Early health-status improvement after transcatheter tricuspid edge-to-edge repair predicts long-term reduction in heart-failure hospitalizations: insights from theTRI-FR randomized trial
E Donal, G Leurent, G Dreyfus, A Coisne, P Guerin, Y Lavie-Badie, G L'official, J Ternacle, M Urena-alcazar, C Diakov, V Auffret, J N Trochu, E OgerAbstract
Background
Randomized trials of transcatheter tricuspid edge-to-edge repair (T-TEER) show marked symptomatic improvement in severe tricuspid regurgitation (TR), yet the relationship between early patient-reported benefit and subsequent clinical outcomes remains unclear.
Purpose
To characterize the trajectory of health-status improvement after T-TEER and determine whether early change predicts long-term heart-failure hospitalization (HFH) and major events.
Methods
TRI-FR randomized 300 patients with severe symptomatic TR to T-TEER plus optimized medical therapy (OMT) or OMT alone. Health status was assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ), Minnesota Living with Heart Failure (MLHF), and Patient Global Assessment (PGA) at baseline through extended follow-up (mean 40 months). Mixed-effects models evaluated between-group differences over time. Associations between 6-week KCCQ change and subsequent clinical outcomes (HFH, tricuspid surgery, cardiovascular death) were tested using Cox and Lin-Wei-Yang-Ying recurrent-event models.
Results
T-TEER produced rapid and sustained health-status improvement versus OMT. At 12 months, KCCQ-OS was higher with T-TEER (66.2 vs 56.8; Δ +9.5 points, p < 0.001) and MLHF lower (27.5 vs 36.0; Δ −8.5, p = 0.001). Benefits persisted through 3 years (ΔKCCQ +8.5, p = 0.014). PGA favored T-TEER (probability of better status > 0.70).
Early KCCQ improvement predicted outcomes only in the T-TEER arm: each 10-point increase at 6 weeks reduced risk of first HFH/surgery/CV death (HR 0.86, 95% CI 0.73–1.00) and recurrent HFH burden (rate ratio 0.85, 95% CI 0.73–0.99; interaction p = 0.005). Overall, T-TEER reduced recurrent HFHs versus OMT (28 vs 45 events).(fig1)
Conclusions
In severe TR, T-TEER induces early and durable improvement in patient-reported health status. Early KCCQ gain identifies patients with subsequent reduction in HF hospitalizations, linking symptomatic benefit to modification of clinical trajectory. These findings support health-status response as an early surrogate of long-term benefit after tricuspid intervention.fig 1For image description, please refer to the figure legend and surrounding text.