Randomized Clinical Trials of PFO Closure for Migraine Headache (MIST, PRIMA, PREMIUM)

Abstract A number of observational studies describe patients with chronic and debilitating migraine headaches who experienced improvement or resolution of their migraine attacks following percutaneous patent foramen ovale (PFO) closure. These observations led to 3 randomized controlled trials to further investigate the efficacy and safety of PFO device closure plus standard of care medical therapy versus medical therapy alone (with or without a sham procedure), for the treatment of migraine headaches. The randomized trials failed to meet their primary endpoints that were defined to replicate the results of prior observational studies. Yet, all showed partial benefits in their subanalyses. The goal of this chapter is to discuss the clinical trials of PFO closure for migraine headache, with emphasis on the lessons learned, limitations, and meta-analyses of these studies. This chapter will serve to provide clinicians with insight to help guide their migraine patients who are found to have a PFO on echocardiographic testing.