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

LBT. DOI: 10.4244/EIJ-D-21-00300

1. University Hospital Bonn, Bonn, Germany, 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, New York, USA
14. Bern University Hospital, Bern, Switzerland

Background: Severe 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) 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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