Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study

Abstract Background and Aims For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes. Methods The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. Results Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III–IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. Conclusions In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490. Structured Graphical Abstract Structured Graphical Abstract One-year results of transcatheter tricuspid valve replacement in patients with ≥ moderate tricuspid regurgitation. The TRISCEND study demonstrated the following for patients treated with the EVOQUE system: 9.1% all-cause mortality and 10.2% HF hospitalization; significant TR reduction to grade ≤ mild in 97.6% of patients; and marked improvement in functional and quality-of-life outcomes, including a 25.7-point increase in KCCQ, 56.2-m increase in 6MWD, and 93.3% of patients in NYHA class I/II. 6MWD, six-minute walk distance; HFH, heart failure hospitalization; KCCQ, Kansas City Cardiomyopathy Quest