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

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Applying the TRILUMINATE Eligibility Criteria to Real-World Patients Receiving Tricuspid Valve Transcatheter Edge-to-Edge Repair. / Stolz, Lukas; Doldi, Philipp M; Kresoja, Karl-Patrik; Bombace, Sara; Koell, Benedikt; Kassar, Mohammad; Kirchner, Johannes; Weckbach, Ludwig T; Ludwig, Sebastian; Stocker, Thomas J; Glaser, Hannah; Schöber, Anne R; Massberg, Steffen; Näbauer, Michael; Rudolph, Volker; Kalbacher, Daniel; Praz, Fabien; Lurz, Philipp; Hausleiter, Jörg.

In: JACC-CARDIOVASC INTE, Vol. 17, No. 4, 26.02.2024, p. 535-548.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Stolz, L, Doldi, PM, Kresoja, K-P, Bombace, S, Koell, B, Kassar, M, Kirchner, J, Weckbach, LT, Ludwig, S, Stocker, TJ, Glaser, H, Schöber, AR, Massberg, S, Näbauer, M, Rudolph, V, Kalbacher, D, Praz, F, Lurz, P & Hausleiter, J 2024, 'Applying the TRILUMINATE Eligibility Criteria to Real-World Patients Receiving Tricuspid Valve Transcatheter Edge-to-Edge Repair', JACC-CARDIOVASC INTE, vol. 17, no. 4, pp. 535-548. https://doi.org/10.1016/j.jcin.2023.11.014

APA

Stolz, L., Doldi, P. M., Kresoja, K-P., Bombace, S., Koell, B., Kassar, M., Kirchner, J., Weckbach, L. T., Ludwig, S., Stocker, T. J., Glaser, H., Schöber, A. R., Massberg, S., Näbauer, M., Rudolph, V., Kalbacher, D., Praz, F., Lurz, P., & Hausleiter, J. (2024). Applying the TRILUMINATE Eligibility Criteria to Real-World Patients Receiving Tricuspid Valve Transcatheter Edge-to-Edge Repair. JACC-CARDIOVASC INTE, 17(4), 535-548. https://doi.org/10.1016/j.jcin.2023.11.014

Vancouver

Stolz L, Doldi PM, Kresoja K-P, Bombace S, Koell B, Kassar M et al. Applying the TRILUMINATE Eligibility Criteria to Real-World Patients Receiving Tricuspid Valve Transcatheter Edge-to-Edge Repair. JACC-CARDIOVASC INTE. 2024 Feb 26;17(4):535-548. https://doi.org/10.1016/j.jcin.2023.11.014

Bibtex

@article{76c86c8fc6a74657aa03f5bec5392dbf,
title = "Applying the TRILUMINATE Eligibility Criteria to Real-World Patients Receiving Tricuspid Valve Transcatheter Edge-to-Edge Repair",
abstract = "BACKGROUND: According to the TRILUMINATE (Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) trial, transcatheter tricuspid edge-to-edge repair (T-TEER) improves quality of life beyond medical treatment, while no effects on heart failure hospitalization (HFH) and survival were observed at 1 year. However, the generalizability of the TRILUMINATE trial to real-world conditions remains a subject of discussion.OBJECTIVES: The aim of this study was to apply the clinical TRILUMINATE inclusion and exclusion criteria to a real-world T-TEER patient group and evaluate symptomatic and survival outcome in TRILUMINATE-eligible and TRILUMINATE-ineligible patients.METHODS: Clinical TRILUMINATE inclusion and exclusion criteria were applied to a cohort of patients who underwent T-TEER at 5 European centers from 2016 to 2022. Study patients were compared regarding baseline characteristics, survival, HFH, and symptomatic outcomes as measured by NYHA functional class, a quality-of-life questionnaire and 6-minute walk distance.RESULTS: Of 962 patients, 54.8% were classified as TRILUMINATE eligible, presenting with superior left ventricular function and fewer comorbidities compared with the ineligible population. Tricuspid regurgitation reduction, improvement in NYHA functional class, quality of life, and exercise capacity were comparable in both groups. However, the 1-year survival and HFH rates significantly differed (tricuspid regurgitation ≤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 indicate the need for additional studies evaluating the outcomes after T-TEER in less selected patient populations.",
author = "Lukas Stolz and Doldi, {Philipp M} and Karl-Patrik Kresoja and Sara Bombace and Benedikt Koell and Mohammad Kassar and Johannes Kirchner and Weckbach, {Ludwig T} and Sebastian Ludwig and Stocker, {Thomas J} and Hannah Glaser and Sch{\"o}ber, {Anne R} and Steffen Massberg and Michael N{\"a}bauer and Volker Rudolph and Daniel Kalbacher and Fabien Praz and Philipp Lurz and J{\"o}rg Hausleiter",
note = "Copyright {\textcopyright} 2023. Published by Elsevier Inc.",
year = "2024",
month = feb,
day = "26",
doi = "10.1016/j.jcin.2023.11.014",
language = "English",
volume = "17",
pages = "535--548",
journal = "JACC-CARDIOVASC INTE",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "4",

}

RIS

TY - JOUR

T1 - Applying the TRILUMINATE Eligibility Criteria to Real-World Patients Receiving Tricuspid Valve Transcatheter Edge-to-Edge Repair

AU - Stolz, Lukas

AU - Doldi, Philipp M

AU - Kresoja, Karl-Patrik

AU - Bombace, Sara

AU - Koell, Benedikt

AU - Kassar, Mohammad

AU - Kirchner, Johannes

AU - Weckbach, Ludwig T

AU - Ludwig, Sebastian

AU - Stocker, Thomas J

AU - Glaser, Hannah

AU - Schöber, Anne R

AU - Massberg, Steffen

AU - Näbauer, Michael

AU - Rudolph, Volker

AU - Kalbacher, Daniel

AU - Praz, Fabien

AU - Lurz, Philipp

AU - Hausleiter, Jörg

N1 - Copyright © 2023. Published by Elsevier Inc.

PY - 2024/2/26

Y1 - 2024/2/26

N2 - BACKGROUND: According to the TRILUMINATE (Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) trial, transcatheter tricuspid edge-to-edge repair (T-TEER) improves quality of life beyond medical treatment, while no effects on heart failure hospitalization (HFH) and survival were observed at 1 year. However, the generalizability of the TRILUMINATE trial to real-world conditions remains a subject of discussion.OBJECTIVES: The aim of this study was to apply the clinical TRILUMINATE inclusion and exclusion criteria to a real-world T-TEER patient group and evaluate symptomatic and survival outcome in TRILUMINATE-eligible and TRILUMINATE-ineligible patients.METHODS: Clinical TRILUMINATE inclusion and exclusion criteria were applied to a cohort of patients who underwent T-TEER at 5 European centers from 2016 to 2022. Study patients were compared regarding baseline characteristics, survival, HFH, and symptomatic outcomes as measured by NYHA functional class, a quality-of-life questionnaire and 6-minute walk distance.RESULTS: Of 962 patients, 54.8% were classified as TRILUMINATE eligible, presenting with superior left ventricular function and fewer comorbidities compared with the ineligible population. Tricuspid regurgitation reduction, improvement in NYHA functional class, quality of life, and exercise capacity were comparable in both groups. However, the 1-year survival and HFH rates significantly differed (tricuspid regurgitation ≤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 indicate the need for additional studies evaluating the outcomes after T-TEER in less selected patient populations.

AB - BACKGROUND: According to the TRILUMINATE (Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) trial, transcatheter tricuspid edge-to-edge repair (T-TEER) improves quality of life beyond medical treatment, while no effects on heart failure hospitalization (HFH) and survival were observed at 1 year. However, the generalizability of the TRILUMINATE trial to real-world conditions remains a subject of discussion.OBJECTIVES: The aim of this study was to apply the clinical TRILUMINATE inclusion and exclusion criteria to a real-world T-TEER patient group and evaluate symptomatic and survival outcome in TRILUMINATE-eligible and TRILUMINATE-ineligible patients.METHODS: Clinical TRILUMINATE inclusion and exclusion criteria were applied to a cohort of patients who underwent T-TEER at 5 European centers from 2016 to 2022. Study patients were compared regarding baseline characteristics, survival, HFH, and symptomatic outcomes as measured by NYHA functional class, a quality-of-life questionnaire and 6-minute walk distance.RESULTS: Of 962 patients, 54.8% were classified as TRILUMINATE eligible, presenting with superior left ventricular function and fewer comorbidities compared with the ineligible population. Tricuspid regurgitation reduction, improvement in NYHA functional class, quality of life, and exercise capacity were comparable in both groups. However, the 1-year survival and HFH rates significantly differed (tricuspid regurgitation ≤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 indicate the need for additional studies evaluating the outcomes after T-TEER in less selected patient populations.

U2 - 10.1016/j.jcin.2023.11.014

DO - 10.1016/j.jcin.2023.11.014

M3 - SCORING: Journal article

C2 - 37987997

VL - 17

SP - 535

EP - 548

JO - JACC-CARDIOVASC INTE

JF - JACC-CARDIOVASC INTE

SN - 1936-8798

IS - 4

ER -