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August 27, 2026Circulation
Risk of Stroke and TIA With Pulsed Field Compared With Radiofrequency Ablation for Atrial Fibrillation
Key result
PFA linked to ~0.4% higher absolute 30-day stroke or TIA risk vs RFA.
- weighted risk difference 0.36%
- 95% CI 0.03%-0.70%
- P=0.03
- n=4,221
Why the study?
Pulsed field ablation for AF has been rapidly adopted based partly on safety expectations, but comparative safety data versus thermal ablation remain limited.
Does pulsed field ablation increase the risk of stroke or TIA compared with radiofrequency ablation in patients undergoing atrial fibrillation ablation?
Population
4221 consecutive AF ablations at a high-volume US academic center
Comparison
PFA vs RFA
Design
Prospective registry with blinded neurology adjudication and propensity score weighting
Follow-up
30 days
Authors
Discussion
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Member takes
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The 30-day rate of stroke/TIA was significantly higher for PFA cases (10 events; 0.47%) compared with RFA (2 events; 0.10%) in both unweighted and propensity score–weighted analyses (weighted risk difference, 0.36% [95% CI, 0.03%–0.70%]; P=0.03).”
“In a high-volume, single-center registry with high clinical granularity and systematic patient follow-up, PFA was associated with a significantly higher risk of stroke/TIA at 30 days compared with RFA. These results call for enhanced postmarket surveillance and dedicated prospective evaluation as the PFA procedural volume continues to exponentially increase.”
Implication
May warrant caution with pulsed field ablation for AF; leaves open confirmation in randomized trials.
Key Points
- To compare the 30-day incidence of stroke and transient ischemic attack between pulsed field ablation and radiofrequency ablation for atrial fibrillation.
- Analyzed a prospective registry of consecutive patients undergoing atrial fibrillation ablation (N=4,221; 2,144 PFA and 2,077 RFA) across 12 operators at a US academic medical center between 2022 and 2026.
- Evaluated the primary endpoint of 30-day stroke or TIA adjudicated by blinded neurologists, applying propensity score inverse probability of treatment weighting to balance baseline characteristics.
- The 30-day stroke/TIA rate was significantly higher with PFA (10 events; 0.47%) than RFA (2 events; 0.10%), with a propensity score–weighted risk difference of 0.36% (95% CI, 0.03%–0.70%; P=0.03).
- PFA procedures were shorter (108 vs. 144 minutes) and more frequently incorporated posterior wall isolation (57% vs. 31%), while other weighted procedural complications remained low (<1%) and similar between groups.
Study Design
Type
Cohort (n=4,221)
Blinding
Single-blind (outcome adjudication)
Multicenter
No
Structured PICO
Does pulsed field ablation increase the risk of stroke or TIA compared with radiofrequency ablation in patients undergoing atrial fibrillation ablation?
P
Population
4,221 patients (mean age 67, 31% female) undergoing atrial fibrillation ablation at a single US center, evaluated for 30-day outcomes.
E
Exposure
Pulsed field ablation (PFA) (68.7% Farawave, 23.3% Sphere 9, 6.9% Varipulse, 0.7% PulseSelect)
C
Comparator
Radiofrequency ablation (RFA)
O
Outcome
Stroke or transient ischemic attack (TIA) within 30 days, independently adjudicated by blinded neurologistssafety
Main Result
Effect estimate: weighted risk difference 0.36% (95% CI 0.03%-0.70%)
Absolute Event Rate: 0.47% vs 0.1%
p-value: p=0.03
In a large, single-center prospective registry, pulsed field ablation for atrial fibrillation was associated with a significantly higher 30-day risk of stroke or TIA compared with radiofrequency ablation.
Limitations
- Low event rates limited exploratory mediation models
- Single-center registry
- Low event rates limiting exploratory mediation models
Cite This Study
Ferro et al. (2026) conducted a cohort in Atrial fibrillation (n=4,221). Pulsed field ablation (PFA) vs. Radiofrequency ablation (RFA) was evaluated on Stroke or transient ischemic attack (TIA) within 30 days (weighted risk difference 0.36%, 95% CI 0.03%-0.70%, p=0.03). Pulsed field ablation for atrial fibrillation was associated with a higher 30-day risk of stroke or TIA compared with radiofrequency ablation (0.47% vs 0.10%; risk difference 0.36%, P=0.03).