{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["17(10)"],"submitter":["Nickenig G"],"pubmed_abstract":["<h4>Background</h4>Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality.<h4>Aims</h4>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.<h4>Methods</h4>Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team.<h4>Results</h4>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).<h4>Conclusions</h4>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."],"journal":["EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology"],"pagination":["809-817"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9724867"],"repository":["biostudies-literature"],"pubmed_title":["Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study."],"pmcid":["PMC9724867"],"pubmed_authors":["Arnold M","Sveric K","Kasner M","Korber MI","Windecker S","Reinthaler M","Hahn RT","Mollmann H","Schewel D","Seidler T","Hakmi S","Wolf F","Alessandrini H","Schafer U","Weber M","Romero-Dorta E","Roder F","von Bardeleben RS","Baldus S","Nickenig G","Dahou A","Linke A","Friedrichs KP","Dreger H","Landendinger M"],"additional_accession":[]},"is_claimable":false,"name":"Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study.","description":"<h4>Background</h4>Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality.<h4>Aims</h4>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.<h4>Methods</h4>Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team.<h4>Results</h4>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).<h4>Conclusions</h4>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.","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Nov","modification":"2026-05-28T06:07:32.163Z","creation":"2024-11-19T16:26:49.383Z"},"accession":"S-EPMC9724867","cross_references":{"pubmed":["34031021"],"doi":["10.4244/EIJ-D-21-00300","10.4244/eij-d-21-00300"]}}