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).
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?
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.
Relative Risk: 2.27 (95% CI 1.29–4.01)
p-value: p=0.009
Abstract 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.Figure
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).