Transcatheter Tricuspid Valve Replacement

By Brenda Lange

Earlier this year, the Edwards EVOQUE tricuspid valve replacement system became the first transcatheter therapy to receive FDA approval for treating tricuspid regurgitation. For the Columbia cardiologists who led the TRISCEND II trial that provided pivotal data, the approval is a gratifying end to a 10-year journey.

“We have been involved in the ‘tricuspid space’ since the very beginning, looking at this disease, testing different devices, and experiencing a lot of failures,” says Susheel Kodali, MD, director of the Structural Heart and Valve Center, professor of medicine, and a principal investigator of the trial. 

“These patients have been undertreated, and to be able to offer them something so effective is one of the most rewarding things we’ve ever done,” says Rebecca Hahn, MD, professor of medicine, director of interventional echocardiography at the Structural Heart and Valve Center, and a principal investigator of the trial.

Tricuspid regurgitation—when the tricuspid valve is damaged, leaks, and allows blood to flow backward—can plague a patient for some time before it is recognized. “It can cause edema, increased abdominal girth from fluid, and fatigue and occurs mostly in women over age 70,” Dr. Hahn says. Other symptoms may include uneven heartbeat, chest pain, and difficulty breathing.

Before the valve replacement system was developed, most patients were treated with medical therapy, mainly diuretics, but that treatment is usually ineffective for patients with severe disease. Surgery is performed infrequently since the risk of death is high. And outcomes are poor: A 20-year study from Australia showed a 30% increase in mortality associated with even mild tricuspid regurgitation.

The device replaces a damaged valve with an artificial valve made of a self-expanding wire frame and bovine tissue. Like transcatheter aortic valve replacement, the tricuspid valve is inserted via a catheter through a vein in the patient’s leg and expanded into place, pushing aside the leaflets of the diseased valve.

The EVOQUE procedure may take the condition down to mild in more than 85% of patients with severe disease, making the device very effective, says Dr. Hahn. “Patients consistently have fewer symptoms and improved quality of life.”

The doctors add that the procedure is not for everyone and they are still learning which patients will benefit the most.

Columbia also was involved in a clinical trial that tested another device for tricuspid disease. Like EVOQUE, the TriClip TEER (transcatheter edge-to-edge repair) device is inserted into the heart via a catheter. The treatment adds clips to the flaps of the tricuspid valve, reducing leakage and restoring normal blood flow. The device is designed to treat a range of tricuspid valve abnormalities and was approved by the FDA in April 2024, two months after the EVOQUE approval.

“The decision between clip and replacement is made by the heart team based on a risk-benefit analysis that considers the clinical and anatomical factors of each patient,” says Dr. Kodali.

“As always, we take a team-based approach with colleagues from echo, heart failure, and surgery,” says Dr. Kodali. “We will continue to innovate, offer options, learn, teach, and train. We want to lead in heart valve research and provide access to therapies that other places don’t have.”

For more information and appointments, visit columbiadoctors.org.