Data continue to emerge supporting the safety and efficacy of transcatheter-edge-to-edge repair (TEER) for the treatment of tricuspid regurgitation (TR).
Three-year data from the TRILUMINATE study, investigating TEER using the TriClip (Abbott) tricuspid repair system, published in September 2024 in JACC: Cardiovascular Interventions, follow shortly after the release of one-year results of the TRI.Fr trial at the 2024 European Society of Cardiology (ESC) congress (30 August–2 September, London, UK).
“Tricuspid regurgitation is a marker of bad prognosis,” Erwan Donal (CHU Rennes, Rennes, France) commented at ESC Congress, where he reported the results of the TRI.Fr trial, a multicentre randomised evaluation of the use of the TriClip device in the treatment of severe TR. “The question is do we have to consider a treatment of this tricuspid regurgitation or not,” said Donal.
TRI.Fr assessed the safety and the efficacy of TEER, comparing TEER plus guideline-directed medical therapy to guideline directed medical therapy alone in 300 patients with symptomatic severe TR, who were ineligible for surgery. In total, 148 patients were randomised to undergo guideline-directed medical therapy and 152 to undergo TEER.
Investigators used a composite clinical score at 12 months to assess the efficacy of the two strategies, comprised of the occurrence of major cardiovascular events, changes in New York Heart Association (NYHA) class, or patient-reported outcomes.
Secondary endpoints included the change in the degree of TR at one year, quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, patient global assessment, and a hierarchical composite endpoint and including all-cause mortality, tricuspid valve surgery, time to heart failure hospitalisation and improvement of more than 15 points of the KCCQ score at 12 months, as well as major cardiovascular events, and deaths.
“We can observe that at one year follow up, 74% of the patients treated with transcatheter edge-to-edge repair improved, as opposed to 40% in the guideline directed medical therapy group. This is highly significant,” said Donal. “If we look in detail at all the components of the primary endpoint, and if we look at all the secondary endpoints, we observe that all the parameters are in favour of the treatment by TEER.”
Donal concluded that much of the success of the treatment was driven by a significant reduction in the degree of TR. “We were also able to see that we have much less death and hospitalisation in our study than in previous registries and even the TRILUMINATE trial,” he said.
“TRI.Fr is a positive prospective study, confirming a clear benefit for patients suffering from severe tricuspid regurgitation,” Donal told Cardiovascular News. “It is important to note that medical treatment and strict monitoring of these patients, who are often in advanced heart failure, are equally crucial.
“What seems to be confirmed is that tricuspid regurgitation treatment with clips effectively complements medical therapy and is a therapeutic option that must be recognised, as overlooking tricuspid regurgitation in our patients should be avoided at all costs.”
TRILUMINATE: Three-year results
Representing the longest follow-up data to date of any tricuspid TEER therapy, the three-year results of the international, prospective, single-arm, multicentre TRILUMINATE trial include outcomes from 98 patients with symptomatic moderate or greater TR receiving the TriClip system.
Investigators report that at three years, TR was reduced to moderate or less in 79% of patients, with a reduction of at least one grade achieved in 92%. The TR reduction achieved at one year was sustained through to the three-year timepoint, the investigators report. The site-reported heart failure hospitalisation rate decreased from 0.43 events/patient-year one year before device implantation to 0.06 events/patient-year one year after device implantation, representing a reduction of 86% (p<0.0001).
