Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study

Nickenig, Georg; Weber, Marcel; Schueler, Robert; Hausleiter, Joerg; Nabauer, Michael; Bardeleben, Ralph Stephan von; Sotiriou, Efthymios; Schaefer, 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. und Maisano, Francesco (2021): Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study. In: Eurointervention, Bd. 16, Nr. 15, E1264-U103

Abstract

Aims: Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report oneand two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of >= moderate functional TR in the TRI-REPAIR study. Methods and results: 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. Conclusions: 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.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 1774-024X
• Sprache: Englisch