It’s well known that congenital heart disease may have significant risk of death both adult and child.
The death risk factor from congenital heart disease as following;
- Congenital defects (such as ventricular septal defect, patent ductus arteriosusp
coarctation of the aorta, ebstein anomali and lessions declined)
- Arrhythmia (that leads to heart failure) especially for the patients with cyanotic lesions.
- Myocardial infarction, especially for the patients with noncyanotic congenital heart disease.

Some recent treatment offered is Transcatheter Pulmonary Valve beside current treatment with open-heart surgery.

This non-surgical method to restore pulmonary function and prolonging the life of prosthetic conduits, thereby decreasing the number of open-heart surgeries required over a patient’s lifetime and the associated risk for bleeding and infection.

As an early intervention to provide better outcomes for patients while avoiding surgical complications, this non invasive method also minimize trauma and improves recovery times.

However, based on FDA review related to the safety of this transcatheter valve, fracture rate of the device, adverse events that may possible linked to device delivery, and the relatively high requirement for re-operation at 4 years, Dr. John Hirsfeld from the University of Pennsylvania, Philadelphia said, the device has ‘unproven long-term durability’.

However, the FDA Circulatory System Device Panel recommended for approval since the target population is one that will require re-intervention of some kind.

One of the panel member, Hirshfeld said, “The panel looked at the device and agreed that this is surely an imperfect device, it surely has a shorter life expectancy than we would like to see. But there is a cohort of patients who clearly benefit from this device and get four, five, or maybe more years of functionality out of the device.”

Dr. William Hellenbrand from Morgan Stanley Children’s Hospiteal of New York-Presbyterian, said, “It’s probably the first of many products that will be presented to the FDA for transcatheter-valve therapy, but this is for a specific patient population. The Pulmonary valve is a unique situation in congenital heart disease, the other valves are mostly for an older adult population. The various risks and difficulties on the systemic circulation are very different on the right side of the heart, so i’m not sure you can really move from one side of the heart to the other side of the heart very easily. It’s going to take different concepts for the left side of the heart.”

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