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Outcomes Stratified by Adapted Inclusion Criteria After Transcatheter Tricuspid Edge-to-Edge Repair.

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

Authors: Giulio Russo, Daniela Pedicino, Marianna Adamo, Hannes Alessandrini, Martin Andreas, Daniel Braun, Kim A Connelly, Gaetano Chiricolo, Paolo Denti, Rodrigo Estevez-Loureiro, Neil Fam, Rebecca T Hahn, Claudia Harr, Joerg Hausleiter, Dominique Himbert, Daniel Kalbacher, Edwin Ho, Azeem Latib, Edith Lubos, Sebastian Ludwig, Gianluca Massaro, Philipp Lurz, Marco Metra, Vanessa Monivas, Georg Nickenig, Giovanni Pedrazzini, Alberto Pozzoli, Fabien Praz, Joseph Rodes-Cabau, Christian Besler, Karl-Philipp Rommel, Joachim Schofer, Andrea Scotti, Kerstin Piayda, Giuseppe Massimo Sangiorgi, Horst Sievert, Gilbert H L Tang, Isaac Pascual, Holger Thiele, Florian Schlotter, Andrea Natale, Ralph Stephan von Bardeleben, John Webb, Stephan Windecker, Martin Leon, Maurice Enriquez-Sarano, Francesco Maisano, Stefan Bloechlinger, Maurizio Taramasso

BACKGROUND: Recent trials demonstrated that tricuspid transcatheter edge-to-edge repair (T-TEER) is particularly effective for symptoms and quality of life improvement. However, its effect on prognosis is still unclear. Moreover, the applicability of trials inclusion/exclusion criteria has not been investigated.

AIMS: The aim of the present study is to investigate the applicability of TRILUMINATE and Tri.Fr trials inclusion and exclusion criteria on real-world patients from TRIVALVE registry, and to evaluate their effects on outcomes.

METHODS: Patients undergoing T-TEER were selected from the TRIVALVE registry and, according to inclusion and exclusion criteria, divided in four groups: TRILUMINATE eligible versus ineligible and Tri.Fr eligible versus ineligible patients. TRILUMINATE and Tri.Fr analysis were conducted separately.

RESULTS: From a total of 664 patients of the TRIVALVE registry, 520 and 519 were included in the TRILUMINATE and Tri.Fr analysis, respectively. In particular, 240 patients (46%) met the TRILUMINATE criteria and 260 (50%) those of Tri.Fr. Baseline characteristics were significantly different between trials' eligible and ineligible patients. TRILUMINATE-eligible patients showed significant lower mortality/rehospitalization compared to ineligible ones (12% vs. 25%, p = 0.028), as well as Tri.Fr-eligible versus ineligible ones (15% vs. 22%, p = 0.007).

CONCLUSIONS: In patients with TR undergoing T-TEER, inclusion and exclusion criteria of TRILUMINATE and Tri.Fr are applicable to around half of real-world patients. Patients matching trials criteria have lower mortality/rehospitalization.

© 2026 Wiley Periodicals LLC.

PMID: 42479752

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