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Diagnosis • Technology • Therapy • Prevention DI EUROPE AUG/SEPT 2017 Hybrid Imaging F-NaF imaging of 18 vulnerable plaques and EUROPE myocardial scar tissue using hybrid PET/CT and PET/MR ECR Symposium Reports Siemens Breast Care Day: Dense Breasts Bracco: CEUS Workflow Dichotomization and the Radiologist’s Workflow Environment Radiation Exposure in Prostatic Embolization Point-of-Care Cardiovascular Ultrasound MRI: Putting Patient Imaging Comfort First Imaging News Industry News Technology Updates DIEUROPE.com
SONOSITE IS THE MOST ADOPTED AND CONSIDERED POCUS PROVIDER. Each year, KLAS – an independent healthcare research agency – interviews thousands of healthcare professionals about the products and services their organisations use. This year’s 2017 KLAS ultrasound report, shows that Fujifilm SonoSite is the most adopted and widely considered vendor for point-of-care ultrasound. READ MORE ON WHICH POINT-OF-CARE ULTRASOUND MACHINE HOSPITALS USE MOST. SONOSITE and the SONOSITE logo are trademarks and registered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. FUJIFILM is a trademark and registered trademark of FUJIFILM Corporation in various jurisdictions. All other trademarks are the property of their respective owners. Copyright © 2017 FUJIFILM SonoSite, Inc. All rights reserved. Subject to change. MKT02929 06/17
DI EUROPE BY Alan barclay, ph.d. VOLUME 33, NUMBER 4 EDITORIAL ADVISORY BOARD FROM THE EDITOR Andreas Adam, London Richard P. Baum, Bad Berka Frits H. Barneveld Binkhuysen, Filipe Caseiro Alves, Coimbra Maksim Cela, Tirana Elias Brountzos, Athens Amersfoort Carlo Catalano, Rome Patrick Cozzone, Marseille GBCAs — the Precautionary Principle Katarzyna Gruszczynska, Andrea Klauser, Innsbruck Gabriele Krombach, Giessen Anne Grethe Jurik, Arhus Katowice Gabriel Krestin, Rotterdam Christiane Kuhl, Bonn behind the differences in attitude between Europe and U.S. ? Philippe Lefere, Roeselare Heinz U. Lemke, Kuessaberg Thoralf Niendorf, Berlin Anne Paterson, Belfast Anders Persson, Linköping Hans Ringertz,Stockholm Gustav von Schulthess, Zurich Valentin E.Sinitsyn,Moscow Patrick Veit-Haibach, Lucerne Thomas J.Vogl,Frankfurt The bureaucratic wheels of the European the brain and have come up so far with the Medicine Agency grind inexorably on. A a “watch-and wait” policy. The FDA pointed EDITORIAL STAFF review of gadolinium contrast agents was out that since to date there was no direct Editor Alan Barclay, Ph.D. E-mail: a.barclay@dieurope.com first initiated more than a year ago at the evidence that gadolinium retention in the Tel. +32 479 370 364 request of the European Commission in brain from any of the GBCAs is harmful, US Consulting Editor Greg Freiherr view of the increasing number of reports they considered that restricting GBCA use E-mail: greg.freiherr@gmail.com Publisher David Lansdowne that deposits of gadolinium were being iden- was not warranted at this time. The FDA E-mail: d.lansdowne@dieurope.com tified in certain areas of the brains of patients will continue to assess the safety of GBCAs. Associate Publisher Bob Warren E-mail: b.warren@dieurope.com who had previously received Gadolinium- Many observers of the European regula- Based Contrast agents (GBCAs) in MRI tory processes explain the difference in examinations. attitude to GBCAs on either side of the Following a clearly described procedure the Atlantic as being due to the application of SUBSCRIBER SERVICES Telephone: +44 1442 877777 Pharmacovigilance and Risk Assessment the (in)famous European “ Precautionary Committee (PRAC) of the European Principle ” which has already caused much Subscription and article reprints: E: info@dieurope.com Medicines Agency was then tasked with controversy in the field of environmental analysing the available evidence. The protection. Subscription rates per annum: Within Europe €60.00 PRAC’s preliminary recommendations Basically the Precautionary Principle may ROW €110.00 were then published in March this year. be invoked when “a phenomenon, product INTERNATIONAL SALES OFFICES Following a request from the commercial or process may have a dangerous effect, as Europe, North America & Japan companies who supplied the market, the identified by a scientific and objective evalu- DI Europe Ltd PRAC re-examined its initial recommenda- ation, if this evaluation does not allow the Tel: + 44 (0)1442 877777 tion to produce final recommendations, risk to be determined with sufficient cer- David Lansdowne which were were then sent to the Committee tainty”. The guidelines for its application are E-mail: d.lansdowne@dieurope.com Bob Warren for Medicinal Products for Human Use threefold : the fullest possible scientific eval- E-mail: b.warren@dieurope.com (CHMP), responsible for questions con- uation, the determination, as far as possible, Marika Cooper cerning medicines for human use, which has of the degree of scientific uncertainty; a risk E-mail: m.cooper@dieurope.com adopted the Agency’s final opinion. This is evaluation and an evaluation of the potential where we are now, with the last step in the consequences of inaction; and finally the China Korea bureaucratic chain still to be finalised — participation of all interested parties in the Adept Marketing Young Media Inc namely the formality of the adoption by the study of precautionary measures, once the 13F Por Yen Bldg 407 Jinyang Sangga 478 Castle Peak Road 120-3 Chungmuro 4 ga European Commission of a legally binding results of the scientific evaluation and/or the Cheung Sha Wan, Kowloon Chung-Ku, Seoul, Korea 100-863 decision applicable in all EU Member States. risk evaluation are available. Hong Kong E-mail: ymedia@chol.com Thus, it is now inevitable that the recom- Despite the differences between the FDA E-mail: adonism@adeptmkg.com.hk Telephone: +82 2 2273 4819 mendations of the PRAC will be enforced in and the European authorities on the need Telephone: +852 2891 7117 Fax: +82 2 2273 4866 Fax: +852 2893 2101 Contact: Young J. Baek European law. to withdraw the marketing authorization Contact: Adonis Mak To summarize, the result is that the market- for linear GBCAs, they share the same view ing authorization for linear GBCAs — the as to the desirability of further research into Article Reprint Sales DI Europe Ltd Tel: +44 1442 877777 chemical chelate which is known to be more the mechanisms behind and characteris- Email: m.cooper@dieurope.com prone to leaching the Gadolinium ions — tics of the deposition of the gadolinium in DIAGNOSTIC IMAGING EUROPE is published eight times a year by DI Europe Ltd will be suspended in Europe, whereas the the brain. And there at least, if the steadily Printed by Manson, St-Albans, UK. Annual subscriptions are available for €60 within Europe where it is also sent free of charge to physicians and radiology more stable macrocylic chelates will con- increasing number of papers published in department heads. Outside of Europe, there is an annual subscription charge of €110 for air mail. Single copy price is €10. Editorial Advisory Board members suggest topics for coverage and answer questions for the editors. They do tinue to be authorized. the field is anything to go by, then the appeal not conduct a formal peer-review of all manuscripts submitted to DI Europe. Throughout the review process, the regula- is being heeded. It will be on the results of Copyright © 2017 DI Europe Ltd. All rights reserved. Reproduction in any form is forbidden without express permission of copyright owner. tory bodies were at pains to point out that such research that any future changes in the although free gadolinium ions are known regulation of GBCAS will be based. to be toxic in themselves, no evidence of In the meantime, one of the most danger- DI Europe Ltd 2 Claridge Court adverse side effects had yet been found in ous effects of the current situation is that, in Lower Kings Road Berkhamsted, Herts HP4 2AF patients where deposits of gadolinium were practice, radiologists may be scared off the UK seen, presumably caused by the dissociation use of all GBCAs, even the macrocyclic form Telephone: +44 1442 877777 of the gadolinium ion from its chelate. which are still on the market and which so far have not been shown to be associated Meanwhile on the other side of the Atlantic, with gadolinium deposits in the brain, with the redoubtable FDA have also been look- the great risk that the diagnostic utility of the ing at the issue of gadolinium deposition in MRI exam may be seriously compromised. DIEUROPE.com AUG/SEPT 2017 D I E U R O P E 3
® AUG/SEPT 2017 EUROPE Cardiovascular Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24-39 According to World Health Organization statistics, Cardiovascular disease (CVD) causes more than half of all deaths across the European Region. CVD causes 46 times the number of deaths and 11 times the disease burden caused by AIDS, tuberculosis and malaria combined in Europe. 80% of premature heart disease Each year cardiovascular disease (CVD) causes 3.9 million and stroke is preventable. deaths in Europe and over 1.8 million deaths in the European Imaging has a vital role to play in prevention, diagnosis and monitoring of therapy Union. CVD is the main cause of death in men in all but 12 countries of Europe and is the main cause of death in women in all but two countries. REPORTS Feature articles ECR Symposium Reports 10-13|Global Insights for CEUS in radiology: a Bracco spon- sored symposium on contrast enhanced ultrasound in the fields of liver, macrovascular and breast imaging CEUS in liver imaging: Cardiac Imaging News Page The future of breast 40-43| Breast Care Day. A day-long the new ACR LI-RADS Page 25 cancer screening — symposium sponsored by classification where can it help the Siemens Healthineers and dense breast ? devoted solely to recent devel- Page 10 opments in breast imaging. Page 40 “Dealing with radiology’s prob- lem child - dense breasts” imaging news MRI reveals striking brain differences in people with genetic autism . 5 Cardiovascular Imaging Experimental PET tracer detects small blood clots . . . . . . . . . . . . . . 5 Optimal method for diagnosis of head injuries in children and 26-28| 18F-NaF imaging of vulnerable 6 minimization of use of CT scans .. . . . . . . . . . . . . . . . . . . . . . . . . . . plaques and myocardial scar tissue using hybrid PET/CT UK must do more to future-proof its MRI capacity, say imaging experts .. 9 and PET/MRI First Alzheimer’s trial with focused ultrasound . . . . . . . . . . . . . . . . 9 30-32| Low-dose coronary computed tomography angiography with RADIOLOGY WORK FLOW prospective ECG triggering to predict cardiac events in the Workflow Dichotomization and the Radiologist’s Workflow Environment. . . 14-16 long term. RADIATION DOSE EXPOSURE 34-35| The role of cardiovascular imaging modalities in the Radiation Exposure in Prostatic Embolization. . . . . . . . . . . . . . . 18-19 evaluation of IgG4-related car- diovascular disease. POINT of CARE ULTRASOUND POC US in regional anaesthesia and intesive care. . . . . . . . . . 44-45 36-38| Early Echocardiography has a Low Yield in Patients with Transient Ischemic Attack. MRI Putting Patient Comfort First: a New Perspective on 20-22|Industry News Improving Imaging Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . 46-47 48-50|Technology Update Coming in the next issue: Visit us at DI EUROPE Breast Imaging DIEUROPE.com AUG/SEPT 2017 D I E U R O P E 4
IMA GI N G NEWS MRI reveals striking brain differences in people with genetic autism In the first major study of its kind, some striking differences in the brain researchers using MRI have identified structures of deletion and duplication structural abnormalities in the brains carriers compared with non-carriers. of people with one of the most com- For instance, the corpus callosum, the mon genetic causes of autism, accord- fiber bundle that connects the left and ing to a new study (Owen JP et al Brain right sides of the brain, was abnor- MR Imaging Findings and Associated mally shaped and thicker in the dele- Outcomes in Carriers of the Reciprocal tion carriers but thinner in the dupli- Copy Number Variation at 16p11.2. cation carriers, compared to the con- Radiology. 2017 Aug :162934. doi: trol group and familial non-carriers. 10.1148/radiol.2017162934) Other stark differences were apparent. The abnormalities visible on brain The deletion carriers displayed fea- images corresponded to cognitive and tures of brain overgrowth, including behavioral impairments in the study the extension of the cerebellum toward group, suggesting a future role for the spinal cord. The duplication car- imaging in identifying people with riers showed characteristics of brain autism who are in most urgent need of undergrowth, such as decreased white intervention. matter volume and larger ventricles. Autism spectrum disorders are When the researchers compared a group of developmental problem; cognitive assessments to imaging find- symptoms typically appear early in life Example images for a control participant, a deletion ings, they found that the presence of and frequently include communica- carrier, and a duplication carrier. In the sagittal image any imaging feature associated with the tion problems and repetitive behav- of the deletion carrier, the thick corpus callosum, deletion carriers — such as a thicker iors. Many people with autism have dens and craniocervical abnormality. Image Credits: corpus callosum — indicated worse Radiological Society of North America abnormalities at a specific site on the daily living, communication and social 16th chromosome known as 16p11.2. skills, compared to deletion carriers Deletion or duplication of a small piece without any radiological abnormalities. of chromosome at this site is one of the most common For the duplication carriers, the presence of decreased genetic causes of autism spectrum disorder. white matter, corpus callosal volume and increased ven- “People with deletions tend to have brain overgrowth, tricle size was associated with decreased full-scale and developmental delays and a higher risk of obesity,” said verbal IQ scores, compared to duplication carriers without study author Dr Julia P. Owen. “Those with duplications those findings. are born with smaller brains and tend to have lower body Senior author Dr Elliott Sherr commented, “Often stud- weight and developmental delays.” The researchers at UCSF ies like this focus on high-functioning individuals, but this and four other sites performed structural MRI exams on 79 was an ‘all-comers’ group,” he said. “We didn’t do math- deletion carriers, ranging in age from 1 to 48, and 79 dupli- ematical algorithms but rather used the trained eyes of cation carriers, ages 1 to 63, along with 64 unaffected fam- neuroradiologists to evaluate the scans of a full range of ily members and 109 participants in a control group. The individuals. When you look at a broad range of people like participants completed a battery of cognitive and behav- this, from developmentally normal to more significantly ioral tests, and neuroradiologists reviewed the brain images challenged, you’re better able to find these correlations.” for development-related abnormalities. The results showed https://tinyurl.com/Owen-et-al-paper Experimental PET tracer detects 58: 1094). Current imaging modalities rely on structural characteristics, such as vascular flow impairment, and do not small blood clots address the critical molecular components. Blood clots in veins and arteries can lead to heart attack, “Currently available diagnostic techniques of thrombus stroke, and pulmonary embolism, which are major causes of imaging rely on different modalities depending on the vas- mortality. In the featured article of The Journal of Nuclear cular territory,” explains Dr Andrew W. Stephens, of Piramal Medicine’s July 2017 issue, German researchers show that Imaging GmbH, Berlin, Germany. “A single imaging modality targeting GPIIb/IIIa receptors, the key receptor involved in that could visualize thrombi from various sources in different platelet clumping, with a fluorine-18 (18F) labeled ligand is anatomic regions would be very valuable.” For this preclinical a promising approach for diagnostic imaging (Lohrke J et al study researchers successfully developed the novel small mol- 18 F-GP1, a Novel PET Tracer Designed for High-Sensitivity, ecule tracer 18F-GP1 for positron emission tomography (PET) Low-Background Detection of Thrombi. J Nucl Med. 2017; imaging that binds with high affinity to GPIIb/IIIa receptors. AUG/SEPT 2017 D I E U R O P E 5
IMAGING NEWS help inform the use of the clinical decision rules for head injuries, which in turn could minimize CT scans, according to Lead investigator, Dr F Babl. who said “The aim of this study was to determine which children need CT scans to detect brain injury,” said Dr Babl.”Most head injuries are mild and don’t require neurosurgical management, however, a small proportion of patients might present as having mild injuries, but have clinically significant intracranial injuries,” he said. “This can be a vexed issue because physicians need to bal- ance the importance of diagnosing an injury with reducing Strong signals are detected at the sites where inserted catheters had roughened surfaces. radiation exposure as much as possible.” Almost no other background signal is visible. Only accumulation in the gallbladder becomes In these cases, clinicians can turn to clinical decision rules, visible at the bottom. Image coutesy of Piramal Imaging GmbH, Berlin Germany which have been developed to identify children at high risk of intracranial injuries, aiming to assist clinicians to minimize F-GP1 showed a strong accumulation at the site of throm- 18 CT scans while still identifying all relevant injuries. bus formation, and its binding ability was not affected by anti- In the prospective observational study, run across 10 coagulants such as aspirin and heparin. The tracer showed Australian and New Zealand tertiary hospitals and involving rapid blood clearance, and PET imaging in a Cynomolgus 20,137 children with head injuries under the age of 18 years, monkey model demonstrated the detection of small venous the research team compared three clinical decision rules and arterial clots, endothelial damage and emboli in the brain. • The Pediatric Emergency Care Applied Research Network Due to the favorable pre-clinical results, a first-in-human study of 18F-GP1 is currently underway. Early results from an interim analysis confirm the preclinical data and were pre- sented at the 2017 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in June. “Although the current studies are preliminary, 18F-GP1 may provide not only more accurate anatomic localization, but also information of the risk of the clot growth or embolization,” Stephens points out. “This may lead to changes in clinical intervention to the individual patient.” Addressing the use of anticoagulants to treat blood clots, he notes, “These drugs can cause significant and life-threatening bleeding. There is a critical need to balance the risk of bleeding against the risk of clotting in each patient. 18F-GP1 may in the future assist in this important decision.” .https://tinyurl.com/Lohrke-et-al-paper (PECARN, USA) ; • The Canadian Assessment of Tomography for Childhood Head Injury (CATCH) rule Optimal method for diagnosis of •The Children’s Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE, UK). head injuries in children and The goal was to determine which of these three decision minimization of use of CT scans rules provided the best option when it came to identifying children at very low risk of a traumatic brain injury. Researchers hope to reduce unnecessary CT scans and The researchers found that all three rules were good radiation exposure in children with head injuries, following options, but only one, the PECARN from the US, did not the results from a large-scale, multicenter validation study miss a single patient requiring neurosurgery. to assess the diagnostic accuracy of three clinical decision Internationally, the findings should provide a useful start- rules used by emergency doctors (Babl FE et al. Accuracy of ing point for individual clinicians as well as hospitals or PECARN, CATCH, and CHALICE head injury decision rules in regional bodies contemplating the introduction or modifica- children: a prospective cohort study. Lancet. 2017 17; 389: 2393). tion of one of the clinical decision rules. Dr Babl pointed Head injuries are one of the most common reasons chil- out : “However, it will be important to relate the findings to a dren are taken to emergency departments. To rule out a seri- number of other factors before implementation, such as the ous brain injury, a percentage of these children require a CT baseline CT use, the effect of the rules on the projected CT scan and while this is obvious for serious head injuries, it’s rate, the baseline clinician diagnostic accuracy and experience, more challenging to determine whether CT scans are neces- parental expectations, the medico-legal climate and economic sary for children with milder injuries. considerations.” The results from the recent Australasian clinical trial will https://tinyurl.com/Babl-et-al-paper 6 D I E U R O P E AUG/SEPT 2017
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The Annual Scientific Meeting of the ESMRMB 19. – 21. 19 21 10. 10 2017 Barcelona / ES S A platform for physicians, engineers, radiograph radiographers hers / research technologists and scientists interested in MR res search and clinical practice. HIGHLIGHTS WILL INCLUDE ∙ Sir Peter Mansfield Lecture by A. Heerschap, Nijmegen / NL ∙ Teaching Sessions on basic & advanced level ∙ Plenary Sessions by renowned speakers from Europe and the USA: ∙ Microstructure - from bench to bedside ∙ Big data from cohort and clinical studies ∙ MRI for neuroscience COME AND JOIN OUR DISCUSSIONS ∙ Hot Topic Debate: “Quantitative relaxation time measurement: boom or bust?” ∙ Roundtable Discussion: “What is the future of contrast agents in MRI?” Dedicated networking opportunities: the opportunity to meet with experts, friends and colleagues. www.esmrmb.org
IMAGING NEWS UK must do more to future-proof its MRI capacity, say imaging experts Imaging experts in the UK are urging hospitals to for- • Only half of the organisations surveyed have plans to mulate clear plans to replace outdated equipment, after replace scanners and there are no succession plans in place a survey revealed that half of healthcare organisations for nearly 40% of MRI systems that are over seven years old do not have any renewal plans, and more than a third of • While clinicians rated the vast majority of their MRI older magnetic resonance imaging (MRI) scanners are scanners as state-of-the-art or adequate, 8% of systems were not scheduled for replacement. While many hospitals are deemed “obsolete” The UK’s MRI capacity is stretched com- operating newer equipment, 58% of MRI systems used pared to other countries. The UK has 6.1 MRI systems by those surveyed are at least five per million people, fewer than coun- years old, meaning they may not be tries including Estonia and Slovenia. able to conduct state-of-the-art imag- By comparison, the US has 38.1 and ing, such as that needed for certain Germany has 30.5 scanners per million. types of heart and prostate cancer As well as assessing the state of their scanning. Nearly a third (29%) of equipment, clinicians were also asked to systems are over ten years old. The estimate future MRI workload. On aver- Clinical Imaging Board (CIB) – a age, departments expect to see demand collaboration between The Royal rise by 13% this year. In addition to College of Radiologists (RCR), the upgrades and the replacement of old Society and College of Radiographers systems, the radiology teams surveyed (SCoR) and the Institute of Physics said they will need approximately 50 and Engineering in Medicine (IPEM) – surveyed NHS brand new scanners to meet escalating demand for imaging. radiology departments across the UK to gauge the state “While many hospitals have MRI replacement plans in place, of MRI equipment. it is concerning to see others do not appear to be planning The survey findings in were issued in the report,“Magnetic for the future, especially when it comes to those working Resonance Imaging (MRI) Equipment, Operations and with older machines. That nearly 40% of MRI scanners that Planning in the NHS”. are seven or more years old are not destined for replacement The CIB survey, which collected data relating to 171 scan- any time soon is a real worry. ners used across the UK, revealed; “Radiology departments are already struggling with ever- • 29% of MRI systems are at least ten years old – the growing workloads and not enough staff, and many now face European Society of Radiology recommends scanners more working with outdated equipment. than ten years old be replaced or risk becoming obsolete. https://tinyurl.com/UK-MRI-report First Alzheimer’s trial with same patient will target a larger area of the focused ultrasound right frontal lobe, and additional images will again evaluate if the blood-brain bar- Researchers at Sunnybrook Health rier is reopened. No drugs will be adminis- Sciences Centre in Toronto, Canada have tered in the study. begun the world’s first clinical trial evalu- “Our trial investigates, for the first time, ating the feasibility and safety of opening the use of focused ultrasound to open the the blood-brain barrier in patients with blood-brain barrier in patients with early- Alzheimer’s disease using focused ultra- to-moderate Alzheimer’s disease, to deter- sound. mine both its safety and technical feasibil- For this trial, six Alzheimer’s patients, ity,” says Nir Lipsman, co-principal inves- provide an important method for more ages 50–85 years, will undergo two non- tigator of the Sunnybrook study. “Results effectively delivering antibodies to the brain invasive focused ultrasound procedures. from our study will help us plan future and may therefore one day be a treatment For the first stage, the Exablate Neuro low- clinical trials to establish what role focused for Alzheimer’s—we just don’t yet know. It frequency platform (Insightec) will apply ultrasound may play, whether alone or in is important to note that at this point we focused ultrasound in a small area of the conjunction with medical treatments, in the are assessing only the feasibility and safety right frontal lobe, and images will evaluate management of Alzheimer’s of opening the blood-brain barrier in these if the blood-brain barrier was temporarily Sandra Black, senior scientist and co- patients.” opened. In the second stage, approximately principal investigator at Sunnybrook adds, https://tinyurl.com/Sunnybrook- one month later, a similar procedure to the “It is possible that focused ultrasound may alzheimer-s AUG/SEPT 2017 D I E U R O P E 9
Symposium Report Global Insights for CEUS in radiology This article summarizes the proceedings of the recent symposium sponsored by Bracco Imaging at ECR 2017 on Contrast Enhanced Ultrasound (CEUS) imaging. Chaired by Prof. J. M. Correas, the symposium featured presentations by three dis- tinguished clinicians experienced in CEUS in the respective fields of liver, macrovas- cular and breast imaging. CEUS in liver imaging: the new ACR influence subsequent management or therapy strategies LI-RADS classification [Figure 1]. Prof. Fabio Piscaglia LR-1 (Definitely Benign). This is the category where In 2013 the American College of Radi- imaging features are diagnostic of a definitely benign ology (ACR) released their recom- entity. This category includes simple cysts, classic hem- mended flowcharts for CT and MRI angioma, definite focal hepatic fat deposition or sparing. characterization of the liver in patients at risk of Hepatocellular Carcinoma LR-2 (Probably Benign). This category is relatively rare (HCC) and introduced the Liver Imag- Dr. Fabio Piscaglia, and occurs when the nodule has imaging features sug- ing Reporting and Data System (LI- is Professor of Internal gestive, but not diagnostic, of a benign entity. The criteria RADS), the system of standardized ter- Medicine, at the for this category are: isoenhancement in all phases; of minology and criteria to interpret and University of Bologna, very small distinct solid nodule (10 mm community to apply consistent terminology; to reduce is iso-enhancing in all phases (ISO-ISO); a distinct solid variability and errors in image interpretation; to facilitate nodule of any size with arterial phase hypoenhancement integration with other imaging modalities and to improve without washout (HYPO-ISO); a solid nodule
and mild and late washout CEUS in vascular imaging of pathol- (very small HYPER-HYPO); a distinct solid nodule ≥ 10 mm ogies in the macrovascular system with hyperhenancement in Prof D-A Clevert arterial phase without washout As background, Prof Clevert of any type (HYPER-ISO). reminded the audience that approxi- mately 25-50% of all strokes (them- LR-5 (definitely HCC). In LR-5 selves the third leading cause of the nodules have imaging fea- death after ischemic heart disease tures diagnostic of HCC. The and cancer) are caused by unstable criteria for LR-5 are a nod- carotid artery plaque. It is also vitally Dr. D-A Clevert is ule ≥ 10 mm showing arterial important to know whether a patient Professor of Radiology and Head of the Interdisciplinary phase enhancement (in whole is suffering or not from a high grade Ultrasound Center, Dept of or in part, excluding rim and stenosis, which in turn can affect the Clinical Radiology, University peripheral discontinuous globu- choice of treatment e.g. stenting, sur- of Munich, Grosshadern, lar enhancement) followed by gery or no therapy. Germany washout (late in onset and mild CT or MRI can already provide d i r k . c l e v e r t @ m e d . u n i - munenchen.de in degree (as observed by 120 clear and extensive information, e.g. seconds after injection). This regarding stenosis of the carotid, so a valid question is what pattern has an extremely high precise additional information does CEUS bring? Figure 2. An example of LR-5, positive predictive value for i.e. definitely HCC, with character- HCC and can be considered Contrast Enhanced Ultrasound (CEUS) istic mild and late Hyper to Hypo enhancement. definitively diagnostic [Figure A typical ultrasound examination of the carotid artery begins Top Panel: base-line. Middle 2]. with standard grey-scale ultrasound, followed by color Dop- Panel: arterial phase. Bottom pler, which however has some well-known limitations, such Panel: portal phase LR-M (Definite or probable as scanning angle and blooming artefacts. malignancy, but not specific CEUS can overcome these limitations. In practice CEUS for HCC). The criteria for this final category are: a nod- examinationscan be performed using different image disply ule with rim enhancement in the arterial phase on wash- techniques: e.g. overlay images including some tissue back- out either early in onset (within 60 seconds of contrast ground information (which is advantageous if the anatomic injection) and/or in intensity, regardless of the type of landmarks are visible) or contrast only images displaying the arterial enhancement. This category includes cholangio- pure contrast signal. carcinoma, mixed hepatocholangiocarcinoma, hepatocel- lular carcinoma ( often of poor differnetaiation grade) or, Stenosis more rarely lymphoma or metasdtatic lesions. Therefore Approximately 10-15% of all ischemic strokes and transi- the management of LR-M can vary but frequently a biopsy tory ischemic attacks occur with a severely stenosed internal is required. carotid artery (ICA). Prior to surgery it is important to be able to differentiate between pre-occlusive stenosis and com- Reasons for incorporating ACR CEUS LI-RADS category plete ICA occlusion [Figure 3[. in reports 1) To establish a definitive diagnosis of HCC and to avoid the possibility of misdiagnosis with cholangiocarcinoma (CCC). 2) To convey clear information to the hepatologist, particularly in non LR-5 cases or where the lesion cannot be biopsied 3) To allow monitoring of the progression of a lesion with time, even in the absence of a change in the size of the lesion. A complete selection of images representing all the CEUS LI-RADS categories can be found in the recent article: F Piscaglia et al. American College of Radiology Contrast Enhanced Ultrasound Liver Imaging Reporting and Data System (CEUS LI-RADS) for the diagnosis of Hepatocellular Carcinoma: a pictorial essay Ultraschall Med. 2017; Figure 3. In cases where standard ultrasound or even color Doppler are not clear, 38: 320 - 324. CEUS shows a definite occlusion in the Internal Carotid Artery AUG/SEPT 2017 D I E U R O P E 11
Symposium Report Pseudo occlusions Carotid Body tumors These can be a particular challenge. In some patients Depending on the size color Doppler flow data can suggest a complete absence of a carotid body tumor of flow (occlusion) — albeit without certainty — while decisions have to be CEUS allows the demonstration of even small residual flow taken as to whether the (pseudo occlusion). With only grey-scale and color doppler tumor should be oper- images, it can be difficult to distinguish flow from pulsation ated on or not. To moni- artefacts. The use of CEUS enables precise information to tor the success of any be communicated to the surgeon regarding whether the intervention, it is useful ICA is patent or not. to establish a basic pre- In other patients, color Doppler shows flow only in the treatment evaluation Figure 4a. Carotid body tumor. Pre-operative external carotid artery, with none in the ICA. Even the use of the perfusion of the CEUS shows a high degree of perfusion in the tumor. of power Doppler sometimes doesn’t help very much in tumor. Post-treatment such situations. In such casesCEUS can directly show the reduction of the perfu- actual flow situation. sion of the tumor indi- cates successful treat- Post-therapy follow-up ment [Figure 4a, 4b]. Traditionally, carotid endarterectomy (CEA) or open sur- Grey scale US and color gery has been the treatment of choice, but carotid artery doppler can provide only stenting (CAS) is an alternative, particularly in patients with orienting information high surgical risk, e.g. patients undergoing neck radiation, but confirmative infor- with high or low cervical lesions or those with significant mation on the tumor Figure 4b. Post-operative CEUS shows much cardiopulmonary disease. In both CEA and CAS, re-steno- viability can be obtained reduced perfusion. sis is a potential problem that should be monitored. In any only with CEUS. case, whether an open surgery or stenting approach is used, post-treatment monitoring is necessary. CEUS can precisely Indications. show in-stent stenosis and the impact on blood flow, in In summary, the EFSUMB guidelines and recommendations particular using cross-sectional views on the clinical practice of CEUS in non-hepatic applications identify several indications for its use in the carotid artery: Dissection • Ruling out stenosis Classified either as traumatic or spontaneous, dissection • Follow-up after carotid stenting of the cervical segments of the carotid and vertebral • Dissection arteries is relatively rare, but when it does occur, the • Complications of vascular intervention result can be blood flow in the false lumen, an increase • Plaque characterisation in the risk of thrombosis resulting in complete occlu- sion or peripheral embolization. Again, on grey scale ultrasound it can sometimes be difficult to spot a dis- CEUS in Breast Imaging: is it useful section, and even with color Doppler the blood flow into for the characterisation and BI-RADS the true and false lumen is difficult to understand. The use of CEUS enables clear identification of dissection classification of focal breast lesions? and the demonstration of the entry of contrast into the Dr Jun Luo, false lumen in realtime. Axial views in CEUS can show Introducing the subject by provid- clearly the false and true lumenincluding the membrane ing background information on the in between. advantages of current ultrasound (US) approaches in breast imag- Rare Cases ing, Dr Luo also pointed out that Other cases where CEUS can be of use are challenges still remain to be faced. Many papers have been published Arteriovenous fistula on the value of US in breast can- Fistulae between carotid artery and the jugular vein, caused for cer screening, e.g. Shen et al Br J Dr Jun Luo, is Head of Ultrasound example by dislocated central catheter line placement can be Cancer. 2015; 112: 998. which com- Department, Sichuan Provincial identified by color doppler, but CEUS provides a clearer image pared modalities used for screening People’s Hospital, Chengdu, Sichuan, China of the problem. for breast cancer in Chinese women Milton-lj@hotmail.com and concluded that US was superior Aneurysm of the external extracranial ICA is also rare, but to mammography from the point of requires characterisation prior to surgery. Color Doppler has view of cancer detection. The J-Start study from Japan (Ohu- limitations, whereas the use of CEUS can clearly identify and chi et al, Lancet. 2016 23; 387: 341) also showed a significant measure the size of the aneurysm and identify whether there increase in sensitivity in the detection of early cancers when are soft plaques or not. US was used as an adjunct to mammography. On the basis 12 D I E U R O P E AUG/SEPT 2017
Predictive Models The overall objective of the use of CEUS predictive models is the maximal reduction of unnecessary biopsies, while minimizing the possibility of missing invasive breast cancer. In addition, the models should be easy to use and have good inter-observer agreement. The predictive model includes 3 defined enhance- ment pattern indicating malignancy [Figure 5a] and three pat- terns indicating a benign lesion [Figure 5b]. An example of the application of these criteria is shown in Figure 6 where the use of CEUS with an apparently benign lesion on 2D US was identified as malignant by application of the model. The altered diagnosis was confirmed by biopsy. Figure 5a. Malignant Predictive Models Refining BI-RADS In Dr Luo’s clinic in Chengdu, China, all (100%) patients who are BI-RADS 4 on the basis of mammography and 2D US, are biopsied, with an overall cancer-to-biopsy yield of only 40%. Implementing the CEUS-based classification, the biopsy rate falls to 25 % and the cancer-to-biopsy ratio increases to 73% with only 2.98% of missed malignant lesions. These lesions would be picked up at the 6 month fol- low-up examination, suggested for all patient downgraded from BI-RADS 4 based on the CEUS examination. These promising results have led to the initiation of a large multi- Figure 5b. Benign Predictive Models center trial in China to confirm the findings and suggested diagnostic algorithm. of these results, US appears beneficial when screening Asian women but one question is whether similar results can be obtained in Caucasian women. Another multi-centre trial carried out in the USA, Canada and Argentina (Berg et al, J Natl Cancer Inst. 2015;108:367) concluded that the cancer detection rate with US was comparable to that of mammog- raphy, with US identifying a greater proportion of invasive and node-negative cancers. However the remaining prob- lem is the substantial increase in the rate of false positives, which are accumulating in the BI-RADS 4 category lesions. Characterising all BI-RADS 4 lesions with biopsy (acc. to the current guidelines) creates a huge number of biopsies with the related patient discomfort and costs. Figure 6. The above CEUS image shows hyperenhancement, a larger lesion, that is regular-shaped and with clear margins. The model would predict malignancy, and Overdiagnosis. this was confirmed to be IDC on biopsy Although overdiagnosis is recognised as being a major challenge in breast cancer screening, methods for estimating its precise rates have not been standardized. Reported rates range from Risk of malignancy transformation from apparently benign 5 – 50 % or more (e.g. Hamashima et al. J Clin Oncol. 2016; 46: lesions 48, McCarthy et al Breast Cancer Res. 2015;17: 1); 7% to 9% of The use of the malignant or benign CEUS enhancement pat- women will have a negative biopsy. tern has been shown to be able to confirm benign lesions The magnitude of these figures shows how big the problem is from apparently benign US images, and identify potentially and suggests that the BI-RADS combination of US and mam- malignant lesions in patients. An analogy of such development mography (which do not provide any microvascular informa- of breast lesions is that of geological volcanoes, which can be tion) needs to be improved. classified as “Dead”, “Silent” or “Active”. In addressing overdiagnosis, the key question is how to assess the risk of malignant transformation in benign lesions. CEUS Conclusions has an important role to play in this context, but in turn also • BI-RADS classifications of breast cancer can be refined if raises certain questions regarding how CEUS should be used, CEUS is incorporated into the screening protocol. which CEUS patterns are useful, how to analyse such patterns • CEUS can help predict the risk of malignant transfor- and whether qualitative or quantitative analyses are more use- mation of benign lesions since such transformations are ful. The concept of predictive models was developed to address accompanied by micro-vascular proliferation which can be these issues. detected by CEUS. AUG/SEPT 2017 D I E U R O P E 13
Radiology WorkFlow Workflow dichotomization and the radiologist’s workflow environment By Dr John-Paul J. Yu W orkflow disruptions are ubiquitous within cog- nitively demanding and complex work environ- ments and are associated with errors, workflow inef- be broadly categorized into image-interpretive (IITs) and non-image interpretive tasks (NITs). In a prospec- tive, randomized, observational investigation at our ficiency, and task prolongation. The healthcare work institution, we observed that individuals spent nearly environment is one such example of an intrinsically 40% of their total time throughout the day performing complex work environment that often finds individuals NITs including answering phone calls, returning pages, engaging in rapid task switching and task shortening providing in-room consultative services for referring with concomitant deleterious effects on patient safety, clinicians, technologists, and other radiologists, exam workflow efficiency, and other quality outcomes [1]. protocoling, and teaching [5]. Moreover, previous work Not surprisingly, these phenomena have garnered sig- at our institution demonstrated that the reading room nificant interest throughout clinical medicine where work environment is highly fragmented with an average the implications of workplace interruptions can include of 14.9 task-switching events (TSEs) per hour, yielding physical, emotional, economic harm, and even loss of a rate of approximately one interruption every four life. By virtue of a dynamic and complex work environ- minutes. The significant time and effort commitment ment and the myriad of responsibilities incumbent on to NITs – in addition to the inherent disruptive nature radiologists, the radiology work environment is par- of these tasks – spurred efforts to better organize and ticularly susceptible to the effects of workplace disrup- handle these NITs in both an efficient and thoughtful tions [2] with radiologists often experiencing significant manner. strain in maintaining a streamlined, efficient workflow [3, 4]. The impact of radiologist workflow dichotomization “... the radiology work environment is Imaging interpretation is one of many components that particularly susceptible to the effects of constitute the full scope of responsibilities in a modern workplace disruptions...” radiology practice. Even as image interpretation remains our most tangible clinical deliverable, it reflects one of many links in the imaging value chain. Additional The complexity of the radiologist’s workflow environ- links in the imaging value chain include consultative ment is largely a consequence of the multiple roles services provided to our referring clinical colleagues, the modern radiologist balances as an imaging expert exam protocoling, patient scanning, and other activities and diagnostician, physician consultant, educator, and previously identified as NITs; however, in spite of the interventionalist. While these responsibilities concep- disruptive nature of NITs, they are an essential com- tually span a wide-range of clinical activities, they can ponent of providing value in today’s clinical environ- ment. The intrinsic value and importance of NITs belies The Author the frustration encountered with NITs throughout the John-Paul J. Yu, MD, PhD workday where NITs – with their stochastic and disrup- Assistant Professor of Radiology, Psychiatry, and Biomedical tive nature – often occur as unanticipated interruptions Engineering, Associate Program Director, Neuroradiology to the radiologist’s primary duty of high-quality image Fellowship Program Division of Neuroradiology, Department of interpretation. At our institution (and anecdotally at Radiology. numerous other academic institutions), the sheer num- Director, Laboratory for Behavioral Systems Neuroscience ber of NITs and frequency of associated task switching Member, Neuroscience Training Program served as an impetus for a more thoughtful approach Member, Clinical Neuroengineering Training Program to reading room workflows, with the goal of a more UW | University of Wisconsin School of Medicine and Public Health efficient, streamlined practice that leverages existing E3/366 Clinical Science Center opportunities for imaging value chain optimization. 600 Highland Avenue | Madison, WI | 53792-3252 United States Towards these ends, we separated our reading room email: jpyu@uwhealth.org tasks into two discrete workflows — IIT and NIT — to 14 D I E U R O P E AUG/SEPT 2017
Table 1. Interruptions facilitate the division of responsibility in the range of 3.2-4.7 minutes [8], Resources [10]. Identified risk factors for these tasks [6]. workflow dichotomization would now for burnout often manifest as descrip- conceivably and comfortably allow tions of job dissatisfaction that include After the implementation of IIT and for the interpretation of a standard work overload, difficult shifts, lack of NIT workflows in our reading room, head CT without interruption and by control, and severe time constraints for an evaluation of our results clearly extension, would reduce the number work output (e.g, exam turn-around demonstrate that workflow dichoto- of interruptions our radiologists could times). We postulate that a highly dis- mization yields successful outcomes expect when interpreting more time- rupted radiology work environment is along multiple dimensions of analysis. intensive, complex imaging. a key culprit underpinning many of Implementing discrete IIT and NIT these sources of job dissatisfaction, workflows resulted in a precipitous which may in turn lead to radiolo- decrease in time spent on NITs by our “... Radiology has experi- gist burnout. Workflow optimization image interpreting radiologists, falling enced diminishing levels efforts, such work dichotomization, to less than 25% of pre-intervention of professional satisfaction to improve reading room efficiencies level furthermore and moreover, repre- over time and excessive may also have the added benefit of senting less than 5% of the radiologists workload is among the most decreased mental burden, workload, overall time in the post-intervention commonly reported reasons related improved provider career satis- period. Perhaps more importantly, the for provider dissatisfaction faction. The analysis of and subsequent decrease in time spent on NITs was ...” improvements to the radiologist’s nearly equally matched with a concom- workflow environment also requires itant increase in time spent on image Workflow dichotomization a careful analysis of individual work- interpretation (up to a total of 73.2% improves workplace satisfaction loads and the impact individual work- post-intervention from 53.8% pre- Beyond the aforementioned posi- loads have on the overall efficiency of a intervention) suggesting a nearly-com- tive quantitative impact of workflow workflow process. These examinations plete direct transfer of NIT-time to IIT- dichotomization, there are less tangible also afford a more nuanced exploration time. The delineation of a discrete NIT but no less important perceptive ben- of the impact workflow design has on workflow also resulted in a 40% reduc- efits derived from separating reading individual operators. Whereas work- tion in TSEs experienced by the pri- room tasks into IIT and NIT work- flow represents the sequence of pro- mary radiologist. The marked reduc- flows. As with other medical special- cesses through which a piece of work tion in TSEs is particularly important ties, radiology has experienced dimin- passes from start to finish, workload and encouraging as numerous previ- ishing levels of professional satisfaction represents the actual amount of work ous studies have demonstrated the over time and excessive workload is to be done. Workload, on the individ- deleterious effects of interruption on among the most commonly reported ual level, is not an absolute quantity the quality of image interpretation [7]. reasons for provider dissatisfaction [9]. and is variably dependent on numer- The reduction in TSEs and increase in The intrinsic and extrinsic risk factors ous intrinsic factors (such as individ- image interpretive time was reflected associated with career-related burn- ual experience and skill) and extrin- throughout our data with the mean out specifically amongst radiologists is sic factors (such as interruptions and time between TSEs more than dou- summarized in a recent report released system failures), which all contribute bling from 05:44 to 11:01. With average by the American College of Radiol- to the overall perception of individual head CT interpretations times reported ogy (ACR) Commission on Human workload. AUG/SEPT 2017 D I E U R O P E 15
Radiology WorkFlow Table 2. Workload Table 3. Satisfaction Evaluation of the impact of measurements (and improvements) in radiologists an opportunity to engage workflow Dichomotization workflow dichotomization. in a rewarding clinical practice. To evaluate the impact of workflow As clinical imaging volumes continue dichotomization on perceptions of to increase, an understanding of work- References: workload, workplace interruptions, place disruptions and their impact of 1. Westbrook J I et al. The impact of interruptions on clinical task completion. Qual. Saf. Health Care. and workplace satisfaction, survey data radiologist productivity and global 2010; 19: 284. were collected before and after work- measures of radiologist workload and 2. Yu J-PJ et al. The radiologist’s workflow environ- flow dichotomization at our institution; workplace satisfaction have become ment: evaluation of disruptors and potential implica- tions. J Am Coll Radiol 2014; 11: 589. data are summarized in Tables 1-3 [11]. increasingly salient. Implementation 3. Kansagra AP et al. Disruption of Radiologist Following implementation of separate of separate dedicated image-interpre- Workflow. Curr Probl Diagn Radiol 2016; 45: 101. dedicated image-interpretive and non- tive and non-image interpretive work- 4. Larson DB et al. Communication in Diagnostic Radiology: Meeting the Challenges of Complexity. Am J Roentgenol. 2014; 203: 957. 5. Schemmel A et al. Radiology Workflow Disruptors: “....Implementing discrete Image Interprteive Tasks (IIT) and A Detailed Analysis. J Am Coll Radiol 2016; 13: 1210 Non-Image Interpretive Tasks (NIT) workflows resulted in a pre- 6. Lee M H et al. Workflow Dynamics and the Imaging cipitous decrease in time spent on NITs by our image interpret- Value Chain: Quantifying the Effect of Designating ing radiologists, a Nonimage-Interpretive Task Workflow. Curr Probl Diagn Radiol. 2016, doi:10.1067/ 7. Balint B J et al. Do Telephone Call Interruptions image interpretive workflows, our work flows resulted in improved radiologist Have an ImPact on Radiology Resident Diagnostic Accuracy? Acad. Radiol. 2014; 21: 1623. demonstrated a measurable uniform perceptions of workplace disruptors 8. Reiner BI et al., Radiologists’ productivity in the improvement in workplace satisfaction and mental effort with a concomitant interpretation of CT scans: A comparison of PACS with a concomitant decrease in percep- improvement in overall workplace with conventional film. Am J Roentgenol. 2001; 176: 861. tions of the workplace disruptions and satisfaction. These and other similar 9. Zafar HM et al. Satisfaction of radiologists in the effort required to complete workplace efforts highlight the importance of United States: A comparison between 2003 and tasks. Beyond the quantitative impact workflow design not only on workplace 1995. Radiology. 2007; 244: 223. of workflow dichotomization, these efficiencies but also in the positive sec- 10. Harolds JA et al. Burnout of Radiologists: Frequency, Risk Factors, and Remedies: A Report of data reflect the perceptive changes ondary gains observed in individual the ACR Commission on Human Resources. J Am that occur in the workplace and cap- workload levels and offers a potential Coll Radiol. 2016; 13: 411. 11. Lee MH et al. Radiology Workflow Dynamics: How ture important benchmarks that might practice model that offers outstand- Workflow Patterns Impact Radiologist Perceptions of otherwise go unnoticed in quantitative ing patient care while also providing Workplace Satisfaction. Acad Radiol. 2017; 24: 483 16 D I E U R O P E AUG/SEPT 2017
International Cancer Imaging Society Meeting & 17th Annual Teaching Course Cancer Imaging and Intervention: a Multidisciplinary Approach 2nd - 4th October 2017 • 2 Keynote lectures ‘Cancer Imaging in the era of precision medicine’ and ‘Immunotherapy: Imaging challenges’ Langenbeck-Virchow • 8 Computer hands-on workshops using Siemens workstations on evaluation of cancer of prostate, breast, lung, liver, lung, ovary, uterus and whole-body imaging Haus, Berlin, Germany • 25 sessions addressing structured reporting, response evaluation, complications of medical and radiation therapy, ICIS 2017 will focus on quantitative metastatic disease, joint sessions with radiation and medical oncologists, precision medicine, radiogenomics, prostate, female and functional oncologic imaging and pelvis, liver, pancreas, lung, lymphoma, CEUS and many more the multidisciplinary management of oncology patients. There will be a spectrum • 4 Scientific Sessions dedicated to proffered papers, and a poster exhibition with prizes for the best overall paper and poster of sessions ranging from innovative and state-of-the-art imaging, practical hands-on- • 4 live-case workshops Transarterial chemoembolization (TACE) in HCC / liver metastases, Radioembolization (SIRT), workshops, essential refresher courses and Microwave ablation of a pulmonary tumour in metastasis or live-case workshops. small lung cancer, Radiofrequency ablation of liver metastasis Delegates will received 17 CPD points from the Royal College of Radiologists (Monday - 6, Tuesday - 6, Wednesday - 5). CME accreditation will be sought from the European Accreditation Council Continuing Medical Education (EACCME). In association with: Call for abstracts: Deadline 29th May 2017 Programme planning committee: Stefan Diederich ICIS President (DE), Submit online at icimagingsociety.org.uk Bernhard Gebauer (DE), Dow-Mu Koh (UK), Beth McCarville (US), Anwar Padhani (UK), Andrea Rockall (UK), Heinz-Peter Schlemmer (DE), Harriet Thoeny (CH). For further information please contact: ICIS, 140-148 Borough High Street, London, SE1 1LB E: louise.mustoe@cancerimagingsociety.org.uk cancerimagingsociety.org.uk
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