Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation

Ole De Backer; Thomas Pilgrim; Matheus Simonato; G Burkhard Mackensen; Claudia Fiorina; Verena Veulemanns; Alfredo Cerillo; Joachim Schofer; Nicolas Amabile; Guy Achkouty; Ulrich Schäfer; Marcus-André Deutsch; Jan-Malte Sinning; Mohammed S Rahman; Fadi J Sawaya; David Hildick-Smith; Jose Maria Hernandez; Won-Keun Kim; Thierry Lefevre; Moritz Seiffert; Sabine Bleiziffer; Anna Sonia Petronio; Nicolas Van Mieghem; Maurizio Taramasso; Lars Søndergaard; Stephan Windecker; Azeem Latib; Danny Dvir

doi:10.1016/j.amjcard.2018.05.044

Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation

Ole De Backer, Thomas Pilgrim, Matheus Simonato, G Burkhard Mackensen, Claudia Fiorina, Verena Veulemanns, Alfredo Cerillo, Joachim Schofer, Nicolas Amabile, Guy Achkouty, Ulrich Schäfer, Marcus-André Deutsch, Jan-Malte Sinning, Mohammed S Rahman, Fadi J Sawaya, David Hildick-Smith, Jose Maria Hernandez, Won-Keun Kim, Thierry Lefevre, Moritz SeiffertSabine Bleiziffer, Anna Sonia Petronio, Nicolas Van Mieghem, Maurizio Taramasso, Lars Søndergaard, Stephan Windecker, Azeem Latib, Danny Dvir

Department of Clinical Medicine

15 Citations (Scopus)

Abstract

Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the "off-label" use of transcatheter heart valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74 ± 12 years, Society of Thoracic Surgeons risk score 6.6 ± 6.2%) underwent transcatheter aortic valve implantation (TAVI) with early generation (43%) or newer generation (57%) devices at 46 different sites. Device success was significantly higher in patients treated with newer as compared with early generation THV (82% vs 47%, p <0.001). The difference was driven by lower rates of device malpositioning (9% vs 33%) and aortic regurgitation (AR) ≥ moderate (4% vs 31%) and translated into higher clinical efficacy at 30 days in patients treated with newer as compared with early generation THV (72% vs 56%, p = 0.041). Both THV under- and oversizing were associated with an increased risk of THV malpositioning. In conclusion, TAVI is a feasible treatment strategy in selected high-risk patients with NAVR but is associated with a considerable risk of THV malpositioning and residual AR. Although newer-generation THV are associated with better outcomes, novel devices for the treatment of NAVR are warranted.

Original language	English
Journal	The American Journal of Cardiology
Volume	122
Issue number	6
Pages (from-to)	1028-1035
ISSN	0002-9149
DOIs	https://doi.org/10.1016/j.amjcard.2018.05.044
Publication status	Published - 15 Sept 2018

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10.1016/j.amjcard.2018.05.044

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De Backer, O., Pilgrim, T., Simonato, M., Mackensen, G. B., Fiorina, C., Veulemanns, V., Cerillo, A., Schofer, J., Amabile, N., Achkouty, G., Schäfer, U., Deutsch, M.-A., Sinning, J.-M., Rahman, M. S., Sawaya, F. J., Hildick-Smith, D., Hernandez, J. M., Kim, W.-K., Lefevre, T., ... Dvir, D. (2018). Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation. The American Journal of Cardiology, 122(6), 1028-1035. https://doi.org/10.1016/j.amjcard.2018.05.044

De Backer, O, Pilgrim, T, Simonato, M, Mackensen, GB, Fiorina, C, Veulemanns, V, Cerillo, A, Schofer, J, Amabile, N, Achkouty, G, Schäfer, U, Deutsch, M-A, Sinning, J-M, Rahman, MS, Sawaya, FJ, Hildick-Smith, D, Hernandez, JM, Kim, W-K, Lefevre, T, Seiffert, M, Bleiziffer, S, Petronio, AS, Van Mieghem, N, Taramasso, M, Søndergaard, L, Windecker, S, Latib, A & Dvir, D 2018, 'Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation', The American Journal of Cardiology, vol. 122, no. 6, pp. 1028-1035. https://doi.org/10.1016/j.amjcard.2018.05.044

@article{6d5b36a001464c39b66a0d2969d34b6b,

title = "Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation",

abstract = "Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the {"}off-label{"} use of transcatheter heart valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74 ± 12 years, Society of Thoracic Surgeons risk score 6.6 ± 6.2%) underwent transcatheter aortic valve implantation (TAVI) with early generation (43%) or newer generation (57%) devices at 46 different sites. Device success was significantly higher in patients treated with newer as compared with early generation THV (82% vs 47%, p <0.001). The difference was driven by lower rates of device malpositioning (9% vs 33%) and aortic regurgitation (AR) ≥ moderate (4% vs 31%) and translated into higher clinical efficacy at 30 days in patients treated with newer as compared with early generation THV (72% vs 56%, p = 0.041). Both THV under- and oversizing were associated with an increased risk of THV malpositioning. In conclusion, TAVI is a feasible treatment strategy in selected high-risk patients with NAVR but is associated with a considerable risk of THV malpositioning and residual AR. Although newer-generation THV are associated with better outcomes, novel devices for the treatment of NAVR are warranted.",

author = "{De Backer}, Ole and Thomas Pilgrim and Matheus Simonato and Mackensen, {G Burkhard} and Claudia Fiorina and Verena Veulemanns and Alfredo Cerillo and Joachim Schofer and Nicolas Amabile and Guy Achkouty and Ulrich Sch{\"a}fer and Marcus-Andr{\'e} Deutsch and Jan-Malte Sinning and Rahman, {Mohammed S} and Sawaya, {Fadi J} and David Hildick-Smith and Hernandez, {Jose Maria} and Won-Keun Kim and Thierry Lefevre and Moritz Seiffert and Sabine Bleiziffer and Petronio, {Anna Sonia} and {Van Mieghem}, Nicolas and Maurizio Taramasso and Lars S{\o}ndergaard and Stephan Windecker and Azeem Latib and Danny Dvir",

note = "Copyright {\textcopyright} 2018. Published by Elsevier Inc.",

year = "2018",

month = sep,

day = "15",

doi = "10.1016/j.amjcard.2018.05.044",

language = "English",

volume = "122",

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TY - JOUR

T1 - Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation

AU - De Backer, Ole

AU - Pilgrim, Thomas

AU - Simonato, Matheus

AU - Mackensen, G Burkhard

AU - Fiorina, Claudia

AU - Veulemanns, Verena

AU - Cerillo, Alfredo

AU - Schofer, Joachim

AU - Amabile, Nicolas

AU - Achkouty, Guy

AU - Schäfer, Ulrich

AU - Deutsch, Marcus-André

AU - Sinning, Jan-Malte

AU - Rahman, Mohammed S

AU - Sawaya, Fadi J

AU - Hildick-Smith, David

AU - Hernandez, Jose Maria

AU - Kim, Won-Keun

AU - Lefevre, Thierry

AU - Seiffert, Moritz

AU - Bleiziffer, Sabine

AU - Petronio, Anna Sonia

AU - Van Mieghem, Nicolas

AU - Taramasso, Maurizio

AU - Søndergaard, Lars

AU - Windecker, Stephan

AU - Latib, Azeem

AU - Dvir, Danny

PY - 2018/9/15

Y1 - 2018/9/15

N2 - Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the "off-label" use of transcatheter heart valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74 ± 12 years, Society of Thoracic Surgeons risk score 6.6 ± 6.2%) underwent transcatheter aortic valve implantation (TAVI) with early generation (43%) or newer generation (57%) devices at 46 different sites. Device success was significantly higher in patients treated with newer as compared with early generation THV (82% vs 47%, p <0.001). The difference was driven by lower rates of device malpositioning (9% vs 33%) and aortic regurgitation (AR) ≥ moderate (4% vs 31%) and translated into higher clinical efficacy at 30 days in patients treated with newer as compared with early generation THV (72% vs 56%, p = 0.041). Both THV under- and oversizing were associated with an increased risk of THV malpositioning. In conclusion, TAVI is a feasible treatment strategy in selected high-risk patients with NAVR but is associated with a considerable risk of THV malpositioning and residual AR. Although newer-generation THV are associated with better outcomes, novel devices for the treatment of NAVR are warranted.

AB - Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the "off-label" use of transcatheter heart valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74 ± 12 years, Society of Thoracic Surgeons risk score 6.6 ± 6.2%) underwent transcatheter aortic valve implantation (TAVI) with early generation (43%) or newer generation (57%) devices at 46 different sites. Device success was significantly higher in patients treated with newer as compared with early generation THV (82% vs 47%, p <0.001). The difference was driven by lower rates of device malpositioning (9% vs 33%) and aortic regurgitation (AR) ≥ moderate (4% vs 31%) and translated into higher clinical efficacy at 30 days in patients treated with newer as compared with early generation THV (72% vs 56%, p = 0.041). Both THV under- and oversizing were associated with an increased risk of THV malpositioning. In conclusion, TAVI is a feasible treatment strategy in selected high-risk patients with NAVR but is associated with a considerable risk of THV malpositioning and residual AR. Although newer-generation THV are associated with better outcomes, novel devices for the treatment of NAVR are warranted.

U2 - 10.1016/j.amjcard.2018.05.044

DO - 10.1016/j.amjcard.2018.05.044

M3 - Journal article

C2 - 30072124

SN - 0002-9149

VL - 122

SP - 1028

EP - 1035

JO - The American Journal of Cardiology

JF - The American Journal of Cardiology

IS - 6

ER -

Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation

Abstract

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