Catheter Cardiovasc Interv. 2026 Jul 21. doi: 10.1002/ccd.70763. Online ahead of print.
ABSTRACT
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.
PMID:42479752 | DOI:10.1002/ccd.70763