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

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

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).

Figures

Figure 1. Typical patient disposition during the…
Figure 1. Typical patient disposition during the follow-up period.
Figure 2. Changes in residual RLS status…
Figure 2. Changes in residual RLS status at different time points during the follow-up period in the transcatheter closure group.
Figure 3. Comparison of migraine relief between…
Figure 3. Comparison of migraine relief between patients with complete and incomplete patent foramen ovale closure at different time points during the follow-up period.
Figure 4. HIT-6 scores before and after…
Figure 4. HIT-6 scores before and after transcatheter patent foramen ovale closure at 12-month follow-up, evaluated in the same patients.
Figure 5. Differences in change scores between…
Figure 5. Differences in change scores between groups.
Mean change scores were statistically different between the transcatheter closure group and the control group. In subgroup analyses, there were statistical differences in mean change scores between the transcatheter closure group and the control group except for the male and provoked RLS subgroups. *Indicates p 

Figure 6. Schematic of the EASTFORM study…

Figure 6. Schematic of the EASTFORM study protocol.

Abbreviations: c-TCD, contrast-enhanced transcranial Doppler; c-TTE, contrast…

Figure 6. Schematic of the EASTFORM study protocol.
Abbreviations: c-TCD, contrast-enhanced transcranial Doppler; c-TTE, contrast transthoracic echocardiogram; RLS, right-to-left shunt; HIT-6, Headache Impact Test-6.
Figure 6. Schematic of the EASTFORM study…
Figure 6. Schematic of the EASTFORM study protocol.
Abbreviations: c-TCD, contrast-enhanced transcranial Doppler; c-TTE, contrast transthoracic echocardiogram; RLS, right-to-left shunt; HIT-6, Headache Impact Test-6.

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