Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease

Darren Mylotte; Thierry Lefevre; Lars Søndergaard; Yusuke Watanabe; Thomas Modine; Danny Dvir; Johan Bosmans; Didier Tchetche; Ran Kornowski; Jan-Malte Sinning; Pascal Thériault-Lauzier; Crochan J O'Sullivan; Marco Barbanti; Nicolas Debry; Jean Buithieu; Pablo Codner; Magdalena Dorfmeister; Giuseppe Martucci; Georg Nickenig; Peter Wenaweser; Corrado Tamburino; Eberhard Grube; John G Webb; Stephan Windecker; Ruediger Lange; Nicolo Piazza

doi:10.1016/j.jacc.2014.09.039

Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease

Darren Mylotte, Thierry Lefevre, Lars Søndergaard, Yusuke Watanabe, Thomas Modine, Danny Dvir, Johan Bosmans, Didier Tchetche, Ran Kornowski, Jan-Malte Sinning, Pascal Thériault-Lauzier, Crochan J O'Sullivan, Marco Barbanti, Nicolas Debry, Jean Buithieu, Pablo Codner, Magdalena Dorfmeister, Giuseppe Martucci, Georg Nickenig, Peter WenaweserCorrado Tamburino, Eberhard Grube, John G Webb, Stephan Windecker, Ruediger Lange, Nicolo Piazza

LUKKET: Institut for Lægemiddeldesign og Farmakologi

194 Citationer (Scopus)

6 Downloads (Pure)

Abstract

Background Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV).

bjectives This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV.

Methods We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV.

Results A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio [OR]: 0.19, 95% confidence intervals [CI]: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03).

Conclusions TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.

Originalsprog	Engelsk
Tidsskrift	Journal of the American College of Cardiology
Vol/bind	64
Udgave nummer	22
Sider (fra-til)	2330-2339
Antal sider	10
ISSN	0735-1097
DOI	https://doi.org/10.1016/j.jacc.2014.09.039
Status	Udgivet - 9 dec. 2014

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10.1016/j.jacc.2014.09.039Licens: CC BY

1-s2.0-S0735109714064845-mainLicens: CC BY

Citationsformater

Mylotte, D., Lefevre, T., Søndergaard, L., Watanabe, Y., Modine, T., Dvir, D., Bosmans, J., Tchetche, D., Kornowski, R., Sinning, J-M., Thériault-Lauzier, P., O'Sullivan, C. J., Barbanti, M., Debry, N., Buithieu, J., Codner, P., Dorfmeister, M., Martucci, G., Nickenig, G., ... Piazza, N. (2014). Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease. Journal of the American College of Cardiology, 64(22), 2330-2339. https://doi.org/10.1016/j.jacc.2014.09.039

Mylotte, D, Lefevre, T, Søndergaard, L, Watanabe, Y, Modine, T, Dvir, D, Bosmans, J, Tchetche, D, Kornowski, R, Sinning, J-M, Thériault-Lauzier, P, O'Sullivan, CJ, Barbanti, M, Debry, N, Buithieu, J, Codner, P, Dorfmeister, M, Martucci, G, Nickenig, G, Wenaweser, P, Tamburino, C, Grube, E, Webb, JG, Windecker, S, Lange, R & Piazza, N 2014, 'Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease', Journal of the American College of Cardiology, bind 64, nr. 22, s. 2330-2339. https://doi.org/10.1016/j.jacc.2014.09.039

@article{3625bb96770041a986f5f65824467dde,

title = "Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease",

abstract = "Background Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV).bjectives This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV.Methods We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV.Results A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio [OR]: 0.19, 95% confidence intervals [CI]: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03).Conclusions TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.",

keywords = "Aged, Aged, 80 and over, Aortic Valve, Aortic Valve Stenosis, Cohort Studies, Female, Heart Valve Diseases, Humans, Male, Prospective Studies, Registries, Retrospective Studies, Transcatheter Aortic Valve Replacement, Treatment Outcome",

author = "Darren Mylotte and Thierry Lefevre and Lars S{\o}ndergaard and Yusuke Watanabe and Thomas Modine and Danny Dvir and Johan Bosmans and Didier Tchetche and Ran Kornowski and Jan-Malte Sinning and Pascal Th{\'e}riault-Lauzier and O'Sullivan, {Crochan J} and Marco Barbanti and Nicolas Debry and Jean Buithieu and Pablo Codner and Magdalena Dorfmeister and Giuseppe Martucci and Georg Nickenig and Peter Wenaweser and Corrado Tamburino and Eberhard Grube and Webb, {John G} and Stephan Windecker and Ruediger Lange and Nicolo Piazza",

year = "2014",

month = dec,

day = "9",

doi = "10.1016/j.jacc.2014.09.039",

language = "English",

volume = "64",

pages = "2330--2339",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier",

number = "22",

}

TY - JOUR

T1 - Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease

AU - Mylotte, Darren

AU - Lefevre, Thierry

AU - Søndergaard, Lars

AU - Watanabe, Yusuke

AU - Modine, Thomas

AU - Dvir, Danny

AU - Bosmans, Johan

AU - Tchetche, Didier

AU - Kornowski, Ran

AU - Sinning, Jan-Malte

AU - Thériault-Lauzier, Pascal

AU - O'Sullivan, Crochan J

AU - Barbanti, Marco

AU - Debry, Nicolas

AU - Buithieu, Jean

AU - Codner, Pablo

AU - Dorfmeister, Magdalena

AU - Martucci, Giuseppe

AU - Nickenig, Georg

AU - Wenaweser, Peter

AU - Tamburino, Corrado

AU - Grube, Eberhard

AU - Webb, John G

AU - Windecker, Stephan

AU - Lange, Ruediger

AU - Piazza, Nicolo

PY - 2014/12/9

Y1 - 2014/12/9

N2 - Background Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV).bjectives This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV.Methods We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV.Results A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio [OR]: 0.19, 95% confidence intervals [CI]: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03).Conclusions TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.

AB - Background Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV).bjectives This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV.Methods We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV.Results A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio [OR]: 0.19, 95% confidence intervals [CI]: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03).Conclusions TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve

KW - Aortic Valve Stenosis

KW - Cohort Studies

KW - Female

KW - Heart Valve Diseases

KW - Humans

KW - Male

KW - Prospective Studies

KW - Registries

KW - Retrospective Studies

KW - Transcatheter Aortic Valve Replacement

KW - Treatment Outcome

U2 - 10.1016/j.jacc.2014.09.039

DO - 10.1016/j.jacc.2014.09.039

M3 - Journal article

C2 - 25465419

SN - 0735-1097

VL - 64

SP - 2330

EP - 2339

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 22

ER -

Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease

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