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New Clinical Trial Offers Treatment for Tricuspid Valve Regurgitation

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Tricuspid valve regurgitation (TR) is a relatively common problem. Millions of Americans have the condition, caused by a leaky tricuspid valve. But unlike problems in other valves, there have been few treatment options for faulty tricuspid valves.

That may be changing. IHVI is participating in a clinical trial to test a new, minimally invasive treatment for TR – a promising potential treatment that could be a major step forward in treating this disorder.

Without treatment, TR can significantly interfere with quality of life and ultimately result in heart failure and death if left untreated. Approximately one in 30 people over the age of 65 in the U.S. have moderate or severe TR. Until recently, surgery was the only definitive treatment. However, surgery is rarely performed due to the high mortality and morbidity rates associated with the procedure.

Triluminate: New Treatment for Tricuspid Regurgitation

“Tricuspid regurgitation is challenging to treat,” said Wayne Batchelor, MD, MHS, Director of Interventional Cardiology and Interventional Cardiology Research for IHVI. “Medications can control symptoms such as swelling, but the only real option to repair the leaky valve has traditionally 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 potential to add a minimally invasive treatment option is what makes the TRILUMINATE Pivotal Trial so promising. A select team of interventional cardiologists who specialize in structural heart disease maneuver special clips into the heart and place them in the valve to close the leak.

“There is a similar procedure for repairing leaks in the mitral valve,” Dr. Batchelor said. “But such an option hasn’t been available for the tricuspid valve. One reason for that is that  the tricuspid valve has more leaflets, or flaps, making it more challenging to place the clips. Another is that its location makes it harder to get clear images of the valve and to place the clips in the right location. Thanks to new imaging techniques and new devices, we’re finally able to test a nonsurgical option for treating this disease.”

Leaders in Heart Valve Disease Treatment

Being one of only three hospitals in Virginia, and the only hospital in Northern Virginia, with access to this new technology, Inova is at the forefront of the TRILUMINATE Pivotal Trial. Along with a limited number of health systems across  the country, IHVI will be evaluating patients to determine whether they might be good candidates for the procedure. Those selected will be randomly assigned to either undergo the procedure or receive medication as usual to demonstrate whether the procedure is safe and effective for treating TR.  

“IHVI’s participation in the study wouldn’t be possible without the strong multidisciplinary team we have in place,” said  Batchelor. “This 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 IHVI makes it possible for us to offer this exciting new treatment. And we’re excited to participate in a study that will help us continue to be leaders in innovation while providing the best care for patients.”

Principal Investigator: Wayne Batchelor, MD
Implanting Physicians: Wayne Batchelor, MD, Nadim Geloo, MD Cardiac Imaging Expert: Abbas Emaminia, MD
Cardiac Anesthesiologist: Samuel Lee, MD
Heart Failure Specialist: Mitchell Psotka, MD
Cardiothoracic Surgeon: Eric Sarin, MD
Research Coordinator: Tracy Plummer, RN

Minimally Invasive PFO Closure 2020: 83

2020 annualized from YTD January – October data

Patient and procedural volumes for 2020 were impacted by a temporary suspension of elective procedures due to COVID-19 beginning in March through the end of May and the nationwide trend of decreased demand for services throughout the pandemic.

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703-776-3135  I  valve@inova.org
inovaheart.org/structuralheart