May 02, 2025
The National Center for Health Research appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposal for Coverage with Evidence Development (CED) for Tricuspid Valve Transcatheter Edge-to-Edge Repair (T-TEER). Based on current data, including the TRILUMINATE Pivotal trial, we believe that T-TEER should not be considered eligible for Medicare coverage due to clear evidence of harms and a lack of evidence of a clinically meaningful benefit for Medicare beneficiaries.
Lack of clinically meaningful benefit:
T-TEER has not demonstrated that it improves survival, reduces the need for tricuspid-valve surgeries, or decreases the overall hospitalization rate. Although the TRILUMINATE Pivotal trial showed a statistically significant decrease in recurrent heart failure hospitalizations in the intention-to-treat (ITT) analysis after two years, the implications are not clear for patients in the real world who make the decision about whether to use this treatment or not. ITT analysis is especially misleading because 59% of the placebo group crossed over to the device group after one year but were counted as the control group in the ITT analysis because that was how they were assigned.
Furthermore, because the trial was unblinded, the reported improvement in the KCCQ score is likely to be biased by the placebo effect.
Evidence of harm:
The one-year and two-year outcomes of the TRILUMINATE Pivotal trial each indicate higher rates of adverse events in the T-TEER group when compared to the control group. Although not statistically significant, these findings at least indicate a lack of benefit. For example:
- Cardiovascular death: 5.8% (T-TEER) vs. 4.0% (Control) at one year, and 12.4% (T-TEER) vs. 9.6% (Control) at two years
- All-cause mortality: 8.6% (T-TEER) vs. 8.0% (Control) at one year, and 17.9% (T-TEER) vs. 17.1% (Control) at two years
- Hospitalizations: 35.3% (T-TEER) vs. 34.2% (Control) at one year, and 58.8% (T-TEER) vs. 54.0% (Control) at two years
Recommendations for strengthening CED:
We encourage CMS to reconsider whether there is currently sufficient evidence to provide coverage for T-TEER, given the known risks and uncertain benefits. If CMS decides to finalize CED despite the shortcomings of available evidence, we strongly urge strengthening the CED study by requiring:
- A primary outcome of all-cause mortality, instead of a composite primary outcome, given the bias of subjective outcome measures in an unblinded study
- Include all hospitalizations in an outcome measure
- Five years of follow-up, analyzed at the end of each year
There are clear problems with composite outcome measures that include subjective and objective measures. CMS should not consider such composite measures appropriate, especially in unblinded trials.
Conclusions:
Based on available evidence, we conclude that T-TEER is neither necessary nor reasonable for Medicare beneficiaries and should therefore not receive Medicare coverage until there is clear and credible evidence of benefit. Should CMS decide to finalize CED, CMS should strengthen the CED criteria as suggested above to ensure that data will eventually be available to determine if the benefits of T-TEER outweigh the risks.