FDA Urged to Nix Black Box Label for Ultrasound Contrast Agents

FDA Urged to Nix Black Box Label for Ultrasound Contrast Agents

September 1, 2020 — Diagnostic Imaging
By Whitney J. Palmer
Grassroots group points to substantial clinical evidence of safety in call for agency to remove the warning.
Citing significant clinical evidence of safety, a multi-institutional, grassroots group has asked the U.S. Food and Drug Administration (FDA) to remove the black box warning from ultrasound contrast agents (UCAs), calling the label “outdated.”
These radiation-free agents are made of biocompatible suspensions that present no known risks for kidney or liver damage, and the body expels them (read more…)

Contrast-Enhanced Ultrasound; State of the Art in North America

Contrast-Enhanced Ultrasound; State of the Art in North America

Ultrasound Quarterly – September 1, 2020
Abstract
The Society of Radiologists in Ultrasound convened a panel of specialists in contrast-enhanced ultrasound (CEUS) to produce a white paper on noncardiac CEUS in North America. The panel met in Chicago, Illinois, on October 24 and 25, 2017. The recommendations are based on analysis of current literature and common practice strategies and are thought to represent a reasonable approach to introduce the advantages of this safe and noninvasive technique for the benefit of our patients. (read more…)

FDA Urged to Remove Boxed Warnings on Ultrasound Contrast Agents

FDA Urged to Remove Boxed Warnings on Ultrasound Contrast Agents

August 31, 2020 — Media release – Business Wire
A grassroots medical society today urged the FDA to remove boxed warnings from ultrasound contrast agents (UCAs), citing compelling scientific data demonstrating their safety and life-saving potential.
“Removing this “black box” will help patients across America access safer, more reliable and more cost-effective diagnostic imaging, while speeding up the introduction of appropriate therapy and saving lives,” according to a Citizens Petition submitted to the FDA by the International Contrast Ultrasound Society (ICUS), a (read more…)

To Give or Not to Give? Ultrasound Enhancing Agents Remain Underutilized Tools for the Quantification of Left Ventricular Ejection Fraction

To Give or Not to Give? Ultrasound Enhancing Agents Remain Underutilized Tools for the Quantification of Left Ventricular Ejection Fraction

August 20, 2020 — JASE
Background
Ultrasound enhancing agents (UEAs) have been demonstrated to improve left ventricular ejection fraction (LVEF) quantification and impact clinical decisions. Nevertheless, UEAs are used in only 6-7% of all transthoracic echocardiographs (TTEs) performed nationally. Furthermore, the decision is left up to the sonographer to give UEAs for subjectively suboptimal images, defined by ASE guidelines as the inability to detect two or more contiguous segments in any three of the apical windows. With a UEA usage rate of (read more…)

Ultrasound Enhanced S100A4-shRNA Delivery Using Acoustically Activated Cationic Lipid Nanodroplets to Reach and Treat Myocytes within the Developing Scar Zone

Ultrasound Enhanced S100A4-shRNA Delivery Using Acoustically Activated Cationic Lipid Nanodroplets to Reach and Treat Myocytes within the Developing Scar Zone

August 20, 2020 — JASE
Background
Definity nanodroplets (DND), formulated from commercial Definity microbubbles (DMB), can extravasate through endothelial barriers and be reactivated to microbubbles by transthoracic ultrasound. The exact location of the droplets within the extravascular space is unknown, but acoustic reactivation (ArA) may be a method of targeting intracellular mediators of scar formation. We hypothesized that ArA may enhance targeted intramyocardial delivery of inhibitory RNA to S100A4 (S100A4-shRNA), a known mediator in cardiac fibrosis.
Methods
Plasmids containing S100A4-shRNA coadministered with DND (DND-P) (read more…)

ASE Features Top 20 Echocardiography Research Abstract Presentations

ASE Features Top 20 Echocardiography Research Abstract Presentations

Echocardiography strain imaging at ASE. #ASE2020
August 20, 2020 — DAIC – Diagnostic and Interventional Cardiology
All ASE 2020 abstracts can be viewed at: www.onlinejase.com/article/S0894-7317(20)30227-3/pdf
More than 350 posters featuring cutting edge research on the advances in cardiovascular ultrasound were presented during the American Society of Echocardiography (ASE) 2020 annual meeting, Aug. 8-10. A special group of investigators were selected as the ASE Foundation’s Top 20.
These early career abstract presenters were selected by the Scientific Sessions Program Committee abstract chairs based on (read more…)

CEUS helps predict chronic kidney disease progression

CEUS helps predict chronic kidney disease progression

August 14, 2020 — AuntMinnie
By Theresa Pablos, AuntMinnie staff writer
Clinicians may be able to use contrast-enhanced ultrasound (CEUS) features to help predict which patients with chronic kidney disease will experience worse outcomes, according to the findings of a prospective study published on August 9 in Ultrasound in Medicine & Biology.
Researchers from Shanghai analyzed which features from CEUS scans were correlated with more severe chronic kidney disease progression in long-term patients. They found derived peak intensity (DPI), in particular, correlated with (read more…)

FDA approves RFID option for Definity contrast

FDA approves RFID option for Definity contrast

August 12, 2020 — Aunt Minnie.com
By AuntMinnie.com staff writers
Lantheus Medical Imaging has received approval from the U.S. Food and Drug Administration for version of its Definity ultrasound contrast agent that uses radiofrequency ID (RFID) technology to control the activation of the agent.
VialmixRFID for Definity uses an RFID-based activation device that is made specifically for Definity, an ultrasound contrast agent indicated for patients with suboptimal echocardiograms. The RFID technology controls the activation rate and time of Definity.
The RFID technology (read more…)

Improving Prognostic and Chronicity Evaluation of Chronic Kidney Disease with Contrast‐Enhanced Ultrasound Index-Derived Peak Intensity

Improving Prognostic and Chronicity Evaluation of Chronic Kidney Disease with Contrast‐Enhanced Ultrasound Index-Derived Peak Intensity

Aug 9, 2020 — Ultrasound in Medicine and Biology
Abstract
The capability of contrast‐enhanced ultrasound (CEUS) to assess the prognosis and chronicity of chronic kidney disease (CKD) was evaluated in patients diagnosed with CKD in 2014 at Ren Ji Hospital, Shanghai, China. Time–intensity curves and quantitative indexes were created using QLab quantification software. Kidney biopsies were analyzed with α-smooth muscle actin immunohistochemistry. According to the renal chronicityscore, patients were divided into four groups: minimal (n = 14), mild (n = 73), moderate(n = 49) and severe (n = 31). Multivariate (read more…)

Contrast-Enhanced Ultrasound Evaluation of Renal Blood Perfusion Changes After Percutaneous Transluminal Renal Angioplasty and Stenting for Severe Atherosclerotic Renal Artery Stenosis

Contrast-Enhanced Ultrasound Evaluation of Renal Blood Perfusion Changes After Percutaneous Transluminal Renal Angioplasty and Stenting for Severe Atherosclerotic Renal Artery Stenosis

August 1, 2020 — Ultrasound in Medicine & Biology
Abstract
This study used contrast-enhanced ultrasound (CEUS) to evaluate changes in renal cortical blood perfusion after percutaneous transluminal renal angioplasty and stenting (PTRAS) for severe renal artery stenosis (RAS) (≥70%). CEUS was performed in 21 patients with 24 severe RASs that underwent PTRAS. Renal cortical perfusion was quantitatively evaluated by comparing time intensity curve (TIC) parameters for SonoVue (Bracco, Milan, Italy) contrast enhancement, including peak intensity (PI), time to peak (TTP), mean transmit (read more…)