Migraine headache is a public health problem of enormous scope that has an impact on both the individual sufferer and on society. In the United States, three large population studies have established the prevalence of migraine at 18% in women and 6% in men. 1, 2, 3 In the American Migraine Study II, 92% of women and 89% of men with severe migraine experienced significant headache related disability.
The biogenesis of migraine headache disorders has yet to be elucidated. The association of PFO closure and the cessation of migraine headaches was published in 2000 by Wilmshurst et al. as an incidental finding while studying the effects of PFO closure on patients with decompression illness.4 A cohort of 37 patients with migraine headaches revealed that 45% had cessation of their headaches after PFO closure. Several studies before and since this report have shown an increased prevalence of PFO in patients with migraine headache disorders.5 This association has been further delineated by studies that indicated migraine patients with aura are twice as likely to have a PFO as control patients while migraine patients without aura have the same prevalence of PFO as controls.6, 7, 8
A number of retrospective, observational studies suggest that PFO closure results in cessation or reduction of migraine headaches.9,10,11,12, 13 The only completed randomized trial of PFO closure for migraine, MIST, not only failed to demonstrate a benefit of PFO closure compared with a Sham procedure, but PFO closure was associated with severe complications.14 The MIST Trial as well as the ongoing Premium Trial and the prematurely halted Escape and MIST II Trials have all demanded for inclusion migraineurs with both significant episodic migraine (4-15 migraine days/month) and symptoms refractory to medications. However, this population is different than the observed stroke and decompression illness populations with rare episodic migraine from which the hypothesis of PFO closure leading to migraine relief was generated. Additional populations including chronic migraine (>15 migraine days per month) and migraine associated with transient neurologic deficit have been proposed for randomized trials of PFO closure.
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4 Wilmshurst PT, N. S. (2000). Effect on migraine of closure of cardiac right-to-left shunts to prevent recurrence of decompression illness or stroke or for haemodynamic reasons. Lancet , 356:1648-1651.
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11 Schwerzmann M, W. B. (2004). Percutaneous closure of patent foramen ovale reduces the frequency of migraine attacks. Neurology , 62:1399-1401.
12 Azarbal B, T. J. (2005). Association of interatrial shunts and migraine headaches. . J AM Coll Cardiol , 45:489-492.
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14 Dowson A, M. M. (2008) Migraine Intervention With STARFlex Technology (MIST) trial: a prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation,117:1397-404.
Taafe M. Am J Cardiol. 2008 May 1;101(9):1353-8.