TY - JOUR
T1 - Tricuspid valve repair with the Cardioband system
T2 - Two-year outcomes of the multicentre, prospective tri-repair study
AU - Nickenig, Georg
AU - Weber, Marcel
AU - Schüler, Robert
AU - Hausleiter, Jörg
AU - Näbauer, Michael
AU - Von Bardeleben, Ralph S.
AU - Sotiriou, Efthymios
AU - Schäfer, Ulrich
AU - Deuschl, Florian
AU - Alessandrini, Hannes
AU - Kreidel, Felix
AU - Juliard, Jean Michel
AU - Brochet, Eric
AU - Latib, Azeem
AU - Montorfano, Matteo
AU - Agricola, Eustachio
AU - Baldus, Stephan
AU - Friedrichs, Kai
AU - Deo, Shekhar H.
AU - Gilmore, Suzanne Y.
AU - Feldman, Ted
AU - Hahn, Rebecca T.
AU - Maisano, Francesco
N1 - Publisher Copyright:
© Europa Digital & Publishing 2021.
PY - 2021
Y1 - 2021
N2 - Aims: 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. 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.
AB - Aims: 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. 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.
KW - Femoral
KW - TTVR
KW - Tricuspid disease
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U2 - 10.4244/EIJ-D-20-01107
DO - 10.4244/EIJ-D-20-01107
M3 - Article
C2 - 33046437
AN - SCOPUS:85101905523
SN - 1774-024X
VL - 16
SP - E1264-E1271
JO - EuroIntervention
JF - EuroIntervention
IS - 15
ER -