Migraine Intervention With STARFlex Technology Trial

Recent epidemiological data suggest that up to 18% of women and 6% of men worldwide have suffered a migraine headache.1,2 Despite its common occurrence, our understanding of both migraine pathophysiology and the optimal means by which to control or abate symptoms remains severely limited.1 For many years, the care of patients with migraines was left in the capable hands of general practitioners and neurologists. As information surfaced on the potential link between migraines and patent foramen ovale (PFO), however, some cardiologists became involved in the care of patients with migraines and were quickly humbled by the often debilitating nature of the disease process. Personally witnessing such intense suffering, the inconsistent effect of rescue medications, and the subsequent reliance on powerful intravenous narcotic agents to achieve some means of comfort until the storm subsides has been a sobering experience. With the development of implantable devices used to close potentially enabling PFOs, however, came a newfound hope in our ability to help these suffering people.Article p 1397 The potential causative link between migraines and PFO became apparent between 2000 and 2004, during which period many single-center reports demonstrated precipitous improvements in migraine frequency in patients undergoing percutaneous PFO closures for nonmigraine indications.3–5 When these preliminary reports surfaced, professional and media interest in this potential association escalated rapidly. This awareness established the groundwork for the Migraine Intervention With STARFlex Technology (MIST) trial, which, by incorporating important elements in trial design (eg, prospective, double-blinded, inclusion of a sham procedure), was viewed as an exciting and bold clinical investigation. The reports of thousands of patients with migraines calling to participate in MIST reaffirmed the notion that large numbers of patients were frustrated by being inadequately treated with both conventional (ie, medications) and unconventional (ie, acupuncture, Botox injections) means. The fact that …