TRISCEND II: Effect of Transcatheter Tricuspid Valve Replacement on Echocardiographic Measures of Right Heart Remodeling and Function.

BACKGROUND

The TRISCEND II (EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device) trial demonstrated clinical benefits for transcatheter tricuspid valve replacement (TTVR) with the EVOQUE System over medical therapy for the primary safety and effectiveness endpoint to 1 year.

OBJECTIVES

The authors report echocardiographic outcomes at 1 year for the randomized cohort and evaluate hemodynamic and structural changes.

METHODS

The multicenter, prospective TRISCEND II trial enrolled 400 patients with severe, symptomatic tricuspid regurgitation (TR) and randomized them in a 2:1 ratio to TTVR (n = 267) or medical therapy (control) (n = 133). The secondary echocardiographic endpoint was reduction in TR severity from baseline to discharge. Echocardiograms were evaluated by an independent echocardiographic core laboratory.

RESULTS

All patients had severe TR at baseline; at discharge, 95.5% of patients who underwent TTVR had mild TR. On paired analysis from baseline to 1 year, 95.3% of patients who underwent TTVR and 2.3% of control patients achieved mild TR. Between baseline and 1 year, the mean inferior vena cava diameter decreased significantly more for patients who underwent TTVR (normal breathing P < 0.001; forced inhalation P = 0.038). Patients who underwent TTVR experienced greater improvements in diastolic right ventricular (RV) size (P < 0.05) and larger decreases in RV systolic function (P < 0.001), consistent with reduced preload from TR reduction. RV stroke volume and cardiac output increased significantly in patients who underwent TTVR (P < 0.001) but not in control patients.

CONCLUSIONS

One-year echocardiographic outcomes from the TRISCEND II trial demonstrated that near elimination of TR following TTVR is associated with reduced venous congestion, RV reverse remodeling, and significant improvements in forward stroke volume and cardiac output. (EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device [TRISCEND II Pivotal Trial]; NCT04482062).