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GORE® CARDIOFORM Septal Occluder for PFO Closure

NEW ANNOUNCEMENT - American Academy of Neurology Patent Foramen Ovale (PFO) and Secondary Stroke Prevention Practice Advisory Guideline Update

In April 2020, the American Academy of Neurology announced that clinicians may recommend PFO closure for select patients to prevent recurrent strokes.

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Practice advisory educational materials

The PFO and Secondary Stroke Prevention materials are based on the latest guidelines from the American Academy of Neurology. They contain practice recommendations for patients with stroke and patent foramen ovale (PFO) and include information pertaining to PFO closure considerations, PFO screening, patient selection and medical management.

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American Academy of Neurology PFO and Secondary Stroke Prevention Practice Advisory Update

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Clinical practice guidelines differ on the appropriate treatment option for the prevention of recurrent stroke in patients who have had a cryptogenic stroke and have a PFO.

Currently available options include1:

  • PFO closure followed by antiplatelet therapy;
  • Anticoagulant therapy; or
  • Antiplatelet therapy 

Nearly one-half of patients with cryptogenic stroke have a PFO.3 The dilemma of whether to close these PFOs percutaneously, in an effort to reduce the risk of recurrent paradoxical embolism, has been a matter of ongoing debate for more than a decade.  Randomized trial data from the Gore REDUCE Clinical Study (REDUCE) and the Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence (CLOSE) Study, as well as long-term follow-up data from the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) Trial have clarified these findings. They showed that with good patient selection, transcatheter PFO closure significantly reduces the risk of recurrent stroke compared with medical therapy in patients with cryptogenic stroke, with no increased risk of serious adverse events or influence on major bleeding.4

In April 2020, the American Academy of Neurology announced that clinicians may recommend PFO closure for select patients to prevent recurrent strokes.  Learn more about the guideline change below.


Review the various guidelines prior to and after the publication of the REDUCE, RESPECT and CLOSE Studies:

Guidelines published prior to the REDUCE, RESPECT and CLOSE Studies

  • 2016: American Academy of Neurology1:
    • Clinicians should not routinely offer PFO closure outside of a research setting due to insufficient evidence to ascertain the effectiveness of PFO closure
    • Clinicians may offer patients with no indication for anticoagulation, antiplatelet medications
       
  • 2014: American Heart Association / American Stroke Association4:
    • Among patients who have had an ischemic stroke or transient ischemic attack (TIA) and have a PFO:
      • Antiplatelet therapy can be recommended, so long as they are not on anticoagulation therapy
      • Closure does not provide a benefit in the absence of deep vein thrombosis (DVT)
      • With a venous source of embolism, then anticoagulation is indicated, and when contraindicated, an inferior vena cava filter is reasonable
    • Among patients with a PFO and DVT, transcatheter PFO closure may be considered

Guidelines published after the REDUCE, RESPECT and CLOSE Studies

  • 2020: American Academy of Neurology2
    • In patients younger than 60 years with a PFO and embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits and risks
    • In patients with a PFO detected after stroke and no other etiology identified after a thorough evaluation, clinicians should counsel that PFO closure probably reduces recurrent stroke risk in select patients
    • In patients who opt to receive medical therapy alone without PFO closure, clinicians may recommend an antiplatelet medication such as aspirin or anticoagulation
       
  • 2018: British Medical Journal’s BMJ Rapid Recommendation5:
    • For treatment of patients that are younger than 60 and have experienced a cryptogenic ischemic stroke thought to be due to a PFO and are void of other etiologies:
      • Strong recommendation: For patients in whom anticoagulation is contraindicated or declined, clinicians may provide PFO closure followed by antiplatelet therapy, instead of antiplatelet therapy alone
      • Weak recommendation: For patients who are open to all options, clinicians may provide PFO closure followed antiplatelet therapy, instead of anticoagulant therapy. Treatment options should be discussed with the patient
      • Weak recommendation: For patients in whom closure is contraindicated or declined, clinicians may provide anticoagulant therapy instead of antiplatelet therapy
         
  • 2018: European Position Paper6:
    • Clinicians who propose PFO closure for a patient must also evaluate the probable benefit for the individual, while also assessing the role of the PFO in the thromboembolic event. This includes the expected results and risk of a life-long medical treatment
    • Shared decision-making should be used when considering PFO closure for patients younger than 18 and older than 65, while also taking into account the risks of intervention and/or drug therapies
    • There are no indications for surgical PFO closure as a first-line treatment, but it may be performed during valvular surgery
       
  • 2017: Canadian Stroke Best Practices7:
    • Among patients who have had an ischemic stroke or TIA and have a PFO:
      • Patients should have an evaluation by clinicians with stroke and cardiovascular expertise
      • For patients between 18 - 60 years with a diagnosis of a non-lacunar embolic ischemic stroke or a TIA with positive neuroimaging or cortical symptoms who have been evaluated by a clinician with stroke expertise who has determined the PFO is the most likely cause of the event, clinicians may recommend PFO device closure plus long-term antiplatelet therapy over long-term antithrombotic therapy alone
      • Recommendations for patients requiring long-term anticoagulation remain unclear, and clinicians may recommend treatment based on individual patient characteristics
      • For patients who do not undergo PFO closure, clinicians may recommend either antiplatelet or anticoagulant therapy

* Refer to the complete practice advisory recommendations.

1. Messé SR, Gronseth G, Kent DM, et al.  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.  Neurology 2016;87(8):815-821.  https://n.neurology.org/content/87/8/815.full

2. Messé SR, Gronseth GS, Kent DM, et al.  Practice advisory update summary: patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology.  Neurology.  In press.  https://www.aan.com/Guidelines/Home/GuidelineDetail/991

3. Caswell J. Holes in the heart. Stroke Connection 2011:16-17. https://scmag-digi.stroke.org/strokeconnection/january_february_2011?article_ id=961624&pg=NaN#pgNaN

4. Kernan WN, Ovbiagele B, Black HR, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association [published correction appears in Stroke. 2015 Feb;46(2):e54]. Stroke 2014;45(7):2160-2236. 

5. Kuijpers T, Spencer FA, Siemieniuk RAC, et al.  Patent foramen ovale closure, antiplatelet therapy or anticoagulation therapy alone for management of cryptogenic stroke? A clinical practice guideline.  BMJ 2018;362:k2515. https://www.bmj.com/content/362/bmj.k2515

6. Pristipino C, Sievert H, D'Ascenzo F, et al; Evidence Synthesis Team; Eapci Scientific Documents and Initiatives Committee; International Experts.  European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism.  European Heart Journal 2019;14(13):1389-1402.

7. Cardiac Issues in Individuals with Stroke - Patent Foramen Ovale (PFO).  Canadian Stroke Best Practices. Heart and Stroke Foundation of Canada website.  Updated October 2017.  Accessed April 14, 2020.   
https://www.strokebestpractices.ca/recommendations/secondary-prevention-of-stroke/cardiac-issues-in-individuals-with-stroke#p91-Patent-Foramen-Ovale-PFO