The major benefit in having a device placed is that cardiac defects can be repaired without surgery.

In some cases,  defects which cannot be corrected surgically can be repaired using this technique.

The discomfort after the catheterization procedure is usually less than after open heart surgery,  and the recovery period is shorter.

A cardiac catheterization is necessary to place the devices.

The device must be properly positioned in order to function effectively.  Malpositioned devices can cause problems.

Device arm fractures similar to those seen with Clamshell I (the original version of the device) can and do occur with the new device.  The long term risks associated with a fracture are unknown at this time.

Additional risks include ones from any cardiac catheterization procedure, namely, disturbance of heart rhythm,   perforation of a blood vessel or heart wall,  damage to heart valves,  infection or release of air bubbles from the catheter.

Catheter related complications are rare;  however,  they may be more likely to occur with the use of the device because the procedure lasts longer and the catheters used are larger.

Surgery

Minimally Invasive Surgery:  In the last two years here at Children's Hospital Boston,  we have introduced  "minimally invasive" cardiac surgery.   The minimally invasive approach involves a limited skin incision which can be as small as 3.5 centimeters.  Some patients may be candidates for this type of surgery.