Key result
TTVR improves symptoms and quality of life over medical therapy in severe TR.
Why the study?
Does transcatheter tricuspid-valve replacement improve clinical and functional outcomes in patients with severe symptomatic tricuspid regurgitation compared to medical therapy alone?
Does transcatheter tricuspid-valve replacement improve clinical and functional outcomes in patients with severe symptomatic tricuspid regurgitation compared to medical therapy alone?
Transcatheter tricuspid-valve replacement is superior to medical therapy alone for improving symptoms and quality of life in severe tricuspid regurgitation, despite higher rates of bleeding and pacemaker implantation.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“While neither trial demonstrated a mortality benefit, these two trials showed that both T-TEER and TTVR were associated with a reduction in TR, reduction of symptoms and improvement in quality of life compared to medical therapy alone.”
May support TTVR use in high-risk severe TR; leaves open need for RCTs on mortality and durability.
BACKGROUND: Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed. METHODS: In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy. RESULTS: A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001). CONCLUSIONS: For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.).
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Hahn et al. (2024) studied this question. Transcatheter tricuspid-valve replacement significantly improved symptoms and quality of life compared to medical therapy in patients with severe tricuspid regurgitation.
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