Patent Foramen Ovale Closure Confers No Significant Reduction in Migraine Headaches

Congenital Heart Disease Surgery Related Deaths
Congenital Heart Disease Surgery Related Deaths
Investigators believed percutaneous closure of a patent foramen ovale with a large right-to-left shunt would reduce the frequency of headaches.

Percutaneous closure of patent foramen ovale (PFO) is not associated with a reduction in migraine headaches in patients with and without aura, according to results of a randomized trial published in the Journal of the American College of Cardiology.

A total of 230 migraineurs with PFO from the double-blind PREMIUM (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management) trial were randomly assigned to undergo PFO closure with the AmplatzerTM PFO Occluder device (St.  Jude Medical; n=123) or sham control (n=107). 

Patients experienced 6 to 14 migraines per month and were nonresponsive to at least 3 preventive medications. The primary end point of the study was a 50% reduction in migraine headache attacks. Reduction in migraine days and efficacy in migraineurs with vs without aura comprised the secondary end point.

At 1 year, the investigators observed no difference between the PFO closure (38.5%) or control (32%) groups with regard to the primary outcome of therapy response (P =.32). Despite this finding, patients undergoing PFO closure experienced a greater reduction in number of headache days (–3.4 vs –2.0 d/mo, P =.025). Approximately 8.5% of patients in the PFO closure group went into complete remission from migraine at 1 year vs 1% of patients in the sham control arm (P =.01).

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This study may have been underpowered due to sample size assumptions having a responder rate twice as high as the control group.

In the 8.5% of participants in this study who experienced complete remission of migraine at 1 year, the investigators suggest that “an atrial shunt may play a causative role for a subset of patients with migraine.”


Tobis JM, Charles A, Silberstein SD, et al. Percutaneous closure of patent foramen ovale in patients with migraine: the PREMIUM trial. J Am Coll Cardiol. 2017;70(22):2766-2774.