Impact of Renal & Liver Function on Clinical Outcomes Following Tricuspid Valve Transcatheter Edge-to-Edge Repair.

ABSTRACT

BACKGROUND: TRILUMINATE Pivotal is a prospective, randomized, controlled study of patients with severe tricuspid regurgitation (TR). Venous congestion due to TR may lead to end-organ dysfunction and failure. The potential to reverse or stop further deterioration in end-organ function is an important goal of treatment. OBJECTIVES: Examine changes in end-organ function after tricuspid transcatheter edge-to-edge repair (TEER) and assess the association of baseline end-organ function with heart failure (HF) hospitalizations and mortality. METHODS: Subjects were randomized 11 to either the TEER group (TriClip™ System + medical therapy) or Control group (medical therapy alone). Laboratory assessments and TR grading were performed at baseline and at all follow-up visits (discharge, 30 days, 6 months, and 12 months). An independent echocardiography core laboratory assessed TR severity and an independent clinical events committee adjudicated adverse events. RESULTS: 572 subjects were enrolled and randomized (285 TEER, 287 Control). Patients with moderate to severe end-organ impairment (eGFR <45 ml/min/1.73m2 or MELD-XI >15) at baseline had increased incidence of HF hospitalization and death through 12 months, regardless of treatment. There were no statistically significant differences between TEER and Control in eGFR or MELD-XI at 12 months. In subgroup analyses examining only successful TEER patients (moderate or less TR at discharge) compared to control patients, as well as when censoring patients with normal baseline values, both eGFR (+3.55 ± 1.04 vs 0.07 ± 1.10 , p=0.022) and MELD-XI (-0.52 ± 0.18 vs 0.34 ± 0.18, p=0.0007) improved. CONCLUSIONS: Baseline end-organ function were associated with HF hospitalization and death in patients with severe TR. At 12 months, eGFR and MELD-XI scores were not statistically significantly different between the overall TEER and Control groups. In patients who had successful TEER, statistically significant, yet small, favorable changes occurred for both eGFR and MELD-XI. Further investigation is needed to assess whether these changes in end-organ function after successful TEER are clinically meaningful and reduce HF hospitalization or death.