Transcatheter tricuspid valve repair has been shown to be superior at one year for reducing outcomes including death and heart failure hospitalisation and improving quality-of-life markers compared to medical therapy alone in patients with severe symptomatic tricuspid regurgitation (TR) deemed to be at high risk for heart failure.
These are headline findings from the TRIC-I-HF trial, a randomised trial investigating whether a valve repair strategy—using devices including the Pascal (Edwards Lifesciences) or Triclip (Abbott) transcatheter systems—on top of medical therapy may be beneficial in patients with severe TR who were considered to be at higher risk for heart failure due to prior hospitalisation, the presence of cardiorenal syndrome or evidence of cardiohepatic syndrome.
The study was conducted at 29 high-volume heart centres in Germany and supported by the German Center for Cardiovascular Research and Ludwig Maximilians University (Munich, Germany), with an unrestricted research grant from Edwards Lifesciences. Results were presented in a hot line session at the 2026 European Society of Cardiology (ESC) congress (28–31 August, Munich, Germany) and published simultaneously in the New England Journal of Medicine.
“Previous studies have shown that transcatheter tricuspid valve interventions can effectively reduce tricuspid regurgitation and improve patient-reported outcomes, including quality of life,” Thomas Stocker (Ludwig Maximilians University, Munich, Germany), a principal investigator in the trial, said, noting that their effect on heart failure hospitalisations and mortality have remained unclear. “In TRIC-I-HF, we enrolled patients in the advanced stages of the disease with higher risk for future heart failure events compared with previous randomised controlled trials.”
Patients were eligible for enrolment in the trial if they had at least severe TR on a five-grade scale (mild, moderate, severe, massive, and torrential), despite medical therapy including diuretics adjusted to the individual optimal dose for at least 30 days. They were randomly assigned 2:1 to the tricuspid repair or medical therapy groups, with valve repair recommended to be performed within 14 days of randomisation.
The first primary endpoint was a hierarchical composite of death from any cause, hospitalisation for heart failure, and quality-of-life improvement at 12 months, assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), with a clinically meaningful improvement defined as an increase of at least 15 points.
A total of 360 patients were randomised: 237 to transcatheter tricuspid valve repair plus medical therapy and 123 to medical therapy alone. Their mean age was 80.3 years and 56.4% were women. Of the patients undergoing intervention, 98% were treated with tricuspid transcatheter edge-to-edge repair (TEER), with 1.3% undergoing an annuloplasty. Among TEER patients, 149 (65.6%) received the Pascal system and 75 (33%) the TriClip system, with implantation of at least one device. The number of devices implanted was one in 28.6% of patients, two in 62.1%, and three or more in 9.4%.
The researchers demonstrated that both primary endpoints were met with tricuspid valve repair.
The first primary endpoint of all-cause mortality, heart failure hospitalisation and failure to achieve quality-of-life improvement at one year significantly favoured tricuspid valve repair over medical therapy alone (win ratio 2.42; 95% confidence interval [CI] 1.76 to 3.33; p<0.001).
Tricuspid repair also resulted in significantly greater freedom from the co-primary endpoint of all-cause mortality or heart failure hospitalisation at three years than medical therapy alone (52.4% vs. 21.0%; hazard ratio 0.40; 95% CI 0.29–0.55; p<0.001). This benefit was driven by reductions in both all-cause mortality and heart failure hospitalisation.
In the medical-therapy group, crossover to transcatheter tricuspid intervention was permitted after a primary endpoint event involving hospitalisation for severe heart failure resulting in intravenous diuretic therapy, the study team report. In 28 of 48 crossovers (58%), the valve-repair procedure was performed during the hospitalisation that constituted the primary endpoint event, whereas the remaining crossover procedures were performed during subsequent hospitalisations.
On secondary endpoints, the study’s authors note that the severity of tricuspid regurgitation at 30 days was moderate or less in 135 of 192 patients (70.3%) in the tricuspid repair group, as compared to 29 of 98 patients (29.6%) in the medical therapy group. The corresponding percentages for mild tricuspid regurgitation or less at one year were 56.3% and 19.2%.
Tricuspid repair was also associated with substantial improvement in New York Heart Association (NYHA) functional class at one year; with NYHA class I or II heart failure reported in 138 of 187 patients (73.8%) in the tricuspid repair group and in 49 of 86 patients (57%) in the medical therapy group. The mean change in KCCQ score from baseline to one-year follow-up was 11.2±21.9 points (95% CI 8–14.5) in the tricuspid repair group and 4.3±24.9 points (95% CI −1.1–9.6) in the medical therapy group.
“Among these high-risk patients, transcatheter tricuspid valve repair on top of medical therapy resulted not only in quality-of-life improvements but also in meaningful and sustained reductions in hard clinical outcomes, which has not been demonstrated before with the intervention. Early and pronounced separation of the event curves in these patients with advanced heart failure underscores the immediate benefit of tricuspid valve repair when added to optimised medical therapy, establishing the intervention as an effective disease-modifying therapy,” commented Jörg Hausleiter (Ludwig Maximilians University, Munich, Germany), a principal investigator in the trial.
The investigators note several limitations of the trial, including that patients were assigned to the medical therapy group despite the availability and reimbursement of transcatheter tricuspid valve repair in Germany, and the fact that crossovers may complicate the interpretation of the secondary endpoint results and limit comparison with other randomised trials.
