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Percutaneous Edge-to-Edge Repair for TR: TRILUMINATE 3-Year Outcomes
Quick Takes
- Among subjects who underwent T-TEER for at least moderate tricuspid regurgitation (TR) in the TRILUMINATE study, there was a sustained decrease in TR severity and 79% of subjects had no more than moderate TR at 3 years.
- The rate of heart failure hospitalizations decreased 75% at 3 years compared to the year prior to T-TEER.
- Although quality of life assessed by KCCQ was improved compared to baseline, it was decreased compared to 1 year following T-TEER.
Study Questions:
What are the 3-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip implant for the treatment of severe symptomatic tricuspid regurgitation (TR)?
Methods:
The TRILUMINATE study is an international, prospective, single-arm, multicenter study to investigate the safety and performance of T-TEER with the TriClip system (Abbott; Santa Clara, CA) in patients with symptomatic moderate or greater TR and high surgical risk. Exclusion criteria included pulmonary artery systolic pressure >60 mm Hg, prior tricuspid valve procedures, or coaptation gap >10 mm. Echocardiographic assessments were performed at a core laboratory.
Results:
Of 98 subjects enrolled at 21 centers, 60 completed a 3-year visit (25 deaths, 10 withdrawals, 3 missed visits); 48 subjects had evaluable TR at baseline and 3-year follow-up. Of these, TR was reduced by ≥1 grade in 92% (44/48) and was moderate or less in 79% (38/48). TR reduction achieved at 1 year was sustained through 3 years. The prevalence of patients with New York Heart Association functional class III/IV symptoms decreased from 76% at baseline to 19% at 3 years. Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ; n = 54) decreased from the improvement seen at 1 year (-12 ± 21 points, p = 0.0001) but was still higher than at baseline (+10 ± 3 points, p = 0.006). Site-reported heart failure hospitalizations decreased from 0.56 events/patient-year 1 year prior to T-TEER to 0.14 events/patient-year 3 years after T-TEER (a 75% reduction, p < 0.0001).
Conclusions:
In the longest follow-up to date of T-TEER therapy, the authors conclude that the TRILUMINATE study demonstrated that the TriClip procedure is effective, with sustained benefits at 3 years in subjects with symptomatic moderate or greater TR.
Perspective:
Significant chronic TR is associated with increased morbidity and mortality. Previous publications have documented the periprocedural safely and short-term efficacy of the TriClip system to treat TR. This study shows that, among the 48 subjects with available echo/Doppler follow-up (of 98 enrolled and 60 completing follow-up), there was a sustained reduction in TR severity and most patients (79%) had moderate or less TR at 3 years. Quality of life by KCCQ was available in 54 of 60 subjects at 3 years and showed net improvement compared to baseline but a significant decrease compared to 1 year; there was a decrease in the rate of heart failure hospitalizations at 3 years compared to the 1 year prior to T-TEER. Without a control group for comparison, this study does not address whether a reduction in TR was causally responsible for improved clinical outcomes or whether worse clinical outcomes (including 25 deaths) might have occurred in the setting of less optimal procedural results.
Clinical Topics: Valvular Heart Disease, Invasive Cardiovascular Angiography and Intervention
Keywords: Heart Valve Diseases, Structural Intervention, Tricuspid Valve Insufficiency
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