Dr. Ravza Betül Akbaş

Name of the Study: Tri.Fr trial – Multicentric randomized evaluation of the transcatheter edge-to-edge repair in the treatment of severe isolated secondary tricuspid regurgitation

Published in Congress: ESC 2024

Link: https://www.tctmd.com/news/trifr-trial-affirms-quality-life-impact-tricuspid-teer

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Background:

Traditionally, tricuspid valve surgery has been recommended for severe symptomatic tricuspid regurgitation or when tricuspid annulus dilation is present before left-sided heart surgery. The TRILUMINATE study, which investigated transcatheter edge-to-edge repair (T-TEER) with the TriClip, demonstrated that T-TEER is effective and safe in reducing tricuspid regurgitation. However, there is a need for studies comparing TriClip with optimal medical therapy.

Objective:

The Tri.Fr study evaluated whether the addition of transcatheter edge-to-edge repair (T-TEER) with the TriClip to optimal medical therapy provides benefits compared to optimal medical therapy alone in patients with severe secondary tricuspid regurgitation.

Methods:

In this prospectively designed, randomized study, patients with functional tricuspid regurgitation were divided into two groups. The first group received optimal medical therapy combined with T-TEER, while the second group received only optimal medical therapy. The primary inclusion criteria were severe symptomatic secondary tricuspid regurgitation despite medical therapy, lack of suitability for surgery, and stability for at least the past 30 days. Patients with a left ventricular ejection fraction of 35% or less, those who had undergone MitraClip placement in the past 3 months, and those with anatomy unsuitable for the TriClip were excluded from the study.
The primary endpoint was the Milton Packer clinical composite score, which categorizes patients into three classifications: improvement, deterioration, or no change. This score is based on assessments of NYHA classification, quality of life scores, and the occurrence of major cardiovascular events.

Results:

A total of 300 patients from 24 centers in France and Belgium were included in the study. The average age of the patients was 78 years, with 54% being female. The composite score was 74.1% in the T-TEER group, compared to 40.6% in the control group (p<0.0001). Follow-up at one year revealed a significant improvement in the severity of tricuspid regurgitation in the T-TEER group compared to the optimal medical therapy group (p<0.0001). Additionally, the Kansas City Cardiomyopathy Questionnaire score at one year was 69.9 in the T-TEER group, compared to 55.4 in the medical therapy group (p<0.0001).

Conclusion:

Transcatheter edge-to-edge repair (T-TEER) significantly improved outcomes and quality of life at one year compared to optimal medical therapy alone.

Interpretations:

Given the results of these studies involving the "forgotten valve" tricuspid valve, it appears likely that T-TEER will become more commonly utilized in clinical practice with appropriate patient selection.