TRILUMINATE: Liver and Kidney Failure in Tricuspid Valve Edge-to-Edge Repair

Severe tricuspid regurgitation (TR) will affect roughly 3% of the 65+ population and may lead to liver and kidney failure, which will cause ascites and peripheral edema. These complications increase hospitalization for cardiac failure and mortality. 

The TRILUMINATE Pivotal included 572 patients with moderate to severe TR randomized to edge-to-edge combined with optimal medical treatment (T TEER, 285 patients) or optimal medical treatment alone (OMT, the remaining patients).

Kidney function was assessed with eGFR and liver function with MELD-XI (Model for End-Stage Liver Disease excluding INR). Primary end point was death or hospitalization at 12 months.

Patient Baseline Characteristics

Both groups had similar baseline characteristics. Mean age was 78, 59% were women, over half were in functional class III-IV. Other relevant findings were:

• Atrial fibrillation: 88%
• Hypertension: 80%
• Prior mitral or aortic intervention: 37%
• Kidney function deterioration: 33%
• Pacemaker presence: 16%
• Liver disease: 7%
• Infarction: 4%
• Stroke: 8%

50% presented torrential TR, 21% massive, 28% severe and the rest, moderate. Mean eGFR was 53.9 ± 14.0 mL/min/1.73 m², and mean MELD-XI score was 10.2 ± 3.5.

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Results: edge-to-edge (T TEER) in severe tricuspid regurgitation

After T TEER, there was significant reduction of TR in 92% of patients, sustained over a year. 

The MELD-XI improved significantly among TEER patients (-0.11 ± 0.13 vs. 0.41 ± 0.13; p=0.0043), while there were no significant differences in eGFR (-0.10 ± 0.79 vs. -2.22 ± 0.82 mL/min/1.73 m²; p=0.063).

However, in patients with successful TEER (moderate or mild TR), both parameters showed improvement. 

• eGFR: +3.55 ± 1.04 mL/min/1.73 m² (vs. 0.07 ± 1.10 mL/min/1.73 m² in the control group; p=0.022).
• MELD-XI: -0.52 ± 0.18 points (vs. 0.34 ± 0.18 increase in the control group; p=0.0007).

The clinical analysis did not show differences in mortality or hospitalization between the groups. However, patients with moderate to severe kidney function deterioration at baseline showed higher rates of hospitalization for cardiac failure (0.34 events/year; p<0.001), regardless treatment type.

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In this subgroup, the primary end point resulted lower among T TEER patients (28.9% vs. 36.2%; p=0.40), though with no statistical significance. 

Conclusion: Effects of severe TR and TRILUMINATE Pivotal outcomes on renal and liver failure 

Severe kidney and liver function deterioration are associated to higher hospitalization and mortality rates in patients with severe TR. At 12 months, there were no statistically significant differences in eGFR and MELD-XI between the groups. However, in patients with successful TEER, there was mild improvement in both parameters. Further studies are required to assess the impact of these changes in the terminal kidney and liver failure, an also in hospitalization and mortality reduction. 

Original Title: Clinical Outcomes of Transcatheter Edge-to-Edge Tricuspid Valve Repair and Organ Function in Severe Tricuspid Regurgitation: TRILUMINATE Trial.

Reference: Ulrich P. Jorde et al. Journal of the American College of Cardiology, Volumen 84, 2446–2456, 2024.