Nickenig, Georg, Weber, Marcel, Schueler, Robert, Hausleiter, Joerg, Nabauer, Michael, von Bardeleben, Ralph Stephan ORCID: 0000-0002-1356-0037, Sotiriou, Efthymios, Schaefer, Ulrich, Deuschl, Florian, Alessandrini, Hannes, Kreidel, Felix, Juliard, Jean-Michel, Brochet, Eric, Latib, Azeem ORCID: 0000-0001-9035-343X, Montorfano, Matteo, Agricola, Eustachio ORCID: 0000-0002-4834-2187, Baldus, Stephan, Friedrichs, Kai P., Deo, Shekhar H., Gilmore, Suzanne Y., Feldman, Ted, Hahn, Rebecca T. and Maisano, Francesco (2021). Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study. EuroIntervention, 16 (15). S. E1264 - 10. TOULOUSE CEDEX 6: EUROPA EDITION. ISSN 1969-6213

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Abstract

Aims: Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report oneand two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of >= moderate functional TR in the TRI-REPAIR study. Methods and results: 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. Conclusions: 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Nickenig, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weber, MarcelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schueler, RobertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hausleiter, JoergUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nabauer, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Bardeleben, Ralph StephanUNSPECIFIEDorcid.org/0000-0002-1356-0037UNSPECIFIED
Sotiriou, EfthymiosUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schaefer, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Deuschl, FlorianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alessandrini, HannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreidel, FelixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Juliard, Jean-MichelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brochet, EricUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Latib, AzeemUNSPECIFIEDorcid.org/0000-0001-9035-343XUNSPECIFIED
Montorfano, MatteoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Agricola, EustachioUNSPECIFIEDorcid.org/0000-0002-4834-2187UNSPECIFIED
Baldus, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Friedrichs, Kai P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Deo, Shekhar H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gilmore, Suzanne Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Feldman, TedUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hahn, Rebecca T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maisano, FrancescoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-604015
DOI: 10.4244/EIJ-D-20-01107
Journal or Publication Title: EuroIntervention
Volume: 16
Number: 15
Page Range: S. E1264 - 10
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
VALVULAR HEART-DISEASE; REGURGITATION; ASSOCIATION; MANAGEMENT; NEEDMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60401

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