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

Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study

DOI: 10.4244/EIJ-D-21-00300

1. University Hospital Bonn, Bonn, Germany; 2. Herz- und Diabeteszentrum NRW, Ruhr University of Bochum, Bad Oeynhausen, Germany; 3. University Hospital Cologne, Cologne, Germany; 4. Friedrich-Alexander-Universität Erlangen- Nuremberg, Erlangen, Germany; 5. Universitätsmedizin Göttingen, Herzzentrum Göttingen, Göttingen, Germany; 6. Asklepios Klinik St. Georg, Hamburg, Germany; 7. Herzzentrum Universitätsklinik Dresden, Dresden, Germany; 8. Marienkrankenhaus, Hamburg, Germany; 9. Charité - Universitätsmedizin Campus Mitte, Berlin, Germany; 10. Berlin Charité-Benjamin Franklin, Berlin, Germany; 11. University Medical Centre Mainz, Mainz, Germany; 12. St. Johannes Hospital, Dortmund, Germany; 13. Cardiovascular Research Foundation, New York, NY, USA; 14. Bern University Hospital, Bern, Switzerland

Background: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality.

Aims: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system (Edwards Lifesciences, Irvine, CA, USA) from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study.

Methods: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team.

Results: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001).

Conclusions: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.

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Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study