Background: The impact of tricuspid regurgitation (TR) on cardiac remodeling has not been thoroughly studied in a randomized controlled trial (RCT) using advanced imaging.

Objectives: To provide comparative longitudinal changes in right heart remodeling using cardiac magnetic resonance (CMR) and time-resolved functional computed tomography (4D-CT) in patients with symptomatic severe TR randomized to TriClip vs medical therapy (control).

Methods: TRILUMINATE Pivotal (NCT03904147) is an international RCT in symptomatic patients with severe TR. A prospective imaging sub-study was performed on TRILUMINATE Pivotal subjects at 10 sites. CMR and 4D-CT were performed following dedicated imaging protocols at baseline and 30 days, and a final 4D-CT at 1 year (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 RV end-diastolic volume (RVEDV) at 30 days. Significant reductions in RVEDV (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. Larger symptomatic improvements were associated with greater RV reverse remodeling.

Conclusions: Advanced imaging from the TRILUMINATE Pivotal imaging sub-study 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, and was associated with symptomatic improvement.

Editors
Editor-in-Chief
Harlan M. Krumholz, MD, SM, FACC 

CME Editor
Ragavendra R. Baliga, MD

Author
Upasana Jarori, MD, FACC

Important Dates
Date of Release: January 20, 2025
Term of Approval/Date of CME/MOC Expiration: January 19, 2026