The TRILUMINATE pivotal trial (NCT03904147) was presented at ACC 2023. Researchers investigated the safety and effectiveness of transcatheter edge-to-edge repair (TEER) of tricuspid valve regurgitation using the TriClip® (Abbott). A total of 350 patients with symptomatic severe tricuspid regurgitation (TR) were randomized to medical therapy or TEER in TRILUMINATE. At 1 year, the primary composite outcome (all-cause death or tricuspid valve [TV] surgery, hospitalization for heart failure [HF], improvement in QoL) favoured TEER vs. control arm (win ratio, 1.48, p=0.02). Quality of life (QoL) in the TEER arm increased significantly vs. control arm (12.3 points vs. 0.6, p<0.001). At 30 days, TR graded moderate or less improved considerably in the TEER group vs control arm (87.0% vs. 4.8%, p<0.001), with only 1.7% of patients who underwent the procedure experiencing any major adverse events.
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Sorajja P et al. The New England Journal of Medicine 4 March 2023.