CMS Approves Coverage of Tricuspid TEER with Conditions
CMS Approves Coverage of Tricuspid TEER with Conditions
Source: Brian Owens | July 18, 2025
1. CMS Approval Overview
• On July 2, 2025, the US Centers for Medicare & Medicaid Services (CMS) approved coverage for Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER).
• However, this approval is conditional under the Coverage with Evidence Development (CED) program, meaning procedures must be performed as part of CMS-approved clinical studies.
2. Reason for Conditional Coverage
• Concerns were raised about limited clinical benefit, particularly from the TRILUMINATE trial, which showed no significant reduction in mortality, surgery rates, or all-cause hospitalizations versus medical therapy.
• CMS acknowledged evidence gaps but considered the data promising enough to support limited access under strict study conditions.
3. Study Requirements
• Clinical studies must measure:
• All-cause mortality
• Heart failure hospitalizations
• With at least 24 months of follow-up
• Patients must have symptomatic tricuspid regurgitation (TR) despite optimal medical therapy.
• Care must be delivered by a multidisciplinary heart team, including:
• A cardiac surgeon
• An interventional cardiologist
• A heart failure specialist
• An interventional echocardiographer
4. Expert Perspectives
• Dr. Shamir Mehta (McMaster University, Canada), an investigator on TRILUMINATE, emphasized that:
• The trial improved patients’ quality of life, a key outcome for those with TR.
• There was a reduction in HF hospitalizations at 2 years, which may correlate with decreased regurgitation over time.
5. Limitations and Study Design Flaws
• TRILUMINATE and TRISCEND II trials borrowed frameworks from left-sided heart failure trials.
• This may have been inappropriate, as right heart failure (RHF) has different presentations and trajectories.
• RHF patients typically develop peripheral fluid retention, often treated outpatient with diuretics, and are less likely to be hospitalized acutely like left HF patients.
6. Implications for Future Research
• Future studies under CED will aim to clarify which RHF patients benefit most from T-TEER.practice.
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