Tricuspid transcatheter edge-to-edge repair did not significantly change overall eGFR or MELD-XI, but successful TEER improved eGFR (+3.55 vs 0.07, p=0.022) and MELD-XI (-0.52 vs 0.34, p=0.0007).
RCT (n=572)
1:1
Does tricuspid transcatheter edge-to-edge repair improve end-organ function compared to medical therapy alone in patients with severe tricuspid regurgitation?
In patients with severe TR, TEER did not significantly improve overall end-organ function at 12 months compared to medical therapy, though successful repair was associated with modest improvements in renal and liver function.
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 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.
“Together with previous studies, these findings strongly argue for earlier intervention for patients with [tricuspid regurgitation] and HF, before the onset of irreversible hepatic and renal dysfunction. Although this approach would be expected to improve relevant clinical outcomes including mortality and HF hospitalization, this hypothesis needs to be tested in randomized clinical trials of [transcatheter tricuspid edge-to-edge valve repair] vs. optimal medical therapy, the results of which are eagerly anticipated.”
Jorde et al. (Sat,) conducted a rct in Severe tricuspid regurgitation (TR) (n=572). Tricuspid transcatheter edge-to-edge repair (TEER) + medical therapy vs. Medical therapy alone was evaluated on Changes in eGFR and MELD-XI at 12 months. Tricuspid transcatheter edge-to-edge repair did not significantly change overall eGFR or MELD-XI, but successful TEER improved eGFR (+3.55 vs 0.07, p=0.022) and MELD-XI (-0.52 vs 0.34, p=0.0007).