2 N E W S & M A NAG E M E N T Disease research: preprocessed or raw data? Falsified genetic pathways may explain poor results Spanish researchers are challenging the validity of many past and ongoing clinical trials and stress the importance of working with raw or preprocessed data in genetic information study, Mélisande Rouger reports TUBB2A 0.970.960.990.990.991.00 1.000.991.00 Preprocessed data, which are typi- cally used to decipher gene expres- sion in a large number of studies, modified and sometimes totally fal- sified genetic pathways in countless scenarios, according to a research team at Oviedo University, Spain, in collaboration with the Brigham and Women’s Hospital in Boston and NIH in Washington, USA. The results (Pub: Journal of Computational Biology 8/2016; Impact of Microarray Preprocessing Techniques in Unravelling Biological Pathways) may have a tremendous impact on the understanding and prediction of many diseases, includ- ing cancer and rare and neurode- generative disorders. FAM63B in Professor Juan Luis Fernández, head of the group of inverse prob- lems, optimisation and machine learning the Mathematics Department at Oviedo University, was working on chronic fatigue in patients with pros- tate cancer undergoing radiotherapy when he found some discrepancy between results from the same measurements. ‘We found those results quite by chance when looking at genetic pathways before treatment, to detect which patients were more at risk of developing those symptoms,’ he said. ‘We published our first results in 2014, but a year later, when car- rying out the same investigation with another data set, we obtained completely different results.’Upset but intrigued, Fernández and his team began to search for where this difference arose. ‘That was very disappointing; what we had origi- nally done wasn’t bad and there we TUBB3 0.99 0.96 HLA-DQA1_LOC100509457 HIPK3 0.93 0.82 HLA-DQB1 0.91 0.92 0.83 FMR1 0.97 ACAP2 0.93 NAP1L1 0.84 LOC100505812 0.96 0.93 DR1 0.94 PREPL HLA-DQB1_LOC101060835 0.92 PHF17 0.90 0.78 LYSMD3 0.94 FAM126A 0.85 DOCK11 0.93 EIF1AX_LOC101060318 0.90 0.86 DENND4C 0.92 SP3 0.91 0.94 ZMYM2 0.90 0.90 MRGBP 0.93 0.94 SMCR8 0.89 ZEB1_LOC100996668 POLR2J4 GNRHR2 0.86 240231_at RP11-727A23.11_OTTHUMG00000183952 0.56 HLA-DQA1 0.97 0.97 0.99 0.75 EPS15P1 Pearson correlation coefficient minimum spanning tree of the 50 first selected probes using raw data in Chronic Fatigue 0.64 BTNL3 0.95 0.89 ZFPL1 0.82 FLJ32790 ended up with very different results. That’s when we noticed we’d been working with preprocessed data the second time. So we started process- ing raw data and realised the data we obtained was very different.’ Raw or preprocessed data? Now enthralled, the researchers sub- sequently launched an investigation to find out which data was more accurate: raw or preprocessed? Preprocessing has the benefit of reducing the size of huge genetic data, which in turn makes data analysis easier to handle. To pro- cess genetic data, researchers most commonly use RMA (Robust Mean Average) a technique that ena- bles noise reduction dur- ing data evaluation and a boost to the signal. IMMP1L Working with raw data, Fernández and his team found they obtained less precise results in predic- tion. However, when working with prepro- cessed data, they could not locate the probes as reliably. While RMA enables amplification of signal-to-noise ratio, it also modifies genetic pathways. So, in the end, it is quite challenging to know which dataset is better to use, Fernández pointed out. ‘It’s almost a philo- sophical problem; if you mix up signal with noise, you interpret part of the noise as signal - and part of the signal as noise.’ Genetic pathways deduced from preprocessed data are different to those deduced with raw data. But, with raw data, one would coincide more with real biology than with preprocessed data, according to the engineer. A lot of researchers are only working with preprocessed data, but he believes there should be more studies based on raw data: ‘In principle it’s more convenient to work with raw data than prepro- essed data when looking for genetic pathways.’ Currently, many genes are consid- ered as therapy targets when possi- bly they are not even involved in the disease process. ‘Preprocessing may totally or partially falsify genetic pathways involved in disease devel- opment. This has serious impact on therapy targets investigation because, if you are looking in the wrong direction, your treatment or diagnosis will be mistaken.’ Current research is failing Fernández believes the absence of results in research speaks for itself. ‘Hundreds of billions of dollars are poured into disease research, and, to be honest, advances are very mediocre. So we must be doing something wrong.’ Furthermore, inadequately cata- loguing samples in biomedical data analysis in expression pathways could have devastating consequen- ces. ‘The worst case scenario is a physician doing false predictions and, for instance, telling his or her patients they won’t have metasta- sis – and then they do, all of this due to an error in genetic pathways analysis.’ Fernández said he had already obtained impacting results in pan- creatic cancer and multiple sclerosis. He is finishing his work on inclu- sion body myositis (IBM), an inflam- matory muscle disease characterised by slowly progressive weakness and wasting of both distal and proximal muscles. ‘We have demonstrated which genetic pathways are defective and, with a set of independent data, which pathways can fully predict phenotype. We have showed that the most important pathway is linked with viral and bacterial infec- tion types, and we have possibly identified which infections.’ He said more results would soon be available in rare and neurode- generative diseases. ‘With our analysis techniques we Carlos Ramírez Calvo MD co-directs the ENT department at Vithas Nuestra Señora de América Hospital and is co-director of the Pablo Iglesias ENT Clinic in Madrid. He is a founding member of IFMEC, a company dedicated to innovation and training in medicine and surgery. He is also a founding member of Voice Clinical Systems. December, the app has been used in two private institutions in Madrid and has already received positive feed- back from physicians who have tested it at various institutions across Spain. Ramirez: ‘Voice Clinical Systems has been tested to check its correspond- ence with clinical diagnosis in 2,000 cases; the correspondence with the clinic has been higher in 99% of the cases.’ The app (Android and iOS) can be down- loaded here: http://www.voicecs.com EUROPEAN HOSPITAL Vol 26 Issue 2/17 Advances in vocal pathology diagnoses New voice app to detect diseases A new app measuring the biomechanics of the voice could impact the market of ENT and speech pathology products, Mélisande Rouger reports from Madrid Acoustic tools that provide glottal source analysis, which are tradition- ally used in the diagnosis of vocal chords pathology, could soon become obsolete due to a recently launched app that has introduced a highly reli- able and entirely mobile technology. Called Voice Clinical Systems, the new device uses the self designed Wave Tracking technology, which focuses on the signal emitted from the patient’s lips. The patient only has to speak for three seconds, directly into a tablet or smartphone, and a diagno- sis follows within minutes. The app is likely to resonate in the vocal chords pathology world, as its correlation with the clinic is unheard of, according to Dr Carlos Ramirez, a Madrid-based ENT physician, who co- developed the app. ‘The information we are extracting has nothing to do with what we’ve used previously. Until now, the analy- sis we have used had very little clini- cal correlation; these tools were not describing the pathology the patient might have been suffering. Our app offers information that has a far bet- ter correlation with the clinic than the previously used technologies,’ he pointed out. As reported, Voice Clinical Systems works by taking a sample of the patient’s voice fed directly into a tablet or smartphone. The record- ing is then sent directly to an online server, for analysis. The information extracted is then returned shortly to the sender in the shape of a record, which is tailored to the on-going investigation. This mobile approach enables phy- sicians to record samples anywhere without the heavy, costly equipment usually needed for voice analysis. ‘Voice analysis systems currently used require hardware and a computer, which is only available at the health- care facilities,’ Ramirez said. ‘Mobility offers flexibility and brings advanced voice analysis technology to places which may not have had the neces- sary infrastructure before.’ The app offers three types of medical reports, which can differ- entiate between organic and func- tional pathology. All patient data are anonymized and the reports only feature the age and gender of the patient. The one-page long basic report is called the clinical screening; this can be used by primary care profession- als and general practitioners to help them refer patients to specialists. It includes straightforward colour-coded graphs, in which red is pathology and green normal. For patients in need of follow-up, specialists may use the intermediate report, which provides them with an alteration index. Information con- tained in this report may be par- ticularly useful in patients who have received polyp surgery or are under- going rehabilitation to correct a func- tional defect. The three-page report is a more complete document, and will help ENT and speech therapists to help diagnose pathology with a high degree of subtlety. Because voice can be an indication of neurologic disorders before any other symptoms develop, neurologists may also use the app for the early detection of Parkinson’s disease. The app only targets HC profes- sionals for the moment, but it may become available to patients within two years, Ramirez said. ‘In that case doctors will still have to interpret the report, but,’ he surmises, ‘patients could definitely go visit a specialist with their report in hand.’ The cost of the report ranges between €10 and 20. Launched in English and Spanish in

4 L A B O R AT O RY POCT all round benefits in emergency units Speeding up treatment decisions Report: Mark Nicholls Point-of-care testing (POCT) is speed- ing up diagnoses in emergency departments by almost instant deliv- ery of laboratory quality results. In cardiac and blood gas testing, for example, POCT leads to quicker decision making, earlier treatment, and improved patient outcomes. Erick Froede, Global Product Manager for Siemens Healthineers’ Critical Care portfolio, is convinced that POCT in the emergency depart- ment (ED) is a ‘win-win’ scenario for hospitals. ‘Essentially, we are trying to deliver accurate, actionable intel- ligence to clinicians – where and when they need it. This, combined with rapid results, leads to better treatment decisions and patient out- comes. We have done some studies on this and, with cardiac testing, for example, we found that the faster turnaround times can reduce mor- tality and bed stay, ultimately saving the hospital money while increasing patient satisfaction.’ Throughout Europe, both the Stratus CS 200 Acute Care Analyzer for cardiac testing as well as the RAPIDPoint 500 Analyzer for blood gas testing are available. The instru- ments deliver results to clinicians within 14 minutes and 60 seconds, respectively. Froede confirms that the instruments are easy to use, cost-effective, and have a low over- head in terms of training require- ments. ‘When a patient goes into the ED it is a really stressful experience,’ he said. ‘They don’t know if they are having a heart attack or another major issue. To have that result in hand and a decision made more quickly is a significant benefit to the patient and their family.’ In the era of smart phones and information at our fingertips, POCT has suffered damage during a heart attack – and NT-proBNP to indicate if a patient is experiencing heart failure. Additionally, the instrument offers the D-dimer test to check for blood clotting issues and to exclude pulmonary embolism at the point- of-care. The instrument is being used by a number of leading hospi- tal EDs across Europe, includ- ing Addenbrooke’s Hospital, near Cambridge, UK, where it is available 24/7 to ensure rapid turnaround times for diagnostic tests. In terms of blood gas testing, the RAPIDPoint 500 Analyzer covers pH and blood gases, electrolytes, metabolites, glucose, lactate, neo- natal bilirubin, total hemoglobin, as well as full CO-oximetry. Froede explained that, with a key indicator of sepsis being lactate lev- els, the instrument’s fast turnaround time enables early detection and treatment of this condition, reducing mortality of patients in the emer- gency department. In addition, Siemens Healthineers offers several point-of-care IT solu- tions. One, called PEP Administrator, is a web-based platform that facili- tates all aspects of instrument technology in the ED is leading the way in meeting patient and doctor expectations, he pointed out. With cardiovascular disease, a major cause of death globally, the ability to use POCT in the ED means quicker diagnoses and treatment. When a patient has a myocardial infarction, or heart attack, with each passing moment heart muscle dies and loses function. Being able to diagnose and treat patients soon- er helps minimize further damage from occurring. The Stratus CS 200 Acute Care Analyser offers an extensive panel of cardiac tests, which include meas- uring levels of Troponin I – the pro- tein released when the heart muscle As Global Product Manager for Point of Care Diagnostics for Siemens Healthineers, Erick Froede MSc is responsible for supply, quality and product innovation across the company’s Critical Care portfolio internationally. He gained his Bachelor and Master of Science degrees in Mechanical Engineering from The Pennsylvania State University. training, from basic operation through advanced maintenance. The RAPIDComm Data Management System is also available, which takes results from the instruments and integrates them into the hospital’s Laboratory Information System and ultimately the Hospital Information System. It also has additional func- tionality to help Point of Care Coordinators manage and control their POCT – instrument status, quality control and operator lock- out, operator competency, and com- pliance management. Finally, Siemens Healthineers recently acquired an open POC infor- matics company called Conworx. ‘With our new POCcelerator soft- ware,’ Froede added, ‘we can con- nect more than 150 POCT devices from over 40 manufacturers, simpli- fying POCT workflows and reduc- ing staff workload – especially important in an ED. The power of an open POC Ecosystem with our point-of-care informatics solution is that it can electronically send test results from all connected POCT devices directly to electronic patient records, and can centrally man- age all instruments, patient results, operators, reagents and quality con- trol materials.’ Alongside cardiac and blood gas testing, Siemens Healthineers also has POCT capabilities and platforms covering diabetes, urinalysis, and coagulation. Small tubes, great impact Evaluating the capillary blood collection system Imagine a few drops of blood could be sufficient to analyse a wide range of parameters. If blood testing could be quick and easy, without searching for veins, staunching or using unnecessary equipment. Thanks to some clever innovations, a small tube is now making daily life a lot easier for users and patients. Sometimes less is more. In some situ- ations, only low quantities of blood can be taken in order to ensure that patients are as safe and comfortable as possible. The system not only benefits geriatric patients or those who need to have blood taken on a regular basis, but also burns victims, for example. Above all, a particularly gentle approach is required when it comes to our youngest patients. With this in mind, the Austrian firm Greiner Bio-One has developed and optimized the MiniCollect capillary blood collection system. Capillary not the vein It’s not always possible to take venous blood from a patient, often due to difficult vein conditions, sometimes the case with geriatric patients, for example. The situation is different for burns victims: infec- tions resulting from unnecessarily large puncture wounds present an additional risk to them. The volumes of blood samples taken from patients with long-term illnesses, who need to have blood taken on a regular basis, should also be kept to a minimum. The MiniCollect capillary blood collection system offers a suitable alternative for these situations as, for the most part, capillary blood samples can be taken quickly and easily, even in dif- ficult situations. Accessories are no longer needed The cumbersome process of transfer- ring the drop of blood using capil- lary tubes or funnels is now a thing of the past, thanks to the MiniCollect System. The special feature here is the blood collection scoop inte- grated into the wide tube opening. In this way, the drop of blood can be transferred to the MiniCollect primary tube quickly and easily, minimising adhesion. The sample comes into contact with the additive immediately. The caps are completely sealed, meet the highest standards and can easily be sent via pneumatic dispatch or other transport systems without losing any sample material. Carrier tubes and combined filling volumes simplify use For centrifugation, the MiniCollect tubes can be screwed into a pre- mium carrier tube using a simple rotational movement. When com- bined, the dimensions correspond to a standard 13 x 75 mm tube format and can easily be placed in a stand- ard rack or standard centrifuge. filling volumes for the EDTA and serum tubes, make the preparation of samples more straightforward. Two easily visible filling marks on the tube provide Combined Prudence is the cornerstone of pre Report: Mark Nicholls Following a top level EU report showing antimicrobial resistance (AMR) remains high, Professor Mike Catchpole, Chief Scientist at the European Centre for Disease Prevention and Control (ECDC), has warned that stricter use of antibiot- ics is critical. The document on AMR in bac- teria by the European Food Safety Authority (EFSA) and ECDC revealed that bacteria found in humans, ani- mals and food continue to show resistance to widely used antimicro- bials, posing a serious threat to pub- lic and animal health, with related infections causing around 25,000 deaths in the EU annually. So concerned is the European Commission that later this sum- mer it intends to launch an Action Plan presenting a new framework for future coordinated actions to reduce the spread of antimicrobial resistance. ‘Treating infections due to resist- ant bacteria is a challenge: antibiot- ics commonly used are no longer effective and doctors have to choose other antibiotics,’ Catchpole said. ‘This may delay getting the right treatment to patients and may result in complications, including death. Also, a patient may need more care as well as alternative and more expensive antibiotics, which may have more severe side-effects. ‘The situation is getting worse with the emergence of new bacterial strains resistant to several antibiot- ics at the same time. A major anti- biotic resistance problem, especially in hospitals, is the emergence of bacteria that are resistant to last-line antibiotics, which therefore severely limits treatment options for infected patients. Such bacteria may eventu- greater flexibility for use. It is no longer necessary to decide on a certain volume in advance, which reduces logistical efforts. Avoid unnecessary agitation When taking a blood sample is una- voidable, tears and anxiety do not affect just the little ones, but also their parents, and should be kept to a minimum. However, the sight of a puncture needle often does cause fear in chil- dren. ‘One of the main advantages for our young patients is that the safety mechanism of the MiniCollect safety lancets means that no needle is visible at any point before or after the puncture. This makes the situa- tion more relaxing for all involved,’ explains Petra Langmayr, former pae- diatric nurse and product specialist at Greiner Bio-One. The puncture can either be carried out by pressing the Lancelino safety lancet down on the puncture site (contact-activated safety lancet), or by pressing down the release button (pressure-activated safety lancet). After the puncture, the needle retracts automatically and is safely enclosed within plastic casing. Thus the risk of needlestick injuries is prevented. EUROPEAN HOSPITAL Vol 26 Issue 2/17

6 I N F E C T I O N C O N T R O L International experts highlight gaps in pandemic planning The world is underprepared for infectious diseases Report: Mark Nicholls A team of international experts has highlighted how the world remains ‘grossly underprepared’ for infec- tious disease outbreaks, which are likely to become more frequent in future decades. the Graduate Led by Professor Suerie Moon at Institute of International and Development Studies in Geneva, the research- ers looked at progress and gaps in actions and concluded: ‘Ebola and, more recently, Zika and yel- low fever, have demonstrated that we do not yet have a reliable or robust global system for preventing, detecting, and responding to disease outbreaks.’ The warning came after the team reviewed reports on the recent Ebola virus outbreak in West Africa and say better preparedness and a faster, more coordinated response could have prevented most of the 11,000 deaths directly attributed to Ebola and also the broader eco- nomic, social, and health crises that ensued. In August 2014, the World Health Organisation (WHO) declared the Ebola outbreak in West Africa a Public Health Emergency of International Concern (PHEIC). In the aftermath, several reports were published reviewing what went wrong and how infectious disease outbreaks should be better managed. However, a lack of clarity in terms of the main priorities and proposed reforms, led the researchers to look closer, synthesising seven major post-Ebola reports to assess recom- mendations and progress. 3D-rendering red blood cells infection with bacteria and virus Their findings recognised that the reports differed in scope and diag- nosis of the key problems and rec- ommendations for action converged in three critical areas: strengthening compliance with the International Health Regulations (IHR); improv- ing outbreak-related research and knowledge sharing; reforming the World Health Organisation (WHO) and the broader humanitarian response system. According to the team, so far progress has been mixed in address- ing the issues raised. Key problems include the fact that investments in country capacity building have been inadequate and difficult to track; arrangements for fair and timely sharing of patient samples remain weak, and reform efforts at the WHO have focused on operational issues but have neglected to address deeper institutional shortcomings. The analysis authors say they found ‘remarkable consensus on what went wrong with the Ebola response’ and what is needed to address the deficiencies but so far ‘not nearly enough has been done’. Warning: prepare or face significant threats Moon has warned that being under- prepared for infectious disease is one of the most significant threats facing the global community: ‘The risk of emerging infectious diseases is increasing due to environmental degradation, increased human-ani- mal interaction, urbanisation, inten- sified trade and travel, and inad- equate investment in health systems. ‘It poses risks to all countries - the richest, poorest and all countries in between. The losses in human lives, health, and economic activity would be devastating. Estimates based on the risk of a major pandemic over the next century have found annual- ised losses in the range of between $60-$570 billion.’ In terms of next steps to avert cri- sis, Moon acknowledges that there has been significant progress since the 2014 Ebola outbreak. ‘But the Dr Suerie Moon is Director of Research at the Global Health Centre, Graduate Institute of International and Development Studies in Geneva and adjunct Lecturer on Global Health at the Harvard T.H. Chan School of Public Health. She was also Study Director of the Harvard-LSHTM Independent Panel on the Global Response to Ebola and co-founded and led the Forum on Global Governance for Health, a focal point at Harvard University for research, debate and strategic convening on issues at the intersection of global governance and health. Her research and teaching focus on global governance and the political economy of global health, focusing on areas such as outbreak preparedness and response. glass is still half-empty, maybe even less than half,’ she warned. ‘Many different organisations need to take action to improve preparedness - local and national governments, intergovernmental organisations, companies, NGOs, academic institu- tions, and others. ‘I’d say three ingredients are espe- cially crucial now: political leader- ship to keep the issue on the global agenda, financing from richer and poorer countries alike, and a system to monitor what is and isn’t being done in order to achieve mutual accountability.’ The researchers urge the glob- al community ‘to mobilise greater resources and put in place monitor- ing and accountability mechanisms to ensure we are better prepared for the next pandemic’. Failure to do so, they conclude, could mean the world will not be prepared for the next outbreak. Rapid sepsis recognition saves lives England’s first dedicated emergency unit Sepsis Team The care failings appeared to occur mainly in the first few hours, when rapid diagnosis and simple treat- ment is critical for patient survival. From that, Leicester Hospital’s began a project in early 2014 and formed a ‘Sepsis Awareness’ group, bringing together the mentioned healthcare professionals, led by Dr Parker and Sepsis Lead Specialist Nurse Sarah Odams. A sepsis improvement project was put in place to raise staff awareness of sepsis, recognising that this is a life-threat- ening con- dition that arises when the body’s response to an infection injures its own tissues and organs and leads to shock, multiple organ failure and death if not recognised early and treated promptly. The trust also implemented meas- ures at that time to improve the management of septic patients across the Trust’s hospitals. Since then, the response to sepsis has evolved in a number of ways. The Trust has written a bespoke ‘Sepsis Adult Screening & Immediate Action’ pathway, which has been shared with staff across hospitals in line with NICE (National Institute for Health and Care Excellence) and the UK Sepsis Trust protocols. ‘We have developed a range of training for our staff, primarily face- to-face,‘ Parker explained. ‘We will Dr John Parker (centre) with the new emergency sepsis team Report: Mark Nicholls The UK’s first dedicated emergency department sepsis team has been set up in one of the country’s lead- ing hospitals. Leicester Hospital’s created the team to recognise and manage sep- sis. The key aim is to strengthen the response, in a timely manner, to sepsis cases admitted to the emer- gency department or to identify rapidly any patients who deteriorate within the unit. The team of medical professionals from various backgrounds includes personnel from intensive and critical care, emergency medicine and oper- ating theatres and is headed by con- sultant anaesthetist Dr John Parker, Lead Consultant for Leicester’s Hospital. Parker explained that the initiative follows ‘Time to Act’, the Parliamentary and Health Service Ombudsman report of 2013, which observed patient deaths in the NHS after failure to diagnose and rapidly treat severe sepsis. The document focused on 10 cases in which patients did not receive urgently needed treatment. also soon have an e-learning pack- age available. Sepsis Awareness training is now mandatory for our staff. We have also carried out regu- lar surveillance audits to make sure that staff are compliant with the care pathway.’ This has seen an improvement in the number of patients being given IV antibiotics and fluids within an hour, as recommended by NHS England, and recognition of sepsis across the Trust is now at 95-100%. ‘With funding from the NHS Litigation Authority, our new dedi- cated Sepsis Team will be in our Emergency Department, where two thirds of our patients present with the symptoms of sepsis,’ Parker pointed out. ‘On an average day there could be between five and 10 people coming into the Emergency Department with potentially life threatening sepsis. ‘The team will support the emer- gency team to recognise and imme- diately treat anyone who we suspect has sepsis. They will then help to make sure that patient gets the right care from emergency surgery to intensive care support.’ EUROPEAN HOSPITAL Vol 26 Issue 2/17

8 R A D I O LO G Y Identifying shipwrecked refugee casualties Radiologist highlights imaging values Interview: Mélisande Rouger Forensic radiology was, yet again, a central theme at ECR 2017, as Italian radiologists unveiled details of their work in the investigation following the shipwreck in the Mediterranean in April 2015. An estimated 900 people lost their lives in what proved to be the worst disaster yet involving migrants, most of them refugees from Syria and sub Saharan countries including Gambia, Sri Lanka and Ghana. For the first time, and in an exclusive interview with European Hospital, Italian radiologists in charge of forensic imaging spoke about their challenging task of identifying corpses that had been trapped under water for more than a year. Dr Giuseppe Lo Re, a forensic radiologist from Palermo University, said he could only start imaging corpses in July 2016 because he had to wait for the rescue team to extract the bodies from the boat, which sank about 60 miles off the Libyan coast and 120 miles south of the Italian island of Lampedusa. ‘The boat was overcrowded; there were seven people per square metre. For some victims we could only identify the bone structure, so we found out which area they came from, but not which country,’ he explained. ‘Skin colour was no indi- cator either as it got washed out; all the corpses were grey.’ Lo Re and his six colleagues (seen with three, far right) were loaned a mobile CT device for just ten days, in which they managed to identify 194 casualties. The whole benefit of forensic imaging in that context, he said, lay in the impossibility of practicing an autopsy in a decomposed corpse. ‘If you cut dissolved bodies, you will not be able to recognise anything once they are open.’ CT enabled identification of the casualties’ sex better and faster than any anthropological study. ‘Anthropology looks at particular bone lines or angles, a long and not so reliable procedure. We know the Caucasian type, but we don’t know the other types so well. ‘Our first days with the CT were difficult because radiology can’t see these items very well. So we changed our point of view and searched for the radiological items of sex,’ he explained. ‘This was a score! We could prove that all of the victims were male.’ Lo Re and his team were also able to determine the age and death pose of the casualties, both key aspects in understanding why and how people died. ‘With CT we can study the bone nucleus, which enables us to deter- mine if the victim was older or younger than 18, a key informa- tion in any legal investigation ,’ he said, adding: ‘The death pose is also very important in forensic sci- ence because it describes the move- ment immediately before death and helps to understand causes of the accident,’ A lot of the victims died because they were stuck in a lower room of the boat and because of oil residu- als or water leakage during the shipwreck. Except for the short time they had to image the bodies, Lo Re and his colleagues faced additional chal- lenges. ‘We scanned the casualties 15 minutes each, 12 hours a day for six consecutive days,’ he said. ‘But we had to stop a whole day because of a worm invasion. I will never for- get that terrible smell. Under the water, the rescue team was also able to find wallets and phones, which helped identify who boarded the vessel. Besides their Biobanks benefit research No biobank donor shortages: UK 500,000; Germany 200,000 Report: Michael Krassnitzer By definition, biobanks are collec- tions of specimens of human bod- ily substances, such as tissue, cells, DNA, proteins, blood or other fluids, with data on the donor attached. They are well suited for large- scale population studies, for exam- ple to understand certain diseases better and to improve prevention, early detection and treatment. ‘Biobanks should also include radi- ology image data,’ says Professor Ritva Vanninen, at the Department of Clinic Radiology in Kuopio University Hospital, University of Eastern Finland. STRESS can be so relaxing. Accutron® MR3! www.i-love-stress.com i s t T h e s p e c i a l f o r S t r e s s - M R I ! Integrated infusion pump! Wireless & 3-Tesla-capable! Innovation – Made in Germany! Hauptstr. 255 66128 Saarbruecken www.medtron.com Contrast medium injectors and consumables for CT, MRI and angiography After all, these images contain quantifiable parameters with prog- nostic or diagnostic value. ‘High quality image data and their reading by radiologists can be an impor- tant contribution to bio-medical research,’ Vanninen emphasises, adding: ‘vice versa, imaging bio- markers are validated by their use in research.’ Biobanks do not lack numbers As of 2014, the member states of the European Society of Radiology (ESR) have been operating 27 biobanks with imaging content. The British UK Biobank, with 500,000 donors, and the German NAKO Health Study collection, with 200,000 donors, are among the largest of these biobanks. Smaller ones were established inter alia in the context of the Dutch Rotterdam Study (approx. 15,000 donors) or the German SHIP study Pineal gland cyst from NAKO (in most cases this type of benign cyst is clinically irrelevant) (c) NAKO (approximately 8,700 donors). Upon request, both UK Biobank as well as NAKO make their data available for research purposes; these data are thus the foundation of many a research project. Modern digital methods to gain data, radiomics and machine learning, the buzzwords here, may at some point in the future contribute to the analysis of biobank content. However, biobanks are not only a source of knowledge; they also raise a number of ethical issues: when collecting data that origi- nally are meant to clarify the rela- tionships between risk factors and diseases and the course of dis- eases, quite frequently incidental findings show up. How to deal with such data? Professor Sabine Weckbach, Consultant at the Clinic of Diagnostic and Interventional Radiology at University Hospital Heidelberg, offered the answer last March, during a session at the 29th European Congress of Radiology (ECR 2017), in Vienna, Austria. Weckbach is among the radi- ologists who analyse MR images acquired for NAKO. The so-called incidental findings, however, are neither incidental nor unexpected. Invariably unplanned findings Examinations with a 3-Tesla system, as prescribed for NAKO, will invaria- bly yield unplanned findings. These may relate to acute diseases but also to diagnoses that are clinically irrelevant. ‘This raises a number of ethical issues,’ Weckbach points out. Which findings should be relayed EUROPEAN HOSPITAL Vol 26 Issue 2/17

1 0 R A D I O LO G Y Breast cancer screening programs Benefits must outweigh risks Report: Mélisande Rouger Biannual mammography can help to reduce breast cancer mortality by 40% in women aged 50-69, but the benefits for women under 35 years old are questionable, eminent Spanish radiologists highlighted dur- ing a session held by SERAM, their national society of radiology, last November, during the International Radiology Day. ‘Mammography today is the only method that has demonstrated capacity to reduce breast cancer mortality. Only in high-risk patients is MRI a proven screening meth- od,’ said Dr Marina Álvarez Benito, President of the Spanish Breast Diagnostic Imaging Society and a radiologist at the Reina Sofía Hospital in Córdoba. Biannual screening reduces mortality by 40% A study recently published in European Radiology showed that early detection through biannual mammography in a screening pro- gram reduces mortality by 40% in women aged 50-69. But there is less evidence for women aged 40-49 and over 70. ‘Actually, for women between 35 and 40 there is very little evidence regarding associated risk factors or patient specific situa- tions,’ explained conference speaker Dr Carmen Carreira, a radiologist at Fuenlabrada University Hospital, in Madrid, and a member of the execu- tive committee of SEDIM. Cancer incidence is very low in a breast cancer screening program – on average five per thousand, Álvarez estimates. This means it is crucial to weight the benefits of screening against the potential risks, she added. Benefits must outweigh potential risks ‘The women who take part in a screening program are healthy and most of them will not develop can- cer; it’s very important to remember that benefits must outweigh poten- tial risks.’ Both radiologists’ comments came a month after the Spanish Society of Gynaecology and Obstetrics issued recommendations advising women to undergo their first clinical explo- ration together with a mammog- raphy as early as 35 years of age, to determine their breast type and morphology, an indication on their potential predisposition to develop cancer (http://www.efesalud.com/ noticias/primera-mamografia-los- 35-anos/). The SERAM asked all parties involved to avoid sending confused messages on breast cancer screen- ing program, which was initiated in the early 1990s in Spain; instead, women should be informed in a clear and transparent manner. ‘The chance of saving a life thanks to early breast cancer detection is 100% superior to the possibility of death caused by the radiation used in the examination,’ the society wrote in a release. Benefits of mammography include mortality reduction and the pos- sibility of conservative treatment. Most common potential risks would be false positives, over diagnosis, overtreatment and the detection of harmless lesions that will trigger useless biopsies and anxiety in the patient. ‘Benefits will only affect a small part of the women whereas poten- tial risks will affect all women who take part in a screening program,’ Álvarez pointed out. The possibility for false positives in a woman who has taken part in 10 screening programs, i.e. during 20 years of her life, is around twenty percent. The only way to improve screen- ing efficiency is to have quality con- trols at every stage of the program, Álvarez believes. The European guidelines offer a wide range of indicators to evalu- ate false positives, including the number of recalls. ‘To have what we call a good false positive rate, recall rates should not rise over 7%. For a program to be efficient, 70% of the women should participate on a regular basis, and not just one time,’ Álvarez said. Know the route from pri- mary to secondary care Adherence to the program is key and The core of patient satisfaction & workflow efficiency Communication is vital Marina Alvarez Benito is Director of the Clinical Management Unit of Radiology and Breast Cancer at Reina Sofía University Hospital in Córdoba, Spain. She is also the current President of the Spanish Society of Diagnostic Breast Imaging. The expert received a bachelor degree and doctorate in medicine and surgery from Córdoba University. A former member of the Board of SERAM, she currently works in partnership with the society. doctors must follow their patients between primary and secondary care to guarantee the proper chain of actions. ‘It’s relevant to know a woman’s circuit from the detec- tion of a lesion in primary care to her management in secondary care,’ she said. ‘One key element here is to communicate screening results within 15 days of the examination.’ Radiologists and radiographers should also undergo dedicated train- ing in breast imaging. Technicians must know how to position and compress the breast, and be able to assess examination quality. the learning curve is extremely long,’ she empha- sised. ‘They need to dedicate a very significant amount of their time to training and practice.’ ‘For radiologists Dr Massimo Calabrese, head of the Complex Operative Unit of Diagnostic Senology in Genoa’s San Martino Hospital, examines aspects of stereotactic breast biopsy procedures and workflow and the need for improvements in certain areas of breast diagnostics. Healthcare administrators constantly seek investments to drive up rev- enue. When making such decisions, two primary aspects to consider include workflow efficiency and patient satisfaction. These important factors share a common thread that is equally necessary for decision makers to keep uppermost in mind: At the core of advancing any workflow scenario, and patient experience, comes a useful examination of com- munication. Italy, This certainly holds true in radiol- ogy, particularly when it comes to the stereotactic breast biopsy procedure. As head of the Complex Operative Unit of Diagnostic Senology in San Martino Hospital, in Genoa, I have per- formed numerous breast biopsies, observing both the wonderful advancements in breast s c r e e n i n g and biopsy technology, as well as areas where a d v a n c e - ments can still be made. I do believe is significant room for improvement when it comes to commu- nication throughout there The lightweight Affirm system integrates with the Hologic tomosynthesis system in under a minute the stereotactic breast biopsy pro- cess, and I have witnessed how this current gap ties directly to workflow efficiency and patient satisfaction. Forms of communication Communication comes in all forms throughout the breast biopsy pro- cedure. Technologists and radiologists, and patients— and even the informatics systems— one way or another, all communicate with each other. This is especially true for the sample ver- ification process during a biopsy. Once the suspicious breast tissue is extracted from the patient, the tech- nologist must verify the appropriate samples were gathered on a tomo- synthesis unit, which is sometimes already in use by another colleague, who is simultaneously screening a patient for a regular mammogram exam appointment, in a different room. As such, radiologists and technolo- gists must constantly communicate with one another—taking turns, waiting and sharing equipment for their respective patients, which is time consuming. This can become particularly cumbersome if the ini- tial breast biopsy samples are not verifiable, in which case the process of extracting, waiting and verifying repeats, until the acquired samples prove positive on the tomosynthesis unit. With each repetition, the technol- ogist travels back and forth between the biopsy procedure room and the area with the sample verification technology, which may interrupt the workflow of those who are using the equipment for breast screening patients. The additional time spent travelling to and from the verifica- tion technology can take an average of five to 10 minutes per biopsy, which accumulates throughout a day of procedures. Furthermore, each time technolo- gists must take the time to sepa- rate the tissue samples into smaller specimens for pathology to properly communicate results. The entire sample verification process—from beginning to end— can contribute to a significant delay in scheduling for radiologists. This may drive radiologists and technolo- gists to be in more of a rush to catch up on their next patient, leaving less time to really connect, and com- municate, with their current patient, creating a less personal patient experience and underwhelming patient satisfaction scores. Open the lines of communi- cation While breast imaging technology has come a long way, it is clear that the stereotactic breast biopsy pro- cedure can still be improved, par- ticularly when observing the overall communication issues throughout the process. As healthcare adminis- trators search to make worthwhile investments for their companies that improve workflow efficiency and patient experience, they should con- Dr Massimo Calabrese is the Chief of the Complex Operative Unit of Diagnostic Senology at San Martino Hospital in Genoa, Italy, a national institute for research and treatment of cancer (IRCCS). IRCSS A.O.U. San Martino is a reference site for a volume of two million people. Every year the institute receives 45,000 women and performs 500 tomography guided vacuum assisted breast biopsies (VABB), 800 ultrasound breast biopsies and 50 VABBs under RM. sider their current states of commu- nication: Does their equipment read and communicate information in an efficient way with other systems, or are extra steps involved? Does the radiologist have enough time to communicate with patients in detail, ensuring they feel as comfortable as possible and essentially to under- stand what they are experiencing along the way? The answers to these questions are very telling and, in this case, dem- onstrate that even medical device manufacturers should be consider- ing communication issues because they develop products to appeal to administrators who demand supe- rior workflows and more satisfied patients. Once administrators are fully in tune with how their facility’s com- ponents are communicating with one another, they will be able to make the right investment decisions to lead to prosperity. EUROPEAN HOSPITAL Vol 26 Issue 2/17

1 2 I T PART 1: What keeps a hospital’s immune system healthy? A strong IT security system Report: Marcel Rasch ‘You can’t get 100 percent security, you can’t avoid all risks – but you can improve security tremendously just by considering some rules,’ explains Torbjörn Kronander, Board member, CEO and President of Sectra AB. When hundreds, or even thousands, of machines and computers are con- nected with each other and diverse operating systems coexist with the PACS, hospitals have real IT secu- rity problems. In addition, today all imaging equipment is no longer simple machines; devices are com- plex computers that could become infected by a virus. The problems hospitals face and what options they have to address those chal- lenges were discussed by European Hospital and Dr Stefan Bücken, IT safety advisor in the Medical Centre for Information and Communication Technology at Erlangen University. IT security can be easy Ideally, a secure system would be totally isolated and blocked but, because there has to be an internet and data has to be exchanged, this situation is unthinkable. ‘We should see IT-security not as a curse, but compare it to our immune sys- tem,’ suggests IT-expert Torbjörn Kronander. ‘When we are born, we don’t know which germs and virus- es will attack us in our lives, but the immune system has a mechanism to detect infections and take care of them. This is actually what a good IT-security system does; it monitors the environment, detects infections or potential harm and applies a mechanism to get rid of those.’ Unfortunately, most hospitals still handle their IT-systems incorrect- ly. They connect every worksta- tion and every computer not car- ing enough about potential risks. ‘Hospitals must understand the seri- ousness of this situation and that they need to invest some time on re- organising their systems. Practically speaking, in PACS workstations, for example, never open private stuff, webpages, email and documents with attachments. Attachments can always contain contagious active elements,’ Kronander points out. Although zip-files carry the biggest risk because antivirus-software often cannot detect potential harm in them, Word-documents, Excel-sheets and even pdfs can also be conta- gious. ‘If you really want to stay safe, open and save documents only in a plain-text format like .rtf,’ he advises. ‘Never click “yes” to enable an active element in an attachment of a document.’ ‘When a hospital looks for an IT-consultant, the management should ensure somehow that this consultant evaluates the entire sys- tem, considering all potential risks. He will also tell you that no user should have administration rights on their computers. There must be some kind of user identifica- tion and authorisation to access a workstation or a computer. There always must be log-in and log-out,’ Kronander points out. What sounds familiar to people who have paid attention at least to some IT-security subjects, appears to be totally new to other hospital staff members. ‘You won’t believe what we some- times experience,’ the IT-consultant reveals, ‘In some hospitals, kids are coming to work with their parents and start playing computer games to dawdle. You never know what potential harm is on that system thereafter.’ According to Kronander ‘the most common security risk today are either USB sticks which inject a code into the system (a safe computer should have all USB ports glued by epoxy) or Phishing attacks, where users are fooled by a seemlingly cor- rect email, often appearing to come from their boss or equivalent safe sender, into clicking on webpages with malicious content that injects malware into their system. Carefully setting up a system helps to pre- vent infections. ‘A lot of hospitals re-install their operating systems every single night to prevent poten- tial harm on their computers. This means that documents in general cannot be saved locally. By having a completely new systems set-up every night, these hospitals avoid any risk of potential viruses that have been saved locally on a local computer during a working day.’ Medical technology comes with deeper risks The biggest challenge, however, is medical devices such as MR and CT, because these are not simple machines anymore; they are com- plex computers. ‘The problem here is that to receive FDA approval, the industry has to nearly freeze the version of the operating system they use. While Microsoft releases an upgrade for Windows every week, to take care of new threats, the version of a MR or CT system can- not be upgraded regularly enough without violating FDA regulations at the same time,’ Kronander explains. ‘This is a big problem the industry must take care about and for which we don’t have an appropriate solu- tion up to today. ‘Is must also be made known that hospitals are prime targets for Part 2: What keeps a hospital’s immune system healthy? be consistently applied. Although there are already some sustainable technical safeguarding procedures, all suppliers of medical technology systems are more or less working according to their own rules. In hos- pitals, however, these concepts must be amalgamated into a meaningful whole. It remains to be seen wheth- er the current, diversified solutions will pass the test of time.’ A rift between users and manufacturers So much for the users’ perspective – ‘the manufacturers’ perspective looks very different,’ Bücken points out. ‘The development and distri- bution of medical devices is par- ticularly regimented. Manufacturers must abide by a comprehensive set of norms, utilise risk management procedures and undergo licensing procedures. Each change to a sys- tem requires companies to carry out repeated, comprehensive con- trol and validation processes. In the context of the innovative environ- The User Perspective these structures in the near future,’ he emphasises. the The publication of IEC 80001-1 norm a few years ago was a first step in the direction of improved security for medical tech- nology systems within networks. This norm describes risk manage- ment for the networked operation of medical devices. The German IT Security Law, the EU-Cyber-Security Guideline (NIS Guideline) and the EU Data Protection Law, which will be legally binding from 2018, will lead to a wider discussion around the increasing networking of IT in the healthcare sector. ‘However’, says Bücken, ‘management systems focused on organisation are only part of the solution, as paper is often very persistent. ‘We also require coherent basic technology concepts that need to the utilisation of networked service structures, which go beyond indi- vidual systems limitations. ‘Apart from the utilisation of cloud services, there is also the large area of systems part of the Internet of Things (IoT), which constitute a particular challenge. Data protection and data security issues here are also similar, no matter whether we are looking at networked infusion pumps or the evaluation of diagnos- tic data somewhere in the cloud.’ The need for discussion How safe can we make hospitals? Complete screening blocks medical advances, but an open-door policy is no solution either, Bücken says. Any disruptions to the running of a hospital can quickly result in life- threatening effects for patients. ‘We need to think very seriously about Report: Marcel Rasch ‘From an IT perspective, medicine is now networked to a very large degree, no matter which depart- ments you look at,’ says Stefan Bücken, IT Security Officer at Erlangen University Hospital, Germany. Just a few years ago it was still possible to look at individual medical technology systems in isola- tion, but this is no longer possible. Medical technology systems must exchange data to make diagnoses and results available for patients’ medical care,’ he emphasises. ‘From an IT department perspec- tive, a hospital should be treated just like any normal company. We face the same technical problems with regards to systems networking as the automotive and other indus- tries face. However, we do need to take into account the extended risks of medical treatments. And techni- cal concepts for the comprehensive operation of networked systems in medical technology are still in their infancy.” The expert sees one current prob- lem in the increasing utilisation of cloud solutions. ‘Making these solutions completely secure is the great challenge we currently face.’ Bücken also believes that the so- called ‘Medical Device Isolation Architecture’ to safeguard net- worked medical technology is not future proof. ‘If you look at devel- opments over the last few years, we no longer look at defined areas of IT. We can no longer run individu- al departments, such as radiology, with a designated MRI scanner and defined interfaces, but are mov- ing increasingly in the direction of With a doctorate in technology and Masters in Business Administration, Torbjörn Kronander PhD was the founder of the medical area, became an executive vice president of Sectra AB, and President of the company’s Medical Systems business section, accounting for 88% of Sectra’s sales. In 2012 he was appointed the company’s CEO and President. Today he is the largest shareholder of the company. “Ransom ware” where the hard disks of all available computers are encrypted and the key for decryp- tion is only made available after a very sizeable amount of money has been paid to some account somewhere. In normal companies the reaction most often is to get a backup and knowingly lose a week of work or so. However, in hospitals, if the wrong medical devices are infected patients may even die. Therefore several hospitals have paid, and this has lead to even more attacks. It should also be noted that these attacks are no longer the work of a 14-year-old hacker somewhere. They are made by organised crime, the IT mafia.’ ment of medical technology and the background of forever changing IT threats, this is an approach unlikely to last in the medium term,’ he explains. the Specifically, orientation towards international markets often makes it difficult for manufactur- ers because each country has its own licensing procedure. ‘It’s under- standable that manufacturers, once they have finally had their prod- ucts approved, ideally don’t want to implement any changes. If they were to do so, this might entail hav- ing to go through the entire licens- ing procedure again,’ he points out. ‘On the other hand, however, the lack of regular software updates is dangerous from an IT security point of view. A hospital network will continue to develop gaps in security that need to be adequately filled. We are currently discussing these prob- lems with medical technology spe- cialists because we continue to use Windows WP at Erlangen, which, as everyone knows, Microsoft officially stopped supporting in April 2014. ‘Therefore, manufacturers try to resolve the problem through risk management and read-only sys- tems; but this hasn’t been thought out enough. Although the system returns to its original status after a restart it will be very vulnerable and easy to attack as long as it remains active around the clock, without any further security measures being implemented.’ ‘Or, imagine a hospital where all systems run on Windows 10. Depending on the system version chosen, the hospital computers, based on Microsoft’s update strategy, would have to undergo operating system updates every six months. In a complex, heterogeneous IT environment, as found in hospitals, this cannot work. Manufacturers and users must engage in a much more EUROPEAN HOSPITAL Vol 26 Issue 2/17

1 4 CA R D I O LO G Y Procedure may establish liver as alternative access in catheterisation NEW: Pulmonary valve placement via a child’s liver A Spanish team has, for the first time, successfully placed a pul- monary valve using catheterisation through the hepatic vein in a paediatric patient. Specialists believe this type of intervention could become an interesting alternative when traditional access points are not available. Report: Mélisande Rouger In what will probably pave the way for further similar interventions, a team at Virgen del Rocío Hospital in Seville has just successfully placed a valve inside the pulmonary artery of a child with congenital heart dis- ease, by entering a catheter in the hepatic vein. Only the second procedure to be performed This is the first time this type of intervention has been carried out in a paediatric patient in the world and the first time it has been performed in a patient in Europe. Before that, Dr Álvaro Iglesias López has worked as a vascular and interventional radiologist at Virgen del Rocío Hospital since 2004. He performs diagnostic and therapeutic studies in peripheral vascular, hepatic and renal pathology, and procedures involving the placement of central and peripheral venous accesses. He also serves as a general radiologist and carries out CT, MR and ultrasound examinations. only one adult patient had under- gone this procedure in the USA. Dr José Félix Coserria Sanchéz, a paediatrician who specialises in cardiology and haemodynamics at Virgen del Rocío Hospital, coordi- nated the intervention. He explained the challenges his team had to face for this type of catheterisation, which is tradition- ally performed from the femoral or jugular artery. ‘It’s very rare to use liver access for this kind of inter- vention,’ he explained during our European Hospital interview. Doctors chose to place the valve through the hepatic vein because the eight-year-old patient, whose implant was failing and needed urgent replacement, had already received multiple surgeries to treat a complex heart disease he had been suffering since birth, called Tetralogy of Fallot (TOF). The haemodynamics team unit benefits from two years’ experience Opening the patient again with tra- ditional surgery simply presented too many risks, Coserria explained. ‘The child had problems in his tra- chea and oesophagus. Traditional access points were thrombosed, so they were not viable.’ Catheterisation has been widely used since 2001 to replace cardiac valves when surgery proved inef- ficient. The haemodynamics unit at Virgen del Rocío Children Hospital has been using this technique for Contrast injection performed in pulmonary trunk, in which previous dysfunctioning pulmonary valve shows severe regurgitation towards the right ventricle Access wire to right atrium by transhepatic puncture physicians usually insert a small catheter through the liver and up to the heart. However, this time, due to the large valve size, doctors had to by-pass the organ so as not to damage it. ‘We could have torn the liver or caused important bleeding had we touched the organ,’ Coserria explained. This is unique in that a child with a congential heart condition is involved To ensure a successful outcome, Coserria performed the intervention with another haemodynamist, Dr Zunuzegui from Gregorio Marañon Hospital in Madrid, and vascular radiologist, Dr Álvaro Iglesias from Vigen del Rocío, who provided image guidance with fluoroscopy at the time of placing the catheter inside the hepatic vein. Iglesias has performed many liver catheterisations in his career. He also stressed the uniqueness of the procedure in the context of a pae- diatric patient with congenital heart disease. ‘Catheters we traditionally use in liver access interventions are in the 8 Fr. range. This time we had to use a 22 Fr. diameter, so about Contrast injection performed in the pulmonary trunk, in which correct function of implanted valve with catheterisation inside the stent is observed the past two years and performs three to five interventions a year to replace valves through the pulmo- nary artery. Liver access is sometimes used in catheterisation for congenital heart disease, but in these interventions TRUECOIN* Study Demonstrates Again: Long-term home monitoring system reduces risk of all-cause mortality Success for pacemaker recipients Biotronik Home Monitoring is an award-winning remote cardiac mon- itoring system that automatically collects data from a patient’s cardiac device, enabling the physician to review cardiac function indepen- dently of in-office visits. According to results presented at last year’s ESC from the TRUECOIN randomised controlled trial, the system reduced the risk of all-cause mortality by 38 percent in ICD patients after one year, and there was a 36 percent reduction in the combined risk of all-cause mortality and hospitalisa- tion for worsening heart failure. The meta-study pooled the results of 2,405 patients from the TRUST, ECOST and IN-TIME trials. Trust included 1,339 ICD patients randomised 2:1 to remote monitor- ing or conventional follow-up at 102 centres, concluding that Biotronik Home Monitoring reduced in-office visits by 45 percent. Ecost showed how continuous monitoring reduced the rate of patients who experienced inappro- priate shocks by 52%. In-Time researchers evaluated heart failure (HF) patients with the remote monitoring system, dem- onstrating a 50 percent decrease in all-cause mortality in ICD and CRT-D patients with symptomatic HF. This is the first randomised trial to demonstrate a benefit in terms of all-cause mortality in remote monitoring. Based on these results, the European Society of Cardiology recommends remote monitoring according to the In-Time approach for this patient group in its latest heart failure guidelines. Dr. Gerhard Hindricks, Director of the Electrophysiology Department at University of Leipzig Heart Centre, Germany; President of the European Heart Rhythm Association and lead investigator of Truecoin and In-Time said: ‘Both studies’ results show that Biotronik Home Monitoring leads to improved clinical outcomes for patients. I believe this is due to dif- ferences in manufacturers’ technol- ogy, the data collected and clinic workflow.’ ‘The system is the only remote monitoring system on sale that is clinically proven to notably reduce risk of all-cause mortality in ICD patients,’ Biotronik points out. ‘To ensure efficacy of remote monitoring,’ Hindricks emphasised, ‘frequent data transmission, quality data, and appropriate responsive treatment pathways from physicians are essential.’ EUROPEAN HOSPITAL Vol 26 Issue 2/17 BIOTRONIK Home Monitoring Reduces Mortality Meta-analysis of Home Monitoring trials TRUST, ECOST and IN-TIME shows the reduction of all-cause mortality in ICD patients * Hindricks G et al., Daily remote monitoring of implantable cardioverter-deibrillators: Pooled individual patient data from IN-TIME, ECOST, and TRUST trials suggest a mechanism of clinical beneit, ESC Congress 2016, Rome. www.biotronik.com

1 6 S U RG E RY Robotic-assisted visceral surgery The advantages are obvious Report: Brigitte Dinkloh The implementation of minimally invasive technology in the 1990s was a milestone for visceral surgery. A further chapter of innovation began about five years ago with advances in robotics, which were able to address certain technologi- cal shortcomings of minimally inva- sive surgery in the fields of optics, instrument technology and recon- struction. If nothing else, pancreatic surgery has benefitted from these develop- ments. ‘It ranks amongst the most complex interventions in abdominal surgery and opens up an important perspective to be able to offer these complicated and very time con- suming interventions, which have been carried out almost exclusive- ly with conventional surgery, with an assistance system and minimal invasion,’ explains Colin M Krüger MD, Dipl.oec, Senior Consultant at the Department for Surgery, in Immanuel Hospital Rüdersdorf, near Berlin. A lower rate of complica- tions First studies and analyses confirm that the quality of organ removal and partial removal is more or less comparable for both procedures, but also that the rate of complica- tions associated with the interven- tion is significantly lower for mini- mally invasive procedures than for open surgery. Therefore, minimally invasive surgery, whilst achieving the same surgical outcome, has clear advantages. But, which patients and indica- tions are suitable for robotic sur- gery? ‘Basically, all patients who are operable and fulfil the surgical entry criteria,’ Krüger responds. ‘If the diagnosis confirms that a patient is likely to benefit from surgery, then this can also be done with mini- mally invasive procedures, or, in the best case, with robotic surgery, such as the da Vinci Surgical System.’ Krüger does not foresee a con- siderably better perspective for patients with pancreatic cancer as 70-80% of them are only diagnosed once the tumour has already spread and is considered inoperable. However, there are other pancre- atic diseases with a less negative and the robot sews with the needle, which you hold in the external nee- dle holder, but inside the abdomen. This is brilliant.’ More ‘radicality’ A further advantage of robot-assist- ed surgery in oncology is immu- nofluorescence. These fluorescent dyes, injected by the anaesthetist, can stain the lymphoid tissue or other vessels and structures during surgery, either to protect them or remove them even more precisely with the respective radicality. The prescribed number of lymph nodes to be removed for certain types of tumour surgery can be significantly increased with the da Vinci system. ‘During open surgery, the dyeing is very complex because there isn’t normally a camera system available, which is why it’s not usually done. ‘For a long time, it was quite con- troversial whether tumour surgery should actually be carried out with the minimally invasive procedure at all,’ Krüger points out. ‘There was always the claim that it is not suf- ficiently radical. However, this has been scientifically refuted. It obvi- ously always depends on the exper- tise of the surgeon, but the proce- dure achieves at least the same, and sometimes even more radicality, and at the same time allows the patient to benefit from the advantages of minimally invasive surgery.’ Costs and viability Only a few patients in Germany currently benefit from robotics in pancreatic surgery. Last year, 43 sur- gical departments had access to one of the 87 systems currently avail- able in that country. The number of departments for visceral surgery and centres that treat a noteworthy number of patients with robotics is considerably lower still; Krüger esti- mates it to be around 10-15 centres. This can most probably be attrib- uted to the increased costs of the procedure, which are €1,000-€1,500 higher than the costs of conven- tional surgery and therefore still not always viable, despite shorter in-patient stays. The discussion as to whether these systems are really required, or not, is still very heated and affected by jealousy. On the other hand, there are currently almost exclu- In April 2017, Dr Colin M Krüger MBA, Dipl.oec, became a senior consultant at the Department for Surgery at the Immanuel Hospital, Rüdersdorf, near Berlin since April 2017. Earlier, as a specialist for general, visceral and vascular surgery and emergency medicine at Vivantes GmbH, he also headed the visceral surgery programme for ‘Robot- assisted, minimally invasive Surgery (Da Vinci)’. From October 2016, he was senior consultant at the Centre for Robotics and Minimally Invasive Surgery in the Department for Surgery, Vivantes Humboldt Hospital, Berlin. Krüger also holds a Master of Business Administration in Health Economics, is a medical advisor at Intuitive Europe and is currently writing his habilitation at the University of Greifswald on the risk stratification in pancreatic surgery. sively only studies that confirm the feasibility, and only very few studies that confirm a clinical advantage of robotics compared to minimally invasive surgery. ‘However, this is to be expected at the moment, as we require a critical number of users and data to confirm clinical supe- riority. Method studies are difficult to carry out anyway, and often only individual parameters are examined. We don’t generally compare the minimally invasive procedure with robotics, so it is difficult to evaluate this,’ he explains. Krüger is establishing the first centre for robotic-assisted visceral surgery in Brandenburg, and plans to carry out his own studies. With gynaecological and urological col- leagues he aims to achieve full capacity for the da Vinci-SI with around 500-600 interventions annu- ally in one to two years’ time. Financial easing could occur from 2018/19 when large manufacturers will break the current monopoly held by Intuitive by releasing their own equipment, and when compe- tition will regulate the prices for acquisition and maintenance. Krüger is sure that ‘in five years’ time the costs will settle down around the level of those currently expected for a complex laparoscopy’. s a a M & x i r B © Colin Krüger is establishing the first centre for robotic-assisted, visceral surgery in Rüdersdorf, near Berlin prognosis, where surgical interven- tion is worthwhile. These include hormone producing tumours, as well as all types of chronic pancrea- titis such as those that may develop due to chronic alcohol abuse or as a result of autoimmune diseases, where the body tries to fight its own pancreatic tissue. The resulting inflammatory changes can cause jaundice, gastroparesis and, most importantly, chronic pain. This is an area of application for robot-assisted surgery. Improved optics and a higher degree of freedom One essential advantage of the da Vinci Surgical System is the improved visibility over the operat- ing area. ‘Unlike conventional lap- aroscopy, which only offers 2-D visualisation, it facilitates 3-D HD visualisation in the same way as open surgery does. The surgical structures can be enlarged up to tenfold, which means more preci- sion during preparation,’ the Berlin- based surgeon emphases. The same applies to handling, with much more freedom when guiding the instruments in the abdo- men compared to conventional lapa- roscopic surgery. “The instruments have up to seven degrees of free- dom,’ Krüger points out. ‘When you work with double-joint technology the instruments carry out their own hand movements. This is the princi- ple of the surgical robot – it controls the manipulators, and the hand movements carried out outside of the operating area are implemented 1:1 to the instrument working inside the abdomen. You sew externally, with the manipulator in your hands, Led lamp to meet surgeon’s needs The right lighting of a surgical site is critical. Bologna-based lighting specialist firm ACEM confirms that the special optics of its LEDS in the firm’s STARLED5 NX surgical lamp ‘generate a shadowless, clear and homogeneous light, assuring visual comfort and best working conditions both for the surgeon and medical staff. Thanks to its next generation LEDs, the lamp can produce a perfect illumination under every condition generating an IR-free light, an excellent colour temperature and a practically end- less life cycle at low consumptions. ‘The 43 LEDs,’ Acem continues, ‘are circularly positioned and divid- ed into five reflectors (with seven LEDs each) and another eight LEDs are radially placed around the han- dle. In this way, the lamp produces a high illumination level of 130.000 lux (160.000 lux optional) for a steady life cycle of about 50,000 hours.’ The firm’s system ACRIS, with microprocessor, to ensure control of electrical curves typical of LEDs to remain unaltered reported is over the time, but maintain- ing a long life cycle. ‘The colour rendering index of Starled5 NX is 95 and its colour temperature is 4,500 °K,’ Acem adds. To meet vari- ous surgical needs, the system can produce focused and ambient light, with a ‘light field focusing tem adjusting the light spot diameter accu- rately assuring an excellent sharp- ness of details in the operating area’. sys- * Acem Medical Company is based in Bologna, Italy. www.acem.it e-contact and queries: Info@acem.it The Starled5 NX surgical lamp with LEDs provides surgical teams with shadowless, clear and homogenous light in the opera- tion and surrounding area EUROPEAN HOSPITAL Vol 26 Issue 2/17 LED lamp for operating roomSTARLED5 NXAcem S.p.A.Medical Company DivisionBologna – ITALYPh. +39 051 721844info@acem.it − www.acem.itMedical Lighting System