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Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM) Trial.
Xing, Ying-Qi; Guo, Yu-Zhu; Gao, Yong-Sheng; Guo, Zhen-Ni; Niu, Peng-Peng; Yang, Yi.
Afiliación
  • Xing YQ; Department of Neurology and Neuroscience Center, the First Hospital of Jilin University, Changchun, China.
  • Guo YZ; Department of Neurology and Neuroscience Center, the First Hospital of Jilin University, Changchun, China.
  • Gao YS; Department of Neurology, Peking University Shenzhen Hospital, Shenzhen, China.
  • Guo ZN; Department of Cardiac Surgery, the First Hospital of Jilin University, Changchun, China.
  • Niu PP; Department of Neurology and Neuroscience Center, the First Hospital of Jilin University, Changchun, China.
  • Yang Y; Department of Neurology and Neuroscience Center, the First Hospital of Jilin University, Changchun, China.
Sci Rep ; 6: 39081, 2016 12 14.
Article en En | MEDLINE | ID: mdl-27966652
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).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cateterismo Cardíaco / Foramen Oval Permeable / Trastornos Migrañosos Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Sci Rep Año: 2016 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cateterismo Cardíaco / Foramen Oval Permeable / Trastornos Migrañosos Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Sci Rep Año: 2016 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido