Key result
Transcatheter PFO closure increases AFib risk ~127% versus medical therapy.
Why the study?
Atrial fibrillation or flutter is a common complication after transcatheter PFO closure, but its incidence compared to medical therapy, timing of occurrence, and relation to age required evaluation.
Does transcatheter patent foramen ovale (PFO) closure increase the incidence of atrial fibrillation or flutter compared to medical therapy in patients with cryptogenic stroke or high-risk PFO features?
Meta-Analysis
Does transcatheter patent foramen ovale (PFO) closure increase the incidence of atrial fibrillation or flutter compared to medical therapy in patients with cryptogenic stroke or high-risk PFO features?
Relative Risk: 2.27 (95% CI 1.29–4.01)
p-value: p=0.009
Transcatheter PFO closure is associated with a more than two-fold increased risk of atrial fibrillation or flutter compared to medical therapy, which does not appear to be influenced by patient age.
Warrants early post-procedural AF monitoring after PFO closure; confirms this excess risk versus medical therapy in meta-analysis.
Background Transcatheter patent foramen ovale (PFO) closure is the treatment of choice in younger patients with cryptogenic stroke or high-risk PFO features. A common complication post-procedurally is atrial fibrillation of flutter (AF/Af). Objective In this study, we evaluate the incidence of AF/Af following PFO closure compared to medical therapy, the time to occurrence, and the role of age in AF/Af occurrence. Methods A systematic literature search was conducted in MEDLINE (Pubmed) and Scopus databases for studies assessing the incidence of AF/Af post-PFO closure in contrast to medical therapy, the incidence within the 1st month post-procedurally or later, and the role of age in AF/Af occurrence. Results Twenty-nine studies (10 randomized, 18 observational, 1 case-control) were included in this systematic review, of which 10 (7 randomized, 3 observational) were meta-analyzed. Subjects undergoing PFO closure were at higher risk of developing AF/Af (RR: 2.27, 95% CI: 1.29, 4.01, p=0.009) (Figure). There was a trend for higher AF/Af rates within the 1st month post-intervention. There was no statistical difference after the 1st month of follow-up (3 studies, RR: 0.60, 95% CI: 0.02-19.88, p=0.60). Mean age of participants did not affect the primary endpoint (β: -0.03, CI: -1.13, 0.06, p=0.45, residual I2=44%, R2=4%). Conclusion Transcatheter PFO occlusion is associated with an increased risk of AF/Af. Data are insufficient to determine whether this risk is primarily due to the higher occurrence of AF/Af within the first month post-procedure or an overall increase in AF incidence during follow-up. The risk does not appear to be significantly influenced by age.
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Spyropoulou et al. (2025) conducted a meta-analysis in Cryptogenic stroke or high-risk PFO features. Transcatheter PFO closure vs. Medical therapy was evaluated on Incidence of atrial fibrillation or flutter (AF/Af) (RR 2.27, 95% CI 1.29, 4.01, p=0.009). Transcatheter PFO closure was associated with a significantly higher risk of developing atrial fibrillation or flutter compared to medical therapy (RR 2.27; 95% CI 1.29-4.01; p=0.009).
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