Landmark Trial Confirms Transcatheter Tricuspid Valve Repair Reduces Heart Failure Hospitalizations and Death

A landmark clinical trial conducted in Germany has demonstrated that transcatheter tricuspid valve repair significantly reduces the combined rate of all-cause death and heart failure (HF) hospitalizations in patients with severe tricuspid regurgitation (TR).

The TRIC-I-HF trial, conducted across 29 high-volume heart-valve centers in Germany and simultaneously published in the New England Journal of Medicine, randomized 360 patients with symptomatic severe TR at a mean age of 80.3 years in a 2:1 ratio to either transcatheter tricuspid valve repair using commercially available devices or medical therapy alone. At baseline, the cohort had a high burden of disease, with 50.8% graded as severe, 34.2% as massive, and 10.3% as torrential TR, and three-quarters were in NYHA class III or IV.

The results showed a win ratio of 2.42 (95% CI 1.76-3.33) in favor of the interventional strategy for reducing all-cause death and HF hospitalization at one year, while also improving quality of life. Even when excluding quality-of-life metrics, the combined rate of death from any cause and HF hospitalization at three years remained significantly lower in the repair group compared to the medical therapy group (52.4% vs. 21.0%, hazard ratio [HR] 0.40, 95% CI 0.29-0.55).

Study investigator Jörg Hausleiter, MD, of Ludwig-Maximilians-Universität München, noted that the number needed to treat to prevent one death or HF hospitalization at one year was just four patients when the procedure was performed at experienced high-volume centers. The procedure involved transcatheter edge-to-edge repair (TEER) in 98.3% of cases, primarily using CE-marked Pascal or TriClip systems, with major adverse events within 30 days occurring in 5.9% of patients.

“This is a landmark study that will inform patients and clinicians about the benefit of transcatheter repair therapy,” said Rebecca Hahn, MD, of Columbia University Medical Center, an ESC session discussant. “The findings extend previous evidence by showing that the benefits of an interventional strategy were not confined to improvements in quality of life but also translated into meaningful differences in hard clinical outcomes.”

Hausleiter emphasized that even the quality-of-life improvement alone is a meaningful outcome for elderly patients, many of whom have limited life expectancy but suffer greatly from symptoms. “For the patients, probably for most of them, the quality of life improvement matters more than an increased lifespan because they’re usually already around 80 years of age,” he said during a press conference.

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