TRILUMINATE Trial: Tricuspid TEER Reduces Heart Failure Hospitalizations by 2 Years

At ACC 2025, 2-year follow-up results from the TRILUMINATE trial, published in Circulation, delivered compelling new evidence that transcatheter edge-to-edge repair (TEER) using the TriClip device significantly reduces hospitalizations for heart failure (HF) in patients with severe tricuspid regurgitation (TR).

---

Why It Matters

At 1 year, TRILUMINATE demonstrated improved quality of life, leading to FDA approval for TEER in severe TR. However, because the primary benefit was patient-reported, skeptics questioned the role of placebo effect in the absence of a sham-control.

Now, 2-year data confirms a 28% reduction in HF hospitalizations, giving the therapy objective, clinically meaningful impact.

---

Study Design

• Design: Randomized, controlled, pivotal trial with adaptive design

• Participants: 572 patients

  • Mean age: 78.1 years

  • Women: 58.9%

• Intervention: TEER with TriClip vs. guideline-directed medical therapy (GDMT)

• Primary endpoints:

  • All-cause death or valve surgery

  • HF hospitalization

  • Quality of life (via KCCQ)

---

Inclusion Criteria

• Severe tricuspid regurgitation

• Not a candidate for tricuspid valve surgery

• NYHA Class II–IV symptoms

• Suitable anatomy for TEER

---

Exclusion Criteria

• Life expectancy <12 months

• Significant comorbid valve disease needing intervention

• Severe pulmonary hypertension

• Severe right ventricular dysfunction

---

Key 2-Year Outcomes

• Annualized HF hospitalization rate:

  • TEER: 0.19/patient-year

  • Control: 0.26/patient-year

  • Hazard Ratio (HR): 0.72; P = 0.02

• TR Severity (≤ moderate):

  • TEER: 84%

  • Control: 63% (boosted by crossover patients)

• All-cause mortality or surgery:

  • Similar across arms, but confounded by crossover

• KCCQ (Health status):

  • Stable/improved in TEER group

  • Improved after crossover

  • Minimal change in non-crossover control group

• Safety:

  • Stroke: 1.9% (TEER) vs. 2.5% (control)

  • New pacemaker: 5.5% (TEER)

  • No device embolization or thrombosis

---

Crossover Impact

• 60% of control patients crossed over to TEER after 1 year

• Of these:

  • 92% had the procedure within 6 months

  • They had more torrential TR, worse symptoms, and more HF hospitalizations at baseline

  • After TEER, 81% had TR reduced to moderate or less

  • In contrast, only 21% of those who remained in the control group improved

---

Reimbursement Implications

• TEER for TR is under review by CMS

• CMS coverage with evidence development currently applies to transcatheter tricuspid valve replacement, but TriClip TEER could soon be added if long-term outcomes continue to show benefit

• These results may influence national coverage determination (NCD) decisions expected soon

---

Limitations

• No sham control, which leaves room for bias in subjective endpoints

• Crossovers, while necessary for ethical reasons, blur treatment comparisons

• Results may not apply to all etiologies of TR or complex anatomies

---

Take-Home Points

• Tricuspid TEER with TriClip significantly reduces heart failure hospitalizations at 2 years

• Benefits in TR severity and functional status are sustained

• Quality of life improvements are reinforced by objective outcomes

• CMS reimbursement may hinge on these findings—coverage decision expected soon

• Best candidates are often symptomatic, high-risk patients with functional TR

• Future directions include longer-term follow-up and cost-effectiveness analyses

---

TEER is no longer just about making patients feel better—it now reduces hard outcomes like hospitalization, opening the door for broader adoption and reimbursement.