Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study
| Autor: | Elena Romero-Dorta, Stephan Baldus, Stephan Windecker, Ralph Stephan von Bardeleben, Helge Möllmann, Frieder Wolf, Marcel Weber, Fabian Roder, Maria Isabel Körber, Krunoslav Sveric, Henryk Dreger, Melanie Landendinger, Tim Seidler, Markus Reinthaler, Rebecca T. Hahn, Ulrich Schäfer, Martin Arnold, Dimitry Schewel, Abdellaziz Dahou, Georg Nickenig, Axel Linke, Hannes Alessandrini, Kai Friedrichs, Mario Kasner, Samer Hakmi |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Tricuspid valve Ejection fraction business.industry medicine.medical_treatment Nyha class High morbidity medicine.anatomical_structure Quality of life Functional tricuspid regurgitation THIRTY-DAY Internal medicine medicine Cardiology Diuretic 610 Medicine & health Cardiology and Cardiovascular Medicine business |
| Zdroj: | EuroIntervention. 17:809-817 |
| ISSN: | 1774-024X |
| DOI: | 10.4244/eij-d-21-00300 |
| Popis: | 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% (pl0.001) 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 pl0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (pl0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (pl0.001) with improvements in overall KCCQ score by 17 points (pl0.001). 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. |
| Databáze: | OpenAIRE |
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