THE TRILUMINATE Pivotal imaging substudy found that the TriClip device significantly reduces tricuspid regurgitation (TR) and promotes cardiac remodeling, with benefits sustained through one year.
This substudy explored the impact of TR on cardiac remodeling by employing advanced imaging techniques in a randomised controlled trial. Sixty-nine patients with symptomatic severe TR were enrolled at 10 international sites and randomised to receive either the TriClip device (n=31) or medical therapy alone (n=38). Participants underwent cardiac magnetic resonance imaging and time-resolved functional computed tomography (4D-CT) at baseline, 30 days, and one year. The imaging protocols were standardised and analysed by a central imaging core lab to ensure consistency.
The findings revealed that TriClip reduced TR volume by 70% at 30 days (P < 0.0001). This reduction was strongly correlated (r = 0.90; P < 0.0001) with decreases in right ventricular (RV) end-diastolic volume, which fell by 12% (P < 0.001). Additionally, the tricuspid annular area was reduced by 11% (P < 0.0001). These structural and functional improvements were sustained over the one-year follow-up. By contrast, no meaningful changes in TR or cardiac remodeling were observed in the control group, highlighting the efficacy of the TriClip intervention.
These findings support the clinical utility of the TriClip device in managing severe TR, particularly given its sustained impact on reversing right heart remodeling. This underscores the importance of early intervention for symptomatic TR to prevent progressive heart failure and improve patient outcomes. Future research should investigate whether these remodeling benefits translate to enhanced long-term survival and quality of life, while exploring optimal patient selection criteria.
Katrina Thornber, EMJ
Reference
Cavalcante JL et al. Advanced imaging assessment of the impact of tricuspid regurgitation on cardiac remodeling: the TRILUMINATE pivotal imaging substudy. Journal of the American College of Cardiology. 2025;85(3):250-61.
