RECENTLY PUBLISHED

THE AMERICAN HEART ASSOCIATION/AMERICAN STROKE ASSOCIATION (AHA/ASA) RELEASED UPDATED GUIDELINES ON SECONDARY STROKE PREVENTION, WITH A RECOMMENDATION FOR PFO CLOSURE.

The guidelines state that “it is now considered reasonable to close patent foramen ovale percutaneously in selected patients: those with younger age with nonlacunar stroke or no other cause at any age.”

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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.

American Heart Association/American Stroke Association (AHA/ASA) 1 - 2021

The American Heart Association/American Stroke Association periodically update their guidelines for stroke prevention based on the newest available evidence. In May 2021, the AHA/ASA updated their stroke guidelines to include a recommendation for PFO closure. They concluded that:

In patients with stroke of undetermined cause and a PFO, the patient, a cardiologist, and a neurologist should jointly make the decision if PFO closure is the appropriate treatment for reducing the risk of another stroke.

In patients 18 to 60 years of age with a stroke of undetermined cause, despite a thorough evaluation and a high-risk PFO, it is reasonable to choose closure with a transcatheter device and long-term antiplatelet medicine over antiplatelet medicine alone for preventing another stroke.

American Heart Association/American Stroke Association 2021 Guideline for Prevention of Stroke

American Academy of Neurology (AAN)2 – 2020

Experts from the American Academy of Neurology, or AAN, carefully reviewed the available evidence about secondary stroke prevention in patients with a patent foramen ovale, or PFO. Based on their review, they conclude the following:

  • Recent studies have shown that for some patients, particularly those younger than 60 years who have had a stroke thought to be caused by a PFO, closure of the PFO reduces the risk of having another stroke better than medical treatments alone.
  • Before recommending PFO closure in people who have had a stroke, it's important for doctors with expertise in stroke to rule out causes other than the PFO.
Practice Advisory Update: PFO and AAN Update: PFO and Secondary Stroke Prevention: Summary for Patients and their Families

Japanese Guidance Document3 – 2019

The Japan Stroke Society, Japanese Circulation Society and Japanese Association of Cardiovascular Intervention and Therapeutics came together to review the evidence on PFO closure and recommend the following: PFO closure should be considered for patients younger than 60 years who have the diagnosis of a cryptogenic stroke and have a PFO. It is critical that the patient is able to take antithrombotic medication after device implantation.

Japanese Guidance Document (Available in Japanese only)

Australian Guidelines4 - 2019

Published by the Stroke Foundation, the Australian guidelines strongly recommend that in ischaemic stroke patients aged <60 in whom a patent foramen ovale is considered the likely cause of stroke after thorough exclusion of other causes, percutaneous closure of the PFO is recommended.

The Clinical Guidelines for Stroke Management, Chapter 4 Secondary Prevention

German Guidelines5 - 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.

Cryptogenic Stroke and Patent Foramen Ovale (abridged and translated version)

Canadian Guidelines6 - 2017

The Heart and Stroke Foundation Canadian Stroke Best Practice Committees recommend 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:

  1. Age 18–60 years;
  2. The diagnosis of the index stroke event is confirmed by imaging
  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 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. Kleindorfer, D. et al, 2021 Guideline for the Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack. A Guideline from the American Heart Association/American Stroke Association. Stroke. 2021;52:00–00. DOI: 10.1161/STR.0000000000000375
  2. 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.
  3. 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/
  4. Australian Stroke Foundation. Clinical Guidelines for Stroke Management. Chapter 4: Secondary Prevention. https://informme.org.au/Guidelines/Clinical-Guidelines-for-Stroke-Management-2017
  5. Diener et al. Neurological Research and Practice https://doi.org/10.1186/s42466-019-0008-2
  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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