Meta-analysis Concludes PFO Closure Could Improve Migraine With Aura

Researchers found closure of patent foramen ovale could result in reduced monthly migraine days.

Treatment with patent foramen ovale (PFO) closure could reduce the frequency of headaches and monthly migraine days among migraineurs, and serves as a potentially efficient treatment of migraine with aura, according to results of a meta-analysis published in the Journal of Interventional Cardiology.

A PFO is a hole in the wall of tissue between the left and right upper chambers of the heart that can only occur after birth when the foramen ovale does not close, according to the American Heart Association. “This hole allows blood to bypass the fetal lungs, which cannot work until they are exposed to air.” The foramen oval closes when a newborn takes its first breath and heals completely within a few months in about three-quarters of humans.

Although approximately 20% to 25% of the adult population have PFO, it is present in between 30% to 50% of migraineurs with aura. However, the pathogenesis of migraine in patients with PFO remains unclear, study authors wrote, and previous studies have yielded mixed results on the effects of PFO closure on migraine.

To better elucidate the impact of PFO closure, the researchers conducted a systematic review and meta-analysis. After searching PubMed, EMBASE, and Cochrane Library, 12 eligible articles were included in the review. Of these, 3 randomized trials and 8 retrospective case series, including 1165 individuals, were included in quantitative synthesis. One pooled study was also included in the meta-analysis.

The researchers saw the following:

  • Compared with control intervention in migraine, PFO closure could significantly reduce headache frequency (odds ratio [OR] , 1.5698; 95% CI, 1.0465-2.3548; P = .0293) and monthly migraine attacks and monthly migraine days (OR, 0.2594; 95% CI, 0.0790-0.4398; P = .0048)
  • A subgroup analysis of patients who completed PFO surgery showed resolution of migraine headache for migraineurs with aura (OR , 1.5856; 95% CI, 1.0665-2.3575; P = .0227)
  • Complete resolution of migraine headache (OR , 3.4327; 95% CI, 0.6625-17.7870; P = .1417) was not significant

“In patients with migraines without aura, PFO closure did not significantly reduce migraine days or improve complete headache cessation,” the authors noted.

A total of 28 serious adverse events were reported in the PFO closure group included in 4 studies (n = 484). All were resolved without sequalae, while during follow-up of patients with a device, no device-related adverse effects were observed.

A sensitivity analysis showed results of the meta-analysis were stable, with no publication bias found in included studies.

Several theories have been proposed to explain the relationship between PFO and migraine, including abnormal thromboembolism, vasoactive substances, and impaired dynamic cerebral blood flow regulation.

Most studies included in the current meta-analysis were retrospective in nature, marking a limitation; only 4 were randomized controlled trials. Postsurgical therapy and protocol for assessing outcomes also differed between studies.

“PFO closure was safe and significantly reduced the mean number of monthly migraine days and monthly migraine attacks, and the treatment was efficient for migraine attacks with aura,” the authors concluded. “The results of this meta-analysis warrant a reevaluation of PFO closure in treating episodic migraine, especially for migraine with frequent aura.”


Zhang Y, Wang H, Liu L. Patent foramen ovale closure for treating migraine: a meta-analysis. J Interv Cardiol. Published online February 2, 2022. doi:10.1155/2022/6456272

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