May 4, 2001 In the past, many people with holes in their hearts have faced a lifetime of anticoagulant therapy or even open heart surgery in order to reduce their high risk of stroke. But now there is a new option -- a minimally invasive procedure using the revolutionary CardioSEAL® Septal Occlusion System that can now close a variety of intracardiac holes in about half an hour. The Emory Heart Center is among the first centers in the nation where the CardioSEAL® procedure is available. Emory Heart Center Director Douglas C. Morris, M.D., and cardiologist Peter C. Block, M.D., working in collaboration with pediatric cardiologist Robert N. Vincent, M.D., lead the Emory University School of Medicine team using the device.
"It’s very exciting to be able to repair hearts in a much less invasive way than in the past," Dr. Block says.
Constructed of a biocompatible metal alloy known as MP35n and covered with a polyester fabric, CardioSEAL® is a small umbrella shaped object with four independent arms that radiate outwards from a connection in the center. Spring coils along the arms allow the device to be collapsed as it is carried on a catheter to the heart, guided through the femoral vein by an Emory cardiologist using echocardiographic imaging.
When the device reaches the site of the cardiac hole, the springs allow it to be opened and the slight tension the springs create holds it in place. In less than a month, tissue grows into the fabric and the implant becomes, literally, a part of the heart.
CardioSEAL® is FDA approved to close three kinds of cardiac holes -- Patent Foramen Ovales (PFOs), Ventricular Septal Defects (VSDs) and Fenestrated Fontans (FF s). PFOs are holes in the heart needed before birth to transfer oxygenated blood from the umbilical cord to the unborn child; if a PFO remains open after birth, it creates a pathway for blood clots. VSDs are abnormal openings between the heart’s chambers that can lead to heart failure. An FF defect results from the Fontan procedure which corrects congenital cardiac defects in people born with three chambered hearts but creates a fenestration, or window-like hole, that eventually must be closed.
The CardioSEAL® procedure takes place in the Emory University Hospital cardiac catheterization lab with patients placed under either or general or local anesthesia. Most can go home the next morning. The risks associated with the procedure are, for the most part, similar to those associated with other heart catheterization procedures, according to Dr. Block.
"The success of this minimally invasive procedure in helping people with PFOs who have experienced strokes has been particularly dramatic," Dr. Block says.
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