November 6, 2008 - Lantheus Medical Imaging Inc. welcomes the “Consensus Statement on the Clinical Applications of Ultrasound Contrast” released by the American Society of Echocardiography (ASE) published in the November issue of the Journal of the American Society of Echocardiography.
Developed by members of the U.S. echocardiography community, 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.
“We applaud the American Society of Echocardiography for its leadership in addressing the effective use of contrast ultrasound by authoring the Contrast Consensus Statement guidance document for the echocardiography community. This important consensus statement speaks to the clinical relevance of contrast and guides clinicians towards a team-approach to care for effective contrast use,” said Don Kiepert, president and CEO, Lantheus Medical Imaging. “The release of this consensus statement serves to validate the clinical need of ultrasound contrast use in echocardiography and reinforces the important role contrast plays in clinical diagnosis, patient management and clinical research.”
ASE’s statement 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 company said.
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 statement also thoroughly reviewed the recent labeling changes by the FDA regarding ultrasound contrast agent use and safety information.
In May 2008, Lantheus announced the initiation of CaRES (Contrast Echocardiography REgistry for Safety Surveillance), a multi-center Phase IV observational study that will further evaluate the safety profile of DEFINITY in patients with suboptimal echocardiograms and provide safety information on the use of ultrasound contrast agents in routine clinical practice. The open-label, non-randomized registry is being conducted in more than 10 clinical sites in the U.S. and include at least 1,600 patients. The study will gather data on patient characteristics and demographics, indication for DEFINITY’s use, results of safety monitoring of patients during and after DEFINITY administration, and the nature and frequency of any adverse events that may occur.
The FDA issued a black box warning for echo contrast agents last fall, but this summer downgraded the level of warning. The FDA reports there have been some rare but serious cardiopulmonary reactions, including fatalities, during or following perflutren-containing microsphere administration. The FDA now requires clinicians to assess all patients for the presence of any condition that precludes echo contrast agent administration. In patients with pulmonary hypertension or unstable cardiopulmonary conditions, clinicians are supposed to monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after administration.
Lantheus said 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. It also should not be administered by intra-arterial injection.
For more information: www.lantheus.com