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CLINICAL STUDIES

Phase III multicenter trial comparing the efficacy of 2% dodecafluoropentane emulsion (EchoGen) and sonicated 5% human albumin (Albunex) as ultrasound contrast agents in patients with suboptimal echocardiograms

Paul A. Grayburn, MD, FACC^a, James L. Weiss, MD, FACC^*, Terrence C. Hack, MD, FACC, Elizabeth Klodas, MD, FACC^*, Joel S. Raichlen, MD, FACC, Manni A. Vannan, MD, FACC, Allan L. Klein, MD, FACC^||, Dalane W. Kitzman, MD, FACC^¶, Steven G. Chrysant, MD, FACC^#, Jerald L. Cohen, MD, FACC^**, David Abrahamson, MD, FACC, Elyse Foster, MD, FACC, Julio E. Perez, MD, FACC, Gerard P. Aurigemma, MD, FACC^||, Julio A. Panza, MD, FACC^¶, Michael H. Picard, MD, FACC^##, Benjamin F. Byrd, III, MD, FACC^***, Douglas S. Segar, MD, FACC, Stuart A. Jacobson, MD, FACC, David J. Sahn, MD, FACC and Anthony N. DeMaria, MD, FACC^||

^a Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, Texas, USA
^* Johns Hopkins University Medical Center, Baltimore, Maryland, USA
Deaconess Nashoba Hospital, Ayer, Massachusetts, USA
Thomas Jefferson University, Philadelphia, Pennsylvania, USA
New England Medical Center, Boston, Massachusetts, USA
^|| Cleveland Clinic Foundation, Cleveland, Ohio, USA
^¶ Bowman Gray Medical Center, Winston-Salem, North Carolina, USA
^# Oklahoma Cardiovascular and Hypotension Center, Oklahoma City, Oklahoma, USA
^** New Jersey Veterans Affairs Medical Center, East Orange, New Jersey, USA
Orange County Heart Institute and Research Center, Orange, California, USA
University of California San Francisco, San Francisco, California, USA
Washington University Medical Center, Saint Louis, Missouri, USA
^|| University of Massachusetts Medical Center, Worchester, Massachusetts, USA
^¶ National Institutes of Health, Bethesda, Maryland, USA
^## Massachusetts General Hospital, Boston, Massachusetts, USA
^*** Vanderbilt University, Nashville, Tennessee, USA
Indiana University, Indianapolis, Indiana, USA
Research for Health, Inc., Houston, Texas, USA
University of Oregon Health Science Center, Portland, Oregon, USA
^|| University of California San Diego, San Diego, California, USA

Manuscript received November 10, 1997; revised manuscript received March 12, 1998, accepted April 8, 1998.

Address for correspondence: Dr. Paul A. Grayburn, Echocardiography Laboratories, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, Texas, 75216-9047
grayburn{at}ryburn.swmed.edu

Objectives. This study was performed to compare the safety and efficacy of intravenous 2% dodecafluoropentane (DDFP) emulsion (EchoGen) with that of active control (sonicated human albumin [Albunex]) for left ventricular (LV) cavity opacification in adult patients with a suboptimal echocardiogram.

Background. The development of new fluorocarbon-based echocardiographic contrast agents such as DDFP has allowed opacification of the left ventricle after peripheral venous injection. We hypothesized that DDFP was clinically superior to the Food and Drug Administration–approved active control.

Methods. This was a Phase III, multicenter, single-blind, active controlled trial. Sequential intravenous injections of active control and DDFP were given 30 min apart to 254 patients with a suboptimal echocardiogram, defined as one in which the endocardial borders were not visible in at least two segments in either the apical two- or four-chamber views. Studies were interpreted in blinded manner by two readers and the investigators.

Results. Full or intermediate LV cavity opacification was more frequently observed after DDFP than after active control (78% vs. 31% for reader A; 69% vs. 34% for reader B; 83% vs. 55% for the investigators, p < 0.0001). LV cavity opacification scores were higher with DDFP (2.0 to 2.5 vs. 1.1 to 1.5, p < 0.0001). Endocardial border delineation was improved by DDFP in 88% of patients versus 45% with active control (p < 0.001). Similar improvement was seen for duration of contrast effect, salvage of suboptimal echocardiograms, diagnostic confidence and potential to affect patient management. There was no difference between agents in the number of patients with adverse events attributed to the test agent (9% for DDFP vs. 6% for active control, p = 0.92).

Conclusions. This Phase III multicenter trial demonstrates that DDFP is superior to sonicated human albumin for LV cavity opacification, endocardial border definition, duration of effect, salvage of suboptimal echocardiograms, diagnostic confidence and potential to influence patient management. The two agents had similar safety profiles.

Abbreviations and Acronyms   DDFP = dodecafluoropentane   ECG = electrocardiogram, electrocardiographic   FDA = Food and Drug Administration   LV = left ventricular

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