Background: The two randomized controlled trials Triluminate pivotal and TRI.FR demonstrated that tricuspid transcatheter edge-to-edge repair (T-TEER) was safe and associated with a strong signal for improved quality of life and symptoms. Our aim was to investigate the use of T-TEER in the German healthcare system to describe the patients treated and to investigate in-hospital outcomes.
Methods: For this retrospective observational study, we performed a database query of the nationwide DRG statistics database of the Research Data Center of the Federal Statistical Office (Years 2012 to 2023). To identify all cases with an intervention or heart surgery on the tricuspid valve procedure, we filtered the available cases with the OPS-Code 5-35a.5 (“Endovaskuläre Trikuspidalklappenrekonstruktion”). Approval of this study was given directly by the Research Data Centre of the Federal Statistical Office of Germany.
Results: We identified 13165 hospital cases with an intervention on the tricuspid valve (TVR). Cases increased from a total of 74 cases in the four years 2012 to 2015 to 4298 cases in 2023 by an exponential rise (lm[log(n) ~ year]: β = 0.5; p = 4.79e-06). The median age of patients receiving TVR was 81 (IQR: 76-84) years, 58% were female. A median Elixhauser comorbidity score of 6 (IQR: 5-7) indicates a high burden of comorbidities in this patient collective. For the years 2022 and 2023 analyzed the count of clips per patient undergoing T-TEER, we found that 31% received one, 57% two and 32% three or more clips. The median length of hospital stay was 8 (IQR: 5-13) days, 12% of the patients received a transfusion, the stroke rate was 0.27%. We found a MACCE event in 3% of the cases, 1.9% of the patients died during the hospital stay.
Conclusion: This is the first comprehensive real-world data analysis on tricuspid treatment in Germany. We found a significant (exponential) increase in interventional tricuspid valve treatment procedures. In-hospital outcomes in this truly all-comers population showed a very acceptable safety profile against the background of an elderly patient population with many comorbidities.
