Why the categorization of indexed effective orifice area is not justified for the classification of prosthesis–patient mismatch

Michiel D. Vriesendorp; G. Michael Deeb; Michael J. Reardon; Bob Kiaii; Vinayak Bapat; Louis Labrousse; Vivek Rao; Joseph F. Sabik; Elizabeth Gearhart; Robert J.M. Klautz

doi:10.1016/j.jtcvs.2020.10.123

Why the categorization of indexed effective orifice area is not justified for the classification of prosthesis–patient mismatch

Michiel D. Vriesendorp, G. Michael Deeb, Michael J. Reardon, Bob Kiaii, Vinayak Bapat, Louis Labrousse, Vivek Rao, Joseph F. Sabik, Elizabeth Gearhart, Robert J.M. Klautz

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

12 Scopus citations

Abstract

Objectives: Although the impact of prosthesis–patient mismatch (PPM) on survival has been widely studied, there has been little debate about whether the current definition of PPM truly reflects hemodynamic obstruction. This study aimed to validate the categorization of indexed effective orifice area (EOAi) for the classification of PPM. Methods: In total, 2171 patients who underwent aortic valve replacement with a surgical stented bioprosthesis in 5 trials (CoreValve US High-Risk, SURTAVI [Surgical Replacement and Transcatheter Aortic Valve Implantation Trial], Evolut Low Risk, PERIGON [PERIcardial SurGical AOrtic Valve ReplacemeNt] Pivotal Trial for the Avalus valve, and PERIGON Japan) were used for this analysis. The echocardiographic images at the 1-year follow-up visit were evaluated to explore the association between EOAi and mean aortic gradient and its interaction with other patient characteristics, including obesity. In addition, different criteria of PPM were compared with reflect elevated mean aortic gradients (≥20 mm Hg). Results: A relatively smaller exponential decay in mean aortic gradient was found for increasing EOAi, as the slope on the log scale was –0.83 versus –2.5 in the publication from which the current cut-offs for PPM originate. The accuracy of the American Society of Echocardiography, Valve Academic Research Consortium-2, and European Association of Cardiovascular Imaging definitions of PPM to reflect elevated mean aortic gradients was 49%, 57%, and 57%, respectively. The relation between EOAi and mean aortic gradient was not significantly different between obese and non-obese patients (P =.20). Conclusions: The use of EOAi thresholds to classify patients with PPM is undermined by a less-pronounced exponential relationship between EOAi and mean aortic gradient than previously demonstrated. Moreover, recent adjustment for obesity in the definition of PPM is not supported by these data.

Original language	English (US)
Pages (from-to)	822-829.e6
Journal	Journal of Thoracic and Cardiovascular Surgery
Volume	164
Issue number	3
DOIs	https://doi.org/10.1016/j.jtcvs.2020.10.123
State	Published - Sep 2022

Keywords

aortic valve replacement
hemodynamic assessment
prosthesis–patient mismatch
prosthetic valves
Heart Valve Prosthesis
Humans
Risk Factors
Bioprosthesis
Treatment Outcome
Clinical Trials as Topic
Aortic Valve Stenosis/diagnostic imaging
Heart Valve Prosthesis Implantation/methods
Obesity/complications
Aortic Valve/diagnostic imaging

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine
Pulmonary and Respiratory Medicine
Surgery

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10.1016/j.jtcvs.2020.10.123

Cite this

Vriesendorp, M. D., Deeb, G. M., Reardon, M. J., Kiaii, B., Bapat, V., Labrousse, L., Rao, V., Sabik, J. F., Gearhart, E., & Klautz, R. J. M. (2022). Why the categorization of indexed effective orifice area is not justified for the classification of prosthesis–patient mismatch. Journal of Thoracic and Cardiovascular Surgery, 164(3), 822-829.e6. https://doi.org/10.1016/j.jtcvs.2020.10.123

Vriesendorp, MD, Deeb, GM, Reardon, MJ, Kiaii, B, Bapat, V, Labrousse, L, Rao, V, Sabik, JF, Gearhart, E & Klautz, RJM 2022, 'Why the categorization of indexed effective orifice area is not justified for the classification of prosthesis–patient mismatch', Journal of Thoracic and Cardiovascular Surgery, vol. 164, no. 3, pp. 822-829.e6. https://doi.org/10.1016/j.jtcvs.2020.10.123

@article{f07ef04e736c400b91bd13fb3de2c47d,

title = "Why the categorization of indexed effective orifice area is not justified for the classification of prosthesis–patient mismatch",

abstract = "Objectives: Although the impact of prosthesis–patient mismatch (PPM) on survival has been widely studied, there has been little debate about whether the current definition of PPM truly reflects hemodynamic obstruction. This study aimed to validate the categorization of indexed effective orifice area (EOAi) for the classification of PPM. Methods: In total, 2171 patients who underwent aortic valve replacement with a surgical stented bioprosthesis in 5 trials (CoreValve US High-Risk, SURTAVI [Surgical Replacement and Transcatheter Aortic Valve Implantation Trial], Evolut Low Risk, PERIGON [PERIcardial SurGical AOrtic Valve ReplacemeNt] Pivotal Trial for the Avalus valve, and PERIGON Japan) were used for this analysis. The echocardiographic images at the 1-year follow-up visit were evaluated to explore the association between EOAi and mean aortic gradient and its interaction with other patient characteristics, including obesity. In addition, different criteria of PPM were compared with reflect elevated mean aortic gradients (≥20 mm Hg). Results: A relatively smaller exponential decay in mean aortic gradient was found for increasing EOAi, as the slope on the log scale was –0.83 versus –2.5 in the publication from which the current cut-offs for PPM originate. The accuracy of the American Society of Echocardiography, Valve Academic Research Consortium-2, and European Association of Cardiovascular Imaging definitions of PPM to reflect elevated mean aortic gradients was 49%, 57%, and 57%, respectively. The relation between EOAi and mean aortic gradient was not significantly different between obese and non-obese patients (P =.20). Conclusions: The use of EOAi thresholds to classify patients with PPM is undermined by a less-pronounced exponential relationship between EOAi and mean aortic gradient than previously demonstrated. Moreover, recent adjustment for obesity in the definition of PPM is not supported by these data.",

keywords = "aortic valve replacement, hemodynamic assessment, prosthesis–patient mismatch, prosthetic valves, Heart Valve Prosthesis, Humans, Risk Factors, Bioprosthesis, Treatment Outcome, Clinical Trials as Topic, Aortic Valve Stenosis/diagnostic imaging, Heart Valve Prosthesis Implantation/methods, Obesity/complications, Aortic Valve/diagnostic imaging",

author = "Vriesendorp, {Michiel D.} and Deeb, {G. Michael} and Reardon, {Michael J.} and Bob Kiaii and Vinayak Bapat and Louis Labrousse and Vivek Rao and Sabik, {Joseph F.} and Elizabeth Gearhart and Klautz, {Robert J.M.}",

note = "Funding Information: This study was funded by Medtronic.Dr Vriesendorp receives research support from Medtronic. Dr Deeb serves on an advisory board and as a proctor for Medtronic; as a consultant and research investigator for Edwards Lifesciences; as a consultant and proctor for Terumo; and as a research investigator for Gore Medical (he receives no personal remunerations). Dr Reardon provides educational services to Medtronic, with fees paid to his department. Dr Kiaii has received personal fees from Medtronic and Boston Scientific as a proctor, consultant, and speaker; has received consulting and speaking fees from Johnson & Johnson; and has received fees from Edwards Lifesciences as a member of the Canadian advisory board, consultant, and proctor. Dr Bapat is a consultant for Medtronic and Boston Scientific and has received speaker fees from Medtronic, Edwards Lifesciences, Boston Scientific, and LivaNova. Dr Rao is a member of the Surgical Advisory Board for Medtronic and a consultant for Abbott Labs. Dr Sabik is a member of the Cardiac Surgery Advisory Board for and the North American Principal Investigator (PI) for the PERIGON Pivotal Trial, and he teaches mitral valve repair techniques for Medtronic. He is the local PI for the Intuity Trial (sponsored by Edwards Lifesciences) and the North American PI for the EXCEL trial (sponsored by Abbott). Ms Gearhart is an employee of Medtronic. Prof Klautz receives research support from Medtronic, consultation and proctoring fees from Medtronic and LivaNova, and participates in speakers' bureaus for Medtronic, LivaNova, and Edwards Lifesciences. Dr Labrousse reported no conflicts of interest. Funding Information: This study was funded by Medtronic . Publisher Copyright: {\textcopyright} 2020 The American Association for Thoracic Surgery. Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).",

year = "2022",

month = sep,

doi = "10.1016/j.jtcvs.2020.10.123",

language = "English (US)",

volume = "164",

pages = "822--829.e6",

journal = "Journal of Thoracic and Cardiovascular Surgery",

issn = "0022-5223",

publisher = "Elsevier",

number = "3",

}

TY - JOUR

T1 - Why the categorization of indexed effective orifice area is not justified for the classification of prosthesis–patient mismatch

AU - Vriesendorp, Michiel D.

AU - Deeb, G. Michael

AU - Reardon, Michael J.

AU - Kiaii, Bob

AU - Bapat, Vinayak

AU - Labrousse, Louis

AU - Rao, Vivek

AU - Sabik, Joseph F.

AU - Gearhart, Elizabeth

AU - Klautz, Robert J.M.

N1 - Funding Information: This study was funded by Medtronic.Dr Vriesendorp receives research support from Medtronic. Dr Deeb serves on an advisory board and as a proctor for Medtronic; as a consultant and research investigator for Edwards Lifesciences; as a consultant and proctor for Terumo; and as a research investigator for Gore Medical (he receives no personal remunerations). Dr Reardon provides educational services to Medtronic, with fees paid to his department. Dr Kiaii has received personal fees from Medtronic and Boston Scientific as a proctor, consultant, and speaker; has received consulting and speaking fees from Johnson & Johnson; and has received fees from Edwards Lifesciences as a member of the Canadian advisory board, consultant, and proctor. Dr Bapat is a consultant for Medtronic and Boston Scientific and has received speaker fees from Medtronic, Edwards Lifesciences, Boston Scientific, and LivaNova. Dr Rao is a member of the Surgical Advisory Board for Medtronic and a consultant for Abbott Labs. Dr Sabik is a member of the Cardiac Surgery Advisory Board for and the North American Principal Investigator (PI) for the PERIGON Pivotal Trial, and he teaches mitral valve repair techniques for Medtronic. He is the local PI for the Intuity Trial (sponsored by Edwards Lifesciences) and the North American PI for the EXCEL trial (sponsored by Abbott). Ms Gearhart is an employee of Medtronic. Prof Klautz receives research support from Medtronic, consultation and proctoring fees from Medtronic and LivaNova, and participates in speakers' bureaus for Medtronic, LivaNova, and Edwards Lifesciences. Dr Labrousse reported no conflicts of interest. Funding Information: This study was funded by Medtronic . Publisher Copyright: © 2020 The American Association for Thoracic Surgery. Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

PY - 2022/9

Y1 - 2022/9

N2 - Objectives: Although the impact of prosthesis–patient mismatch (PPM) on survival has been widely studied, there has been little debate about whether the current definition of PPM truly reflects hemodynamic obstruction. This study aimed to validate the categorization of indexed effective orifice area (EOAi) for the classification of PPM. Methods: In total, 2171 patients who underwent aortic valve replacement with a surgical stented bioprosthesis in 5 trials (CoreValve US High-Risk, SURTAVI [Surgical Replacement and Transcatheter Aortic Valve Implantation Trial], Evolut Low Risk, PERIGON [PERIcardial SurGical AOrtic Valve ReplacemeNt] Pivotal Trial for the Avalus valve, and PERIGON Japan) were used for this analysis. The echocardiographic images at the 1-year follow-up visit were evaluated to explore the association between EOAi and mean aortic gradient and its interaction with other patient characteristics, including obesity. In addition, different criteria of PPM were compared with reflect elevated mean aortic gradients (≥20 mm Hg). Results: A relatively smaller exponential decay in mean aortic gradient was found for increasing EOAi, as the slope on the log scale was –0.83 versus –2.5 in the publication from which the current cut-offs for PPM originate. The accuracy of the American Society of Echocardiography, Valve Academic Research Consortium-2, and European Association of Cardiovascular Imaging definitions of PPM to reflect elevated mean aortic gradients was 49%, 57%, and 57%, respectively. The relation between EOAi and mean aortic gradient was not significantly different between obese and non-obese patients (P =.20). Conclusions: The use of EOAi thresholds to classify patients with PPM is undermined by a less-pronounced exponential relationship between EOAi and mean aortic gradient than previously demonstrated. Moreover, recent adjustment for obesity in the definition of PPM is not supported by these data.

AB - Objectives: Although the impact of prosthesis–patient mismatch (PPM) on survival has been widely studied, there has been little debate about whether the current definition of PPM truly reflects hemodynamic obstruction. This study aimed to validate the categorization of indexed effective orifice area (EOAi) for the classification of PPM. Methods: In total, 2171 patients who underwent aortic valve replacement with a surgical stented bioprosthesis in 5 trials (CoreValve US High-Risk, SURTAVI [Surgical Replacement and Transcatheter Aortic Valve Implantation Trial], Evolut Low Risk, PERIGON [PERIcardial SurGical AOrtic Valve ReplacemeNt] Pivotal Trial for the Avalus valve, and PERIGON Japan) were used for this analysis. The echocardiographic images at the 1-year follow-up visit were evaluated to explore the association between EOAi and mean aortic gradient and its interaction with other patient characteristics, including obesity. In addition, different criteria of PPM were compared with reflect elevated mean aortic gradients (≥20 mm Hg). Results: A relatively smaller exponential decay in mean aortic gradient was found for increasing EOAi, as the slope on the log scale was –0.83 versus –2.5 in the publication from which the current cut-offs for PPM originate. The accuracy of the American Society of Echocardiography, Valve Academic Research Consortium-2, and European Association of Cardiovascular Imaging definitions of PPM to reflect elevated mean aortic gradients was 49%, 57%, and 57%, respectively. The relation between EOAi and mean aortic gradient was not significantly different between obese and non-obese patients (P =.20). Conclusions: The use of EOAi thresholds to classify patients with PPM is undermined by a less-pronounced exponential relationship between EOAi and mean aortic gradient than previously demonstrated. Moreover, recent adjustment for obesity in the definition of PPM is not supported by these data.

KW - aortic valve replacement

KW - hemodynamic assessment

KW - prosthesis–patient mismatch

KW - prosthetic valves

KW - Heart Valve Prosthesis

KW - Humans

KW - Risk Factors

KW - Bioprosthesis

KW - Treatment Outcome

KW - Clinical Trials as Topic

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Heart Valve Prosthesis Implantation/methods

KW - Obesity/complications

KW - Aortic Valve/diagnostic imaging

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U2 - 10.1016/j.jtcvs.2020.10.123

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JF - Journal of Thoracic and Cardiovascular Surgery

IS - 3

ER -

Why the categorization of indexed effective orifice area is not justified for the classification of prosthesis–patient mismatch

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