Registry Links Pulsed Field Ablation to Higher Stroke/TIA Risk Than Radiofrequency Ablation

A prospective registry reported in Circulation compared pulsed field ablation (PFA) with radiofrequency ablation (RFA) for atrial fibrillation at a high-volume US academic center between 2022 and 2026. The analysis included 4,221 consecutive procedures performed by 12 operators: 2,144 PFA and 2,077 RFA. The primary endpoint was stroke or transient ischemic attack (TIA) within 30 days, independently adjudicated by blinded neurologists. Investigators used inverse probability of treatment weighting to balance patient characteristics.

Stroke/TIA occurred after 10 PFA procedures (0.47%) and two RFA procedures (0.10%). The weighted risk difference was 0.36 percentage points (95% CI, 0.03–0.70; P=0.03). PFA procedures were shorter (108 versus 144 minutes) and more frequently included posterior wall isolation (57% versus 31%). Events did not cluster around PFA adoption or individual operators. Weighted rates of other procedural complications were below 1% and similar between groups.

The findings identify a potential cerebrovascular safety signal warranting enhanced postmarket surveillance and prospective evaluation. However, this single-center observational comparison cannot establish causation, and the low event count limits precision and exploratory analyses of procedural explanations. Mediation models did not identify more extensive ablation as an independent stroke risk factor, but were constrained by few events. Only the abstract was available for this update.