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Harmony Transcatheter Pulmonary Valve in Congenital Heart Disease Patients

April 26, 2023

In May 2021, Bryan Goldstein, MD, and his team at the Heart Institute at UPMC Children’s became one of the first sites nationwide to implant the Harmony™ transcatheter pulmonary valve (TPV), a newly approved device by the U.S. Food and Drug Administration (FDA). The Medtronic Harmony TPV is the first FDA-cleared, commercially available device designed for transcatheter pulmonary valve replacement (PVR) in patients with congenital heart disease and RV outflow tract dysfunction — without an existing surgical graft/conduit or prosthesis in the pulmonary position.

Dr. Goldstein and his team have successfully implemented the use of the Harmony TPV to expand our existing portfolio for transcatheter PVR, which also includes the Medtronic Melody TPV, Edwards Sapien 3 and Edwards Alterra Adaptive Prestent.

This collaborative effort has allowed Arvind Hoskoppal, MD, director of the UPMC Adult Congenital Heart Disease Program, to treat a much larger cohort of congenital heart disease patients than were previously amenable to transcatheter PVR. This dual effort provides an opportunity for Dr. Hoskoppal to refer patients who previously required cardiac surgery for PVR to undergo catheter-based intervention for PVR with Dr. Goldstein and his team instead.

As of April 2023, UPMC Children’s has successfully implanted 31 Harmony valves. Our center remains amongst the highest volume implant centers in the country.

A Multidisciplinary Treatment Approach – Brandy’s Story

The team at the Heart Institute regularly collaborates across the specialty centers and programs to provide innovative, comprehensive are to patients of all ages.

Brandy Lubozynski was 6 years old when she received her first open-heart surgery at UPMC Children’s to repair her Tetralogy of Fallot. She grew up having a normal childhood and remained symptom-free for the next 40 years.

But in March 2021, Brandy began experiencing shortness of breath, making daily tasks difficult.

“I couldn’t even walk to the garage without having to stop and catch my breath,” says Brandy. “So, in May, I finally decided to go to the emergency room. Originally, the team suggested that I had COVID-19. But after running several tests, they found that my left ventricle was only functioning at 20% and I had excess fluid in my stomach.”

Brandy was referred to Arvind Hoskoppal, MD, an adult congenital and pediatric cardiologist, and the director of the UPMC Adult Congenital Heart Disease Center.

After running a series of tests, Dr. Hoskoppal found that Brandy had severe left ventricular dysfunction (LVD) and collaborated with the team at the Interventional Cardiology Program to determine the next steps for Brandy’s care.

Given her severely diminished left heart function, Brandy was not an ideal candidate to undergo a surgical pulmonary valve replacement (PVR). Bryan H. Goldstein, MD, a pediatric interventional cardiologist and director of the Interventional Cardiology Program at UPMC Children’s, evaluated Brandy’s candidacy for a transcatheter, minimally invasive approach to PVR.

Dr. Goldstein and his team determined that Brandy was a candidate for the new Medtronic Harmony TPV, the first FDA-approved transcatheter valve system to treat children and adults with severe pulmonary regurgitation. The experts at the Interventional Cardiology Program at UPMC Children’s were among the first in the world to implant the Harmony TPV following FDA approval in 2021.

I got a call from Dr. Goldstein the day after I got home,” says Brandy. “He told me that I was a candidate for the new Harmony TPV and asked me to come to UPMC Children’s for the procedure. I was a little shocked; I never expected to go to UPMC Children’s. But most importantly, I just wanted to breathe again.”

On May 27, 2021, Brandy underwent successful placement of a Harmony TPV in the cardiac catheterization lab at UPMC Children’s. She recovered well and was discharged the following day.

“Dr. Goldstein and the entire team were great,” says Brandy. “If I had to undergo the procedure again, I hope Dr. Goldstein would be the person to do it.”

At Brandy’s one-year follow-up appointment, Dr. Hoskoppal performed a cardiac MRI and found normal RV size and function, and normal LV function, a significant improvement from prior to the procedure.

Brandy is scheduled to attend yearly appointments with Dr. Hoskoppal and the team at the Adult Congenital Heart Disease Center to continually monitor her condition.

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