The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Two-year Outcomes with the Cardioband Tricuspid System from the Multicentre, Prospective TRI-REPAIR Study

DOI: 10.4244/EIJ-D-20-01107

1. University Hospital Bonn, Bonn, Germany, Germany
2. Ludwig-Maximilians University Hospital Munich, Munich, Germany, Germany
3. University Medical Centre Mainz, Mainz, Germany, Germany
4. Marienkrankenhaus, Hamburg, Germany, Germany
5. Asklepios Klinik St. Georg, Hamburg, Germany, Germany
6. Hôpital Bichat-Claude Bernard, AP-HP, Paris, France,
7. Université Paris-Diderot, Paris, France,
8. INSERM U-1148, Paris, France, France
9. Montefiore Medical Center, Bronx, New York, USA, United States
10. IRCCS San Raffaele Scientific Institute, Milan, Italy, Italy
11. University Hospital Cologne, Cologne, Germany, Germany
12. Herz- und Diabeteszentrum NRW, Ruhr University of Bochum, Bad Oeynhausen, Germany, Germany
13. Edwards Lifesciences, Irvine, CA, USA, United States
14. Cardiovascular Research Foundation, New York, New York, USA, United States
15. University Hospital Zurich, Zurich, Switzerland, Switzerland

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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 to have ≥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 was 604 ± 227 days). At baseline, 83% were in NYHA Class III-IV, and mean LVEF was 58%. Technical success was 100%. At two years, there were eight deaths. Echocardiography showed 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.

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