Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry)

Carlo A. Pivato; Davide Cao; Alessandro Spirito; Samantha Sartori; Johny Nicolas; Mauro Chiarito; Clayton Snyder; Julinda Mehilli; Thierry Lefèvre; Giulio G. Stefanini; Patrizia Presbitero; Piera Capranzano; Didier Tchetche; Alessandro Iadanza; Birgit Vogel; Gennaro Sardella; Nicolas M. Van Mieghem; Matteo Nardin; Anne H. Tavenier; Emanuele Meliga; Nicholas Dumonteil; Chiara Fraccaro; Daniela Trabattoni; Ghada Mikhail; Samin Sharma; Maria Cruz Ferrer; Christoph Naber; Peter Kievit; Usman Baber; Anna S. Petronio; Marie C. Morice; Alaide Chieffo; George Dangas; Roxana Mehran

doi:10.1016/j.amjcard.2022.02.025

Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry)

Carlo A. Pivato
, Davide Cao
, Alessandro Spirito
, Samantha Sartori
, Johny Nicolas
, Mauro Chiarito
, Clayton Snyder
, Julinda Mehilli
, Thierry Lefèvre
, Giulio G. Stefanini
, Patrizia Presbitero
, Piera Capranzano
, Didier Tchetche
, Alessandro Iadanza
, Birgit Vogel
, Gennaro Sardella
, Nicolas M. Van Mieghem
, Matteo Nardin
, Anne H. Tavenier
, Emanuele Meliga

Nicholas Dumonteil, Chiara Fraccaro, Daniela Trabattoni, Ghada Mikhail, Samin Sharma, Maria Cruz Ferrer, Christoph Naber, Peter Kievit, Usman Baber, Anna S. Petronio, Marie C. Morice, Alaide Chieffo, George Dangas, Roxana Mehran^*

^*Corresponding author for this work

Cardiology

Icahn School of Medicine at Mount Sinai
IRCCS Istituto Clinico Humanitas - Rozzano (Milano)
Humanitas University
Ludwig Maximilian University of Munich
Institut Hospitalier Jacques Cartier
University of Catania
Clinique Pasteur Toulouse
Azienda Ospedaliera Universitaria Senese
University of Rome La Sapienza
Université Paul Sabatier Toulouse III
University of Padua
IRCCS Centro Cardiologico S.P.A. Fondazione Monzino - Milano
Hammersmith Hospital
University of Zaragoza
Elisabeth-Krankenhaus Essen
University of Pisa
Vita-Salute San Raffaele University
Mauriziano Umberto I Hospital
Radboud University Medical Center

Research output: Contribution to journal › Article › Academic › peer-review

14 Citations (Scopus)

1 Downloads (Pure)

Abstract

Although most patients with small aortic annulus are women, there is paucity of data on the prognostic impact of small aortic prosthesis in women who underwent transcatheter aortic valve implantation (TAVI). Therefore, we aimed to evaluate the impact of small valve size on 1-year clinical outcomes after TAVI in women. The Women's INternational Transcatheter Aortic Valve Implantation is an all-women registry evaluating patients with severe aortic stenosis who underwent TAVI. Based on the size of the aortic bioprosthesis implanted, women were stratified into small (≤23 mm) and nonsmall (>23 mm) valve. The primary efficacy endpoint was the Valve Academic Research Consortium-2 composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Of 934 women who underwent TAVI, 388 (41.5%) received a small valve. Women with a small valve size had a lower body mass index, lower surgical risk scores, were less likely to suffer from atrial fibrillation, less often required postdilation and had a lower rate of residual aortic regurgitation grade ≥2. The occurrence of the Valve Academic Research Consortium-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0% vs 16.3%, p = 0.881; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00). Likewise, there were no significant differences in the occurrence of other secondary endpoints after multivariable adjustment. In conclusion, women with severe aortic stenosis who underwent TAVI with the implantation of a small valve bioprosthesis had similar 1-year outcomes as those receiving a nonsmall bioprosthesis.

Original language	English
Pages (from-to)	73-80
Number of pages	8
Journal	American Journal of Cardiology
Volume	172
Early online date	20 Apr 2022
DOIs	https://doi.org/10.1016/j.amjcard.2022.02.025
Publication status	Published - 1 Jun 2022

Bibliographical note

Funding Information:
Dr. Baber received an institutional research grant from AstraZeneca; personal fees from Amgen, AstraZeneca, and Boston Scientific. Dr. Petronio received consultancy fees from Medtronic, Abbott, Boston, and funds from Boston and Abbott. Dr. Mehilli received institutional grants from Boston Scientific and lecture fees from AstraZeneca, Bristol-Myers Squibb, Boston Scientific, and Edwards Lifescience. Dr. Lefèvre proctors for Edwards and Boston. Dr. Stefanini received speaker fees from Abbott Vascular and Boston Scientific. Dr. Sardella received sponsorships from Medtronic in terms of technical training courses and congress assistance. Dr. Van Mieghem received research grant support from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Abiomed, PulseCath BV, Daiichi Sankyo. Dr. Dumonteil received proctoring and consultancy fees from Abbott Vascular, BostonScientific, Edwards LifeSciences, Medtronic. Dr. Mikhail is the Director of Imperial Valve and Cardiovascular Course (IVCC), which is supported by a number of device and pharmaceutical companies; and has received an educational grant from Abbott for an Interventional Fellowship. Dr. Ferrer-Gracia received sponsorships from Medtronic and Edwards companies in terms of: Technical training courses and congress assistance. Dr. Sharma served on the Speakers Bureau of Abbott Vascular, Boston Scientific, and Cardiovascular Systems, Inc. Dr. Morice is CEO and shareholder of CERC, a CRO based in Massy that had no role in WINTAVI. Dr. Dangas received consulting fees from GE HealthCare, Janssen Pharmaceuticals, Inc., and Medtronic, Inc.; <1% equity with Claret Medical and Elixir Medical; delivered industry-sponsored lectures for The Medicines Company; and is on Scientific Advisory Board of AstraZeneca. Dr. Chieffo received speaker/consultant fees from Abiomed, Abbott vascular, Biosensor, Cardinal Health, GADA, Magenta Medical. Dr. Mehran reports institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe AG, Medtronic, OrbusNeich, Philips, Transverse Medical, Zoll; personal fees from ACC, Boston Scientific, California Institute for Regenerative Medicine (CIRM), Cine-Med Research, Janssen, WebMD, SCAI; consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, CardiaWave, CeloNova, Chiesi, Concept Medical, CSL Behring, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, Philips; Equity <1% in Applied Therapeutics, Elixir Medical, STEL, CONTROLRAD (spouse); Scientific Advisory Board for AMA, Biosensors (spouse); Faculty CRF (no fee). The other authors have no conflicts of interest to declare.

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© 2022 Elsevier Inc.

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10.1016/j.amjcard.2022.02.025Licence: Unspecified

Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry)Final published version, 607 KBLicence: Article 25fa Dutch Copyright Act

Cite this

Pivato, C. A., Cao, D., Spirito, A., Sartori, S., Nicolas, J., Chiarito, M., Snyder, C., Mehilli, J., Lefèvre, T., Stefanini, G. G., Presbitero, P., Capranzano, P., Tchetche, D., Iadanza, A., Vogel, B., Sardella, G., Van Mieghem, N. M., Nardin, M., Tavenier, A. H., ... Mehran, R. (2022). Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry). American Journal of Cardiology, 172, 73-80. https://doi.org/10.1016/j.amjcard.2022.02.025

@article{ce621445ff2242ca86da3f6c4acb0274,

title = "Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry)",

abstract = "Although most patients with small aortic annulus are women, there is paucity of data on the prognostic impact of small aortic prosthesis in women who underwent transcatheter aortic valve implantation (TAVI). Therefore, we aimed to evaluate the impact of small valve size on 1-year clinical outcomes after TAVI in women. The Women's INternational Transcatheter Aortic Valve Implantation is an all-women registry evaluating patients with severe aortic stenosis who underwent TAVI. Based on the size of the aortic bioprosthesis implanted, women were stratified into small (≤23 mm) and nonsmall (>23 mm) valve. The primary efficacy endpoint was the Valve Academic Research Consortium-2 composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Of 934 women who underwent TAVI, 388 (41.5\%) received a small valve. Women with a small valve size had a lower body mass index, lower surgical risk scores, were less likely to suffer from atrial fibrillation, less often required postdilation and had a lower rate of residual aortic regurgitation grade ≥2. The occurrence of the Valve Academic Research Consortium-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0\% vs 16.3\%, p = 0.881; adjusted hazard ratio 1.34, 95\% confidence interval 0.90 to 2.00). Likewise, there were no significant differences in the occurrence of other secondary endpoints after multivariable adjustment. In conclusion, women with severe aortic stenosis who underwent TAVI with the implantation of a small valve bioprosthesis had similar 1-year outcomes as those receiving a nonsmall bioprosthesis.",

author = "Pivato, \{Carlo A.\} and Davide Cao and Alessandro Spirito and Samantha Sartori and Johny Nicolas and Mauro Chiarito and Clayton Snyder and Julinda Mehilli and Thierry Lef{\`e}vre and Stefanini, \{Giulio G.\} and Patrizia Presbitero and Piera Capranzano and Didier Tchetche and Alessandro Iadanza and Birgit Vogel and Gennaro Sardella and \{Van Mieghem\}, \{Nicolas M.\} and Matteo Nardin and Tavenier, \{Anne H.\} and Emanuele Meliga and Nicholas Dumonteil and Chiara Fraccaro and Daniela Trabattoni and Ghada Mikhail and Samin Sharma and Ferrer, \{Maria Cruz\} and Christoph Naber and Peter Kievit and Usman Baber and Petronio, \{Anna S.\} and Morice, \{Marie C.\} and Alaide Chieffo and George Dangas and Roxana Mehran",

note = "Funding Information: Dr. Baber received an institutional research grant from AstraZeneca; personal fees from Amgen, AstraZeneca, and Boston Scientific. Dr. Petronio received consultancy fees from Medtronic, Abbott, Boston, and funds from Boston and Abbott. Dr. Mehilli received institutional grants from Boston Scientific and lecture fees from AstraZeneca, Bristol-Myers Squibb, Boston Scientific, and Edwards Lifescience. Dr. Lef{\`e}vre proctors for Edwards and Boston. Dr. Stefanini received speaker fees from Abbott Vascular and Boston Scientific. Dr. Sardella received sponsorships from Medtronic in terms of technical training courses and congress assistance. Dr. Van Mieghem received research grant support from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Abiomed, PulseCath BV, Daiichi Sankyo. Dr. Dumonteil received proctoring and consultancy fees from Abbott Vascular, BostonScientific, Edwards LifeSciences, Medtronic. Dr. Mikhail is the Director of Imperial Valve and Cardiovascular Course (IVCC), which is supported by a number of device and pharmaceutical companies; and has received an educational grant from Abbott for an Interventional Fellowship. Dr. Ferrer-Gracia received sponsorships from Medtronic and Edwards companies in terms of: Technical training courses and congress assistance. Dr. Sharma served on the Speakers Bureau of Abbott Vascular, Boston Scientific, and Cardiovascular Systems, Inc. Dr. Morice is CEO and shareholder of CERC, a CRO based in Massy that had no role in WINTAVI. Dr. Dangas received consulting fees from GE HealthCare, Janssen Pharmaceuticals, Inc., and Medtronic, Inc.; <1\% equity with Claret Medical and Elixir Medical; delivered industry-sponsored lectures for The Medicines Company; and is on Scientific Advisory Board of AstraZeneca. Dr. Chieffo received speaker/consultant fees from Abiomed, Abbott vascular, Biosensor, Cardinal Health, GADA, Magenta Medical. Dr. Mehran reports institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe AG, Medtronic, OrbusNeich, Philips, Transverse Medical, Zoll; personal fees from ACC, Boston Scientific, California Institute for Regenerative Medicine (CIRM), Cine-Med Research, Janssen, WebMD, SCAI; consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, CardiaWave, CeloNova, Chiesi, Concept Medical, CSL Behring, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, Philips; Equity <1\% in Applied Therapeutics, Elixir Medical, STEL, CONTROLRAD (spouse); Scientific Advisory Board for AMA, Biosensors (spouse); Faculty CRF (no fee). The other authors have no conflicts of interest to declare. Publisher Copyright: {\textcopyright} 2022 Elsevier Inc.",

year = "2022",

month = jun,

day = "1",

doi = "10.1016/j.amjcard.2022.02.025",

language = "English",

volume = "172",

pages = "73--80",

journal = "American Journal of Cardiology",

issn = "0002-9149",

publisher = "Elsevier Inc.",

}

Pivato, CA, Cao, D, Spirito, A, Sartori, S, Nicolas, J, Chiarito, M, Snyder, C, Mehilli, J, Lefèvre, T, Stefanini, GG, Presbitero, P, Capranzano, P, Tchetche, D, Iadanza, A, Vogel, B, Sardella, G, Van Mieghem, NM, Nardin, M, Tavenier, AH, Meliga, E, Dumonteil, N, Fraccaro, C, Trabattoni, D, Mikhail, G, Sharma, S, Ferrer, MC, Naber, C, Kievit, P, Baber, U, Petronio, AS, Morice, MC, Chieffo, A, Dangas, G & Mehran, R 2022, 'Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry)', American Journal of Cardiology, vol. 172, pp. 73-80. https://doi.org/10.1016/j.amjcard.2022.02.025

TY - JOUR

T1 - Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry)

AU - Pivato, Carlo A.

AU - Cao, Davide

AU - Spirito, Alessandro

AU - Sartori, Samantha

AU - Nicolas, Johny

AU - Chiarito, Mauro

AU - Snyder, Clayton

AU - Mehilli, Julinda

AU - Lefèvre, Thierry

AU - Stefanini, Giulio G.

AU - Presbitero, Patrizia

AU - Capranzano, Piera

AU - Tchetche, Didier

AU - Iadanza, Alessandro

AU - Vogel, Birgit

AU - Sardella, Gennaro

AU - Van Mieghem, Nicolas M.

AU - Nardin, Matteo

AU - Tavenier, Anne H.

AU - Meliga, Emanuele

AU - Dumonteil, Nicholas

AU - Fraccaro, Chiara

AU - Trabattoni, Daniela

AU - Mikhail, Ghada

AU - Sharma, Samin

AU - Ferrer, Maria Cruz

AU - Naber, Christoph

AU - Kievit, Peter

AU - Baber, Usman

AU - Petronio, Anna S.

AU - Morice, Marie C.

AU - Chieffo, Alaide

AU - Dangas, George

AU - Mehran, Roxana

N1 - Funding Information: Dr. Baber received an institutional research grant from AstraZeneca; personal fees from Amgen, AstraZeneca, and Boston Scientific. Dr. Petronio received consultancy fees from Medtronic, Abbott, Boston, and funds from Boston and Abbott. Dr. Mehilli received institutional grants from Boston Scientific and lecture fees from AstraZeneca, Bristol-Myers Squibb, Boston Scientific, and Edwards Lifescience. Dr. Lefèvre proctors for Edwards and Boston. Dr. Stefanini received speaker fees from Abbott Vascular and Boston Scientific. Dr. Sardella received sponsorships from Medtronic in terms of technical training courses and congress assistance. Dr. Van Mieghem received research grant support from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Abiomed, PulseCath BV, Daiichi Sankyo. Dr. Dumonteil received proctoring and consultancy fees from Abbott Vascular, BostonScientific, Edwards LifeSciences, Medtronic. Dr. Mikhail is the Director of Imperial Valve and Cardiovascular Course (IVCC), which is supported by a number of device and pharmaceutical companies; and has received an educational grant from Abbott for an Interventional Fellowship. Dr. Ferrer-Gracia received sponsorships from Medtronic and Edwards companies in terms of: Technical training courses and congress assistance. Dr. Sharma served on the Speakers Bureau of Abbott Vascular, Boston Scientific, and Cardiovascular Systems, Inc. Dr. Morice is CEO and shareholder of CERC, a CRO based in Massy that had no role in WINTAVI. Dr. Dangas received consulting fees from GE HealthCare, Janssen Pharmaceuticals, Inc., and Medtronic, Inc.; <1% equity with Claret Medical and Elixir Medical; delivered industry-sponsored lectures for The Medicines Company; and is on Scientific Advisory Board of AstraZeneca. Dr. Chieffo received speaker/consultant fees from Abiomed, Abbott vascular, Biosensor, Cardinal Health, GADA, Magenta Medical. Dr. Mehran reports institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe AG, Medtronic, OrbusNeich, Philips, Transverse Medical, Zoll; personal fees from ACC, Boston Scientific, California Institute for Regenerative Medicine (CIRM), Cine-Med Research, Janssen, WebMD, SCAI; consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, CardiaWave, CeloNova, Chiesi, Concept Medical, CSL Behring, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, Philips; Equity <1% in Applied Therapeutics, Elixir Medical, STEL, CONTROLRAD (spouse); Scientific Advisory Board for AMA, Biosensors (spouse); Faculty CRF (no fee). The other authors have no conflicts of interest to declare. Publisher Copyright: © 2022 Elsevier Inc.

PY - 2022/6/1

Y1 - 2022/6/1

N2 - Although most patients with small aortic annulus are women, there is paucity of data on the prognostic impact of small aortic prosthesis in women who underwent transcatheter aortic valve implantation (TAVI). Therefore, we aimed to evaluate the impact of small valve size on 1-year clinical outcomes after TAVI in women. The Women's INternational Transcatheter Aortic Valve Implantation is an all-women registry evaluating patients with severe aortic stenosis who underwent TAVI. Based on the size of the aortic bioprosthesis implanted, women were stratified into small (≤23 mm) and nonsmall (>23 mm) valve. The primary efficacy endpoint was the Valve Academic Research Consortium-2 composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Of 934 women who underwent TAVI, 388 (41.5%) received a small valve. Women with a small valve size had a lower body mass index, lower surgical risk scores, were less likely to suffer from atrial fibrillation, less often required postdilation and had a lower rate of residual aortic regurgitation grade ≥2. The occurrence of the Valve Academic Research Consortium-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0% vs 16.3%, p = 0.881; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00). Likewise, there were no significant differences in the occurrence of other secondary endpoints after multivariable adjustment. In conclusion, women with severe aortic stenosis who underwent TAVI with the implantation of a small valve bioprosthesis had similar 1-year outcomes as those receiving a nonsmall bioprosthesis.

AB - Although most patients with small aortic annulus are women, there is paucity of data on the prognostic impact of small aortic prosthesis in women who underwent transcatheter aortic valve implantation (TAVI). Therefore, we aimed to evaluate the impact of small valve size on 1-year clinical outcomes after TAVI in women. The Women's INternational Transcatheter Aortic Valve Implantation is an all-women registry evaluating patients with severe aortic stenosis who underwent TAVI. Based on the size of the aortic bioprosthesis implanted, women were stratified into small (≤23 mm) and nonsmall (>23 mm) valve. The primary efficacy endpoint was the Valve Academic Research Consortium-2 composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Of 934 women who underwent TAVI, 388 (41.5%) received a small valve. Women with a small valve size had a lower body mass index, lower surgical risk scores, were less likely to suffer from atrial fibrillation, less often required postdilation and had a lower rate of residual aortic regurgitation grade ≥2. The occurrence of the Valve Academic Research Consortium-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0% vs 16.3%, p = 0.881; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00). Likewise, there were no significant differences in the occurrence of other secondary endpoints after multivariable adjustment. In conclusion, women with severe aortic stenosis who underwent TAVI with the implantation of a small valve bioprosthesis had similar 1-year outcomes as those receiving a nonsmall bioprosthesis.

UR - https://www.scopus.com/pages/publications/85130242076

U2 - 10.1016/j.amjcard.2022.02.025

DO - 10.1016/j.amjcard.2022.02.025

M3 - Article

C2 - 35461697

AN - SCOPUS:85130242076

SN - 0002-9149

VL - 172

SP - 73

EP - 80

JO - American Journal of Cardiology

JF - American Journal of Cardiology

ER -

Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry)

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