Closure of the patent foramen ovale (PFO) resulted reduction of monthly migraine days and attacks or complete cessation. These findings, from a pooled analysis of 2 randomized trials, were published in the Journal of the American College of Cardiology.

Study researchers pooled data from the Percutaneous Closure of Patent Foramen Ovale in Migraine with Aura (PRIMA) trial and the Prospective Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects with Migraine and PFO Using the Amplatzer PFO Occluder Compared to Medical Management (PREMIUM) trial for this analysis. The primary endpoint for the PRIMA study was reduction of monthly migraine days at 10 to 12-months following randomization compared with a 3 month baseline. For the PREMIUM study, the primary endpoint was at least a 50% reduction of monthly migraine from 2-months baseline to the 10 to 12 month follow-up.

A total of 176 patients underwent PFO closure and 161 were controls. Patients in the intervention and control arms had a mean age of 43.1 and 43.2 years, 88.1% and 87.0% were women, 10.2% and 11.3% had a history of head trauma, and 75.6% and 77.0% had migraine with aura, respectively.

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The average reduction of monthly migraine days was 1.2 days greater among the intervention group than the control cohort (-3.1±4.5 days vs -1.9±4.2 days, respectively; P =.02). Similarly, mean migraine attacks were more greatly reduced among the intervention group (-2.0±2.0 vs -1.4±1.9 attacks, respectively; P =.01). A total of 14 (9%) who received PFO closure reported complete migraine cessation compared with only 1 (0.7%) of the control participants (P <.001).

Migraine attack reduction of at least 50% was not significantly greater among the PFO group (38%) compared with controls (29%; P =.13).

Stratified by aura, patients with aura in the intervention arm reported fewer migraine days compared with controls (-3.2±4.8 vs -1.8±4.4 days, respectively; P =.03). This difference was not significant in patients without aura compared with controls (-2.8±3.4 vs -2.2±4.0, respectively; P =.53). Complete cessation was reported by 11% of intervention recipients among patients with aura compared to 0.9% of controls (P =.002). Among intervention recipients without aura, and 5% reported cessation compared with 0% of controls (P =.16).

Patients with frequent aura (³50% of attacks) reported the greater reduction of monthly migraine days (P =.002) and a significant response rate (³50% reduction; P =.005) following PFO closure compared with control patients.

During the PFO procedure, few adverse events were observed (hematoma: n=2; hypotension: n=2; tachycardia: n=2; access-site bleeding: n=1; arm phlebitis: n=1; vasovagal episode: n=1).

This pooled analysis may have been limited by the differing primary end points of the 2 studied trials.

Study researchers concluded that their findings suggested that “PFO closure was safe and significantly reduced the mean number of monthly migraine days and monthly migraine attacks, and resulted in a greater number of [patients] who experienced complete migraine cessation.” Patients with aura migraines would benefit from PFO closure, in which monthly migraine days and attacks would likely decrease with a 9% chance of complete migraine cessation.

Disclosure: Multiple authors declared affiliations with the pharmaceutical industry. Please refer to the original article for a full list of disclosures.


Mojadidi MK, Kumar P, Mahmoud AN, et al. Pooled Analysis of PFO Occluder Device Trials in Patients With PFO and Migraine. J Am Coll Cardiol. 2021;77(6):667-676. doi:10.1016/j.jacc.2020.11.068