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U.S. and International Stroke Guidelines

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U.S. and International Stroke Guidelines

The United States and countries across the globe have updated their stroke guidelines to include PFO closure. See below for brief summaries of the guidelines, as well as links to the full publications.

United States Guidelines1 - 2020

An updated practice advisory from the American Academy of Neurology (AAN) concludes that patent foramen ovale (PFO) closure may be recommended for some patients with a PFO, an embolic-appearing infarct and no other mechanism of stroke identified. This advisory has been endorsed by the American Heart Association/American Stroke Association, the Society for Cardiovascular Angiography and Interventions and the European Academy of Neurology.

Recommendation: In patients younger than 60 years with a PFO and an embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (reduction of stroke recurrence) and risks (procedural complication and atrial fibrillation) (Level C).

American Academy of Neurology Practice Advisory Update: Patent Foramen Ovale and Secondary Stroke Prevention

Japanese Guidance Document2 – 2019

The Japan Stroke Society, The Japanese Circulation Society, and Japanese Association of Cardiovascular Intervention and Therapeutics came together to review the evidence on PFO closure and recommend the following when it comes to selecting the appropriate patient for PFO closure:

Indication criteria for percutaneous closure of PFO for the purpose of stroke recurrence prevention:

  1. Indispensable condition: Implementation of the intervention will be considered in case of satisfaction of all items described below:
    1. Patients who meet the diagnosis criteria for PFO related cryptogenic stroke
    2. Patients in whom antithrombotic therapy can be conducted during a certain period after percutaneous closure implementation
    3. Patients with <60 years of age in principle
    4. Female patients who are not pregnant or do not want to become pregnant within a year
  2. Recommendation condition: Implementation of the intervention will be recommended in case of satisfaction of all aforementioned items and any items described below:
    1. The presence of high risk PFO in terms of function/anatomy such as:
      1. Large volume of shunt
      2. Concomitant atrial septal aneurysm (ASA)
      3. Concomitant Eustachian valve (EV)
      4. Concomitant Chiari network
      5. Right-left shunt found at rest (without Valsalva maneuver)
    2. Onset of the aforementioned type of cryptogenic stroke during appropriately conducted antithrombotic therapy.
Japanese Guidance Document (Available in Japanese only)

Australian Guidelines3 - 2019

Published by the Stroke Foundation, the Australian guidelines were written by Content Development Working Group, a multi-disciplinary group of physicians involved in stroke care. In summary, the guidelines involving PFO closure state:

Strong Recommendation:

In ischaemic stroke patients aged <60 in whom a patent foramen ovale is considered the likely cause of stroke after thorough exclusion of other aetiologies, percutaneous closure of the PFO is recommended (Turc et al. 2018 [182], Saver et al. 2018 [184]).

The Clinical Guidelines for Stroke Management, Chapter 4 Secondary Prevention

German Guidelines4 - 2018

Physicians from cardiology, internal medicine and neurology joined together to publish new stroke guidelines related to PFO closure in patients with cryptogenic stroke. The guidelines state that interventional PFO closure should be performed in patients aged 16 to 60 years (after extensive neurological and cardiological diagnostic work-up) with a history of cryptogenic ischaemic stroke and patent foramen ovale, with moderate or extensive right-to-left shunt. Recommendation level A, Evidence level I.

Kryptogener Schlaganfall und offense Foramen ovale (Full guideline, published in German)

The British Medical Journal (BMJ)5 - 2018

Among patients younger than age 60 who have had a cryptogenic ischemic stroke thought to be secondary to PFO (due to absence of other etiologies):

  • Strong recommendation: among patients in whom anticoagulation is contraindicated or declined—to provide PFO closure + antiplatelet therapy, vs antiplatelet therapy alone
  • Weak recommendation: among patients who are open to all options - to provide PFO closure + antiplatelet therapy vs anticoagulant therapy
  • Weak recommendation: among patients in whom closure is contraindicated or declined—to provide anticoagulant therapy vs antiplatelet therapy
Patent Foramen Ovale Closure, Antiplatelet Therapy or Anticoagulation Therapy Alone for Management of Cryptogenic Stroke? A Clinical Practice Guideline

Canadian Guidelines6 - 2017

Published in the International Journal of Stroke, the Canadian guidelines were written by a group of physicians on behalf of the Heart and Stroke Foundation Canadian Stroke Best Practice Committees. In summary, PFO guidelines have been updated with the following:

Patent Foramen Ovale

For carefully-selected patients with a recent ischemic stroke or TIA attributed to a PFO, PFO device closure plus long-term antiplatelet therapy is recommended over long-term antithrombotic therapy alone, provided all the following criteria are met:

[Evidence Level A]:

  1. Age 18–60 years;
  2. The diagnosis of the index stroke event is confirmed by imaging as a nonlacunar embolic ischemic stroke or a TIA with positive neuroimaging or cortical symptoms;
  3. The patient has been evaluated by a neurologist or clinician with stroke expertise, and the PFO is felt to be the most likely cause for the index stroke event following a thorough etiological evaluation to exclude alternate etiologies.
Canadian Stroke Best Practice Recommendations: Secondary Prevention of Stroke, sixth edition practice guidelines, update 2017

Position Papers

In addition to guidelines, there have also been position papers and consensus statements published regarding PFO closure in patients with cryptogenic stroke.

Asian-Pacific Consensus Statement7 - 2020

With most of the evidence on PFO closure being obtained from Caucasian patients, a consensus statement was developed by Asian-Pacific clinical experts, accounting for the specific stroke and bleeding characteristics of Asian-Pacific patients and the specific Asian-Pacific context.

Key aspects of this consensus statement include:

  • Regarding indications for PFO closure, follow international/global guidelines.
  • Ensure that patients with recent embolic stroke of undetermined source (ESUS) are screened for PFO, using imaging modalities that are readily available in the hospital and on which the staff is best trained and most experienced (e.g. TTE, contrast TCD, TEE, ICE). Contrast TCD is widely available in the Asian-Pacific region and may be used as a first screening tool, followed by confirmation using TEE or TTE with bubble contrast.
  • ESUS patients with significant PFO should undergo PFO closure as early as possible.

It was emphasized that clinical evidence for the above aspects should be collected among Asian-Pacific patients.

Closure of the patent foramen ovale in patients with embolic stroke of undetermined source: A clinical expert opinion and consensus statement for the Asian-Pacific region Left atrial appendage occlusion for ischemic stroke prevention in patients with non-valvular atrial fibrillation: clinical expert opinion and consensus statement for the Asian-Pacific region

European Position Paper8 - 2018

EuroIntervention published a European position paper regarding the management of patients with PFO. The paper was developed by eight scientific societies and international stroke experts.

Recommendation:

“Position of our societies is to perform percutaneous closure of PFO in carefully selected patients from 18 to 65 years with confirmed cryptogenic stroke, TIA or systemic embolism and estimated high probability of causal role of PFO as assessed by clinical, anatomic and imaging features.”

“The interventional procedure must be proposed to each patient evaluating the individual probability of benefit based on an assessment of both the role of the PFO in the thromboembolic event and the expected results and risks of a lifelong medical therapy.”

European Position Paper on the Management of Patients with Patent Foramen Ovale. General Approach and Left Circulation Thromboembolism
References
  1. Messé SR, Gronseth GS, Kent DM, Kize JR, Homma S, et al. Practice Advisory Update: Patent Foramen Ovale and Secondary Stroke Prevention. Neurology® 2020;94:1-10.
  2. The Japan Stroke Society, The Japanese Circulation Society, and Japanese Association of Cardiovascular Intervention and Therapeutics Guidance on Percutaneous Closure of Patent Foramen Ovale (PFO) in Cryptogenic Stroke Patients https://pfo-council.jp/publications/
  3. Australian Stroke Foundation. Clinical Guidelines for Stroke Management. Chapter 4: Secondary Prevention. https://informme.org.au/Guidelines/Clinical-Guidelines-for-Stroke-Management-2017
  4. Diener et al. Neurological Research and Practice https://doi.org/10.1186/s42466-019-0008-2
  5. Kuijpers et al. Patent foramen ovale closure, antiplatelet therapy or anticoagulation therapy alone for management of cryptogenic stroke? A clinical practice guideline. British Medical Journal; 2018.
  6. Wein et al, Canadian Stroke Best Practice Recommendations: Secondary Prevention of Stroke, Sixth Edition Practice Guidelines, Update 2017. International Journal of Stroke, 2017. DOI: 10.1177/1747493017743062
  7. Diener, HC, Akagi, T, Durongpisitkul, K, et al. Closure of the patent foramen ovale in patients with embolic stroke of undetermined source: A clinical expert opinion and consensus statement for the Asian-Pacific region. Int J Stroke 2020; 0(0) 1–8.
  8. Pristipino et al. European Position paper on the management of patients with patent foramen ovale. Eurointervention 2018: Jaa-434 2018
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