Health Problem: A patent foramen ovale (PFO) is a persistent, flap-like opening between the atrial septum primum and secundum. In 25% of adults, the foramen ovale remains open, or patent. The presence of a PFO has no therapeutic consequence in otherwise healthy adults; however, right-to-left shunting can generate thrombus, with the potential for embolism to the brain or coronary arteries causing stroke or transient ischemic attack (TIA).
Technology Description: Transcatheter occlusion with a permanently implanted device has been proposed as an alternative or addition to long-term anticoagulant therapy for the treatment of PFOs associated with cryptogenic stroke.
Controversy: Since a direct association between PFO and cryptogenic stroke is suspected but unproven, it is unknown whether transcatheter closure of PFO would have an impact on the incidence of cerebrovascular events.
- How does transcatheter closure of PFO compare with medical treatment at reducing the recurrence of stroke and TIA in patients with cryptogenic stroke?
- How do transcatheter closure devices compare with each other for reducing the recurrence of stroke and TIA in patients with PFO and cryptogenic stroke?
- Are transcatheter PFO occluders safe?
- Have definitive patient selection criteria been identified for transcatheter PFO occluders?
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