November 11, 2008 – In a Consensus Statement on the Clinical Applications of Ultrasound Contrast released by the American Society of Echocardiography (ASE), the ASE recognizes contrast echocardiography as an important diagnostic tool in a broad number of clinical settings.
Developed by members of the United States echocardiography community and published in the November issue of the Journal of the American Society of Echocardiography, ASE’s Consensus Statement outlines when and how ultrasound contrast agents are to be used appropriately and efficiently to enhance the diagnostic capability of echocardiography. In the document, ASE substantiates the established use of ultrasound contrast agents in diagnostic cardiovascular imaging in echocardiography and discusses the important role physicians, sonographers and nurses play in efficiently integrating the use of contrast agents into the echocardiography laboratory.
Additionally, the document highlights the role of echocardiography contrast imaging agents in improving cardiac structural definition and outlines the clinical situations when non-enhanced imaging does not yield diagnostic information.
Lantheus’ echocardiography contrast agent, DEFINITY Vial For (Perflutren Lipid Microsphere) Injectable Suspension, is specifically indicated for the use of patients with suboptimal echocardiograms to opacify the left ventricular chamber. Although the Consensus Statement also discusses, among other things, the use of contrast agents in stress echocardiography, the safety and efficacy of DEFINITY with exercise stress or pharmacologic stress testing have not been established.
The recommendations are based on a critical review of the existing medical literature, including prospective clinical trials, and when no significant study data were available, expert consensus opinion. The Consensus Statement also thoroughly reviewed the recent labeling changes by the United States Food and Drug Administration regarding ultrasound contrast agent use and 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.
Activated DEFINITY should not be administered to patients with known or suspected cardiac shunts (right-to-left, bi-directional or transient right-to-left), or hypersensitivity to perflutren. Do not administer DEFINITY by intra-arterial injection.
In postmarketing use, uncommon but serious reactions observed during or shortly following perflutren-containing microsphere administration included fatal cardiac or respiratory arrest, loss of consciousness, convulsions, symptomatic arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or fibrillation), hypotension, respiratory distress or cardiac ischemia (see ADVERSE REACTIONS). The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias or respiratory failure, including patients receiving mechanical ventilation). In the absence of these underlying conditions, observe patients closely during and following DEFINITY administration. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY administration and monitor all patients for acute reactions.