Transcatheter Tricuspid Valve Replacement With the Novel System: 1-Year Outcomes From the TRAVEL Study

Abstract

Background: Transcatheter tricuspid valve replacement (TTVR) is emerging as a promising surgical alternative for high-risk patients with tricuspid regurgitation (TR). Nonetheless, the feasibility of more dedicated devices and the need for additional clinical evidence warrant further exploration.

Objectives: The purpose of this study was to report the 1-year outcomes of the TRAVEL (Transcatheter Right Atrial-Ventricular Valve Replacement With LuX-Valve) study with the LuX-Valve system for patients with severe TR.

Methods: A total of 126 patients with symptomatic severe TR were prospectively enrolled in the single-arm, multicenter TRAVEL study from June 2020 to August 2021. All patients underwent TTVR via the transatrial approach using the LuX-Valve system. The primary endpoint was all-cause mortality and hospitalization for heart failure at 1-year follow-up. Clinical and echocardiographic outcomes were reported.

Results: At baseline, all enrolled patients (mean age 65.8 ± 7.5 years, 79.4% women) were at high surgical risk (mean Society of Thoracic Surgeons score 9.2% ± 4.4%), with severe or greater TR and NYHA functional class ≥ III. In 1-year follow-up, all-cause mortality was 10.3%, and 4.0% of patients were hospitalized for heart failure. TR was reduced to mild or less in 95.2% (P < 0.001), with decreases in right atrial systolic volume (-38.3 ± 21.7 mL; P < 0.001) and mid right ventricular end-systolic diameter (-6.4 ± 2.3 mm; P < 0.001). NYHA functional class I or II was achieved in 79.8% (P < 0.001), and 6-minute walking distance increased by 71.3 ± 42.8 m (P < 0.001).

Conclusions: The 1-year outcomes of the TRAVEL study showed a sustained reduction in TR among patients who underwent LuX-Valve TTVR, accompanied by significant right heart reverse remodeling and improved functional status. Favorable procedural success and survival benefits were also demonstrated. (the TRAVEL Trial: Transcatheter Right Atrial-Ventricular Valve Replacement With LuX-Valve; NCT04436653).

Keywords: LuX-Valve; functional status; survival; transcatheter tricuspid valve replacement; tricuspid regurgitation.