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 - http://www.scopus.com/inward/record.url?scp=85130242076&partnerID=8YFLogxK
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 -