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Neurology. 2016 Aug 23;87(8):815-21. doi: 10.1212/WNL.0000000000002961. Epub 2016 Jul 27.

Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter): Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.

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From the Department of Neurology (S.R.M., S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (G.G., L.R.), University of Kansas Medical Center, Kansas City; Institute for Clinical Research and Health Policy Studies (D.M.K.), Tufts University School of Medicine, Boston, MA; Departments of Medicine (Cardiology) and Epidemiology and Population Health (J.R.K.), Albert Einstein College of Medicine, Bronx; and Division of Cardiology (S.H.), Columbia University Medical Center, New York, NY.



To update the 2004 American Academy of Neurology guideline for patients with stroke and patent foramen ovale (PFO) by addressing whether (1) percutaneous closure of PFO is superior to medical therapy alone and (2) anticoagulation is superior to antiplatelet therapy for the prevention of recurrent stroke.


Systematic review of the literature and structured formulation of recommendations.


Percutaneous PFO closure with the STARFlex device possibly does not provide a benefit in preventing stroke vs medical therapy alone (risk difference [RD] 0.13%, 95% confidence interval [CI] -2.2% to 2.0%). Percutaneous PFO closure with the AMPLATZER PFO Occluder possibly decreases the risk of recurrent stroke (RD -1.68%, 95% CI -3.18% to -0.19%), possibly increases the risk of new-onset atrial fibrillation (AF) (RD 1.64%, 95% CI 0.07%-3.2%), and is highly likely to be associated with a procedural complication risk of 3.4% (95% CI 2.3%-5%). There is insufficient evidence to determine the efficacy of anticoagulation compared with antiplatelet therapy in preventing recurrent stroke (RD 2%, 95% CI -21% to 25%).


Clinicians should not routinely offer percutaneous PFO closure to patients with cryptogenic ischemic stroke outside of a research setting (Level R). In rare circumstances, such as recurrent strokes despite adequate medical therapy with no other mechanism identified, clinicians may offer the AMPLATZER PFO Occluder if it is available (Level C). In the absence of another indication for anticoagulation, clinicians may routinely offer antiplatelet medications instead of anticoagulation to patients with cryptogenic stroke and PFO (Level C).

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