Comprehensive Echocardiographic Assessment of Normal Transcatheter Valve Function

Rebecca T. Hahn; Jonathon Leipsic; Pamela S. Douglas; Wael A. Jaber; Neil J. Weissman; Philippe Pibarot; Philipp Blanke; Jae K. Oh

doi:10.1016/j.jcmg.2018.04.010

Comprehensive Echocardiographic Assessment of Normal Transcatheter Valve Function

Rebecca T. Hahn, Jonathon Leipsic, Pamela S. Douglas, Wael A. Jaber, Neil J. Weissman, Philippe Pibarot, Philipp Blanke, Jae K. Oh

Cardiovascular Medicine

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

60 Scopus citations

Abstract

Objectives: This study aims to establish parameters for identifying normal function for each of the 3 iterations of balloon-expandable valves and 2 iterations of self-expanding valves. Background: Expected transthoracic echocardiographic Doppler-derived hemodynamic data for transcatheter aortic valves inform pre-implant decision-making and post-implanted monitoring of longitudinal valve function. Methods: We collected the echocardiography core Lab measured mean gradients and effective orifice area (EOA) from discharge or 30-day echocardiograms from randomized trials; the PARTNER (Placement of Aortic Transcatheter Valves) trials for the balloon-expandable valves and the Medtronic CoreValve US Pivotal trial and Medtronic CoreValve Evolut R United States IDE Clinical Study for the self-expanding valves. Results: For all SAPIEN (Edwards Lifesciences, Irvine, California) valve sizes, mean EOA is 1.70 ± 0.49 cm ² with a mean gradient of 9.36 ± 4.13 mm Hg. For all SAPIEN XT valve sizes, mean EOA is 1.67 ± 0.46 cm ² with a mean gradient of 9.52 ± 3.64 mm Hg. For all SAPIEN 3 valve sizes, the mean EOA is 1.66 ± 0.38 cm ² with a mean gradient of 11.18 ± 4.35 mm Hg. For all CoreValve valve sizes, the mean EOA is 1.88 ± 0.56 cm ² with a mean gradient of 8.85 ± 4.14 mm Hg. For all Evolut R valve sizes, the mean EOA is 2.01 ± 0.65 cm ² with a mean gradient of 7.52 ± 3.19 mm Hg. The SAPIEN 3 post-implant EOA was progressively larger for each quintile of baseline annular area by computed tomography (p < 0.001). Similarly, for the Evolut R valve, post-implantation EOA was significantly larger for each quintile of baseline annular perimeter (p < 0.001). Conclusions: Tables of expected mean transcatheter aortic valve hemodynamics by valve type and size are essential in evaluating the function of these transcatheter prosthetic valves. Tables of expected EOA by the native annular anatomy may be useful for pre-implantation decision making. Criteria for defining structural valve dysfunction are proposed.

Original language	English (US)
Pages (from-to)	25-34
Number of pages	10
Journal	JACC: Cardiovascular Imaging
Volume	12
Issue number	1
DOIs	https://doi.org/10.1016/j.jcmg.2018.04.010
State	Published - Jan 2019

Keywords

echocardiography
effective orifice area
hemodynamics
transcatheter aortic valve replacement

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging
Cardiology and Cardiovascular Medicine

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10.1016/j.jcmg.2018.04.010

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@article{f6e6f02a3f0e42cd8b323684c9217516,

title = "Comprehensive Echocardiographic Assessment of Normal Transcatheter Valve Function",

abstract = " Objectives: This study aims to establish parameters for identifying normal function for each of the 3 iterations of balloon-expandable valves and 2 iterations of self-expanding valves. Background: Expected transthoracic echocardiographic Doppler-derived hemodynamic data for transcatheter aortic valves inform pre-implant decision-making and post-implanted monitoring of longitudinal valve function. Methods: We collected the echocardiography core Lab measured mean gradients and effective orifice area (EOA) from discharge or 30-day echocardiograms from randomized trials; the PARTNER (Placement of Aortic Transcatheter Valves) trials for the balloon-expandable valves and the Medtronic CoreValve US Pivotal trial and Medtronic CoreValve Evolut R United States IDE Clinical Study for the self-expanding valves. Results: For all SAPIEN (Edwards Lifesciences, Irvine, California) valve sizes, mean EOA is 1.70 ± 0.49 cm 2 with a mean gradient of 9.36 ± 4.13 mm Hg. For all SAPIEN XT valve sizes, mean EOA is 1.67 ± 0.46 cm 2 with a mean gradient of 9.52 ± 3.64 mm Hg. For all SAPIEN 3 valve sizes, the mean EOA is 1.66 ± 0.38 cm 2 with a mean gradient of 11.18 ± 4.35 mm Hg. For all CoreValve valve sizes, the mean EOA is 1.88 ± 0.56 cm 2 with a mean gradient of 8.85 ± 4.14 mm Hg. For all Evolut R valve sizes, the mean EOA is 2.01 ± 0.65 cm 2 with a mean gradient of 7.52 ± 3.19 mm Hg. The SAPIEN 3 post-implant EOA was progressively larger for each quintile of baseline annular area by computed tomography (p < 0.001). Similarly, for the Evolut R valve, post-implantation EOA was significantly larger for each quintile of baseline annular perimeter (p < 0.001). Conclusions: Tables of expected mean transcatheter aortic valve hemodynamics by valve type and size are essential in evaluating the function of these transcatheter prosthetic valves. Tables of expected EOA by the native annular anatomy may be useful for pre-implantation decision making. Criteria for defining structural valve dysfunction are proposed. ",

keywords = "echocardiography, effective orifice area, hemodynamics, transcatheter aortic valve replacement",

author = "Hahn, {Rebecca T.} and Jonathon Leipsic and Douglas, {Pamela S.} and Jaber, {Wael A.} and Weissman, {Neil J.} and Philippe Pibarot and Philipp Blanke and Oh, {Jae K.}",

note = "Funding Information: Drs. Pibarot, Hahn, and Weissman are the Directors of the Echocardiography Core Labs for the P2S3 Trials (sponsored by Edwards Lifesciences) for which they receive no direct compensation. Drs. Blanke and Leipsic are the Co-Directors of the CT Core lab for the P2S3 Trial for which they receive no direct compensation. Dr. Jaber is the Director of the Echocardiography Core Lab for PARTNER II, Cohorts A and B (sponsored by Edwards Lifesciences) for which he receives no direct compensation. Dr. Oh is the Director of the Echocardiography Core Lab for CoreValve/Evolut R; and a consultant for Medtronic. Dr. Leipsic is a consultant for Edwards. Dr. Douglas has received a grant from Edwards Lifesciences. Dr. Weissman has received grants from Boston Scientific, Edwards, Medtronic, Abbott, and LivaNova. Dr. Blanke is a consultant with Edwards Lifesciences. Publisher Copyright: {\textcopyright} 2019 American College of Cardiology Foundation",

year = "2019",

month = jan,

doi = "10.1016/j.jcmg.2018.04.010",

language = "English (US)",

volume = "12",

pages = "25--34",

journal = "JACC: Cardiovascular Imaging",

issn = "1936-878X",

publisher = "Elsevier Inc.",

number = "1",

}

TY - JOUR

T1 - Comprehensive Echocardiographic Assessment of Normal Transcatheter Valve Function

AU - Hahn, Rebecca T.

AU - Leipsic, Jonathon

AU - Douglas, Pamela S.

AU - Jaber, Wael A.

AU - Weissman, Neil J.

AU - Pibarot, Philippe

AU - Blanke, Philipp

AU - Oh, Jae K.

N1 - Funding Information: Drs. Pibarot, Hahn, and Weissman are the Directors of the Echocardiography Core Labs for the P2S3 Trials (sponsored by Edwards Lifesciences) for which they receive no direct compensation. Drs. Blanke and Leipsic are the Co-Directors of the CT Core lab for the P2S3 Trial for which they receive no direct compensation. Dr. Jaber is the Director of the Echocardiography Core Lab for PARTNER II, Cohorts A and B (sponsored by Edwards Lifesciences) for which he receives no direct compensation. Dr. Oh is the Director of the Echocardiography Core Lab for CoreValve/Evolut R; and a consultant for Medtronic. Dr. Leipsic is a consultant for Edwards. Dr. Douglas has received a grant from Edwards Lifesciences. Dr. Weissman has received grants from Boston Scientific, Edwards, Medtronic, Abbott, and LivaNova. Dr. Blanke is a consultant with Edwards Lifesciences. Publisher Copyright: © 2019 American College of Cardiology Foundation

PY - 2019/1

Y1 - 2019/1

N2 - Objectives: This study aims to establish parameters for identifying normal function for each of the 3 iterations of balloon-expandable valves and 2 iterations of self-expanding valves. Background: Expected transthoracic echocardiographic Doppler-derived hemodynamic data for transcatheter aortic valves inform pre-implant decision-making and post-implanted monitoring of longitudinal valve function. Methods: We collected the echocardiography core Lab measured mean gradients and effective orifice area (EOA) from discharge or 30-day echocardiograms from randomized trials; the PARTNER (Placement of Aortic Transcatheter Valves) trials for the balloon-expandable valves and the Medtronic CoreValve US Pivotal trial and Medtronic CoreValve Evolut R United States IDE Clinical Study for the self-expanding valves. Results: For all SAPIEN (Edwards Lifesciences, Irvine, California) valve sizes, mean EOA is 1.70 ± 0.49 cm 2 with a mean gradient of 9.36 ± 4.13 mm Hg. For all SAPIEN XT valve sizes, mean EOA is 1.67 ± 0.46 cm 2 with a mean gradient of 9.52 ± 3.64 mm Hg. For all SAPIEN 3 valve sizes, the mean EOA is 1.66 ± 0.38 cm 2 with a mean gradient of 11.18 ± 4.35 mm Hg. For all CoreValve valve sizes, the mean EOA is 1.88 ± 0.56 cm 2 with a mean gradient of 8.85 ± 4.14 mm Hg. For all Evolut R valve sizes, the mean EOA is 2.01 ± 0.65 cm 2 with a mean gradient of 7.52 ± 3.19 mm Hg. The SAPIEN 3 post-implant EOA was progressively larger for each quintile of baseline annular area by computed tomography (p < 0.001). Similarly, for the Evolut R valve, post-implantation EOA was significantly larger for each quintile of baseline annular perimeter (p < 0.001). Conclusions: Tables of expected mean transcatheter aortic valve hemodynamics by valve type and size are essential in evaluating the function of these transcatheter prosthetic valves. Tables of expected EOA by the native annular anatomy may be useful for pre-implantation decision making. Criteria for defining structural valve dysfunction are proposed.

AB - Objectives: This study aims to establish parameters for identifying normal function for each of the 3 iterations of balloon-expandable valves and 2 iterations of self-expanding valves. Background: Expected transthoracic echocardiographic Doppler-derived hemodynamic data for transcatheter aortic valves inform pre-implant decision-making and post-implanted monitoring of longitudinal valve function. Methods: We collected the echocardiography core Lab measured mean gradients and effective orifice area (EOA) from discharge or 30-day echocardiograms from randomized trials; the PARTNER (Placement of Aortic Transcatheter Valves) trials for the balloon-expandable valves and the Medtronic CoreValve US Pivotal trial and Medtronic CoreValve Evolut R United States IDE Clinical Study for the self-expanding valves. Results: For all SAPIEN (Edwards Lifesciences, Irvine, California) valve sizes, mean EOA is 1.70 ± 0.49 cm 2 with a mean gradient of 9.36 ± 4.13 mm Hg. For all SAPIEN XT valve sizes, mean EOA is 1.67 ± 0.46 cm 2 with a mean gradient of 9.52 ± 3.64 mm Hg. For all SAPIEN 3 valve sizes, the mean EOA is 1.66 ± 0.38 cm 2 with a mean gradient of 11.18 ± 4.35 mm Hg. For all CoreValve valve sizes, the mean EOA is 1.88 ± 0.56 cm 2 with a mean gradient of 8.85 ± 4.14 mm Hg. For all Evolut R valve sizes, the mean EOA is 2.01 ± 0.65 cm 2 with a mean gradient of 7.52 ± 3.19 mm Hg. The SAPIEN 3 post-implant EOA was progressively larger for each quintile of baseline annular area by computed tomography (p < 0.001). Similarly, for the Evolut R valve, post-implantation EOA was significantly larger for each quintile of baseline annular perimeter (p < 0.001). Conclusions: Tables of expected mean transcatheter aortic valve hemodynamics by valve type and size are essential in evaluating the function of these transcatheter prosthetic valves. Tables of expected EOA by the native annular anatomy may be useful for pre-implantation decision making. Criteria for defining structural valve dysfunction are proposed.

KW - echocardiography

KW - effective orifice area

KW - hemodynamics

KW - transcatheter aortic valve replacement

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Comprehensive Echocardiographic Assessment of Normal Transcatheter Valve Function

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