One of the most common types of birth defects is heart valve problems. Over 40,000 babies are born in the United States each year with a congenital heart defect, and almost a third of those babies will have a problem with their heart valves.

For decades, doctors have relied on mechanical or tissue-based valve replacements for children needing valve replacement surgery. But now, doctors have a new tool in their arsenal: the Harmony transcatheter pulmonary valve.

This valve, developed by the life sciences company Medtronic, is revolutionary in its ability to adjust with the child’s growth.

The Problem with Traditional Valve Replacements

Traditional valve replacements for children come with their own set of problems. Mechanical valves are durable but require lifelong anticoagulation therapy to prevent blood clots.

Tissue valves, made from cow or pig heart tissue, do not require anticoagulation therapy but have a limited lifespan. Children who receive a tissue valve will likely need to have it replaced as they grow.

Additionally, traditional valve replacements require open-heart surgery, which is a major procedure with its own set of risks and challenges.

Children who undergo open-heart surgery may need to stay in the hospital for several days or even weeks to recover.

The Harmony Valve

The Harmony valve is different from traditional valve replacements in several significant ways.

Firstly, the Harmony valve is made from a combination of materials, including stainless steel, cobalt-chromium alloy, and polyethylene.

It is designed to mimic the function of the pulmonary valve, which is responsible for regulating blood flow between the right ventricle of the heart and the lungs.

Secondly, the Harmony valve is delivered to the heart through a catheter. This means that the valve can be implanted without the need for open-heart surgery. Instead, the valve is threaded through a vein in the leg and up to the heart.

Once there, the valve is deployed, and the catheter is removed. The entire procedure typically takes just a few hours.

Finally, the Harmony valve is unique in its ability to adjust with the child’s growth.

Traditional valve replacements do not grow or change with the child, which means that children who receive a tissue-based valve will likely need to have it replaced as they grow. The Harmony valve, on the other hand, is designed to expand as the child grows, meaning that it can stay in place for several years, potentially avoiding the need for additional surgeries.

Who is a Candidate for the Harmony Valve?

The Harmony valve is designed for children who need a pulmonary valve replacement.

This includes children who were born with a congenital heart defect involving the pulmonary valve or children who have developed pulmonary valve problems later in life due to infection or other factors.

The Harmony valve is not appropriate for all children, however. Children with certain medical conditions, such as severe pulmonary hypertension or an overly large right ventricle, may not be candidates for the Harmony valve.

Additionally, children with a history of allergies to specific materials, such as nickel or cobalt, may need to avoid the Harmony valve.

Potential Benefits of the Harmony Valve

One of the most significant benefits of the Harmony valve is its ability to adjust with the child’s growth.

This means that children who receive the Harmony valve may be able to avoid additional surgeries, reducing the overall risk and stress associated with heart surgery.

The Harmony valve may also offer a faster recovery time compared to traditional valve replacements. Traditional valve replacement surgery requires an open-heart incision, which can take several weeks to heal fully.

Children who undergo transcatheter valve replacement surgery, on the other hand, may be able to return to normal activities much more quickly.

Finally, the Harmony valve may offer a lower risk of complications compared to traditional valve replacements. Mechanical valves require lifelong anticoagulation therapy, which can increase the risk of bleeding and other complications.

Tissue valves, on the other hand, have a limited lifespan, which means that children who receive a tissue valve will likely need to have it replaced as they grow. The Harmony valve, which is designed to adjust with the child’s growth, may offer a lower risk of complications compared to these traditional valve replacements.

Potential Risks of the Harmony Valve

As with any medical procedure, the Harmony valve does come with some risks. Potential risks and complications associated with the Harmony valve include:.

Bleeding
Infection
Arrhythmia
Valve displacement or malposition
Valve fracture
Need for additional surgery or intervention

It is important for parents of children who are being considered for the Harmony valve to discuss the potential risks and benefits with their child’s medical team to determine if the Harmony valve is the best option for their child.

Conclusion

The Harmony transcatheter pulmonary valve is a revolutionary device that offers hope to children with heart valve problems.

Its ability to adjust with the child’s growth means that children who receive the Harmony valve may be able to avoid additional surgeries and complications associated with traditional valve replacements. While the Harmony valve is not appropriate for all children, it is a promising tool in the treatment of congenital heart defects and other pulmonary valve problems.