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Closure of Patent Foramen Ovale for Migraine Relief: A Study Headache

The final results from the MIST trial are disappointing.

Migraine with aura is more prevalent in individuals with a patent foramen ovale (PFO) than in the general population. Reports of resolved or improved migraine in retrospective studies of percutaneous-device closure of PFO for stroke provided the rationale for this prospective, randomized trial. The study was funded by the device manufacturer, which also had a substantial role in its design and oversight.

Included were 147 patients with 5 migraine headache days per month who had failed treatment with at least two classes of preventive medication and who had a moderate to large right-to-left shunt due to a PFO. They were randomized to percutaneous closure with implantation of a STARFlex septal repair device or to a sham procedure under general anesthesia. Neither patients nor follow-up headache specialists were informed of treatment allocation.

During a 3-month analysis phase that followed a 90-day healing phase, three patients in each group achieved the primary endpoint of migraine cessation, and no between-group differences from baseline were seen in frequency of migraine attacks per month, total headache days, or attack severity. When two apparent outliers (patients with a particularly large number of headache days per month) were excluded from the per-protocol analysis, the median number of total headache days per month was significantly reduced by 0.9 days in the implant group. Five patients in the implant group (6.8%) experienced serious bleeding, arrhythmia, or effusion that was definitely or possibly related to the procedure or the device.

Comment: In this randomized, double-blind, sham-controlled trial, a high prevalence of right-to-left shunts was found in patients with severe migraine accompanied by aura. However, device closure of patent foramen ovale had no effect on subsequent headache incidence. In addition to the possibility that PFO is not causally related to migraine, other potential explanations for the lack of efficacy demonstrated in this trial include incomplete PFO closure with the device, the severity of migraine required for study inclusion, continued use of migraine medications during follow-up, and too short a follow-up period. Finally, as noted in an accompanying editorial, the publication of these findings has prompted concerns about the trial conduct, owing to repeated earlier presentations of more positive results at national meetings. For now, I do not believe that PFOs should be closed for the treatment of migraine, except in clinical trials.

— Howard C. Herrmann, MD

Published in Journal Watch Cardiology March 26, 2008

Citation(s):

Carroll JD. Migraine intervention with STARFlex Technology Trial: A controversial trial of migraine and patent foramen ovale closure. Circulation 2008 Mar 18; 117:1358.

• Original article (Subscription may be required)
• Medline abstract (Free)

Dowson A et al. Migraine intervention with STARFlex Technology (MIST) Trial: A prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation 2008 Mar 18; 117:1397.

• Original article (Subscription may be required)
• Medline abstract (Free)