A nationwide real-world study has provided strong evidence confirming the safety of LUMASON® (sulfur hexafluoride lipid-type A microspheres) and other ultrasound enhancing agents (UEAs) in contemporary echocardiographic practice. The findings, published on May 14, 2025, in the Journal of the American Heart Association, analyzed data from more than 11.4 million adult patients who underwent echocardiograms between 2018 and 2022 in the United States.
The research, led by Dr. Jordan B. Strom and colleagues, specifically evaluated rates of death and serious complications within two days of echocardiographic procedures. Of the study population, 500,073 patients received UEAs during their echocardiograms.
Key Safety Findings
Using rigorous data extraction and statistical analysis methodology, the study demonstrated several important findings:
- Very low rates of death and other serious complications were observed across all echocardiographic procedures
- Lower odds of death were associated with LUMASON® and other UEAs compared to unenhanced procedures
- Similar rates of non-fatal serious complications, including anaphylaxis, between UEA-enhanced and unenhanced procedures
- Comparable safety profiles among LUMASON® and other UEAs in clinical use in the United States
- Consistent safety outcomes before, during, and after the COVID-19 pandemic
"Understanding the safety and potential benefits of UEAs is crucial for our medical community," said Dr. Strom, who serves as Director of the Echocardiography Laboratory and Section Head of Cardiovascular Imaging Research 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."
Clinical Implications
LUMASON® is currently the only UEA approved for multiple indications in both adult and pediatric patients. In echocardiography, it is specifically approved to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border in patients with suboptimal echocardiograms.
Alberto Spinazzi, MD, Chief Medical & Regulatory Officer at Bracco Imaging, emphasized the significance of these findings: "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 in echocardiography and reinforces our confidence in LUMASON UEA as an effective tool to drive better outcomes."
Dr. Spinazzi further noted that when LUMASON® was used, the odds of short-term mortality were reduced, and exposure to the agent was associated with very low rates of serious complications, comparable to other UEAs or even unenhanced echocardiograms.
Study Methodology
The research utilized all-payor claims data to evaluate outcomes following echocardiograms. The primary endpoint was death within two days of the procedure, with secondary endpoints including anaphylaxis, myocardial infarction, ventricular tachycardia, and cardiac arrest.
The study's comprehensive approach included matching and statistical analysis to ensure reliable comparisons between enhanced and unenhanced procedures. This methodology allowed researchers to draw robust conclusions about the safety profiles of different UEAs in contemporary clinical practice.
Broader Context
The findings come at a time when diagnostic accuracy and efficiency in cardiac imaging are increasingly important. UEAs like LUMASON® have been shown to improve diagnostic capabilities, potentially reducing the need for additional testing and associated healthcare costs.
Dr. Strom expressed optimism about the implications of these findings: "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."
About LUMASON®
LUMASON® (sulfur hexafluoride lipid-type A microspheres) is an ultrasound contrast agent with multiple approved indications:
- In echocardiography to opacify the left ventricular chamber and improve endocardial border delineation in adult and pediatric patients with suboptimal echocardiograms
- In ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
- In ultrasonography of the urinary tract for evaluation of suspected or known vesicoureteral reflux in pediatric patients
While the agent has demonstrated a strong safety profile, healthcare providers should be aware of important safety information, including rare but serious cardiopulmonary reactions that can occur during or following administration. Patients should be assessed for conditions that might preclude administration, and resuscitation equipment and trained personnel should always be readily available.
The most common adverse reactions reported with LUMASON® use include headache (1%) and nausea (0.5%).
This latest research adds to the growing body of evidence supporting the safety and efficacy of UEAs in improving diagnostic capabilities while maintaining favorable safety profiles across diverse patient populations and clinical settings.
