Abstract
Objective: 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.
Methods: Systematic review of the literature and structured formulation of recommendations.
Conclusions: 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%).
Recommendations: 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).
This guideline is retired. The recommendations and conclusions are no longer considered valid and no longer supported by the AAN. Retired guidelines should be used for historical reference only. Please see AAN current guidelines here: https://www.aan.com/policy-and-guidelines/guidelines/.
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Approved by the Guideline Development, Dissemination, and Implementation Subcommittee on April 22, 2015; by the Practice Committee on August 25, 2015; and by the AAN Institute Board of Directors on June 2, 2016.
- Received September 3, 2015.
- Accepted in final form May 3, 2016.
- © 2016 American Academy of Neurology
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