ICUS Weekly News Monitor 2-9-2017

1.  Mass Device,  Feb 2, 2017,  Lantheus wins FDA nod for Definity imaging agent label update     By Fink Densford
 
2.  StreetInsider.com,  Feb 2, 2017,  Lantheus (LNTH) Announces FDA Approval of DEFINITY Label Update
 
3.  RSNA Radiology,  Feb 1, 2017,  Integration of Contrast-enhanced US into a Multimodality Approach to Imaging of Nodules in a Cirrhotic Liver: How I Do It     Authors: Patricia C. Jo, MD, et al
 
 
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Mass Device
Feb 2, 2017
Lantheus wins FDA nod for Definity imaging agent label update
By Fink Densford
 
Lantheus Medical Imaging (NSDQ:LNTH) said today it won FDA approval for a label update on its Definity imaging agent which removed a contraindication related to use in patients with a known or suspected cardiac shunt.
 
The agent is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border, the North Billerica, Mass.-based company said.
 
The FDA’s decision to remove the contraindication was based on publications and data supporting the safety of the contrast fluid in patients with cardiac shunts, Lantheus said.
 
“The echocardiography medical and scientific community has long demonstrated the safety of echocardiographic contrast agents through published clinical studies which has supported the removal of the contraindication for Definity in patients with cardiac shunts. This is particularly noteworthy as Definity is the most widely used echocardiography agent in the U.S. with published data supporting its safety profile across multiple care settings and across gender and race in adults, including those age 65 and older. This is an important step toward broader acceptance and appropriate use of echo contrast agents, which can safely and cost effectively provide critical information to help clinicians accurately diagnose and manage patients to achieve better outcomes,” Dr. Neil Weissman of Washington D.C.’s MedStar Health Research Institute
 
“The label change implemented by FDA is reflective of both the extensive data on contrast agents and the well characterized and stable safety profile of Definity, which has been used to perform more than seven million echocardiography studies. The removal of the cardiac shunt contraindication is expected to provide patients who could benefit from this important diagnostic tool with greater access to Definity when undergoing cardiac ultrasound imaging,” chief medical officer Cesare Orlandi said in a press release.
 
Last September, Lantheus priced a $40 million offering with funds slated to pay down approximately $55 million of the outstanding principal balance under its senior secured credit facilities.
 
In August, Lantheus sold its Australian radiopharmacy servicing business to Global Medical Solutions.
 
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StreetInsider.com
Feb 2, 2017
 
Lantheus (LNTH) Announces FDA Approval of DEFINITY Label Update
 
Lantheus Medical Imaging, Inc. (“Lantheus”) today announced U.S. Food and Drug Administration (FDA) approval of an important label update for DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension which removes the contraindication statement related to use in patients with a known or suspected cardiac shunt from the U.S. Prescribing Information. DEFINITY is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
 
A cardiac shunt is a pattern of blood flow in the heart that deviates from the normal path of the circulatory system, which may present in 10 to 35 percent of patients. These patients were previously excluded from receiving a valuable echo contrast study of the left ventricle. The FDA’s decision to remove the contraindication concerning known or suspected cardiac shunts was based on Lantheus’ submission referencing several publications and data supporting the safety of echocardiography contrast products in patients with cardiac shunts. Information concerning administration in patients with a cardiac shunt appears in the Warnings section of the DEFINITY Prescribing Information.
 
“The label change implemented by FDA is reflective of both the extensive data on contrast agents and the well characterized and stable safety profile of DEFINITY, which has been used to perform more than seven million echocardiography studies,” said Cesare Orlandi, Chief Medical Officer at Lantheus. “The removal of the cardiac shunt contraindication is expected to provide patients who could benefit from this important diagnostic tool with greater access to DEFINITY when undergoing cardiac ultrasound imaging.”
 
Neil Weissman, M.D., President of MedStar Health Research Institute (Washington, DC), Professor of Medicine at Georgetown University and Past President of the American Society of Echocardiography commented, “The echocardiography medical and scientific community has long demonstrated the safety of echocardiographic contrast agents through published clinical studies which has supported the removal of the contraindication for DEFINITY in patients with cardiac shunts. This is particularly noteworthy as DEFINITY is the most widely used echocardiography agent in the U.S. with published data supporting its safety profile across multiple care settings and across gender and race in adults, including those age 65 and older.”
 
Dr. Weissman continued, “This is an important step toward broader acceptance and appropriate use of echo contrast agents, which can safely and cost effectively provide critical information to help clinicians accurately diagnose and manage patients to achieve better outcomes.”
 
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RSNA
Radiology
DOI: http://dx.doi.org/10.1148/radiol.2016151732
Feb 1, 2017
 
Integration of Contrast-enhanced US into a Multimodality Approach to Imaging of Nodules in a Cirrhotic Liver: How I Do It
Authors: Patricia C. Jo, MD; Hyun-Jung Jang, MD; Peter N. Burns, PhD; Kelly W. Burak, MD; Tae Kyoung Kim, MD; Stephanie R. Wilson, MD
 
From the Department of Radiology (P.C.J., S.R.W.) and Department of Medicine, Division of Gastroenterology (K.W.B., S.R.W.), Foothills Medical Centre, University of Calgary, 1403 29 St NW, Calgary, AB, Canada T2N 2T9; Department of Medical Imaging, Toronto General Hospital, University of Toronto, Toronto, Ont, Canada (H.J.J., T.K.K.); and Department of Imaging Research, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ont, Canada (P.N.B.).Address correspondence to S.R.W. (e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. ).
 
Abstract
Accurate characterization of cirrhotic nodules and early diagnosis of hepatocellular carcinoma (HCC) are of vital importance. Currently, computed tomography (CT) and magnetic resonance (MR) imaging are standard modalities for the investigation of new nodules found at surveillance ultrasonography (US). This article describes the successful integration of contrast material–enhanced US into a multimodality approach for diagnosis of HCC and its benefits in this population. The application of contrast-enhanced US immediately following surveillance US allows for prompt dynamic contrast-enhanced evaluation, removing the need for further imaging of benign lesions. Contrast-enhanced US also provides dynamic real-time assessment of tumor vascularity so that contrast enhancement can be identified regardless of its timing or duration, allowing for detection of arterial hypervascularity and portal venous washout. The purely intravascular nature of US contrast agents is valuable as the rapid washout of nonhepatocyte malignancies is highly contributory to their differentiation from HCC. The authors believe contrast-enhanced US provides complementary information to CT and MR imaging in the characterization of nodules in high-risk patients.

ICUS Weekly News Monitor 2-2-2017

1.  Diagnostic Imaging,  Feb 1, 2017,  Contrast-enhanced Ultrasound in Children
 
2.  American Journal of Roentgenology,  Feb, 1, 2017,  Retrospective Analysis of the Safety and Cost Implications of Pediatric Contrast-Enhanced Ultrasound at a Single Center     Authors: Gibran T. Yusuf, et al
 
3.  Medscape - Heartwire,  Jan 12, 2017,  FDA Removes Shunt Contraindication From Lumason Label     By Larry Hand
 
4.  Central European Journal of Urology,  Nov 30, 2016,  Contrast enhanced ultrasound in urothelial carcinoma of urinary bladder: An underutilized staging and grading modality.     Authors:  Gupta VG, et al
 
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Diagnostic Imaging
Feb 1, 2017
 
Contrast-enhanced Ultrasound in Children
 
Pediatric contrast-enhanced ultrasound (CEUS) is a safe procedure and allows for less ionizing radiation and gadolinium contrast administration, according to a study in the American Journal of Roentgenology.
 
Researchers from the United Kingdom analyzed adverse incidents encountered in pediatric CEUS, and sought to determine if there were financial benefits to reducing the number of CT and MRI examinations among children.
 
The researchers analyzed all CEUS examinations performed on children aged 18 and younger between January 2008 and December 2015. The children received a median dose of 2.4 mL of a sulfur hexafluoride microbubble contrast agent, with ranges from 0.1 mL to 4.8 mL. All immediate reactions deemed due to contrast examinations were documented in radiology reports. Electronic patient records were examined for adverse reactions within 24 hours not due to an underlying pathologic condition. Costs were also compared: CEUS utilization cost at $94, CT at $168, and MRI at $274.
 
The results showed that of 187 boys and 118 girls (305 children total), 147 studies (48.2%) were ordered to characterize liver lesions and 113 studies (37.1%) for trauma. The remaining 45 studies (14.8%) were for renal, vascular, and intracavitary assessment. There were no immediate adverse reactions and delayed adverse reactions occurred in two patients (0.7%): transient hypertension and transient tachycardia. Neither was symptomatic, and both were deemed not due to the underlying disorder. The potential cost savings of CEUS was $74 per examination over CT and $180 over MRI.
 
The researchers concluded that the use of pediatric CEUS is safe and potentially cost-effective. Using CEUS in this population allows reduction in the ionizing radiation associated with CT and in the gadolinium contrast administration, sedation, and anesthesia sometimes required for MRI.
 
_________________________________
American Journal of Roentgenology
Volume 208, Number 2
Feb, 1, 2017
 
Retrospective Analysis of the Safety and Cost Implications of Pediatric Contrast-Enhanced Ultrasound at a Single Center
Authors: Gibran T. Yusuf1, Maria E. Sellars1, Annamaria Deganello1, David O. Cosgrove1 and Paul S. Sidhu1
 
Affiliation: 1Department of Radiology, King's College London, King's College Hospital, Denmark Hill, London SE5 9RS, UK.
Citation: American Journal of Roentgenology. 2017;208: 446-452. 10.2214/AJR.16.16700
 
ABSTRACT :
OBJECTIVE. Because of concern over medical ionizing radiation exposure of children, contrast-enhanced ultrasound (CEUS) has generated interest as an inexpensive, ionizing radiation–free alternative to CT and MRI. CEUS has received approval for pediatric hepatic use but remains off-label for a range of other applications. The purposes of this study were to retrospectively analyze adverse incidents encountered in pediatric CEUS and to assess the financial benefits of reducing the number of CT and MRI examinations performed.
 
MATERIALS AND METHODS. All pediatric (patients 18 years and younger) CEUS examinations performed between January 2008 and December 2015 were reviewed. All immediate reactions deemed due to contrast examinations were documented in radiology reports. Electronic patient records were examined for adverse reactions within 24 hours not due to an underlying pathologic condition. With tariffs from the U.K. National Institute of Clinical Excellence analysis, CEUS utilization cost ($94) was compared with the CT ($168) and MRI ($274) costs of the conventional imaging pathway.
 
RESULTS. The records of 305 pediatric patients (187 boys, 118 girls; age range, 1 month–18 years) undergoing CEUS were reviewed. Most of the studies were for characterizing liver lesions (147/305 [48.2%]) and trauma (113/305 [37.1%]); the others were for renal, vascular, and intracavitary assessment (45/305 [14.8%]). No immediate adverse reactions occurred. Delayed adverse reactions occurred in two patients (2/305 [0.7%]). These reactions were transient hypertension and transient tachycardia. Neither was symptomatic, and both were deemed not due to the underlying disorder. The potential cost savings of CEUS were $74 per examination over CT and $180 over MRI.
 
CONCLUSION. Pediatric CEUS is a safe and potentially cost-effective imaging modality. Using it allows reduction in the ionizing radiation associated with CT and in the gadolinium contrast administration, sedation, and anesthesia sometimes required for MRI.
 
Read More: http://www.ajronline.org/doi/abs/10.2214/AJR.16.16700
 
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Medscape - Heartwire
January 12, 2017
 
FDA Removes Shunt Contraindication From Lumason Label
By Larry Hand
 
Bracco Diagnostics has announced that the Food and Drug Administration has removed from the label of Lumason the contraindication that it should not be used in patients with known or suspected right-to-left, bidirectional, or transient right-to-left cardiac shunts.
 
The FDA posted the new label for Lumason (sulfur hexafluoride lipid-type A microspheres) on its website December 22, 2016.
 
The new label maintains a specific warning that some intravenously injected microspheres could bypass the filtering by the lung and enter the arterial circulation and that Lumason should not be administered by intra-arterial injection.
 
"The removal of this contraindication implies that the FDA has determined that the benefits from the diagnostic information that could be obtained through the use of Lumason in patients with cardiac shunts may outweigh the risk for systemic embolization," Dr Alberto Spinazzi (Global Medical and Regulatory Affairs, Bracco Group) stated in the release.
 
Lumason, an ultrasound contrast agent made up of gas-filled microspheres to enhance echogenicity of blood or urine, was initially approved by the FDA in 2014 for use in adults with suboptimal echocardiograms. Known globally as Sonavue, it gained additional approval in 2016 for use in ultrasonography of the liver in adult and pediatric patients and for use in the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
 
The Centers for Medicare and Medicaid Services granted "pass-through" status in 2015 for reimbursement of Lumason in liver or abdominal ultrasound with contrast.
 
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Central European Journal of Urology
Cent European J Urol. 2016;69(4):360-365.
doi: 10.5173/ceju.2016.893. Epub 2016 Nov 30
Nov 30, 2017.
 
Contrast enhanced ultrasound in urothelial carcinoma of urinary bladder: An underutilized staging and grading modality.
Authors:  Gupta VG1, Kumar S2, Singh SK1, Lal A3, Kakkar N4.
 
1Post Graduate Institute of Medical Education and Research, Chandigarh, India.
2Department of Urology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
3Department of Radiodiagnosis, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
4Department of Histopathology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
 
Abstract
 
INTRODUCTION:
To evaluate contrast enhanced ultrasound (CEUS) as a modality to predict T stage of cancer of urinary bladder (CAUB) and to predict the grade of the tumor preoperatively.
MATERIAL AND METHODS:
110 patients with CAUB presenting to the Department of Urology at our institution between July 2014 and December 2015 underwent CEUS prior to endoscopic resection and the CEUS findings were compared with histopathology results.
RESULTS:
CEUS had a sensitivity of 75, 65 and 90% and specificity of 95, 85 and 92% in detecting Ta, T1 and muscle invasion respectively. CEUS had a sensitivity of 78% and specificity of 85% in detecting the grade of the lesion.
CONCLUSIONS:
CEUS is a good alternative for T staging and grading of CAUB preoperatively. It is uniquely advantageous in detecting clots or necrosis and in patients with low eGFR where other imaging modalities are contraindicated.

ICUS Weekly News Monitor 1-13-2017

1.  DOTmed.com HealthCareBusiness,  Jan 12, 2017,  Bracco's LUMASON contrast agent gets FDA approval for use in pediatric ultrasound of the urinary tract for vesicoureteral reflux
 
2.  Yahoo! Finance,  Jan 11, 2017,  The FDA removes the contraindication for use of Bracco Diagnostics Inc.'s LUMASON®
 
3.  ICUS,  (recorded webinar),  Contrast-enhanced Abdominal Ultrasound; What is it? How does it work? What is it good for?       By  Stephanie R. Wilson, MD
 
4.  ICUS,  (recorded webinar),  Contrast-enhanced Cardiac Ultrasound - A Tutorial       By Steven B. Feinstein, MD
 
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DOTmed.com
HealthCareBusiness
Jan 12, 2017
 
Bracco's LUMASON contrast agent gets FDA approval for use in pediatric ultrasound of the urinary tract for vesicoureteral reflux
 
(PRNewswire) -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that its contrast agent LUMASON is the first ultrasound contrast agent to obtain Food and Drug Administration (FDA) approval for use in ultrasonography of the urinary tract (voiding ultrasonography) for the evaluation of suspected or known vesicoureteral reflux (VUR) in pediatric patients.
 
VUR is a urinary tract abnormality in neonates, infants and children characterized by retrograde flow of urine from the bladder into the ureter and toward the kidney and represents a common cause of recurrent urinary tract infections and chronic nephropathy in pediatric patients.1 Voiding cystourethrography and direct radionuclide cystography are the imaging procedures currently used to diagnose VUR in the U.S., and both require exposure to ionizing radiation.1
 
"The approval of LUMASON for voiding ultrasonography answers an unmet medical need for an effective imaging study to detect and follow-up VUR without exposing neonates, infants and young children to the potential harmful effects of ionizing radiation," stated Alberto Spinazzi, MD, Head, Global Medical and Regulatory Affairs, Bracco Group. "This approval reflects the efforts of Bracco to seek and provide new and expanded indications for this class of products working collaboratively with the FDA."
 
LUMASON, known globally as SonoVue®, which has been marketed since 2001 and now in more than 30 countries, was initially approved in October 2014 by the FDA for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. LUMASON then gained FDA approval in March 2016 for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, and in December 2016, for use for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
 
With a proven safety profile, LUMASON is an ultrasound contrast agent made up of gas-filled microspheres that reflect the sound waves to enhance the echogenicity of the blood or urine, which results in an improvement in the diagnostic quality of the ultrasound images. The agent is packaged in a convenient three-part portable kit that does not require refrigeration or mechanical agitation. Each kit contains a LUMASON vial containing 25 mg of lipid-type A lyophilized powder and 60.7 mg sulfur hexafluoride headspace, a prefilled syringe containing 5 mL of Sodium Chloride 0.9% Injection, USP (Diluent), and a Mini-Spike.2
 
In late 2015, the Centers for Medicare and Medicaid Services (CMS) granted "pass-through" status for LUMASON reimbursement, under the Hospital Outpatient Prospective Payment System (HOPPS). Contrast material is not separately paid by Medicare for outpatient hospitals under HOPPS unless the product has "pass-through" status. This additional payment is unique to LUMASON due to its new technology status. Effective October 1, 2016, CMS approved the request for coverage and coding for liver and/or abdominal ultrasound with contrast under the HOPPS indicating that Healthcare Common Procedure Coding System (HCPCS) code C9744 can be assigned for these procedures when performed in the hospital outpatient setting
 
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Yahoo! Finance
Jan 11, 2017
 
The FDA removes the contraindication for use of Bracco Diagnostics Inc.'s LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use,
 
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that the U.S. Food and Drug Administration (FDA) has removed the contraindication for use of LUMASON in patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts.
 
In view of a potential safety hazard deriving from the use of LUMASON in this patient population, i.e., some of the intravenously injected microspheres bypassing the filtering by the lung and entering the arterial circulation, a specific warning has been maintained in the approved labeling of the agent (WARNINGS AND PRECAUTIONS section, 5.3: Systemic Embolization). Also, LUMASON must not be administered by intra-arterial injection.
 
"The removal of this contraindication implies that the FDA has determined that the benefits from the diagnostic information that could be obtained through the use of LUMASON in patients with cardiac shunts may outweigh the risk for systemic embolization," stated Alberto Spinazzi, MD, Head, Global Medical and Regulatory Affairs, Bracco Group. "FDA review is critical to ensuring the quality, safety and efficacy of contrast agents like LUMASON, and, in general, of medicinal products."
LUMASON, known globally as SonoVue®, which has been marketed since 2001 and now in more than 30 countries, was initially approved in October 2014 by the FDA for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. LUMASON then gained FDA approval in March 2016 for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, and in December 2016, for use for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
 
With a proven safety profile, LUMASON is an ultrasound contrast agent made up of gas-filled microspheres that reflect the sound waves to enhance the echogenicity of the blood or urine, which results in an improvement in the diagnostic quality of the ultrasound images. The agent is packaged in a convenient three-part portable kit that does not require refrigeration or mechanical agitation. Each kit contains a LUMASON vial containing 25 mg of lipid-type A lyophilized powder and 60.7 mg sulfur hexafluoride headspace, a prefilled syringe containing 5 mL of Sodium Chloride 0.9% Injection, USP (Diluent), and a Mini-Spike.1
 
In late 2015, the Centers for Medicare and Medicaid Services (CMS) granted "pass-through" status for LUMASON reimbursement, under the Hospital Outpatient Prospective Payment System (HOPPS). Contrast material is not separately paid by Medicare for outpatient hospitals under HOPPS unless the product has "pass-through" status. This additional payment is unique to LUMASON due to its new technology status. Effective October 1, 2016, CMS approved the request for coverage and coding for liver and/or abdominal ultrasound with contrast under the HOPPS indicating that Healthcare Common Procedure Coding System (HCPCS) code C9744 can be assigned for these procedures when performed in the hospital outpatient setting.n patients with cardiac shunts.
 
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 image015


Contrast-enhanced Abdominal Ultrasound
What is it? How does it work? What is it good for?
 
Stephanie R. Wilson, MD, FRCPC
Radiologist, Foothills Medical Centre, Calgary
Clinical Professor of Radiology and Medicine, Division of Gastroenterology, University of Calgary
Co-President, International Contrast Ultrasound Society
 
Free ,on-demand lecture presented as part of ICUS Grand Rounds
Recording of a live webinar presented on June 16, 2016
 
image022A certified, pre-recorded one-hour webinar for radiologists, radiologic technologists, gastroenterologists, nephrologists, urologists, oncologists, and internists.
 
Format: ARCHIVED Webinar
Credit:  1.0 AMA-PRA Category 1
Credit:  1.0 ARRT Category A+
Tuition: none
 
 
 
Course Overview
Contrast-enhanced ultrasound (CEUS) imaging requires administration of a microbubble contrast agent and specialized imaging techniques to show sensitive blood flow and tissue perfusion information. CEUS is a safe and easily performed technique that does not require ionizing radiation and has no risk of nephrotoxicity. Although commonly used in Canada, Europe and Asia, the use of microbubble contrast has been off-label and therefore not widely adopted in the U.S.1 The recent Food and Drug Administration approval of a microbubble agent for characterization of focal liver lesions is expected to bring the use of abdominal CEUS into clinical practice in the U.S.
 
This course covers patient indications for abdominal CEUS; how the contrast medium employs gas-filled microbubbles to improve the visualization of abdominal structures; and the benefits and disadvantages of using abdominal CEUS.
 
To register go to:  http://courses.icpme.us/index?string=&keywords=icus&category=&certificate=&format=&author=&x_submission=get
 
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 image015


Contrast-enhanced Cardiac Ultrasound
A Tutorial
 
Steven B. Feinstein, MD, FACC, FESC
Professor of Medicine-Cardiology
Academic Cardiologist, Rush University Medical Center,  Chicago, IL
 
Free, on demand; presented as part of ICUS Grand Rounds


image023A certified one-hour archived webinar for cardiologists, cardiac sonographers, radiologists, and radiologic technologists
 
Format: Archived Webinar
Credit:  1.0 AMA PRA Category 1
Credit:  1.0 ARRT Category A
Tuition: none
 
 
Course Overview
Contrast-enhanced cardiac ultrasound, also called contrast echocardiography, improves the diagnostic applications of non-enhanced echocardiography, including delineation of the left ventricular endocardial borders to better assess ejection fraction and evaluation of blood perfusion and volume.(1) Recent studies have also shown that cardiac echo is also a reliable vehicle for drug delivery for diseases of the cardiovascular system.(2) Contrast echo has a high safety profile compared to contrast enhanced- CT and -MRI and is portable and cost-effective.
 
1. The  Basics. American Society of Echocardiography website. http://contrastzone.com/ Accessed October 17, 2016.
2. Castle J, Feinstein SB. Drug and Gene Delivery using Sonoporation for Cardiovascular Disease. Adv Exp Med Biol. 2016;880:331-338.
 
To register go to:  http://courses.icpme.us/index?string=&keywords=icus&category=&certificate=&format=&author=&x_submission=get

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