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Tricuspid-Valve Intervention in Heart Failure
Jörg HausleiterThomas J. StockerTobias GeislerPhilipp LurzWolfgang RottbauerEdith LubosNiklas SchoferChristian FrerkerJohanne FrankHolger ThieleRico OstereschVolker RudolphAlexander LautenErion XhepaJürgen RotheTienush RassafStephan BaldusGeorg NickenigD L David Manuel LeistnerEike TiggesVictoria KehlMirjam KeßlerTobias KisterTobias RufMuhammed GerçekMeinrad GawazDerk FrankIngo EitelRalph Stephan von BardelebenDaniel KalbacherOsama SolimanMichael NäbauerSteffen Maßberg
Key result
Transcatheter tricuspid repair cuts death or HF hospitalization ~60% versus medical therapy.
- Win Ratio 2.42
- 95% CI 1.76-3.33
- P<0.001
- n=360
Why the trial?
Significant tricuspid regurgitation is common in heart failure and carries a poor prognosis, but whether intervening on the valve improves outcomes beyond medical therapy remains uncertain. TRIC-I-HF tested tricuspid valve intervention in this population.
Does transcatheter tricuspid-valve repair plus medical therapy improve a composite of death, heart failure hospitalization, and quality of life in patients with symptomatic severe tricuspid regurgitation?
Key Points
- To evaluate the efficacy and safety of transcatheter tricuspid-valve repair added to medical therapy versus medical therapy alone in patients with symptomatic severe tricuspid regurgitation at high risk for heart failure events.
- Randomized, controlled trial assigning 360 patients in a 2:1 ratio to transcatheter tricuspid-valve repair plus medical therapy (N=237) or medical therapy alone (N=123; NCT04634266).
- Evaluated a first primary hierarchical composite endpoint (all-cause death, heart-failure hospitalization, and quality-of-life improvement at 1 year via win ratio) and a second primary endpoint of all-cause death or heart-failure hospitalization through 3 years.
- Tricuspid-valve repair significantly improved the 1-year hierarchical primary composite outcome compared with medical therapy alone (win ratio, 2.42; 95% CI, 1.76 to 3.33; P<0.001).
- Through 3 years, freedom from all-cause death or heart failure hospitalization was 52.4% (95% CI, 43.2 to 63.6) with repair versus 21.0% (95% CI, 12.7 to 34.6) with medical therapy alone (HR, 0.40; 95% CI, 0.29 to 0.55; P<0.001).
- Major adverse events occurred in 14 patients (5.9%) within 30 days of the tricuspid-valve repair procedure.
Evidence details
What drove the result?
| Outcome | TV repair | Medical |
|---|---|---|
| Death, HF hospitalization, QoL improvement (hierarchical, 1 yr) | ||
| First primary · win ratio 2.42 (95% CI 1.76–3.33; p<0.001) favoring repair; per-arm values not reported | ||
| Freedom from death or HF hospitalization through 3 years | 52.4% | 21.0% |
| Second primary · HR 0.40 (95% CI 0.29–0.55; p<0.001) for death or HF hospitalization | ||
Limitations & tradeoffs
Safety
Major adverse events within 30 days occurred in 14/237 (5.9%) in the repair arm.
Statistical certainty
2:1 randomization left a modest medical-therapy arm of 123 patients, and 3-year Kaplan–Meier estimates carry wide confidence intervals (52.4% [43.2–63.6] vs 21.0% [12.7–34.6]).
Design limitations
The first primary endpoint includes patient-reported quality of life, and blinding is not described in the record.
Structured PICO
Does transcatheter tricuspid-valve repair plus medical therapy improve a composite of death, heart failure hospitalization, and quality of life in patients with symptomatic severe tricuspid regurgitation?
P
Population
360 patients (mean age 80.3 years, 56.4% women) with symptomatic severe tricuspid regurgitation and increased risk of future heart-failure events, followed for up to 3 years.
I
Intervention
Transcatheter tricuspid-valve repair plus medical therapy
C
Comparator
Medical therapy alone
O
Outcome
First primary end point: hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year. Second primary end point: composite of death from any cause or hospitalization for heart failure through 3 years.composite
Main Result
Effect estimate: Win Ratio 2.42 (95% CI 1.76-3.33)
p-value: p=<0.001
Transcatheter tricuspid-valve repair added to medical therapy significantly improves a hierarchical composite of death, heart failure hospitalization, and quality of life at 1 year, and reduces death or heart failure hospitalization through 3 years in patients with severe tricuspid regurgitation.
Discussion
Key questions
No takes yet. Share an insight, caveat, or question.
Where experts stand
Experts broadly read TRIC-I-HF as a landmark result, with multiple cardiologists highlighting that transcatheter tricuspid repair now has evidence for improving hard outcomes like mortality and heart failure hospitalization, not just symptoms.
The reaction is overwhelmingly positive, with clinicians calling this the first robust evidence that transcatheter tricuspid repair improves survival and reduces hospitalizations beyond symptom relief. Several note the trial extends prior findings from TRILUMINATE, which showed symptom benefit but no mortality signal. The live question is whether these results, drawn from high-volume German centers, will reshape guidelines and accelerate adoption internationally.
Agreement
Multiple clinicians emphasize that TRIC-I-HF is significant because it demonstrates hard-outcome benefits, including reduced mortality and heart failure hospitalizations, moving beyond the symptom-only improvements seen in earlier tricuspid repair trials.
4 clinicians say this directly
1 take classified by contention axis so far — the map appears as more land.
Still unclear
John Mandrola flags that baseline TR severity was greater in TRILUMINATE than in TRIC-I-HF, raising questions about how patient selection may explain differences between trials. It remains to be seen whether guidelines will move quickly on these data and how broadly the results apply outside high-volume German valve centers.
Key expert perspectives
“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.”
First evidence that transcatheter tricuspid repair improves mortality, not just symptoms
Thamman emphasizes that TRIC-I-HF finally shows transcatheter tricuspid repair improves mortality and heart failure hospitalization, not just symptoms. She highlights the echofirst evidence of sustained TR grade reduction with the device up to 3 years.
Distilled from their postX post
A major step forward in managing severe tricuspid regurgitation in heart failure
Recio highlights significant reductions in HF hospitalizations, marked improvement in NYHA and QoL (KCCQ), and a favorable safety profile, calling the trial a major step forward.
Distilled from their postX post
Implication
Supports transcatheter tricuspid repair plus medical therapy in symptomatic severe tricuspid regurgitation; delivers first randomized evidence of hard-endpoint benefit.
Abstract
BackgroundThe effect of transcatheter tricuspid-valve repair on clinical outcomes, including death and hospitalization for heart failure, in patients with severe tricuspid regurgitation remains uncertain. MethodsWe randomly assigned patients with symptomatic severe tricuspid regurgitation and an increased risk of future heart-failure events in a 2:1 ratio to tricuspid-valve repair plus medical therapy (tricuspid-repair group) or medical therapy alone (medical-therapy group). The first primary end point was a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year, assessed by win ratio. If the between-group difference was significant, a second primary end point would be tested: a composite of death from any cause or hospitalization for heart failure through 3 years. ResultsA total of 360 patients underwent randomization (237 patients were assigned to the tricuspid-repair group and 123 to the medical-therapy group). The mean (±SD) age of the patients was 80.3±6.4 years, and 56.4% were women. The win ratio for the first primary end point was 2.42 (95% confidence interval [CI], 1.76 to 3.33; P<0.001), favoring tricuspid-valve repair. The Kaplan–Meier estimate for freedom from death from any cause or hospitalization for heart failure (second primary end point) through 3 years was 52.4% (95% CI, 43.2 to 63.6) in the tricuspid-repair group and 21.0% (95% CI, 12.7 to 34.6) in the medical-therapy group (hazard ratio for death from any cause or hospitalization for heart failure, 0.40; 95% CI, 0.29 to 0.55; P<0.001). Major adverse events within 30 days occurred in 14 patients (5.9%) in the tricuspid-repair group. ConclusionsAmong patients with symptomatic severe tricuspid regurgitation, transcatheter tricuspid-valve repair plus medical therapy was superior to medical therapy alone with respect to a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year and was also associated with a lower risk of a composite of death from any cause or hospitalization for heart failure through 3 years. (Funded by the German Center for Cardiovascular Research and others; TRIC-I-HF ClinicalTrials.gov number, NCT04634266.)
NEJM · ESC 2026 · RCT. Transcatheter repair of severe tricuspid regurgitation cuts death or HF hospitalization. TRIC-I-HF: Tricuspid-Valve Intervention in Heart Failure 360 patients: Symptomatic severe tricuspid regurgitation, mean age 80.3. Randomized, followed up to 3 years: Transcatheter repair plus medication vs Medical therapy alone. Freedom from death or HF hospitalization, 3 years: TV repair 52.4% vs Medical 21.0%. HR 0.40 (95% CI 0.29–0.55), P<0.001. Hazard ratio for death or HF hospitalization. 5.9% major adverse events: Within 30 days of the repair procedure. Bottom line: First randomized hard-endpoint evidence supports repair plus medical therapy in symptomatic severe tricuspid regurgitation.
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
Cite This Study
Hausleiter et al. (2026) conducted an RCT in symptomatic severe tricuspid regurgitation (n=360). transcatheter tricuspid-valve repair plus medical therapy vs. medical therapy alone was evaluated on hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year (Win Ratio 2.42, 95% CI 1.76-3.33, p=<0.001). Transcatheter tricuspid-valve repair was superior to medical therapy for a composite of death, heart failure hospitalization, and quality of life (Win Ratio 2.42; 95% CI 1.76-3.33; P<0.001).