Nickenig, Georg, Weber, Marcel, Schueler, Robert, Hausleiter, Jorg, Naebauer, Michael, von Bardeleben, Ralph S., Sotiriou, Efthymios, Schaefer, Ulrich, Deuschl, Florian, Kuck, Karl-Heinz, Kreidel, Felix, Juliard, Jean-Michel, Brochet, Eric, Latib, Azeem ORCID: 0000-0001-9035-343X, Agricola, Eustachio ORCID: 0000-0002-4834-2187, Baldus, Stephan, Friedrichs, Kai, Vandrangi, Prashanthi, Verta, Patrick, Hahn, Rebecca T. and Maisano, Francesco ORCID: 0000-0002-3691-1709 (2019). 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation. J. Am. Coll. Cardiol., 73 (15). S. 1905 - 1916. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1558-3597

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Abstract

BACKGROUND Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. OBJECTIVES The authors report the 6-month safety and performance of a transcatheter tricuspid valve reconstruction system in the treatment of moderate to severe functional TR in 30 patients enrolled in the TRI-REPAIR (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System) study. METHODS Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective trial. Patients were diagnosed with moderate to severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to 6 months post-procedure. An independent core lab assessed all echocardiographic data, and an independent clinical event committee adjudicated the safety events. RESULTS Mean patient age was 75 years, 73% were female, and 23% had ischemic heart disease. At baseline, 83% were in New York Heart Association (NYHA) functional class III to IV, and mean left ventricular ejection fraction was 58%. Technical success was 100%. Through 6 months, 3 patients died. Between 6 months and baseline, echocardiography showed average reductions of annular septolateral diameter of 9% (42 mm vs. 38 mm; p < 0.01), proximal isovelocity surface area effective regurgitant orifice area of 50% (0.8 cm(2) vs. 0.4 cm(2); p < 0.01), and mean vena contracta width of 28% (1.2 cm vs. 0.9 cm; p < 0.01). Clinical assessment showed that 76% of patients improved by at least 1 NYHA functional class with 88% in NYHA functional class I or II. Six-minute walk distance improved by 60 m (p < 0.01), and Kansas City Cardiomyopathy Questionnaire score improved by 24 points (p < 0.01). CONCLUSIONS Six-month outcomes show that the system performs as intended and appears to be safe in patients with symptomatic and moderate to severe functional TR. Significant reduction of TR through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results. (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System [TRI-REPAIR]; NCT02981953) (C) 2019 by the American College of Cardiology Foundation.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Nickenig, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weber, MarcelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schueler, RobertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hausleiter, JorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Naebauer, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Bardeleben, Ralph S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sotiriou, EfthymiosUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schaefer, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Deuschl, FlorianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuck, Karl-HeinzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreidel, FelixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Juliard, Jean-MichelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brochet, EricUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Latib, AzeemUNSPECIFIEDorcid.org/0000-0001-9035-343XUNSPECIFIED
Agricola, EustachioUNSPECIFIEDorcid.org/0000-0002-4834-2187UNSPECIFIED
Baldus, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Friedrichs, KaiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vandrangi, PrashanthiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Verta, PatrickUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hahn, Rebecca T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maisano, FrancescoUNSPECIFIEDorcid.org/0000-0002-3691-1709UNSPECIFIED
URN: urn:nbn:de:hbz:38-150456
DOI: 10.1016/j.jacc.2019.01.062
Journal or Publication Title: J. Am. Coll. Cardiol.
Volume: 73
Number: 15
Page Range: S. 1905 - 1916
Date: 2019
Publisher: ELSEVIER SCIENCE INC
Place of Publication: NEW YORK
ISSN: 1558-3597
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
VALVULAR HEART-DISEASE; TO-EDGE REPAIR; EUROPEAN ASSOCIATION; MITRACLIP SYSTEM; TRANSCATHETER TREATMENT; AMERICAN SOCIETY; IMPACT; MANAGEMENT; ECHOCARDIOGRAPHY; FEASIBILITYMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/15045

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