Tricuspid valve repair with the Cardioband system: Two-year outcomes of the multicentre, prospective tri-repair study

Georg Nickenig, Marcel Weber, Robert Schüler, Jörg Hausleiter, Michael Näbauer, Ralph S. Von Bardeleben, Efthymios Sotiriou, Ulrich Schäfer, Florian Deuschl, Hannes Alessandrini, Felix Kreidel, Jean Michel Juliard, Eric Brochet, Azeem Latib, Matteo Montorfano, Eustachio Agricola, Stephan Baldus, Kai Friedrichs, Shekhar H. Deo, Suzanne Y. GilmoreTed Feldman, Rebecca T. Hahn, Francesco Maisano

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)E1264-E1271
JournalEuroIntervention
Volume16
Issue number15
DOIs
StatePublished - 2021

Keywords

  • Femoral
  • TTVR
  • Tricuspid disease

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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