Clinical and economic evaluation of transcatheter edge-to-edge repair with the TriClip system in patients with severe tricuspid regurgitation at high surgical risk in the Russian healthcare system

Objective: To evaluate the clinical and economic effectiveness of the TriClip ® transcatheter edge-to-edge repair system compared with optimal medical therapy (OMT) in patients with severe tricuspid regurgitation in the Russian healthcare system using mathematical modeling. Material and methods. A model was developed to evaluate the clinical and economic outcomes of alternative treatment strategies in patients at high surgical risk with grade 3–4 severe tricuspid regurgitation and New York Heart Association (NYHA) functional classes II–IV. The methods included cost-effectiveness, cost-utility, and budget impact analyses. The treatment strategies compared were transcatheter edge-to-edge repair of the tricuspid valve using the TriClip ® system and OMT. The base-case time horizon for the clinical and economic analysis was 15 years. Scenario analyses with time horizons of 5, 10, and 20 years were also performed to assess the robustness of the results, along with analyses accounting for hospitalizations and crossover study results. Results. Compared with OMT, TriClip ® increased life years gained (LYGs) and quality-adjusted life years (QALYs) by 1.36 and 1.41, respectively. Over the 15-year modeling horizon, the incremental cost-effectiveness ratio for TriClip ® versus OMT was 3.3 million rubles per QALY. The budget impact analysis showed that introducing TriClip ® in addition to OMT would increase healthcare expenditures by 2.8 billion rubles over 5 years compared with OMT alone. Conclusion. Use of the TriClip ® tricuspid valve repair system is associated with higher direct medical costs as well as increased LYGs and QALYs compared with OMT. Despite the higher initial costs associated with the intervention, TriClip ® is cost-effective from the perspective of the Russian healthcare system, with its clinical benefits becoming more pronounced over longer time horizons.