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Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study

Standard

Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study. / Sawaya, Fadi J; Deutsch, Marcus-André; Seiffert, Moritz; Yoon, Sung-Han; Codner, Pablo; Wickramarachchi, Upul; Latib, Azeem; Petronio, A Sonia; Rodés-Cabau, Josep; Taramasso, Maurizio; Spaziano, Marco; Bosmans, Johan; Biasco, Luigi; Mylotte, Darren; Savontaus, Mikko; Gheeraert, Peter; Chan, Jason; Jørgensen, Troels H; Sievert, Horst; Mocetti, Marco; Lefèvre, Thierry; Maisano, Francesco; Mangieri, Antonio; Hildick-Smith, David; Kornowski, Ran; Makkar, Raj; Bleiziffer, Sabine; Søndergaard, Lars; De Backer, Ole.

in: JACC-CARDIOVASC INTE, Jahrgang 10, Nr. 10, 22.05.2017, S. 1048-1056.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Sawaya, FJ, Deutsch, M-A, Seiffert, M, Yoon, S-H, Codner, P, Wickramarachchi, U, Latib, A, Petronio, AS, Rodés-Cabau, J, Taramasso, M, Spaziano, M, Bosmans, J, Biasco, L, Mylotte, D, Savontaus, M, Gheeraert, P, Chan, J, Jørgensen, TH, Sievert, H, Mocetti, M, Lefèvre, T, Maisano, F, Mangieri, A, Hildick-Smith, D, Kornowski, R, Makkar, R, Bleiziffer, S, Søndergaard, L & De Backer, O 2017, 'Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study', JACC-CARDIOVASC INTE, Jg. 10, Nr. 10, S. 1048-1056. https://doi.org/10.1016/j.jcin.2017.03.004

APA

Sawaya, F. J., Deutsch, M-A., Seiffert, M., Yoon, S-H., Codner, P., Wickramarachchi, U., Latib, A., Petronio, A. S., Rodés-Cabau, J., Taramasso, M., Spaziano, M., Bosmans, J., Biasco, L., Mylotte, D., Savontaus, M., Gheeraert, P., Chan, J., Jørgensen, T. H., Sievert, H., ... De Backer, O. (2017). Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study. JACC-CARDIOVASC INTE, 10(10), 1048-1056. https://doi.org/10.1016/j.jcin.2017.03.004

Vancouver

Sawaya FJ, Deutsch M-A, Seiffert M, Yoon S-H, Codner P, Wickramarachchi U et al. Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study. JACC-CARDIOVASC INTE. 2017 Mai 22;10(10):1048-1056. https://doi.org/10.1016/j.jcin.2017.03.004

Bibtex

@article{5916b2a5e07540848b876c1de14c4cf4,
title = "Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study",
abstract = "OBJECTIVES: The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR).BACKGROUND: Limited data are available about the {"}off-label{"} use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR.METHODS: The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria.RESULTS: A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m2, STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively.CONCLUSIONS: TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option.",
keywords = "Aged, Aged, 80 and over, Aortic Valve/diagnostic imaging, Aortic Valve Insufficiency/diagnostic imaging, Bioprosthesis, Coronary Angiography, Echocardiography, Female, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation/adverse effects, Humans, Male, Middle Aged, Prosthesis Failure, Registries, Risk Factors, Time Factors, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome",
author = "Sawaya, {Fadi J} and Marcus-Andr{\'e} Deutsch and Moritz Seiffert and Sung-Han Yoon and Pablo Codner and Upul Wickramarachchi and Azeem Latib and Petronio, {A Sonia} and Josep Rod{\'e}s-Cabau and Maurizio Taramasso and Marco Spaziano and Johan Bosmans and Luigi Biasco and Darren Mylotte and Mikko Savontaus and Peter Gheeraert and Jason Chan and J{\o}rgensen, {Troels H} and Horst Sievert and Marco Mocetti and Thierry Lef{\`e}vre and Francesco Maisano and Antonio Mangieri and David Hildick-Smith and Ran Kornowski and Raj Makkar and Sabine Bleiziffer and Lars S{\o}ndergaard and {De Backer}, Ole",
note = "Copyright {\textcopyright} 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.",
year = "2017",
month = may,
day = "22",
doi = "10.1016/j.jcin.2017.03.004",
language = "English",
volume = "10",
pages = "1048--1056",
journal = "JACC-CARDIOVASC INTE",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "10",

}

RIS

TY - JOUR

T1 - Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study

AU - Sawaya, Fadi J

AU - Deutsch, Marcus-André

AU - Seiffert, Moritz

AU - Yoon, Sung-Han

AU - Codner, Pablo

AU - Wickramarachchi, Upul

AU - Latib, Azeem

AU - Petronio, A Sonia

AU - Rodés-Cabau, Josep

AU - Taramasso, Maurizio

AU - Spaziano, Marco

AU - Bosmans, Johan

AU - Biasco, Luigi

AU - Mylotte, Darren

AU - Savontaus, Mikko

AU - Gheeraert, Peter

AU - Chan, Jason

AU - Jørgensen, Troels H

AU - Sievert, Horst

AU - Mocetti, Marco

AU - Lefèvre, Thierry

AU - Maisano, Francesco

AU - Mangieri, Antonio

AU - Hildick-Smith, David

AU - Kornowski, Ran

AU - Makkar, Raj

AU - Bleiziffer, Sabine

AU - Søndergaard, Lars

AU - De Backer, Ole

N1 - Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

PY - 2017/5/22

Y1 - 2017/5/22

N2 - OBJECTIVES: The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR).BACKGROUND: Limited data are available about the "off-label" use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR.METHODS: The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria.RESULTS: A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m2, STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively.CONCLUSIONS: TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option.

AB - OBJECTIVES: The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR).BACKGROUND: Limited data are available about the "off-label" use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR.METHODS: The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria.RESULTS: A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m2, STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively.CONCLUSIONS: TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve/diagnostic imaging

KW - Aortic Valve Insufficiency/diagnostic imaging

KW - Bioprosthesis

KW - Coronary Angiography

KW - Echocardiography

KW - Female

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/adverse effects

KW - Humans

KW - Male

KW - Middle Aged

KW - Prosthesis Failure

KW - Registries

KW - Risk Factors

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

U2 - 10.1016/j.jcin.2017.03.004

DO - 10.1016/j.jcin.2017.03.004

M3 - SCORING: Journal article

C2 - 28521923

VL - 10

SP - 1048

EP - 1056

JO - JACC-CARDIOVASC INTE

JF - JACC-CARDIOVASC INTE

SN - 1936-8798

IS - 10

ER -