CMS Approves Tricuspid TEER Coverage – With Limitations
CMS greenlights Coverage with Evidence Development for Tricuspid Valve Repair
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The Centers for Medicare & Medicaid Services (CMS) has announced a decision to allow coverage with evidence development (CED) for transcatheter tricuspid valve edge-to-edge repair (T-TEER),a groundbreaking procedure for patients suffering from severe tricuspid regurgitation (TR). This decision, while acknowledging existing evidence gaps, signals a promising pathway for patient access to this innovative treatment.
The CMS decision comes in the wake of the pivotal TRILUMINATE trial, which, while demonstrating improvements in quality of life and a reduction in heart failure hospitalizations, did not show a statistically significant decrease in mortality, tricuspid valve surgeries, or overall hospitalizations when compared to medical therapy alone.
“While we agree that there are evidence gaps that still need to be addressed regarding T-TEER, we believe the evidence while insufficient, is promising enough to allow coverage with evidence development,” CMS stated in its announcement. The agency emphasized that the study criteria, which include all-cause mortality and hospitalizations through a minimum of 24 months, are designed to strike an appropriate balance between generating crucial evidence and ensuring patient access.
Patient Eligibility and the Heart Team Approach
Under the CED framework, eligible patients must have symptomatic severe tricuspid regurgitation that persists despite optimal medical therapy. A critical component of the coverage criteria is the requirement that patients be under the care of a multidisciplinary heart team. This team must include a cardiac surgeon, an interventional cardiologist, a heart failure specialist, and an interventional echocardiographer, ensuring a comprehensive and expert approach to patient management.
Expert Perspectives on TRILUMINATE and Future Research
Shamir Mehta, MD, a cardiologist at McMaster University in Hamilton, Ontario, Canada, and an investigator on the TRILUMINATE trial, highlighted the positive aspects of the study. “The trial showed improvements in quality of life, and that’s an important outcome from the patients’ perspective,” Dr. Mehta commented. He also pointed to the observed reduction in heart failure hospitalizations at two years, suggesting that longer-term follow-up may reveal a correlation with a reduction in tricuspid regurgitation.
Dr. Mehta acknowledged that some criticisms of the TRILUMINATE trial were valid, attributing the primary issue to initial assumptions about the trial’s design. He explained that prior to TRILUMINATE, right heart failure and tricuspid regurgitation were relatively understudied. Consequently, the trial, along with the subsequent Triscend II trial, was designed using a paradigm similar to that used for left-sided heart failure, focusing on event reduction.
Understanding the Nuances of Heart Failure Presentation
“We made an assumption that the same outcomes that we observed in mitral regurgitation would also apply to patients with right heart failure,” Dr. Mehta stated.”Maybe, the outcomes that we should be looking at with right-sided heart failure should be different.” He elaborated on the distinct ways left-sided and right-sided heart failure can manifest. Patients with left-sided heart failure often present with pulmonary edema and require hospitalization for acute heart failure. In contrast,those with right-sided heart failure tend to accumulate fluid in the periphery and may be managed in outpatient clinics with diuretics,often being admitted for complications such as renal failure rather than acute heart failure itself.
“There are two types of heart failure, and they can present in very different ways,” Dr. Mehta emphasized.
The trials conducted under the CMS CED process are expected to shed further light on these differences, leading to a more refined understanding of when T-TEER is the most appropriate treatment option for patients. “This is an evolving area and we’re learning more as we have more randomized trials,” Dr.Mehta concluded.
Dr. Mehta has served as an investigator on the TRILUMINATE and CLASP TR trials.Brian Owens is a freelance journalist based in New Brunswick, Canada.