First-in-human description of a novel transcatheter tricuspid valve prosthesis to preserve the asymmetric shape of the right ventricle

Transcatheter tricuspid valve replacement (TTVR) may provide a safe means of complete relief of tricuspid regurgitation (TR). Nevertheless, there are notable challenges, including the asymmetry and large size of the tricuspid annulus, potential interactions with the ventricular septum, and the short distance of the tricuspid annulus to the right ventricular free wall. Consequences of these concerns include conduction disturbances, ventricular pseudoaneurysms, excessive tricuspid and right ventricular enlargement, and reduced eligibility for TTVR therapy.

We herein describe a novel TTVR prosthesis (VDyne Valve; VDyne) whose design intent is to preserve the asymmetric shape of the tricuspid annulus and right ventricle. The VDyne system is composed of a double-frame, nitinol prosthesis, which houses a 30 mm porcine trileaflet valve (Figure 1). The outer frame is asymmetric, designed to fit a tricuspid annulus with a perimeter of up to 180 mm (i.e., 42 to 56 mm diameter). This asymmetry, with securement mechanisms at the right ventricular outflow tract (RVOT), ventricular free wall and posterior septum, permits minimal annular oversizing (i.e., <10%). The procedure does not require leaflet identification with echocardiography. To reduce the risk of ventricular afterload mismatch, a pop-off aperture can...