Transcatheter Tricuspid Valve Clinical Trials: Incomplete Data and FDA-Approved Devices

Abstract

Each reviewed trial of transcatheter tricuspid valve intervention demonstrated clinically meaningful improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ)-defined quality of life and favorable right ventricular remodeling. KCCQ correlates with tricuspid regurgitation (TR) reduction, heart failure hospitalization, and mortality. Change in KCCQ is therefore meaningful both as a measure of quality of life and as a surrogate endpoint of the impact of TV interventions. TRILUMINATE, the first randomized trial to evaluate the safety and efficacy of tricuspid edge-to-edge repair, demonstrated clinically important benefits in KCCQ score and favorable right ventricular remodeling, which are appropriate endpoints for this symptomatic population. TRISCEND II, which evaluated the safety and effectiveness of the EVOQUE valve, enrolled patients with more New York Heart Association class III and IV heart failure and lower KCCQ scores than TRILUMINATE. EVOQUE tricuspid valve replacement in TRISCEND II reduced TR to mild or less in 94% of patients compared to 50% of patients treated with TriClip in TRILUMINATE. The higher-risk TRISCEND II population and the near elimination of TR with EVOQUE are consistent with the favorable trend in EVOQUE mortality. Patients with diminished left ventricular systolic function being considered for either of these tricuspid valve interventions should be optimized with guideline directed medical therapy. Significant left-side valve disease should be treated. Patients should be optimally diuresed and excluded with severe pulmonary hypertension. Patients with persistent severe TR and symptoms or right ventricular enlargement should be considered for intervention. Smaller coaptation gaps without significant pacemaker impingement may be well served with transcatheter tricuspid edge-to-edge repair, while larger coaptation gaps and leaflets pinned by right ventricular leads, particularly in patients tolerating oral anticoagulation, may be best served with transcatheter tricuspid valve replacement.