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