Universität zu Köln

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:	Creators Email ORCID ORCID Put Code Nickenig, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Weber, Marcel UNSPECIFIED UNSPECIFIED UNSPECIFIED Schueler, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Hausleiter, Jorg UNSPECIFIED UNSPECIFIED UNSPECIFIED Naebauer, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED von Bardeleben, Ralph S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sotiriou, Efthymios UNSPECIFIED UNSPECIFIED UNSPECIFIED Schaefer, Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Deuschl, Florian UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuck, Karl-Heinz UNSPECIFIED UNSPECIFIED UNSPECIFIED Kreidel, Felix UNSPECIFIED UNSPECIFIED UNSPECIFIED Juliard, Jean-Michel UNSPECIFIED UNSPECIFIED UNSPECIFIED Brochet, Eric UNSPECIFIED UNSPECIFIED UNSPECIFIED Latib, Azeem UNSPECIFIED orcid.org/0000-0001-9035-343X UNSPECIFIED Agricola, Eustachio UNSPECIFIED orcid.org/0000-0002-4834-2187 UNSPECIFIED Baldus, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Friedrichs, Kai UNSPECIFIED UNSPECIFIED UNSPECIFIED Vandrangi, Prashanthi UNSPECIFIED UNSPECIFIED UNSPECIFIED Verta, Patrick UNSPECIFIED UNSPECIFIED UNSPECIFIED Hahn, Rebecca T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Maisano, Francesco UNSPECIFIED orcid.org/0000-0002-3691-1709 UNSPECIFIED
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:	Keywords Language VALVULAR HEART-DISEASE; TO-EDGE REPAIR; EUROPEAN ASSOCIATION; MITRACLIP SYSTEM; TRANSCATHETER TREATMENT; AMERICAN SOCIETY; IMPACT; MANAGEMENT; ECHOCARDIOGRAPHY; FEASIBILITY Multiple languages Cardiac & Cardiovascular Systems Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/15045