Patent foramen ovale: when does it need closure?

A patent foramen ovale (PFO) is present in approximately 25% of the general population. Its clinical significance is primarily in patients with cryptogenic stroke. Randomized trials have evaluated whether transcatheter PFO closure reduces recurrent stroke compared to medical therapy. Evidence outside stroke, including migraine, decompression illness, and platypneaorthodeoxia syndrome, is limited. We reviewed major randomized controlled trials and extended follow-up studies evaluating transcatheter PFO closure in patients with cryptogenic stroke. Key trials included RESPECT, REDUCE, CLOSE, DEFENSEPFO, and RESPECTLate. Study populations, procedural outcomes, and post-procedural management were summarized. Non-stroke indications were evaluated using available randomized and observational data. In the RESPECT trial (n=980; mean age 46±11 years; 38% female; median follow-up 5.9 years), recurrent ischemic stroke occurred in 3.6% of patients undergoing PFO closure vs 5.8% with medical therapy (HR 0.55; 95% CI, 0.31–0.999; p=0.046). The REDUCE trial (n=664; mean age 45±10 years; 42% female) demonstrated a 77% relative risk reduction in recurrent stroke with closure vs antiplatelet therapy alone (1.4% vs 5.4%; p=0.002). The CLOSE trial (n=663; mean age 45±11 years; 40% female) reported no recurrent strokes in the closure group vs 14 events (6%) in the anti-platelet group over 5.3 years (p<0.001). DEFENSEPFO (n=120; mean age 52±12 years; 45% female) showed stroke in 0% vs 12.9% with medical therapy at 2 years (p=0.013). RESPECTLate demonstrated sustained benefit over 10 years (HR 0.54; 95% CI, 0.29–0.999; p=0.046). Pooled analysis across trials indicated a 59% lower risk of recurrent stroke with closure (HR 0.41; 95% CI, 0.200.83). The benefit was most pronounced in patients with large shunts or atrial septal aneurysms. Post-procedural atrial fibrillation occurred in 35% of patients; serious procedural complications were <2%. Dual antiplatelet therapy was administered for 3–6 months, and successful shunt elimination exceeded 90%. Evidence for PFO closure in migraine with aura or decompression illness remains limited; closure in platypneaorthodeoxia syndrome shows symptomatic improvement based on small case series. Transcatheter PFO closure significantly reduces recurrent stroke in adults aged 1860 years with cryptogenic stroke and highrisk anatomical features. The procedure is generally safe, with low rates of serious complications. Nonstroke indications remain investigational, and patient selection with multidisciplinary evaluation is essential to maximize benefit and minimize risk.