Quality of Life After Transcatheter Tricuspid Valve Replacement: One-Year Results From TRISCEND II Pivotal Trial

In this study, the authors conducted an in-depth analysis of the health status of patients enrolled in the TRISCEND II pivotal trial (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device) to help quantify the benefit of intervention for these patients. The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater tricuspid regurgitation (TR) to transcatheter tricuspid valve replacement (TTVR) with the EVOQUE tricuspid valve plus optimal medical therapy (OMT), or OMT alone. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-OS) and the 36-Item Short Form Health Survey. Changes in health status in the span of one year were compared between treatment groups using mixed-effects repeated-measures models. The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 plus or minus 7.6 years, 75.5 percent women, 56.1 percent with massive or torrential TR). Patients had substantially impaired health status at baseline (mean KCCQ-OS 52.1 plus or minus 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 plus or minus 8.4). TTVR plus OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up point. Mean between group differences in the KCCQ-OS favored TTVR plus OMT at each point: 11.8 points (95 percent CI: 7.4-16.3 points) at 30 days, 20.8 points (95 percent CI: 16.1-25.5 points) at six months, and 17.8 points (95 percent CI: 13.0-22.5 points) at one year. Furthermore, TTVR plus OMT improved health status to a greater extent among patients with torrential or massive TR compared to those with severe TR (treatment effect 23.3 versus 22.6 versus 11.3; interaction P = 0.049). At one year, 64.6 percent of TTVR plus OMT patients were alive and well (KCCQ-OS greater than or equal to 60 points and no decline of greater than or equal to 10 points from baseline) compared with 31.0 percent in the OMT-only group. In conclusion, compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR plus OMT resulted in substantial improvement in patients’ symptoms, function, and quality of life. These benefits were evident 30 days after TTVR, continued to increase through six months, and remained durable through one year.