The foramen ovale is a small hole or channel in the wall between the top two heart chambers that allows oxygenated blood to mix in a baby before it is born. After a baby is born, the foramen ovale typically closes although for perhaps 20-30% of us, a channel persists and is termed a patent foramen ovale (PFO). In unusual situations, a clot from the veins of the body can pass across this channel and find its way into the brain circulation.
A catheter can also be used to guide the placement of a patent foramen ovale closure device - which becomes a permanent implant - that will close the hole (prevent the flaps from opening) in the heart wall. The catheter is initially inserted into a large vein through a small incision made usually in the inner thigh (groin area). The catheter is slowly moved into the heart and the PFO closure device is moved through the catheter to the heart and specifically to the location of the heart wall defect.
Once in the correct location, the PFO closure device is allowed to expand its shape to straddle each side of the hole. The device will remain in the heart permanently to stop the abnormal flow of blood between the two atria chambers of the heart. The catheter is then removed and the procedure is complete. The cardiac catheterization procedure for a PFO closure typically takes 2 to 4 hours to complete. A local anesthetic is used to numb the groin area where the catheter was inserted. Use of general anesthesia or sedation by IV is situation dependent — depending on doctor preference and particular patient needs.
Blood thinning medications including antiplatelet agents such as aspirin and anticoagulant medications such as warfarin are typically used. The hole can also be closed with heart surgery or with newer devices that are inserted at the time of a catheterization. Some approaches may be superior to others in stroke prevention and clinical research is actively ongoing to determine the best approach.
No. At the present time, the FDA has approved the use of some devices for only very specific indications. The catheter-based procedure has not been compared with medical therapy (the blood-thinning drugs aspirin, warfarin) for PFO closure in the “gold standard” format for comparison, a clinical trial. However, many patients are eligible for the procedure who enroll in clinical trials that are being performed to assess the safety and effectiveness of this approach.
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This information is provided by the Cleveland Clinic and is not intended to replace the medical advice of your doctor or healthcare provider. Please consult your healthcare provider for advice about a specific medical condition. This document was last reviewed on: 05/18/2015