Related Experiment Video
Updated: Jul 14, 2026

Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
The patent foramen ovale-migraine question
S J Tepper1, F D Sheftell, M E Bigal
1The New England Center for Headache, 778 Long Ridge Road, Stamford, CT 06902, USA. sjtepper@aol.com
Abstract:
A strong association between migraine with aura and patent foramen ovale (PFO) with shunting has been suggested. Similarly, an association of migraine with aura and Osler-Weber-Rendu disease, probably also due to shunting though pulmonary arteriovenous malformations has been proposed. PFOs are also comorbid with cryptogenic strokes, refractory hypoxaemia in right ventricular infarction or severe lung disease, orthostatic oxygen desaturation and decompression illness in scuba divers.Multiple open-label, retrospective and case-controlled studies of PFO closure report improvement of migraine with aura. MIST, the only prospective sham-controlled study of PFO closure for migraine with aura, did not reach its primary endpoint for migraine resolution, although it clearly demonstrated an association between migraine with aura and the severity of the PFO shunt. One reported secondary endpoint showed a significant 42% reduction of migraine days, suggesting the need for further randomised, sham-controlled PFO closure studies.
Insights
Patent foramen ovale (PFO) closure may reduce migraine with aura days. While one study didn't meet its primary goal, it showed a significant reduction in migraine frequency, suggesting further research is needed.
Area of Science:
- Cardiology
- Neurology
- Vascular Medicine
Background:
- Patent foramen ovale (PFO) is associated with migraine with aura.
- PFOs are also linked to conditions like cryptogenic strokes and hypoxemia.
- Pulmonary arteriovenous malformations in Osler-Weber-Rendu disease may also contribute to migraine with aura.
Purpose of the Study:
- To evaluate the efficacy of PFO closure in patients with migraine with aura.
- To investigate the relationship between PFO shunt severity and migraine with aura.
Main Methods:
- Review of open-label, retrospective, and case-controlled studies on PFO closure for migraine with aura.
- Analysis of the MIST trial, a prospective, sham-controlled study on PFO closure for migraine with aura.
Main Results:
- Multiple observational studies suggest PFO closure improves migraine with aura.
- The MIST trial did not meet its primary endpoint for migraine resolution but showed a significant association between PFO shunt severity and migraine with aura.
- A secondary endpoint in the MIST trial indicated a 42% reduction in migraine days.
Conclusions:
- While definitive evidence is pending, PFO closure shows promise for reducing migraine with aura frequency.
- Further randomized, sham-controlled trials are warranted to confirm the benefits of PFO closure for migraine with aura.
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