biostudies-literatureUnknown17(10)Nickenig G<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.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology809-817https://www.ebi.ac.uk/biostudies/studies/S-EPMC9724867biostudies-literatureThirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study.PMC9724867Arnold MSveric KKasner MKorber MIWindecker SReinthaler MHahn RTMollmann HSchewel DSeidler THakmi SWolf FAlessandrini HSchafer UWeber MRomero-Dorta ERoder Fvon Bardeleben RSBaldus SNickenig GDahou ALinke AFriedrichs KPDreger HLandendinger MfalseThirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study.<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.2021-01-01T00:00:00Z2021 Nov2026-05-28T06:07:32.163Z2024-11-19T16:26:49.383ZS-EPMC97248673403102110.4244/EIJ-D-21-0030010.4244/eij-d-21-00300