Applying the TRILUMINATE Eligibility Criteria to Real-World Patients Receiving Tricuspid Valve Transcatheter Edge-to-Edge Repair.

Abstract

BACKGROUND

According to the Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System (TRILUMINATE) trial, transcatheter tricuspid edge-to-edge repair (T-TEER) improves quality of life beyond medical treatment, while no effects on heart failure hospitalizations (HFH) and survival were observed at 1 year. However, the generalizability of the TRILUMINATE trial to real-world conditions remains subject of discussion.

OBJECTIVES

To apply the clinical TRILUMINATE in- and exclusion criteria to a real-world T-TEER patient group and evaluate symptomatic and survival outcome in TRILUMINATE eligible and ineligible patients.

METHODS

Clinical TRILUMINATE in- and exclusion criteria were applied to a cohort of patients who underwent T-TEER at five European centers from 2016 until 2022. Study patients were compared regarding baseline characteristics, survival, HFH, and symptomatic outcomes as measured by New York Heart Association (NYHA) functional class, quality of life questionnaire and six-minute walk test distance (6MWD).

RESULTS

Out of 962 patients, 54.8% were classified as TRILUMINATE eligible, presenting with superior left ventricular function and fewer comorbidities compared to the ineligible population. TR reduction, improvement in NYHA class, quality of live and exercise capacity were comparable in both groups. However, the 1-year survival and HFH rates significantly differed (TR≤2+ at discharge: 82% vs. 85%; survival: 85% vs. 75%; HFH: 14% vs. 22% for eligible vs. ineligible patients).

CONCLUSIONS

The observed differences in survival and HFH outcomes suggest a limited generalizability of TRILUMINATE to real-world conditions and they indicate the need for additional studies evaluating the outcomes after T-TEER in less selected patient populations.