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

Fadi J Sawaya; Marcus-André Deutsch; Moritz Seiffert; Sung-Han Yoon; Pablo Codner; Upul Wickramarachchi; Azeem Latib; A Sonia Petronio; Josep Rodés-Cabau; Maurizio Taramasso; Marco Spaziano; Johan Bosmans; Luigi Biasco; Darren Mylotte; Mikko Savontaus; Peter Gheeraert; Jason Chan; Troels H Jørgensen; Horst Sievert; Marco Mocetti; Thierry Lefèvre; Francesco Maisano; Antonio Mangieri; David Hildick-Smith; Ran Kornowski; Raj Makkar; Sabine Bleiziffer; Lars Søndergaard; Ole De Backer

doi:10.1016/j.jcin.2017.03.004

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

Fadi J Sawaya, Marcus-André Deutsch, Moritz Seiffert, Sung-Han Yoon, Pablo Codner, Upul Wickramarachchi, Azeem Latib, A Sonia Petronio, Josep Rodés-Cabau, Maurizio Taramasso, Marco Spaziano, Johan Bosmans, Luigi Biasco, Darren Mylotte, Mikko Savontaus, Peter Gheeraert, Jason Chan, Troels H Jørgensen, Horst Sievert, Marco MocettiThierry Lefèvre, Francesco Maisano, Antonio Mangieri, David Hildick-Smith, Ran Kornowski, Raj Makkar, Sabine Bleiziffer, Lars Søndergaard, Ole De Backer

Department of Clinical Medicine

56 Citations (Scopus)

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.

Original language	English
Journal	J A C C: Cardiovascular Interventions
Volume	10
Issue number	10
Pages (from-to)	1048-1056
Number of pages	9
ISSN	1936-8798
DOIs	https://doi.org/10.1016/j.jcin.2017.03.004
Publication status	Published - 22 May 2017

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

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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. J A C C: Cardiovascular Interventions, 10(10), 1048-1056. https://doi.org/10.1016/j.jcin.2017.03.004

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 et al.

In: J A C C: Cardiovascular Interventions, Vol. 10, No. 10, 22.05.2017, p. 1048-1056.

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

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', J A C C: Cardiovascular Interventions, vol. 10, no. 10, pp. 1048-1056. https://doi.org/10.1016/j.jcin.2017.03.004

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. J A C C: Cardiovascular Interventions. 2017 May 22;10(10):1048-1056. doi: 10.1016/j.jcin.2017.03.004

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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",

year = "2017",

month = may,

day = "22",

doi = "10.1016/j.jcin.2017.03.004",

language = "English",

volume = "10",

pages = "1048--1056",

journal = "J A C C: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier",

number = "10",

}

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

T2 - 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

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 - Journal article

C2 - 28521923

SN - 1936-8798

VL - 10

SP - 1048

EP - 1056

JO - J A C C: Cardiovascular Interventions

JF - J A C C: Cardiovascular Interventions

IS - 10

ER -