Nationwide Children’s Hospital today announced its first implant of the Medtronic Harmony™ Transcatheter Pulmonary Valve (TPV)—an investigational heart valve designed to help patients with Congenital Heart Disease (CHD)—as part of a new clinical study that will evaluate the valve’s safety and effectiveness. The procedure was performed at Nationwide Children’s by John P. Cheatham, MD, George H. Dunlap Endowed Chair in Interventional Cardiology and Co-Director of The Heart Center at Nationwide Children’s.*
Congenital heart disease (CHD) is the most common type of birth defect in the United States, affecting an estimated 40,000 infants each year.i ii There are many different types of CHD, including abnormalities in the structure of the heart and pulmonary artery/valve. After surgical correction of these defects, ie. Tetralogy of Fallot, the pulmonary valve is altered or removed, resulting in severe leakiness of the valve. With severe pulmonary valve regurgitation symptoms may occur, ranging from mild to severe, from tiredness or shortness of breath to fatigue, dizziness or weakness while performing normal activities. It can also lead to irregular heartbeats, chest pain or fainting (syncope).
For CHD patients born with pulmonary artery/valve abnormalities who undergo a surgical repair early in life, the Harmony TPV is designed to provide a less invasive option to restore normal valve function later in life. Currently, the only approved option in the United States for these patients is an open heart surgical valve replacement.
The Harmony TPV therapy builds off of the Medtronic Melody TPV technology, which has been implanted in more than 10,000 patients worldwide. The Melody TPV was designed for patients with a failing right ventricular to pulmonary artery valved conduit, which accounts for only about 23% of this patient population. The Harmony TPV Clinical Study is expected to enroll 40 patients across approximately 10 centers in the United States and Canada, and if successful can potentially serve ~ 77% of this patient population.
“We are honored to be the first site to implant this device, both in the past Early Feasibility Study and now as part of this pivotal clinical trial,” said Dr. Cheatham.
About Nationwide Children’s Hospital
Named to the Top 10 Honor Roll on U.S. News & World Report’s 2016-17 list of “America’s Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit freestanding pediatric healthcare systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents, as well as adult patients with congenital disease. Nationwide Children’s has a staff of more than 11,000 providing state-of-the-art pediatric care during more than 1.2 million patient visits annually. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded freestanding pediatric research facilities. More information is available at NationwideChildrens.org.
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i Hoffman JL, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002;39(12):1890-1900.
ii Reller MD, Strickland MJ, Riehle-Colarusso T, Mahle WT, Correa A. Prevalence of congenital heart defects in Atlanta, 1998-2005. J Pediatrics 2008;153:807-813.
*Dr. Cheatham is a paid consultant for Medtronic.