Radial Artery Provides Reliable Conduit Option
Deborah Offers Nonsurgical Treatment for ASD

Traditionally, the only treatment for ASD had been open heart surgery, requiring incisions through the breastbone and heart muscle, use of cardiopulmonary bypass, and manual stitching or patching of the defect. Surgical repair typically lasts more than three hours, and requires a four- to five-day hospital stay and a significant post-operative recovery period.

However, with the recent FDA approval of AMPLATZER, patients now have an alternative. Manufactured by AGA Medical Corp., Minneapolis, MN, AMPLATZER is a self-expanding device comprised of two Nitinol-wire mesh discs, connected by a “waist” that corresponds to the size of the defect (U.S. waist sizes range from 4 mm to 38 mm). The discs and waist are lined with polyester fabric to inhibit blood flow and promote occlusion, and super-elastic properties allow the device to spring back and regain its shape after being compressed inside a sheath for catheter delivery.

The implantation procedure is performed in Deborah’s Catheterization Laboratory, where Cardiologists size the ASD and thread an AMPLATZER Septal Occluder of corresponding dimension onto the delivery cable. The delivery sheath is threaded through the femoral vein to the inferior vena cava, then up to the ASD. The delivery cable is then loaded into the sheath. Once the cable passes through the ASD, the distal disc is released into the left atrium and pulled back against the septum. The right atrial disc is then deployed. Once properly seated, the device is released from the delivery cable, and the cable and sheath are removed from the patient. The device’s two discs “clamp” against the septum; the waist fills the ASD. The procedure is completed in one to two hours, and typical post-procedure hospital stay is less than 24 hours. Because transesophageal echocardiography is used throughout the procedure to monitor device placement and confirm there is no effect on heart valves or pulmonary venous return from the lungs, patients undergo general anesthesia; however, patients are extubated before leaving the Catheterization Laboratory. Within three to six months, heart tissue will grow over the device, making it part of the heart wall.

According to Dr. Sperrazza, the procedure offers numerous benefits to ASD patients. “In addition to a procedure that lasts half as long, patients receiving the AMPLATZER device stay only one night in the hospital, and are back to their normal activities within several days. There is no exposure to cardiopulmonary bypass, no surgical incision scar, and pain and discomfort are minimal. The procedure also offers substantial savings compared with the overall cost of surgery,” said Dr. Sperrazza. “This device offers remarkable advantages to ASD patients, and Deborah is proud to be one of a handful of centers able to offer this alternative.”

It is expected that the AMPLATZER Septal Occluder will benefit a significant number of ASD patients. The American Heart Association estimates that 40,000 people annually are born with congenital heart defects, and 10 percent of those patients will have an ASD. Of those, as many as 2,500 will need repair. The AMPLATZER Septal Occluder is the first device of its kind to be approved for the treatment of ASD; prior, those patients would have been subject to surgical repair.

Besides approving AMPLATZER for the treatment of a secundum ASD, the FDA also approved its use for closing fenestrations, which are small holes made by cardiac surgeons when performing a Fontan procedure for the treatment of hypoplastic left heart syndrome and other single ventricle anatomy. Deborah also performed the State’s first device closure of a fenestration in December 1999.