The study in question presents a prospective randomized trial that evaluated the efficacy and safety of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) in patients with severe tricuspid regurgitation. Conducted across 65 centers in North America and Europe, 350 patients were randomized into two equal groups, with one group undergoing TEER and the other receiving conventional medical therapy. The primary composite endpoint encompassed factors such as all-cause mortality or tricuspid valve surgery, heart failure hospitalization, and improvement in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Also evaluated were the severity of tricuspid regurgitation and the safety profile of TEER.
The trial concluded with results favoring the TEER group (win ratio, 1.48; 95% CI, 1.06-2.13; P=0.02), although rates of death, tricuspid-valve surgery, and heart failure hospitalization showed no significant difference between the two groups. The TEER group exhibited a marked improvement in KCCQ scores compared to the control group (mean change 12.3±1.8 vs. 0.6±1.8; P<0.001) and a significant reduction in the severity of tricuspid regurgitation at the 30-day mark (87.0% TEER group vs. 4.8% control group with tricuspid regurgitation of no greater than moderate severity; P<0.001). The safety profile for TEER was reassuring, with 98.3% of patients remaining free from major adverse events at 30 days post-procedure.
In summary, percutaneous tricuspid TEER was found to be safe and effective in improving the quality of life and reducing tricuspid regurgitation severity in patients with severe tricuspid regurgitation.