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

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 1:1 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/1.73m

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.

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Copyright © 2024. Published by Elsevier Inc.