TY - JOUR
T1 - Impact of Renal and Liver Function on Clinical Outcomes Following Tricuspid Valve Transcatheter Edge-to-Edge Repair
AU - Jorde, Ulrich P.
AU - Benza, Raymond
AU - McCarthy, Patrick M.
AU - Ailawadi, Gorav
AU - Whisenant, Brian
AU - Makkar, Raj
AU - Tadros, Peter
AU - Naik, Hursh
AU - Fam, Neil
AU - Sauer, Andrew J.
AU - Murthy, Sandhya
AU - Kar, Saibal
AU - von Bardeleben, Ralph Stephan
AU - Hahn, Rebecca T.
AU - Hamid, Nadira
AU - Zbinden, Jacob
AU - Sorajja, Paul
AU - Adams, David
N1 - Publisher Copyright:
© 2024
PY - 2024/12/17
Y1 - 2024/12/17
N2 - Background: The TRILUMINATE Pivotal trial 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: This study sought to 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: A total of 572 subjects were enrolled and randomized (285 TEER, 287 control patients). Patients with moderate-to-severe end-organ impairment (estimated glomerular ejection fraction [eGFR] <45 mL/min/1.73 m2 or Model for End-Stage Liver Disease excluding INR [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 patients in eGFR or MELD-XI at 12 months. In subgroup analyses examining only successful TEER patients (moderate or less TR at discharge) compared with control patients, as well as when censoring patients with normal baseline values, both eGFR (+3.55 ± 1.04 mL/min/1.73 m2 vs 0.07 ± 1.10 mL/min/1.73 m2; P = 0.022) and MELD-XI (−0.52 ± 0.18 vs 0.34 ± 0.18; P = 0.0007) improved. Conclusions: Baseline end-organ function was 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.
AB - Background: The TRILUMINATE Pivotal trial 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: This study sought to 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: A total of 572 subjects were enrolled and randomized (285 TEER, 287 control patients). Patients with moderate-to-severe end-organ impairment (estimated glomerular ejection fraction [eGFR] <45 mL/min/1.73 m2 or Model for End-Stage Liver Disease excluding INR [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 patients in eGFR or MELD-XI at 12 months. In subgroup analyses examining only successful TEER patients (moderate or less TR at discharge) compared with control patients, as well as when censoring patients with normal baseline values, both eGFR (+3.55 ± 1.04 mL/min/1.73 m2 vs 0.07 ± 1.10 mL/min/1.73 m2; P = 0.022) and MELD-XI (−0.52 ± 0.18 vs 0.34 ± 0.18; P = 0.0007) improved. Conclusions: Baseline end-organ function was 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.
KW - renal and liver end-organ function
KW - transcatheter edge-to-edge repair
KW - tricuspid regurgitation
UR - http://www.scopus.com/inward/record.url?scp=85206076012&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2024.08.044
DO - 10.1016/j.jacc.2024.08.044
M3 - Article
C2 - 39222896
AN - SCOPUS:85206076012
SN - 0735-1097
VL - 84
SP - 2446
EP - 2456
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 25
ER -