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For the first time at the University of North Carolina, cardiologists were able to implant a percutaneous transcatheter tricuspid valve replacement device to treat severe tricuspid valve regurgitation. One of only around 50 sites in the U.S. participating in the TRISCEND II clinical trial, experts at UNC believe this therapy is going to dramatically change treatment options for patients.

Previously, this valvular heart disease would need to be treated using open-heart surgery. However, many patients are too ill to undergo this operation and remain untreated.

“It’s a very common problem and one that leads to not only significant symptoms but is associated with a shorter length of life. This procedure we think will not only significantly improve symptoms, but will help people live longer and robust lives,” said John P. Vavalle, MD, MHS, associate professor of medicine and Medical Director of the Structural Heart Disease Program.

Severe tricuspid valve regurgitation occurs when a person’s leaflets, flaps of tissue that open and close to circulate blood correctly, in the tricuspid valve don’t close all the way. Blood then flows back into the heart causing shortness of breath and swelling of the abdomen, legs or veins in your neck. If left untreated it can lead to heart, liver and kidney failure.

Through the TRISCEND II clinical trial, the University of North Carolina Structural Heart Team, including Dr. Vavalle, placed a small tube in a patient’s leg vein known as a catheter. During this minimally invasive procedure cardiologists used advanced imaging to reach the heart and implant the EVOQUE tricuspid valve. The device acts as a leaflet would in a healthy heart, opening and closing to let blood through. Thanks to the robust collaboration between cardiology, cardiothoracic surgery lead by Thomas Caranasos, MD, and cardiac imaging lead by Joseph Sivak, MD, FACC, the procedure was successful.

“CT and ultrasound images of the heart are done weeks in advance, and the heart teams meet to plan the approach for the procedure,” Dr. Sivak said. “During the case, we use 3D transesophageal ultrasound imaging to guide the implant. The collaboration, both in preparation and while performing this procedure, was key to its success.”  

The Edwards EVOQUE is only available through clinical trial. The study is evaluating the safety and effectiveness of the replacement device. Two studies suggest EVOQUE is safe and durable at 30-day and 1-year follow up. As a participant in this trail, UNC Cardiology continues to be at the forefront of medical research.

“It’s really a privilege for us to be able to provide this therapy to our patients,” Dr. Vavalle said. “We really believe this is going to be such a life changing procedure for so many patients out there who have severe TR that currently aren’t treated. And you know, our first patient has done exceptionally well with this, and we hope to treat many, many more.”