In August 2021, the Herma Heart Institute at Children’s Wisconsin became the first hospital in the state of Wisconsin to begin implanting the Harmony™ Transcatheter Pulmonary Valve (TPV) from Medtronic. It was approved by the U.S. Food and Drug Administration (FDA) earlier this year.
The Harmony™ TPV is the first artificial valve able to be implanted non-surgically for certain patients with severe pulmonary valve regurgitation, a condition in which the valve separating the right side of the heart and the arteries leading to the lungs doesn’t function properly. Issues with the pulmonary valve are common for individuals with many congenital heart defects, such as tetralogy of Fallot, and they often require pulmonary valve replacement. The Harmony TPV device offers a minimally invasive treatment option that delays the need for open-heart repair, and is intended to reduce the number of surgeries required over a patient’s lifetime. Eventually, it is anticipated that such valves will replace the need for surgical replacement in many patients altogether.
“The Harmony™Transcatheter Pulmonary Valve is a game changer for our congenital heart disease patients, as it offers a non-surgical option to correct right ventricle outflow issues in the majority of cases we see,” said Susan Foerster, MD, medical director of Interventional Cardiology at the Herma Heart Institute. “As the largest pediatric cardiac care center in the state, we know it is vital to have interventional cardiologists on our team trained in this cutting-edge technology to provide the best care for our patients while reducing the need for surgical intervention.”
Prior to the Harmony TPV, most patients who needed replacement of a leaky (or regurgitant) pulmonary valve were treated with open-heart surgery, which carries a larger risk and often results in longer lengths of stay in the hospital. The Harmony TPV procedure is done through a minimally invasive cardiac catheterization. In a 3-3.5 hour procedure with the patient completely asleep, the specialized cardiologist places a thin tube (called a catheter) in a vein in the leg and advances the TPV through the heart and past the lung valve and places it in the lung artery. Upon implantation, valve function is restored immediately and blood flow from the heart to the lungs improves. Most patients only require a overnight stay with low levels of pain and can rapidly return to their normal activities with less time off from work or school.
Congenital heart defects are the most common types of birth defects, occurring in nearly 1 in every 100 babies born. They can range from mild to very serious. The Herma Heart Institute at Children’s Wisconsin is the largest pediatric cardiac care center in the state and is ranked as one of the best in the nation for pediatric cardiology and heart surgery. The Herma Heart Institute continues to be among the highest volume congenital heart programs in the nation, performing around 500 catheter based procedures and more than 500 heart surgeries per year.
The first cases using the Harmony TPV at the Herma Heart Institute and Children’s Wisconsin were implanted in August with additional cases scheduled for the coming weeks.
