Iryna Dykun, Giulio Russo, Amir A. Mahabadi, Holger Thiele, Hannes Alessandrini, Martin Andreas, Kim A. Connelly, Rodrigo Estévez-Loureiro, Rebecca T. Hahn, Francesco Maisano, Jörg Hausleiter, Tienush Rassaf, Dominique Himbert, Azeem Latib, Vanessa Moñivas, Neil Fam, Giovanni Pedrazzini, Marianna Adamo, Horst Sievert, John G. Webb, Gilbert H.L. Tang, Lukas Stolz, Philipp Lurz, Tomas Benito-Gonzalez, Maurizio Taramasso, Rishi Puri
BACKGROUND: Bleeding remains among the most common complications following catheter-based structural heart procedures. Its clinical implications following transcatheter tricuspid valve interventions have yet to be systematically evaluated. OBJECTIVES: The aim of this study was to evaluate the incidence of bleeding and its predictors and prognostic implications following transcatheter tricuspid valve repair. METHODS: TriValve (International Multisite Transcatheter Tricuspid Valve Therapies Registry; NCT03416166) is an international multicenter registry capturing a range of transcatheter tricuspid valve interventions. Bleeding events were classified according to the Bleeding Academic Research Consortium (BARC). For this analysis, BARC bleeding events type 2, 3, and 5 occurring within 1 year of transcatheter tricuspid valve repair were retrospectively evaluated. RESULTS: A total of 440 patients (mean age 76.6 ± 8.9 years, 57.7% women) were included. The BARC major bleeding incidence was 11.4% (50 patients). Postprocedural tricuspid regurgitation severity (adjusted ORl]: 1.83; 95% CI: 1.12-3.01; P = 0.02), higher systolic pulmonary artery pressures (adjusted OR: 1.61; 95% CI: 1.16-2.24; P = 0.0048), and increasing procedure duration (adjusted OR: 1.49; 95% CI: 1.00-2.22; P = 0.049) were associated with bleeding, whereas concomitant oral anticoagulation was not (adjusted OR: 1.51; 95% CI: 0.74-3.10; P = 0.30). Major bleeding was associated with a markedly increased risk for in-hospital death (adjusted OR: 106; 95% CI: 1.31-8,553; P = 0.04). Likewise, bleeding was significantly associated with a 1-year composite of death or all-cause hospital readmission (adjusted HR: 2.41; 95% CI: 1.39-4.19; P = 0.002), all-cause death (adjusted HR: 3.55; 95% CI: 1.75-7.21; P = 0.0004), and cardiovascular death (adjusted HR: 3.72; 95% CI: 1.62-8.52; P = 0.002). CONCLUSIONS: BARC major bleeding occurs in about 11% of patients following transcatheter tricuspid valve repair and is a major determinant of in-hospital and 1-year death. Enhanced patient selection and procedural optimization (with shorter procedural times) may help curb bleeding risk.