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

EuroIntervention. 2021 Feb 5;16(15):e1264-e1271. doi: 10.4244/EIJ-D-20-01107.


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. Identifier: NCT02981953.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Cardiac Catheterization
  • Heart Valve Prosthesis Implantation* / adverse effects
  • Humans
  • Prospective Studies
  • Retrospective Studies
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Tricuspid Valve / diagnostic imaging
  • Tricuspid Valve / surgery
  • Tricuspid Valve Insufficiency* / diagnostic imaging
  • Tricuspid Valve Insufficiency* / surgery

Associated data