Over the years there have been reports of people who have migraine headaches and also have a small hole across their heart called a patent foramen ovale (PFO), and that surgical closure of the PFO (for reasons other than treating migraine headache) resulted in fewer migraine headaches. Is this really true or just anecdotal?

A recent study specifically looking at whether closure of a PFO could alleviate migraine headaches has caused quite a debate among neurologists. The MIST (Migraine Intervention with STARFlex Technology) trial, which enrolled 147 subjects, resulted in complete resolution of migraine headaches in only six subjects, three of whom had real surgery and three of whom were control subjects and had "sham" (fake) surgery. Based on that endpoint, this study was an unequivocal failure.

Some neurologists say that the endpoint in this trial should not have been a complete resolution of migraine headaches, but rather a reduction of 50% or better in migraine headaches. This is usually the way that trials are set up when medication therapy is used to treat migraine headaches. When looking at the data from this vantage point, 42% of patients who had real PFO closure had a 50% or better reduction in migraine headaches, whereas only 23% of patients after the sham procedure had that result.

Migraine and PFO are both common disorders, with about 12% of the population having migraine headaches and about twice as many (25%) having PFO. If all migraine sufferers with a PFO became candidates for PFO closure, not surprising, the market for this device would rise significantly. And as an added benefit, it is known that there is an association between stroke and PFO. Therefore treating the patient with a PFO may reduce migraine headaches as well as reduce the risk of a stroke in those individuals.

It used to be that surgical closure of a PFO could only be done by open-heart surgery, but more recently, catheter-based devices like the STARFlex can be delivered endovascularly, in a fashion similar to a cardiac catheterization. And with this newer type of procedure, risks and complications may be lower; however about 7% of people in this trial had serious adverse events, some of which were life-threatening.

Therefore the MIST data cannot suggest treatment of migraine headaches by closing a coexisting PFO over medical management alone at this time. Most neurologists are not suggesting at this time that closure of a PFO solely for migraine prevention is justified. Further trials are needed and there are at least three trials currently recruiting patients who are willing to have their PFO closed to determine the safety and effectiveness of PFO closure in reducing the frequency of migraine headaches compared with medical therapy alone.

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