title: Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM) Trial.
abstract: We evaluated the safety and effectiveness of transcatheter patent foramen ovale (PFO) closure for the treatment of migraine in a Chinese population. This non-randomized clinical trial enrolled 258 consecutive substantial or severe migraineurs with a right-to-left shunt (RLS) (grade II-IV) and grouped subjects according to their election or refusal of PFO closure. Migraine was diagnosed according to the International Classification of Headache Disorders III-beta and evaluated using the Headache Impact Test-6 (HIT-6). In total, 241 participants (125 in the transcatheter closure group and 116 in the control group) were included in the study. In general, the PFO closure procedure was found to be safe. At 1 month after closure, 76.1% of patients returned for c-TCD evaluation; of these, 85.7% were downgraded to negative status or a grade-I shunt. Residual shunts and placebo effects were thought to resolve by 12 months post-procedure, when migraine impact was reported to decrease by 73.6%. Transcatheter PFO closure was demonstrated to be effective for the treatment of migraine by comparing HIT-6 scores between the transcatheter closure and control groups (p < 0.001). Our results suggest that transcatheter PFO closure is a safe and effective approach for the treatment of migraine in the Chinese population, especially in females with constant RLS. Clinical trial no. NCT02127294 (registered on April 29, 2014).
authors.affiliation: Department of Neurology and Neuroscience Center, the First Hospital of Jilin University, Changchun, China.
authors.forename: Ying-Qi
authors.initials: YQ
authors.lastname: Xing
authors.affiliation: Department of Neurology and Neuroscience Center, the First Hospital of Jilin University, Changchun, China.|Department of Neurology, Peking University Shenzhen Hospital, Shenzhen, China.
authors.forename: Yu-Zhu
authors.initials: YZ
authors.lastname: Guo
authors.affiliation: Department of Cardiac Surgery, the First Hospital of Jilin University, Changchun, China.
authors.forename: Yong-Sheng
authors.initials: YS
authors.lastname: Gao
authors.affiliation: Department of Neurology and Neuroscience Center, the First Hospital of Jilin University, Changchun, China.
authors.forename: Zhen-Ni
authors.initials: ZN
authors.lastname: Guo
authors.affiliation: Department of Neurology and Neuroscience Center, the First Hospital of Jilin University, Changchun, China.
authors.forename: Peng-Peng
authors.initials: PP
authors.lastname: Niu
authors.affiliation: Department of Neurology and Neuroscience Center, the First Hospital of Jilin University, Changchun, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Yang
mesh_terms: D000328:Adult; D006328:Cardiac Catheterization / Q000379:methods*; D002681:China; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000209:etiology / Q000628:therapy*; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome