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The United States and countries around the world have updated their stroke guidelines to recommend PFO closure. See below for brief summaries of the guidelines, as well as links to the full publications.
Recommendation: In patients between the ages of 18 and 60 with a prior PFO-associated stroke, the SCAI guideline panel recommends PFO closure rather than antiplatelet therapy alone (strong recommendation, moderate certainty of evidence).
This recommendation is independent of patient anatomy (i.e., presence of ASA, size of shunt). A RoPE score of ≥ 7 may identify patients who are likely to receive greater benefit from PFO closure.
The guidelines were developed by SCAI, with representation from the American Academy of Neurology (AAN).
In the 2021 Guideline for the Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack, the AHA/ASA recommend PFO closure in select patients.
Recommendation: In patients 18 to 60 years of age with a non-lacunar ischemic stroke of undetermined cause, despite a thorough evaluation and a PFO with high-risk anatomic features, it is reasonable to choose closure with a transcatheter device and long-term antiplatelet therapy over antiplatelet therapy alone for preventing recurrent stroke. (Recommendation level 2b, level of evidence B-R).
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:
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:
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 , Saver et al. 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.
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):
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:
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]:
In addition to guidelines, there have also been position papers and consensus statements published regarding PFO closure in patients with cryptogenic stroke.
In patients who have suffered a stroke that may be PFO-associated, it’s important to screen for atrial fibrillation (AF). Given the lack of clear and specific guidance available on the optimal monitoring modality and duration, an expert panel set out to provide a straightforward and personalized approach to AF detection in these patients.
The new framework provides:
Monitoring duration may be reduced based on presence of high-risk PFO features (i.e. large shunt and/or ASA).
Guidelines and consensus statements emphasize the importance of multidisciplinary clinical decision-making regarding PFO closure. This multidisciplinary team – also known as the Heart and Brain Team – involves several clinical specialties, including neurology and cardiology, as well as the patient.
This review provides insights into the implementation, composition, organization and operation of a heart and brain team, as well as metrics to evaluate the team’s role.
An impactful Heart and Brain team requires upfront networking, implements an organized structure and routinely assesses effectiveness. When done well, patient waiting time and risk of loss to follow up is reduced.
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:
It was emphasized that clinical evidence for the above aspects should be collected among Asian-Pacific patients.
EuroIntervention published a European position paper regarding the management of patients with PFO. The paper was developed by 8 scientific societies and international stroke experts.
“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.”