Key result
TriClip cuts tricuspid regurgitant volume ~70% vs. medical therapy, driving sustained RV reverse remodeling.
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Why the study?
The impact of tricuspid regurgitation on cardiac remodeling had not been thoroughly evaluated in a randomized controlled trial using advanced imaging.
Does TriClip improve right heart remodeling in symptomatic patients with severe tricuspid regurgitation compared to medical therapy?
RCT (n=69)
randomized
Yes
Does TriClip improve right heart remodeling in symptomatic patients with severe tricuspid regurgitation compared to medical therapy?
Transcatheter tricuspid valve repair with TriClip leads to significant and sustained right heart reverse remodeling proportional to the degree of TR reduction.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The quantification that is capable... through the lens of cardiac MRI is very important to provide us a physiological understanding of how this therapy will affect the remodeling and eventually the outcomes of these patients.”
“There's positive remodeling of the right heart, and that's impactful because we weren't aware of that before, because we couldn't see it on 2D echo, so knowing that that exists gives us more promise that there's reason to treat tricuspid regurgitation.”
TriClip may improve RV remodeling in severe TR; extends small RCT imaging data but leaves clinical outcome impact open.
BACKGROUND The impact of tricuspid regurgitation (TR) on cardiac remodeling has not been thoroughly studied in a randomized controlled trial using advanced imaging. OBJECTIVES The goal of this analysis was to provide comparative 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). METHODS TRILUMINATE Pivotal (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal) is an international randomized controlled trial in symptomatic patients with severe TR. A prospective imaging substudy was performed on TRILUMINATE Pivotal subjects at 10 sites. Cardiac magnetic resonance and 4D-CT were performed following dedicated imaging protocols at baseline and at 30 days, and a final 4D-CT at 1 year (all assessed by an imaging core lab). RESULTS Sixty-nine randomized subjects (31 TriClip, 38 control) were enrolled. TR volume significantly decreased with TriClip at 30 days (P < 0.0001; 70% reduction). A strong association (r = 0.90; P < 0.0001) was observed between changes in TR volume and right ventricular end-diastolic volume at 30 days. Significant reductions in right ventricular end-diastolic volume (12% reduction; P < 0.001) and tricuspid annular area (11% reduction; P < 0.0001) were seen at 30 days and sustained through 1 year with TriClip. No meaningful changes were observed in the control group. CONCLUSIONS Advanced imaging from the TRILUMINATE Pivotal imaging substudy demonstrated that TriClip effectively reduced TR. Significant cardiac remodeling was observed at 30 days and sustained at 1 year. With TriClip, the extent of cardiac remodeling was associated with the degree of TR reduction. (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal; NCT03904147)
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Cavalcante et al. (2024) conducted an RCT in symptomatic severe tricuspid regurgitation (n=69). TriClip vs. Medical therapy was evaluated on Change in tricuspid regurgitant volume at 30 days (70% reduction, p=<0.0001). TriClip significantly reduced tricuspid regurgitant volume by 70% at 30 days compared to medical therapy, leading to sustained right ventricular reverse remodeling at 1 year.
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