Results from the TRILUMINATE study, presented this week at EuroPCR 2019 in Paris, suggest Abbott’s minimally invasive tricuspid valve repair system is an effective solution for patients with structural heart disease, reducing the severity of tricuspid regurgitation (TR) in more than 85% of test cases.
According to a statement from the company, Abbott’s transcatheter tricuspid valve repair (TTVR) system builds on the recent success of its MitraClip technology, which treats people with leaky mitral valves. Around one in 30 people over age 65 in the U.S. have moderate to severe TR—a condition that results in potentially fatal backflow of blood into the right chamber of the heart—but surgery is often too high-risk to attempt.
The TTVR system, a potential alternative to surgery, was put to the test in Georg Nickenig, MD, PhD, et al.’s study of 85 patients with symptomatic moderate or greater TR. All patients were flagged as good candidates for percutaneous transcatheter intervention.
Thirty days after treatment with the TTVR tech, the researchers reported 86.6% of patients saw a reduction in TR severity of at least one grade. More than 80% of patients were categorized in New York Heart Association class I or II, a significant jump from the 25.6% classified the same way at the study’s baseline.
Nickenig and colleagues also said patients experienced a mean improvement in their KCCQ score from 53.03 at baseline to 67.25 at 30 days. The KCCQ score is a self-assessed measure of social abilities, disease symptoms and quality of life.
“Treating a leaky tricuspid heart valve has long presented a significant challenge for cardiologists because it is an extremely complex and difficult heart valve to treat,” Nickenig said in the company’s statement. “These data are extremely encouraging, and I am excited about the potential of transcatheter tricuspid valve repair as a minimally invasive treatment option for these very ill patients who have no other options.”
Right now, the TTVR system is strictly an investigational device. Clinical follow-up in the TRILUMINATE study is expected to continue through three years.