Tricuspid transcatheter edge-to-edge repair (TEER) was safe for patients with severe tricuspid regurgitation and was found to reduce the severity of tricuspid regurgitation, according to results from the TRILUMINATE Pivotal trial presented at ACC.23/WCC in New Orleans and simultaneously published in the New England Journal of Medicine. TEER was also associated with an improvement in quality of life, researchers said.

The trial enrolled 350 patients with symptomatic severe tricuspid regurgitation from 65 centers in the U.S., Canada and Europe and randomly assigned them to receive either TEER (n=175) or medical therapy (n=175). The mean age of patients across both groups was 75 years and 55% were women. The primary endpoint was a hierarchical composite that included death from any cause or tricuspid-valve surgery, hospitalization for heart failure, and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ). Researchers also looked for an increase of at least 15 points in the KCCQ score at the one-year follow-up.

Overall results for the primary endpoint favored the TEER group, researchers said. There was no apparent difference between the two groups in the incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (p<0.001). At 30 days, 87% of the patients in the TEER group compared with 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (p<0.001). Researchers also noted that 98.3% of the patients who underwent the TEER procedure were free from major adverse events at 30 days.

"Patients with tricuspid regurgitation, when treated with [TEER] with the TriClip device, experienced significant improvements in quality of life," said Paul Sorajja, MD, FACC, lead author of the study. "In a patient population with a high symptom burden, this is a meaningful benefit."

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Interventions and Structural Heart Disease

Keywords: ACC Annual Scientific Session, ACC23, Tricuspid Valve, Tricuspid Valve Insufficiency, Cardiac Surgical Procedures, ACC.23/WCC Meeting Newspaper, ACC Scientific Session Newspaper

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