{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["16(15)"],"submitter":["Nickenig G"],"pubmed_abstract":["<h4>Aims</h4>Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study.<h4>Methods and results</h4>Thirty patients were enrolled in this single-arm, multicentre, prospective study. Patients were evaluated as having ≥moderate, symptomatic functional TR and deemed inoperable due to unacceptable surgical risk. Clinical, functional, and echocardiographic data were prospectively collected up to two years (mean duration 604±227 days). At baseline, 83% were in NYHA Class III-IV, and the mean LVEF was 58%. Technical success was 100%. At two years, there were eight deaths. Echocardiography showed a significant reduction in septolateral annular diameter of 16% (p=0.006) and 72% of patients (p=0.016) with ≤moderate TR grade; 82% of patients were in NYHA Class I-II (p=0.002). Six-minute walk distance and KCCQ score improved by 73 m (p=0.058) and 14 points (p=0.046), respectively.<h4>Conclusions</h4>These results demonstrate that the Cardioband tricuspid system showed favourable results in patients with symptomatic, ≥moderate functional TR. Annular reduction and TR severity reduction remained significant and sustained at two years. Patients experienced improvements in quality of life and exercise capacity. ClinicalTrials.gov Identifier: NCT02981953."],"journal":["EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology"],"pagination":["e1264-e1271"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9724932"],"repository":["biostudies-literature"],"pubmed_title":["Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study."],"pmcid":["PMC9724932"],"pubmed_authors":["Schafer U","Weber M","Agricola E","Kreidel F","von Bardeleben RS","Sotiriou E","Baldus S","Nickenig G","Nabauer M","Latib A","Deo SH","Friedrichs KP","Brochet E","Deuschl F","Juliard JM","Hahn RT","Hausleiter J","Gilmore SY","Feldman T","Maisano F","Schuler R","Alessandrini H","Montorfano M"],"additional_accession":[]},"is_claimable":false,"name":"Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study.","description":"<h4>Aims</h4>Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study.<h4>Methods and results</h4>Thirty patients were enrolled in this single-arm, multicentre, prospective study. Patients were evaluated as having ≥moderate, symptomatic functional TR and deemed inoperable due to unacceptable surgical risk. Clinical, functional, and echocardiographic data were prospectively collected up to two years (mean duration 604±227 days). At baseline, 83% were in NYHA Class III-IV, and the mean LVEF was 58%. Technical success was 100%. At two years, there were eight deaths. Echocardiography showed a significant reduction in septolateral annular diameter of 16% (p=0.006) and 72% of patients (p=0.016) with ≤moderate TR grade; 82% of patients were in NYHA Class I-II (p=0.002). Six-minute walk distance and KCCQ score improved by 73 m (p=0.058) and 14 points (p=0.046), respectively.<h4>Conclusions</h4>These results demonstrate that the Cardioband tricuspid system showed favourable results in patients with symptomatic, ≥moderate functional TR. Annular reduction and TR severity reduction remained significant and sustained at two years. Patients experienced improvements in quality of life and exercise capacity. ClinicalTrials.gov Identifier: NCT02981953.","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Feb","modification":"2026-05-28T06:07:36.842Z","creation":"2024-11-19T16:26:48.315Z"},"accession":"S-EPMC9724932","cross_references":{"pubmed":["33046437"],"doi":["10.4244/eij-d-20-01107","10.4244/EIJ-D-20-01107"]}}