Inova plays a key role in trial of innovative treatment for tricuspid valve regurgitation that is now approved by the FDA

Update as of April 24, 2024: Inova’s structural heart team has now completed the first case in the Washington, DC region since the FDA approved a new device to treat tricuspid regurgitation (TR).

Inova Schar Heart and Vascular’s Structural Heart/Valve Disease Program was among the top enrollers in the TRILUMINATE™ Pivotal Trial demonstrating the safety and effectiveness of the TriClip™ transcatheter edge-to-edge system. Inova’s team played a key role in the data that formed the basis of the United States Food and Drug Administration’s (FDA) approval of the device in early April.  

The new device from Abbott offers patients another option for treatment of tricuspid regurgitation – a condition where there is a backflow of blood or “leakage” in the heart’s tricuspid valve. This issue impacts 1.6 million Americans. As a key participant in the clinical trial, Inova is already one of the most experienced sites in the U.S., having performed 29 procedures as of April 2024.

“Clinical research studies, such as the TRILUMINATE Pivotal Trial, are necessary to provide insight into the safety and efficacy of new medical devices,” said Wayne Batchelor, MD, MHS, Director of Interventional Cardiology and Interventional Cardiology Research at Inova Schar Heart and Vascular. “We are pleased to have access to trials evaluating some of the most innovative technologic advances in cardiovascular medicine.“

What is tricuspid valve regurgitation?

The tricuspid valve is located on the right side of the heart. In a healthy heart, the valve prevents blood from leaking back into the heart’s right atrium. But when the tricuspid valve begins to leak, it causes the right side of the heart to work harder, resulting in symptoms such as:

• Fatigue
• Shortness of breath
• Swelling in the abdomen, legs and feet
• Impaired kidney function
• Enlarged liver

Without treatment, tricuspid regurgitation can significantly interfere with quality of life and eventually lead to heart failure.

New treatment for tricuspid regurgitation

Tricuspid regurgitation is challenging to treat. While medications can control symptoms such as swelling, traditionally the only option to repair the leaky valve has been open heart surgery. Unfortunately, that option is too risky for many patients with tricuspid regurgitation, who tend to be older and often have other health problems.

“The TRILUMINATE Pivotal Trial tested a new, minimally invasive procedure,” said Dr. Batchelor. “Using a catheter inserted into a blood vessel in the groin, we maneuver special clips into the heart and place them on the valve to repair the leak.” 

A similar procedure exists for repairing leaks in the mitral valve, but this option hasn’t been available for the tricuspid valve. One reason for that is the complex anatomy of the tricuspid valve, which has more leaflets, or flaps, making it more challenging to place clips. Another is that its location makes it harder to get clear images of the valve. Good imaging is crucial to help the physician place the clips in the right location.

“Thanks to improved imaging techniques and new devices, we’re finally able to utilize a nonsurgical option for treating this disease,” said Dr. Batchelor.

According to Abbott, the TRILUMINATE Pivotal Trial was the world’s first randomized, controlled clinical study to evaluate the safety and effectiveness of the TriClip system compared to medical therapy in people with severe disease who were at intermediate or greater risk with open heart surgery. Ninety percent of patients who received the TriClip system experienced significant improvement in regurgitation within 30 days – a reduction that was sustained at one year. The trial also demonstrated the safety of the device, with 98% of patients being free of major adverse events through 30 days, and a significant improvement in quality of life.

Leaders in heart valve disease treatment

As one of the hospitals at the forefront of the TRILUMINATE Pivotal Trial, Inova was the only center in Northern Virginia with access to this new technology.

Inova Schar Heart and Vascular’s multidisciplinary structural heart team has extensive expertise in repairing and replacing all types of heart valves. The TriClip procedure requires experts in heart failure, imaging, cardiothoracic surgery and interventional cardiology, as well as skilled nurses, advanced practice providers and others experienced in structural heart disease. The breadth and depth of knowledge and teamwork at Inova Schar Heart and Vascular made it possible for Inova to offer this exciting new treatment. 

“Our experience in the clinical trial has identified that TriClip is a very safe, minimally invasive treatment option for patients who are in need of tricuspid valve repair and are struggling with medical therapy alone,” said Matthew Sherwood, MD, MHS, Co-Director of Inova’s Structural Heart/Valve Disease Program. “Inova is proud that we were able to make a significant contribution to this innovative therapy, which we expect will make a major difference in the lives of so many of our patients.”

Learn more about the full scope of Inova’s Structural Heart/Valve Disease Program.