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6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation

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6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation. / Nickenig, Georg; Weber, Marcel; Schueler, Robert; Hausleiter, Jörg; Näbauer, Michael; von Bardeleben, Ralph S; Sotiriou, Efthymios; Schäfer, Ulrich; Deuschl, Florian; Kuck, Karl-Heinz; Kreidel, Felix; Juliard, Jean-Michel; Brochet, Eric; Latib, Azeem; Agricola, Eustachio; Baldus, Stephan; Friedrichs, Kai; Vandrangi, Prashanthi; Verta, Patrick; Hahn, Rebecca T; Maisano, Francesco.

In: J AM COLL CARDIOL, Vol. 73, No. 15, 23.04.2019, p. 1905-1915.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Nickenig, G, Weber, M, Schueler, R, Hausleiter, J, Näbauer, M, von Bardeleben, RS, Sotiriou, E, Schäfer, U, Deuschl, F, Kuck, K-H, Kreidel, F, Juliard, J-M, Brochet, E, Latib, A, Agricola, E, Baldus, S, Friedrichs, K, Vandrangi, P, Verta, P, Hahn, RT & Maisano, F 2019, '6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation', J AM COLL CARDIOL, vol. 73, no. 15, pp. 1905-1915. https://doi.org/10.1016/j.jacc.2019.01.062

APA

Nickenig, G., Weber, M., Schueler, R., Hausleiter, J., Näbauer, M., von Bardeleben, R. S., Sotiriou, E., Schäfer, U., Deuschl, F., Kuck, K-H., Kreidel, F., Juliard, J-M., Brochet, E., Latib, A., Agricola, E., Baldus, S., Friedrichs, K., Vandrangi, P., Verta, P., ... Maisano, F. (2019). 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation. J AM COLL CARDIOL, 73(15), 1905-1915. https://doi.org/10.1016/j.jacc.2019.01.062

Vancouver

Nickenig G, Weber M, Schueler R, Hausleiter J, Näbauer M, von Bardeleben RS et al. 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation. J AM COLL CARDIOL. 2019 Apr 23;73(15):1905-1915. https://doi.org/10.1016/j.jacc.2019.01.062

Bibtex

@article{b0e7c4ae4ba84c0a9832c1e148913c86,
title = "6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation",
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 cm2 vs. 0.4 cm2; 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).",
keywords = "Age Factors, Aged, Aged, 80 and over, Cardiac Catheterization/methods, Echocardiography, Doppler/methods, Female, Follow-Up Studies, Heart Valve Prosthesis Implantation/methods, Hospital Mortality/trends, Humans, Internationality, Male, Middle Aged, Minimally Invasive Surgical Procedures/methods, Prospective Studies, Reconstructive Surgical Procedures/methods, Risk Assessment, Severity of Illness Index, Survival Rate, Time Factors, Treatment Outcome, Tricuspid Valve Insufficiency/diagnostic imaging",
author = "Georg Nickenig and Marcel Weber and Robert Schueler and J{\"o}rg Hausleiter and Michael N{\"a}bauer and {von Bardeleben}, {Ralph S} and Efthymios Sotiriou and Ulrich Sch{\"a}fer and Florian Deuschl and Karl-Heinz Kuck and Felix Kreidel and Jean-Michel Juliard and Eric Brochet and Azeem Latib and Eustachio Agricola and Stephan Baldus and Kai Friedrichs and Prashanthi Vandrangi and Patrick Verta and Hahn, {Rebecca T} and Francesco Maisano",
note = "Copyright {\textcopyright} 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.",
year = "2019",
month = apr,
day = "23",
doi = "10.1016/j.jacc.2019.01.062",
language = "English",
volume = "73",
pages = "1905--1915",
journal = "J AM COLL CARDIOL",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "15",

}

RIS

TY - JOUR

T1 - 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation

AU - Nickenig, Georg

AU - Weber, Marcel

AU - Schueler, Robert

AU - Hausleiter, Jörg

AU - Näbauer, Michael

AU - von Bardeleben, Ralph S

AU - Sotiriou, Efthymios

AU - Schäfer, Ulrich

AU - Deuschl, Florian

AU - Kuck, Karl-Heinz

AU - Kreidel, Felix

AU - Juliard, Jean-Michel

AU - Brochet, Eric

AU - Latib, Azeem

AU - Agricola, Eustachio

AU - Baldus, Stephan

AU - Friedrichs, Kai

AU - Vandrangi, Prashanthi

AU - Verta, Patrick

AU - Hahn, Rebecca T

AU - Maisano, Francesco

N1 - Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

PY - 2019/4/23

Y1 - 2019/4/23

N2 - 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 cm2 vs. 0.4 cm2; 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).

AB - 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 cm2 vs. 0.4 cm2; 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).

KW - Age Factors

KW - Aged

KW - Aged, 80 and over

KW - Cardiac Catheterization/methods

KW - Echocardiography, Doppler/methods

KW - Female

KW - Follow-Up Studies

KW - Heart Valve Prosthesis Implantation/methods

KW - Hospital Mortality/trends

KW - Humans

KW - Internationality

KW - Male

KW - Middle Aged

KW - Minimally Invasive Surgical Procedures/methods

KW - Prospective Studies

KW - Reconstructive Surgical Procedures/methods

KW - Risk Assessment

KW - Severity of Illness Index

KW - Survival Rate

KW - Time Factors

KW - Treatment Outcome

KW - Tricuspid Valve Insufficiency/diagnostic imaging

U2 - 10.1016/j.jacc.2019.01.062

DO - 10.1016/j.jacc.2019.01.062

M3 - SCORING: Journal article

C2 - 30999993

VL - 73

SP - 1905

EP - 1915

JO - J AM COLL CARDIOL

JF - J AM COLL CARDIOL

SN - 0735-1097

IS - 15

ER -