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The following is a summary of “Advanced Imaging Assessment of the Impact of Tricuspid Regurgitation on Cardiac Remodeling: The TRILUMINATE Pivotal Imaging Substudy,” published in the January 2025 issue of Cardiology by Cavalcante et al.
The effect of tricuspid regurgitation (TR) on cardiac remodeling has not been extensively examined in a randomized controlled trial (RCTs) with advanced imaging techniques.
Researchers conducted a retrospective study to compare longitudinal changes in right heart remodeling using cardiac magnetic resonance and time-resolved functional computed tomography (4D-CT) in patients with symptomatic severe TR randomized to TriClip vs medical therapy (control).
They evaluated symptomatic patients with severe TR from the TRILUMINATE Pivotal trial at 10 sites. Cardiac magnetic resonance and 4D-CT were performed at baseline and 30 days, with a final 4D-CT at 1 year, following dedicated imaging protocols and assessed by an imaging core lab.
The results showed 69 subjects (31 TriClip, 38 control) were enrolled. The TR volume decreased significantly by 70% (P < 0.0001) with TriClip at 30 days. A strong correlation (r = 0.90; P < 0.0001) was found between changes in TR volume and right ventricular end-diastolic volume at 30 days. Right ventricular end-diastolic volume decreased by 12% (P < 0.001) and tricuspid annular area by 11% (P < 0.0001) at 30 days, with improvements sustained through 1 year in the TriClip group while, no significant changes were noted in the control group.
Investigators concluded the advanced imaging from the TRILUMINATE Pivotal imaging substudy demonstrated that the TriClip device effectively reduced TR but also revealed significant cardiac remodeling at 30 days, which persisted at 1 year. Furthermore, the extent of this remodeling was associated with the degree of TR reduction achieved with the TriClip device.