MUNICH — Transcatheter tricuspid valve repair added to medical therapy substantially reduced the risk for death or heart failure (HF) hospitalization compared with medical therapy alone in high-risk patients with severe tricuspid regurgitation (TR), according to results from the randomized Tricuspid Intervention in HF (TRIC-I-HF) trial.

At 3 years, tricuspid repair plus medical therapy was associated with a 60% lower risk for death or HF hospitalization than medical therapy alone.

“Tricuspid repair improves not only the quality of life of our patients but it also results in a significant reduction in hard clinical events, including heart failure hospitalizations as well as all-cause mortality,” said principal investigator and presenter Jörg Hausleiter, MD, of Ludwig-Maximilians-University of Munich in Munich, Germany.

The findings were presented at the European Society of Cardiology (ESC) Congress 2026, and published simultaneously in The New England Journal of Medicine.

Higher-Risk Population and a Need for Robust Clinical Outcomes

Previous randomized trials showed that transcatheter tricuspid valve repair improved quality of life but did not reduce HF hospitalization or mortality at 1 year. More recent 2-year data suggested a reduction in HF hospitalization, although low event rates limited assessment of clinical benefit, according to the authors.

The investigator-initiated, open-label TRIC-I-HF trial enrolled 360 patients with symptomatic severe TR at 29 high-volume German heart-valve centers. Patients had severe TR despite at least 30 days of individually optimized medical therapy, including diuretics, and were required to have an increased risk for future HF events. Patients qualified on the basis of an HF decompensation in the preceding 12 months, cardiorenal syndrome, or cardio-hepatic syndrome.

Mean age was 80.3 years, and 56.4% were women. Three quarters had New York Heart Association (NYHA) class III or IV HF, 55.0% had been hospitalized for HF in the previous year, 81.7% had cardiorenal syndrome, and 46.2% had cardio-hepatic syndrome.

Patients were randomized 2:1 to tricuspid repair plus medical therapy (n = 237) or medical therapy alone (n = 123). Of 231 patients who underwent transcatheter treatment, 227 underwent planned transcatheter edge-to-edge repair; and among those undergoing edge-to-edge repair, 65.6% received the PASCAL system and 33.0% the TriClip system.

Both Primary Endpoints Met

The first primary endpoint was a hierarchical composite of all-cause death, HF hospitalization, and improvement in quality of life at 1 year, assessed using a win-ratio analysis that prioritized the more serious outcomes.

Results significantly favored tricuspid repair, with 58.0% of patient-pair comparisons won by the repair group vs 23.9% by medical therapy, giving a win ratio of 2.42 (95% CI, 1.76-3.33; P < .001).

The second primary endpoint — a composite of death from any cause or HF hospitalization — also favored intervention. Event-free survival was 73.9% vs 48.4% at 1 year and an estimated 52.4% vs 21.0% at 3 years with a hazard ratio (HR) of 0.40 (95% Cl, 0.29 to 0.55, P < .0001).

In a post hoc analysis, the number needed to treat with tricuspid repair to prevent one death or HF hospitalization over 1 year was 4 (95% CI, 3-6).

HF Hospitalization Benefit Emerged Early

The difference was particularly marked for HF hospitalization, one of the secondary endpoints. At 1 year, 79.6% of patients in the repair group were alive and free of HF hospitalization compared with 51.3% of those in the medical-therapy group. At 3 years, the corresponding Kaplan-Meier estimates were 62.4% and 31.0%, respectively (HR, 0.35; 95% CI, 0.25-0.51).

Survival estimates, another secondary endpoint, were also higher with intervention: 86.5% vs 82.5% at 1 year and 72.3% vs 53.9% at 3 years (HR for death, 0.62; 95% CI, 0.40-0.96). However, the investigators cautioned that secondary endpoint CIs were not adjusted for multiplicity and should not be interpreted as providing definitive treatment effects.

Previous trials of transcatheter tricuspid valve intervention demonstrated reductions in TR and improvements in quality of life but had not established benefits for HF hospitalization or mortality.

“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 randomized controlled trials,” said Thomas Stocker, MD, an interventional cardiologist at LMU University Hospital Munich in Munich, Germany, and a principal investigator of TRIC-I-HF alongside Hausleiter. The investigators suggested that selection of this higher-risk population may have helped reveal an effect on hard clinical outcomes.

TR severity and symptoms also improved. At 1 year, TR had been reduced to mild or less in 56.3% of patients assigned to repair compared with 19.2% of those receiving medical therapy. NYHA class I or II status was reported in 73.8% vs 57.0%, while mean Kansas City Cardiomyopathy Questionnaire score increased by 11.2 vs 4.3 points.

Major adverse events occurred in 14 patients (5.9%) within 30 days of repair. One patient died 17 days after treatment from a noncardiac cause.

Who and When to Treat?

Rebecca T. Hahn, MD, of Columbia University Irving Medical Center in New York City, described TRIC-I-HF as a “landmark study.” She noted that its second primary endpoint allowed investigators to determine whether reducing TR could translate into robust clinical outcomes over 3 years, describing the finding as “just an incredible result.” She also congratulated the investigators for demonstrating improvements encompassing mortality, HF hospitalization, and quality of life.

“There was a mortality benefit at 3 years but very little benefit seen at 1 year,” Hahn said. “But you can see a heart failure hospitalization benefit early, and that continued to diverge [from the control arm].”

Hahn also highlighted questions around patient selection and timing, noting the substantial crossover from medical therapy to intervention. The cumulative incidence of crossover was 36% at 1 year and 43.7% at 3 years. Crossover was permitted only at least 30 days after randomization and after an HF hospitalization requiring intravenous diuretics, meaning that a primary endpoint event had already occurred.

Finally, she said subgroup analyses would be important to establish “who and when to treat as well as ‘how’ to treat.”

Hausleiter reported receiving research contracts for Edwards Lifesciences and consulting for Edwards Lifesciences and Tricares. Stocker reported receiving speaker honoraria from Edwards Lifesciences.