Background: Migraine headaches both with and without aura vary in frequency, duration and intensity, affecting the quality of life of up to 10% of the total population. Migraines are treated with both prophylactic and acute medications. Patent foramen ovale (PFO) is one likely cause of migraine headaches and this is present in up to 25% of the total population. Percutaneous PFO closure is a likely option for definitive treatment for migraine. Once proven refractory to medical treatment, do patients with PFO and migraine respond to percutaneous PFO closure to reduce the frequency, duration and intensity of migraine headaches?
Methods: An exhaustive search of available medical literature was conducted using Medline/Ovid, CINAHL and Evidence-Based Medicine Reviews Multifile using the keywords: patent foramen ovale, migraine disorders, therapeutics and refractory. Inclusion criteria consisted of participants with a known patent foramen ovale and migraine headaches refractory to medical treatment, as well as studies performing percutaneous PFO closure measuring cessation or reduction in frequency, duration and intensity of migraine headaches. All articles were assessed for quality using GRADE.
Results: One randomized controlled trial, three prospective observational studies and one retrospective observational study fit the inclusion criteria. All observational studies demonstrated resolution of migraine with aura along with improved migraine symptomology in MIDAS score, frequency, duration and intensity of migraines. However the only randomized controlled trial (RCT) to date demonstrated no resolution of migraine headaches after six months. No other endpoints were measured such as frequency, duration or intensity. Many complications, both minor and serious, resulted in this RCT. After GRADE assessment, the RCT was determined to be high validity and all observational studies very low validity.
Conclusion: Four observational studies show some benefit to percutaneous PFO closure as treatment for refractory migraine headaches. However, one randomized controlled trial shows no benefit, unable to meet its endpoints. At this time, a recommendation cannot be made for percutaneous PFO closure in patients with refractory migraine headaches until further RCTs are performed and improvements are made in future studies.
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