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Nickenig, Georg; Weber, Marcel; Schüler, Robert; Hausleiter, Jörg; Nabauer, Michael; von Bardeleben, Ralph Stephan; Sotiriou, Efthymios; Schäfer, Ulrich; Deuschl, Florian; Alessandrini, Hannes; Kreidel, Felix; Juliard, Jean-Michel; Brochet, Eric; Latib, Azeem; Montorfano, Matteo; Agricola, Eustachio; Baldus, Stephan; Friedrichs, Kai P; Deo, Shekhar H; Gilmore, Suzanne Y; Feldman, Ted; Hahn, Rebecca T; Maisano, Francesco
EuroIntervention, 2021-Feb-05, Volume: 16, Issue: 15Journal Article
Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study. Thirty patients were enrolled in this single-arm, multicentre, prospective study. Patients were evaluated as having ≥moderate, symptomatic functional TR and deemed inoperable due to unacceptable surgical risk. Clinical, functional, and echocardiographic data were prospectively collected up to two years (mean duration 604±227 days). At baseline, 83% were in NYHA Class III-IV, and the mean LVEF was 58%. Technical success was 100%. At two years, there were eight deaths. Echocardiography showed a significant reduction in septolateral annular diameter of 16% (p=0.006) and 72% of patients (p=0.016) with ≤moderate TR grade; 82% of patients were in NYHA Class I-II (p=0.002). Six-minute walk distance and KCCQ score improved by 73 m (p=0.058) and 14 points (p=0.046), respectively. These results demonstrate that the Cardioband tricuspid system showed favourable results in patients with symptomatic, ≥moderate functional TR. Annular reduction and TR severity reduction remained significant and sustained at two years. Patients experienced improvements in quality of life and exercise capacity. ClinicalTrials.gov Identifier: NCT02981953.
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