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.
Results: Eighty-six patients (79% female, mean 35 ± 6.7 years) were enrolled and 40 met criteria for transcatheter PFO closure. Patients ineligible for PFO closure received standard of care medical management. Transcatheter PFO closure was successful and performed without periprocedural complications in all 40 subjects. The Amplatzer PFO Occluder was used in eight patients, Amplatzer Cribriform Occluder in 14 patients, and Premere occlusion system in 18 patients. At a mean follow-up of 29.2 ± 14.8 months, mean MIDAS score had fallen from 35.8 ± 4.7 to 8.3 ± 7.8 (p < 0.03) in the PFO closure group, and from 22.6 ± 7.1 to 19.1 ± 8.2 (p = 0.06) in the medical management group. PFO closure without residual shunt was achieved in 95% of subjects. Of 32 subjects who reported migraine with aura at baseline, all subjects reported abolishment of aura at follow-up. New-onset atrial fibrillation developed in 5% of PFO closure patients during follow-up.
Conclusions: In a highly selected population of patients with medically-refractory migraines and PFO with certain proposed high-risk anatomic and functional features, transcatheter PFO closure resulted in a marked reduction in migraine severity and abolition of aura.
Perspective: The MIST (Migraine Intervention with Starflex Technology) study, a large, randomized, sham-controlled study, failed to demonstrate significant symptomatic improvement in patients with migraine undergoing PFO closure. The question remains as to whether a subset of selected patients with migraine might benefit from PFO closure. This nonrandomized, possibly nonconsecutive, series reported by Rigatelli et al. is unique in its selection of patients with high-risk characteristics (for R-L shunt and microembolism) for PFO closure. This kind of highly selected group (whether using the described characteristics or others) may represent a subset of migraineurs more likely to respond to transcatheter therapy. However, the absence of a sham-control group and randomization of consecutive subjects severely limit the generalization of these data. Timothy B. Cotts, M.D., F.A.C.C., Bryan Goldstein, M.D.
Citation: JACC Cardiovasc Interv 2010;3:282-287.