MUSC Health first in US to implant new device for the heart disease TR

Doctors at the MUSC Health Heart and Vascular Center were the first in the country to implant a new, experimental treatment device in a patient suffering from the heart condition known as tricuspid regurgitation, or TR. 

Nicholas Amoroso, M.D., and Nicolas Pope, M.D., did the procedure in Charleston, South Carolina, using Topaz. The transcatheter tricuspid heart valve replacement system is made by TriCares. Their patient, a woman, is now recovering at home.

“I think what this signals is that MUSC in Charleston is a leader in heart valve therapies, not just in the state of South Carolina but nationally. And we are working with companies on innovation to help patients in ways that they couldn't previously be helped,” Amoroso said.

Pope said it also signals that teamwork is key. “The heart team approach to these complex problems really offers a big advantage over a less collaborative approach.”

TR patients often suffer for years from symptoms such as fatigue and breathlessness that can progress to more serious issues. Amoroso said their bellies may swell, and TR can lead to cirrhosis of the liver. “People who have severe TR with significant symptoms, their two- to three-year mortality is somewhere in the 40 to 70% range.”

Amoroso, an associate professor in the College of Medicine at the Medical University of South Carolina, is pleased to be part of the push to change that. The Food and Drug Administration has already approved two other transcatheter devices for TR. But Amoroso said they aren’t available to, or wouldn’t work for, everybody who needs treatment. Adding another option means more patients with TR can find something that works for them. 

“We've seen the consequences of leaving TR untreated. So we're trying to right that wrong,” Amoroso said.

Trying to right that wrong in this case involves an early feasibility study with about eight sites in the United States and Canada, including MUSC. Such studies focus on a small number of patients, looking at how well a device functions and gathering information about safety.

The tricuspid valve at the center of the research is one of four valves in the heart. It sits between the heart’s two chambers on the right side. When someone develops TR, the valve doesn’t work properly. Some of the blood that should go forward flows backward instead.

There’s a range of causes for the condition. “Sometimes, it happens because of other heart disease problems on the left side of the heart rather than the right. Or it happens because people have AFib. It may happen if you've had liver disease or lung disease or kidney disease. It can happen from infections or some other rare things. But most commonly, it is happening because of another medical illness that has made the heart stretch out and led to the valve not being able to close effectively,” Amoroso said.

The Topaz System uses a prosthetic valve to try to change that. A doctor threads the prosthetic through a vein in the groin up to the right side of the heart, where it is implanted to take on the work the diseased valve can no longer do. The device is made of biological heart valve material, according to its manufacturer, and uses a two-in-one stent design. 

Amoroso said it’s a welcome addition to the treatment options for TR. “When TR becomes severe, it is no longer open-heart surgery or nothing. We now have a growing complement of catheter therapies. That's not the right answer for every patient, but we're excited that we do have more and growing treatment options. The Topaz valve and some of our other clinical trials are included in that list. MUSC is excited to be a leader in the field of both commercially available technology as well as early feasibility studies for clinical trial devices.”