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Why Use DEFINITY®?

The Evidence is Clear on Efficacy

  • A suboptimal image is one in which at least 2 out of 6 myocardial segments of the left ventricle cannot be visualized in the apical views, as defined by the American Society of Echocardiography (ASE).1,2
  • Up to 20% of resting studies result in suboptimal echocardiograms.1,2,3

    DEFINITY® significantly improves visualization in difficult-to-image segments    5,4,88

    DEFINITY apical 4-chamber

    DEFINITY Apical 2-Chamber

It's a Matter of Quality of Imaging

  • In a retrospective analysis, in a subset of subjects (n=12 to 47) having at least two adjacent non-evaluable segments on non-contrast imaging, activated DEFINITY® converted a baseline non-evaluable image to an evaluable image in 58% to 91% of the patients, depending on the reader.4,5
  • Clinicians observed improved image quality compared to baseline in 5 separate clinical trials.4
  • The duration of DEFINITY's® clinical useful enhancement is sufficient to evaluate LV function. 5,6
*Pooled data on file from 126 patients in two open-label multicenter trials with similar study design and patient populations. Results from institutional reads refer to percentage of patients with improvement in segmental endocardial border delineation after administration of one or more 10 uL/Kg boluses of DEFINITY®. Tests of significance were conducted using 2-sided McNemar’s test at the 5% level of significance.

  1. Waggoner AD, et al, Guidelines for the cardiac sonographer in the performance of contrast echocardiography. J Am Soc Echocardiogr. 2001: 417-420.
  2. Mulvagh SL et al. contrast Echocardiography: Current and future applications. J Am Soc Echocardiogr 2000; 13:331-42.
  3. Edited by Scott d. Solomon, MD, Essential Echocardiography, A Practical handbook with DVD. Humana Press; 2007 Chapter 5: Ventricular Systolic function, P113.
  4. DEFINITY® US Package Insert
  5. Kitzman DW et al. Efficacy and Safety of the Novel Ultrasound Contrast Agent Perflutren (Definity) in Patients With Suboptimal Baseline Left Ventricular Echocardiographic Images. Am J Cardiol. 2000; 86:669-674.
  6. Weissman NJ, Infusion versus bolus contrast echocardiography: A multicenter, open-label, crossover trial. Am Heart J 2000: 39(3): 399-404.
  7. Lang RM et al. Recommendations for chamber quantification: a report from the American Society of Echocardiography’s Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr 2005; 18(12): 1440-1463.
  8. Data on file, Lantheus Medical Imaging, Inc.
QUALITY IMPROVEMENT IN ECHOCARDIOGRAPHY
Presented by:
John Dent, MD
Medical Director of Echocardiography
UVA Health System


Audio Presentation
unenhanced and enhanced examples

INDICATIONS

Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

The safety and efficacy of DEFINITY® with exercise stress or pharmacologic stress testing have not been established.

CONTRAINDICATIONS

Do not administer DEFINITY® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren.

IMPORTANT SAFETY INFORMATION

WARNING: Serious Cardiopulmonary Reactions 

Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration.

  • Assess all patients for the presence of any condition that precludes DEFINITY® administration (see CONTRAINDICATIONS).
  • In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after DEFINITY® administration (see WARNINGS).
  • Always have resuscitation equipment and trained personnel readily available.


In post marketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration (see ADVERSE REACTIONS). The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.

Please See Full Prescribing Information and Letter to Healthcare Providers.