Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM) Trial.

Ying-Qi Xing,Yi Yang,Zhen-Ni Guo,Yong-Sheng Gao,Yu-Zhu Guo,Peng-Peng Niu

doi:10.1038/srep39081

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).

Highlights

Patent foramen ovale (PFO) is the most common congenital defect of the atrial septum and affects about 25% of the general population[2]
The groups were matched in terms of age, gender, disease course, aura, type of right-to-left shunt (RLS), and baseline Headache Impact Test-6 (HIT-6) score
Data presented at cardiology conferences in 2006, 2014, and 2015 representing the MIST, PREMIUM, and PRIMA trials offered negative results regarding the utility of patent foramen ovale (PFO) closure for the treatment of migraine[22,23,24]

Summary

Introduction

Patent foramen ovale (PFO) is the most common congenital defect of the atrial septum and affects about 25% of the general population[2]. The foramen ovale closes shortly after birth following a rise in left atrial pressure due to an increase in pulmonary blood flow after the initiation of breathing. Transcatheter closure of the PFO has been available for more than two decades, the use of this procedure has remained controversial due to a paucity of evidence to guide patient eligibility and device selection[14]. Recent contemporary studies have investigated PFO closure as treatment for patients with cryptogenic stroke, migraine, and orthodeoxia/platypnea, such that longitudinal data regarding the safety and efficacy www.nature.com/scientificreports/. No study to date has investigated PFO closure for the treatment of migraine in the Chinese population.

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