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.

Key Questions:

  • 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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