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Saint Barnabas Medical Center Performs North Jersey’s First Non-Surgical Repair of Hole in the Heart LIVINGSTON, NJ -- Twenty-eight-year-old Mark Gilmore of Newark had just dropped his older daughter off at her grandmother’s house and then stopped by a car dealership with his girlfriend. Suddenly, while walking in the parking lot, the right side of his body became weak and he lost his balance. At the same time, his vision blurred and he began to see stars. Then he could barely see anything. When he tried to respond to his girlfriend’s alarmed questions, his speech was slurred and rambling. He felt as though he were delirious. Mr. Gilmore was taken to his local emergency room where numerous tests were performed. “They couldn’t figure out what happened,” he relates, “until a cardiologist came in and said that I had a stroke.” After learning about a new non-surgical procedure to correct the condition, Mr. Gilmore – whose stroke was caused as a result of a hole in his heart from birth -- became the first person in northern New Jersey to have his heart repaired at The HEART HOSPITAL of New Jersey at Saint Barnabas Medical Center. Called the CardioSEALâ or “clamshell device,” the new procedure offered a non-surgical method to close the hole. The clamshell closure of the hole, a medical condition known as patent foramen ovale (PFO), would reduce Mr. Gilmore’s risk of further stroke to approximately 1 percent a year, the same as surgery. In addition, Mr. Gilmore would not have to take a daily blood thinner for the rest of his life. “There are a million strokes in the United States every year,” says Sabino Torre, M.D., the cardiologist at The HEART HOSPITAL who performed the new procedure. “The majority of them are caused by blockages in the carotid (neck) arteries. In some cases they are caused by a clot leaving the heart. In conditions like atrial fibrillation, clots may form in the heart – these are embolic strokes. Other causes include hypertension and in rare cases migraine headaches.” The remaining 20 percent of strokes are called cryptogenic – strokes without a clear cause. Of the 200,000 Americans suffering from cryptogenic strokes annually, 50 percent, or 100,000 are identified as having PFO, or a hole in the heart. The condition occurs after a baby is born and a flap located between two chambers of the heart fails to close. In most people, the flap closes once a newborn takes his or her first breath. However, in some individuals the hole remains patent (open) and under certain circumstances the door can swing open and clots can be released. “These blood clots (in Mr. Gilmore’s heart) were just waiting to be released into the left side of circulation and make their way to the brain,” says Dr. Torre. At first, Mr. Gilmore was given three treatment options. The first option was to do nothing, which would carry with it a 6 percent chance of a second stroke per year. The second option was major heart surgery to close the hole and reduce the stroke risk to 1 percent per year. The third option was to take a strong blood thinner, warfarin. The use of warfarin reduces the stroke risk to about 1 percent per year, the same as heart surgery, but Mr. Gilmore would have to take warfarin daily for the rest of his life with blood tests every month. He would also be subject to excessive bleeding in case of a cut, sports injury or motor vehicle accident, potentially leading to hemorrhage or even death. When Mr. Gilmore learned about the non-surgical minimally invasive Clamshell procedure, he knew that this was the best option possible. “I chose the new device because it was a way to take care of the problem directly,” says Mr. Gilmore. “It’s amazing what they can do with the new technology. I had the procedure on August 14 and I was out the next day.” The new minimally invasive technique utilizes a tiny fabric-and-spring device, reminiscent of a clamshell, called the CardioSEAL Septal Occluderâ. After anesthesia is administered, it is delivered to the heart in a catheter inserted in the groin and threaded through the veins to the heart. Once there, it is placed across the hole and its two parts are deployed so that they close together perfectly over the hole in order to keep it closed. The cardiologist uses an x-ray monitor and echocardiographic guidance in the cardiac catheterization laboratory to appropriately position the device. In the months after the procedure, tissue grows over the fabric so that it becomes part of the heart itself. To protect against clotting while the lining of the heart starts to grow over the metal and fabric device, patients must take aspirin and clopidogrel, a mild blood-thinner, for two to three months. The CardioSEAL Septal Occluderâ has been approved by the FDA for use in selected patients with PFO and a history of embolic stroke. The approval was obtained under the Human Device Exemption pathway. This fast track was established to provide a method for companies to receive approval for devices targeted for less common “orphan” conditions in smaller patient populations. Under these regulations, products are evaluated for safety and for probable benefit and must demonstrate both elements under clinical trial settings. Saint Barnabas is the first hospital in Northern New Jersey to offer the technology. Plans are underway this fall for the same clamshell technology to be available to pediatric cardiac patients at The HEART HOSPITAL at Newark Beth Israel Medical Center. For more information about the clamshell device, please call The HEART HOSPITAL of New Jersey at Saint Barnabas Medical Center at [ top ] |
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