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Updated: Aug 9, 2026
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Patent foramen ovale and migraine--bringing closure to the subject
Todd J Schwedt1, David W Dodick
1Department of Neurology, Mayo Clinic College of Medicine, 13400 E. Shea Blvd, Scottsdale, AZ 85259, USA.
Abstract:
There is increasing interest in the relationship between migraine and patent foramen ovale (PFO). PFO is more common in migraineurs with aura, and migraine with aura is more prevalent in patients with PFO. Retrospective analyses of PFO closure for stroke prevention and decompression illness in divers have suggested that migraineurs with and without aura may derive significant benefit from PFO closure, but to date no prospective, randomized, sham-controlled study to confirm this has been completed. Herein we review published data regarding the relationship between migraine and PFO and discuss the rationale, justification, and important factors to consider in the conduct of prospective, controlled, clinical trials designed to evaluate the efficacy and safety of percutaneous device closure of PFO for migraine prevention.
Insights
Patent foramen ovale (PFO) is linked to migraine, especially with aura. While studies suggest PFO closure may benefit migraineurs, further research is needed to confirm efficacy and safety.
Area of Science:
- Neurology
- Cardiology
- Vascular Medicine
Background:
- A patent foramen ovale (PFO) is more frequently observed in individuals experiencing migraines with aura.
- Migraine with aura is also more prevalent in patients diagnosed with PFO.
Purpose of the Study:
- To review existing data on the association between migraine and PFO.
- To discuss the rationale and considerations for prospective, controlled trials evaluating PFO closure for migraine prevention.
Main Methods:
- Review of published literature on migraine and PFO.
- Discussion of factors pertinent to designing clinical trials for PFO closure in migraine.
Main Results:
- Retrospective studies suggest potential benefits of PFO closure for migraineurs, both with and without aura.
- No prospective, randomized, sham-controlled studies have been completed to validate these findings.
Conclusions:
- Further investigation through well-designed clinical trials is necessary to establish the efficacy and safety of percutaneous PFO device closure for migraine prevention.
