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A Hole in the Heart - Patent Foramen Ovale (PFO)

When a person has stroke or transient ischemic stroke (TIA) "out of the blue" with no obvious risk factors, doctors often check to see if the event was caused by a "hole" in the heart called a patent foramen ovale (PFO)? About 1 in 5 Americans has a PFO. Many don't know it until a medical condition like a stroke or TIA occurs. PFOs often have no symptoms but they may increase your risk for stroke and TIA. Many PFO-related strokes are called cryptogenic, meaning they have no apparent cause.

What is a PFO?
All people are born with flap-like openings in their hearts. But, for most, the opening closes by itself shortly after birth.

In some people, an open flap remains between the two upper chambers of the heart (the left and right atria). This opening can allow a blood clot from one part of the body to travel through the flap and up to the brain, causing a stroke.

What can you do about it?
The first step is to get a diagnosis. An ultrasound of the heart, called an echocardiogram, can show doctors if a PFO is present.

The second step is to ask a doctor about treatment options. Currently, there are two main treatment methods for PFO: medicines or PFO closure, which can include open-heart surgery or a newer procedure that closes the flap without major surgery.

Medications don't treat the actual PFO, but they can control clotting factors in the blood so stroke-causing blood clots are less likely to form in the first place.

Open-heart surgery is rarely used for people who don't respond to the drugs. But, as with any major surgery, patients and their doctors need to weigh the risks of the surgery with the benefits before moving ahead with this treatment option. In recent years, a new approach has been developed enabling doctors to seal the PFO without major surgery. An implanted closure device, which can resemble a tiny two-ended umbrella, is delivered to the PFO using a small tube threaded to the heart from a vein in the thigh. The implant is inserted through the flap and released from the tube. It expands and tissue grows in and around the implant to seal the PFO from both sides. This procedure requires minimal recovery time. Currently, the U.S. Food and Drug Administration (FDA) allows this treatment method only for "humanitarian" uses, meaning that the procedure is only used for people who don't respond to the medicines and have already had a second stroke.

On-going Research
Which is the better treatment option: medicine or PFO closure? That question still needs to be answered.

The good news is that research now is being conducted to see if PFO-closure implant procedures are better than medications at helping reduce the risk of recurrent stroke in stroke and TIA survivors. But, the only way scientists will have meaningful research studies is if they have enough people participating.

For more information about treatment options for the PFO through a clinical trial, you can get more information about clinical trials by visiting the Clinical Trials Resource Center.

Clinical trial participants are carefully evaluated by doctors and receive extensive follow-up care. During treatment, patients may also receive the latest version of a current PFO closure device. The FDA has approved a prior version of this device and more than 15,000 people around the world have been treated with this procedure. Clinical trial participation is helping medical science find the most effective treatment to lower the number of PFO-related strokes and TIAs

Additional Resources

Visit the website for the National Institutes of Health.

This web page was sponsored by an unrestricted educational grant from AGA Medical.


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