Improved left ventricular endocardial border delineation and opacification with OPTISON (FS069), a new echocardiographic contrast agent

Results of a phase III multicenter trial

Jerald L. Cohen, Jorge Cheirif, Douglas S. Segar, Linda Gillam, John S. Gottdiener, Eva Hausnerova, Denise E. Bruns

Research output: Contribution to journalArticle

239 Citations (Scopus)

Abstract

The echocardiographic contrast-enhancing effects and safety profile of ALBUNEX (a suspension of air-filled albumin microspheres) were compared with the new contrast agent OPTISON (formerly FS069: a suspension of albumin microspheres containing the gas perfluoropropane) in 203 patients with inadequate noncontrast echocardiograms. Background. The efficacy of ALBUNEX has been limited by its short duration of action. By using perfluoropropane instead of air within the microsphere, its duration of action is increased. Methods. Each patient received ALBUNEX (0.8 and 0.22 mL/kg) and OPTISON (0.2, 0.5, 3.0, and 5.0 mL) on separate days a minimum of 48 hours apart. Echocardiograms were evaluated for increase in left ventricular (LV) endocardial border length, degree of LV opacification, number of LV endocardial border segments visualized, conversion from a nondiagnostic to a diagnostic echocardiogram, and duration of contrast enhancement. A thorough safety evaluation was conducted. Results. Compared with ALBUNEX, OPTISON more significantly improved every measure of contrast enhancement. OPTISON increased well-visualized LV endocardial border length by 6.0 ± 5.1, 6.9 ± 5.4, 7.5 ± 4.7, and 7.6 ± 4.8 cm, respectively, for each of the four doses, compared with only 2.2 ± 4.5 and 3.4 ± 4.6 cm, respectively, for the two ALBUNEX doses (p < 0.001). 100% LV opacification was achieved in 61%, 73%, 87%, and 87% of the patients with the four doses of OPTISON, but in only 16% and 36% of the patients with the two ALBUNEX doses (p < 0.001). Conversion of nondiagnostic to diagnostic echocardiograms with contrast occurred in 74% of patients with the optimal dose of OPTISON (3.0 mL) compared with only 26% with the optimal dose of ALBUNEX (0.22 mL/kg) (p < 0.001). The duration of contrast effect was also significantly greater with OPTISON than with ALBUNEX. In a subset of patients with potentially poor transpulmonary transit of contrast (patients with chronic lung disease or dilated cardiomyopathy), OPTISON more significantly improved the same measures of contrast enhancement compared with ALBUNEX and did so to the same extent as in the overall population. Side effects were similar and transient with the two agents. Conclusion. OPTISON appears to be a safe, well-tolerated echocardiographic contrast agent that is superior to ALBUNEX.

Original languageEnglish (US)
Pages (from-to)746-752
Number of pages7
JournalJournal of the American College of Cardiology
Volume32
Issue number3
DOIs
StatePublished - Sep 1 1998

Fingerprint

Contrast Media
Multicenter Studies
perflutren
Microspheres
Albumins
Suspensions
Air
Safety
Dilated Cardiomyopathy
FS 069
Lung Diseases
Chronic Disease
Gases
Population

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

@article{fc5075e0b667445581f1914a0171a9ec,
title = "Improved left ventricular endocardial border delineation and opacification with OPTISON (FS069), a new echocardiographic contrast agent: Results of a phase III multicenter trial",
abstract = "The echocardiographic contrast-enhancing effects and safety profile of ALBUNEX (a suspension of air-filled albumin microspheres) were compared with the new contrast agent OPTISON (formerly FS069: a suspension of albumin microspheres containing the gas perfluoropropane) in 203 patients with inadequate noncontrast echocardiograms. Background. The efficacy of ALBUNEX has been limited by its short duration of action. By using perfluoropropane instead of air within the microsphere, its duration of action is increased. Methods. Each patient received ALBUNEX (0.8 and 0.22 mL/kg) and OPTISON (0.2, 0.5, 3.0, and 5.0 mL) on separate days a minimum of 48 hours apart. Echocardiograms were evaluated for increase in left ventricular (LV) endocardial border length, degree of LV opacification, number of LV endocardial border segments visualized, conversion from a nondiagnostic to a diagnostic echocardiogram, and duration of contrast enhancement. A thorough safety evaluation was conducted. Results. Compared with ALBUNEX, OPTISON more significantly improved every measure of contrast enhancement. OPTISON increased well-visualized LV endocardial border length by 6.0 ± 5.1, 6.9 ± 5.4, 7.5 ± 4.7, and 7.6 ± 4.8 cm, respectively, for each of the four doses, compared with only 2.2 ± 4.5 and 3.4 ± 4.6 cm, respectively, for the two ALBUNEX doses (p < 0.001). 100{\%} LV opacification was achieved in 61{\%}, 73{\%}, 87{\%}, and 87{\%} of the patients with the four doses of OPTISON, but in only 16{\%} and 36{\%} of the patients with the two ALBUNEX doses (p < 0.001). Conversion of nondiagnostic to diagnostic echocardiograms with contrast occurred in 74{\%} of patients with the optimal dose of OPTISON (3.0 mL) compared with only 26{\%} with the optimal dose of ALBUNEX (0.22 mL/kg) (p < 0.001). The duration of contrast effect was also significantly greater with OPTISON than with ALBUNEX. In a subset of patients with potentially poor transpulmonary transit of contrast (patients with chronic lung disease or dilated cardiomyopathy), OPTISON more significantly improved the same measures of contrast enhancement compared with ALBUNEX and did so to the same extent as in the overall population. Side effects were similar and transient with the two agents. Conclusion. OPTISON appears to be a safe, well-tolerated echocardiographic contrast agent that is superior to ALBUNEX.",
author = "Cohen, {Jerald L.} and Jorge Cheirif and Segar, {Douglas S.} and Linda Gillam and Gottdiener, {John S.} and Eva Hausnerova and Bruns, {Denise E.}",
year = "1998",
month = "9",
day = "1",
doi = "10.1016/S0735-1097(98)00311-8",
language = "English (US)",
volume = "32",
pages = "746--752",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "3",

}

Improved left ventricular endocardial border delineation and opacification with OPTISON (FS069), a new echocardiographic contrast agent : Results of a phase III multicenter trial. / Cohen, Jerald L.; Cheirif, Jorge; Segar, Douglas S.; Gillam, Linda; Gottdiener, John S.; Hausnerova, Eva; Bruns, Denise E.

In: Journal of the American College of Cardiology, Vol. 32, No. 3, 01.09.1998, p. 746-752.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Improved left ventricular endocardial border delineation and opacification with OPTISON (FS069), a new echocardiographic contrast agent

T2 - Results of a phase III multicenter trial

AU - Cohen, Jerald L.

AU - Cheirif, Jorge

AU - Segar, Douglas S.

AU - Gillam, Linda

AU - Gottdiener, John S.

AU - Hausnerova, Eva

AU - Bruns, Denise E.

PY - 1998/9/1

Y1 - 1998/9/1

N2 - The echocardiographic contrast-enhancing effects and safety profile of ALBUNEX (a suspension of air-filled albumin microspheres) were compared with the new contrast agent OPTISON (formerly FS069: a suspension of albumin microspheres containing the gas perfluoropropane) in 203 patients with inadequate noncontrast echocardiograms. Background. The efficacy of ALBUNEX has been limited by its short duration of action. By using perfluoropropane instead of air within the microsphere, its duration of action is increased. Methods. Each patient received ALBUNEX (0.8 and 0.22 mL/kg) and OPTISON (0.2, 0.5, 3.0, and 5.0 mL) on separate days a minimum of 48 hours apart. Echocardiograms were evaluated for increase in left ventricular (LV) endocardial border length, degree of LV opacification, number of LV endocardial border segments visualized, conversion from a nondiagnostic to a diagnostic echocardiogram, and duration of contrast enhancement. A thorough safety evaluation was conducted. Results. Compared with ALBUNEX, OPTISON more significantly improved every measure of contrast enhancement. OPTISON increased well-visualized LV endocardial border length by 6.0 ± 5.1, 6.9 ± 5.4, 7.5 ± 4.7, and 7.6 ± 4.8 cm, respectively, for each of the four doses, compared with only 2.2 ± 4.5 and 3.4 ± 4.6 cm, respectively, for the two ALBUNEX doses (p < 0.001). 100% LV opacification was achieved in 61%, 73%, 87%, and 87% of the patients with the four doses of OPTISON, but in only 16% and 36% of the patients with the two ALBUNEX doses (p < 0.001). Conversion of nondiagnostic to diagnostic echocardiograms with contrast occurred in 74% of patients with the optimal dose of OPTISON (3.0 mL) compared with only 26% with the optimal dose of ALBUNEX (0.22 mL/kg) (p < 0.001). The duration of contrast effect was also significantly greater with OPTISON than with ALBUNEX. In a subset of patients with potentially poor transpulmonary transit of contrast (patients with chronic lung disease or dilated cardiomyopathy), OPTISON more significantly improved the same measures of contrast enhancement compared with ALBUNEX and did so to the same extent as in the overall population. Side effects were similar and transient with the two agents. Conclusion. OPTISON appears to be a safe, well-tolerated echocardiographic contrast agent that is superior to ALBUNEX.

AB - The echocardiographic contrast-enhancing effects and safety profile of ALBUNEX (a suspension of air-filled albumin microspheres) were compared with the new contrast agent OPTISON (formerly FS069: a suspension of albumin microspheres containing the gas perfluoropropane) in 203 patients with inadequate noncontrast echocardiograms. Background. The efficacy of ALBUNEX has been limited by its short duration of action. By using perfluoropropane instead of air within the microsphere, its duration of action is increased. Methods. Each patient received ALBUNEX (0.8 and 0.22 mL/kg) and OPTISON (0.2, 0.5, 3.0, and 5.0 mL) on separate days a minimum of 48 hours apart. Echocardiograms were evaluated for increase in left ventricular (LV) endocardial border length, degree of LV opacification, number of LV endocardial border segments visualized, conversion from a nondiagnostic to a diagnostic echocardiogram, and duration of contrast enhancement. A thorough safety evaluation was conducted. Results. Compared with ALBUNEX, OPTISON more significantly improved every measure of contrast enhancement. OPTISON increased well-visualized LV endocardial border length by 6.0 ± 5.1, 6.9 ± 5.4, 7.5 ± 4.7, and 7.6 ± 4.8 cm, respectively, for each of the four doses, compared with only 2.2 ± 4.5 and 3.4 ± 4.6 cm, respectively, for the two ALBUNEX doses (p < 0.001). 100% LV opacification was achieved in 61%, 73%, 87%, and 87% of the patients with the four doses of OPTISON, but in only 16% and 36% of the patients with the two ALBUNEX doses (p < 0.001). Conversion of nondiagnostic to diagnostic echocardiograms with contrast occurred in 74% of patients with the optimal dose of OPTISON (3.0 mL) compared with only 26% with the optimal dose of ALBUNEX (0.22 mL/kg) (p < 0.001). The duration of contrast effect was also significantly greater with OPTISON than with ALBUNEX. In a subset of patients with potentially poor transpulmonary transit of contrast (patients with chronic lung disease or dilated cardiomyopathy), OPTISON more significantly improved the same measures of contrast enhancement compared with ALBUNEX and did so to the same extent as in the overall population. Side effects were similar and transient with the two agents. Conclusion. OPTISON appears to be a safe, well-tolerated echocardiographic contrast agent that is superior to ALBUNEX.

UR - http://www.scopus.com/inward/record.url?scp=0031670557&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0031670557&partnerID=8YFLogxK

U2 - 10.1016/S0735-1097(98)00311-8

DO - 10.1016/S0735-1097(98)00311-8

M3 - Article

VL - 32

SP - 746

EP - 752

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 3

ER -