Use of the Amplatzer Septal Occluder device has been a successful surgical alternative for pediatric heart patients suffering from atrial septal defects. The device, is currently undergoing FDA clinical trials at MUSC’s Pediatric Catherterization Lab.

An innovative alternative to expensive, invasive open heart surgery for children suffering from an atrial septal defect, or “hole” in an inner wall of the heart, continues to yield successful results since the procedure was first tried in August.

The procedure, which is performed during heart catheterization, was first introduced at MUSC in FDA (Food and Drug Administration) clinical trials with the device’s manufacturer, AGA Medical Corporation and principal investigator Wolfgang Radtke, MD., assistant professor of pediatric cardiology. To date, 15 children with the congenital abnormality have had the non-surgical atrial septal defect procedure performed.

An trial septal defect is an abnormal opening in the heart that occurs in the wall or septum that divides the upper chamber of the heart. A catheter is inserted into the heart and the compressed device is delivered through a tiny tube. This catheter procedure eliminates the need for open heart surgery, allowing patients to go home the next day. Apart from being a less stressful, pain-free procedure, the patient can recover quickly, sometimes resuming physical activity within three days.

The device is a self-expandable double disk made from a Nitinol wire mesh. The two disks are linked together by a short connecting waist which clamp the defect, creating a tight seal. Prior to catheterization and implantation, a transesophageal echocardiography is performed to determine the exact size and location of the defect. Previously, similar devices have been produced and tested, but none were suitable to accommodate sizes for infants and small children.

Since September 1995, more than 450 patients have undergone successful implantation of the device in Europe and Australia. As part of post-operative process , patients are monitored for up to 24 hours following the procedure. Patients return after three months and then yearly to complete a physical examination and echocardiography procedure.