Key result
Transcatheter PFO closure increases atrial fibrillation or flutter risk ~127% vs. medical therapy.
Why the study?
Does transcatheter 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 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 significantly increases the short-term risk of atrial fibrillation or flutter compared to medical therapy, though these events are typically transient and age-independent.
Introduction: 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 or flutter (AF/Af). 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). 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 I 2 =44%, R2 =4%). Discussion: AF/Af risk is elevated following PFO closure, particularly early post-procedure, likely due to procedural factors. However, the arrhythmias are often transient and not agedependent. Study heterogeneity and limited monitoring methods may affect the reported incidence. result: 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). 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: PFO closure increases short-term AF/Af risk compared to medical therapy, but the events are typically mild and age-independent. This should be weighed against the long-term benefit of stroke prevention. Moreover, standardized monitoring is needed to better define this risk
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Spyropoulou et al. (2026) conducted a meta-analysis in Cryptogenic stroke or high-risk PFO features. Transcatheter patent foramen ovale (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 significantly increased the 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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