Imagent improves endocardial border delineation, inter-reader agreement, and the accuracy of segmental wall motion assessment

Navin C. Nanda, Dalane W. Kitzman, Howard C. Dittrich, Gail Hall, Masood Ahmad, Gerard Aurigemma, Leon Axel, Benjamin Byrd, Farooq Chaudhry, Jerald Cohen, Harold Copans, Linda Crouse, George W. Dennish, Kenneth Ford, Linda Gillam, Martin Goldman, Paul Grayburn, David Hill, Michael Imburgia, Larry Jacobs & 17 others Morris Kotler, George Lighty, Sunil Mankad, Natesa Pandian, John Panidis, Julio Perez, Joel Raichlen, David Rubenson, Thomas Ryan, Douglas Segar, Edward Shapiro, Jamshid Shirani, Martin St John Sutton, Stephen A. Stowers, William Van Decker, Flordeliza Santos Villanueva, William Zoghbi

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Background: This study was conducted to assess the ability of a new echocardiographic contrast agent, Imagent (perflexane lipid microspheres; Alliance Pharmaceutical Corp., San Diego, CA), to improve endocardial border delineation (EBD) and assessment of segmental wall motion (SWM). This was achieved by analysis of inter-reader agreement by echocardiography and comparison with an independent imaging technique, magnetic resonance imaging (MRI). Methods: Two separate, independent, prospective, randomized, controlled, multicenter trials were conducted at 26 centers and included a total of 409 efficacy-evaluable patients. In Study A 206 patients were randomized to receive either Imagent or saline and in Study B, 203 patients received Imagent with a subset imaged by both echocardiography and MRI. All patients were required to have suboptimal baseline images using fundamental imaging. Images were optimized at baseline prior to contrast and the settings maintained post-contrast. Imagent, a suspension of perfluorohexane-filled spheres with flexible lipid shells, was administered as an IV bolus at 0.125 mg/kg body weight. Gated MRI studies were performed within 48 hours of dosing in a subset of 26 subjects. Six expert independent blinded readers reviewed unpaired noncontrast and contrast exams and scored EBD and SWM. Analysis of interreader agreement was performed by comparing the SWM score (1 to 5) recorded by each reader pair. In addition, unanimity between readers for SWM was evaluated. For comparison to MRI, the results from echo readers 4, 5, and 6 were each compared with a single independent MRI reader. Results: The patients enrolled in these clinical trials displayed markedly suboptimal images with 49% and 71% (Study A and Study B) of the segments determined by the readers to be suboptimal prior to contrast administration. All readers recorded statistically significant (P < 0.0001) improvement in total EBD scores following the administration of Imagent. Comparison of noncontrast SWM scores for each pair of echo readers resulted in agreement in an average of 39%, of segments in Study A, and 31% of the segments in Study B. Use of Imagent improved agreement in SWM scores to 65% in Study A, and 48% of segments in Study B (P < 0.0001) for all reader pairs in both studies. Reader unanimity in SWM scores increased from 13% to 41% of the segments with the administration of Imagent. Blinded review of the noncontrast echo examinations resulted in agreement with MRI derived SWM scores in 15% of the segments. The administration of Imagent improved this agreement to 47%, of the segments (P ≤ 0.0005 for each blinded reader). Conclusions: Use of Imagent during echocardiographic imaging improves EBD, providing a significant improvement in inter-reader agreement in SWM evaluation with echo and greater than a threefold improvement in SWM scoring accuracy with MRI.

Original languageEnglish
Pages (from-to)151-161
Number of pages11
JournalEchocardiography
Volume20
Issue number2
DOIs
StatePublished - Feb 2003

Fingerprint

Magnetic Resonance Imaging
Echocardiography
perflexane
Lipids
Microspheres
Contrast Media
Multicenter Studies
Suspensions
Randomized Controlled Trials
Body Weight
Clinical Trials
Pharmaceutical Preparations

Keywords

  • Contrast echocardiography
  • Imagent
  • LV endocardial border delineation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Cite this

Imagent improves endocardial border delineation, inter-reader agreement, and the accuracy of segmental wall motion assessment. / Nanda, Navin C.; Kitzman, Dalane W.; Dittrich, Howard C.; Hall, Gail; Ahmad, Masood; Aurigemma, Gerard; Axel, Leon; Byrd, Benjamin; Chaudhry, Farooq; Cohen, Jerald; Copans, Harold; Crouse, Linda; Dennish, George W.; Ford, Kenneth; Gillam, Linda; Goldman, Martin; Grayburn, Paul; Hill, David; Imburgia, Michael; Jacobs, Larry; Kotler, Morris; Lighty, George; Mankad, Sunil; Pandian, Natesa; Panidis, John; Perez, Julio; Raichlen, Joel; Rubenson, David; Ryan, Thomas; Segar, Douglas; Shapiro, Edward; Shirani, Jamshid; Sutton, Martin St John; Stowers, Stephen A.; Van Decker, William; Santos Villanueva, Flordeliza; Zoghbi, William.

In: Echocardiography, Vol. 20, No. 2, 02.2003, p. 151-161.

Research output: Contribution to journalArticle

Nanda, NC, Kitzman, DW, Dittrich, HC, Hall, G, Ahmad, M, Aurigemma, G, Axel, L, Byrd, B, Chaudhry, F, Cohen, J, Copans, H, Crouse, L, Dennish, GW, Ford, K, Gillam, L, Goldman, M, Grayburn, P, Hill, D, Imburgia, M, Jacobs, L, Kotler, M, Lighty, G, Mankad, S, Pandian, N, Panidis, J, Perez, J, Raichlen, J, Rubenson, D, Ryan, T, Segar, D, Shapiro, E, Shirani, J, Sutton, MSJ, Stowers, SA, Van Decker, W, Santos Villanueva, F & Zoghbi, W 2003, 'Imagent improves endocardial border delineation, inter-reader agreement, and the accuracy of segmental wall motion assessment', Echocardiography, vol. 20, no. 2, pp. 151-161. https://doi.org/10.1046/j.1540-8175.2003.03014.x
Nanda, Navin C. ; Kitzman, Dalane W. ; Dittrich, Howard C. ; Hall, Gail ; Ahmad, Masood ; Aurigemma, Gerard ; Axel, Leon ; Byrd, Benjamin ; Chaudhry, Farooq ; Cohen, Jerald ; Copans, Harold ; Crouse, Linda ; Dennish, George W. ; Ford, Kenneth ; Gillam, Linda ; Goldman, Martin ; Grayburn, Paul ; Hill, David ; Imburgia, Michael ; Jacobs, Larry ; Kotler, Morris ; Lighty, George ; Mankad, Sunil ; Pandian, Natesa ; Panidis, John ; Perez, Julio ; Raichlen, Joel ; Rubenson, David ; Ryan, Thomas ; Segar, Douglas ; Shapiro, Edward ; Shirani, Jamshid ; Sutton, Martin St John ; Stowers, Stephen A. ; Van Decker, William ; Santos Villanueva, Flordeliza ; Zoghbi, William. / Imagent improves endocardial border delineation, inter-reader agreement, and the accuracy of segmental wall motion assessment. In: Echocardiography. 2003 ; Vol. 20, No. 2. pp. 151-161.
@article{05f2398c46264654809753290738aef1,
title = "Imagent improves endocardial border delineation, inter-reader agreement, and the accuracy of segmental wall motion assessment",
abstract = "Background: This study was conducted to assess the ability of a new echocardiographic contrast agent, Imagent (perflexane lipid microspheres; Alliance Pharmaceutical Corp., San Diego, CA), to improve endocardial border delineation (EBD) and assessment of segmental wall motion (SWM). This was achieved by analysis of inter-reader agreement by echocardiography and comparison with an independent imaging technique, magnetic resonance imaging (MRI). Methods: Two separate, independent, prospective, randomized, controlled, multicenter trials were conducted at 26 centers and included a total of 409 efficacy-evaluable patients. In Study A 206 patients were randomized to receive either Imagent or saline and in Study B, 203 patients received Imagent with a subset imaged by both echocardiography and MRI. All patients were required to have suboptimal baseline images using fundamental imaging. Images were optimized at baseline prior to contrast and the settings maintained post-contrast. Imagent, a suspension of perfluorohexane-filled spheres with flexible lipid shells, was administered as an IV bolus at 0.125 mg/kg body weight. Gated MRI studies were performed within 48 hours of dosing in a subset of 26 subjects. Six expert independent blinded readers reviewed unpaired noncontrast and contrast exams and scored EBD and SWM. Analysis of interreader agreement was performed by comparing the SWM score (1 to 5) recorded by each reader pair. In addition, unanimity between readers for SWM was evaluated. For comparison to MRI, the results from echo readers 4, 5, and 6 were each compared with a single independent MRI reader. Results: The patients enrolled in these clinical trials displayed markedly suboptimal images with 49{\%} and 71{\%} (Study A and Study B) of the segments determined by the readers to be suboptimal prior to contrast administration. All readers recorded statistically significant (P < 0.0001) improvement in total EBD scores following the administration of Imagent. Comparison of noncontrast SWM scores for each pair of echo readers resulted in agreement in an average of 39{\%}, of segments in Study A, and 31{\%} of the segments in Study B. Use of Imagent improved agreement in SWM scores to 65{\%} in Study A, and 48{\%} of segments in Study B (P < 0.0001) for all reader pairs in both studies. Reader unanimity in SWM scores increased from 13{\%} to 41{\%} of the segments with the administration of Imagent. Blinded review of the noncontrast echo examinations resulted in agreement with MRI derived SWM scores in 15{\%} of the segments. The administration of Imagent improved this agreement to 47{\%}, of the segments (P ≤ 0.0005 for each blinded reader). Conclusions: Use of Imagent during echocardiographic imaging improves EBD, providing a significant improvement in inter-reader agreement in SWM evaluation with echo and greater than a threefold improvement in SWM scoring accuracy with MRI.",
keywords = "Contrast echocardiography, Imagent, LV endocardial border delineation",
author = "Nanda, {Navin C.} and Kitzman, {Dalane W.} and Dittrich, {Howard C.} and Gail Hall and Masood Ahmad and Gerard Aurigemma and Leon Axel and Benjamin Byrd and Farooq Chaudhry and Jerald Cohen and Harold Copans and Linda Crouse and Dennish, {George W.} and Kenneth Ford and Linda Gillam and Martin Goldman and Paul Grayburn and David Hill and Michael Imburgia and Larry Jacobs and Morris Kotler and George Lighty and Sunil Mankad and Natesa Pandian and John Panidis and Julio Perez and Joel Raichlen and David Rubenson and Thomas Ryan and Douglas Segar and Edward Shapiro and Jamshid Shirani and Sutton, {Martin St John} and Stowers, {Stephen A.} and {Van Decker}, William and {Santos Villanueva}, Flordeliza and William Zoghbi",
year = "2003",
month = "2",
doi = "10.1046/j.1540-8175.2003.03014.x",
language = "English",
volume = "20",
pages = "151--161",
journal = "Echocardiography",
issn = "0742-2822",
publisher = "Wiley-Blackwell",
number = "2",

}

TY - JOUR

T1 - Imagent improves endocardial border delineation, inter-reader agreement, and the accuracy of segmental wall motion assessment

AU - Nanda, Navin C.

AU - Kitzman, Dalane W.

AU - Dittrich, Howard C.

AU - Hall, Gail

AU - Ahmad, Masood

AU - Aurigemma, Gerard

AU - Axel, Leon

AU - Byrd, Benjamin

AU - Chaudhry, Farooq

AU - Cohen, Jerald

AU - Copans, Harold

AU - Crouse, Linda

AU - Dennish, George W.

AU - Ford, Kenneth

AU - Gillam, Linda

AU - Goldman, Martin

AU - Grayburn, Paul

AU - Hill, David

AU - Imburgia, Michael

AU - Jacobs, Larry

AU - Kotler, Morris

AU - Lighty, George

AU - Mankad, Sunil

AU - Pandian, Natesa

AU - Panidis, John

AU - Perez, Julio

AU - Raichlen, Joel

AU - Rubenson, David

AU - Ryan, Thomas

AU - Segar, Douglas

AU - Shapiro, Edward

AU - Shirani, Jamshid

AU - Sutton, Martin St John

AU - Stowers, Stephen A.

AU - Van Decker, William

AU - Santos Villanueva, Flordeliza

AU - Zoghbi, William

PY - 2003/2

Y1 - 2003/2

N2 - Background: This study was conducted to assess the ability of a new echocardiographic contrast agent, Imagent (perflexane lipid microspheres; Alliance Pharmaceutical Corp., San Diego, CA), to improve endocardial border delineation (EBD) and assessment of segmental wall motion (SWM). This was achieved by analysis of inter-reader agreement by echocardiography and comparison with an independent imaging technique, magnetic resonance imaging (MRI). Methods: Two separate, independent, prospective, randomized, controlled, multicenter trials were conducted at 26 centers and included a total of 409 efficacy-evaluable patients. In Study A 206 patients were randomized to receive either Imagent or saline and in Study B, 203 patients received Imagent with a subset imaged by both echocardiography and MRI. All patients were required to have suboptimal baseline images using fundamental imaging. Images were optimized at baseline prior to contrast and the settings maintained post-contrast. Imagent, a suspension of perfluorohexane-filled spheres with flexible lipid shells, was administered as an IV bolus at 0.125 mg/kg body weight. Gated MRI studies were performed within 48 hours of dosing in a subset of 26 subjects. Six expert independent blinded readers reviewed unpaired noncontrast and contrast exams and scored EBD and SWM. Analysis of interreader agreement was performed by comparing the SWM score (1 to 5) recorded by each reader pair. In addition, unanimity between readers for SWM was evaluated. For comparison to MRI, the results from echo readers 4, 5, and 6 were each compared with a single independent MRI reader. Results: The patients enrolled in these clinical trials displayed markedly suboptimal images with 49% and 71% (Study A and Study B) of the segments determined by the readers to be suboptimal prior to contrast administration. All readers recorded statistically significant (P < 0.0001) improvement in total EBD scores following the administration of Imagent. Comparison of noncontrast SWM scores for each pair of echo readers resulted in agreement in an average of 39%, of segments in Study A, and 31% of the segments in Study B. Use of Imagent improved agreement in SWM scores to 65% in Study A, and 48% of segments in Study B (P < 0.0001) for all reader pairs in both studies. Reader unanimity in SWM scores increased from 13% to 41% of the segments with the administration of Imagent. Blinded review of the noncontrast echo examinations resulted in agreement with MRI derived SWM scores in 15% of the segments. The administration of Imagent improved this agreement to 47%, of the segments (P ≤ 0.0005 for each blinded reader). Conclusions: Use of Imagent during echocardiographic imaging improves EBD, providing a significant improvement in inter-reader agreement in SWM evaluation with echo and greater than a threefold improvement in SWM scoring accuracy with MRI.

AB - Background: This study was conducted to assess the ability of a new echocardiographic contrast agent, Imagent (perflexane lipid microspheres; Alliance Pharmaceutical Corp., San Diego, CA), to improve endocardial border delineation (EBD) and assessment of segmental wall motion (SWM). This was achieved by analysis of inter-reader agreement by echocardiography and comparison with an independent imaging technique, magnetic resonance imaging (MRI). Methods: Two separate, independent, prospective, randomized, controlled, multicenter trials were conducted at 26 centers and included a total of 409 efficacy-evaluable patients. In Study A 206 patients were randomized to receive either Imagent or saline and in Study B, 203 patients received Imagent with a subset imaged by both echocardiography and MRI. All patients were required to have suboptimal baseline images using fundamental imaging. Images were optimized at baseline prior to contrast and the settings maintained post-contrast. Imagent, a suspension of perfluorohexane-filled spheres with flexible lipid shells, was administered as an IV bolus at 0.125 mg/kg body weight. Gated MRI studies were performed within 48 hours of dosing in a subset of 26 subjects. Six expert independent blinded readers reviewed unpaired noncontrast and contrast exams and scored EBD and SWM. Analysis of interreader agreement was performed by comparing the SWM score (1 to 5) recorded by each reader pair. In addition, unanimity between readers for SWM was evaluated. For comparison to MRI, the results from echo readers 4, 5, and 6 were each compared with a single independent MRI reader. Results: The patients enrolled in these clinical trials displayed markedly suboptimal images with 49% and 71% (Study A and Study B) of the segments determined by the readers to be suboptimal prior to contrast administration. All readers recorded statistically significant (P < 0.0001) improvement in total EBD scores following the administration of Imagent. Comparison of noncontrast SWM scores for each pair of echo readers resulted in agreement in an average of 39%, of segments in Study A, and 31% of the segments in Study B. Use of Imagent improved agreement in SWM scores to 65% in Study A, and 48% of segments in Study B (P < 0.0001) for all reader pairs in both studies. Reader unanimity in SWM scores increased from 13% to 41% of the segments with the administration of Imagent. Blinded review of the noncontrast echo examinations resulted in agreement with MRI derived SWM scores in 15% of the segments. The administration of Imagent improved this agreement to 47%, of the segments (P ≤ 0.0005 for each blinded reader). Conclusions: Use of Imagent during echocardiographic imaging improves EBD, providing a significant improvement in inter-reader agreement in SWM evaluation with echo and greater than a threefold improvement in SWM scoring accuracy with MRI.

KW - Contrast echocardiography

KW - Imagent

KW - LV endocardial border delineation

UR - http://www.scopus.com/inward/record.url?scp=0037297396&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0037297396&partnerID=8YFLogxK

U2 - 10.1046/j.1540-8175.2003.03014.x

DO - 10.1046/j.1540-8175.2003.03014.x

M3 - Article

VL - 20

SP - 151

EP - 161

JO - Echocardiography

JF - Echocardiography

SN - 0742-2822

IS - 2

ER -