Background. Results of previous trials about PFO closure as a treatment for migraine are still doubtful and inconclusive. We sought to evaluate the long-term (>10 years) effectiveness of migraine treatment by means of patent foramen ovale (PFO) closure.
Methods. From 2006 to 2010, 86 patients (68 female, mean age 40.0 ±3.7 years) with disabling, medication-refractory migraine and PFO were enrolled in a prospective study over a 48-month period. Criteria for transcatheter closure were all the following: presence of a permanent right-to-left shunt (RLS) having a shower/curtain pattern, presence of interatrial septal aneurysm and Eustachian valve, 3 to 4 class Migraine Disability Assessment Score (MIDAS), coagulation abnormalities, and medication-refractory migraine with or without aura.
Results. Forty patients (46.5%) (34 females, mean age 35.0±6.7 years, mean MIDAS 35.8 ± 4.7) underwent transcatheter closure. After a mean follow-up of 118.2 ±19.1 months (range 96 to 144), 37 patients continued the follow-up and experienced symptomatic improvement: aura was abolished in the totality of patients along with a durable improvement of migraine throughout the extended follow up also in patients without aura. The mean MIDAS significantly decreased in the closure group (p<0.0001) (Figure 1). Patients with complete migraine resolution presented a shorter history of migraine, a more severe thrombophilic profile, more severe RLS and larger left atrial diameter and volume.
Conclusions Primary transcatheter PFO closure in selected high-risk patients having disabling refractory migraine resulted in abolition of aura and in a sustained reduction in migraine in the very long-term period.