Patent foramen ovale (PFO) closure in addition to medical therapy may be associated with significant reductions in the number of migraine days and attacks when compared with medical treatment, according to a study published Feb. 8 in the Journal of the American College of Cardiology.

Mohammad K. Mojadidi, MD, FACC, et al., sought to assess the efficacy and safety of percutaneous device closure as a therapy for episodic migraine with or without aura by reporting the results of a pooled analysis of individual patient-level data from two randomized trials (PRIMA and PREMIUM) using the Amplatzer PFO Occluder.

Researchers examined data from 337 patients, including 176 who received device closure and 161 who received only medical treatment. The efficacy endpoints were mean reduction in monthly migraine days, responder rate, mean reduction in monthly migraine attacks, and percentage of patients who experienced complete cessation of migraine.

The analysis met three of the four efficacy endpoints in patients who received device closure vs. those who received medical treatment, including mean reduction of monthly migraine days (-3.1 days vs. -1.9 days); mean reduction of monthly migraine attacks (-2.0 days vs. -1.4 days); and number of patients who experienced complete cessation of migraine (14 vs. 1).

"PFO closure was associated with a 9% chance of complete headache cessation compared with 1% in control subjects. PFO closure did not show a significant benefit in responder rate," explain Mojadidi et al. "Both PREMIUM and PRIMA had larger than expected reductions of migraine in the medically treated control populations. The results of this pooled analysis, which increased the power of the [two] trials, warrant a reevaluation of PFO closure in treating episodic migraine, especially migraine with frequent aura."

"Migraine remains one of the most debilitating illnesses among otherwise healthy young people," write Zubair Ahmed, MD, and Robert J. Sommer, MD, in an accompanying editorial comment. "Medical treatment continues to advance, but severe side effects of some medications, and the limited efficacy of many others, demand additional understanding of the underlying mechanisms of migraine. Mojadidi et al., have pushed forward the concept of PFO-related migraine and the potential benefit of PFO closure."

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Congenital Heart Disease

Keywords: Foramen Ovale, Patent, Septal Occluder Device, Migraine Disorders, Migraine with Aura, Headache, Epilepsy, Cardiology

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