From the Guidelines
PFO closure is recommended for carefully-selected patients with a recent ischemic stroke or TIA attributed to a PFO, who are between 18-60 years old, and meet specific criteria, including a nonlacunar embolic ischemic stroke or a TIA with positive neuroimaging or cortical symptoms, and have been evaluated by a neurologist or clinician with stroke expertise 1, 2. The procedure involves placing a device through a catheter to close the abnormal opening between the heart's upper chambers. Before the procedure, patients typically undergo antiplatelet therapy with aspirin 81-325mg daily. During the procedure, patients receive anticoagulation with heparin. After PFO closure, patients should take dual antiplatelet therapy with aspirin 81-325mg daily plus clopidogrel 75mg daily for 1-6 months, followed by aspirin alone for at least 5 years, as supported by the findings of the CLOSE trial and the REDUCE trial 2. The procedure is generally safe with a success rate over 95% and complication rate under 5%. Common complications include atrial fibrillation, device embolization, and bleeding. PFO closure is effective because it prevents paradoxical embolism, where blood clots pass from the right to left atrium through the PFO and potentially cause stroke. Not all patients with PFO need closure; the decision should be individualized based on stroke risk factors, PFO characteristics, and patient preferences after discussion with a cardiologist and neurologist. It is essential to note that PFO closure is not recommended for patients with stroke or TIA who are aged >60 years, and those at any age whose PFO is most likely incidental rather than causal for the index stroke event, as stated in the Canadian stroke best practice recommendations 1. In such circumstances, antiplatelet therapy alone is recommended for secondary stroke prevention, unless there is a separate evidence-based indication for anticoagulant therapy. Patient counseling and shared decision-making, taking into account patient values and preferences, are important considerations, as emphasized in the guidelines 2.
From the Research
Procedure for Patent Foramen Ovale (PFO) Closure
The procedure for PFO closure is relatively straightforward to learn compared to other cardiology procedures, but it must be performed meticulously to minimize the risk of post-procedural complications 3.
- A double-disk occlusion device is usually used, followed by antiplatelet therapy 3, 4.
- The Food and Drug Administration (FDA) has approved the Amplatzer PFO Occluder and the GORE Cardioform Septal Occluder for percutaneous closure in patients predominately between ages 18 and 60 years with a cryptogenic stroke due to presumed paradoxical embolism 5.
- Current guidelines recommend closing a PFO in patients who have experienced a cryptogenic or cardioembolic stroke, have a high-risk PFO, and are aged between 16 and 60 years (class A recommendation, level I evidence) 3, 4.
Patient Selection for PFO Closure
Patient selection is crucial for PFO closure, and the decision to close a PFO should be made on a case-by-case basis, especially for conditions other than stroke 3, 4.
- The RoPE Score index can help determine the likelihood that an existing PFO is related to a cryptogenic stroke, and guide the clinician and patient when contemplating percutaneous PFO closure 5.
- Imaging of the intracranial arteries, cervical, and aortic arch vessels should be performed to rule out other causes of stroke, and prolonged monitoring should be performed to rule out atrial fibrillation 5.
- A work-up for a hypercoagulable state should also be considered, including an ultrasound of the lower extremities or consideration of deep pelvic vein thrombosis 5.
Efficacy of PFO Closure
The efficacy of PFO closure has been demonstrated in several trials, including the CLOSE, RESPECT, and REDUCE trials 3, 4.