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
Georg Nickenig1; Marcel Weber1; Robert Schüler1; Jörg Hausleiter2; Michael Näbauer2; Ralph S. von Bardeleben3; Efthymios Sotiriou3; Ulrich Schäfer4; Florian Deuschl4; Hannes Alessandrini5; Felix Kreidel3; Jean-Michel Juliard6,7,8; Eric Brochet6,7,8; Azeem Latib9; Matteo Montorfano10; Eustachio Agricola10; Stephan Baldus11; Kai Friedrichs12; Shekhar H. Deo13; Suzanne Y. Gilmore13; Ted Feldman13; Rebecca T. Hahn14; Francesco Maisano15;
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.