Transcatheter repair for patients with tricuspid regurgitation

Tricuspid transcatheter edge-to-edge repair (TEER) reduced the severity of tricuspid regurgitation (TR) at 1 year and was associated with an improved quality of life in patients with severe tricuspid regurgitation. These were the main findings of the prospective, randomised TRILUMINATE trial.

TRILUMINATE (NCT03904147) was designed to evaluate the safety and effectiveness of medical therapy alone or percutaneous TEER the TriClip^TM G4 Delivery System for severe TR usage [1]. First author Dr Paul Sorajja (Minneapolis Heart Institute, MI, USA) said over 450 participants had thus far been enrolled at 65 centres in the USA, Canada, and Europe; he went on to present the main results of the first 350 patients [2]. Key inclusion and exclusion criteria are shown in the Table.

Table: Enrolment criteria of the TRILUMINATE trial. Derived from [2]



GDMT, guideline-directed medical therapy; HTN, hypertension.

The participants were randomly assigned to TEER (n=175) or medical therapy (n=175). The mean age was 78 years, and 54.9% were women. The primary endpoint was a composite assessed hierarchically of all-cause death or the number of participants with tricuspid valve surgery, hospitalisation for HF, and quality of life improvement assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year. The secondary endpoints were: 1) freedom from major adverse events (MAE) after procedure attempt at 30 days (in the experimental group only); 2) change in quality of life as measured with the KCCQ; 3) TR reduction to moderate or less at 30 days; 4) change in 6-minute walking distance (6MWD) at 1 year.

The results for the primary endpoint favoured the TEER group (win ratio 1.48; 95% CI 1.06–2.13; P=0.02). Dr Sorajja noted that this result was driven mainly by the improvement in quality of life. The incidence of death or tricuspid-valve surgery and hospitalisation for heart failure in both groups were similar. The KCCQ score improved by a mean (±SD) of 12.3±1.8 points, as compared with 0.6±1.8 points in the control group (P<0.001). TR was reduced by TEER to moderate or less in 87% of patients compared with only 4.8% in the control group; this reduction was sustained for 1 year of follow-up. The degree of TR reduction was related to the degree of improvement in quality of life. The 30-day MAE rate was only 1.7%; death and pacemaker implant both occurred in 0.6%. Survival without valve surgery was high at 1 year in both groups: around 90%.

“These results are very meaningful for a highly symptomatic population whose quality of life is impacted by TR,” said Dr Sorajja. “With the excellent benefit-to-risk ratio of the TriClip system, a historically untreated population will have a treatment option to improve their quality of life.”

1. Sorajja P, et al. N Engl J Med 2023; Mar 4. DOI: 10.1056/NEJMoa2300525.
2. Sorajja P, et al. Triluminate pivotal: A landmark randomized clinical trial of transcatheter tricuspid valve edge-to-edge repair for tricuspid regurgitation. Session 402-08, ACC Scientific Session 2023, 4–6 March, New Orleans, USA.

 

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Posted on 7 June 20237 June 2023