What is the evidence for patent foramen ovale (PFO) closure in the setting of cryptogenic stroke?

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Last updated: April 30, 2025View editorial policy

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From the Guidelines

Peyton Freeman should undergo patent foramen ovale (PFO) closure in the setting of cryptogenic stroke, as the most recent and highest quality evidence suggests it reduces the risk of recurrent stroke by approximately 50-60% compared to medical therapy alone. The evidence supporting this recommendation comes from multiple randomized clinical trials, including the CLOSE trial 1, which demonstrated that PFO closure was superior to medical therapy for prevention of stroke recurrence in carefully-selected patients. For PFO closure to be considered, several criteria should be met: confirmation of a cryptogenic stroke after thorough evaluation has ruled out other causes, detection of a PFO on echocardiography (typically with bubble study), and ideally features suggesting the PFO is likely pathogenic such as an atrial septal aneurysm or large shunt. Some key points to consider in the decision-making process include:

  • The patient's age, as PFO closure is recommended for those 60 years or younger 1
  • The presence of an atrial septal aneurysm or a large interatrial shunt, which may increase the likelihood of paradoxical embolism 1
  • The patient's ability to undergo the procedure safely, with a low complication rate (1-3%) 1
  • The importance of patient counseling and shared decision-making, taking into account patient values and preferences 1 Following PFO closure, patients typically require dual antiplatelet therapy with aspirin 81-325mg daily and clopidogrel 75mg daily for 1-6 months, followed by aspirin monotherapy indefinitely. The mechanism by which PFO contributes to stroke is presumed to be paradoxical embolism, where a venous thrombus passes through the PFO into the arterial circulation, bypassing the lungs which normally filter such emboli.

From the Research

Evidence for Peyton Freeman of Valley Closure in Cryptogenic Stroke

  • The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is supported by several studies 2, 3, 4.
  • A multinational trial involving patients with a PFO who had had a cryptogenic stroke found that PFO closure combined with antiplatelet therapy was associated with a lower risk of recurrent stroke compared to antiplatelet therapy alone 2.
  • A systematic review and meta-analysis of randomized controlled trials found that PFO closure was associated with a lower risk of recurrent stroke compared to antithrombotic therapy (antiplatelet therapy or anticoagulation) 3.
  • The effect of PFO closure on stroke recurrence was found to be larger in patients with atrial septal aneurysm or large shunt compared to patients without these anatomical features 3.
  • However, PFO closure was also associated with an increased risk of device complications and atrial fibrillation 2, 3, 5.
  • A meta-analysis of randomized controlled trials found that anticoagulation conveyed no net benefit in prevention of recurrent stroke compared to antiplatelet treatment, and was associated with a non-significant higher risk of major bleeding 6.
  • The use of the Amplatzer PFO Occluder was found to result in significant stroke-prevention benefit over medical therapy alone 5.

Patient Selection for PFO Closure

  • The selection of patients for PFO closure is crucial, and factors such as the presence of atrial septal aneurysm or large shunt may influence the decision to undergo closure 3, 4.
  • The RoPE score may help in selecting patients who would benefit from anticoagulation 6.
  • Further trials are needed to delineate the risk/benefit profile of anticoagulation and to determine the optimal antithrombotic strategy for patients with cryptogenic stroke and PFO 6.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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