Nickenig, Georg, Friedrichs, Kai P., Baldus, Stephan, Arnold, Martin, Seidler, Tim, Hakmi, Samer, Linke, Axel, Schaefer, Ulrich, Dreger, Henryk, Reinthaler, Markus, von Bardeleben, Ralph Stephan ORCID: 0000-0002-1356-0037, Moellmann, Helge, Weber, Marcel, Roder, Fabian, Koerber, Maria Isabel, Landendinger, Melanie, Wolf, Frieder, Alessandrini, Hannes, Sveric, Krunoslav, Schewel, Dimitry, Romero-Dorta, Elena, Kasner, Mario, Dahou, Abdellaziz, Hahn, Rebecca T. and Windecker, Stephan (2021). Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: the TriBAND study. EuroIntervention, 17 (10). S. 809 - 823. TOULOUSE CEDEX 6: EUROPA EDITION. ISSN 1969-6213

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Abstract

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 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Nickenig, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Friedrichs, Kai P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baldus, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Arnold, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seidler, TimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hakmi, SamerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Linke, AxelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schaefer, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dreger, HenrykUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reinthaler, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Bardeleben, Ralph StephanUNSPECIFIEDorcid.org/0000-0002-1356-0037UNSPECIFIED
Moellmann, HelgeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weber, MarcelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roder, FabianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koerber, Maria IsabelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Landendinger, MelanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolf, FriederUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alessandrini, HannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sveric, KrunoslavUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schewel, DimitryUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Romero-Dorta, ElenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kasner, MarioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dahou, AbdellazizUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hahn, Rebecca T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Windecker, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-603215
DOI: 10.4244/EIJ-D-21-00300
Journal or Publication Title: EuroIntervention
Volume: 17
Number: 10
Page Range: S. 809 - 823
Date: 2021
Publisher: EUROPA EDITION
Place of Publication: TOULOUSE CEDEX 6
ISSN: 1969-6213
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
VALVE REPAIRMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60321

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