PFO and Migraine: Is There a Role for Closure?

Observational studies suggest that closure of a patent foramen ovale for other indications may reduce or even eliminate migraine attacks, particularly migraine with aura. The first randomized clinical trial of patent foramen ovale (PFO) closure for prevention of migraine, the MIST trial, showed negative results. The results of the other two completed studies in this area have recently been published in the last year. PRIMA and PREMIUM were also both negative for their primary endpoints. The PREMIUM trial did show a reduction in headache days in the migraine with aura subgroup but the final results of this subset analysis have not been published. There may be an as yet undetermined subgroup of patients with migraine who would benefit from closure, but slow recruitment has been a barrier to further study. Several potentially life-threatening procedure-related adverse events occurred in the clinical trials. At this time, we recommend against offering PFO closure as a preventive treatment for migraine. Based on available observational data, patients for whom PFO closure is indicated for other reasons may see some improvement in their migraines.