Diagnostic
Challenges

The Challenges of Nondiagnostic Echos

Even with advancements in echocardiography, imaging can be suboptimal, which may lead to^1-4:

Inadequate treatment plans
Unnecessary additional testing
Increased hospital stays
Avoidable hospital admissions

Apical hypertrophic cardiomyopathy

Unenhanced

DEFINITY®

How to Obtain Diagnostic Echos

Implementing the American Society of Echocardiography (ASE) guidelines for ultrasound enhancing agents can help improve efficiency and patient care.⁵

A summary from the ASE UEA guidelines³:

When 2 or more LV segments cannot be visualized
In all patients for whom quantitative assessment of LVEF is important
For all technically difficult ICU and ED patients for quick and accurate diagnosis and to reduce additional diagnostic testing
In ED patients presenting with myocardial ischemia and nondiagnostic ECG

When LV thrombus cannot be ruled in or out
When structural abnormalities, such as noncompaction cardiomyopathy, apical hypertrophy, and aneurysms, cannot be adequately assessed
For diagnosis and exclusion of pseudoaneurysms

Create written policies for using ultrasound enhancing
agents³

Establish quality assessment and improvement programs²

Maintain personnel
training and credentialing^2,3

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Understanding suboptimal echo rates' impact on efficiency

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ECG=electrocardiogram; ED=emergency department; ICU=intensive care unit; LV=left ventricular; LVEF=left ventricular ejection fraction; UEA=ultrasound enhancing agent.

INDICATION

DEFINITY® is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: SERIOUS CARDIOPULMONARY REACTIONS

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration.

Assess all patients for the presence of any condition that precludes DEFINITY^® administration.
Always have resuscitation equipment and trained personnel readily available.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

BOXED WARNING: SERIOUS CARDIOPULMONARY REACTIONS

Assess all patients for the presence of any condition that precludes DEFINITY® administration.
Always have resuscitation equipment and trained personnel readily available.

CONTRAINDICATIONS:

Contraindicated in patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG).

WARNINGS AND PRECAUTIONS:

Serious Cardiopulmonary Reactions have occurred during or following administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias).

Serious Hypersensitivity Reactions have been observed during or shortly following administration including anaphylaxis, with manifestations that may include death. DEFINITY® contains PEG and may increase risk of serious reactions including death in patients with prior hypersensitivity reaction(s) to PEG. Clinically assess patients for prior hypersensitivity reactions to products containing PEG. Monitor all patients for hypersensitivity reactions.

Systemic Embolization may occur in patients with a cardiac shunt. Assess patients with shunts for embolic phenomena following administration. DEFINITY® is only for intravenous administration and must not be administered by intra-arterial injection.

There is a risk of Ventricular Arrhythmia Related to High Mechanical Index. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. The maximum recommended mechanical index for use with DEFINITY® is 0.8 in adult patients and 0.3 in pediatric patients.

Acute Pain Episodes in Patients with Sickle Cell Disease (SCD) shortly following administration have been reported. Discontinue DEFINITY® in SCD patients experiencing new or worsening pain.

ADVERSE REACTIONS:

The most common adverse reactions (≥0.5%) are headache, back/renal pain, flushing, nausea, chest pain, injection site reactions, and dizziness.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information and Important Safety Information, including boxed WARNING regarding serious cardiopulmonary reactions.

References:

Lindner JR. A practical approach to contrast echocardiography. American College of Cardiology. July 10, 2017. Accessed March 18, 2021. https://www.acc.org/latest-in-cardiology/articles/2017/07/10/09/17/a-practical-approach-to-contrast-echocardiography
Picard MH, Adams D, Bierig SM, et al. American Society of Echocardiography recommendations for quality echocardiography laboratory operations. J Am Soc Echocardiogr. 2011;24(1):1-10. doi:10.1016/j.echo.2010.11.006
Porter TR, Mulvagh SL, Abdelmoneim SS, et al. Clinical applications of ultrasonic enhancing agents in echocardiography: 2018 American Society of Echocardiography guidelines update. J Am Soc Echocardiogr. 2018;31(3):241-274. doi:10.1016/j.echo.2017.11.013
Main ML, Fu JW, Gundrum J, LaPointe NA, Gillam LD, Mulvagh SL. Impact of contrast echocardiography on outcomes in critically ill patients. Am J Cardiol. 2021;150:117-122. doi:10.1016/j.amjcard.2021.03.039
Mulvagh SL, Rakowski H, Vannan MA, et al. American Society of Echocardiography consensus statement on the clinical applications of ultrasonic contrast agents in echocardiography. J Am Soc Echocardiogr. 2008;21(11):1179-1281. doi:10.1016/j.echo.2008.09.009

DEFINITY® Customer Service 1.800.299.3431

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TOP

Diagnostic Challenges

The Challenges of Nondiagnostic Echos

How to Obtain Diagnostic Echos

INDICATION

IMPORTANT SAFETY INFORMATION

BOXED WARNING: SERIOUS CARDIOPULMONARY REACTIONS

DEFINITY® Customer Service 1.800.299.3431

DEFINITY® Customer Service 1.800.299.3431

Diagnostic
Challenges

DEFINITY® Customer Service
1.800.299.3431