Twelve-month outcomes of the LuX-Valve for transcatheter treatment of severe tricuspid regurgitation

Background: Severe functional tricuspid regurgitation is associated with adverse clinical outcomes. Conventional surgical risk for patients with advanced tricuspid regurgitation stage is high. Alternative approaches are therefore required. Aims: The purpose of this study was to investigate the feasibility, technical details, and midterm outcomes of implantation of a novel radial force-independent orthotopic transcatheter tricuspid valve - the LuXValve - in patients with severe functional tricuspid regurgitation. Methods: The implantations of the LuX-Valve were performed in six patients with left-sided valvular surgery and secondary massive tricuspid regurgitation. The anatomy of the tricuspid valve and right heart measurements were evaluated by echocardiography and computed tomography in all patients. Conventional right ventricular (RV) function parameters and RV global longitudinal strain were obtained at baseline and 12-month follow-up. LuX-Valve implantation was performed under the guidance of digital subtraction angiography and transoesophageal echocardiography. Results: All patients had successful implantations of LuX-Valves through the right atrium with a substantial reduction in the degree of tricuspid regurgitation. Although one patient with moderate paravalvular leakage died because of right heart failure during three-month follow-up, the five patients who lived had no significant paravalvular leakage, and displayed significant improvements in mean transvalvular gradient, right heart sizes, conventional RV function indices and RV global longitudinal strain, and a reduction in New York Heart Association Functional Class during 12-month follow-up. Conclusions: Transcatheter tricuspid valve replacement with the LuX-Valve was feasible and safe for patients with severe functional tricuspid regurgitation. This strategy seems a promising treatment option for patients at high surgical risk.