Article Impact Level: HIGH Data Quality: STRONG Summary of Journal of the American College of Cardiology, 83(1), 1–13. https://doi.org/10.1016/j.jacc.2023.10.008 Dr. Suzanne V. Arnold et al.
Points
- The TRILUMINATE Pivotal trial compared tricuspid transcatheter edge-to-edge repair (T-TEER) with medical therapy for severe tricuspid regurgitation (TR).
- T-TEER significantly improved health status at one month and showed sustained improvement at one year compared to medical therapy.
- Patients receiving T-TEER were more likely to be alive and well at one year, with a notable number needed to treat 3.5.
- The benefit of T-TEER diminished as the baseline health status score increased, suggesting varying impacts based on initial health status.
- The health status benefit of T-TEER was strongly correlated with reduced 1-year mortality and heart failure hospitalization, emphasizing its potential impact on patient outcomes.
Summary
The study explored the health status benefits of tricuspid transcatheter edge-to-edge repair (T-TEER) within the TRILUMINATE Pivotal trial. Patients with severe tricuspid regurgitation (TR) were randomized to receive T-TEER or medical therapy in this trial. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, one month, six months, and 12 months. The primary endpoint was to compare the KCCQ overall summary score between the treatment groups.
The results revealed that T-TEER significantly improved health status at one month, with a mean between-group difference in KCCQ overall summary score of 9.4 points and a small additional improvement at one year. Furthermore, T-TEER patients were more likely to be alive and well at one year than those receiving medical therapy, with a notable number needed to treat 3.5. Interaction analyses indicated that the benefit of T-TEER diminished as the baseline KCCQ overall summary score increased. Additionally, exploratory analyses suggested that much of the health status benefit of T-TEER could be attributed to TR reduction and that the improvement in health status was strongly correlated with reduced 1-year mortality and heart failure hospitalization.
In conclusion, the study demonstrated that T-TEER with the TriClip system led to substantial and sustained health status improvement in patients with severe TR compared to medical therapy alone. These findings provide valuable insights into the health status benefits of T-TEER, emphasizing its potential impact on patient outcomes and highlighting the importance of TR reduction in improving health status.
Link to the article: https://www.sciencedirect.com/science/article/pii/S0735109723077434
References Arnold, S. V., Goates, S., Sorajja, P., Adams, D. H., Von Bardeleben, R. S., Kapadia, S. R., & Cohen, D. J. (2024). Health Status After Transcatheter Tricuspid-Valve Repair in Patients With Severe Tricuspid Regurgitation. Journal of the American College of Cardiology, 83(1), 1–13. https://doi.org/10.1016/j.jacc.2023.10.008
