TY - JOUR
T1 - Predictors and Clinical Impact of Prosthesis-Patient Mismatch After Self-Expandable TAVR in Small Annuli
AU - TAVI-SMALL Investigators
AU - Leone, Pier Pasquale
AU - Regazzoli, Damiano
AU - Pagnesi, Matteo
AU - Sanz-Sanchez, Jorge
AU - Chiarito, Mauro
AU - Cannata, Francesco
AU - Van Mieghem, Nicolas M.
AU - Barbanti, Marco
AU - Tamburino, Corrado
AU - Teles, Rui
AU - Adamo, Marianna
AU - Miura, Mizuki
AU - Maisano, Francesco
AU - Kim, Won Keun
AU - Bedogni, Francesco
AU - Stefanini, Giulio
AU - Mangieri, Antonio
AU - Giannini, Francesco
AU - Colombo, Antonio
AU - Reimers, Bernhard
AU - Latib, Azeem
N1 - Funding Information:
Dr. Van Mieghem has received institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Abiomed, PulseCath, and Daiichi-Sankyo. Dr. Barbanti is a consultant for Edwards Lifesciences; and serves as an advisory board member for Biotronik. Dr. Tamburino has received speaker fees from Boston Scientific and Abbott. Dr. Teles has received a received a research grant (to the institution) from Abbott. Dr. Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received consulting fees and honoraria (personal and institutional) from Abbott, Medtronic, Edwards Lifesciences, Xeltis, and CardioValve; receives royalty income from and has intellectual property rights with Edwards Lifesciences; and is a shareholder (including share options) in CardioGard, Magenta, SwissVortex, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr. Kim is a proctor for Boston Scientific, Meril Lifesciences, and Abbott; and has received speaker fees from Boston Scientific, Abbott, Medtronic, and Edwards Lifesciences. Dr. Stefanini has received a research grant (to the institution) from Boston Scientific; and speaker and consulting fees from B. Braun, Biosensors, and Boston Scientific. Dr. Reimers has received speaker honoraria from Boston Scientific. Dr. Latib serves on the advisory boards of Medtronic and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2021 American College of Cardiology Foundation
PY - 2021/6/14
Y1 - 2021/6/14
N2 - Objectives: The aim of this study was to define predictors of prosthesis-patient mismatch (PPM) and its impact on mortality after transcatheter aortic valve replacement (TAVR) with self-expandable valves (SEVs) in patients with small annuli. Background: TAVR seems to reduce the risk for PPM compared with surgical aortic valve replacement, especially in patients with small aortic annuli. Nevertheless, predictors and impact of PPM in this population have not been clarified yet. Methods: Predictors of PPM and all-cause mortality were investigated using multivariable logistic regression analysis from the cohort of the TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) registry, which included patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transcatheter SEVs: 445 patients with (n = 129) and without (n = 316) PPM were enrolled. Results: Intra-annular valves conferred increased risk for PPM (odds ratio [OR]: 2.36; 95% confidence interval [CI]: 1.16 to 4.81), while post-dilation (OR: 0.46; 95% CI: 0.25–0.84) and valve oversizing (OR: 0.53; 95% CI: 0.28–1.00) seemed to protect against PPM occurrence. At a median follow-up of 354 days, patients with severe PPM, but not those with moderate PPM, had a higher all-cause mortality rate compared with those without PPM (log-rank p = 0.008). Multivariable Cox regression confirmed severe PPM as an independent predictor of all-cause mortality (hazard ratio: 4.27; 95% CI: 1.34 to 13.6). Conclusions: Among patients with aortic stenosis and small aortic annuli undergoing transcatheter SEV implantation, use of intra-annular valves yielded higher risk for PPM; conversely, post-dilation and valve oversizing protected against PPM occurrence. Severe PPM was independently associated with all-cause mortality.
AB - Objectives: The aim of this study was to define predictors of prosthesis-patient mismatch (PPM) and its impact on mortality after transcatheter aortic valve replacement (TAVR) with self-expandable valves (SEVs) in patients with small annuli. Background: TAVR seems to reduce the risk for PPM compared with surgical aortic valve replacement, especially in patients with small aortic annuli. Nevertheless, predictors and impact of PPM in this population have not been clarified yet. Methods: Predictors of PPM and all-cause mortality were investigated using multivariable logistic regression analysis from the cohort of the TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) registry, which included patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transcatheter SEVs: 445 patients with (n = 129) and without (n = 316) PPM were enrolled. Results: Intra-annular valves conferred increased risk for PPM (odds ratio [OR]: 2.36; 95% confidence interval [CI]: 1.16 to 4.81), while post-dilation (OR: 0.46; 95% CI: 0.25–0.84) and valve oversizing (OR: 0.53; 95% CI: 0.28–1.00) seemed to protect against PPM occurrence. At a median follow-up of 354 days, patients with severe PPM, but not those with moderate PPM, had a higher all-cause mortality rate compared with those without PPM (log-rank p = 0.008). Multivariable Cox regression confirmed severe PPM as an independent predictor of all-cause mortality (hazard ratio: 4.27; 95% CI: 1.34 to 13.6). Conclusions: Among patients with aortic stenosis and small aortic annuli undergoing transcatheter SEV implantation, use of intra-annular valves yielded higher risk for PPM; conversely, post-dilation and valve oversizing protected against PPM occurrence. Severe PPM was independently associated with all-cause mortality.
KW - TAVR
KW - prosthesis-patient mismatch
KW - self-expandable valves
KW - small annuli
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U2 - 10.1016/j.jcin.2021.03.060
DO - 10.1016/j.jcin.2021.03.060
M3 - Article
C2 - 34112458
AN - SCOPUS:85106920595
SN - 1936-8798
VL - 14
SP - 1218
EP - 1228
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 11
ER -