Study Question: What is the effectiveness of transcatheter patent foramen ovale (PFO) closure in improving migraine in a group of patients with high-risk anatomic and functional characteristics for paradoxical embolism?
Methods: In this single-center, nonrandomized, prospective trial, patients with medication-refractory migraine and PFO referred for consideration of transcatheter PFO closure were enrolled. The Migraine Disability Assessment Score (MIDAS) was administered to all patients for evaluation of migraine severity. Device closure of PFO was performed in patients meeting high-risk inclusion criteria, including: curtain shunt pattern of right-to-left (R-L) shunt on transcranial Doppler (TC-D) and transesophogeal echocardiography (TEE), refractory and disabling migraine (MIDAS class 3-4), PFO, R-L shunt during normal respiration, atrial septal aneurysm, coagulation abnormalities, and presence of eustachian valve. Transcatheter PFO closure was performed using devices from AGA Medical Corporation and St. Jude Medical Incorporated, based on specific intracardiac echocardiographic findings. Follow-up included TEE, TC-D, MIDAS, and clinical interviews.