Predictors and Clinical Impact of Prosthesis-Patient Mismatch After Self-Expandable TAVR in Small Annuli

TAVI-SMALL Investigators; Marianna Adamo

doi:10.1016/j.jcin.2021.03.060

Predictors and Clinical Impact of Prosthesis-Patient Mismatch After Self-Expandable TAVR in Small Annuli

TAVI-SMALL Investigators
, Marianna Adamo

Cardiology

Humanitas University
IRCCS Istituto Clinico Humanitas - Rozzano (Milano)
University of Catania
Santa Cruz Hospital
University of Zurich
Kerckhoff Heart and Lung Center
Gruppo Ospedaliero San Donato
Maria Cecilia Hospital
Montefiore Medical Center
IRCCS Ospedale San Raffaele
University of Brescia

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

103 Citations (Scopus)

158 Downloads (Pure)

Abstract

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.

Original language	English
Pages (from-to)	1218-1228
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	14
Issue number	11
DOIs	https://doi.org/10.1016/j.jcin.2021.03.060
Publication status	Published - 14 Jun 2021

Bibliographical note

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

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@article{0ebfa45476814ed59b77f5c3653f27d7,

title = "Predictors and Clinical Impact of Prosthesis-Patient Mismatch After Self-Expandable TAVR in Small Annuli",

abstract = "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{\textendash}0.84) and valve oversizing (OR: 0.53; 95\% CI: 0.28{\textendash}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.",

author = "\{TAVI-SMALL Investigators\} and Leone, \{Pier Pasquale\} and Damiano Regazzoli and Matteo Pagnesi and Jorge Sanz-Sanchez and Mauro Chiarito and Francesco Cannata and \{Van Mieghem\}, \{Nicolas M.\} and Marco Barbanti and Corrado Tamburino and Rui Teles and Marianna Adamo and Mizuki Miura and Francesco Maisano and Kim, \{Won Keun\} and Francesco Bedogni and Giulio Stefanini and Antonio Mangieri and Francesco Giannini and Antonio Colombo and Bernhard Reimers and Azeem Latib",

note = "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: {\textcopyright} 2021 American College of Cardiology Foundation",

year = "2021",

month = jun,

day = "14",

doi = "10.1016/j.jcin.2021.03.060",

language = "English",

volume = "14",

pages = "1218--1228",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "11",

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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.

UR - https://www.scopus.com/pages/publications/85106920595

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 -

Predictors and Clinical Impact of Prosthesis-Patient Mismatch After Self-Expandable TAVR in Small Annuli

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