Transcatheter Versus Medical Treatment of Patients With Symptomatic Severe Tricuspid Regurgitation.
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Taramasso Maurizio, Benfari Giovanni, van der Bijl Pieter, Alessandrini Hannes, Attinger-Toller Adrian, Biasco Luigi, Lurz Philipp, Braun Daniel, Brochet Eric, Connelly Kim A, de Bruijn Sabine, Denti Paolo, Deuschl Florian, Estevez-Loureiro Rodrigo, Fam Neil, Frerker Christian, Gavazzoni Mara, Hausleiter Jörg, Ho Edwin, Juliard Jean-Michel, Kaple Ryan, Besler Christian, Kodali Susheel, Kreidel Felix, Kuck Karl-Heinz, Latib Azeem, Lauten Alexander, Monivas Vanessa, Mehr Michael, Muntané-Carol Guillem, Nazif Tamin, Nickening Georg, Pedrazzini Giovanni, Philippon François, Pozzoli Alberto, Praz Fabien, Puri Rishi, Rodés-Cabau Josep, Schäfer Ulrich, Schofer Joachim, Sievert Horst, Tang Gilbert H L, Thiele Holger, Topilsky Yan, Rommel Karl-Philipp, Delgado Victoria, Vahanian Alec, Von Bardeleben Ralph Stephan, Webb John G, Weber Marcel, Windecker Stephan, Winkel Mirjam, Zuber Michel, Leon Martin B, Hahn Rebecca T, Bax Jeroen J, Enriquez-Sarano Maurice, Maisano Francesco
Аннотация
OBJECTIVES: The purpose of this study was to investigate the potential benefit of TTVI over medical therapy in a propensity score matched population.
METHODS: The TriValve (Transcatheter Tricuspid Valve Therapies) registry collected 472 patients from 22 European and North American centers who underwent TTVI from 2016 to 2018. A control cohort formed by 2 large retrospective registries enrolling medically managed patients with ≥ moderate tricuspid regurgitation in Europe and North America (n = 1,179) were propensity score 1:1 matched (distance ± 0.2 SD) using age, EuroSCORE II, and systolic pulmonary artery pressure. Survival was tested with Cox regression analysis. Primary endpoint was 1-year mortality or HF rehospitalization or the composite.
RESULTS: After matching, 268 adequately matched pairs of patients were identified. Compared with control subjects, TTVI patients had lower 1-year mortality (23 ± 3% vs. 36 ± 3%; p = 0.001), rehospitalization (26 ± 3% vs. 47 ± 3%; p < 0.0001), and composite endpoint (32 ± 4% vs. 49 ± 3%; p = 0.0003). TTVI was associated with greater survival and freedom from HF rehospitalization (hazard ratio [HR]: 0.60; 95% confidence interval [CI]: 0.46 to 0.79; p = 0.003 unadjusted), which remained significant after adjusting for sex, New York Heart Association functional class, right ventricular dysfunction, and atrial fibrillation (HR: 0.39; 95% CI: 0.26 to 0.59; p < 0.0001) and after further adjustment for mitral regurgitation and pacemaker/defibrillator (HR: 0.35; 95% CI: 0.23 to 0.54; p < 0.0001).
CONCLUSIONS: In this propensity-matched case-control study, TTVI is associated with greater survival and reduced HF rehospitalization compared with medical therapy alone. Randomized trials should be performed to confirm these results.