PFO Basics

PFO Related Terms

Here are common terms related to PFO.

  • Fetal circulation:
    The blood circulation in the fetus before birth. A normal part of the fetal circulation in all people is an open, i.e. patent, foramen ovale allowing blood to bypass the non-functioning lungs.
    • Circulation:
      The movement of blood through the vessels of the body that is induced by the pumping action of the heart and serves to distribute nutrients and oxygen to and remove waste products from all parts of the body
    • Circulation in Merriam-Webster’s Medical Dictionary(accessed: May 11, 2010)
  • Shunting:
    Diversion of blood flow thru an abnormal opening or pathway
  • Clinical syndrome:
    A constellation of symptoms, physical exam findings, and medical test results that characterize a disease or disorder.
  • Cryptogenic Stroke:
    Stroke of undetermined cause.
    • Classification of subtype of acute ischemic stroke. Definitions for use in a multi-center clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Adams HP Jr; Bendixen BH; Kappelle LJ; Biller J; Love BB; Gordon DL; Marsh EE 3rd. Stroke 1993 Jan;24(1):35-41.
  • Hypoxemia:
    Insufficient or abnormally low oxygenation of blood
  • Decompression illness:
    Symptoms and physical findings upon ascending from a deep underwater dive that are caused by nitrogen bubbles forming in the blood and tissues
  • High altitude sickness:
    A general term including different disorders occurring at high altitude. Acute mountain sickness, high-altitude pulmonary edema, and high-altitude cerebral edema are the three major clinical syndromes.
  • Sleep apnea:
    A medical condition including repeated abnormal pauses in breathing. Obstructive sleep apnea i(OSA) includes the occurrence of obstruction of the airway to the lungs.
  • Catheter-based therapies:
    Catheters, thin flexible tubes, are inserted in the body and used for delivering therapies such as medications, electrical energy, or implanting medical devices, like a PFO closure device.
  • Multi-center randomized trials:
    A type of scientific study to determine the relative merits of two or more different treatments. Patients are assigned randomly (by chance alone) to one of the treatments. The study is performed at multiple different medical sites.
  • Sham procedure:
    A procedure is performed that closely resembles the true procedure but the main element of the real procedure is omitted. For a PFO closure procedure, a sham procedure can involve anesthetizing the patient, making a nick over the vein in the neck, but not actually implanting a PFO device. The goal is to have the patient blinded, i.e. not knowing whether or not they have received the device.
  • Transient ischemic attack:
    A neurological event with the signs and symptoms of a stroke but only transient in duration and without permanent brain damage.
  • Paradoxical embolism:
    The passage of a clot from its origin in the venous system to a location in the arterial system often resulting in obstruction of the artery.
  • Off-label use:
    The use of a medication or medical device for an unapproved indication. The regulations of the Food and Drug Administration (FDA) permit physicians to use medications and devices for other than their intended indication. “If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects. Use of a marketed product in this manner when the intent is the “practice of medicine” does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB).”
    • Read more from the FDA
  • Secundum atrial septal defect:
    A type of heart defect, i.e. lack of cardiac tissue, in the wall separating the left and right upper heart chambers, the atria.
  • CE Mark approval:
    “The CE marking (also known as CE mark) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements. CE stands for Conformité Européenne, “European conformity” in French.”