BEGIN YOUR JOURNEY TOWARDS PREVENTING CRYPTOGENIC STROKE
If you’ve had a stroke due to an unknown cause, learn how you may be able to prevent another with the Amplatzer™ PFO Occluder.
Options that can help prevent recurrent stroke in patients with an ischemic, cryptogenic stroke and a patent foramen ovale (PFO) include closure of the PFO by a percutaneous device, medical therapy with antithrombotic agents and, in rare cases, a surgical approach.
Closure of a PFO may prevent paradoxical embolism by preventing a venous thrombus from passing through the PFO and thereby reducing the risk of recurrent stroke. While some results are conflicting, evidence from the most recent randomized controlled trials now suggests that PFO closure is effective in reducing the risk of recurrent stroke for select patients with cryptogenic stroke.
For patients who are ≤60 years old, have a PFO and have experienced an ischemic stroke, PFO closure may be warranted. A critical piece in determining if a patient can benefit from PFO closure is ensuring that a comprehensive stroke workup is completed, concluding that no other evident source of stroke can be found, and the evaluation suggests that the embolism passed through the PFO.
Patients with PFO who have an ischemic stroke or transient ischemic attack (TIA), who have not undergone PFO closure, should be treated with all appropriate risk reduction strategies, most importantly, antithrombotic therapy. Other measures include lifestyle modification (diet and exercise), blood pressure reduction and statins (if indicated).
For most patients with an embolic-appearing cryptogenic stroke and a PFO who do not have device closure, antithrombotic therapy with antiplatelet agents is recommended¹.
Another antithrombic option is anticoagulation. However, recent trials that explored anticoagulation treatment for patients with an Embolic Stroke of Unknown Source (ESUS) were negative.² Anticoagulation is indicated for most patients with an ischemic, cryptogenic stroke and PFO who have evidence of acute deep vein thrombosis (DVT), pulmonary embolism, other venous thromboembolism (VTE) or a hypercoagulable state.
For patients aged ≤60 years who have had a cryptogenic stroke and a PFO with no other evident source of stroke and who have a concurrent indication for cardiac surgery, surgical closure of PFO via standard or minimally invasive techniques for secondary stroke prevention may be an alternative to percutaneous PFO closure.
The reported efficacy of surgical closure of a PFO in patients with prior cerebrovascular ischemic events has been variable, and randomized trials comparing surgical PFO closure with percutaneous closure or with medical therapy have not been performed.
Neurologists and cardiologists should discuss consideration of the PFO closure procedure, including benefits, risks and alternative treatment options with the patient. The patient should understand the immediate and long-term potential benefits and risks of treatment options to make a well-informed decision that considers their values and preferences.
Find out how you can reduce the risk of another stroke with PFO closure.
Exclusions to device closure
Please see list of contraindications in the IFU.