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A Cardi-O-Fix? ASD occluder has two disks and a connecting waist. It closes atrial septal defects of various sizes. Shown here is a ¡°capless¡± occluder that has the advantage of speed up growth of neoendocardium and the endothelialization process.
 
Cardi-O-Fix ASD Occluder is a self-expandable device made of shape-memorizing Nitinol wire mesh that can be implanted in the defect part of the atrial septum using a catheter delivery system. An ASD occluder has two disks joined by a connecting waist that corresponds to the diameter of the defect. The left atrial disk has a larger diameter than the right atrial disk. Polyester patches are placed in each disk and the waist to aid in occlusion of the shunt.

The septum is the wall that separates the right and left sides of the heart. A hole in the wall between the two upper chambers is called an atrial septal defect, or ASD. There are three different kinds of ASDs. The most common form of ASD is the secundum defect which usually occurs as an isolated defect. The primum ASD is associated with a cleft in the mitral valve which may also cause the valve to leak. The third kind of ASD is the sinus venosus defect, located in the superior portion of the atrial septum and typically associated with abnormal drainage of the right upper pulmonary vein.

Atrial septal defects can vary greatly in size. Some ASDs will close on their own and no surgery is needed. Some ASDs are closed in the catheterization lab and do not require open-heart surgery. Many ASDs are not detected until adulthood. Left untreated for decades, potential problems include lung disease, exercise intolerance, heart rhythm abnormalities, shortened life expectancy and the increased risk of a stroke.

 
Implantation of the ASD occluder, from A to E: The delivery catheter is positioned across the atrial defect; the left atrial disc with the self-centering connecting stalk is delivered; the device is withdrawn so that the connecting stalk is within the ASD and the left disc is firm against the atrial septum; the right atrial disc is delivered, and the delivery cable is disconnected from the device. Until the delivery cable is disconnected, the device can be withdrawn back into the catheter and removed from the body.
 

Starway Medical¡¯s Cardi-O-Fix septal occluder offer several advantages over competing designs. Because of its Nitinol (memory wire) construction and unique design, it can be withdrawn back into the catheter and removed from the body if proper positioning in the heart is not possible. The device is available in a range of sizes from 4 mm to 40 mm; the appropriate size allows the connecting stalk to fill the ASD, center the device, ensure complete closure and allow the atrial disks to be relatively smaller than those of competing designs.

The procedure is currently performed under general or local anesthesia to allow for transesophageal echo during the procedure. The patient is observed overnight and discharged the next morning. Patients take aspirin daily for six months until endothelialization of the device is complete. Follow-up consists of an echocardiogram and a chest x-ray at six months and one year. Current criteria for such an operation include a defect size of less than or equal to 36 mm and a 4 mm rim of atrial septal tissue surrounding the defect.

 
 

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