Tricuspid-Valve Intervention in Heart Failure

Authors, Journal, Affiliations, Type, DOI

• Authors: Jörg Hausleiter and Thomas J. Stocker (co-first authors); Tobias Geisler; Philipp Lurz; Wolfgang Rottbauer; Edith Lubos; Niklas Schofer; Christian Frerker; Johanne Frank; Holger Thiele; Rico Osteresch; Volker Rudolph; Alexander Lauten; Erion Xhepa; Jürgen Rothe; Tienush Rassaf; Stephan Baldus; Georg Nickenig; David M. Leistner; Eike Tigges; Victoria Kehl; Mirjam Kessler; Tobias Kister; Tobias Ruf; Muhammed Gerçek; Meinrad Gawaz; Derk Frank; Ingo Eitel; Ralph Stephan von Bardeleben; Daniel Kalbacher; Osama Soliman; Michael Näbauer; Steffen Massberg — for the TRIC-I-HF-DZHK24 Investigators
• Affiliations: LMU University Hospital Munich (Dept of Medicine I); German Center for Cardiovascular Research (DZHK) partner sites; and 28 further German university and heart centres (Tübingen, Mainz, Ulm, Hamburg, Lübeck, Kiel, Leipzig, Bremen, Bad Oeynhausen, Erfurt, TUM Munich, Freiburg-Bad Krozingen, Essen, Cologne, Bonn, Frankfurt, and others); Münchner Studienzentrum and TUM biostatistics; Royal College of Surgeons in Ireland / Mater Private Network, Dublin
• Journal: New England Journal of Medicine 2026;395:1363-73 (published online 30 August 2026)
• Type: Investigator-initiated, prospective, multicentre, open-label, randomized, controlled strategy trial (superiority design, 2:1 allocation)
• DOI: 10.1056/NEJMoa2606934
• Registration: NCT04634266 (TRIC-I-HF / DZHK24)
• Funding: German Center for Cardiovascular Research (DZHK, funding code 81X1600213), LMU University Hospital Munich, and an unrestricted research grant from Edwards Lifesciences

Overview

TRIC-I-HF is the first randomized trial to show that transcatheter tricuspid-valve repair improves hard clinical outcomes rather than quality of life alone. In 360 patients with symptomatic severe tricuspid regurgitation and advanced heart failure — 75% NYHA class III/IV, 55% hospitalised for heart failure in the preceding year, 82% with cardiorenal syndrome — tricuspid edge-to-edge repair plus medical therapy was superior to medical therapy alone on a hierarchical composite of death, heart-failure hospitalisation and quality-of-life improvement at 1 year (win ratio 2.42), and reduced the composite of death or heart-failure hospitalisation through 3 years by 60% (HR 0.40). All patients were treated at 29 high-volume German heart-valve centres with substantial prior tricuspid-repair experience. The authors attribute the divergence from TRILUMINATE Pivotal and Tri.Fr chiefly to a substantially sicker enrolled population and greater operator experience.

Keywords

Tricuspid regurgitation, transcatheter tricuspid-valve repair, tricuspid edge-to-edge repair, TEER, heart failure, right heart failure, win ratio, hierarchical composite end point, heart-failure hospitalisation, quality of life, KCCQ, cardiorenal syndrome, cardiohepatic syndrome, TRI-SCORE, EuroSCORE II

Key Takeaways

Trial Design

• Investigator-initiated, prospective, multicentre, open-label, randomized, controlled strategy trial testing superiority of transcatheter tricuspid-valve repair plus medical therapy over medical therapy alone
• 29 high-volume heart-valve centres in Germany; participants enrolled March 2022 – June 2025
• Randomization 2:1 (repair : medical therapy), permuted blocks, stratified by trial site and tricuspid-regurgitation severity
• Repair was recommended within 14 days of randomization; clinical follow-up at 1 and 12 months then annually to 3 years (±6 weeks)
• Two primary end points in sequence: the first was tested, and only if significant was the second tested
• Hospitalizations adjudicated by an independent clinical-events committee; echocardiographic data read by an independent core laboratory
• Patient selection and enrolment were at local heart-team discretion, with no central eligibility committee and no screening of baseline medical treatment
• Advanced-risk inclusion criterion (prior decompensation within 12 months or cardiorenal/cardiohepatic syndrome) was added to the protocol in July 2023 — i.e. after enrolment had begun

The Two Primary End Points

• First primary — hierarchical composite of death from any cause, heart-failure hospitalization, and quality-of-life improvement at 1 year, by win ratio: 2.42 (95% CI 1.76–3.33; P<0.001), favouring repair
• Win-ratio components, expressed as wins among 29,151 patient pairs (repair vs medical therapy):
  • Death from any cause: 15.0% vs 10.9% (difference 4.1 percentage points for repair)
  • Hospitalization for heart failure: 31.8% vs 9.8% (difference 22.0 percentage points for repair) — the dominant contributor
  • Quality-of-life improvement: 11.2% vs 3.2% (difference 8.0 percentage points for repair)
  • Total wins: 58.0% vs 23.9% (difference 34.1 percentage points)
• Second primary — composite of death from any cause or hospitalization for heart failure through 3 years: Kaplan–Meier freedom 52.4% (43.2–63.6) with repair vs 21.0% (12.7–34.6) with medical therapy; HR 0.40 (95% CI 0.29–0.55; P<0.001). Events occurred in 79 patients (33.3%) vs 76 (61.8%)
• The benefit was driven by a lower incidence of each component. Mean follow-up 1.6 years
• Post hoc analysis: number needed to treat of 4 to prevent one death or heart-failure hospitalization at 1 year — a magnitude the authors compare favourably with established interventional strategies such as transcatheter repair for secondary mitral regurgitation

Secondary End Points (all unadjusted for multiplicity)

The trial's own footnote states that confidence intervals for secondary end points were not adjusted for multiplicity and should not be used to infer treatment effects. This matters for how the mortality result is read:

• 1-year survival alone was not statistically significant. The mortality signal is carried by the composite and by the 3-year time point, not by the 1-year survival end point
• Echocardiographic and functional response was substantial: TR of moderate or less at 30 days in 70.3% vs 29.6%, and mild or less at 1 year in 56.3% vs 19.2%; NYHA class I/II at 1 year 73.8% vs 57.0%

Population — Advanced Heart Failure, Deliberately Unlike Prior Trials

• N=360 randomized: 237 to tricuspid repair plus medical therapy, 123 to medical therapy alone
• Mean age 80.3±6.4 years (range 53–92); 56.4% women; mean BMI 26.1
• 75.0% NYHA class III or IV; 55.0% hospitalised for heart failure in the previous year
• 81.7% cardiorenal syndrome (eGFR <60); 46.2% cardiohepatic syndrome (elevation of ≥2 of bilirubin, alkaline phosphatase, γ-glutamyltransferase)
• Estimated GFR 46.0±17.5 ml/min/1.73 m²; median NT-proBNP 2022 pg/ml (IQR 1229–3283); KCCQ 51.9±22.3; 6-minute walk 240±128 m
• 92.0% atrial fibrillation or flutter; 79.3% hypertension; 25.3% diabetes; 46.4% coronary artery disease; median EurSCORE II 4.3%; median TRI-SCORE 4.0
• TR severity at baseline: severe 50.2%, massive 34.2%, torrential 10.5%
• The population is the pivotal difference from earlier trials — prior-year HF hospitalization 55.0% (TRIC-I-HF) vs 23.8% (TRILUMINATE Pivotal) vs 40.3% (Tri.Fr); NYHA III/IV 75.0% vs 55.1% vs 42.3%; and 1-year mortality in the medical-therapy arm 17.5% vs 8% vs 5.4% respectively

Safety

• Major adverse events within 30 days in 14 patients (5.9%) in the repair group
• One death 17 days after edge-to-edge repair, attributed to noncardiac causes
• Single-leaflet device attachment within 30 days in 4 patients (1.7%)
• No device-specific conclusions are possible — the trial used different tricuspid-valve repair systems

Crossover

• Crossover from medical therapy to transcatheter tricuspid intervention was permitted only after a primary end-point event (hospitalization for severe heart failure requiring intravenous diuretics): 48 patients crossed over, 28 of 48 (58%) during the hospitalization that constituted the end-point event
• The authors argue crossovers did not affect the primary analysis, since they followed the qualifying event, but state they complicate interpretation of the secondary end points and limit direct cross-trial comparison — so functional, quality-of-life and echocardiographic changes in the medical-therapy group should be interpreted with caution
• They also note crossover may have attenuated the estimated treatment effect, and that all-cause mortality nevertheless remained lower with repair

Interpretation

• The authors' explanation for the positive result, in two parts: (1) a more advanced heart-failure population, generating enough events to detect a difference where earlier trials were underpowered by low event rates; and (2) operator experience, citing the volume–outcome relationship in tricuspid repair (anatomically variable valve, thin leaflets with large coaptation gaps, demanding intraprocedural imaging) and higher success rates at experienced centres in the PASTE registry. Participating sites had performed a mean of 176±163 tricuspid procedures before site initiation
• The trial extends earlier evidence by showing benefit "not confined to improvements in quality of life but also translated into meaningful differences in hard clinical outcomes"
• Positioning: transcatheter tricuspid-valve repair was already the most widely adopted transcatheter tricuspid intervention, with high procedural success and a favourable safety profile; isolated tricuspid-valve surgery is rarely performed because of high operative risk

Limitations of the document

• Open-label design, which may have influenced quality-of-life assessment (the authors argue concordant clinical end points mitigate this)
• Secondary end points were not adjusted for multiplicity and, by the trial's own explicit statement, cannot be used to infer treatment effects — so the 3-year survival result (HR 0.62) and the heart-failure hospitalization results should be read as supportive rather than confirmatory
• 1-year survival was not significant (HR 0.74; CI 0.42–1.29). The trial was not powered for mortality as a standalone end point
• National, single-country design at 29 German heart-valve centres with high procedural volume limits generalisability to lower-volume or less-experienced centres, where outcomes are known to be worse
• Patients were randomized to medical therapy alone despite transcatheter tricuspid repair being available and reimbursed in Germany. The authors acknowledge the 2:1 allocation and the restriction of crossover to after a primary end-point event were necessary to support recruitment in that setting — a design compromise that also means the medical-therapy arm does not reflect what a patient could actually obtain outside the trial
• Crossover (48 patients) complicates the secondary end points and limits comparison with other randomized trials, as the authors state
• Different devices were used, precluding conclusions about the relative efficacy or safety of specific tricuspid-valve repair systems
• Follow-up is incomplete at 3 years — complete through 1 year only, with 3-year follow-up still ongoing for later-enrolled patients, so longer-term outcomes carry greater uncertainty
• Selection at local heart-team discretion, without a central eligibility committee or baseline-treatment screening, introduces potential between-site heterogeneity in who was enrolled
• The advanced-risk inclusion criterion was added mid-enrolment (July 2023), so the enrolled population is not uniform across the recruitment period
• Sponsor and funding: supported by the DZHK and LMU Munich plus an unrestricted research grant from Edwards Lifesciences, a manufacturer of transcatheter valve systems, in a trial whose conclusion favours the interventional strategy. The authors state they had unrestricted data access and wrote all drafts

Key Concepts Mentioned

• concepts/Tricuspid-Regurgitation — the condition treated; this trial supplies the first positive hard-outcome evidence for its transcatheter treatment
• concepts/Right-Ventricular-Failure — TR begets RV volume overload and failure; repair interrupts the congestion–dysfunction cycle
• concepts/Cardiorenal-Syndrome — 82% of the enrolled population; decongestion is the plausible mechanism of the heart-failure hospitalization benefit
• concepts/Valvular-Heart-Disease — positioning of transcatheter tricuspid intervention within valve-disease management
• entities/Heart-Failure — trial population had advanced heart failure; benefit measured in heart-failure events
• entities/Atrial-Fibrillation — 92% of participants had AF or flutter, the dominant aetiology of annular dilatation and functional TR

Key Entities Mentioned

• Edwards Lifesciences — manufacturer of transcatheter valve systems; provided an unrestricted research grant for this trial. No wiki page exists and none is warranted on the strength of a single funding disclosure
• German Center for Cardiovascular Research (DZHK) — principal funder (funding code 81X1600213); the trial is registered as TRIC-I-HF-DZHK24

Wiki Pages Updated

• wiki/sources/TRIC-I-HF-NEJM-2026.md — created (this page)
• wiki/concepts/Tricuspid-Regurgitation.md — TEER section rewritten around the positive hard-outcome result; source_count 6→7
• wiki/concepts/Right-Ventricular-Failure.md — tricuspid intervention as a means of interrupting RV volume overload; source_count 4→5
• wiki/concepts/Cardiorenal-Syndrome.md — TRIC-I-HF decongestion data added
• wiki/entities/Heart-Failure.md — tricuspid-valve intervention in advanced HF added
• wiki/concepts/Valvular-Heart-Disease.md — transcatheter tricuspid intervention evidence upgraded
• wiki/sourceindex.md — index row
• log.md — ingest entry