ICUS Weekly News Monitor 10-6-2016

1.  MassDevice.com,  Oct 3, 2016,  FDA approves label changes for GE’s Optison
By Sarah Faulkner
 
2.  Aunt Minnie,  Oct 3, 2016,  Contrast US boosts diagnostic power of breast ultrasound
By Erik L. Ridley
 
3.  Journal of Ultrasound in Medicine,  Oct 1, 2016,  Diagnostic Value of Contrast-Enhanced Sonography for Differentiation of Breast Lesions;  A Meta-analysis
Authors:  Xuelei Ma, MD,  et al
 
4.  Journal of Ultrasound in Medicine,  Oct 1, 2016,  Hepatic Vein Arrival Time for Diagnosis of Liver Cirrhosis; A 10-Year Single-Center Experience With Contrast-Enhanced Sonography
Authors: Teresa Abbattista, MD, et al
 
5.  ICUS,  Oct 1, 2016,  CMS Announces Coding for liver and/or abdominal ultrasound with contrast
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*To view presentations live-streamed from the 31st Annual Advances in Contrast Ultrasound Bubble Conference held in Chicago, 8/9 September 2016, go to: www.livemedia.com/register/bubble16
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MassDevice.com
Oct 3, 2016
 
FDA approves label changes for GE’s Optison
By Sarah Faulkner
 
GGE Healthcare (NYSE:GE) announced today that the FDA approved label changes for its ultrasound contrast agent Optison, removing contraindications for use in patients with cardiac shunts and for administration by intra-arterial injection.
 
Optison is the 1st contrast agent available in the U.S. to receive this label change, according to GE.
 
“Up to one-third of our patients have known or suspected cardiac shunts and, thanks to this important FDA decision, they too will now have access to ultrasound contrast agents, which offer an inexpensive and radiation-free option for diagnostic imaging,” International Contrast Ultrasound Society co-prez Dr. Steven Feinstein said in prepared remarks. “The International Contrast Ultrasound Society applauds the FDA for its decision, and believes it will benefit individual patients as well as our healthcare delivery system,”
 
Previously, to determine if a patient was contraindicated to receive an ultrasound contrast agent, doctors used an agitated saline procedure to see if the blood flow pattern in the heart was characteristic of a cardiac shunt.
 
“We welcome this FDA decision and hope that this will allow more patients access to contrast-enhanced ultrasound procedures and improve the management of their conditions,” chief technology officer Ger Brophy added.
 
“We are extremely pleased that the FDA has changed the labeling for cardiac shunts with Optison when it is used in the clinically important group of patients who have suboptimal echocardiograms, and a need for left ventricular opacification and delineation of LV borders. Many of these patients have limited options for cardiac imaging, and the FDA’s decision will facilitate their care,” head of global medical services Mark Hibberd explained.
 
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Aunt Minnie
Oct 3, 2016
Contrast US boosts diagnostic power of breast ultrasound
By Erik L. Ridley, AuntMinnie staff writer
 
Contrast-enhanced ultrasound (CEUS) can be an effective method for the differential diagnosis of benign and malignant breast lesions, offering improvements in diagnostic accuracy over conventional breast ultrasound, according to research published in the October issue of the Journal of Ultrasound in Medicine.
 
In a meta-analysis incorporating nearly 30 studies and more than 2,000 patients, a team from Sichuan University in Chengdu, China, found that contrast-enhanced ultrasound offered a combined sensitivity of 88% and specificity of 80%. What's more, diagnostic performance also improved with the advent of second-generation contrast agents.
 
Dr. Xuelei Ma from Sichuan University.
"Contrast-enhanced sonography could be developed as a promising and effective tool for distinguishing benign from malignant breast lesions, which may be a valuable supplement to fine-needle aspiration [biopsy]," first author Dr. Xuelei Ma told AuntMinnie.com. "Meanwhile, in terms of contrast-enhanced breast sonography, the second-generation contrast agents might increase the diagnostic accuracy, and the harmonic mode might be more suitable for performance."
 
Improving accuracy?
 
Breast ultrasound has been shown to have relatively high sensitivity of approximately 90% and specificity of around 40%, according to the researchers. CEUS has been suggested as a way to improve the modality's diagnostic accuracy, but relevant studies have shown sensitivity ranging from 50% to 100% and specificity ranging from 37% to 100%.
 
"Meanwhile, the overall analysis of different types of contrast agents and contrast modes has not been assessed systematically," Ma said. "Therefore, we carried out this study to investigate the performance of contrast-enhanced sonography in the differential diagnosis of benign and malignant breast lesions."
 
The researchers searched PubMed and Embase for all relevant studies performed before January 2015. They also manually reviewed references of related articles (J Ultrasound Med, October 2016, Vol. 35:10, pp. 2,095-2,102).
 
Clinical studies were included in the meta-analysis if they met the following criteria:
They focused on the diagnostic value of contrast-enhanced sonography in breast cancer.
Histopathologic findings were used as the reference standard for lesion diagnosis.
 
They offered sufficient data to construct a table corresponding to true-positive, true-negative, false-positive, and false-negative rates.
 
The sample size must have been more than 10 patients and duplicate results needed to be eliminated.
 
The researchers did not include letters, reviews, editorials, and case reports. In cases where a study involved the same author or authors from the same medical center and had similar data and patient design, the researchers selected the article with the larger sample size. A total of 29 eligible studies satisfied the inclusion criteria and included an aggregate of 2,234 patients and 2,929 lesions.
 
Next, the team used the true-positive, false-positive, false-negative, and true-negative rates from all of the studies to produce a summary of sensitivity, specificity, positive likelihood ratios, negative likelihood ratios, and diagnostic odds ratio. They constructed a receiver operator characteristics (ROC) curve to summarize the true-positive and false-positive rates. They also assessed the quality of the studies using version 2 of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) method.
 
CEUS showed high sensitivity and specificity:
 
Sensitivity: 88%
Specificity: 80%
Pooled diagnostic odds ratio: 30.35
Area under the curve: 0.9115
Newer agents perform better
 
In further analysis, the researchers also compared the results of studies that used first-generation ultrasound contrast agents such as Levovist (Schering) and second-generation agents such as SonoVue (Bracco Diagnostics). In addition, they assessed the type of contrast mode used in each study.
 
"We found that the second-generation agent group had relatively higher sensitivity and specificity compared with the first-generation group, and the diagnostic performance was
significantly higher in the harmonic mode in comparison with the power/color Doppler mode," Ma said.
 
Performance by contrast media type:
                Sensitivity           Specificity            Diagnostic odds ratio      Area under the curve
1st-generation contrast agents  86%        77%        26.3        0.81
2nd-generation contrast agents                90%        85%        47.2        0.94
Performance by contrast mode
 
                Sensitivity           Specificity            Diagnostic odds ratio      Area under the curve
Power/color Doppler     85%        69%        18.7        0.88
Harmonic             90%        87%        51.6        0.94
 
"Our study suggests that contrast-enhanced sonography is a promising and effective method for differential diagnosis of benign and malignant breast lesions," the authors wrote. "It may be a valuable supplement to fine-needle aspiration [biopsy], which is still needed in cases of Breast Imaging Reporting and Data System category 3 and 4 lesions."
 
Further studies are still required to confirm their findings, according to the group. The researchers also plan to investigate the performance of CEUS in the differential diagnosis of benign and malignant lesions other than breast cancer.
 
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Journal of Ultrasound in Medicine
JUM October 1, 2016 vol. 35 no. 10 2095-2102
Oct 1, 2016
 
Diagnostic Value of Contrast-Enhanced Sonography for Differentiation of Breast Lesions
A Meta-analysis
 
Authors:
Xuelei Ma, MD⇑
State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu, China, Department of Oncology, West China Hospital, Sichuan University, Chengdu, China, Collaborative Innovation Center for Biotherapy, Chengdu, China
Address correspondence to Xuelei Ma, MD, West China Hospital, 37 Guoxue Alley, 610041 Chengdu, China. E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
 
Rongjun Liu, MS
West China School of Medicine, West China Hospital, Sichuan University, Chengdu, China
 
Chenjing Zhu, MD
State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu, China, Collaborative Innovation Center for Biotherapy, Chengdu, China
 
Jing Zhang, MD;  Wenwu Ling, MD
West China School of Medicine, West China Hospital, Sichuan University, Chengdu, China
 
Abstract
 
Objectives— The purpose of this study was to systematically review and evaluate the diagnostic accuracy of contrast-enhanced sonography in the differential diagnosis of benign and malignant breast lesions.
 
Methods— The scientific literature databases PubMed and Embase were comprehensively searched for relevant studies before January 2015. Data were pooled to yield the summary sensitivity, specificity, and diagnostic odds ratio using meta-analysis software.
 
Results— A total of 29 studies with 2296 lesions were included in the analysis. The pooled sensitivity and specificity were 0.88 (95% confidence interval [CI], 0.86–0.90; inconsistency index [I2] = 77.9%) and 0.80 (95% CI, 0.78–0.83; I2 = 84.0%), respectively. The pooled diagnostic odds ratio was 30.35 (95% CI, 15.75–58.48; I2= 82.1%), and the area under the summary receiver operating characteristic curve was 0.9115 (SE, 0.0243).
 
Conclusions— The comprehensive results suggest that contrast-enhanced sonography could be a potentially effective method for differential diagnosis of benign and malignant breast lesions.
 
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Journal of Ultrasound in Medicine
Oct 1, 2016
 
Hepatic Vein Arrival Time for Diagnosis of Liver Cirrhosis
A 10-Year Single-Center Experience With Contrast-Enhanced Sonography
 
Authors: Teresa Abbattista, MD⇑
Division of Radiology, Principe di Piemonte Hospital, Senigallia, Italy
Address correspondence to Teresa Abbattista, MD, Division of Radiology, Principe di Piemonte Hospital, via Cellini 1, 60019 Senigallia, Italy. E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
 
Francesco Ridolfi, MD, PhD
Division of Gastroenterology, Principe di Piemonte Hospital, Senigallia, Italy
 
Giovanni Traina Consalvo, MD
Division of Radiology, Principe di Piemonte Hospital, Senigallia, Italy
 
Eugenio Brunelli, MD
Division of Gastroenterology, Principe di Piemonte Hospital, Senigallia, Italy
 
Abstract
 
Objectives— To evaluate the performance of contrast-enhanced sonography with a second-generation contrast agent in assessing the severity of chronic diffuse liver disease and differentiating cirrhotic from noncirrhotic liver disease.
 
Methods— Contrast-enhanced sonography was performed after intravenous bolus injection of a second-generation contrast agent in 14 healthy control participants and 160 consecutive patients with cirrhotic and noncirrhotic liver disease (n = 78 and 82, respectively) enrolled between March 2004 and April 2014. The intensity of enhancement in a main hepatic vein was used to determine hepatic vein arrival time, time to peak intensity, and peak contrast enhancement.
 
Results— The hepatic vein arrival time was lower in cirrhotic patients compared with both noncirrhotic patients and controls (mean ± SD, 15.0 ± 2.8, 21.5 ± 3.4, and 25.6 ± 4.7 seconds, respectively; P < .05). The hepatic vein arrival time in noncirrhotic patients was also significantly lower than that in controls (P < .05). The time to peak intensity was significantly lower in cirrhotic patients compared with noncirrhotic patients and controls (40.7 ± 13.7, 49.4 ± 12.8, and 51.2 ± 13.7 seconds; P < .05). A receiver operating characteristic curve analysis revealed that the hepatic vein arrival time more accurately excluded a diagnosis of liver cirrhosis than the time to peak intensity (area under the receiver operating characteristic curve, 0.953 versus 0.694). Specifically, a hepatic vein arrival time cutoff value of 17 seconds excluded liver cirrhosis with 91.1% sensitivity and 93.6% specificity.
 
Conclusions— Contrast-enhanced sonography is a valid alternative method for noninvasive staging of liver diseases. The hepatic vein arrival time could be used to exclude liver cirrhosis in a clinical setting.
 
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ICUS
Oct 1, 2016
 
CMS Announces Coding for liver and/or abdominal ultrasound with contrast
 
CMS has announced approval for coverage and coding for liver and/or abdominal ultrasound with contrast under the HOPPS.   Effective October 1, 2016, liver and/or abdominal ultrasound procedures with contrast can be assigned Healthcare Common Procedure Coding System (HCPCS) code C9744, when performed in the hospital outpatient setting.
 
ICUS is pleased with this development, noting the broad use of contrast enhanced ultrasound imaging that has been available for several years in Europe, Asia and elsewhere. It marks a significant step in bringing the US into line with the rest of the world, giving patients access to non-invasive, non-radiation-based diagnostic imaging for tumors and organ systems throughout the body.

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