Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging, announced today that the results of a nationwide real-world study, published by Dr. Strom et al. in the Journal of the American Heart Association on 14 May 2025,ยน provide valuable information on safety outcomes of cardiac ultrasound procedures in contemporary practice in the United States (U.S.).
According to the article, all-payor claims data from more than 11.4 million adult individuals were used to evaluate rates of death (primary endpoint) and other serious complications, i.e., anaphylaxis, myocardial infarction, ventricular tachycardia or cardiac arrest within 2 days of echocardiograms conducted between 2018 and 2022 in the U.S. Of the study population, a total of 500,073 had undergone echocardiograms with the use of an ultrasound enhancing agent.
Using rigorous data extraction, matching and statistical analysis methodology, the study conducted by Strom et al. showed:
- A very low rate of death or other serious complications,
- Lower odds of death when LUMASONยฎ (an injectable suspension, sulphur hexafluoride lipid-type A microsphere for intravenous and intravesical use) and other UEAs are used,
- Similar rates of non-fatal serious complications between unenhanced and UEA-enhanced procedures, anaphylaxis included,
- Very low and similar rates of death and non-fatal serious complications between LUMASON UEA and the other two UEAs in clinical use in the U.S., and
- Similar rates of adverse events before, during and after the COVID-19 pandemic, anaphylaxis included.
The Authors of the paper conclude that the results of the study overall underscore the continued safety of UEAs in contemporary clinical practice.
“Understanding the safety and potential benefits of UEAs is crucial for our medical community,” says Dr. Jordan B. Strom, Director of the Echocardiography Laboratory, Section Head of Cardiovascular Imaging Research at the Smith Center at Beth Israel Deaconess Medical Center, and Associate Professor at Harvard Medical School. “UEAs are associated with reduced downstream testing, and costs, and improve diagnoses and workflows. Our study not only reaffirms the safety of these agents but also highlights their association with reduced mortality. We believe that these findings will help pave the way for broader usage of UEAs to the benefit of our patients. The goal is to enhance diagnostic accuracy, improve patient outcomes, and ultimately, save more lives.”
LUMASON is the only UEA approved for use in multiple indications in adult and pediatric patients. In echocardiography, it is approved to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms.2
“This nationwide large and rigorous analysis, broadly representative of healthcare activity in the entire U.S., provides new and valuable insights about the safety of ultrasound enhancing agents (UEAs) in echocardiography and reinforces our confidence in LUMASON UEA as an effective tool to drive better outcomes.” said Alberto Spinazzi, MD, Chief Medical & Regulatory Officer at Bracco Imaging. “Indeed, when LUMASON UEA was used, the odds of short-term mortality were reduced. Also, the exposure to LUMASON UEA was associated with a very low rate of serious complications, like that observed with the other UEAs in clinical use or even that of echocardiograms with no use of UEAs. Notably, no differences in the safety profile of the agent were apparent before, during, and after the COVID-19 pandemic.”
1 Strom JB, Mulvagh SL, Porter TR, et al. Contemporary safety of ultrasound enhancing agents in a nationwide analysis. J Am Heart Assoc. 2025;14:e039480. DOI: 10.1161/JAHA.124.039480
*Out of 11.4M patients, 500K patients received UEAs.
2 LUMASONยฎ (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; August 2021.
