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Lourdes Interventional Cardiologists Offer New Device to Help Reduce Stroke Risk in Patients with Heart Defect

Our Lady of Lourdes Medical Center, a designated comprehensive stroke center, recently performed its first procedures using a device to close a hole between the chambers of the heart. The hole, called a patent foramen ovale (PFO), is a congenital heart defect and can cause ischemic strokes.

Ischemic strokes are the result of a blockage within a blood vessel supplying blood to the brain. It’s estimated that approximately 100,000 Americans suffer a PFO-related stroke each year. 

The device that Lourdes interventional cardiologists are using is called a GORE CARDIOFORM Septal Occluder to permanently close the hole. It is made of fabric similar to that found in durable waterproof clothing.

“Many people don’t realize that strokes could be caused by a hole between the top chambers of the heart,” said Lourdes interventional cardiologist Ibrahim Moussa, DO, FACC, FSCAI, RPVI. “With a PFO, a clot can pass from the right side of the heart to the left and block a blood vessel supplying the brain, causing a stroke. By closing the PFO minimally invasively with a device like GORE CARDIOFORM Septal Occluder, we can reduce the risk of a stroke.”

Surgery to close a PFO is usually not the first line of defense. Most people live normally without symptoms, even though blood is leaking from the right atrium to the left. PFO patients are typically prescribed a blood thinner to prevent a clot from forming should their case warrant treatment. However, a patient’s medical team, including a cardiologist and neurologist, may recommend closing the hole.

To close the hole with the GORE CARDIOFORM Septal Occluder, Lourdes interventional cardiologists use a special catheter to insert the CARDIOFORM occluder into a vein in the groin and thread it to the left side of the heart. The occluder is deployed in two stages, first closing the right side of the hole and then the left. The catheter is then removed.

The device is made of a nickel-titanium metal alloy frame covered by a soft, conformable material called ePTFE. It comes in different sizes depending on the width of the hole.

“Over time, the occluder is covered with heart tissue and becomes part of the body,” said Dr. Moussa. “Patients typically spend overnight in the hospital and return to normal activities within a few days.”

Patients continue to take a blood thinner to further prevent blood clotting and other potential causes of stroke.

The device was first developed by GORE, the maker of GORE-TEX fabric, to close another type of hole in the heart called an atrial septal defect.

In March 2018, the U.S. Food and Drug Administration approved its use for PFO. The REDUCE trial found a 77 percent reduction in recurrent ischemic stroke in patients who underwent PFO closure with a GORE device in conjunction with antiplatelet therapy compared to antiplatelet therapy alone (with an average follow-up of 3.4 years).

“A stroke can happen to anyone. Our first patient with this device was a 28-year-old,” said Dr. Moussa. “We are pleased to offer this new treatment to the South Jersey community.”

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