The TRILUMINATE Pivotal randomized trial1 demonstrated that transcatheter edge-to-edge repair (T-TEER) with the TriClip system is a safe and effective therapy for symptomatic severe TR. The study showed significant improvements in quality of life and functional status at one year, driven largely by significant reductions in TR severity and improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. Importantly, the recently published two-year data demonstrated a significant reduction in recurrent heart failure hospitalizations compared with medical therapy alone, while mortality remained similar between groups. The majority of treated patients had moderate or less TR, suggestive of the durability of repair therapy and that earlier intervention may favorably influence long-term clinical trajectories.
TRISCEND II1,2 added to the therapeutic landscape with randomized evidence for transcatheter tricuspid valve replacement (TTVR) using the EVOQUE system. The trial showed near complete removal of TR in most patients and major improvements in symptoms, exercise ability and quality of life. Health-status analyses demonstrated particularly large gains in KCCQ scores compared with optimal medical therapy alone, underscoring the profound symptomatic benefit of complete TR elimination. At the same time, the study highlighted important unanswered questions regarding right ventricular adaptation after sudden TR removal, pacemaker implantation, anticoagulation strategies and the best long term management of the patient. The data suggest that replacement therapies may be particularly attractive in patients with advanced annular dilation or anatomies less suited to repair.
The European TRI.FR trial3 provided an important transatlantic and academic perspective on T-TEER for severe symptomatic TR. The study, conducted in multiple centers in France and Belgium, confirmed that T-TEER in combination with optimized medical therapy significantly improved patient reported outcomes and reduced the severity of TR compared to medical therapy alone. The primary benefit was mainly driven by improvements in symptoms, NYHA class, patient global assessment and KCCQ scores. The trial also highlighted the importance of careful Heart Team selection, imaging expertise, and phenotype-driven therapy. TRI.FR noted the growing divergence between European and US treatment philosophies, with Europe possibly shifting to a more selective and individualized implementation strategy.
Taken together, these trials suggest that the future of tricuspid intervention will likely not be driven by a single device or technique, but rather by personalized patient profiling that includes anatomy, right ventricular function, systemic congestion, frailty, timing of intervention, and multimodality imaging. Thus, repair and replacement strategies should be increasingly seen as complementary rather than competing approaches.
Against this backdrop, an important next question arises: how will these landmark trials influence real-world therapeutic approaches and clinical decision-making on both sides of the Atlantic? Although the United States may see a relatively rapid transition to a broader adoption of transcatheter tricuspid interventions following the positive randomized data from TRILUMINATE and TRISCEND II, European centers may be expected to implement a more selective and phenotype-driven approach at first, including careful patient profiling, Heart Team evaluation, and integration within existing health care structures.
The evolving balance between repair and replacement, the optimal timing of intervention, the role of multimodality imaging, and the management of advanced right heart disease may therefore be interpreted somewhat differently in the US compared with Germany and Europe. At the same time, both healthcare systems share a common challenge: identifying the patients who will derive the greatest long-term clinical benefit from intervention before irreversible right ventricular dysfunction and systemic congestion occur.
To better understand these transatlantic perspectives and future treatment paradigms, we invited both US experts and German/European experts to discuss how TRILUMINATE, TRISCEND II, and TRI.FR may change the current and future management of tricuspid regurgitation.
The three expert perspectives come together with one key message: with TRILUMINATE, TRISCEND II and TRI.FR, tricuspid regurgitation is finally out of the “forgotten valve” to become a treatable disease with evidence- based transcatheter options. The question is no longer whether to intervene, but which patient should receive which therapy – and when. Repair and replacement are more and more viewed as alternative rather than competing strategies. All experts highlight the importance of early referral, comprehensive multimodality imaging and careful assessment of right ventricular function, systemic congestion and frailty. At the same time, they agree, stronger evidence in the long-term showing prognostic benefit beyond symptom relief will be key to help further refine guidelines and clinical practice.
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