Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial

Mattle, Heinrich; Evers, Stefan; Hildick‐Smith, David; Becker, Werner J.; Baumgartner, Helmut; Chataway, Jeremy; Gawel, Marek; Göbel, Hartmut; Heinze, Axel; Horlick, Eric; Malik, Iqbal; Ray, Simon; Zermansky, Adam; Findling, Oliver; Windecker, Stephan; Meier, Bernhard

doi:10.1093/eurheartj/ehw027

Cited by 177 publications

(121 citation statements)

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“…The answer depends on how the result will affect treatment. In three randomized clinical trials of PFO closure in persons with MA, there was no evidence for decrease in frequency, intensity, or severity of migraine, and it is therefore not routinely recommended as a treatment option . Closure of PFO, might, however, still be considered in the setting of recurrent migraine‐like transient neurological events despite use of antiplatelet therapy, and MRI abnormalities, including white matter T2 hyperintensities and stroke‐like lesions.…”

Section: Implications For Diagnosis and Treatmentmentioning

confidence: 99%

Hypercoagulability and Migraine

Tietjen

Collins

2017

Headache

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Background.-A growing body of literature suggests that migraineurs, particularly those with aura, have an increased risk for ischemic stroke, but not via enhanced atherosclerosis. The theory that micro-emboli induced ischemia provokes cortical spreading depression (ie, symptomatic aura) in migraineurs but transient ischemic attacks in others highlights a potential role for hypercoagulability as a link between migraine (with aura) and stroke.Aim.-Our objective is to summarize the literature evaluating the association of migraine with various acquired or inheritable thrombophilic states, including those related to elevated estrogen levels, endothelial activation and dysfunction, antiphospholipid antibodies (aPL), deficiency of coagulation inhibitors, and presence of certain genetic polymorphisms.Findings.-Although definitive studies are lacking, a preponderance of available evidence links migraine, and especially aura, to increased levels of estradiol (eg, oral contraceptive pill [OCP] use, pregnancy), thrombo-and erythrocytosis, von Willebrand factor (vWF) antigen, fibrinogen, tissue plasminogen activator (tPA) antigen, and endothelial microparticles. Studies of a link to migraine are conflicting for aPL, homocysteine, Protein S, and the methylenetetrahydrofolate reductase (MTHFR) C677T polymorphism. No association with migraine was found in meta-analyses of Factor V Leiden, and of prothrombin gene mutation. Within a large, young ischemic stroke sample, migraine with aura was associated with a thrombophilic state and with patent foramen ovale (PFO). In the non-stroke population, meta-analyses show an association of PFO and migraine with aura (MA), but two populationbased studies do not support the link.Recommendations.-For persons with MA and (1) a personal history or family history of thrombosis, or (2) MRI evidence of micro-vascular ischemia or of stroke, an evaluation for hypercoagulability is warranted. In cases of MA alone, consider screening for markers of endothelial activation (eg, vWF, high sensitivity c-reactive protein [hs CRP], and fibrinogen). Rigorous management of other stroke risk factors is paramount, but efficacy of anti-thrombotic agents in the treatment of migraine is unproven. Closure of PFO is not routinely recommended based on negative randomized trials.

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Section: Implications For Diagnosis and Treatmentmentioning

confidence: 99%

Hypercoagulability and Migraine

Tietjen

Collins

2017

Headache

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“…Indeed, data presented at cardiology conferences in 2006, 2014, and 2015 representing the MIST, PREMIUM, and PRIMA trials offered negative results regarding the utility of PFO closure for the treatment of migraine222324. The present (EASTFORM) study evaluated the long-term impact of PFO closure on migraine in a real-world setting of patients enrolled and included in a continuous registry at a single centre in China, and importantly addressed ethnic differences in the efficacy and safety of PFO closure for migraine.…”

Section: Discussionmentioning

confidence: 99%

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

Xing¹,

Guo²,

Gao³

et al. 2016

Sci Rep

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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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“…Therefore, this unequal and greater effect on migraine with aura is likely a true effect of PFO closure. There was only one vascular major complication and one transient atrial fibrillation reported from the interventional procedure [34]. …”

Section: Discussionmentioning

confidence: 99%

Transcatheter Closure of Patent Foramen Ovale: A Single Center Experience

Milev¹,

Zafirovska²,

Zimbakov³

et al. 2016

Open Access Maced J Med Sci

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BACKGROUND:Percutaneous transcatheter closure (PTC) of patent foramen ovale (PFO) is implicated in cryptogenic stroke, transitional ischemic attack (TIA) and treatment of a migraine.AIM:Our goal was to present our experience in the interventional treatment of PFO, as well as to evaluate the short and mid-term results in patients with closed PFO.MATERIAL AND METHODS:Transcatheter closure of PFO was performed in 52 patients (67.3% women, mean age 40.7 ± 11.7 years). Patients were interviewed for subjective grading of the intensity of headaches before and after the PFO closure.RESULTS:During 2 years of follow-up, there was no incidence of new stroke, TIA and/or syncope. Follow-up TCD performed in 35 patients showed complete PFO closure in 20 patients (57.1%). Out of 35 patients, 22 (62.9%) reported having a migraine before the procedure with an intensity of headaches at 8.1 ± 1.9 on a scale from 1 to 10. During 2 years of follow-up, symptoms of a migraine disappeared in 4 (18.2%) and the remaining 18 patients reported the significant decrease in intensity 4.8 ± 2.04 (p = 0.0001). In addition, following PFO closure the incidence of the headaches decreased significantly (p = 0.0001).CONCLUSIONS:Percutaneous transcatheter closure of PFO is a safe and effective procedure showing mid-term relief of neurological symptoms in patients as well as significant reduction of migraine symptoms.

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Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial

Abstract: In patients with refractory migraine with aura and PFO, PFO closure did not reduce overall monthly migraine days.

Cited by 177 publications

References 24 publications

Hypercoagulability and Migraine

Hypercoagulability and Migraine

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

Transcatheter Closure of Patent Foramen Ovale: A Single Center Experience

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