Meta-analysis of randomized trials on percutaneous patent foramen ovale closure for prevention of migraine

Background: The role of percutaneous patent foramen ovale (PFO) closure for prevention of migraine is controversial. Methods: We performed a computerised search of MEDLINE, EMBASE and COCHRANE databases through December 2017 for randomised trials evaluating PFO closure versus control in patients with migraine headaches (with or without aura). The main study outcome was the reduction in monthly migraine attacks after PFO closure compared with the control group. Results: The final analysis included three randomised trials with a total of 484 patients. Reduction in monthly migraine attacks was higher in PFO closure compared with the control group (standardised mean difference-SMD = 0.25; 95% CI: 0.06-0.43; p =.01). There was higher reduction of monthly migraine days in PFO closure group compared with control group (SMD = 0.30; 95% CI: 0.08-0.53; p =.01). There was no statistically significant difference in complete resolution of migraine attacks (OR: 3.67; 95% CI: 0.66-20.41; p =.14) and in responders' rate (OR: 1.92; 95% CI: 0.76-4.85; p =.17) between PFO closure and control groups. In patients whose majority of migraine attacks are with aura, there was an observed reduction in migraine attacks in PFO closure compared with control groups (SMD = 0.86; 95% CI: 0.07-1.65; p =.03). Conclusion: PFO closure might be beneficial in migraine patients by reducing migraine attacks and migraine days, especially in patients whose majority of migraine attacks are with aura. However, those benefits were not associated with an improvement in responders' rate or complete resolution of migraine; raising concerns on the magnitude of clinical benefit of PFO closure in migraine prevention.