Last updated June 7, 2022

Management of Patent Foramen Ovale

Percutaneous PFO closure versus medical therapy (antiplatelet or anticoagulation or composite)/no therapy in adults without a prior PFO-associated stroke

In persons experiencing migraines without a prior PFO-associated stroke, the SCAI guideline panel suggests against the routine use of PFO closure for the treatment of migraine. (C, M)
Remarks: Patients, particularly those with debilitating migraines who have failed to benefit from conventional medical therapy, who place a high value on the uncertain benefits of having their PFO closed and a lower value on the uncertain harms, may reasonably choose PFO closure.
620

In self-contained underwater breathing apparatus (SCUBA) divers with prior decompression illness (DCI) and without a prior PFO-associated stroke, the SCAI guideline panel suggests against the routine use of PFO closure to prevent DCI. (C, VL)
Remarks: Patients who place a high value on the potential, but uncertain, benefits of having their PFO closed and a lower value on risks may reasonably choose PFO closure.
620

In persons with platypnea-orthodeoxia syndrome (POS) and without a prior PFO-associated stroke, in whom other causes of hypoxia have been excluded, the SCAI guideline panel suggests PFO closure rather than no PFO closure. (C, VL)
Remarks: Patients who place a higher value on the risks of closure and a lower value on the uncertain benefits may reasonably decline PFO closure.
620

In persons with thrombophilia and without a prior PFO-associated stroke, the SCAI guideline panel suggests against the use of PFO closure in addition to antithrombotic therapy. (C, VL)
620

In persons with atrial septal aneurysm (ASA) and without a prior PFO-associated stroke, the SCAI guideline panel suggests against the use of PFO closure. (C, VL)
620

In persons with systemic embolism and without a prior PFO-associated stroke, in whom other embolic etiologies have been excluded, the SCAI guideline panel suggests PFO closure rather than medical therapy alone. (C, VL)
Remarks: Patients who place a high value on the risks and a lower value on the uncertain benefits may reasonably decline PFO closure.
620

In persons with a history of transient ischemic attack (TIA) and without a prior PFO-associated stroke, the SCAI guideline panel suggests against PFO closure. (C, VL)
Remark: Patients, particularly those with recurrent, high-probability TIAs, who place a high value on the uncertain benefits and a low value on procedural risks may reasonably choose PFO closure.
620

In persons with a history of deep vein thrombosis (DVT) and without a prior PFO-associated stroke, the SCAI guideline panel suggests against PFO closure. (C, VL)
620

Percutaneous PFO closure versus antiplatelet therapy in adults with a prior PFO-associated stroke

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. (S, M)
Remark: This recommendation is independent of patient anatomy (ie, presence of ASA, size of shunt) due to limited clinical data on these sub-populations. A RoPE (risk of paradoxical embolism) score ≥7 may identify patients who are likely to receive greater benefit from PFO closure.

This recommendation also applied to patients with high-risk anatomy (ie, ASA) and patients evaluated with a RoPE score.
620

In patients 60 years or older with a prior PFO-associated stroke, the SCAI guideline panel suggests PFO closure rather than long-term antiplatelet therapy alone. (C, VL)
Remark: Patients in this age group who place a lower value on the uncertain benefits of PFO closure and a higher value on the possible procedure related risks may reasonably decline PFO closure.
620

In patients with a history of atrial fibrillation (AF) who have had an ischemic stroke, the SCAI guideline panel suggests against the routine use of PFO closure. (C, VL)
620

In patients with thrombophilia on antiplatelet therapy and not anticoagulation therapy and who have had a prior PFO-associated stroke, the SCAI guideline panel suggests PFO closure rather than antiplatelet therapy alone. (C, VL)
Remark: Patients who place lower value on the uncertain benefits of PFO closure and a higher value on the possible procedure related risks may reasonably decline PFO closure.
620

The SCAI guideline panel makes no recommendation regarding PFO closure based on prolonged time since stroke. (U, U)
620

Percutaneous PFO closure versus anticoagulation therapy in adults with a prior PFO-associated stroke

In patients between the ages of 18 and 60 with a prior PFO-associated stroke and no other indication for treatment with anticoagulation, the SCAI guideline panel suggests PFO closure plus antiplatelet therapy rather than anticoagulation therapy alone. (C, L)
Remark: This recommendation is independent of patient anatomy (ie, presence of ASA, size of shunt) due to limited clinical data on these sub-populations. A RoPE score ≥7 may identify patients who are likely to receive greater benefit from PFO closure.

This recommendation also applied to patients with high-risk anatomy (ie, ASA) and patients evaluated with a RoPE score.

620

In patients 60 years or older with a prior PFO-associated stroke and no other indications for treatment with anticoagulation, the SCAI guideline panel suggests PFO closure plus antiplatelet therapy rather than long-term anticoagulation therapy alone. (C, VL)
Remark: Patients in this age group who place a lower value on the uncertain benefits of PFO closure and a higher value on the possible procedure related risks may reasonably decline PFO closure.
620

The SCAI guideline panel makes no recommendation regarding PFO closure based on prolonged time since stroke. (U, U)
620

Percutaneous PFO closure plus lifelong anticoagulation versus anticoagulation alone in adults with a prior PFO-associated stroke

In patients with thrombophilia and a prior PFO-associated stroke, the SCAI guideline panel suggests PFO closure in addition to lifelong anticoagulation therapy rather than anticoagulation therapy alone. (C, VL)
Remark: Patients who need long term anticoagulation and who place a lower value on the uncertain benefits of PFO closure and a higher value on the possible procedure related risks may reasonably decline PFO closure.
620

In patients with a history of DVT requiring lifelong anticoagulation and a concomitant PFO-associated stroke, the SCAI guideline panel suggests PFO closure plus lifelong anticoagulation rather than lifelong anticoagulation alone. (C, VL)
Remark: Patients who need lifelong anticoagulation and who place a lower value on the uncertain benefits of PFO closure and a higher value on the possible procedure related risks may reasonably decline PFO closure.
620

In patients with a history of pulmonary embolism (PE) requiring lifelong anticoagulation and a concomitant PFO-associated stroke, the SCAI guideline panel suggests PFO closure plus lifelong anticoagulation rather than lifelong anticoagulation alone. (C, VL)
Remark: Patients who need lifelong anticoagulation may place a lower value on the uncertain benefits of PFO closure and a higher value on the possible procedure related risks and may reasonably decline PFO closure.
620

Post-procedure management of patients undergoing percutaneous PFO closure with a regimen of 1 month of aspirin plus clopidogrel followed by 5 months of aspirin versus another antiplatelet regimen or anticoagulation

The SCAI guideline panel makes no recommendation regarding duration beyond 1 month of dual antiplatelet therapy after PFO closure. (U, U)
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Recommendation Grading

Overview

Title

Management of Patent Foramen Ovale

Authoring Organization

Publication Month/Year

May 19, 2022

Document Type

Guideline

Country of Publication

US

Document Objectives

Patent foramen ovale (PFO) is a vestigial congenital cardiovascular structure present in around 25% of adults. In most cases, PFO is entirely benign and requires no treatment. However, it may cause serious complications under certain circumstances. These evidence-based guidelines from the Society for Cardiovascular Angiography and Interventions (SCAI) aim to support patients, clinicians, and other stakeholders in decisions about management of PFO.

Inclusion Criteria

Male, Female, Adult, Older adult

Health Care Settings

Emergency care, Hospital, Operating and recovery room

Intended Users

Nurse, nurse practitioner, physician, physician assistant

Scope

Treatment, Management

Diseases/Conditions (MeSH)

D054092 - Foramen Ovale, Patent

Keywords

pfo, patent foramen ovale, PFO closure

Source Citation

DOI: https://doi.org/10.1016/j.jscai.2022.100039