Transcatheter Valve Replacement in Severe Tricuspid Regurgitation

In the TRISCEND II trial, a total of 400 patients with severe symptomatic tricuspid regurgitation were randomized in a 2:1 ratio to undergo either transcatheter tricuspid valve replacement with medical therapy (valve-replacement group) or medical therapy alone (control group). A total of 267 patients were assigned to the valve replacement group and 133 to the control group. At one-year, tricuspid valve replacement and medical therapy were superior to medical therapy alone, with a win ratio of 2.02 (95 percent confidence interval [CI], 1.56 to 2.62; P<0.001). This was based on a hierarchical composite primary outcome that included death from any cause, implantation of a right ventricular assist device or heart transplantation, post-index tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score, an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 meters on the six-minute walk distance. Patients in the valve replacement group had more wins than the control group with respect to death from any cause (14.8 percent versus 12.5 percent), post-index tricuspid-valve intervention (3.2 percent versus 0.6 percent), and improvements in the KCCQ-OS score (23.1 percent versus 6.0 percent), NYHA class (10.2 percent versus 0.8 percent), and six-minute walk distance (1.1 percent versus 0.9 percent).  

However, the valve replacement group had fewer wins than the control group regarding the annual heart failure hospitalization rate (9.7 percent versus 10.0 percent). Furthermore, severe bleeding occurred in 15.4 percent of the valve replacement group and 5.3 percent of the control group (P=0.003), and new permanent pacemaker implantation was required in 17.4 percent and 2.3 percent, respectively (P<0.001).  

These findings suggest that transcatheter tricuspid valve replacement combined with medical therapy is superior to medical therapy alone in patients with severe tricuspid regurgitation, particular in terms of the primary hierarchical composite outcome, which was primarily driven by improvements in symptoms and quality of life.