On July 19, The Society of Thoracic Surgeons (STS) submitted a joint letter recommending specific coverage guidelines to the Centers for Medicare & Medicaid Services (CMS) for transcatheter tricuspid valve replacement (TTVR) therapy.
STS was joined in this effort by the American Association for Thoracic Surgery (AATS), Association of Black Cardiologists (ABC), American College of Cardiology (ACC), American Society of Echocardiography (ASE), Heart Rhythm Society (HRS), and Society for Cardiovascular Angiography and Interventions (SCAI).
Support for a National Coverage Determination for TTVR
The FDA’s recent approval of the EVOQUE tricuspid valve replacement system marks a significant advancement in the treatment of tricuspid regurgitation (TR). Our letter supports the establishment of a National Coverage Determination (NCD) for TTVR. This emerging technology offers a new therapeutic option for patients with severe TR who are symptomatic despite optimal medical therapy and are at intermediate or greater risk for traditional surgical intervention.
Surgeons Are Key Members of the Heart Team
The role of surgeons as essential members of the heart team performing TTVR procedures is critical to the successful rollout of this new technology. The involvement of cardiac surgeons, alongside interventional cardiologists, is vital to ensuring the highest quality of patient care. Surgeons bring unique expertise, particularly in controlling and managing complications that may arise during the procedure. Our joint recommended inclusion criteria for any new TTVR program aims to replicate the successful multidisciplinary approach used in transcatheter aortic valve replacement (TAVR), which has demonstrated significant benefits in patient outcomes.
Balancing Safety and Access
Our recommendation highlights the importance of balancing enhancing patient safety and optimizing care without restricting access to TTVR. The coalition advocated for a cautious rollout of TTVR technology to protect public trust and ensure patient safety. By implementing a structured and thoughtful approach, CMS can facilitate the safe integration of TTVR into clinical practice. As experience grows and outcomes improve, CMS can reassess the process for TTVR procedures to determine the most appropriate pathway forward.
Tricuspid Surgery: A Viable Option
Surgical interventions for TR are more common and less risky than previously believed. Data from the STS National Database between 2017 and 2023 show that there were 13,587 isolated tricuspid valve surgeries, with an observed operative mortality of 5.5% for repairs and 5.7% for replacements. These findings highlight significant advancements in surgical techniques and patient safety. STS encourages using the STS tricuspid calculator, a tool calibrated for the TTVR population, to support clinical decision-making and ensure patient selection and risk assessment are based on contemporary data.
Next Steps
CMS will consider the feedback it received from STS and other stakeholders and is expected to issue a proposed coverage decision by the end of the year. Additionally, it is anticipated that CMS will soon conduct a similar national coverage analysis for transcatheter tricuspid edge-to-edge repair (T-TEER) therapy in response to the recently FDA-approved TriClip technology. STS will actively provide guidance and feedback for this upcoming analysis to ensure optimal patient care and safety.