Transcatheter patent foramen ovale closure achieves high efficacy in migraine patients: a single-center retrospective cohort study in China

Introduction Patent foramen ovale (PFO) is closely associated with migraine, and transcatheter PFO closure is a potential therapeutic intervention, yet large-scale real-world evidence in the Chinese population remains scarce. Methods This single-center retrospective cohort study evaluated the efficacy, safety, and predictive factors of transcatheter PFO closure for migraine in Chinese patients, and explored the impact of procedural expertise evolution on treatment outcomes. A total of 974 consecutive migraine patients (15–65 years) who underwent successful transcatheter PFO closure at the Second Hospital of Hebei Medical University from July 2020 to December 2024 were enrolled, all with moderate-to-large right-to-left shunt (RLS) and a baseline Headache Impact Test-6 (HIT-6) score ≥60. All patients received standardized dual antiplatelet therapy (DAPT) post-procedure, and a cross-sectional follow-up was conducted between May 2024 and December 2024 (median follow-up: 16.0 months). Treatment response was defined as a ≥ 50% reduction in baseline HIT-6 score or monthly migraine days. Results The overall migraine responder rate was 83.98%, with 59.90% achieving complete/near-complete relief (Grade I). Younger age was a strong predictor of better outcomes, with the highest responder rate in the 15–24 years group (89.67%) compared to the 45–54 years group (80.66%, p = 0.022). More recent procedure year was an independent predictor of higher success (OR = 0.89 per half-year delay, 95% CI: 0.81–0.97, p = 0.028), reflecting a significant learning curve effect. The procedure had a 100% technical success rate, with 3.49% minor complications and no major adverse events. Therapeutic benefit was sustained after DAPT discontinuation (responder rate 81.93% at >12 months). No significant differences were observed by sex, BMI, or occluder type. Discussion In conclusion, transcatheter PFO closure is highly effective and safe for Chinese migraine patients with concomitant PFO, with sustained effects after DAPT withdrawal. Younger age and more recent procedural performance are key predictors of favorable outcomes.