In February, 2002, the US Food and Drug Administration (FDA) approved two devices designed to help children born with congenital heart defects. The CardioSEAL Septal Occlusion System and the Amplatzer Septal Occluder are designed to repair holes in the heart when a child cannot undergo surgery.
The heart has four chambers—the upper two are the right and left atria and the lower two are the right and left ventricles. The right and left sides of the heart are divided by an internal partition called the septum. Some congenital cardiovascular defects let blood flow between the heart's right and left chambers due to an unnatural opening in the septum.
The two most common types of this defect are:
- Atrial septal defect (ASD)—an opening exists between the heart's two upper chambers. In the US, about 4%-10% of babies born with cardiovascular defects have this type.
- Ventricular septal defect (VSD)—an opening exists between the two lower chambers of the heart. In the US, about 14%-17% born with cardiovascular defects have this type of defect.
The CardioSEAL Septal Occlusion System, made by NMT Medical, was approved to close complex ventricular septal defects. CardioSEAL is made of two metal frameworks shaped like umbrellas—one for each side of the septum. A polyester fabric is attached to each umbrella.
Using spring coils in the framework, CardioSEAL can be collapsed into an artery or a vein for insertion into the heart. Once it is positioned with an umbrella on each side of the defect, the CardioSEAL is opened. The septal tissue grows into and around the umbrella, incorporating it into the septum.
A registry was formed to track the safety of this device. In the initial report, researchers concluded that the CardioSEAL is safe.
The Amplatzer Septal Occluder, made by AGA Medical Corporation, was approved to close secundum atrial defects—those located in the mid-portion of the atrial septum. The Amplatzer is a self-expandable, double disc device filled with polyester fabric. The discs are linked by a short connecting waist that corresponds to the size of the septum's defect.
The Amplatzer is implanted through a small catheter that is inserted into a vein in the patient's groin. The doctor threads the device through some of the body's largest veins until it reaches the heart. Once the device is in place, the doctor releases it from the end of the catheter. The Amplatzer springs open and clamps the defect. The body's tissue eventually encases the device.
A study published in The American Association for Thoracic Surgery concluded that the device is a "fairly safe alternative to surgery in infants."
Both devices have warnings, precautions, and reasons why the device cannot be used. Several centers have reported that the devices have moved in the patient's body, which requires urgent open surgery. Discuss all of your child's options with the doctor before making any decision. Also, make sure the doctor is aware of the latest literature on both of these devices.
Last reviewed June 2008 by Kari Kassir, MD
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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