Severe tricuspid regurgitation (TR) has been associated with higher mortality, increased risk of hospitalization for cardiac failure (CF), reduced functionality and poor health status.  Tricuspid edge-to-edge repair (T-TEER) with TriClip effectively reduces TR with low risk of post-procedural complications. 

The TRILUMINATE Pivotal trial (Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal) compared T-TEER against medical treatment and did not find differences in mortality or CF related hospitalization at 1 year, but did observe improved health status with T-TEER.

The aim of this prospective, multicenter and randomized study was to assess the benefit of T-TEER in health status. 

Health status was measured by the Kansas questionnaire (KCCQ, Kansas City Cardiomyopathy Questionnaire) based on time reference points: at kickoff, 1 month, 6 months and 1 year. 

Read also: TCT 2023 The LIFE-BTK Trial.

A total 350 patients were randomized: 175 to receiving T-TEER and 175 to medical treatment (MT). Mean age was 78, and most patients were women. At 1 month, T-TEER resulted in improved health status and showed continuous improvement at 1 year, vs. MT. Patients undergoing T-TEER saw better survival and good health status at one year, vs MT patients (74,8% vs. 45,9%, p<0,001) with necessary number to treat (NNT) 3.5.

Conclusion

In conclusion, in this study, patients treated with T-TEER experienced improved health status vs patients receiving MT alone, and this improvement was more evident in patients with symptomatic TR. Improved health status was more evident at 1 month and was maintained at 1 year followup. 

Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.

Original Title: Health Status after Transcatheter Tricuspid-Valve Repair in Patients with Severe Tricuspid Regurgitation: Results from the TRILUMINATE Pivotal Trial.

Reference: Suzanne V. Arnold, MD MHA et al TCT 2023.

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