Emerging evidence suggests a potential link between patent foramen ovale (PFO) and refractory headache, especially migraine with aura. PFO closure has been advocated as a viable treatment, but clinical data on its use in refractory headache remains limited. This study aimed to evaluate the efficacy of PFO closure in patients with refractory headache.

In this single-center observational study, patients with concomitant PFO and refractory headache, defined as ≥ 2 headache attacks per month and failed ≥ 2 categories of standardized medication, underwent transcatheter PFO closure. Headache frequency, duration, severity (measured by Headache Impact Test [HIT-6] score and visual analog scale [VAS]), and medication use were assessed before and after the procedure at 3, 6, and 12 months. Responders were defined as patients with ≥ 50% reduction in headache frequency.

A total of 85 patients (mean age 47 years, 45.88% female) were included. Prior to closure, 36.47% had migraine with aura. At 12-month follow-up, 74.11% of patients achieved responder status, with a significant reduction in mean monthly headache days (from 2.4 ±0.8 vs 1.1±0.3, P < 0.01), HIT-6 score (61.2±7.2 vs 42.5±8.4, P<0.01)) and VAS scores (from 7.1±1.8 to 3.5±1.0, P<0.01). No major procedural complications occurred, though minor adverse events (e.g., transient arrhythmias) were noted in7.01%.

 PFO closure may be an effective treatment for select patients with refractory headache, particularly those with migraine with aura. Larger randomized trials are needed to confirm these findings and identify optimal patient selection criteria.