PRINCETON, N.J., May 14, 2025 /PRNewswire/ -- 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 2025,¹ 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:
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A very low rate of death or other serious complications,
Lower odds of death when LUMASON® (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."
