Patent Foramen Ovale and Migraine: Closing the Debate--A Review.

BACKGROUND: A link between patent foramen ovale (PFO) and migraine as well as the utility of closure of PFO and its effect on migraine have been subjects of debate. The present review is an effort to gather the available evidence on this topic and formulate recommendations.

METHODS: A systematic search of electronic databases (Medline, Embase, Cochrane Library) was performed. A separate search in associated reference lists of identified studies was done. Observational studies and clinical trials published in English using the International Headache Society criteria for diagnosis of migraine were included in the analysis. The search was performed in 3 categories: prevalence of migraine in patients with PFO, prevalence of PFO in migraine patients, and effect of PFO closure and its effect on migraine. The quality of evidence and strength of recommendations during review of these studies was analyzed.

RESULTS: About 14 observational studies with 2602 subjects who had PFO were identified. Migraine prevalence ranged from 16% to 64%. Another 20 studies reported 2444 patients with migraine; the prevalence of PFO ranged from 15% to 90%. About 20 observational studies (1194 patients) that examined the effect of PFO closure on migraine were identified. Resolution of migraine was reported in 10% to 83% of patients, improvement in 14% to 83%, no change in 1% to 54%, and worsening in 4% to 8%. The overall quality of these observational studies was poor. Finally, 3 randomized clinical trials included a total of 238 patients who underwent PFO closure compared with 234 patients in the control groups. All 3 trials failed to meet their primary end points defined as migraine resolution and greater than 50% reduction in migraine days at 1 year. In 2 of the clinical trials, there was some benefit noted in a small subset of migraine patients with aura, but the numbers were too small to extrapolate the findings to the general migraine population.

CONCLUSIONS: There is no good quality evidence to support a link between migraine and PFO. Closure of PFO for migraine prevention does not significantly reduce the intensity and severity of migraine. We do not recommend the routine use of this procedure in current practice.