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Heart Institute at UPMC Children’s One of Nation’s First Centers to Implant Harmony TPV

August 17, 2021

In May 2021, the Heart Institute at UPMC Children’s Hospital of Pittsburgh began implanting the Harmony Transcatheter Pulmonary Valve (TPV) from Medtronic. UPMC Children’s was the third site in the country to begin using the new device for congenital heart disease (CHD) patients.

The UPMC Children’s Cardiac Catheterization Laboratory (CCL) team members — led by Bryan H. Goldstein, MD; Jacqueline Kreutzer, MD; and Sara M. Trucco, MD — performed the first four cases on May 27 and May 28. 

To date, the interventional cardiology team at UPMC Children’s has implanted 10 Harmony valves in CHD patients, with another six cases planned by the end of October. This places the Pittsburgh program amongst the busiest Harmony TPV implant sites in the world. 

“The Medtronic Harmony TPV is now the first FDA-cleared, commercially-available, device designed for transcatheter pulmonary valve replacement (PVR) in patients with CHD and RV outflow tract dysfunction, without an existing surgical graft/conduit or prosthesis in the pulmonary position,” says Dr. Goldstein, director of the CCL at UPMC Children’s. “This will expand our existing portfolio of valves (Medtronic Melody and Edwards Sapien 3) for transcatheter PVR, enabling treatment of a much larger cohort of CHD patients than were previously eligible for this procedure.”

The majority of patients with right ventricular outflow tract (RVOT) dysfunction, a consequence of childhood treatment for CHD (such as tetralogy of Fallot (TOF) or pulmonary valve stenosis), can now be treated with the new device, allowing these patients to avoid open heart surgery.  In most cases, the procedure takes just a few hours, and patients are discharged home the following day.

Many of the initial Harmony TPV recipients in Pittsburgh have been referred from the UPMC Adult Congenital Heart Disease (ACHD) program, led by Arvind Hoskoppal, MD, MHS.  

“We are extremely fortunate to be able to offer this state-of-the-art technology to our congenital heart disease patients,” says Dr. Hoskoppal. “We look forward to the continued success of the program.”

The Heart Institute at UPMC Children’s was selected to participate in the Medtronic Harmony TPV post-approval study (PAS), with Dr. Goldstein serving as site PI. The Pittsburgh program will also be participating in a new multicenter registry of native RV outflow tract transcatheter pulmonary valve devices, designed to track long-term outcomes following development of this new procedure.

UPMC Children’s was part of Medtronic’s early commercial launch of the Harmony TPV. View the Twitter post and photos from the first case at UPMC Children’s.