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Multicenter Study
. 2021 Jun 14;14(11):1218-1228.
doi: 10.1016/j.jcin.2021.03.060.

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

Pier Pasquale Leone  1 , Damiano Regazzoli  2 , Matteo Pagnesi  3 , Jorge Sanz-Sanchez  4 , Mauro Chiarito  1 , Francesco Cannata  1 , Nicolas M Van Mieghem  5 , Marco Barbanti  6 , Corrado Tamburino  6 , Rui Teles  7 , Marianna Adamo  8 , Mizuki Miura  9 , Francesco Maisano  9 , Won-Keun Kim  10 , Francesco Bedogni  11 , Giulio Stefanini  1 , Antonio Mangieri  12 , Francesco Giannini  12 , Antonio Colombo  13 , Bernhard Reimers  4 , Azeem Latib  14 ; TAVI-SMALL Investigators
Affiliations
Free article
Multicenter Study

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

Pier Pasquale Leone et al. JACC Cardiovasc Interv. .
Free article

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.

Keywords: TAVR; prosthesis-patient mismatch; self-expandable valves; small annuli.

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Conflict of interest statement

Funding Support and Author Disclosures 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.

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