V O L 2 7 I S S U E 4 / 1 8 A u g u s t / S e p t e m b e r 2 0 1 8 T H E E U R O P E A N F O R U M F O R T H O S E I N T H E B U S I N E S S O F M A K I N G H E A L T H C A R E W O R K NEWS & RESEARCH • AI solutions aid choices in diagnostic and therapy 1-5 • Blockchain: hype will fade but the technology will remain • Designer visions for future hospitals 22-23 INFECTIONS • The Asian tiger mosquito has come West • Myth and truth about antibiotics, antiseptics and vaccinations 9-16 ESC SPECIAL reports and more The ‘bionic’ radiologist Three steps towards healthcare improvements Professor Marc Dewey, Vice Chair of the Department of Radiology at Charité – Universitätsmedizin Berlin, made value-based radi- ology the main theme of the Wilhelm Conrad Röntgen Honorary Lecture during ECR 2018. Radiology practice needs change, he said, and radiologists should grasp at new technol- ogy to drive their future. His lecture was summarised in a recent comment in The Lancet. See Link: www.thelancet.com/ journals/lancet/article/PIIS0140- 6736%2818%2931193-0/fulltext Report: Sascha Keutel Dewey’s lecture presented a list of issues regarding current healthcare systems. Among foremost patients’ complaints on hospital admittance is being asked about their medical history multiple times from different staff members or departments. Also, patient care services that decide the clinical strategy and tests to be made have conflicts of inter- ests and different aims. ‘We’re not using evidence-based approaches to make those decisions,’ Dewey said. Additionally, the idiosyncratic ter- minology in radiologists’ reports prevents major critical findings from being detected. According to Dewey, a recent study on determi- nation and communication of criti- cal findings in abdominal imaging found that one-third of it went undetected. (https://www.ncbi.nlm. nih.gov/pubmed/19581643). A vision of the future Dewey spoke of a Commonwealth Fund study that concluded that increasing healthcare spending per GDP does not equate to better patient outcomes, or the perfor- mance of the healthcare system measured by equity and accessibil- ity. Reality: the more money nations invest in their health care system, the worse the outcome in terms of performance is – a really dra- matic result and reason to intro- duce value-based medicine in radi- ology, he said. The general goal of value-based radiology is to improve patient outcome with lower cost. ‘Sometimes that means doing less – especially less imaging.’ radiology, Value-based he believes, will gain a central role in addressing three issues: 1. Improving personalised decision- Marc Dewey is Heisenberg Professor of Radiology, Vice-Chair of Radiology at Charité – Universitätsmedizin Berlin, Germany, and he presided over the Berlin Röntgen Society from 2011 to 2013. He received the Röntgen Award in 2009 and the Curie Ring in 2012 – the German Röntgen Society’s two highest scientific awards. Dewey was also secretary of the 2011 German Röntgen Congress. language processing, standardised dictation could continue, he sug- gests. This would make transition easier because, in the end, ‘culture eats strategy for lunch’. Challenges and conclusion ‘Everyone wants to be an innova- tor, yet no one wants to change,’ he said, adding that addressing cultural issues is also important in changing radiologists’ practice. But, for Dewey, the ‘potentially greatest challenge is the half-life of clinical data’. A study on test order prediction tools found that the accu- racy of data to predict inpatient orders has a half-life of only four months (https://www.ncbi.nlm.nih. gov/pubmed/28495350). As health- care changes rapidly, researchers won’t be able to use robust data older than five years. Thus, says Dewey, ‘we don’t need big data; we need good data!’ Success in the three listed areas will free the radiologist to partici- pate more actively in patient care, where automated systems are not good (yet). www.healthcare-in-europe.com CONTENTS NEWS & RESEARCH RADIOLOGY CARDIOLOGY LABORATORY 1-5 6-8 9-16 17-21 INFECTION CONTROL 22-23 Figure 1 making about if, when, and which patients need diagnostic imaging 2. Increasing consistency in how images are acquired and inter- preted by the ‘bionic’ radiologist 3. Enhancing the link on findings and reports with treatment rec- ommendations and management decisions. Evidence-based decisions First: Decision support tools, based on evidence, could help to over- come too much imaging in the wrong patients. AI tools would allow better predictions and free up radiologists’ time to talk to a patient. This needs a patient’s data integration with decision support tools, such as the European Society of Radiology’s iGUIDE and eGUIDE. The bionic radiologist Second: The integration of AI with human efforts – the ‘bionic radiolo- Figure 2 Automatic coronary artery tree segmentation (Dr. Christian Wald and Prof. Marc Dewey) 4D-CT perfusion images of the heart (Dr. Kakuya Kitagawa and Prof. Marc Dewey) Figure 3 Fractal analysis of myocardial MR perfusion imaging. Fractal analysis has been established as a method to differentiate obstructive coronary artery disease and microvascular dysfunction. In this patient, a perfusion defect due to coronary artery disease with a fractal dimension of 2.47 is depicted (arrows) (Dr. Florian Michallek and Prof. Marc Dewey) gist’ – has great potential to increase consistency in radiological image analysis and reduce errors. Dewey foresees a human doctor using a device to gain an automated analysis and then interpreting the results and strategies along with a patient. An existing example is 4D-CT of the heart, which produces three billion voxels for a single patient (Figure 1). Patients can’t hold their breath for long, so there’s heart and lungs motion. Can we manually adjust? Can we go through these three billion voxels? That’s very hard to achieve.’ Dewey then explained that radiologists need automated approaches that do reg- istration and pre-processing before a doctor even begins. Figure 2 shows such a pre-processing exam- ple of automatic coronary tree seg- mentation based on 3D cardiac CT. The bionic radiologist makes use of automated pre-processed data, e.g. using fractal analysis (https:// w w w. n c b i . n l m . n i h . g o v / p u b - med/27436024) while still being the major interpreter and integrator of the data (see Figure 3). This com- bined approach to leverage both the consistency of automatic analy- sis and individual interpretation of human image analysis ‘is a para- digm shift,’ Dewey said. Linking findings to treat- ment recommendations Third: Structured that reports combine audio-visual information linked to patient data make them searchable and analysable and therefore improve the reporting, Dewey believes. A study of pan- creatic cancer imaging showed that the evaluation greatly improved with structured vs. non-structured reports (https://www.ncbi.nlm.nih. gov/pubmed/25286323). Dewey concludes that structured reporting improves the way radiologists’ dis- cuss a case with referring physicians and plan treatment. Natural language processing may also help radiologists to avoid a possible culture shock when clas- sic dictation vanishes. While the structure is captured by natural
2 N E W S & R E S E A RC H Computers will support clinicians, not replace them AI solutions aid diagnoses and therapy choices Report: Cornelia Wels-Maug Neuroscientist Lynda Chin MD, Founder and CEO of Real-world Education Detection and Intervention, has lit- tle doubt: ‘Artificial intelligence to the rescue,’ she proclaimed in her keynote address at the Artificial Intelligence and Machine Learning Summit, held in Las Vegas this spring. ‘We need a system and ana- lytics to interpret data!’ she urged, despite being well aware that build- ing a suitable algorithm, as well as training it to discover patterns and identify relationships, is a tedious task. ‘We train an artificial intelli- gence (AI) system just as we would train a doctor’, she explained and Roland Berger of the strategy con- sultants and human venture capital firm Asgard, ‘Artificial Intelligence – A strategy for European startups’, the healthcare and FinTech industries together, after B2B services, attract most AI start-ups on a European and global level. Nonetheless, have those undertakings in AI, machine learning (ML) and deep learning effected improvements in healthcare on a larger scale? Solving real problems Although AI has become a buzz word in the healthcare world, its use is still in early days. AI is accredited with revealing clinical and opera- tional insights and contributing to impending cardiological problem. However, they are wrong in one in five cases, leading to patients being discharged and suffering a heart attack at home or having unneces- sary surgery. To train Ultromics, Leeson used the scans of 1,000 patients he had treated over the past seven years, along with information about whether those patients continued having heart problems. The solu- tion picks up details in the images doctors cannot see and gives recom- mendations as to whether a patient should be treated further. Ultromics has been tested in clini- cal trials in six cardiology units and, according to Leeson, the data indi- Radiomics discovers relationships between image features and clinical data. The ‘heatmap’ groups patients with similar features and represents them in areas of the same colour. By courtesy Fraunhofer MEVIS pondered, ‘What is the equivalent of a residency programme for an AI programme?’ Global interest in AI Work to derive actionable insights from ever-increasing data is the next logical step. Hence, self-learn- ing algorithms and their underlying neuronal networks have become a major focus in software develop- ment. As the development of AI is high- ly correlated with the availability of data, healthcare attracts a lot of AI activities. According to a study by spare patients from unnecessary procedures and worry. Some exam- ples on how AI enhances diagnos- tics and improves disease manage- ment include: Picking up illnesses earlier Ultromics, a new AI-based solution developed by Paul Leeson, Professor for Cardiovascular Medicine at the University of Oxford, diagnoses car- diac scans to determine a patient’s risk of an imminent cardiological problem. Currently, cardiologists can defer from the timing of the heartbeat in scans if there is an cates that the solution has greatly out-performed its fellow cardiolo- gists. The trial results suggest fur- ther that Ultromics could save lives and spare patients unnecessary sur- gery, which Leeson reckons could save England’s NHS more than £300 million per year. Another example is an AI/ ML-based system by the British start-up Optellium, which addresses the management of patients with large clumps of cells – nodules – in the lungs. According to Optellium, up to 30% of all patients scanned have such small nodules of which Paul Leeson, Professor for Cardiovascular Medicine at the University of Oxford the majority are harmless. However, radiologists often struggle to deter- mine if a nodule is cancerous, lead- ing to an indeterminate diagnosis that needs up to two years follow-up imaging to monitor potential growth and, in some cases, the performance of biopsies and surgeries. The solution, the firm reports, ‘provides an objective risk score of nodule malignancy learned from a database of thousands of examples with known ground-truth diagno- ses’, enabling clinicians to ‘confi- dently stratify lung nodule patients earlier, potentially on the basis of only one or two scans’. Optellium’s chief science and technology officer, Dr Timor Kadir, reports that trials of the system in Manchester imply that more than 4,000 lung cancer patients a year, in the UK alone, could be diagnosed much earlier and hence have a much greater chance of survival. Radiomics on the radar The Fraunhofer Institute for Medical Image Computing (MEVIS) and part- ners are deploying radiomics to dis- cover relationships between image features and clinical data within the Patient-Oriented Oncological Therapy Assistance (PANTHER) pro- ject. The aim is to develop a clinical decision support system for physi- cians to help determine the best course of therapy (medication, radi- ation, or a mix of both) for patients suffering from cancer of the colon or lymphoma. This will allow ben- efits to be maximised and curtail the side effects of a chosen therapy in a hitherto uncharted way by adjusting the course of prescribed therapy early in the treatment. Jan Hendrik Moltz PhD, Research Scientist at Fraunhofer MEVIS, explained: ‘So far, the size devel- opment of a tumour is the most important criterion in evaluating CT images. However, there is much more information hidden in those scans that has hardly been used.’ He refers to information on changes in the shape and texture of a tumour that occur during therapy, but that cannot be detected by physicians with their bare eyes. By deploying AI and deep learn- ing on historical data from the Medical Centre of the University of Munich, it is hoped to reveal insights into the effectiveness of the therapy of bowel cancer and lymphoma. Mid-term into the three-year-long project, Moltz reports good progress Jan Hendrik Moltz PhD, Research Scientist at the Fraunhofer Institute for Medical Image Computing (MEVIS). Image: Fraunhofer MEVIS on homogenising the data, as well as segmenting computed tomography scans – segmenting refers to mark- ing the structures to be analysed on the scans. ‘Analysing the spleen, for example, manually, is very time-con- suming,’ Moltz explained. We have managed to develop a segmentation algorithm based on deep learning that is already so effective that it almost needs no further manual cor- rections. Automating the segmenta- tion enables us to obtain outcomes much faster.’ The future role of the clinician Last November, ‘Xiaoyi’, meaning ‘lit- tle doctor’, an AI-fed robot, success- fully passed the medical approval test in China, even with above aver- age results. Will this be the future? Chin shook her head: ‘Data ana- lytics helps healthcare to be more efficient, but AI is just a tool. It needs clinical experts to understand the problem. Although computers will make therapy decisions, they will support clinicians, not replace them.’ Top Spanish innovation gains awar Tackling an epidur anaesthesia complication Report: Mélisande Rouger Four potentially game changing solu- tions selected for the annual com- mercial acceleration program of the Spanish foundation for innova- tion and prospective in healthcare (Spanish: FIPSE), included Duralock, a system that could ease post partum Carlos García (left) led a team of anaesthetists and engineer PDPH. A researcher at the Valencia foundation for healthcar among the Top 10 Spanish Talent list, which competed in the Eur EUROPEAN HOSPITAL Vol 27 Issue 4/18
The researchers developed a sen- sor that uses a photonic crystal cav- ity, a ‘trap’ of just a few micrometers into which incoming light falls if it has the right frequency. Fiore: ‘This trap is contained in a membrane, into which the captured light gener- ates a tiny electrical current that is precisely measured, retaining just a very tiny frequency interval and therefore measuring only light at that frequency.’ Two of the membranes were placed closely, one above the other, allowing them to influence one another: a slight change in dis- tance means the measured light frequency also changes. To ensure a varying distance between the mem- branes, the researchers incorporated a MEMS (micro-electromechanical system). A similar type of MEMS is already present in smartphones Sketch of proposed microspectrometer and other devices to sense free fall and put the sensitive parts in secure mode before ground impact. Fiore: ‘Using our present system, the sensor covers a wavelength range of around thirty nanometers, within which the spectrometer can discern some hundred thousand frequencies. This is exceptionally precise because we can control dis- tance between the membranes to just a few tens of femtometers’ (one femtometer is one millionth of a billionth of a meter, or about one million times smaller than typical atom size). Applications Measuring light gives a spectrom- eter a wide range of applications – two of the most interesting being in food and medical industries, says Fiore, used, for example, to measure CO2, check the pill you take is cor- rect, measure blood sugar level via Report: Madeleine van de Wouw Checking a lump for malignancy, finding out if food is fresh, just with your smartphone? It’s possible, according to Eindhoven University of Technology researchers in the Netherlands. Their recently presented spec- trometer is small enough to insert into a smartphone. This device is not yet ready for use on a big scale, Professor Andrea Fiore, supervisor of the Eindhoven research team points out. Spectrometry is the analysis of visible and invisible light. Every material and tissue has its own spectrum of light absorption and reflection. Some information on the spectrum of visible light is already gathered by our eyes – it gives the colour of the material. The invisible part of the spectrum also carries a lot of useful information, and can be ‘seen’ by a spectrometer. However, current devices are large due to the work they need to do: splitting light into frequencies (different colours). Each frequency must be measured separately, which can only be made some tens of cen- timetres after the splitting. Small v. big Created by Zarko Zobenica, a PhD candidate at Eindhoven under the supervision of Professor Fiore and colleague Dr Rob van der Heijden, the new microscale device is a small version of normal tabletop spec- trometers currently used in scientific labs. The difference is the way the small spectrometer works. Tackling an epidural anaesthesia complication Continued from page 3 Above: Optical-microscope image of fabricated microspectrometer Below: Electron-microscope image of the active area, with zoom-in on the photonic crystal cavity thin skin on the earlobes. Another application is to gain skin and tis- sue information, for example during surgery, using the spectrometer to determine whether exposed tissue is cancerous and help decide how much tissue to be removed, he sug- gests. The frequency range is too small to use on a big scale, Fiore explains. ‘The sensor covers only a few per- cent of visible and near-infrared light, the most used part of the spectrum. We need to expand this range for more general use. We also will need to integrate a light source so that the smartphone sensor can function independent of external sources. So, it will take years before the new spectrometer will be inte- grated within a smartphone and at least ten years before it’s on the market.’ Prof Andrea Fiore graduated in Electrical Engineering and Physics from the University of Rome ‘La Sapienza’. Between 1994-97, he wrote his PhD thesis on nonlinear frequency conversion in semiconductor waveguides at Thomson CSF Central Research Laboratory (Orsay, France). He held postdoctoral appointments at University of California in Santa Barbara, at the Ecole Polytechnique Fédérale de Lausanne in France and a research position at the Italian National Research Council. Between 2002-07, as assistant professor he led Quantum Devices activities at the Ecole Polytechnique Fédérale de Lausanne. Since October 2007, he has been Chair of Nanophotonics at Eindhoven University of Technology, the Netherlands. Nothing gives so much inf 4 N E W S & R E S E A RC H This app will become as normal as having a camera Smartphone to measure light spectrum The future Many companies and scientists are developing microspectometers, with different approaches. The Eindhoven team is also working to enlarge the measured spectrum width. ‘The technology will get there,’ Fiore assures. ‘The question is only whether a market for these microspectrometers exists and, if so, which company will produce them. If I’m correct, the future will show that having a spectrometer in your smartphone is as normal as having a camera. The only thing is the future must wait a couple of years.’ Being able to seal this breach by placing an implant can help prevent the occurrence of invalidating and sometimes long lasting headaches, according to Carlos García Vitoria, an anaesthesiologist from Valencia, who long thought about a way to get past the problem. ‘Epidural puncture aims to relieve pain, but paradoxically in 2% of cases it can cause a more intense and lasting pain than the original discomfort, which motivated drug administration. We need to evalu- ate how to act before headache occurrence to discard this invalidat- ing clinical scenario,’ said García, who led a team of anaesthesiolo- gists and engineers from Dr Preset University Hospital and Valencia Biomechanical Institute to develop Duralock, a sealing system that can help avoid PDPH. The system comes in a kit that includes an implant and tools nec- essary for its insertion through a needle that is conventionally used in epidural puncture. The implant can be applied in 30 seconds with just one hand in a completely ster- ile way, and does not present any risk of additional dural perforation, García pointed out. Besides impairing the patient’s life, PDPH can extend hospital stay by five days and generate higher healthcare costs. In 2005 in Spain, Doctors working in the eight-bed Paediatric Intensive Care Unit (PICU) at the Ramón y Cajal University Hospital in Madrid extensive- ly use point-of-care ultrasound to evaluate the condition of critically ill children, and they find it essential in their work, as Dr José Luis Vázquez Martínez, Head of PICU at Hospital Ramón y Cajal, with over 25 years’ experience in paediatric intensive care medicine, explained. P o i n t - o f - c a r e u l t r a s o u n d is used (POCUS) extensively in our unit, allow- ing comprehensive, head-to-toe assessment of critically ill children, including respiratory, oncology and post-operative car- diac patients, as well as those being treated for sepsis or multiple trau- ma. The POCUS approach allows not only an initial diagnosis, but also routine monitoring of treatment to see whether or not a patient’s condition changes, enabling alterna- tive strategies to be implemented if there is no improvement. POCUS helps paediatric doctors in many ways. For example, ultra- sound scans enable evaluation of a patient’s haemodynamic state, look- ing at their heart function and blood volume to see if these factors are contributing to respiratory failure. Conversely, doctors can see if a lung problem, such as pneumonia, is affecting the heart. For a patient in a coma due to multiple trauma, ultrasound is used to look for signs of bleeding – a potential cause of unexplained anaemia – and to assess the intracranial pressure. It’s also used to monitor kidney function in children with blood pressure problems, and visualise intestinal indications of sepsis. In addition, ultrasound guidance can be used for endotracheal intuba- tion. In short, broader applications that we did not anticipate until very recently. We have used ultrasound in our PICU for more than a decade, and have always had SonoSite systems, upgrading them as new technol- ogy is introduced. In the beginning, when my knowledge was more limited, the aim was to perform clinical echocardiography but, when the SonoSite representative showed me the linear probe and the various EUROPEAN HOSPITAL Vol 27 Issue 4/18 accidents occurred during 3,425 dural punctures. García estimated that Duralock could help to save as much as €10,500,000 annually for the nation’s health service. Due to the award, received in March in Madrid, the product can benefit from the medical industry’s expertise to help speed up release to market, notably by helping recipi- ents to remodel strategy and busi- The team’s solution, named Duralock, comes in a kit that includes an implant and necessary tools for insertion through a needle ness plans. Among the winning initiatives, Duralock will be featured at BioBoston 2018 and JP Morgan Healthcare 2019 in San Francisco, to boost its visibility in the North American market. 50 μm1 μm500nm
N E W S & R E S E A RC H 5 15th century hospital shows tomorrow’s health ‘cells’ Designer visions for future hospitals muted colours, pleasant sounds and smells create an oasis of peace in an increasingly chaotic world – a place that provides shelter to the ill. The transparent space, which asserts the need of sensory wellbeing does, how- ever, link up with a virtual world of healthcare: the transparent walls pro- voke reflections on privacy, a further important aspect of future healthcare. The installation is a joint project by architect Filippo Tadelli, Raffaello Furlan, professor of internal medicine at Humanitas University in Milano, and Dr Mauro Gatti, Research & Business at IBM Italy, all with previous experi- ence in healthcare and technology concepts. The cells were produced by Universal Selecta, a Milan-based inte- rior design company that specialises in creating sound-absorbing spaces. This impressive installation, with its spaces reflecting on the future of healthcare, raises the question of how today’s healthcare system can move towards a better future… how it can achieve a balance between virtuality and sheltering the patient. This could be the time for more hospitals to inte- grate design trends to support heal- ing by providing a positive sensory environment. Above: The installation, which ventures into the future of healthcare, is located in the courtyard of the old Milano hospital. Below left: A mirrored cubicle represents the future relationship between humans and technology. Below right: A second cubicle represents the architectural future of hospitals and their impact on patients’ environment Report: Carla Zimmermann In the hustle and bustle of the Salone del Mobile – Milan’s famous design week – an oasis of peace and calm comes as a surprise. The Cortile dei Bagni is such a surprise; this inner bath courtyard is part of a Milan hos- pital built in the 15th century. Here, architect Filippo Taidelli installed a contemplative space experience that tells a story about the future of health- care. Its title ‘Cells’ refers not only to the cells of the human body but also to the word’s Latin origin: cella, small room. In two cells at opposite corners of the courtyard visitors can explore two opposing tendencies of modern healthcare: the first room visualises technology-oriented medicine which creates a virtual healthcare environ- ment for the patient, redefining the relationship between humans and technology. In the second room the interior of a hospital is shown that increasingly tries to emulate a ‘home’. Sci-fi atmosphere The first cell is mirrored; the interior is invisible from the outside. From inside, however, there is a clear, unob- structed view of the outside. In the world of healthcare this paradoxi- cally creates an initial sense of comfort and shelter. The 2x5x3 metre cubi- cle embodies the future relationship between human beings and health- care technology, a relationship many people expect to be dominated by technology; to be virtual and sterile. being and an avatar filling the sparsely furnished room. The ceiling window pretends to open up to the sky – but it is virtual sunlight, produced by a company called Coelux to create the effect of natural light in hospitals. The moment visitors become aware of the virtuality of the space – and the sensory experience will produce this awareness – the sense of comfort vanishes and a feeling of being locked in creeps up. The more virtual healthcare becomes, the less sensory it will be. No doubt, the senses can be simulated by technological means, but how do patients feel when their recupera- tion depends on an interaction with avatars? Peace and wellbeing The second cubicle, located at the other end of the courtyard, repre- sents the architectural future of hos- pitals and their impact on a patient’s environment. The cell’s transparent outer shell symbolises the link to nature, which will play an increas- ingly important role in healthcare. There are pleasant smells, warm light and ambient music, sounds of nature interspersed with children’s laughter. Created by designer Nicola Ratti, this sound world envelopes the patient in a comfort blanket. The furniture is friendly and unob- trusive. The table and interior floors, by Casalgrande Padana, are made of porcelain. Their antimicrobial proper- ties were achieved by a special treat- ment of the surface. The atmosphere is reminiscent of a science fiction movie, complete with a sound dialogue between a human Contemporary hospital interior design welcomes nature in order to tap into nature’s healing powers: Like a ventilator, ultrasound is essential in an ICU es so much info so quickly this is unquestionably a great ben- efit to the scientific community – long may it last! Today, we are seeing a boom in the use of ultrasound in paediatric care, as it non-invasively provides immediate information in situa- tions where time is of the essence. Our advice to people attending our training courses, who do not have – or have to share – an ultrasound system, is to tell their hos- pital managers that, just like a ventilator, it is an essential piece of equipment for an inten- sive care unit. time, this has expanded to include neuromonitoring, respiratory and abdominal monitoring. I acquired my ultrasound experience through a combination of external training in adult ultrasound and practical, hands-on learning, and am largely self-taught. If courses like these had been available when I started using ultrasound, I would have saved so much time. FUJIFILM SonoSite is clearly committed to organising and supporting ultrasound training, and techniques available, it was as if I was being shown electricity after using candles! It was amazing, a real turning point in the use of ultra- sound, and everyone recognised it as a step forward in the paediatric intensive care world. For the patients, a major benefit of ultrasound is that exposure to radiation can be reduced. Before ultrasound, X-ray examinations were performed two or three times in the first few days after admission to try to establish the cause of the prob- lem, often with limited suc- cess. With ultrasound, we can scan the patient as often as necessary, implement- ing treatment and mon- itoring its effect with- out exposing the child to more radiation. In PICU, we consid- er an ultrasound sys- tem essential – there is nothing else that gives us so much informa- tion, so quickly and non- invasively – and today we Dr. José Luis Vázquez Martinez, Head of PICU at Hospital Ramón y Cajal, is a pioneer in using ultrasound across Spain have a dedicated Edge II ultrasound system with linear, including hockey stick, and adult and paediatric car- diac transducers. It is in constant demand and is a perfect fit for our work, fulfilling all our expectations. All my colleagues use it, and we are very satisfied with it. The system is high quality and ergonomic, and strikes a good bal- ance between image quality and ease of use. It is also quick to boot up, which is crucial for an instrument that is frequently moved between different beds in the unit. Robustness is vital too; if a patient deteriorates, we may have to move any equipment surrounding the bed very quickly to create space to treat them. However careful you are, there is always the risk of uninten- tional knocks to the system. A while ago someone said to me that they ‘sell ultrasound machines, but don’t offer training’, but this view isn’t enough – it’s very short- sighted – training is very important. Ramón y Cajal pioneered the use of ultrasound in PICUs across Spain, and was the first hospital to offer external training courses for doctors from other facilities, initially focused on clinical echocardiography. Over www.healthcare-in-europe.com MEDICAL LIGHTING SYSTEM STARLED3 NX SURGICAL LED LAMP ACEM SPA | Medical Company Division VIA DELLA TECNICA 29, 40050 - ARGELATO, BO - ITALY PH +39 051 721844 | FAX +39 051 721855 | firstname.lastname@example.org | WWW.ACEM.IT
How can DBT image reading time be decreased? ‘If I had an answer to that, I’d prob- ably be rich. It’s a difficult question with no clear-cut solution. However, there are several promising studies and approaches. One way to short- en reading time could be to use the so-called slabbing technique, where thinner image slices are combined in thicker slices to reduce the image volume. ‘Hotly discussed are also devel- opments including AI and Deep Learning. I myself would like to nav- igate easier in the tomo-stack, so a CAD system that indicates important features or lesions would be much appreciated. I could also imagine a system trained on a big data set that gives you a rating of probability of malignancy to be beneficial. So CAD and AI are very likely the way forward to assist radiologists find- ing the relevant parts in the DBT volume more quickly. ‘Another interesting experi- ment was conducted recently: Our research group used an eye tracker to see how fast readers were find- ing lesions in differently presented DBT images, and found out that, when DBT images were displayed horizontally, the radiologists read them a lot faster, because their eyes were more adjusted to the horizon- tal alignment. ‘There is powerful potential for improvements out there, but we also should not forget that reading images has always been a matter of training and experience. It’s not unthinkable that we can reduce time and improve sensitivity and specific- ity significantly simply by working with DBT on an every-day basis. It has almost become a proverb by now, but we really need more stud- ies in this area.’ Future plans ‘There’s still a lot of information to analyse from the trial, such as bio- logical tumour characteristics. But, we are also planning to execute a Associate Professor Sophia Zackrisson MD PhD is senior consultant radiologist at Skåne University Hospital in Malmö, Sweden, and a senior lecturer in radiology at Lund University and research group leader of diagnostic radiology. Her research focus lies on mammography screening and breast cancer. She received her medical degree from Lund University in 1999 and her PhD in Epidemiology in 2006. Following her residency in radiology in Skåne, from 2012-17 she headed the department of oncological imaging at Skåne University Hospital. meta-analysis of three studies in the first step – the STORM, Oslo and Malmo trials – including even more trials along the way to get influen- tial results and see if we can show, for example, a common decrease in interval cancers. ‘The question that always comes up is: are we going to imple- ment tomosynthesis in screening? Ultimately, I don’t know, but I am positive that it could happen. Breast cancer screening is one of the best screening programs we have in Sweden, but DBT could enhance it even more. It will be a long journey, but I’m convinced that, if you want to improve, tomosynthesis is an easy way forward. You just replace a unit in the same building in the same room with the same technologies and receive better mammography. People only need to be convinced of the benefits. ‘If you start using DBT in your own practice, you soon notice how many cancers you miss with 2-D only and usually that’s enough to convince people. Tomosynthesis is not perfect and we should not have blind faith in it, but it’s a great screening tool for a vast majority of average risk women. Personally, I think that a grass roots approach would help. ‘Start in several places by install- ing units in different centres and invite radiologists to try them out. When using it yourself, you really understand what the technology can give.’ n e d e w S , ö m l a M l a t i p s o H y t i s r e v i n U e n å k S : y s e t r u o c e g a m I 3-D mammography (tomosynthesis) to the left shows a 1 cm large tumour which is not as clearly visible on the 2-D mammography image to the right. The breast is quite fatty and it is evident that not much overlapping tissue is needed to compromise lesion visibility on 2-D mammography and hence the case illustrates the superiority of the tomosynthesis technique. dose for one-view DBT than two- view DM. Though radiation expo- sure has lost much of its signifi- cance in discussions, since we could strongly reduce dosage over recent years, it is still a valuable accom- plishment if we can improve our results and lower radiation exposure at the same time. 6 R A D I O LO G Y Digital breast tomosynthesis improves diagnosis DBT could boost breast screening Tomosynthesis is under international review, with a surprising number of enticing studies carried out in Northern European countries, among them one headed by Professor Sophia Zackrisson at Lund University, Sweden. When interviewed by Lena Petzold of European Hospital, she not only revealed surprising trial results, but also shared her thoughts on practical implementation and unusual speed-reading methods. ‘Our institute’s connection to tomo- synthesis goes a long way back,’ explained Sophia Zackrisson, sen- ior consultant radiologist at Skåne University Hospital. ‘We began to try out a prototype unit from Siemens as early as 2006 under my men- tor Ingvar Andersson, a well-known breast radiologist and researcher. We were, and still are, positively surprised by the technology’s ben- efits, especially in terms of eliminat- ing the so-called overlapping tissue effect. ‘We were quite sure that tomo- synthesis could have a major impact on screening, so we started some initial smaller studies. Yet, to really prove its effects, we needed data on a much larger scale, so we set out to implement a prospective trial. ‘When we decided on the basic outline, we reviewed the principles of screening: it should be acceptable for the population, should be fast, and should be safe. So, we decided to use a very simple protocol and show that it is still feasible to gain the same or even better results with one-view digital breast tomosyn- thesis (DBT) than two-view DBT + digital mammography (acquired or synthetic) as compared with two- view digital mammography (DM). We used the Siemens Mammomat Inspiration, but actually read the images on our regular Sectra PACS system. ‘We screened nearly 15,000 women over several years. Our participants were recruited from the regular screening population in Malmö, where according to Swedish recom- mendation every woman between 40 and 74 years of age is invited in different intervals for a preventive screening. Participants received the regular two-view mammogram first and then were screened with one- view DBT and reduced compres- sion, a special feature of the trial.’ Results ‘We collected a huge amount of data; and our most important results were that we not only found more predominantly invasive cancers in all density categories but that the detection rate with one-view DBT was 34 percent higher than with DM. When starting out, we were hoping for a 10 or maybe even 15 percent increase, so we were very happy when the results showed such a powerful augmentation. ‘We were also astonished that the detection was better in all densities including quite fatty breasts and not just in dense breasts. It shows that you do not need much overlapping tissue to hide a spiculated tumour. Furthermore, we were happy that we could reduce the compression in the DBT part of the trial by up to forty percent without losing valuable image quality. This could positively affect future screening attendance rates, since many women refrain from going because they fear the painful part of the examination. Dose ‘Another positive effect we came across concerned the radiation dose. We were able to use a 15 percent lower so-called average glandular Like a box of pumpkins, data contains big v Machine learning Standardised and well-structured data, as well as the definition of clear objectives, are indispensable prerequisites for artificial intelli- gence implementation into clinical processes. Report: Michael Krassnitzer ‘Ask not what artificial intelligence can do for you but what you can do for artificial intelligence!’ This vari- ation on John F Kennedy’s famous quote comes from Dr Ben Glocker, Senior Lecturer in Medical Image Computing at Imperial College London, UK. The occasion was a lec- ture given by the computer scientist at the European Radiology Congress (ECR 2018) on how machine learn- ing can be routinely implemented in medical image analysis. Artificial Intelligence (AI) was among the main topics at the con- gress; this also includes machine learning and its subdivision ‘deep learning’, which is based on so- called neural networks. AI entails an artificial network learning from examples and recognising inherent patterns and regularities by itself. Based on this, numerous applica- tions are already used in imag- ing, such as image segmentation, where an algorithm precisely marks out certain anatomic or pathologi- cal structures from their environ- ment (e.g. healthy brain tissue from tumour tissue in MRI brain scans, or whole body MRI scans of organs). Machine learning also facilitates the detection of new disease patterns, the extraction of clinically relevant information from multi-dimensional, multimodal image data that would otherwise remain concealed. Clearly defined objective needed ‘It’s basically a mathematical func- tion,’ says Glocker explaining machine learning. ‘This function is fairly complex, and we also cannot say exactly what is looks like, but like every function it has an input and an output.’ According to this UK-based German computer scien- tist, there are frequently misleading ideas around the necessary input. EUROPEAN HOSPITAL Vol 27 Issue 4/18
R A D I O LO G Y 7 Women should know about breast density Driving cancer screening compliance Formalising protocols can lead to better patient outcomes, advises Tracy Accardi, Hologic’s Global Vice President of Research and Development for Breast Health & Skeletal Solutions Breast density: it’s a topic that comes up often in the breast imag- ing industry and plays a crucial role in breast screening, as women with very dense breasts are four to five times more likely to develop breast cancer than women with less dense breasts (1. Boyd NF, Guo H, Martin LJ, et al. Mammographic density and the risk and detection of breast cancer. N Engl J Med. 356(3):227-36, 2007. 2. Yaghjyan L, Colditz GA, Collins LC, et al. Mammographic breast density and subsequent risk of breast cancer in postmenopausal women accord- ing to tumour characteristics. J Natl Cancer Inst. 103(15):1179-89, 2011.). Additionally, the masking effect that breast density can have on an image, which can make it extremely challenging for radiologists to see and diagnose cancer using tradition- al 2-D mammography, demonstrates that breast density greatly impacts on the breast screening process as a whole. These facts make it par- ticularly important for radiologists to educate their patients about what their breast density is and what that means for their health. According to a 2017 Kadence study, 74 percent of radiologists surveyed in Europe talk to their patients about dense breasts and, of those, 25 percent list diagnosis/ detection as their top challenge when it comes to screening women with dense breasts. However, only two percent of the surveyed radiolo- gists have a formal screening proto- col in place for patients with dense breasts (Kadence study conducted in partnership with Hologic in 2017. Data on file.). The proven impact of density on screening, coupled with these research findings, shows a clear need for radiologists to formalise their approaches to addressing breast density, from patient educa- tion and assessment through screen- ing. This will help to ensure that all patients – including those with dense breasts – have the best pos- sible clinical outcomes. Driving breast cancer screening compliance is an essential part of improving clinical outcomes, and one way to do this is to educate women about their breast density. Knowing breast cancer risk factors, such as family history, can help encourage patients to remain com- pliant with screening guidelines, and breast density is no excep- tion. By informing patients who have very dense breasts that they may be at greater risk for breast cancer diagnosis, radiologists can help improve screening compliance among women who may not have previously felt a strong need to be screened. Therefore they may have a better chance of early cancer detec- tion. However, to be effective, dis- cussing breast density with patients starts with breast density assess- ment, an exercise that is currently undergoing a great deal of change, especially as artificial intelligence (AI) continues to advance. Typically, to categorise their patients’ breast density, radiolo- gists complete a visual assessment of digital images using the Breast Imaging Reporting and Data System (BI-RADS) classification estab- lished by the American College of Radiology (ACR) in 1993. The cur- rent need for a visual assessment to indicate a BI-RADS score means that breast density categorisation can be subjective to the person reading the images and lead to variations depending on who is looking at the image. The rising trend of machine learning in the medical device space, however, is becoming increasingly relevant spe- , ) G P J . C C _ 1 _ s a s n e D _ s a m a M : e l i F / i k i w / g r o . a i d e m i k i w . s n o m m o c / / : s p t t h ( o l l u d r a i C S e d o c l a g e l / 0 . 3 / a s - y b / s e s n e c i l / g r o . s n o m m o c e v i t a e r c / / : s p t t h , “ C C 1 s a s n e D s a m a M „ cifically for analysing breast density. Machine learning-based algorithms are especially useful for classifica- tion issues, and categorising breast density using parenchymal patterns and texture is just the type of need these algorithms can help fulfil. When combined with expertise from radiologists, who can provide patient and situational-specific con- text to supplement the AI, the use of such technology can help stand- ardise breast density classifications. Thus, machine learning can greatly impact on breast density assess- ments by providing a more uni- form, objective classification system across the industry. Thus clinicians can make more confident screening decisions and recommendations for their patients. Since dense breast tissue can make identifying cancers more dif- ficult on certain imaging modali- ties, breast density can help to inform which screening protocol is best for each patient. This can vary based on the pros and cons of the technology and specific needs of a patient. Ultrasound, commonly used in Europe for example, is very use- ful for women with dense breasts because it can identify the differ- ence in density between tumours and the breast tissue around them. Unfortunately, ultrasound also has significantly higher false positive rates. Contrast enhanced breast MRI provides very clear images that make it easier to spot cancer in dense breasts and doesn’t use ionis- ing radiation, but it can also lead to false-positives, is very expensive and is limited in availability. Although 3-D digital mammogra- phy uses a radiation dose, it pro- vides accurate, high-quality images that can help detect invasive cancers Tracy Accardi MSc is Hologic’s Vice President of Global Research and Development at the Breast and Skeletal Health Division. – and it is without question that accuracy is by far the most impor- tant part of any breast screening. If a radiologist was to perform a 3-D mammography exam on a patient with dense breasts and not see any- thing, then he/she can be especially confident the patient is done with screening and only move on to an ultrasound option if there are any suspicious spots. Despite the fact that there is no general consensus on what screen- ing protocols for dense breasts should be, some imaging modalities are more effective than others. In fact, Hologic’s 3-D Mammography exam is the only mammogram that is FDA-approved as superior to standard 2-D mammography for routine breast cancer screening of all women, including those with dense breasts (FDA submissions P080003, P080003/S001, P080003/ S004, P080003/S005.). Therefore, radiologists should place more of a priority on formalising their breast exams based on breast density, while of course keeping in mind any other relevant factors distinctive to each patient. The concept of breast density is an eye-opening one because it truly captures the unique profile of each patient. Although two women may have the same breast density classification, other factors in their life, such as family history, race and more, each play a different role in creating a somewhat different patient profile. By addressing breast density head-on through educating patients on the topic and imple- menting a more formal assessment and screening process, radiologists can help each patient have the best chance of early cancer detection, which is the ultimate goal for all. e a box of pumpkins, data contains big variations l g r i b / y a b r a x i P : e c r u o S ‘The approach “We have a lot of data and are going to do something with it with the help of machine learn- ing” is not the best starting point.’ Therefore, Glocker’s first advice is: If you want to use machine learning successfully you need to start with a clearly defined objective. ‘Machine www.healthcare-in-europe.com Expectation v. reality: Like variously shaped pumpkins, radiology data sets can differ significantly from one another learning is always geared towards a very specific task,’ he emphasises. Another common obstacle to the use of machine learning is the qual- ity of data. Glocker explains that, on many occasions, clinicians prom- ise him homogenous data sets for respective projects, which actually turn out to be different, insufficiently structured data. He compares this to pumpkins: ‘We are expecting a box of these vegetables of equal size, equal shape and equal colour, but what we actually receive is a deliv- ery of pumpkins of different sizes and different varieties.’ For data to be used for machine learning it not only needs to be correct and labelled but most definitely also standardised and labelled in a standardised way. ‘Machine learning can only begin when data is usable and when a specific task has been determined,’ Glocker concludes. The develop- ment of an AI application also needs the relevant medical expertise for its use: ‘The experts must be involved in all stages of development,’ the computer scientist emphasises. He means that medics and computer sci- entists must work together in inter- disciplinary teams. He also offers other inevitably important advice: ‘Artificial Intelligence applications must be integrated seamlessly into clinical processes.’ Ben Glocker PhD is a senior lecturer in medical image computing at Imperial College London, UK, and deputy head of its biomedical image analysis group. He gained his PhD from the Technical University Munich, Germany. He was then a post-doc at Microsoft Research and a research fellow at the University of Cambridge, United Kingdom. In his research he specialises on applying machine learning and artificial intelligence to automate image analysis.
www.healthcare-in-europe.com CARDIOLOGY 2 8 1 0 N E W S A N D T E C H N O L O G Y U P D A T E S F O R C A R D I A C C A R E M U N I C H G E R M A N Y 2 5 A U G – 2 9 A U G 2 0 1 8 At the heart of research Scanning impacts on cardiology When delegates from around 150 countries converge on Munich for ESC Congress 2018 they will no doubt reflect on what they themselves eat. Yes, nutrition is up for debate, ques- tioning, for example, whether weight loss therapies can also prevent heart attacks and strokes. Results from the CAMELLIA-TIMI 61 trial of 12,000 overweight individuals with established cardiovascular disease or diabetes could tell us ‘whether becoming slimmer with weight loss therapies also makes you health- ier,’ explained Professor Stephan Achenbach, Chairperson of the ESC Congress Program Committee and ESC President Elect. That trial is being presented at the congress. Results with big impact Additionally, the huge PURE study, which examined what constitutes a healthy diet in over 200,000 peo- ple from more than 50 countries, will be aired. ‘The results will give us new insights on the relation- ship between the types of food we eat – for example fruit, vegetables, nuts, dairy products and meat – and health and disease,’ Achenbach explained. The Chair also expressed excitement about other trials to be presented, with results ‘set to have a big impact, either because they affect large popu lation groups or involve innovative treatments.’ For example, two aspiring trials to examine for preventing first heart attacks and strokes prevention will be presented – the ARRIVE trial involved more than 12,000 individu- als at moderate risk and the ASCEND trial involved over 15,000 diabetics. ‘We had assumed that taking aspirin can only be good for you, and what’s the harm?’ said Achenbach. ‘But then we discovered that, while aspirin can protect against heart attacks and stroke, it causes bleeding. So it’s not at all clear who will actually benefit from taking aspirin to prevent a first heart attack or stroke. These two trials will shed light on this issue, impacting many millions of people worldwide.’ 2018 European Society of Cardiology (ESC) and European Society of Hypertension guidelines on hypertension are another impor- tant talking point. ‘The American guidelines (released in 2017) were very strict and lowered the definition of high blood pressure. It will be exciting to see what the Europeans say about what blood pressure quali- fies as “high” and how strictly it should be treated,’ Achenbach sur- mised. The MARINER trial will reveal whether potentially fatal blood clots can be prevented in acutely ill patients by continuing to administer oral anticoagulation therapy after they return home. ‘Treating patients after discharge is a completely new concept and could affect the millions of people hospitalised every year with heart attack, pneumonia, or broken bones,’ Achenbach prophe- sied. Oral anticoagulation is also a focus of the COMMANDER HF trial, which will reveal whether these drugs improve survival and reduce heart attack and stroke in heart fail- ure (HF) patients who do not have atrial fibrillation. Achenbach: ‘This is a massively large patient group that so far not been considered for oral anticoagulation unless they have atrial fibrillation and the trial could change our approach to their management.’ Prof. Stephan Achenbach, FESC Chairperson 2016-2018 of ESC Congress Programme Committee more than 47,000 patients will reveal whether using high-sensitivity tro- ponin to confirm the diagnosis in those with suspected heart attack leads to more or less deaths and repeat heart attacks after one year. ‘I’m excited by how diverse car- diology is and feel it is my respon- sibility to represent and balance the needs of the cardiologists, healthcare providers and researchers in every country that belongs to the ESC and also across the entire spectrum of cardiovascular disease,’ Achenbach pointed out. This ethos includes spreading news of scientific findings from ESC journals and registries, guidelines, congresses, and other educational activities. In our special Cardiology section you will also learn from medical sci- ence experts how far machines and scanning skills are shaking the very roots of your discipline. Enjoy the stimulation of new con- cepts and technological develop- ments. Enjoy EH along with ESC 2018. Welcome! Prof. Jeroen J. Bax, FESC President 2016- 2018 of European Society of Cardiology Trials and more Achenbach also highlighted the MITRA.fr study, which indicates whether treating the mitral valve with a device inserted via a catheter is advantageous in HF patients. An entire late breaking science session is devoted to transcatheter aortic valve implantation (TAVI) and is aligned to the congress spot- light, Valvular Heart Disease. This includes the LRT Clinical Trial and GARY registry in low-risk patients, the TAVI-PM study on the durability of TAVI, and the five-year follow-up from the FRANCE-2 Registry, which will report on clinical outcomes and valve durability in high-risk patients. Major drug trials include ATTR- ACT, which assessed the efficacy and safety of tafamidis in transthyretin amyloid cardiomyopathy, a condi- tion that currently has few treatment options. The High-STEACS trial of Study examines genes and lifestyle links to dilated cardiomyopathy Titin: the commonest genetic cause of DCM Report: Mark Nicholls A major study has been launched to investigate the interaction between genes and lifestyle factors and dilated cardiomyopathy (DCM). Led by Professor Stuart Cook, at the National Heart and Lung Institute, this, the largest ever DCM study, will investigate why people develop DCM, with a focus on who is most at risk of sudden death or heart failure (HF). Six hospital trusts across England – including the Royal Brompton and Harefield NHS Trusts and Imperial College London – will recruit patients for the study. DCM thins cardiac muscle, mak- ing it less able to pump blood around the body. About one in 250 (260,000) people in the UK are www.healthcare-in-europe.com Due to thinned cardiac muscle, a heart affected by dilated cardiomyopathy (left) can pump less blood around the body than a normal heart (right) affected, with around one in 100 (650,000) believed to be at risk of developing the condition due to a common mutation in the titin pro- tein. This mutation predisposes the heart to developing DCM when it is placed under stress such as during pregnancy, some cancer treatments and possibly alcohol abuse. Study to improve diagnos- tics and therapy DCM is a complex condition and can be caused by a variety of genetic and environmental factors but cardiologists also recognise it is poorly understood, with most causes unknown. A leading course of heart trans- plantation, and after coronary heart disease, DCM is the leading cause of heart failure. The condition has poor outcomes with research sug- gesting that 15% of patients do not survive beyond five years after diagnosis, and up to half of deaths occur within the first two years of diagnosis. In the new multi-centre study of more than 2,000 patients research- ers will use advanced DNA sequenc- ing, biological markers in the blood and cardiac imaging approaches to assess interactions between genes as they seek to discover new genetic mutations underlying DCM, as well as to assess potential environmental interactions. Ultimately the study aims to find better ways to diagnose, treat and prevent deaths from DCM. Stuart Cook is Professor of Clinical & Molecular Cardiology at Imperial College London in the UK and head of the Cardiovascular Genetics and Genomics group within Genetics & Imaging at the National Heart and Lung Institute (NHLI). He also directs the genetics and genomics group that plays an integral research role within the Royal Brompton Hospital cardiovascular biomedical research unit. An expert in cardiovascular MRI, with special interest in genetics in cardiac muscle disease, his research focuses on the genetics of cardiovascular disease, particularly inherited cardiac conditions that cause electrical abnormalities of the heart and heart failure. Professor Cook, who is also Professor of Clinical and Molecular Cardiology at Imperial College Continued on page 11
1 0 CA R D I O LO G Y Intracardiac echocardiography (ICE) has benef Refined guidance with no need for anaesthetic Intracardiac echocardiography (ICE) is an increasingly important guiding tool for structural heart disease interventions – without gen- eral anaesthesia. José Ribeiro, who works in the thorax and circula- tion unit at Gaia Hospital Centre, Portugal, who has worked with this technology for the past two years, explained its benefits and limitations in an exclusive interview with Daniela Zimmermann of European Hospital. Discussing developments in Intracardiac echocardiography (ICE), José Ribeiro, cardiologist at the thorax and circu- lation unit in Gaia Hospital Centre, Portugal, explained that recently the need for a different ultrasound tool to guide patient treatment beyond transoesophageal echocardiography (TEE) became clear. ‘Consequently,’ he added, ‘a significant number of interventional cardiologists have start- ed to use ICE. ‘We still have limitations with ICE for structural heart disease, because we don’t see all the structure in the same plan and need to navigate with a catheter inside the heart. That’s why it’s so important for 3-D imaging to guide procedures. ‘We don’t need too much imaging to guide the intervention for struc- tural heart disease. But we need to have a good pre-procedure evaluation and to plan the procedure, and after that we only need specific steps to ensure procedure quality and check the results. If we can get the cardiac structures on 3-D, we have a signifi- cant advantage for guidance. ‘We initially had a narrow angle catheter, which only enabled us to view small volumes of the heart. This is not enough to image entire structures, for instance a valve, left appendage or oval fossa. So we devel- oped a new device with a wide open- ing angle; it’s a 12.5-Fr catheter and this enables us to view significant vol- umes of the cardiac tissue, including the whole mitral valve. This develop- ment appears to be a great advantage for guidance.’ DZ: When using ICE, is the image in front of you and can you see the relation between the structures? ‘Yes. When we have a volume, we can look inside and decompound it in a different 2-D plan to navigate more easily, which enables us to be more confident when doing the procedure. ‘With a 3-D wide angle ICE cath- eter, we have the same benefits as with 2-D ICE, meaning we don’t need an anaesthetist, the interventional car- diologist can do the intervention him- or herself, by putting the catheter in the right place to see the heart. ‘But we can also obtain a signifi- cantly higher amount of information and anatomy, so that the interven- Images of intracardiac echocardiography obtained with Acunav V wide angle catheter (Siemens Healthineers); on 3D images we can see entire cardiac structures: on top right the fossa ovalis, on top left the left atrial appendage opening (LAA), on bottom right the mitral valve with anterior (AL) and posterior (PL) leaflets and on bottom left the device occluding LAA. More people need nuclear cardiology training Ischaemia: Advances in nuclear imaging Experts outlined approaches to ischaemia imaging during the recent British Cardiovascular Society confer- ence. In a ‘Detection of ischaemia by cardiac imaging in 2018’ session, comparisons were made between solid state SPECT cameras, whether spatial resolution or visual assessment was of the greater importance, if CT-FFR offered advantages over CT perfusion, and the challenges in defining a gold standard of imaging ischaemia Discussing ‘Advances in nuclear ischae- mic testing, from SPECT to PET and beyond’, Dr Kshama Wechalekar, who heads Nuclear medicine and PET at the Royal Brompton Hospital in London, and is President of the British Nuclear Cardiology Society (BNCS), told delegates that advances in nucle- ar imaging with solid state technol- ogy offered improved ability to detect ischaemia. ‘There is improved spatial resolution from multiple solid state CZT (Cadmium Zinc Telluride) detec- tors and therefore sensitivity is very high,’ she explained. ‘You can reduce the acquisition time at least by half President of British Nuclear Cardiology Society Dr Kshama Wechalekar leads nuclear medicine and PET at the Royal Brompton Hospital in London, where she specialises in heart/lung nuclear imaging. Her main interests lie in using hybrid- imaging techniques, such as SPECT-CT and PET-CT, to improve understanding of pathophysiological processes affecting the heart and lungs. She has special interest in cardiac sarcoidosis and other inflammatory conditions of the heart. with excellent quality and the equip- ment has a small footprint. The advan- tages of solid state detector cameras is that you can reduce the radiation dose by one third, have high sensitivity and resolution, an open design suitable for claustrophobic patients, and good image quality even in obese patients.’ SPECT, PET and CMR Recent studies have shown ability to do dynamic imaging offering potential in quantitative myocardial perfusion with SPECT, Wechalekar pointed out, adding that SPECT is less expensive than current PET and MRI. ‘The future of SPECT Nuclear car- diac imaging,’ she concluded, ‘is in solid-state technology. Dynamic imag- ing, although technically challenging, can add value to MPI in the detec- tion of ischaemia. Whilst PET is the most accurate imaging technique for ischaemia assessment and prognosis, it remains expensive and less acces- sible.’ She also felt that the new trac- er, Flurpiridaz, with results of phase III trials in the UK pending, might change the future of PET MPI. One area of concern was how to persuade more people to train in nuclear cardiology with falling num- bers in the field. ‘The BNCS Council is working hard to improve curricu- lum, organise level 1 and 2 training courses, and to identify centres that can offer nuclear cardiology training across the country that is easily acces- sible for trainees,’ she said. Dr Chiara Bucciarelli-Ducci, in Lecturer Consultant Senior Dr Chiara Bucciarelli-Ducci is Consultant Senior Lecturer in Cardiology/non Invasive Imaging at the Bristol Heart Institute, University of Bristol, and co-Director of the Clinical Research and Imaging Centre (CRIC Bristol). She is currently one of the vice-presidents and chair of cardiac MRI of the European Association of Cardiovascular Imaging (EACVI). Invasive Cardiology/non Imaging Bristol Heart Institute, University of Bristol, explored the issue of quan- titative versus visual assessment in CMR stress perfusion. She explained that stress CMR has been included in the ESC guidelines since 2014 (ESC revascularisation guidelines) based on evidence using visual assessment of ischaemia, rather than quantitative. Bucciarelli-Ducci discussed pros and cons of both visual and quan- titative assessment, limitations and opportunities to increase spatial reso- lution, and very recent studies show- ing that there is no difference in diag- nostic accuracy visual vs. quantitative. Quantitative perfusion is promising, but the acquisitions and analysis need Single photon vs. Positron ET simplification to meet the need of a busy clinical service. ‘CMR perfusion (visual) is a good clinical tool already,’ she concluded, ‘but can get better while quantita- tive CMR perfusion is evolving into faster and robust tools. While several methods are available, more in-vivo and clinical validation is needed with a number of studies in the pipeline.’ Function addition can improve specificity Dr Marc Dweck, BHF Reader in Cardiology and Consultant Cardiologist at the University of Edinburgh and the Edinburgh Heart Centre, posed the question ‘CT-FFR/CT perfusion - nei- ther or both?’ ‘CT Perfusion,’ he acknowledged, ‘is interesting, but I’m not sure how we are going to use it in clinical practice. With CT-FFR you get beautiful pic- tures, where you can look down the coronary arteries and see areas that are not getting enough blood. The advantage of this technique is that you can use it on a post-hoc basis, on scans where you are not sure if a lesion is obstructive or not, without any extra radiation or medication for the patient. This may be useful in low- ering the rates of patients being sent EUROPEAN HOSPITAL Vol 27 Issue 4/18 Dr Marc Dweck is Senior Lecturer and Consultant Cardiologist at the University of Edinburgh and the Edinburgh Heart Centre. A British Heart Foundation Intermediate Clinical Research Fellow, he is a keen advocate of multi-modality cardiovascular imaging and is trained in echocardigraphy, carotid ultrasound, computed tomography (CT), cardiovascular magnetic resonance (CMR), PET/CT and PET/MR imaging.
CA R D I O LO G Y 1 1 school in 1992 he became a cardiology specialist in 1996, which was followed by an echocardiography fellowship at Onze-Lieve-Vrouwziekenhuis in Aalst, Belgium. He also became a member of the Portuguese Cardiology College. Since 2001, he has led the echo lab (with 9,600 studies in 2017) and, from 2006, has been cardiology consultant in the Espinho Hospital Centre at Vila Nova de Gaia, where he has implemented new techniques, including transoesophageal echocardiography, as well as coordinated several telemedicine projects. José Manuel Coelho Ribeiro MD directs the Thorax and Circulation Unit at Vila Nova de Gaia Hospital Centre in Portugal. Having graduated from Oporto medical TEE. Both methods are alternative. ICE is a step forward, especially with this new dimension – 3-D ICE. But,’ he concluded, ‘in the future we need to check what’s the best option for each patient.’ y (ICE) has benefits tional cardiologist can do the whole procedure without having to navigate with the image catheter. We can put the catheter in the right place, and then we don’t need to move it to see what we need to see.’ What are the benefits of not having to move the catheter? ‘Moving the catheter to view the cardiac structures means more work, more time, more risk and more radia- tion. ‘In the interventional lab, we always use angiography and ultrasound. Angiography, i.e. radiation imaging, helps us to carry out the procedure and navigate to place the ICE catheter inside the heart. If we don’t need to move the catheter because we can see everything at once, we of course also need less radiation. ‘If we have a technology that gives us everything with the catheter in the same place, it’s much better.’ Many specialists are needed in such an intervention. One day, could just one person do this? ‘That’s the big point. But we need to train interventional cardiologists, to change their mind-set. They typi- cally use angiography and ignore ultrasound. ‘However, this is changing now. Everything is changing in the inter- ventional lab. We are using TEE in a significant number of procedures; but with TEE we also need special- ists. With ICE, we can do everything while the patient is awake, without discomfort and anaesthesia, and with fewer people inside the room and less radiation. ‘In the lab, for ICE guidance we use the echocardiography machine to direct the image and ICE catheter manipulation beyond the angio room equipment. In future, we could have all the controls on the table – connect- ing angio and ultrasound controls. Also, we need to improve the imaging display software, with specific play sets for detailed procedures, to give the right plans for each interventional procedure. ‘Right now, in our hospital, we simultaneously use display ultrasound imaging and angio imaging on the same screen. We can switch to all the positions we need, but we need lots of training to be able to see it. The learning curve for intervention- al cardiologists is long. Some inter- ventional cardiologists already have experience with 2-D imaging, and they have a significant advantage to give the final step to use 3-D imaging in ultrasound. The learning curve is more important when you are using angio only.’ For which cases do you use TEE and ICE? ‘In our lab we check all patients in the echo lab in a selection process and, when we are very confident about the pathology or anatomy, we use the ultrasound image (TEE or ICE) for guidance and to improve confidence during the procedure. In simple cases, such as ASD or PFO closure, we use ICE. As men- tioned earlier, ICE gives us many advantages - no anaesthesia needed, more comfort, etc. For more complex cases we must decide how much imaging we need. ‘We also use ICE in normal mitral valve repair and left a; we have initial experience with this wide angle 3-D ICE catheter that crosses the inter-atri- al septum to scan left side structures, for instance. ‘So far, our experience with ICE is limited. But even with more experi- ence, in complex cases we tend to prefer the technique or imaging tool with which we have more experience. So TEE may still be preferred in such scenarios. The main limitation of ICE is lack of experience with the tech- nology. In addition, if the case is too complex, we may need to cross with the catheter to the left side, so we need to move the catheter to be sure.’ ‘ICE could be useful in some patients who cannot be imaged with ances in nuclear imaging Professor Darrel Francis is Professor of Cardiology, Imperial College London. His work in ischaemia has included the ORBITA trial of revascularisation and the BRAVO trial of automated haemodynamic optimisation of cardiac resynchronisation therapy pacemakers. increased, while CT-FFR has increased cost, though CT-FFR potentially fitted in better with patient workflows. Professor Darrel Francis discussed the problems of computed tomog- raphy in the presentation ‘Ischaemia detection - are all our ideas com- pletely wrong?’ He pointed out that all previous speakers had described sensitivities and specificities, concepts that are meaningful only if ischae- mia is dichotomous (present versus absent). His audience poll revealed cardiologists unanimously considered ischaemia to be a continuous grada- tion rather than dichotomous. mn Quantitative myocardial perfusion reserve with Rb-82 PET to the cath lab following CT.’ Patients most likely to use CT-FFR, he added, are those with borderline lesions, though he stressed the key lies in a patient’s history and only using CT-FFR in patients with recalcitrant angina symptoms. CT is a powerful imaging technique that informs about coronary artery anatomy (plaque burden, stenosis severity, plaque characteristics), he concluded, but emphasised that the addition of functional technique to the scan protocol can improve its specific- ity to identify obstructive stenosis, pro- viding a comprehensive assessment of anatomy and function. With CT perfusion, radiation dose is At the heart of research Continued from page 9 London, said: ‘For about 1 in 4 patients with DCM we can find a genetic cause. But that leaves us with hundreds of thousands of people with DCM that we cannot explain, which hin- ders our ability to diagnose and treat the patients or help their fami- lies. ‘There are currently no targeted treatments that are specific for DCM but, as we get a better understand- ing of the genes which cause the condition, we can hope to develop new treatments which target these genes and pathways.’ Professor Sir Nilesh Samani, Medical Director of the British Heart Foundation, which has delivered £2m funding for the study, said: ‘In many cases, we can track the inheritance pattern and test family members of peo- ple with inherited heart conditions. But unfortunately, genetic testing is often not helpful for people with DCM, as we only know about a small number of genes which cause the condition.’ In 2011, Professor Cook and his team established the genet- ics and genomics group at NHLI and have developed and applied unbi- ased, integrated systems genetics and genomics approaches combined with high-resolution cardiovascular phenotyping to identify new genes and mechanisms for cardiac hyper- trophy and dysfunction. The team has used genome-wide association in humans to identify new loci and genes for DCM and has already identified titin as the commonest genetic cause of DCM. www.healthcare-in-europe.com NEWAll congress resourcesin one online libraryWatch the sessions you missedor replay the ones you likeat your convenienceMore than 84,500 cardiovascularslide sets, videos and abstracts from the ESC family of congressesNew platformEnhanced search functionYear round accesswww.escardio.org/365ESC 365 is supported by Bayer, Boehringer Ingelheim, Bristol-Myers Squibb and Pfizer Alliance, and Novartis Pharma AG in the form of an educational grant.
1 2 CA R D I O LO G Y Coronary angiography will lose diagnostic value The changing face of imaging in cardiology While the question is still debated as to whether MRI is the better CT, along comes a potential game changer – a new data based 3-D reconstruction method of heart anatomy and function that aims to replace diagnostic coronary angiography. In the near future not only adult patients with coronary heart disease could benefit from this new technique but also children with complex congenital heart defects. Meanwhile imaging is conquering the cardiac operating room (OR). Report: Emilie Hofstetter Long before coronary heart disease (CHD) manifests its presence on an ECG, CT and MRI can detect it due to low perfusion caused by a stenosis of the coronary vessels. Dr Bettina Baessler, radiologist and researcher at the University Hospital Cologne, Germany, looks into mul- tiparametric imaging strategies. She considers both techniques comple- ment one another although MRI definitely produces images that are ‘more beautiful, almost works of art’. Professor Ulf Teichgräber, Head of Radiology at University Hospital Jena, Germany, agrees and thus predicts the demise of cardiac angi- ography. His opinion is corrobo- rated by the recently completed SYNTAX III study, whose results will be presented at the Transcatheter Cardiovascular Therapeutics From Vision to Impact. That’s Excellence for Life. From First German Pacemaker to Connected Cardiac Care. biotronik.com flow and can thus show whether a haemodynamically relevant block- age is present, i.e. whether the patient needs a stent or a bypass. In 2015, Professor Pamela S Douglas, cardiologist and Head of Multimodal Imaging at the Duke Clinical Research Institute in Durham, North Carolina, USA, showed the potential benefit of this method using 584 patient cases from 11 hospitals. Ten patients with suspected CHD underwent diagnos- tic cardiac catheterisation, but the suspicion was confirmed only in three patients – seven underwent unnecessary catheterization. Six out of ten patients with suspected CHD, whose FFRCT was determined first, did not need angiography. In three out of the four patients who did receive angio, the suspicion was confirmed – i.e. only one patient underwent an unnecessary angiog- raphy. ‘This feasible and safe meth- od shows a significantly lower rate of unnecessary invasive angiogra- phies,’ Douglas confirmed. Investors seem to buy in: HeartFlow, which today is already cooperating with the Big Three – GE, Siemens, Philips – recently raised USD 240 million to further develop the technology, launch new studies and drive com- mercialisation of its product. To establish 3-D imaging in con- genital heart disease treatment, paediatric cardiologists Animesh Tandoon and Tarique Hussein founded VARYFII Imaging, LLC, in Dallas, USA. They construct complex anatomical models of the individual patient’s pathologies using MRI or CT data. Cardiologists as well as sur- geons can enter the virtual and aug- mented realities of the anatomical models with the help of data head- sets to lift certain structures, analyse and reposition and thus devise the best strategy them 3-D reconstruction of a coronary system, detached from the heart muscle. Fractional flow reserve in the individual vessel sections is colour-coded. Courtesy: HeartFlow, Inc. Y-conduit of right and left internal thoracic artery in epicardial ultrasound. A: 2-D Long axis view, B: 2-D short axis view, C: Colour Flow Mapping long axis, D: Colour flow short axis. Courtesy: Di Giammarco to correct the heart defect prior to surgical intervention. ‘Our heart beats in 3-D, so why not examine it in 3-D?’ asks Dr Sandy Engelhardt, researcher at the Computer-Assisted Surgery Group at the Department of Simulation and Graphics in Otto von Guericke University, Germany. In addition to treatment planning and education she envisages a further application of this new technology: informing the parents of the young patients. The flow must continue Imaging has arrived in cardiac surgery – during the intervention itself and combined with flow measurements. Professor Gabriele Di Giammarco, cardiac surgeon at Gabriele D’Annunzio University Hospital in Chieti, Italy, considers the combination of high-frequency epicardial ultrasound (ECUS) and transit flow measurement (TTFM) in a single device ‘deci- sion making’ and explains: ‘Hard calcifications in the aorta, I can feel. I do not feel the dangerous soft plaques. With MiraQ, I see them in intraoperative ultrasound, can adapt my strategy and perform surgery in no-touch technique and off-pump.’ time Dr Daniel Wendt, Managing Senior Physician at the Cardiac Surgery Department of University Hospital Essen, Germany, uses intraoperative flow measurement of newly cre- ated bypasses not only for quality assurance purposes – he records a follow-up intervention rate of slightly below three percent – but also for training purposes: ‘It’s a tool to improve your skills, helps flat- tening the learning curve.’ The combination of risk minimisation and qual- ity assurance has proved suc- In cessful. 2017, the Oslo-based m a n u - f a c t u r e r M e d i s t i m sold prod- ucts and procedures worth NOK 229.8 million, up 14.6 percent over the previ- ous year – another chapter in the success story of surgical interven- tion in CHD patients. EUROPEAN HOSPITAL Vol 27 Issue 4/18 The physician, using smart glasses, in the virtual space has just removed the aorta at its root from the heart to examine it separately. Observers can follow on conventional screens. Courtesy: S. Engelhardt Symposium 2018 in San Diego in September. A team comprised of a radiologist, cardiologist and sur- geon (Heart Team A) evaluated the angiogram of a patient, calculated the SYNTAX II score and decided on the type of therapy, either invasive or non-invasive. The team members then saw the multislice CT (MSCT) scan with 3-D reconstructed coronary vessels and the relevant fractional flow reserve (FFRCT) and could either confirm or revise their decision. A second team (Heart Team B) of those pro- fessionals received CT and FFRCT of the same patient first. The team members calculated the Syntax III score, decided on the type of ther- apy and then saw the angiogram in order to either confirm or revise their decision. ‘The Syntax score was designed to inform the decision “invasive or non-invasive”, based exclusively on anatomical features,’ Teichgräber explained. ‘Syntax II took comorbidities into account and now Syntax III includes a functional component – FFRCT. Thus coronary angiography will lose importance in diagnostics and therapy planning.’ Non-invasive first To date, only the California-based HeartFlow Inc. can calculate FFRCT. Based on data obtained in a conven- tional CT, the company’s software, using flow mechanics, can recon- struct heart, aorta and coronary ves- sels in terms of geometrics as well as pathophysiology and function in 3-D. Moreover it visualises the
CA R D I O LO G Y 1 3 The future POCT heart attack test Dr Tom Kaier is a BHF Research Fellow, having previously been a Specialist Registrar in Cardiology at Barts Health NHS Trust and the Royal Free London NHS Foundation Trust in the UK. . In part, the research has been the British Heart funded by Foundation, which said the initial results from the cMyC test look ‘very promising’ for patients and acknowledges that it could lead to quicker diagnosis and treatment, or see patients reassured and dis- charged. However, BHF Associate Medical Director Professor Jeremy Pearson stressed that further research was necessary before cMyC could be recommended as a replacement for the troponin test. On the way: mobile cMyC analysis Experts report that a new blood test to diagnose heart attacks could be carried out on a hand- held device in the not-too-distant future. a blood test to measure troponin levels. With the cMyC blood test shown by the KCL team to have a better rule-in and rule-out rate for heart attack, the research team believes this will be a valid tool in reassur- ing patients sooner and avoiding unnecessary hospital stays for fur- ther tests. Report: Mark Nicholls The test, devised by a team at Kings College London, uses similar tech- nology to the troponin test, but instead analyses cardiac myosin- binding protein C (cMyC). In research presented at the British Cardiovascular Society con- ference in Manchester, UK, this June, Dr Tom Kaier, BHF Research Fellow, explained that levels of cMyC in the blood increase more rapidly after a heart attack and to a higher extent than troponin. With this offering the opportunity to rule out a heart attack in a higher proportion of patients instantly, the research team believes it has a role in providing a swift diagnosis in Accident & Emergency (A&E) departments. Scientists are optimistic that this relatively straightforward test could be used as a hand-held point of care test (POCT), and avoid samples being sent to the laboratory. cMyC outperformed tro- ponin Kaier, who was among the lead researchers, emphasised the impor- tance for doctors and patients to know, as early as possible, who has had a heart attack and who has not. ‘Now that we know this test is sensitive enough to give an almost immediate heart attack diagnosis,’ he said, ‘we need to work on devel- oping a testing device.’ As work on developing a POCT device continues, the team hope that it could be used in wards - or ambulances - within five years, replacing time-consuming despatch of samples to hospital labs. Trials of the test have been con- ducted around Europe by interna- tional collaborators. In Denmark, blood was taken from 776 patients travelling to hospital by ambulance, which the King’s College London researchers then tested for cMyC protein. In patients who had suffered heart attacks, Kaier said, the protein was present in high enough con- centrations 95% of the time for an on-the-spot diagnosis. The cMyC test outperformed the existing troponin test, which diag- nosed only around 40% of patients in this way, mainly because troponin takes longer to reach detectable lev- els in the blood after a heart attack. ‘A stand-out feature is cMyC’s ability to more effectively triage patients,’ Kaier said. ‘This distinction is likely related to the documented greater abundance and more rapid release profile of cMyC. If used on a POCT platform, cMyC could sig- nificantly improve the early triage of patients with suspected AMI.’ Better rule-in and rule-out rate Figures show that more than 65% of people who attend A&E with chest pain have not had a heart attack, though all will receive an ECG and www.healthcare-in-europe.com Hitachi Medical Systems Europe Holding AG, Switzerlandwww.hitachi-medical-systems.comRedefining the Vision of Cardiovascular UltrasoundLISENDO 880 offers a dedicated HemoDynamic Analytics package: LV eFLOW iDGD (Dual Gate Doppler) with R-R Navigation Vector Flow Mapping eTRACKING with Wave IntensitySeamless Workflowto ensure high user operability by applying Artificial Intelligence (AI) technology, significantly improving efficiencyYour Applicationto reach a clear visualization of the blood flow patterns, its mechanisms and an impressive 4D image displayPure Imageto attain remarkable fundamental image quality achieving more reliability during diagnosis and treatmentVisit us at ESC 2018Exhibition Hall 3 Booth H320
CA R D I O LO G Y 1 5 Heard at CMR 2018 Session highlights cardiac rest in women ocardial infarction with non-obstructive coro- y affects women but is often left untreated, Both modalities miss a lot of disease in women,’ she pointed out. The novel field of non-contrast MRI, which uses T1 and T2 map- ping, may be an additional tool to detect areas of microvasculature perfusion in women. The technique has a lot of prospects but it is still a very new area of research and requires more investigation, Hays The same is true for CT, because you’re just taking pictures to know how much narrowing or blockage there is, but it does not capture how much small vessel disease you have. underlined. In the USA the Women’s HARP study, a multi-centre, diag- nostic observational study that aims to compare perfusion MRI results of women with heart attack to cardiac catheterisation techniques using optical coherent tomography will bring more knowledge of MRI’s value within the next two years. It will also provide information on plaque inflammation and see whether this correlates with micro- vascular abnormalities. ‘That will be interesting, to determine the reasons why there is microvascular dysfunc- tion,’ Hays said. MRI is usually less available than other modalities, but it is worth the extra effort to find centres of excellence because of the unique insights it offers, and not just in microvasculature, she believes. ‘CT and nuclear tests are not so sensitive to image microvasculature. MRI plays a critical role not only for microvasculature disease, but also for heart failure, since a lot of women have heart failure with pre- served injection fraction.’ mr do not have disease in the coronary arteries,’ Hays explained. Instead, women who suffer a heart attack usually present with myocar- dial infarction with non-obstructive coronary disease (MINOCA), a much less common condition in men. This difference suggests that biology of the coronary arteries differs greatly between sexes. Women have a much higher incidence of microvascular diseases, i.e. the very small vessels that are embedded into the heart muscle itself. Worse prognosis for women Treatment usually includes life- style modifications and traditional ways to lower risk factors such as blood pressure and high choles- terol. Nonetheless, heart attack has a worse prognosis in women than men, because it is generally not treated as aggressively as it should be, Hays argued. ‘A lot of women don’t have com- plete heart blockages and some- times they’re left untreated. So it’s very important to recognise that even when a woman comes in with a heart attack and they don’t have heart blockages that are detected on cardiac cath, it’s very important that you still treat them for the small ves- sels disease aggressively with heart medication,’ Hays said. A main focus of CMR 2018 was to highlight the different and atypical presentation of women compared to men when it comes to heart attacks and how they can be detected, pre- vented and addressed in women, to improve outcome in the future. Although cardiac arrest is the first cause of death in women as well, it was the first time the conference featured a dedicated session on the topic, probably because women are now better represented in the organising societies, Hay believes. ‘In the last two years of the Society for Cardiovascular Magnetic Resonance, membership of women has grown significantly, going up from 20% to 40% today. So women are now more represented and more involved. I myself was one of the organisers, and found it was impor- tant to talk about that issue. The ses- sion was well attended, and we’ve had very good questions from the audience. I think this topic should be there every single year, because there’s a lot of research in that area,’ she said. Stress MRI is a good tool for women Awareness of that issue among the medical field must be increased, and the approach in detection must change, particularly regarding stress perfusion MRI, because this is an ideal tool to image heart disease in women, Hays believes. ‘Some stress tests are better tailored to women because they are more sensitive. Stress MRI is particularly suited to heart attack detection in women because it’s better at imaging micro- vasculature. EKG is not so sensitive for women and you can miss a lot. www.healthcare-in-europe.com Your dedicated cardiovascular MRI scanner at ESC booth #H400 Embrace new capabilities with cardiac MRI MAGNETOM Sola Cardiovascular Edition A dedicated MRI scanner designed to meet the demands of cardiovascular examinations MAGNETOM Sola¹ Cardiovascular Edition automatically adjusts to patient biovariability to overcome unwarranted variations in cardiac MRI examinations. Gain speed, reliability and ease of use with BioMatrix Technology. Expand toward precision medicine by improving diagnostic accuracy and facilitating individual treatment strategies. Connect with new capabilities Free breathing exams: Get high-quality consistent cardiac MRI scans with Compressed Sensing Cardiac Cine for functional imaging even for patients with arrhythmias or dyspnea. Tissue characterization: MyoMaps with HeartFreeze to detect myocardial injury and get patients on the right treatment pathway fast. Consistent results, fast: BioMatrix Sensors and the AI-powered Cardiac Dot Engine provide fast patient setup and step-by-step guidance for standardized diagnostic cardiac MRI exams. ¹ MAGNETOM Sola is 510(k) pending and not commercially available in some countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens organization for further details. siemens-healthineers.com/sola-cardiovascular
1 6 CA R D I O LO G Y HemoDynamic Analytics in Ultrasound A new tool box enhances heart failure diagnosis One of the challenges for every echo- cardiography lab is the technically difficult patient. Conventionally, labs use contrast agents to enhance endocardial border visualization. The application of contrast agents increases the exam time, resources and costs. Additionally, the use of contrast turns a previously non- invasive exam into an invasive pro- cedure. Hitachi Healthcare has now devel- oped a collection of cardiovascular analytic tools called HemoDynamic Analytics (HDAnalytics). These tools can be used for evaluation of the left ventricle (LV) when visualization is limited. One of the main applica- tions of the collection, LV eFlow was designed to demonstrate the discrimination between the blood flow and the cardiac tissue and offer an alternative to contrast agent use in some cases. LV eFlow is a high-definition left ventricular cavity blood flow imaging mode which substantially improves spatial and temporal reso- lution for a better visualization of the endocardial border in the left ventricle. The new tool operates with higher sensitivity and resolu- tion than conventional methods. LV eFlow may change a technically dif- ficult study into a diagnostic exam without using contrast agent. Head-to-head with echo contrast Dr. Zuyue Wang and technolo- gist Marvin Tyson of MedStar Washington Hospital Center had an opportunity to use this tech- nology in their practice over a period of 3 months. Their protocol included identifying patients that were candidates for contrast agents due to the difficulty in visualizing the endocardial border of the left ventricle. LV eFlow was added to the exam protocol for this patient set. Following the exam, the quality of the endocardial border delineation was evaluated by comparing the LV eFlow images with the images using contrast agents. Dr. Wang and Marvin Tyson com- pared LV eFlow and echo contrast agents in patients with suboptimal image quality and were impressed with the results. They found that “LV eFlow was comparable to echo contrast in improving visualization of difficult-to-image segments in selected patients”. Additionally, they found “a markedly more precise endocardial border delineation” and stated that “contrast agents should only be utilized when LV eFlow fails to enhance the endocardial borders”. Left: LV eFLOW – technically difficult patient; right: VFM – relative pressure with a dilated cardiomyopathy. Source: Hitachi Medical Systems Europe Vector Flow Mapping & Dual Gate Doppler Another tool in the HDAnalytics collection is Vector Flow Mapping (VFM), a novel and validated appli- cation that allows users to assess cardiovascular blood flow distribu- tion in an observation plane. This non-invasive technique is derived from the Color Doppler velocity data and generates the velocity fields on the 2D image. This allows to visual- ize, measure and analyze different parameters from the blood flow dis- tribution. For example, energy loss which is the rate of energy dissipa- tion due to blood viscosity, increas- es where turbulence flow occurs. In addition, wall shear stress, relative pressure and vortex characteristics can be evaluated. The Dual Gate Doppler (iDGD) generates a full Fast Fourier Transform (FFT) analysis and dis- play from two separate sample gates allowing measurements from two different locations during the same cardiac cycle. Hitachi Artificial Intelligence technology enables automatic sample gate placement and measurement at appropriate heart beats, resulting in 5 seconds to get E/e’ (83% shorten time com- pared with conventional measure- ment). Furthermore, iDGD works well for PW/PW and TDI/TDI com- binations. 2D tissue tracking (i2DTT) With 2D Tissue Tracking (i2DTT), the HDAnalytics set also provides an advanced tool which allows users to track the displacement of the cardiac tissue by using a novel and accurate algorithm of “Speckle Tracking”. Doppler based methods such as TDI are limited in evaluat- ing the displacement velocity of the tissue due to angle dependency. i2DTT allows the detection of veloc- ity components perpendicular to the beam which is impossible with conventional Doppler techniques. Tracking image by image, the natu- ral patterns of the cardiac tissue in B-Mode permits the user to quanti- tatively evaluate the movement and the thickening of the myocardium. i2DTT provides precise quantitative information such as longitudinal and radial strain, torsion rotation angle, displacement, wall thicken- ing and various other parameters to visualize, quantify and analyze myocardial mechanics. Applications include cardiac function analysis, resynchronization therapy, cardio- myopathy, stress echo and other global and regional studies. New analysis suggests workflow is key in remote monitoring It’s time to look again at IN-TIME As the world’s largest cardiology con- gress gets underway in Munich, it’s worth looking back to previous ESC sessions to see how scientific debates have evolved. At ESC 2016, held in Rome, REM-HF investigators presented data suggesting remote monitoring in implantable cardiac devices offered no added clinical benefit. Two years on, there are new reasons to re-examine that conclu- sion, with a recent analysis of the IN-TIME trial suggesting the key to remote monitoring benefits might be found in workflow processes. Published in The Lancet in 2014, the IN-TIME study is the only trial, to date, to have demonstrated a clear benefit of implant-based remote monitoring in heart failure (HF) patients – showing a more than 50% reduction in all-cause mortality – while eight other studies included in a 2015 meta-analysis, and three other recent trials, found no signifi- cant clinical benefit. However, IN-TIME was also the only implant-based remote monitor- ing trial using a transmission tech- nology that sent daily updates to a central monitoring unit. By contrast, REM-HF used technology that trans- mitted implant data on a weekly basis. So why does IN-TIME show positive results when other remote monitoring studies don’t? What is so fundamentally different in its methodology that might account for its results? Multiparametric data in This the recently published Remote is a central question Monitoring and Clinical Outcomes: Details on Information Flow and Workflow in the IN-TIME Study by Husser et al. The authors note that IN-TIME featured multiparamet- ric data that was transmitted daily. Crucially, a workflow process was set up such that study investigators could typically contact patients less than a day after receiving an event alert and arrange any necessary follow-ups for less than a week later. The study authors point out that, in the recent TRUECOIN meta- analy sis, the IN-TIME approach was shown to be beneficial for patients with heart failure, since it provides early enough warning to potentially prevent deterioration in the patient’s condition due to new onset atrial fibrillation, asymptomatic ventricu- lar tachycardia, or other adverse events. It is this early appraisal – facilitated by efficient workflow processes, including multiparamet- ric daily transmissions — that make the difference in the IN-TIME study, authors argue. As the European cardiology com- munity gathers for ESC 2018, it’s an excellent time to re-examine exist- ing evidence for clues we may have missed, alongside the latest break- ing research. That’s why it’s time to look again at IN-TIME. EUROPEAN HOSPITAL Vol 27 Issue 4/18 Home Monitoring Service Center Central Monitoring Unit Clinic Patient BIOTRONIK ICD/CRT-D Prompt in-office FU if interview is ‘positive’ (asap) Daily automatic transmission (Mo-Su) Prompt patient contact if IN-TIME event is clinically relevant (asap) Daily HM alert evaluation and classification as IN-TIME events (Mo-Fr) Device diagnostics (last 24h) HM alerts IN-TIME Events Structured Interview Immediate automatic data evaluation (Mo-Su) IN-TIME 365 messages 83% - 94% received after 1 - 3 day(s) n.a. 100% of HM alerts notified on the same day 4.0 In-Time events n.a. Until next working day 2.1 contacts n.a. Median 1 day [IQR 0 – 5] ACTIVITY WORKFLOW PERFORMANCE Events per patient year Success Delay IN-TIME Workflow Performance Less than one week
L A B O R AT O RY 1 7 Half a century of Shimadzu Europa’s innovations Mass spectrometry and ever more… As Shimadzu celebrates its 50th anniversary in Europe, our EH representative spoke with Stéphane Moreau, Manager of LC-MS & Life Sciences at the Marketing Europe/Analytical Business Unit of Shimadzu Europa GmbH, about today’s and many more decades of exciting clinical developments. This newly designed MALDI-TOF mass spectrometer is functionally simple but provides outstanding MS performance in a compact footprint. the similarity index and recognition confidence. New high speed LC-MS/ MS is also being tested. The aim is to have a system that is not only for use in toxicology labs but also, thanks to CLAM-2000, can be used in Accident and Emergency (A&E) units, which need a 24/7 service for rapid diag- nosis – currently not provided by toxicology labs. investigation. ‘This is of importance for doc- tors who are treating patients for diseases such as cancer with new mAb-based (biologic) drugs to moni- tor and assess therapeutic levels, something that is very difficult to do today. Shimadzu is actively working in this field to develop the practical- ity of the analytical technique.’ nSMOL is currently targeted for biopharma scientists and research groups. Do you foresee its application in the clinical lab? If so, what kind of lab would typi- cally use the nSMOL technique? ‘nSMOL stands for nano-surface and molecular orientation limited prote- olysis. This proprietary technology enables rapid and accurate mea- surement of large molecules such as monoclonal antibodies (mAbs) in the blood. Although originally aimed for use by biopharma companies and CROs, it was hospital labs that showed the most interest in the tech- nique. Traditional methods for mAb detection based on immunoassay require a long lead time to create the capture antibodies, are expensive and present the risk of contamina- tion and cross-reactivity. Therefore, nSMOL offers a rapid identification method and quantification of mAb blood levels by LC-MS, applicable to routine testing of many different pharmaceutical antibodies as the methodology is the same regardless of the mAb under Shimadzu Corporation in Japan and others developed a blood test to predict the risk of developing Alzheimer’s disease. The test is based on immuno-precipitation and mass spec. Can you tell us more about this? ‘Measurement of the amount of amyloid beta-protein (A ) depos- ited in the brain is used to detect early changes in individuals because it suggests they are at risk for Alzheimer’s disease (AD). Methods in existence today for detecting A -protein, PET Scan or CSF sampling, are not compatible with large scale screening of populations, being too expensive and/or invasive. ‘Mass spectrometry by MALDI- TOF has shown to be useful for screening new-borns for anoma- lies such as sickle cell disease etc. Therefore, as part of an interna- tional collaborative research team, Shimadzu has developed a highly sensitive blood test to detect A -pro- tein using immunoprecipitation and mass spectrometry (IP-MS). ‘Used in large cohorts of patients from Australia and Japan, the meth- od detected early onset disease with 90% accuracy, as published in Nature maga- EH: Mass spectrometry has been widely used in various fields, yet only recently entered medicine. For lab clinicians, the challenge is to understand this totally dif- ferent, more chemistry-based tech- nology, for which they are not yet trained. How does Shimadzu help with understanding, use and integration of mass spectrometry into their daily routine? Stéphane Moreau: ‘Liquid chroma- tography coupled with mass spec- troscopy (LC-MS) or tandem mass spectrometry (LC-MS/MS), began to be introduced into medical labs at the beginning of the 2000s, often used to diagnose inborn errors in metabolism, from profiling amino acids in blood spots from neonates. However, the revolution in how mass spectrometry is used in the clinical lab really began in 2006 – in microbiology labs. Up till this, the identification of bacteria and diagnosis of infections were based on traditional methods reliant on culturing, or sensitive and time con- suming techniques such as 16sRNA sequencing. ‘Shimadzu’s Koichi Tanaka, who was awarded the 2002 Nobel Prize for Chemistry for his demonstration of the possibility of applying laser technology to biological macromol- ecules, was behind the invention of MALDI-TOF mass spectrometry. This created, for the first time, a system that enabled the rapid identification of microorganisms from biological fluids and offer rapid and accurate diagnosis. Nevertheless, mass spectrometry is complex, especially in terms of sample preparation and handling, which creates a barrier for clinical labs because they particularly like to automate this step to reduce work- load and minimize operator error. ‘To overcome those prac- prob- tical lems and ease clinical workflow, Shimadzu introduced in 2016 the CLAM-2000 LC-MS/MS, the Clinical Laboratory Automated sample prep- aration Module. The system is fully automated and simple to use, offer- ing the first fully-integrated LC-MS/ MS sample preparation system. Additionally, having understood how labs would want to use LC-MS, Shimadzu has deliberately kept the system flexible; it is not a “black- box”. ‘This means that labs can use com- mercial kits, transfer their existing LC-MS/MS methodology, or create new tests, all of which will be com- patible with the automated system. In this way, the CLAM-2000 fits into laboratory workflow providing simplicity for novice users and the complete flexibility or “openness” demanded by an experienced opera- tor.’ Which classical procedures can be replaced by LC-MS/MS? ‘There’s a long list of potential ana- lytical applications for which the CLAM-2000 could be used but, typ- ically today, commercial kits are available to analyze immunosup- pression, vitamin D, anti-epileptics, antibiotics, steroids etc. There is also potential use in toxicology, which is difficult to bring into a routine lab because of the risk of a high number of false negatives and false positives, and also in forensics, where solid phase sample preparation is current- ly an obstacle to use on the system. ‘Shimadzu has started its European Innovation Center (https://www.shi- madzu.eu/euic) headquartered in Duisburg, Germany. The EUIC has a decentralized structure and com- bines academic-scientific know-how from universities with Shimadzu’s technological expertise to even bet- ter respond to leading users’ needs, and also to create new solutions for tomorrow. Currently, a new data- base of available compounds – over 2000 new compounds – has been created that will increase CLAM-2000 provides users with a seamless integration of automated sample preparation with LC-MS/MS to improve data quality, sample throughput, laboratory efficiency and safety. www.healthcare-in-europe.com In 1994, Stéphane Moreau obtained his diploma from INSA (Institut national des sciences appliquées de Rouen) in fine chemistry and engineering with a specialization in chemical process engineering. He then started his professional career in laboratory equipment distribution before he joined the brand new Shimadzu France subsidiary in 2002. Since then, he has held various positions to develop the MS range business. Since September 2013, he has been product manager for the MS range with Shimadzu Europa. zine earlier this year. Initially, this methodology will be used in screen- ing for AD, but hopefully, with time, it can be adapted to help in drug development and therapeutic moni- toring as part of the on-going chal- lenge to alleviate the high disease burden. In view of the analytical and measuring instruments division of Shimadzu Europa’s 50th anni- versary, can you point to what made Shimadzu Europe so suc- cessful for half a century? ‘If you look at Shimadzu’s various technologies in analytical instru- mentation, there have been many “world’s firsts” and awards underlin- ing Shimadzu’s approach to over- come technological borders and pro- vide the markets with even better qualities and solutions. Today, many of these technologies and methods have become standards for various applications and industries. ‘Looking back to just Shimadzu’s instrument part I am specializing in, the introduction of MS to the microbiology lab has been revolu- tionary in the time saved to have rapid diagnosis from days to just a few hours. New faster MS technol- ogy will continue to create robust and cost-effective tests suitable for routine medical laboratory use. ‘nSMOL is a nice technology to have, because it’s a way to measure the new drugs, the macromolecules the pharmaceutical industry is now moving towards, away from small molecules. ‘Also the constant search for new ways to implement modern health- care will ensure that Shimadzu Europe continues its success. One example I can think of is microsam- pling, originally designed for use in small animals, this device is currently a research only technique, whereby small amounts of blood (µl) can be taken by the patient themselves and sent to the lab for LC-MS, rather than the patient going to the lab. ‘Another area is Probe Electrospray Ionization/mass spectrometry (PESI- MS), a new MS technique being test- ed on biopsy samples, today patients may have to wait for an anxious few weeks for a result. With PESI-MS, validated in Japan and under inves- tigation in hepatocellular cancer in a cohort of Italian patients, an answer can be obtained in just half an hour. ‘All the time we are, of course, seeking to improve sampling and sampling techniques and to make our software as intuitive and user friendly as possible to ensure the continuous popularity and practical- ity of our product offering.’
1 8 L A B O R AT O RY Vital vitamin D testing LC-MS outperforms immunoassays In recent years, clinicians have increasingly focused on vitamin D deficiency. Studies show that previous reference values – particularly for Vitamin D3 – were most probably set too high. Liquid chromatography with mass spectrometry (LC-MS) can help achieve more precise measurements of vitamin D levels than previously established immunoassay procedures, explains Dr Torsten Binscheck-Domass, formerly a phar- macologist and toxicologist at the joint laboratory of the Charité and the Vivantes Group in Berlin, and an expert in clinical mass spectrometry at Thermo Fisher Scientific. However, in its current shape this com- plex technology is not suitable for all laboratories. Report: Daniela Zimmermann Although the relevance of the thresh- old values remains controversial, there is agreement on one point: Vitamin D deficiency is associated with a range of clinical pictures, such as osteomalacia or respectively, rickets in children, as well as with increased susceptibility to infections. In the aged, a lack of vitamin D can also have severe consequences, as Binscheck-Domass explains: ‘Studies are currently being carried out to examine a correlation between vita- min D deficiency in older patients and osteoporosis as well as a reduc- tion in muscle strength, which leads to an increased risk of falls. For older patients, falls are complications that can have severe consequences, such as fractures, traumatic brain inju- ries and long-term hospitalisation, etcetera.’ UV-radiation from the sun is a nat- ural remedy, but is often not enough. ‘We recommend vitamin D screen- ing for people with little exposure to sunlight, particularly for vitamin D3,’ he adds. Basically, everyone whose face, hands, and ideally also lower arms, are exposed to the sun for at least 30 minutes twice a week should absorb sufficient vitamin D3 to also last them through longer periods without sunlight. However, deficiencies are documented for hos- pitalised patients, people in nursing homes and sometimes even for chil- dren and adolescents who spend lit- tle time outdoors. Vitamin D2, which is mainly absorbed via nutrition – such as edible mushrooms – plays a slightly less important role. LC-MS separates the wheat from the chaff One problem with measuring vita- min D levels in the body is that the different intermediate products are often very similar and cannot be dif- ferentiated correctly with antibody- based tests such as immunoassays. Together with the comparatively low concentration of calcitriol – the bio- logically active form – this often leads to measurement values that have little significance, the expert points out. LC-MS has a big advan- tage here as it can separate the bio- logically inactive epimers from the molecule of the vitamin. Therefore, LC-MS-based diagnosis achieves sig- nificantly higher specificity. Currently there are still hurdles which laboratories need to over- come when switching from immuno- assays to LC-MS, Binscheck-Domass explains; this centres less around the associated costs – the acquisi- tion requiring investments in the mid-six figure range, depending on the device – but rather the changes to the normal work flows: ‘These are complicated devices and you need trained staff who can not only oper- ate the equipment but also carry Torsten Binscheck-Domass MD is a Systems Lead Scientist in Clinical Mass Spectrometry at Thermo Fisher Scientific. Qualified in medicine, he is a medical and forensic expert consultant in analytical pharmacology and toxicology. He has more than 25 years of experience in the fields of therapeutic drug monitoring, drugs of abuse testing and systematic toxicological analysis. Dr Binscheck-Domass is a strong advocate of clinically applied LC-MS/MS and has been exploring the technology’s unique benefits to clinical labs for more than 10 years. out evaluations.’ Furthermore, some laboratories are deterred by regula- tory requirements because the quali- fication of the systems requires a lot of effort, with numerous calibration and test runs. Selection criteria for a laboratory information system Marry (a LIS) in haste, repent at leisure standard operating procedures (SOPs) they can visualise the spe- cific workflow of core processes to ensure relevant standards are met. Laboratorians should have easy access to quick visual overviews Buying a laboratory information system (LIS) means entering a long- term relationship with a software vendor. The selection criteria are many, but which, ask Markus Neumann, Harald Maier and Gabriele Egert, are just fashionable and which might be underestimated? donations, or for own blood dona- tions, are less well known. Generally, the trend is towards process monitoring. If a lab has The decision to buy a LIS – i.e. to form a relationship with one or more software vendors – is based on a slew of criteria, and excitement occurs over a long-term relationship. However, years pass before quality can be assessed. Hard economic, technical and functional criteria can easily be expressed in figures, whilst others are ‘soft’ and difficult to quan- tify; however, they should provide sound information to shape qual- ity in vendor/user cooperation. A purchasing decision results from balancing hard and soft factors. Specifications The basis of a specifications docu- ment to be provided to bidders for the tender is what’s required. If there is no in-house IT specialist, use of an IT consulting firm might be advisable. The checklist offers an initial overview of topics to be covered. Vendors invited to submit a quotation need careful selec- tion. Vendor criteria e.g. finan- cial position, years of continuous market activity and responsibility/ accountability. Visits to reference labs and infor- mation exchange with users can offer important insights. Beware: although criteria are important, they are no guarantee that soft- ware development will continue. Technical criteria Hard data concern software, hard- ware and database structure. Which operating systems, programming languages and web technologies will be used? How does the data- base perform under heavy work- load? An important question is user autonomy. Can you customise parameters, e.g. database queries? What training is included; what cost? Finally, physical interfaces support must be ascertained: Are popular interface protocols, e.g. HL7/IHE or ASTM, used and how are they practically integrated within the lab instruments? For vendors, programming customised device interfaces is a core busi- ness; over years this can amount to several thousand euros per ana- lyser – a significant position in the budget. Interfaces are also relevant in background processes, such as billing and controlling, or external communication with physicians to exchange order data and results. Functional criteria Every vendor offers many mod- ules listed in the table under ‘Functionality’. However, it makes sense to look at procedures and review their control by master data and parameters. Nowadays, many lab workflows must meet certain standards. Quality management standards, or ISO 15189, 17025, or even ISO 22870 for POCT, are pretty obvi- ous; others, such as GMP for blood Company Product Functionality Integration Results Feature Size, financial position Continuity, accountability/responsibility Reference customers Customer testimonials Soft skills Implementation concept Service Training Architecture Hardware Software Response time Maintenance contracts License policy Modules Data protection/privacy concept Tracking Compliance Master data management Order entry and capturing results Quality control Technical and medical validation Reading Billing Archiving Statistics Configurability Internal communication External communication hardware Existing data Costs Own contributions Costs over five-year period Continued on page 20 Checklist for a LIS selection Explanation Number of permanent and freelance staff, revenue, core business Type of company, year of incorporation, guarantees, ISO certification Number, size, scope, reputation Adherence to deadlines and delivery schedules, keeping promises, staff commitment, cooperation with instrument manufacturers Personality and competence of vendor’s staff during conversation Is it comprehensible? Volume, solution visualisation Hotline, response time, specialist availability Documents, online support, on-site training, seminars Client-server architecture, periphery, central master data server Central computer, PC network, terminals, printers, storage space, operating system Data base, data protection/privacy concept and confirmations, use of standard software, customisation of parameters (by user) Depending on database volume, number of web connections and online users (particularly in multi-site facilities) Type and scope, hardware, software, remote access Online devices, database, multiple installations (campus license), pay-per-use (instead of purchase) Clinical chemistry, microbiology, blood bank, pathology, billing, order entry, automation and control Permission-based, controlling access to patient data (e.g. lab values) Search and sort functions, order status and sample tracking RiLi-BÄK (in Germany), ISO 15189, ISO 17025, ISO 22870, GMP, etc. Data maintenance, parameters, copying, use of legacy data, across modules Keyboard, card reader, order entry, material ID, different bar codes, device interfaces RiLi-BÄK (Germany), Westgard, other quality systems, visualisation Auto-validation, rules, alarms, automated repeat measurements, visualisation Sort criteria for orders and lab, rules systems, ICD codes, footnotes in identical texts Multi-client capability, service portfolio, accrued accounts Procedure, duration, access, reactivation, archiving of image data Saved and spontaneous queries, SQL assistant, export to standard software Adaptation of software and user screens to the on-site situation Link to HIS and departments/wards, POCT devices, de-central printers, standard interfaces can be configured (HL7, Link to other hospitals, specialist physician labs, lab groups Use of existing printers, scanners, PC, receipt readers Use of legacy data, retaining identification logic Acquisition costs incl. commissioning, database, operating costs Which contributions are required (configuration, AP computer, preparation of hardware and server), These indicate whether a Europe-wide tender is required EUROPEAN HOSPITAL Vol 27 Issue 4/18
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