background on how pulmonary vein isolation (PVI) works as the cornerstone of AF ablation, the Cleveland Clinic provides a useful overview.
"As we continued to do more of the procedures, we started to understand that perhaps the safety profile was a little bit more nuanced," said lead researcher Dr. Enrico Ferro. His team noted observing a "shower of microbubbles" under intracardiac echocardiography (ICE) during PFA procedures — a finding that raised concern even when it didn't immediately translate into a neurological event.
Researchers were unable to pinpoint a single cause for the difference. Patient demographics, operator experience, and procedural workflow differences were all examined, but none fully explained the higher stroke signal. Possible mechanisms include microbubble formation, thrombus formation, and endothelial disruption during more extensive ablation of the posterior left atrial wall.
The study arrives amid a broader pattern of scrutiny. The NEMESIS-PFA registry previously reported higher rates of troponin leak, hemolysis, and renal dysfunction with PFA compared to RFA. And in early 2025, Johnson & Johnson temporarily paused U.S. rollout of its Varipulse PFA system after four neurovascular events were reported during an external evaluation — a rate of stroke and TIA around 3%, well above the expected 1% benchmark for this type of surgery.
Experts emphasize that perspective is important. The absolute event rates remain well below 0.5% in both groups — consistent with prior ablation studies. Still, commentators agree the signal warrants dedicated follow-up. "Every brain cell matters," said Dr. Wilber Su of Banner University Medical Center Phoenix, noting that silent cerebral emboli are an ongoing concern across PFA trials. A 2026 EHRA/HRS scientific statement on PFA likewise acknowledged the technology's distinct safety profile and the need for ongoing vigilance.
Next steps include a large US claims database study and a nationwide FDA-supported postmarket surveillance study focused on stroke risk associated with PFA. As Dr. Su put it: "The more experience we have with PFA, the more we can learn how to be safer with it."
References
- Ferro EG. Comparative safety of PFA vs RFA for stroke events: insights from a high-volume US medical center. Presented at: EHRA 2026. April 12, 2026. Paris, France. Reported by TCTMD.
- Lakkireddy D, et al. NEMESIS-PFA: investigating collateral tissue injury associated with pulsed field ablation. JACC Clin Electrophysiol. 2025.
- Ha FJ, et al. Advent of pulsed field ablation for atrial fibrillation: state-of-the-art review. Rev Cardiovasc Med. 2025;26.
- Kühne M, et al. Pulsed field ablation for the interventional treatment of atrial fibrillation: a scientific statement of EHRA, HRS, APHRS, LAHRS, and CHRS. EP Europace. 2026.
- Sun M, et al. Pulsed field ablation for atrial fibrillation: clinical applications and research advances. Front Cardiovasc Med. 2025.
- Johnson & Johnson MedTech. J&J pauses Varipulse PFA cases in US. MedTech Dive. January 8, 2025.
- Cleveland Clinic. Pulmonary vein isolation (PVI) ablation. Cleveland Clinic Health Library.