#USA #Princeton #Bracco Diagnostics #LUMASON #Echocardiography

New Nationwide Study Confirms the Safety of LUMASON® in Echocardiographic Practice

In a significant development for the field of diagnostic imaging, Bracco Diagnostics Inc., a leader in this sector and a subsidiary of Bracco Imaging S.p.A., announced that new nationwide findings validate the safety of LUMASON®, an ultrasound enhancing agent (UEA), in echocardiographic procedures. This revelation comes from a comprehensive study published in the Journal of the American Heart Association on May 14, 2025, by Dr. Jordan B. Strom and colleagues, which evaluated the safety outcomes of over 11.4 million adult patients undergoing echocardiograms in the United States.

The study utilized all-payor claims data from echocardiograms conducted between 2018 and 2022, focusing on critical endpoints such as mortality and serious complications, including anaphylaxis, myocardial infarction, and cardiac arrests that were documented within two days following the cardiac ultrasound procedures. Notably, about 500,073 patients in this dataset underwent echocardiograms with the aid of LUMASON®.

The analysis revealed some remarkable outcomes:

• - A minimal rate of mortality or serious complications was observed among those who received LUMASON®.
• - There was a reduced risk of death associated with the use of LUMASON® compared to other UEAs, highlighting its effectiveness.
• - The likelihood of non-fatal serious complications was comparable between both UEA-enhanced and unenhanced echocardiograms, including instances of anaphylaxis.
• - Both LUMASON® and other UEAs demonstrated similarly low rates of serious complications.
• - Noteworthy, there were no differences in adverse events associated with LUMASON® before, during, and after the COVID-19 pandemic, suggesting its consistent safety profile.

Dr. Strom emphasized the importance of understanding the safety and benefits of UEAs for the medical community. As the director of the Echocardiography Laboratory at Beth Israel Deaconess Medical Center and an associate professor at Harvard Medical School, he stated, "Our findings affirm the safety of these agents while also indicating a correlation between their use and reduced mortality rates. This reinforces the notion that greater adoption of UEA can lead to enhanced diagnostic accuracy, improved patient outcomes, and ultimately, save more lives."

His sentiments were echoed by Dr. Alberto Spinazzi, Chief Medical Regulatory Officer at Bracco Imaging, who commented on the study's significance in portraying LUMASON® as a critical tool in improving healthcare outcomes. "This large-scale analysis offers valuable insights into the safety of ultrasound enhancing agents in echocardiography and reinforces our confidence in LUMASON®'s role in driving better patient outcomes," he noted.

LUMASON® is the sole UEA approved for various applications in both adult and pediatric patients. In echocardiographic practice, it is specifically utilized to enhance visual clarity of the left ventricular chamber and delineates the left ventricular endocardial border in cases of suboptimal echocardiograms. Thus, it plays a crucial role in ensuring accurate diagnoses in clinical settings.

Despite its advantages, LUMASON® is subject to specific safety protocols. Serious cardiopulmonary reactions have been documented, albeit uncommonly, during or post administration, necessitating medical personnel preparedness for resuscitation. Moreover, patients with known hypersensitivities to components such as polyethylene glycol (included in LUMASON®) are cautioned against its use.

In summary, the latest findings herald a positive trend in the application of LUMASON® in cardiac ultrasound, providing healthcare providers with the confidence to utilize this agent, enhancing diagnostic capabilities and improving patient safety across the board.

For further information regarding LUMASON®'s safety and application, including potential risks and fully detailed prescribing information, healthcare professionals are encouraged to refer to the official documentation provided by Bracco Diagnostics.