Medical Device Daily

A recent consensus statement released by the American Society of Echocardiography (ASE; Morrisville, North Carolina) is a well-received piece of literature in the contrast-imaging community.

One of these companies, Lantheus Medical Imaging (North Billerica, Massachusetts) said that it welcomes the release of the statement.

Developed by members of the U.S. 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.

Sharon Mulvagh, MD, a lead author of the statement and a cardiologist at the Mayo Clinic (Rochester, Minnesota), reminded Medical Device Daily that this statement is designed for the physicians' benefit and not necessarily the device companies. "The purpose of the statement is really to be able to review what the details are regarding contrast agents, the equipment used to detect these agents, and the clinical applications and indications. In addition, we address detailed methodology of administration and any safety concerns and what the physicians and nurses and sonographers must know to use these agents effectively, optimally and safely. I would hope that to improve the quality of our echocardiographic images that we will see an increase in the use of contrast agents, not for the sake of increasing it, but for improving the quality [to the patient]."

ASE's consensus statement 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.

"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/CEO of 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."

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 FDA regarding ultrasound contrast agent use and safety information.

Mulvagh told MDD, "This [statement] gives a clear framework within which the cardiologists in the community and in the clinical laboratory can use for the indication for usage of contrast and the comfort level for being able to use them. In this recent era of what we have just gone through with black-box warnings, and relaxing of black-box warnings, and the fluctuation by the FDA what the safety signal was, it turns out that there are some excellent publications that have come out recently that attest to the safety of contrast agents in huge numbers of patients. Those are the pieces of information that we could include in the document."

She added, "We are hoping that this document will be able to reassure and reemphasize the importance of using contrast agents in a quality echocardiography lab, and that the personnel that use them can feel comfortable that they are safe to use. That's the biggest message we need to get out in this particular area. "

The company says that since its launch in 2001, activated Definity Vial For (Perflutren Lipid Microsphere) Injectable Suspension has been administered to over two million patients. In patients with suboptimal echocardiograms, Definity enables physicians to visualize the borders of the heart more clearly.

In May 2008, Lantheus reported 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.