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Question answered:28/05/08
It would appear that there is a lack of robust evidence to support this intervention.
In 2006 3 secondary reviews were published. Bandolier reported [1]:
“Healthy scepticism should be the watchword here. On the basis of current evidence, it would hardly be wise to have cardiac surgery for migraine, when even in the best hands there is always the risk of something going seriously wrong. Let's keep an open mind, but bearing in mind what Bertrand Russell said: the trouble with the world is that the stupid are cocksure and the intelligent are full of doubt.”
The UK’s National Horizon Scanning Centre stated [2]:
“Although the prevalence of PFO in patients with migraine is higher than in people without migraine, until results from intervention trials are presented, a cause and effect relationship cannot be assumed. The first intervention trial to report is relatively small, and any positive results may need confirming. Although there is increasing interest from patients and health staff, diffusion may be limited by the number of neurologists and interventional cardiologists available to screen patients with migraine for subsequent PFO closure.”
The Australian National Horizon Scanning Unit concluded [3]
“Preliminary results from one high quality study indicate that closure of a patent foramen ovale may reduce the frequency and severity of migraine headaches, but not completely abolish them”
Since then more research and reviews have been published, we’ll simply report the title and conclusions below (see URLs for further details:
Title: Patent foramen ovale in patients with migraine headache. Should it be closed? (2007) [4]
Conclusion: The evidence of a benefit on migraine headache following PFO closure is not convincing, but certainly intriguing. With currently ongoing trials, more information related to this topic can be expected. In the meantime, the question whether we should close PFOs in patients with migraine headaches cannot be answered.
Title: Patent foramen ovale and migraine (2007) [5]
Conclusion: Although the results of uncontrolled observational studies suggest the PFO closure may have a beneficial effect on migraine frequency, a large randomized trial failed to support such a conclusion. Until there is more evidence from ongoing large controlled trials, PFO closure should not be performed in clinical practice for the prophylaxis of migraine.
Title: Patent foramen ovale and migraine: a quantitative systematic review (2008) [6]
Conclusions: The low-to-moderate grade of evidence from observational studies supports an apparent association between PFO and migraine. Although PFO closure seemed to affect migraine patterns favourably, the very low grade of available evidence to support this association precludes definitive conclusions.
Title: 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 (2008) [7]
Conclusions: This trial confirmed the high prevalence of right-to-left shunts in patients with migraine with aura. Although no significant effect was found for primary or secondary end points, the exploratory analysis supports further investigation. The robust design of this study has served as the model for larger trials that are currently underway in the United States and Europe.
References
1) http://www.jr2.ox.ac.uk/bandolier/band142/b142-4.html
2) http://www.pcpoh.bham.ac.uk/publichealth/horizon/outputs/documents/2006/PFOclosure.pdf
3) http://www.horizonscanning.gov.au/internet/horizon/publishing.nsf/Content/8F86C8B4D8513895CA25715C0005D972/$File/Foramen%20Ovale%20Closure%20devices%20for%20the%20treatment%20of%20migrane%20June2006.pdf
4) http://www.ncbi.nlm.nih.gov/pubmed/17372579
5) http://www.ncbi.nlm.nih.gov/pubmed/17504652
6) http://www.ncbi.nlm.nih.gov/pubmed/18355348
7) http://www.ncbi.nlm.nih.gov/pubmed/18316488
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