Interventions for valvular disease and heart failure

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

EuroIntervention 2021;16:e1264-e1271. DOI: 10.4244/EIJ-D-20-01107

Georg Nickenig
Georg Nickenig1, MD; Marcel Weber1, MD; Robert Schüler1, MD; Jörg Hausleiter2, MD; Michael Nabauer2, MD; Ralph Stephan von Bardeleben3, MD; Efthymios Sotiriou3, MD; Ulrich Schäfer4, MD; Florian Deuschl4, MD; Hannes Alessandrini5, MD; Felix Kreidel3, MD; Jean-Michel Juliard6,7,8, MD; Eric Brochet6,7,8, MD; Azeem Latib9, MD; Matteo Montorfano10, MD; Eustachio Agricola10, MD; Stephan Baldus11, MD; Kai P. Friedrichs12, MD; Shekhar H. Deo13, MBBS, PhD; Suzanne Y. Gilmore13, MPIA; Ted Feldman13, MD; Rebecca T. Hahn14, MD; Francesco Maisano15, MD
1. University Hospital Bonn, Bonn, Germany; 2. Ludwig-Maximilians University Hospital Munich, Munich, Germany; 3. University Medical Centre Mainz, Mainz, Germany; 4. Marienkrankenhaus, Hamburg, Germany; 5. Asklepios Klinik St. Georg, Hamburg, Germany; 6. Université Paris-Diderot, Paris, France; 7. INSERM U-1148, Paris, France; 8. Hôpital Bichat-Claude Bernard, AP-HP, Paris, France; 9. Montefiore Medical Center, Bronx, NY, USA; 10. IRCCS San Raffaele Scientific Institute, Milan, Italy; 11. University Hospital Cologne, Cologne, Germany; 12. Herz- und Diabeteszentrum NRW, Ruhr University of Bochum, Bad Oeynhausen, Germany; 13. Edwards Lifesciences, Irvine, CA, USA; 14. Cardiovascular Research Foundation, New York, NY, USA; 15. University Hospital Zurich, Zurich, Switzerland

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

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