2 european hospital vol 25 issue 5/16 news & management the planned restriction by the nhs vale of york clinical commissioning group (ccg) would have seen elec- tive surgery for non-life threatening procedures – such as hip and knee operations - delayed by a year for those with a body mass index (bmi) exceeding 30. however, the proposal is now under review after officials at nhs england - which oversees the clinical commissioning groups responsible for commissioning or buying local health and care services - stepped in and ordered a re-think. vale of york ccg is already under ‘special measures’ after being labelled ‘inadequate’ under a new ratings system and is being offered high level support to manage and run its services. it had initially planned to imple- a remote monitoring service for car- diac device patients, created by biotronik home monitoring, is asso- ciated with a 38 percent reduced risk of all-cause mortality after one year across all implantable cardio- verter defibrillator (icd) indications. in the truecoin meta-study inves- tigators observed these results in comparison with conventional in- office follow-up for icd patients. additionally, they found a 36 per- cent reduction in the combined risk of all-cause mortality or hospitalisa- tion for worsening heart failure. first presented by dr gerhard hindricks, of the leipzig heart centre, germany, at the european society of cardiology’s 2016 con- ference in rome, the meta-study pooled 2,405 patients from three previous home monitoring trials: trust (varma n, et al. eur heart j. 2014, 35 (20), ecost (guedon- moreau l, et al. europace. 2014, 16(8), and in-time (hindricks g, et al. lancet. 2014, 384 (9943). the in-time trial, showed a more than 50 percent risk reduction for all-cause mortality in heart failure patients specifically. results of the new study extend the mortality ben- efit to all icd patients. ‘the results suggest biotronik home monitoring is effective in helping to reduce mortality in patients with a wide variety of icd indications, and to slow the progres- healthcare professionals have much to learn as medical technology continues to present them with new developments. to meet that need, medical technology manufac- turer xenios ag, which produces sophisticated heart and lung sup- port devices on a single platform, this year established the xenios campus. this aims to provide medi- cal teams with a global digital net- work that ‘unites all advantages of an integrating learning management system’, the firm explains. ‘the broad offering, encompass- ing tried and tested e-learning tools such as seminars, quizzes and webi- nars, as well as videos, documents, presentations and classroom train- ing, creates a complete blended learning environment. ‘since cross-border cooperation is essential, particularly in high- ly specialised fields, the multilin- gual approach of this learning pro- gramme is another clear advantage.’ already available in several lan- guages, it will be expanded con- tinuously to provide internationally flexible and effective training and information. ‘comprehensive and up-to-date knowledge transfer with regard to life-saving and life-supporting devices for lung and heart is a core component of the quality and qual- ity assurance programme of xenios ag,’ the company reports. ‘in healthcare, e-learning is vital. digital learning allows medical research results and innovations to be disseminated quickly to a wide ment restrictions that would mean obese patients would receive a refer- ral for surgery in less than a year if they lost 10% of their body weight. and smokers would have proce- dures delayed for up to six months unless they gave up, or at least stopped smoking for eight weeks. the ccg said the proposals were part of a package of measures being considered to reduce costs at a time when the local system was under ‘severe pressure’ and felt it was the ‘best way of achieving maximum value from the limited resources available.’ nhs england has said it recognis- es that reducing obesity and cutting smoking benefits patients and saves the nhs millions of pounds and also that major surgery poses much higher risks for severely overweight sion of heart failure,’ commented hindricks, who is the study’s lead investigator. ‘we observed these benefits by analysing studies that only used home monitoring, rather than com- bining data from patients followed using systems that have differing operational features. ‘hence, analysing individual remote monitoring systems may be preferable to global analyses.’ hindricks further highlighted that not all remote monitoring systems are the same. the automatic, daily transmission and a specific multi- parametric data set are unique to audience. in addition, medical staff has to be aware of regulatory issues – which differ from country to coun- try – in order to ensure compliance.’ the e-learning industry has shown a double-digit growth annually. ‘it-supported learning in pro- fessional and continuous training is well established. mobile learn- patients who smoke. however, a spokesman pointed out: ‘this does not and cannot mean blanket bans on particular patients such as smokers getting operations, which would be inconsistent with the national health service’s con- stitution.’ nhs england has now asked the ccg to review its proposed approach ‘to ensure it is propor- tionate, clinically reasonable, and consistent with applicable national clinical guidelines.’ home monitoring. ‘biotronik home monitoring is the only remote monitoring system on the market to demonstrate a significant reduction of clinically relevant endpoints in randomised controlled trials,’ the firm reports. ‘additionally, proper management guidelines (standard operating procedures) must be in place to respond to relevant patient alerts that could, for example, require changes to drug or device therapy.’ according to hindricks, these fac- tors appear to have a significant influence on patient well being. in response, the ccg said it would now ‘review the draft approach’ and, the group added, ‘hold off imple- menting anything until we have an agreed way forward’. in a statement, it added: ‘we will ensure any plans are implemented in line with national guidance, are in the best interests of our patients and are clinically robust.’ chris hopson, chief executive of nhs providers, said that with local health services under severe finan- cial pressure, there was a need to prioritise the treatments and proce- dures they pay for within the avail- able funding but it was important to realise such decisions are not simply made on cost grounds alone. ‘the decision to operate is based on a number of factors and there are often good clinical reasons why some restrictions would be placed on patients accessing treatment,’ he added. ‘no one will want to see patients waiting in pain longer than is clinically necessary. however, given that we are in the middle of the longest and deepest financial squeeze in the nhs’ history, we are likely to see more decisions like this in future. what is important is that this is managed on an nhs-wide basis.’ the ccg estimates obesity cost the nhs in the vale of york £46m in 2015 and comes at a time when lat- est figures show there are believed to be 6.8 million obese men in the united kingdom and around 7.7 million obese women. while the proposed restrictions - described by the royal college of surgeons (rcs) as ‘some of the most severe the modern nhs has ever seen’ - are unusual, they are not rare and serve to illustrate the financial pressures the nhs is under at pre- sent as it strives to save money. reports of ‘rationing’ of services have emerged after nhs england admitted that its provider sector overspent by £2.45 billion in 2015- proposing penalties for those with lifestyle related illnesses success for implantable cardioverter defibrillator patients the wave of the future: mobile learning and e nhs targets obese patients home monitoring device reduces mortality a new online e-c a health authority in england has sparked a major debate within the nhs after suggesting that obese patients and smokers could be refused surgery to help save money, mark nicholls reports

4 european hospital vol 25 issue 5/16 laboratory the association of biofilms with multi- drug resistance has highlighted the need for further understanding of biofilms and for anti-biofilm strate- gies. this september, in a satellite symposium sponsored by heraeus medical, manufacturer of products for orthopaedic surgery and trauma- tology, at the 35th annual meeting of the european bone and joint infection society, in oxford, the lat- est knowledge of biofilms and local methods of overcoming the chal- lenge of infection was discussed. biofilm-related implant mal- function in orthopaedics, bacteria may colo- nise a surface for months or years but remain undetected until they trigger an immune response and signs of infection. during this time, there may be low-grade infection, and symptoms such as persistent pain, stiffness, lack of range-of-movement, fibrosis, ‘aseptic’ implant loosening and non-union of fractures. biofilms and multi-drug resistance a mature biofilm can form within 24 hours of contact with an implant and can even penetrate the surface of titanium. as the biofilm matrix is more abundant than the bacteria in europe, the first baby with zika-related microcephaly was born in july. the mother had contracted the zika virus while travelling in america. how dangerous is the virus for europeans, particularly since many visited brazil for the olympic games in rio? european hospital asked professor, head of the immunology and virology research group at hamburg’s bernhard nocht institute for tropical medicine. asked, in terms of the zika virus, whether one should be cautious about visiting south america, prof. schmidt-chanasit responded with lit- tle doubt: ‘i would definitely go. the zika virus has in no way affected the security of travellers – except preg- nant women. there are many dis- eases that are much more problem- atic than zika fever, such as dengue or malaria. the only group i would recommend abstaining from a visit to those countries are women during the first three months of pregnancy since there is a low risk of harming the foetus. this fact has caused a lot of concern and received considerable media attention. generally speak- ing, however, a zika virus infection is not a problem for non-pregnant persons. and most people do not get ill. therefore i would travel to south america anytime.’ might the disease be sexually transmitted? ‘the main transmission vector is the mosquito. sexual transmission may happen but it is very rare – a mar- ginal phenomenon. of all zika virus infections known in germany one documented infection was transmit- ted sexually. if it does happen it’s always transmitted from the male to the female. there is no known case the other way around. men who are known to carry the virus should always have safe sex with pregnant women. the virus can be detected in sperm for at least three months, maybe even a bit longer – we need further research on this issue. thus men who were tested positive and have unsafe sex with pregnant women are the only group who pose a problem.’ could this mean that a virus transmitted to a woman will not cause damage in any of her sub- sequent pregnancies? ‘there is no indication that the virus will persist in women and cause problems or malformations in later pregnancies.’ how can we protect ourselves from the mosquito? sprays, mosquito nets, long-sleeved shirts and air-conditioned environ- ments offer the best protection. the spray should contain diethyltolu- amide (deet) because of its long- lasting effectiveness and because you can spray it on your clothes. beyond these, there are anti-zika programmes that need to be organ- ised by public health authorities. are people carrying the zika virus more at risk of developing guillain-barré syndrome? ‘this disease also occurs with other infections, such as campylobacter jejuni. it does not occur more fre- quently after a zika virus infection than after any other infection – as was recently shown with regard to the outbreak in french polynesia. this auto-immune disease is not new to us.’ what about european zika infec- tions? ‘since may 1 the infection has to be reported under the german infection protection act, for example. in this country about 100 zika infections were reported.’ is there a risk of a pandemic? ‘no. today the virus has spread basi- cally all over the world. in many countries it has been endemic for a number of years; in south east asia it has been known in thailand for decades. the hysteria fired by the media is incomprehensible. currently, europe and australia are the only non-affected continents, but we do expect imported and locally acquired infections during the sum- mer. but there will not be an out- break comparable to the one we’ve seen in brazil. therefore, there is no reason to worry in europe.’ then why was an international health emergency declared? in february it was still not clear whether there was a connection between microcephaly and the zika virus. therefore it was correct to declare the emergency. it triggered an intensification of research efforts and the connection was soon estab- lished. declaring the emergency was the right step. but obviously it is very different from ebola, which killed 70 percent of the infected persons.’ when will there be a safe vaccine? ‘unlike with ebola there was no immediate vaccine candidate for zika. however, now there is one that’s currently being tested on mon- keys. clinical studies, about to start shortly, will take a few years to com- plete. thus any vaccine won’t help in the current situation. however, the epidemic is subsiding in colombia and brazil. the vaccine research is an investment in the future, if there is another outbreak in 20 or 30 years. most people in south america are immune, the so-called herd immunity, thus there is no, or only a low, intensity virus circulation. consequently the vaccine is not that crucial because it’s too late for the current epidemic.’ themselves, the biofilm must be dis- rupted in order to expose the bacte- ria to antimicrobial agents. multi-drug resistance may also be related to biofilm formation, for example, methicillin-resistant staphylococcus aureus (mrsa) pro- duces more biofilm than methicillin- susceptible s. aureus (mssa), and therefore biofilms may magnify the cost, suffering and mortality associ- ated with antibiotic resistance. superior outcome in hip and knee arthroplasty through antibiotic-loaded bone cements (alac) in addition to the well-documented benefit of bone cements such as palacos r+g in total hip replacement (thr), registry data was present- ed showing that significantly fewer revisions are required when that bone cement was used in total knee replacement surgery, compared to all other bone cements (data on file. national joint registry (njr, www. njrcentre.org.uk) data licensed to heraeus medical gmbh, wehrheim). palacos r+g with gentamicin also significantly outperforms plain palacos. significant reduction of sur- gical site infections (ssis) through dual antibiotic-load- ed bone cements it is particularly important to opti- mise strategies for reducing peri- prosthetic joint infections (pjis) in high risk patients, but which bone cement best overcomes the cur- rent challenges in pji prevention? a quasi-randomised, double blind study was carried out, comparing the two bone cements, palacos r+g and copal g+c, in patients requir- ing haemiarthroplasty for a frac- tured neck of femur. there was a significant reduction in both deep and superficial ssis with copal g+c compared with palacos r+g (tyas b, marsh m, molyneux c. et al. abstract 59 presented at the oxford meet- ing) explained by the previously- observed high antibiotic concentra- tions in wound fluid. extrapolating the reduction in infection rates to the entire uk hip haemiarthroplasty population would lead to healthcare savings of over £4 million. dual antibiotic-loaded cement does not affect anti- biotic resistance profiles a concern regarding the use of anti- biotic loaded bone cements is wheth- er they cause antibiotic resistance. the study reported no significant differences in resistance between palacos r+g and copal g+c. the only cases of resistance with copal g+c were to gentamicin and clinda- mycin, which is as expected. resistance to other standard anti- biotics remained low. furthermore, copal g+c completely eradicated infection caused by corynebacterium species and s. aureus. source: heraeus medical manufacturer of medical products for orthopaedic surgery and traumatology. the products list includes bone cement.s understanding biofilms and multi-drug resistance aiming for anti-biofilm strategies ‘i would travel to south america any time,’ virologist confirms zika infections subside among all cement brands in the njr palacos r+g is superior jonas schmidt-chanasit md gained his doctorate at the charité berlin medical school. still a student, he spent time as a researcher at kasetsart university in bangkok. in 2006/2007 he was research fellow at the institute for medical virology in frankfurt am main, germany, and then became head of virology central diagnostics at bernhard nocht institute hamburg. in 2010 qualified for university professorship in virology at johann wolfgang goethe-university, in frankfurt am main, and was appointed professor in arbovirology* at university of hamburg in 2015. * relating to any of numerous viruses that replicate in blood-feeding arthropods, such as mosquitoes and ticks

make the connection the world’s easiest to use hba1c analyzers just got even better. quo-test and quo-lab from ekf diagnostics now come with poct1-a2 connectivity, qc and user id lockout as standard. make your connection today:  hba1c-test.com  +44 (0)2920 710 570  connect@ekfdiagnostics.com 1 2 3 4 5 6 7 8 9 10 11 12 visit us at medica stand #c70, hall 3 diagnostics for life connectivity now available on quo-test and quo-lab a1c analyzers. 6 european hospital vol 25 issue 5/16 laboratory european regulators have turned the world of in vitro diagnostics (ivds) upside down with new legislation that will come into effect at the end of this year. the stricter rules are especially tougher for advanced molecular diagnostics and lab-on-chip assays used in the clinic to help identify a patient’s pathology. but also coming under scrutiny for the first time will be diy pregnancy kits or at-home nutrigenetic tests that have not been covered by the current regulations. outraged by the scandal over breast implants that fraudulently used industrial-grade silicon and with on-going concerns for metal- on-metal hip implants, the european parliament launched a total over- haul of the directives for awarding the ce mark for medical devices and although currently considered the ‘gold standard’, tissue biopsies are not without limitations. thus, in recent years, a new alternative, liquid biopsy, has gained atten- tion. when cells die, they release their dna (so-called cell free dna, cfdna) into the bloodstream. for tumour cells that die after therapy, the cfdna contains mutations that could be detected and analysed with pcr or sequencing tools for non- invasive diagnosis. however, the sensitivity and clini- cal information provided by liquid biopsy is less clear, prompting the group to investigate further. by collaborating with partners at the heidelberg thoraxklinik, the dkfz researchers recruited a focused cohort of 16 lung cancer patients, all carrying prominent mutations, and were undergoing tyrosine kinase inhibitor (tki) treatment. over a period of up to two years, the researchers collected sequential blood plasma samples from each patient and extracted the dna. by analysing the data, the scien- tists made three interesting observa- tions. first, the number of mutated alleles in patients changed accord- ing to the clinical course of the disease. for example, in one patient, the initiation of tki therapy was paralleled by a drastic and immedi- ate (within 26 hours) rise of mutated cfdna in the blood plasma, prob- in vitro diagnostics (ivds) devices. the reform movement in brussels has resulted in nothing less than an upheaval of the landscape for manufacturers. for example, all ivds will need to be recertified, including products already on the market. and where the current eu directives allowed a self-certification of the vast majority of tests, the new ivdr now requires 80 percent of all assays and reagents to undergo a strict level of inde- pendent scrutiny that runs up the supply chain to include subcontrac- tors and software associated with the product. while there is a five-year transi- tion period provided in the new laws, that may not be enough for many manufacturers, according to gert bos, the executive director at qserve group, a medical device consulting firm based in amsterdam. he also is the past-president of the european association of notified bodies for medical devices. the notified bodies are the gate- keepers for access to the eu mar- ket, independent companies accred- ited by a member state to assess whether a product to be placed on the market meets the preordained standards. ‘most manufacturers will have to revisit all technical files and the quality systems for all their devices, they will need to generate additional clinical and performance evidence,’ bos wrote in a detailed guide entitled, dos and don’ts: how to prepare for and implement the upcoming in vitro diagnostic regulations (ivdr). the white paper was co-authored by erik vollebregt, a partner at axon lawyers in amsterdam, an expert on eu regulation and the author of the widely followed blog, medical device legal. with permission of the authors, this article extracts highlights from the white paper. ‘the ivdr will bring about extremely significant changes. most critical is the full revision of the classification system into a rule- based risk classification matrix. in contrast to the current situation, this means the vast majority of products will need to be evaluated by the notified bodies.’ as the result of greater scrutiny since 2013, the number of noti- fied bodies has been dramatically reduced, a critical issue for manu- facturers. bos estimates that, by the end of 2016, there will be from 40 to 45 certified notified bodies remain- ing from approximately 80 before the 2011 breast implant scandals that provoked the reform movement for eu regulations. ‘manufacturers must be aware that they may need to change a noti- fied body as a result of this develop- ment, and act accordingly if their current notified body is not able to support the manufacturer anymore,’ he cautions. in addition, he said that the administrative burden will increase substantially for manufacturers as a result of registration require- ments and the implementation of a unique device identification (udi) system. ‘consequently,’ he wrote, ‘manufacturers must take a proac- tive approach to the new regulation, plan and budget for the transition of existing devices in a timely and detailed way, and allocate resources for this effort.’ ivdr shares many new features with the upcoming eu medical devices regulation (mdr) proposal, such as new supply chain require- ments and the implementation of a central database (eudamed) here are the four major develop- ments specific to the ivdr field highlighted by bos and vollebregt. 1. extension of the concept of in vitro diagnostic devices to include tests of ‘indirect medical purpose’ and ‘prediction’ to include nutrige- netic tests and lifestyle tests, which are not covered by the current ivd directive. 2. ivds will no longer be subject to the list-based system currently in the ivd directive, but to the risk classes developed by the global harmonisation task force (ghtf), dividing the landscape of ivds into risk classes from a (low- risk) to d (high public and high patient risk) with seven classification rules. with notified bodies having to perform conformity assessment on all but class a devices, the land- scape is dramatically changing in terms of files to be reviewed and audits to be performed pre- and post-market. 3. the conformity assessment routes for ivds are amended to fit the new classification logic. ivds that do not fit any of the other clas- sification rules fall into class b and have to be certified by a notified body. this is a major change com- pared to the ivd directive, which allows such ivds to be self- certi- fied. as a consequence 80 percent of all ivds will need to be certified by a notified body under the ivdr, as compared to 20 percent currently under the ivd directive. 4. clinical performance studies will be required to support the ce mark under the ivdr. as a con- sequence ivd manufacturers will need to produce significantly more clinical evidence. the ivdr will contain rules for interventional clini- cal performance studies and other clinical performance studies that largely overlap with the clinical studies regime in the mdr proposal. it is crucial for manufacturers of ivds currently on the market to plan the generation of additional clinical evidence well, and timely assess what clinical evidence will likely be required, how long it will take to generate this and plan ahead for notified body slots for conform- ity assessment. in short, the clinical performance evaluation will include not only the classic clinical performance and analytical performance, but also sci- entific validity. with this change, the first steps towards manufacturers becoming fully responsible for the clinical utility of their devices are initiated. the ivdr will bring about extremely significant changes the level of mutated dna in blood corresponds t ivds under the microscope liquid biopsy dete tumour changes in new eu legislation gives manufacturers five years to meet strict standards. that may not be enough time, john brosky reports new findings from a scientific collaboration between the german cancer research centre (dkfz), the national centre for tumour diseases (nct) heidelberg and the thoraxklinik heidelberg sug- gest liquid biopsy as a promising tool to monitor lung cancer patient tumours early. scientists associated liquid biopsy readouts with clinical data and could track tumour responses to cancer drugs in real-time. gert bos is an influential voice for european regulatory issues. for many years he served as the president of the notified body association team- nb, and as vice chair of the medical notified body forum. until 2016 he was the head of regulatory and clinical affairs of british standards institute for medtech. currently he is the executive director and partner at qserve consultancy.  +44 (0)2920710570

8 european hospital vol 25 issue 5/16 laboratory the greater romagna area hub laboratory has recently installed the beckman coulter dxn veris molecular diagnostics system and is already reporting improved work- flow and quicker turnaround time for results. laboratory director professor vittorio sambri explained that the system is being used for the four key tests of hiv-1, hbv (hepatitis b virus), hcv (hepatitis c virus) and cmv (cytomegalovirus) in his centre, which delivers all microbiol- ogy testing, bacteriology, serology investigation and molecular diag- nostics for virology for 11 hospi- tals with 4200-plus beds between them, serving the 1.2m popula- tion of the greater romagna region. the lab, which opened in 2009, upgraded to the beckman coulter dxn veris molecular diagnostics system earlier this summer. professor sambri explained: we decided to go for the beckman coulter system for the analyti- cal and organisational features it offered, as well as price. however, cost was a secondary issue. the greatest benefit has been the organisation of the workflow which is much easier, it is more linear and on-demand so you do not need to batch samples, which means we can provide reports to cli- whilst objects such as beds, medical devices or other materi- als may be easy to acquire, lease or hire, the situa- tion is different when it comes to human resources. there is a lack of nurses, doctors, medical engi- neers and it specialists, across the entire european employment mar- ket. nothing damages a hospital’s reputation more than a rating that states it does not provide adequate patient care. there has been no getting away from it: long waiting times and deteriorating care caused by a lack of staff on the wards are standard in many hospitals. this is particularly frustrating for all con- cerned when the respective budget is actually in place but suitable staff cannot be found. there are obviously various ways to solve these problems. the easiest, but not necessarily most effective solution is to put the blame and responsibility on the ‘system’ and to wait until the system solves the problem. actually, this tends to be the most common approach! a much more successful line is to utilise improve productivity in existing resources more efficiently. a closer look at workflows repeat- edly reveals a multitude of activities that originated in the past, but the necessity of which has never since been questioned. one of the factors that could lead to a significant improvement in the situation is the handling of laboratory tests beyond the labora- tory. a look at the entire process for some essential laboratory tests shows, without a doubt, that some tests could benefit from substantial improvements if the analysis was carried out on site, i.e. via a point- of-care test (poct), rather than by a centralised service provider – the laboratory. some excellent examples of poct can be found in the a&e depart- ment. nowadays, to determine a troponin level via a poct, within 15 minutes, is no longer a prob- lem. however, the majority of a&e departments still send samples to the central laboratory. this results in long waiting times, unnecessary additional work for nurses and doc- tors and in patients spending far too much time in treatment rooms. what applied in the past is still relevant today: time is money. a solid analy- sis of the current situation and the willingness of all those involved to allow changes can lead to consider- able increases in efficiency. naturally, it would be wrong to say that poc does not exist in european hospitals at all; it is already in practice in many places. the most important examples are blood glucose measuring systems and blood gas analysis. the ques- tion is, whether the right systems are being used. finding systems that actually worsen a situation, instead of improving it, is not uncommon. systems must fit into the workflow. in other words: when the decision is taken to establish poc, the opti- mum work process must be defined before the required systems are chosen. whether or not a poc concept supports workflows in a meaning- ful way depends to a large part on the performance of the it systems used. modern systems specifically developed for poc offer the user many opportunities to make work- ing with the systems as easy and safe as possible. however, for this, an it system that supports the different opportunities offered by poct systems is a prerequisite. the latest systems make the use of pen and paper completely redundant. it makes no sense to make laboratory test results available more quickly if old, standard forms are then used to document patients’ results, or for the obligatory quality con- trol documentation still required in some countries. a combination of ‘modern’ with ‘stone age’ would be counterproductive in this case. what we would like to tell the observant reader with this contribu- tion is that the integration of poc can only be successful if thorough preparation takes place beforehand. the change to poc is more than a discussion as to whether a system is technologically suitable to carry out certain types of analyses or not. as the resulting profitability of a poc project directly depends on the increase in efficiency expected, all those involved should take enough time for a detailed analysis of the current situation and the results to be expected. if everything has been done properly poc will be the quiet force that helps to utilise the existing resources in the best possible way for a long time to come. nicians in a faster and more timely way.” with a simplified, flexible work- flow and single sample random access, the dxn veris molecular diagnostics system is an automated system for routine core lab work that combines all the sample dna extraction, purification, assays set up and analysis in a four-step work- flow: load samples onto rack; place on the dxn veris system; hit run; read results 70 minutes later (dna) or 110 minutes later (rna). by reducing manual intervention, and automating the steps from sam- ple loading to reporting of results, the dxn veris system has the potential to revolutionise labora- tory workflows and reduce time to results. there is no lengthy set-up with all consumables/reagents refrigerated on-board, enabling better use of staff resources, and random access is one-step sample loading per spec- imen as compared to the current batch systems. the dxn veris system enables each sample to be independently tested, with results reported imme- diately when the individual test is complete, eliminating the wait time associated with batch results reporting. “from an organisational point of view, it is much faster and easier,” added professor sambri. with the installation still relatively new, the italian team is working closely with beckman personnel on calibrations and controls and professor sambri has asked for a closer look at analysis of hbv sam- ples, for exam- ple. “with hiv and hcv the system is really robust and with cmv the num- ber of indeter- minate results is extremely low,” he said. “patients are also ben- efitting with results provided much sooner. before having this system in place we were reporting results with clinicians in general within three days because we were performing three runs in a week. right now, we report 97% of results within the same day of sampling.” he added that there have been no major issues reported from clini- cians within the first months of its use but the laboratory staff will be meeting with clinicians in the near future to fully evaluate the beckman system. jaime m. menendez-humara, global strategic marketing director for molecular diagnostics, beckman coulter, said: “the dxn veris sys- tem ensures the ability that labo- ratories can run any of the four available assays, any sample, at any given time. it’s the ultimate in ease of use, giving the laboratory manager or director the choice of how to best optimize their team to do the work they want, when they want.” the quiet force to optimise existing resources a one-step system for faster turnaround of hospital samples opinion: the value of point-of-care a new molecular diagnostics system is revolutionising analysis of hospital samples across an area of northern italy. some significant changes in the european hospital sector have occurred over the last 20 years. ‘the necessity to contain the explod- ing costs in particular has led to a reduction in the number of hospi- tals and hospital beds, and staffing levels have also been affected by the many cost cutting measures. this has not been without its conse- quences, as we now know,’ writes ludwig f rutten. professor vittorio sambri is associate professor of microbiology, dimes, university of bologna and head of the unit of microbiology at the greater romagna area hub laboratory. he is involved in research related to outbreaks of chikungunya fever and west nile virus in emilia romagna region in the recent years, and of new and emerging vector born infectious diseases in italy. professor sambri is vice president of the association for the study of the infections and his work has resulted in more than 180 scientific publications in international peer-reviewed journals. currently co-owner of poctmedconsult gmbh, in germany, ludwig rutten has more than 10 years’ experience in marketing point of care (poc) products. in a previous role, for example, he initiated several studies and workshops on process optimisation and poc. the dxn veris molecular diagnostics system is an automated system for routine core lab work equpment advances according to needs. pocts can increasingly be carried out beyond a centralised service provider, easing pressures on hospital or external laboratories

10 european hospital vol 25 issue 5/16 ultrasound in the beginning there was the bubble, even if no one was quite sure what they were supposed to do with it. once injected into the blood stream, it was clear to anyone conducting an ultrasound examination that these microbubbles introduced by bracco imaging under the name sonovue (sulphur hexafluoride microbubbles) absolutely and instantly highlighted blood vessels. twenty years later, microbubbles are popping up everywhere as clini- cians continually demonstrate new and innovative applications, not only for detecting and diagnosing disease, but more recently for treating it as well. tiny microbubbles in the blood have already revolutionised medi- cal imaging, yet hold a promise for going much further. in september 2016 bracco brought together in geneva scientists and clinicians from globally renown research centres for the 9th global contrast enhanced ultrasound is part of clinical routine and makes a substantial contribution towards increasing the significance of tissue and organ diagnosis with ultrasound for difficult cases. ‘ceus allows us to optimise our daily routines, to achieve the correct diagnosis fast- er and to improve solutions for unclear cases,’ explains professor dirk-andré clevert md, head of the interdisciplinary ultrasound centre at the ludwig maximilian university of munich. the emer- gence of new competitors in the market and increasing competition between providers further enhances technological innovations. ultrasound, and specifically con- trast ultrasound, is not inferior to cross-sectional imaging. particularly in cases where the result of a ct or mri scan is not clear, ultrasound often provides an important second opinion. unlike a primary radiologi- cal diagnosis contrast ultrasound does not just deliver a snapshot but an entire image or, as clevert puts it, the entire news programme, from the welcome to the weather fore- cast. ‘the advantage of ultrasound is its high temporal resolution, which really allows us to observe how the microbubbles flow over a period of several minutes. we can see the process and also observe what hap- pens afterwards, which is especially helpful in cases where the process is not quite typical.’ in his opinion, the comparison between cross-sectional imaging and ultrasound is also impaired because ct or mri scanning with contrast media is often compared to native ultrasound. comparing both technologies without contrast media would be much closer to the truth and reality. for clevert it is therefore logi- cal that ceus is now licensed in its primary field of application for liver diagnostics, and specifically to detect and characterise liver lesions, in the usa, canada and brazil, with mexico soon to follow this example. clevert has also experienced the benefits of off-label use of ceus, especially for children. the use of contrast-enhanced ultrasound in children is governed by very strict rules. an example of how helpful it can be is the case of a young girl with an aortic isthmus stenosis. the two-and-a-half-year-old had been fit- ted with an aortic stent, but suffered a partial tear of the external iliac artery when the sheath was with- drawn. after surgery, using a patch, a large haematoma developed in the abdomen which was to be punc- tured with the help of ultrasound, because the ct scan showed no bleeding. only the contrast ultra- sound image actually showed a small leak in the patch. consequently, no puncture was carried out, but immediate surgery to remove the haematoma and revise the patch. ‘although the use of contrast medium in this case was off-label,’ says clevert, ‘the medical team were within their rights to uti- lise ceus, as its use paid off for the patient 100%.’ not all problems can be solved by using ultrasound, however. as a rule, the following applies: the bet- ter an organ can be visualised with ultrasound the better the results of contrast-enhanced ultrasound will be. if visualising the liver is diffi- cult because of meteorism contrast- enhanced ultrasound also cannot rule out liver lesions. ‘the better the basic settings, the cleaner the use of ultrasound, the better the result achieved with ceus. obviously you also need a good system for this,’ he points out. ‘we can’t expect the same performance from a mid-range scanner as from a high-end system. in other words, we have to adapt our expectations to the equipment!’ clevert is pleased that samsung has now penetrated the established market for high-end equipment. most companies have decades of experience and can adapt their sys- tems to customer specifications. ‘if you want to compete in this market your system must have an edge over those offered by the competi- tion. as a new player in this market, samsung had to make large invest- ments to get to the point where a scanner is not just a ‘nice to have tool’ but diagnostically innovative. but the company is gaining ground, aided by its fast development of software and the openness towards suggestions from clinicians,’ clevert enthuses. within clinical routine, samsung’s rs80a with prestige mostly wins over in workflow. the company is at an advantage here, due to its exten- sive experience with monitors in the consumer sector. the touchscreen is of a particularly large, conveni- ent size and clearly arranged. an additional, flexible, portable touch- screen, which could be used to pre- sent the day’s caseload during meet- ings, would be beneficial, but would basically be a ‘nice to have tool.’ what is really essential for high- end equipment is good, contrast enhanced ultrasound, whilst com- pression and shear wave elastogra- phy are now also a ‘must’, and so is image fusion, and the rs80a with prestige offers all of this. ‘there are r&d symposium entitled bubble world to explore the numerous opportunities for microbubbles, not only to see-and-treat disease in the human body, but to explore and discuss future potentials for medical and non-medical applications. diagnostic imaging there is a long list of things where microbubbles have proven to add value to clinical practice, according to professor peter burns, chairman of medical biophysics at the university of toronto. one of the first, the most success- ful, and most widely used appli- cation of microbubbles is for the identification and differentiation of cancer from other vascular entities. cancerous tumours are known to create their own blood vessels, but no one had ever seen so quickly and clearly these micro networks until microbubbles illuminated them on the ultrasound screen. sonovue highlights where there is blood flow and where blood is not flowing but should be, burns explained. ischemia imaging with ultrasound in combination with bubbles can answer clinical questions such as whether myocardial function has been successfully restored after an intervention. a closely related area is imaging inflammation to identify malignancy, he said, as an emerging practice and an alternative to the current standard of care. following conventional prac- tice, he said, ‘younger people being diagnosed with this condition will receive 20 abdominal ct exams by the time they are 20 years old. ‘bubbles are the only true intra- vascular contrast agent in diagnostic medicine and magnificent amplifiers of ultrasound with a sensitivity that is capable of identifying individual bubbles,’ burns said in his presenta- tion. therapeutic applications of micro bubbles in november 2015 professor kullervo hynynen was part of a scientific team that achieved a world-first in human medicine by using micro- bubbles to open temporarily the blood-brain barrier. the technique opens a new approach for deliver- ing drugs to fight brain cancer, as well as creating a novel approach to treating neurological disorders, such as alzheimer’s disease. the chair of the image-guided therapy group at the university of toronto, hynynen worked with col- leagues at the sunnybrook health sciences centre to apply focused ultrasound beams at a point where microbubbles were circulating. the vibration of millions of bubbles under the sonic signal caused the tight network of interlocking cells to loosen enough for a limited flow to pass out of the blood vessel and into brain tissue. today, only 2% of drugs for treating a brain tumour actually reach the tumour because they are blocked by the blood-brain barrier. opening this barrier with microbub- bles allows a significantly greater dose of chemotherapy to penetrate to tumour tissue. ‘this also presents the possibility to deliver novel drugs, such as dna-loaded nanoparticles, viral vectors, or antibodies to the brain to treat a range of neurologi- cal conditions,’ he told colleagues in geneva. piercing this barrier also allows the body’s own natural defence mecha- nisms to fight disease. hynynen said researchers found, in animal studies, a partial restoration of memory after brief blood-brain barrier opening, which they believe is the result of two effects. first, the body’s own agents of the immune system were able to attack and reduce the amy- loid plaque that is characteristic of alzheimer’s disease, and second, the treatment stimulated growth of neu- rons. jessica foley, the chief scientific officer at the focused ultrasound foundation in charlottesville, virginia told scientists at the sympo- sium that the high-intensity focused ultrasound (hifu) platform for one company has already received regu- latory approval to treat the brain and that many other companies are now seeking approval. ‘there are more than 35 companies advancing hifu technology, an exponential growth after many years of this being a research tool,’ she said, add- ing that 100,000 patients have been safely treated using hifu to destroy tumours. ‘breaching the blood-brain barrier opens up a new frontier to non- invasively deliver therapies for a number of brain disorders,’ she said. ‘microbubbles loaded with a thera- peutic and activated with focused ultrasound have the potential to sonic boom with bubbles illuminating blood vessels, opening the blood-brain barrier and deliv- ering drugs. what will be the next big thing that tiny microbubbles can do? john brosky investigates ultrasound: the requirements for high-end equipment only convincing with contrast liver lesion of a neuroendocrine tumour in the b-image and with ceus in arterial and later phase bubbles now work in various explorations

iso 13485:2003 © 2014 parker laboratories, inc. ad-01-6 rev 0 what’s the difference between aquasonic® 100 and those other gels? clarity, reliability, and economy. aquasonic 100 ultrasound transmission gel the clarity that sonographers have counted on for over fifty years. www.parkerlabs.com/aquasonic-100.asp v i s i t u s a t m e d i c a 9 d 4 1 r s n a # 1 7 0 8 a100_the_difference_ad-01-6_rev_0_europeanhospital_92216.qxp_european hospital - issue 5 - 2016 9/22/16 3:20 pm page 1 12 european hospital vol 25 issue 5/16 ultrasound with clients worldwide, the 20-year- old imaging and digital radiography solutions firm medical econet pro- vides mobile radiography systems to hospitals, ambulance and mobile home care services, military clinics in conflict zones, as well as medical facilities on sea-going vessels. to that end, the firm’s radiogra- phy solutions are equipped with a ultrasound examinations are consid- ered cost-efficient, fast and effec- tive. the e-fast (extended-focused assessment with sonography for trauma) is a standardised examina- tion used in accident & emergency medicine worldwide. the procedure helps to diagnose internal bleed- ing and organ damage in severely injured patients in the resuscitation room and, in some regions, even during emergency transport to the hospital, gaining valuable time for the primary care of these patients. [awmf register no. 012/019]. ‘apart from haemorrhagic shock there are other forms of traumatic shock which are just as life-threat- ening,’ explains dr dieter von ow, assistant director of the central accident & emergency department at the cantonal hospital st. gallen. although haemorrhagic shock is common there are also non-haem- orrhagic types of shock, such as tension pneumothorax, cardiac tam- ponade or severe paraplegia with neurogenic shock. with tension pneumothorax, a valve mechanism, particularly during artificial ventilation, increases pres- sure in the pleural cavity so much that the venous return to the heart is impaired, resulting in circulatory shock. a cardiac tamponade leads to direct compression of the cardiac chamber and thus a reduction of the stroke volume. cardiac tampon- ade is relatively rare, but fatal if not diagnosed. these two types of shock are not caused by blood loss,’ von ow explains, ‘but by the aforemen- tioned, direct increases in pressure in the mediastinum or the pericardium. not rarely do the latter two types of shock also occur combined with finding shocking and potentially fatal bleeding in the lesser pelvis is not always easy because dissecting aneu- rysms are not always easy to detect retroperitoneally. severely injured patients in persistent shock, i.e. so- called ‘non-responders’ defined by unchanged blood pressure readings below 80mmhg, despite the adminis- tration of fluid, who have large blood loss in the thorax, abdomen or pelvis diagnosed via the e-fast procedure must undergo emergency surgery without delay. multiple trauma patients who need to be stabilised in the resuscitation room – the so-called ‘responders’ or ‘transient responders’ – are imme- diately given a polytrauma ct scan and, depending on the results of this scan, the further (surgical) strategy is then determined,’ von owe explains. [klinikarzt 2012; 41 (1): 26-30] this point-of-care ultrasound is handled in a very similar way in many trauma centres and is always carried out at the beginning of treat- ment. it is conducted by specialists in emergency medicine, traumatolo- gists, anaesthetists or radiologists in the resuscitation room, requires six sectional planes to ensure a safe diagnosis and takes only a few minutes. it answers a small number of spe- cific questions: is it a tension pneu- mothorax? a cardiac tamponade? is there fluid – i.e. blood – in one of the three large cavities, i.e. the tho- rax, abdomen or pelvis? (the ability to differentiate between these types of shock requires conducting 50-100 such bedside examinations under supervision). the results of the examination either lead to life-saving interven- tion in the resuscitation room, or they support the life-saving triage decision ‘emergency surgery or poly- trauma ct’. in other words, ‘e-fast can save lives,’ von ow is convinced. current data from large trauma registers con- firm this statement. when multi- ple trauma patients are given a ct scan without being assessed via this system beforehand, this does not improve their chances of survival [the lancet 2016; 388: 673-83] the parenchymal organs, the liver, spleen and kidneys can also be assessed via contrast medium ultra- blood loss, which leads to severe impairment of the patient’s circula- tion and requires fast treatment.’ each patient with potential mul- tiple injuries or uncertain injuries admitted to the central accident and emergency department at the cantonal hospital st. gallen is exam- ined with the e-fast procedure. ‘this involves assessing the thoracic cavity, or the pleural cavity respec- tively, in so-called sectional planes, ventrally and from the side towards the armpits. this provides clues as to the potential presence of tension pneumothorax or haemothorax. the subcostal plane makes it possible to diagnose a cardiac tamponade. a ten- sion pneumothorax, a massive hae- mothorax or a cardiac tamponade require immediate release of air, or blood respectively, by the insertion of the appropriate drainage in the resuscitation room.’ responses to responders and non-responders the peritoneal cavity is also exam- ined for the presence of free fluid via sectional planes from the sides, toward the abdomen and in planes directed towards the lesser pelvis. unique hybrid-powered technology. the firm describes its mobile x-ray system pox-100bt as ‘an ideologi- cal designed foldable device, which allows the user to work completely without any cables and without dependence to electricity due to its integrated high-performance lithium-ion battery. with one full charge it is possible to make up to 1,000 images, which allows a mobile digital x-ray units for hospitals an wireless radiogra the move with clients worldwide, the 20-year-old imaging and digital radiography solutions firm medical econet provides mobile radiography systems to hospitals, ambulance and mobile home care services, military clinics in conflict zones, as well as medical facilities on sea-going vessels. ultrasound can reveal different types of shock in trauma resuscitation: e-fast or ct? tension-/pneumothorax: (lack of lung sliding in the moving image), lack of comet tail artefacts and distinct reverberations (‘lines’) pericardial effusion: fluid (blood, hypoechoic) between the pericardial sac and the heart suggested compression of the right ventricle (tamponade) normal findings: (lung sliding, moving image), comet tail artefacts (on the left in the image) haematoperitoneum: fluid (blood, hypoechoic) between kidney and liver, i.e. in the morison’s pouch (massive) haemothorax: fluid (blood, hypo­ echoic) between diaphragm and thoracic wall, with an atelectatic lung section (‘half moon’) ‘swimming’ inside haematoperitoneum: fluid (blood, hypo­ echoic) in the lesser pelvis, with the uterus and full bladder, separated by the bladder wall (on the right in image) ‘swimming’ inside a100_the_difference_ad-01-6_rev_0_europeanhospital_92216.qxp_european hospital - issue 5 - 20169/22/163:20 pm page 1

ϭϭ ϲθ ϭ ϭ ϵϳ ϰϯ 14 european hospital vol 25 issue 5/16 radiology on the left, 19f mri lung shots of a healthy person with normal regional breathing and on the right a copd patients with significantly impaired breathing asked whether the computerised assessment of pulmonary nod- ules is on the way, kaucsor con- firmed: ‘colleagues from oxford and groningen and our team are indeed working on using computer algo- rithms based on ct images to detect and characterise pulmonary nod- ules. we submitted the proposal for eu funding and received a favour- able response. ‘thus, we expect the project, to be known as ‘lucinda’, to start next year. it aims to develop a method for intelligent lung cancer diagnosis. ‘the task at hand is to validate the performance of an algorithm, which was initiated by a team at oxford university hospital headed by fergus gleeson and then further developed by optellum, a spin-off company. preliminary tests and pub- lications are promising. ‘the idea is to use big data and machine learning. we’ll have to assess whether the programme also works with images from different sources, such as different scanners, and with different slice thicknesses usually, a general practitioner diagno- ses pulmonary hypertension, rather than a hospital-based specialist. the patient is referred to a pneumologist who charts the further course of action, which might include a surgi- cal intervention or balloon pulmo- nary angioplasty (bap). imaging is a pillar of the diagnostic work-up, but ct has turned out to be inadequate to detect so-called web stenosis in the pulmonary vessels. this is where mri comes in, which today offers local lung function assess- ment supplementing ct. a milestone in pulmonary research ‘we are still charting unknown ter- ritory,’ wacker concedes, ‘but the research results are promising.’ he and his team, headed by professor jens vogel-claussen at the institute of diagnostic and interventional radiology, are exploring potential uses of mri in lung function diag- nostics. ‘mri diagnostics now offers a method to not only assess tissue change and morphology but also the function of different lung sec- tions and to quantify blood flow,’ wacker explains. ‘beyond knowing how much blood is passing through which lung section we need to assess ventilation and gas exchange.’ the fact that gas exchange can be measured in mri is nothing short of a revolution in lung function diagnostics. ‘we use hyperpolarised xenon to visualise the gas exchange,’ he explains. in a first step the xenon has to be processed in a polariser for the mri scanner to achieve high snr. the hanover medical school works closely with the fraunhofer institute item in hanover to show the path of the gas and the speed of diffusion from the alvioli into the blood circulation. ‘basically we use two gases: fluo- rine shows the distribution of tidal air. however, this gas does not pen- etrate the alveoli – which can be an advantage as well as a drawback,’ wacker points out. the gas stays in the lungs rather than being absorbed by the body, which allows precise steady state assessment. ‘in mri, fluorine can be selectively stimulated. but, to examine the passage across a mem- brane we need xenon since, unlike fluorine, it does not remain in the alveoli but enters the blood stream through the membrane and can be measured in the mri scanner,’ wacker says of this milestone in pulmonary research. benchmarking nevertheless, much research remains to be done in order to define ‘normal’ values. ‘obviously, we are progressing systematically,’ he emphasises. ‘we look at study participants, copd patients and others and, based on known pathol- ogies, we try to establish what a “typical” mr image is supposed to look like.’ hanover offers an excellent envi- ronment for intensive and meticu- lous research. ‘we are lucky to have on board professor tobias welte, an internationally renowned pneumol- ogist, and professor marius hoeper, a specialist on lung hypertension. moreover, we have access to the largest lung transplantation pro- gramme, which was established by professor axel haverich. moreover, the teams in pneumology, httg surgery and radiology are doing world-class research,’ he adds. not to forget the team at the previously mentioned item, which also focuses on pulmonary research. all lung specialists in hanover are part of the research network ‘biomedical research in endstage and obstructive lung disease, hanover (breath)’, one of the five sites of the german centre for lung and different reconstruction algo- rithms. we will contribute a set of ct images of the lung with a validated diagnosis of pulmonary nodules. the images were acquired in our heidelberg lung cancer screening cohort lusi and in clinical routine at the thorax clinic of heidelberg university hospital. the colleagues from groningen will draw on the nelson cohort, a dutch-belgian lung cancer screening cohort. ‘we aim to collect 2,000 data sets. we hope, when reading the 2001st data set, the algorithm will tell with 90 percent specificity whether the tumour is malignant or benign.’ could a computer alone come p with a diagnosis? ‘the computer will facilitate our work – and that reflects the fact that there are fewer and fewer experts in this highly specialised area. as radi- ologists, we want the machine to do the groundwork but we’ll remain the ones to make the final decision. ‘if the radiologist turns into a mere report generator, the discipline will lose its charm and the profes- sion will lose its attraction. nobody wants to be in a profession where the mark of distinction is the abil- ity to read 1,000 images or more a day. to diagnose more patients with more images in less time – that is not going to improve quality. ‘machine learning is a promising option for the radiologist to get help with the basics. but in the end the machine cannot evaluate the results it generates. the role of the radiolo- gist will move towards placing the results in a context, evaluating and communicating them. ‘for example, an algorithm that can reliably assess a pulmonary nodule can be used very well for screening purposes. the primary aim is to find out whether we are dealing with a malignant tumour or whether the lesion might become malignant. if a lesion is found to be malignant it is the task of the radi- ologist to refer the patient for fur- ther diagnostic work-up and therapy algorithms based on ct images to detec research: measuring gas exchange in mri ‘dr computer’ may aid intelligent lu a revolution in lung function diagn in imaging diagnostics computers are taking over – well, not quite, but they might soon play an important role, according to professor hans-ulrich kauczor, medical director of the clinic of diagnostic and interventional radiology at university hospital heidelberg. meeting with european hospital, he discussed an eu-funded project to assess malignancy in pulmonary nodules and its implications for the radiologist’s profession. since lung diseases tend to be complex, imaging is a crucial diagnostic tool. while computed tomography has become the standard modality, which is frequently used outside hospital settings, specialised mri diagnostics remains the preserve of large university medical centres. until recently, lung mri was consid- ered a difficult procedure. now, new methods enable lung function measuring, particularly gas exchange, in the mr scanner. with his team, professor frank wacker, director of the institute of diagnostic and interventional radiology at the medical school hanover, focuses on this research. marcel rasch reports. ©marcel gutberlet, jens vogel-claussen © agilo kern, jens vogel-claussen normal case with xenon pulmonary nodule malignancy scores predicted by a research prototype of the system. the images show axial slices of a chest ct volume (5cm x 5cm screenshot centered on the nodule of interest). research (dzl). wacker calls it ‘an ideal set-up which offers perfect synergies’. japanese researchers are pioneer- ing treatment approaches, particu- larly for chronic thromboembolic pulmonary hypertension (cteph), triggered inter alia by the fact that japanese physicians, for cultural reasons, tend to avoid open thoracic surgery and prefer balloon pulmo- nary angioplasty. ‘this method is an option for many patients who are considered non-operable,’ wacler pomts out. ‘initial results at the hanover medical school are rather promising.’ while stenoses are usually cal- cifications in the large arteries of the pelvis or the thigh, cteph is characterised by web-like mem- branes in the pulmonary arteries. both, the working group headed by professor meyer in radiology, and the one headed by professor

16 european hospital vol 25 issue 5/16 radiology source: siemens healthineers, mr image data supplied by max planck institute, leizpig, germany john brosky reports cloud-based mining of medical imag- es will transform clinical radiology the same way that online access to genetic data has transformed clinical biology, according to frederik brag, the ceo of median technologies. microsoft corporation believes he is right and this summer created a joint initiative with median to inte- grate its ibiopsy software into that company’s azure cloud platform to provide clinicians with capabilities for analysing medical images for can- cer diagnosis and treatment. ‘using big data analytics we can now do what we call decoding imag- es, breaking them down to identify unique signatures or fingerprints that correspond to a specific kind of can- cer,’ brag told european hospital. ‘it’s like performing an imaging biop- sy and this is especially powerful. a regular biopsy gives you partial information at best about a piece of tissue to be analysed. ‘we can look at the whole image of an organ and any tumours. we can sequence the image, decode it and correlate our results to a biopsy report.’ since 2002, median has stead- ily improved its software algorithms for detecting, identifying and track- ing changes in tumours. over the past three years the company has emerged from its headquarters in sophia-antipolic, france, to become a leading provider of automated image analytics for pharmaceutical companies conducting clinical trials. medical imaging is the established standard of care in oncology and is used to determine if a new drug is having any impact on a patient. during the course of a clinical trial, a single patient will undergo up to eight imaging examinations to deter- mine whether a lesion is stable, if it is continuing to grow, or if it is get- ting smaller. he estimates imaging represents almost 15 percent of oncology clini- cal trial budgets, with each drug company spending up to €50 million per year for imaging interpretation and analysis, creating a global mar- ket valued at €1 billion annually. previously, a dedicated team of radiologists would gather the mas- sive batch of images for each clinical trial and would manually read, inter- pret and report on the outcomes. ‘they are selling radiology services at a premium to the drug companies,’ said brag. ‘these central lab teams do not have the capacity for under- standing exactly the type of tumour they are looking at, they are not equipped to do quantitative imaging and in 40 percent of the cases two radiologists will report two different assessments of how the same patient is responding to treatment. ‘we use software to standardise the interpretation and make results reproducible, automatically detecting cancer lesions and measuring them in 3-d to get the full volume of a specific tumour and extract much more meaningful information that gives a pharma group a much bet- ter understanding of how a patient is responding to treatment,’ he said. today, there is a new breed of technology moving into this space, driven by companies like microsoft, as well as google, amazon and ibm. ‘it’s a combination of capabilities coming from different fields that are dramatically changing the landscape. ‘there are faster processors today. we do billions of computations on one image and we can now index the data in a totally different way. just two years ago it took us two weeks to do the analysis on just one patient. today, we can do it in less than one minute. this means the analytics can be applied in a much wider space,’ brag pointed out. bernard ourghanlian, chief technology officer with microsoft said, ‘by taking advantage of the microsoft azure cloud platform, ibiopsy will provide faster imag- ing and health data analysis and will accelerate the discovery and delivery of new biomarkers for cancer diag- nosis and treatment monitoring.’ by identifying the unique visual characteristics of tumours, ibiopsy is progressively extracting biomarkers of disease from medical images. ‘this is at the core of the microsoft-median technologies precision medicine project,’ brag confirmed. ‘big data computing and analyt- ics will allow efficient processing and analysis of imaging biomarkers, which is essential for early detection of cancer and monitoring of new targeted cancer treatments. our col- laboration with microsoft will allow us to deliver these solutions into routine clinical practice on a global scale on the azure cloud computing platform.’ the billions of medical images taken and diagnoses made every year across the globe are as varied in quality, detail and structure as the situations in which they are obtained. contrary to popular belief the huge majority of medical data is available only in unstructured form which consider- ably impairs efficiency in the health- care system. peter aulbach, siemens healthineers’ business manager for ct in germany, explains how these data – if they were analysed systemat- ically – could provide clinical insights and help improve patient care. many research projects worldwide focus on machine learning: soft- ware that is able to automatically answer clinical questions such as the assessment of medical images. how will such algorithms impact the healthcare system? that is a very exciting field of research which will dramatically alter the healthcare landscape. as a com- pany we are observing a few trends that are most likely here to stay, such as automation, you mentioned it, or the increasing role of artificial intel- ligence – ai – in healthcare. all these topics aim to generate many and above all comparable, respectively reproducible data. in which areas will artifi- cial intelligence play a role? ai is primarily important in decision support sys- tems. we talk about arti- ficial intelligence when an algorithm or a soft- ware programme can learn and suggest a diagnosis or even a therapy based on evidence. the more the sys- tem learns the better it will be in the future and the fewer user interactions are required. that is a prospect many people find scary. maybe. one thing, though, is cer- tain: we cannot work without com- puters anymore! computers are far superior to human beings when it comes to rational intelligence and they do make better decisions. that’s a fact. ideally, we manage to align the machine‘s rational intelligence with the emotional skills that characterize us as human beings. the population is ageing and we need more and more trained people who are able to diagnose, interpret and treat. but the number of these people does not increase exponentially; quite on the contrary, the number of experts is decreasing, widening the gap in our system. that also holds true for radiologists who are inundated with slice images and are having an increasingly hard time catching up. with dna sequencing, functional mri and ci imaging and many other digital developments, the data floods will continue to rise. this is where radiology is facing another problem: we still lack stand- ardisation and structured storing of image and diagnostic data. amassing data won’t help if these data are not structured. huge unstructured data pools are useless. today, most of the data obtained gather dust so to speak in the modalities; only 2 percent are archived for later use. what would a solution look like? we consider so-called dicom struc- tured reports to be key. these reports are the wheel-barrows with which data are carried from the modal- ity to a big data form. widely used structured reporting will ensure that quantified data are transferred automatically from the imaging modalities to the pacs – and thus are converted into a big data-usable form. in the usa, for example, by law every tv show has to be transformed into text. the texts can be analysed using algorithms. thus you can find out how often the words clinton or trump or any other word were used in a certain period of time. that’s a quintessential big data application. in our field, however, things are much more complicated. while we do have many video and image data, they are of little value since they are not categorised. the structured report is the key to this treasure trove. templates will allow us to make huge steps forward, since tem- plates are configurable, but even more importantly – if dicom and hl7 can agree on a single standard – they will contain the acquired image data as well as the aha and acc guidelines and transfer these tem- plates to the pacs. you aim to automate sequences, protocols and post-processing. won’t that make the radiologist obsolete? no, we don’t want to make the radi- ologist obsolete. quite on the con- microsoft lifts french software into cloud computing to teach machines how to read tumour ‘fingerprints’ turning a ct scan into a virtual biopsy automation helps radiologists monitoring changes to a pulmonary lesion measured by recist (response evaluation criteria in solid tumours) criteria using the lesion management solution from median technologies

european hospital vol 25 issue 5/16 european hospital vol 25 issue 5/16 more than just mri accessories www.allmri.com radiology it’s like acquiring a porsche but only able to use 1st gear a small x-ray system on large all-terrain wheels 50 shades of grey in hybrid imaging the go anywhere medical a fusion imaging will create a mul- ti-modality monster for radiology groups that already struggle to deal with data from dual-modal- ity hybrid systems, john brosky reports hybrid imaging is growing so big it is gaining a new name: multi- parametric imaging. you might see it as converging streams of digital data from genomics, metabolomics and proteomics. or on a bad day it may seem more like the multiple heads of a hydra rising up to gobble every gigabyte of patient data they can grasp. but that comes later. because thomas beyer is a professor of physics of medical imaging at the medical university vienna, he likes to take a step back for a run- ning start before leaping into the future. as the deputy head of the centre for medical physics and biomedical engineering at the medical university, beyer presented an overview of the growth of hybrid imaging at a well-attended course for the european school of radiology. in the beginning there was hard- raphy (ct) to ultrasound (us) and magnetic resonance imaging (mri). the origin of many of these modali- ties was around the 1950’s, with the developmental approaches being mainly independent. the combina- tion of anatomical and functional imaging was first attempted when clinicians, as early as the 1960s, used a pen to mark body contours around scintigrams, or else adjusting over- lays of printouts on light tables to co-register images from the nuclear medicine and radiology examina- developed entirely by the rostock firm oehm und rehbein (or) tech- nology, the fully digital amadeo m mini x-ray system incorporates a sophisticated design that reduces components to the most essential, functional operating elements. the device is therefore particularly suit- able for portable use and can easily be transported due to its low weight (approximately 68 kg) and com- pact build, the manufacturer points out. ‘the new system is attractive wherever it’s not possible to move patients to a hospital for diagnostic radiology. areas of application are first aid services, home care, nurs- ing homes, medically oriented aid organisations, military purposes and for ships or oil rigs.’ additionally, the lightweight sys- tem can be pulled easily over steps and obstacles and swivelled in all directions – a huge advantage in con- fined spaces and elevators, the firm adds. ‘the x-ray system is stable and does not tip over on uneven terrain. its large, all-terrain wheels permit effortless movement. the amadeo m mini includes all necessary compo- nents of a functional system: x-ray detector, x-ray generator and image processing workstation. the latter is delivered with a globally prov- en software package dicompacs dx-r, which includes a convenient x-ray positioning guide for fine adjustment (except the ax-version).’ oehm und rehbein gmbh (also known as or technology) will be demonstrating the firm’s products at medica 2016, in dusseldorf, germany. 14–17 november. booth e35. hall 10. details: www.or-technology.com. tions. the fusion of images, using software that is familiar to us today, really took off in the 1990s with the digital availability of images and increase in computing power. beyer explains that the problem with both software and manual fusion is that they only work for lim- ited axial ranges that largely exclude image co-registration between the two modalities being used. for this reason, hardware fusion has emerged, where two imaging modali- ties are physically combined within one gantry so that two co-registered exams can be taken as a single examination protocol. the three clinically relevant hybrid imaging examinations combining dual modalities are spect/ct, pet/ ct, and pet/mri. while pet/ct and spect/ct came out about the same time, commercially available around 2000 and 2001, spect/ct has not enjoyed the same level of adoption, he said, estimating that for every spect/ct system installed around the world there are five pet/ ct systems. pet/mr was introduced in 2006 and commercially available in 2011, he said; yet there are barely 120 systems installed worldwide to date. ‘it remains hotly debated whether pet/mr is a clinical or a research machine because there is not yet any data supporting a clinical application with a proven clinical benefit,’ said beyer. ‘clinical pet/mr is a bit like the ipad, something everyone wants, that no one needs, but once you have it you are actually quite happy using it.’ like a late child in the family, pet/ mr is challenged by the prior exist- ence of pet/ct. johannes czernin, who leads the nuclear medicine group at the university of california los angeles, once said pet/ct is a technological evolution that led to a medical revolution. beyer finds that pet/mr is something like a medi- cal evolution based on a technical revolution. a further evolution to multi-par- ametric imaging seems inevitable, where swelling databases of digital images and ever-faster computer pro- cessing will combine other imaging modalities, biopsy data, patient pre- dispositions from genetic informa- tion and biologic data. ‘this rises to the level of big data, where some companies, like microsoft and google, are already thinking about how they can put all of this together,’ he noted. his concern about the rush to multi-parametric diagnosis is that clinicians are still struggling with the flood of information from dual- modality platforms. ‘we will need to multi-parametric imaging of tumour biology ware, said beyer, a wide range of imaging modalities from x-ray, scintigraphy, to computed tomog- 18

european hospital vol 25 issue 5/16 oncology editor-in-chief: brenda marsh art director: olaf skrober managing editor: sylvia schulz editorial team: sascha keutel, marcel rasch senior writer: john brosky executive director: daniela zimmermann founded by heinz-jürgen witzke correspondents austria: walter depner, michael kraßnitzer, christian pruszinsky. china: nat whitney france: annick chapoy, jane macdougall.germany: anja behringer, annette bus, bettina döbereiner, matthias simon, axel viola, cornelia wels-maug, holger zorn. great britain: brenda marsh, mark nicholls. malta: moira mizzi. poland: pjotr szoblik. russia: olga ostrovskaya, alla astachova. spain: mélisande rouger, eduardo de la sota. switzerland: dr. andré weissen. usa: cynthia e. keen, i.t. communications, nat whitney. subscriptions janka hoppe, european hospital, theodor-althoff-str. 45, 45133 essen, germany subscription rate 6 issues: 42 euro, single copy: 7 euro. send order and cheque to: european hospital subscription dept printed by: wvd, mörfelden-walldorf, germany publication frequency: bi-monthly european hospital issn 0942-9085 representatives china & hongkong: gavin hua, sun china media co, ltd. phone: +86-0755-81 324 036 e-mail: gh@european-hospital.com germany, austria, switzerland: ralf mateblowski phone: +49 6735 912 993, e-mail: rm@european-hospital.com france, italy, spain: eric jund phone: +33 493 58 77 43, e-mail: ej@european-hospital.com gb, scandinavia, benelux: simon kramer phone/fax: +31 180 6200 20 e-mail: sk@european-hospital.com israel: hannah wizer, international media dep. of el-ron adv. & pr co., ltd., phone: +972-3-6 955 367 e-mail: hw@european-hospital.com south korea: ch park, mci phone: +82 2 730 1234, e-mail: chp@european-hospital.com usa & canada: hanna politis, media international tel: +1 301 869 66 10, e-mail: hp@european-hospital.com all company, brand and product names in this publication are the property of their respective holders. extending intra-operative radiotherapy to breast treatments vienna: the 13th forum on hospital management in vienna dutch centre of excellence a dedicated device cost cutting cancer drugs patients with locally advanced rectal cancer have been treated with intra- operative radiotherapy (iort) for over twenty years. partly due to this type of radiation, survival rates in a group of patients considered to have inoperable cancer changed dramati- cally from five to 70 percent. the top clinical and referral cen- tre catharina hospital in eindhoven is one of two hospitals in the netherlands where patients with rec- tal or breast cancer can be treated with iort. recently, the hospital installed a mobetron – the first mobile, self-shielded, electron linear accelerator to deliver iort to cancer patients during surgery. the manufacturer notes that the device brings safe, reliable radiation to the operating theatre without the need for costly shielding renovations or retrofits. self-developed adaptation ‘in our breast centre we used all possible methods of treatment, except iort,’ explained breast can- cer surgeon yvonne van riet, at the catherina cancer institute. ‘we were interested in this technique, but it’s not a toy and should be safe. we started to use it in 2012 because of the outcomes of the first randomised study on iort use on breast cancer patients, by professor umberto veronesi at the italian cancer institute in milan.’ the breast cancer treatment is focused on irradiating the area where the tumour tissue (radical) has been removed and to do this report: michael krassnitzer how to cut the high cost of can- cer drugs engendered high interest at the recent forum on hospital management held in vienna. ‘when it comes to cancer drugs, we have a daily dilemma with effectiveness and financial viability,’ laments professor gabriela kornek, medical director at vienna’s general hospital (akh). whilst there have been huge advanc- es in cancer treatment over recent years, the price of cancer drugs has risen just as much as the number of cancer patients. more and more people affected are aged above 50 years – the age where the probability of developing cancer increases significantly. the survival time after a cancer diagno- sis has risen considerably. in austria, for example, 60% of cancer patients survive for more than five years. patients only used to receive treat- ment for six months, but nowadays cancer treatment can last for a year or, if the tumour is inoperable, for life. this means an increasing num- ber of people receive cancer drugs. at the same time, costs have exploded. nowadays, drugs for colon cancer treatment cost €122,000 for 22 months, whereas a few years ago this was just €600 for 12 months. ‘the cost of treatment has risen by two hundred-fold,’ kornek empha- sises. in 1985 a melanoma diagnosis was more or less a death sentence. today, up to 22% of patients can actually be cured. however, the combination of drugs required to achieve this amounts to €125,000 over two years. ‘the cost of the lead- ing 58 drugs per year of life gained was €54,000 in 1995; in 2013 it was €207,000,’ kornek points out. at vienna’s akh, 43 percent of all the money spent on drugs is allocated to cancer drugs. how might this expenditure be cut? at the forum, kornek listed a number of possibilities – including the inclusion of patients in clinical studies. by including 18 patients at the in the akh novo-study, which examined the effects of nivolumab on lung cancer patients, melanoma patients and those with renal cell carcinoma, the hospital could save €2.8 million in 2013/14. hospitals can also cut costs for effective but very expensive drugs by negotiating with drug manufac- turers. the so-called capping model, where the cost of drugs per patient is capped, is one example. the annual dose of bevacizumab for a colon cancer patient weighing 70kg is 9,100 milligram per year; for other types of tumours the dose required for patients of the same weight is twice as high. due to pressure from customers, the drugs manufacturer is now offering bevacizumab ‘free of charge’ for amounts from 10,000 milligrams per year, i.e. costs are capped at around €55,000. another cost saving route is the ‘pay for performance’ model. one feature of modern cancer drugs is that, dependent on the tumour genome; they are effective for cer- tain patients but not others. the manufacturer of bortezomib, licensed to treat multiple myeloma, has negotiated the following deal with the national health service: the nhs initially pays for four treat- ment cycles. if the patient responds to treatment the nhs will bear the cost of further treatment; however, if the patient does not respond the manufacturer will refund the cost of the first four cycles. oncologists have also thought of a decision aide for the use of expensive cancer drugs: the magnitude of clinical benefit scale of the european society for medical oncology (esmo) assesses the actu- al clinical benefit of tumour treat- ments. this includes, for instance, the stipulation that a cure has pri- ority over delay and death, or that direct endpoints (overall survival, quality of life) have priority over surrogate parameters (progression- free survival, response rate). ‘after approval of a new drug, the esmo committee evaluates it. drugs with the highest classification are includ- ed in the esmo guidelines,’ kornek explains. ‘they receive full sup- port for absorption of costs in the european committees.’ to the least possible surrounding healthy tissue. in italy and in other centres, they stick the tissue together to determine the irradiation site. we realised that there could be a more accurate way, so, with our radio- therapy department, we developed a screen plate that we place in the breast muscle after tumour removal. this protects the underlying ribs, lungs, and also the left side of the heart from the applied radiation. then the mammary gland tissue to be irradiated is stuck together; the irradiation tube is positioned and coupled with the irradiation unit. in this way you can determine very precisely where you need to irradi- ate without affecting the surround- ing tissue.’ new device choice the old linear accelerator used for iort needed replacement. ‘the mobetron meets all our require- ments. it is user-friendly and safer because there is less radiation leak- age into the environment. it’s not only an investment in equipment, but also in the possibility to con- tinue the treatment and help even more women,’ said radiation oncolo- gist jeltsje cnossen, explaining the institute’s choice. ‘for iort you need specially equipped operating rooms with extra thick walls,’ van riet added. ‘and, very important: you need a team of experienced specialists, sur- geons and radiation oncologists who seamlessly respond to each other.’ therefore iort cannot be applied in every hospital. currently, in the netherlands, it is provided in only the catharina cancer institute and the medical centre haaglanden, in the hague. less harmful than regular radiation iort is meant for women of 60 years and older with diagnosed breast cancer and a tumour no more than 2 centimetres in size. in addi- tion, it should be sensitive to female hormones and there should be no malignant cells detected in the senti- nel lymph node. ‘the treatment lasts one and a half hours,’ van riet said. ‘after the tumour removal by surgeons the area is treated only once with a higher dose of radiation than in external radiation. the patient is discharged from hospital the same viennese native professor gabriela kornek md is medical director at vienna general hospital (akh), one of europe’s largest hospitals. a specialist in haemato-oncology, she is also deputy head of the department for oncology at the university clinic for internal medicine i at the akh, and also programme director for ear, nose and throat tumours and head of the cancer school at the vienna’s comprehensive cancer centre. the professor has published 164 scientific articles in peer-reviewed journals, along with a specialist book plus further book contributions. she is also a member of numerous scientific associations. © gabriela kornek 20 phone: +86-0755-81324036 phone: +496735912993, e-mail: rm@european-hospital.com phone: +33493587743, e-mail: ej@european-hospital.com phone/fax: +31180620020 & pr co., ltd., phone: +972-3-6955367 phone: +8227301234, e-mail: chp@european-hospital.com tel: +13018696610, e-mail: hp@european-hospital.com

european hospital vol 25 issue 5/16 study reveals therapy-induced osteoporosis can drop by 50% vienna peaks in breast cancer research report: michael krassnitzer ‘today vienna is one of the top addresses with regard to breast cancer research,’ professor michael gnant proudly reports – and he certainly knows what he is talking about. the surgeon is director of the university clinic for surgery at the vienna’s medical university, deputy director of the university‘s comprehensive cancer centre (ccc) and president of abcsg, the austrian breast & colorectal cancer study group. during the past few months, all three institutions pub- lished stunning research results in the lancet. abcsg-18 demonstrates that, in patients with early hormone- receptor positive breast cancer, the administration of the human monoclonal antibody denosumab, along with the standard endocrine therapy, can reduce by 50 percent therapy-induced osteoporosis, a long-term side effect. subcutaneous administration of 60 mg denosum- ab, twice a year, basically halves the risk of fractures without side effects. moreover, the study results show that bone density in the spine increased by ten percent, in the hip by eight percent and in the femural neck by six percent. ‘these results are truly path- breaking and will certainly lead to changes in the current therapy regime,’ professor gnant under- lines. ‘two injections per year may spare many women severe suffer- report: mark nicholls uk-based researchers believe per- sonalised treatment for breast can- cer is within sight after uncovering what they say is the most detailed picture to date of which genetic var- iations contribute to development of the disease. with colleagues, study lead- er dr serena nik-zainal, at the wellcome trust sanger institute near cambridge, identified a num- ber of new genes that, when mutat- ed, drive the development of breast cancer tumours. in what is the largest-ever study to sequence the whole genomes of breast cancers, the team has uncov- ered five new genes associated with the disease and 13 new mutational signatures that influence tumour development. the team’s work (published in two papers in nature and nature communications) also reveals what genetic variations exist in breast cancers and where they occur in the genome. the research – an international collaboration which included breast cancer patients from the usa, europe and asia – involved analysis of 560 breast cancer genomes – 556 from women and four from men. dr nik-zainal’s team hunted for mutations that encourage cancers to grow and looked for mutational signatures in each patient’s tumour. they found that women who carry mutations in the brca1 or brca2 gene indicating an increased risk of developing breast and ovarian cancer, had whole cancer genome profiles that were highly distinctive from each other and were also very different to other breast cancers. she believes that this discovery could be used to classify patients more accurately for treatment. ‘in the future, we’d like to be able to profile individual cancer genomes so that we can identify the treat- ment most likely to be successful for a woman or man diagnosed with breast cancer,’ nik-zainal added. ‘it’s a step closer to personalised health- care for cancer.’ researchers, recognising that unpicking the genetic variations between cancers is crucial to devel- oping improved therapies, say the results reveal more about the causes of breast tumours and provide evi- dence that breast cancer genomes are highly individual. exactly where mutations occur in breast cancer genomes is also important. dr ewan birney from the european bioinformatics institute collaborated in the research and used com- putational techniques to analyse the sequence of genetic information held in each of the sample genomes. ‘we know genetic changes and their position in the cancer genome influ- ence how a person responds to a cancer therapy,’ he said. ‘for years we have been trying to figure out if parts of dna that don’t code for anything specific have a role in driv- ing cancer development. ‘this study gave us both the first large-scale view of the rest of the genome, uncovering some new rea- sons why breast cancer arises, and gave us an unexpected way to char- acterise the types of mutations that happen in certain breast cancers.’ the wellcome trust sanger institute is one of the world’s lead- ing genome centres, while the european bioinformatics institute is part of the european molecular biology laboratory (embl) and is a global leader in the storage, analy- sis and dissemination of large bio- logical datasets. it is located on the wellcome genome campus in hinxton, cambridge. professor sir mike stratton, director of the wellcome trust sanger institute, said the study takes scientists ‘much closer to a complete description of the changes in dna in breast cancer and thus to a com- prehensive understanding of the causes of the disease and the oppor- tunities for new treatments.’ ing.’ today, aromatase inhibitors are the treatment of choice for hormone receptor-positive breast cancer; they suppress the body’s natural oestro- gen production and thus negatively impact on bone metabolism. two further studies showed that adjuvant anti-hormone therapy as well as bisphosphonate therapy could reduce the recurrence rate and mortality of postmenopausal patients with hormone-dependent breast cancer. the first of these meta-analyses compared the efficacy of adjuvant aromatase inhibitors and tamoxifen. aromatase inhibitors are adminis- tered to suppress the production of oestrogen, which promotes tumour cell growth in hormone-depend- ent breast cancer, while tamoxifen blocks the oestrogen receptors on the surface of cancer cells which prompt these cells to grow. results: post tumour surgery aro- matase inhibitor therapy is superior to tamoxifen therapy. compared to tamoxifen alone, aromatase inhibi- tor therapy reduces the risk of recurrence by one third. moreover, figures indicate that a five-year aro- matase inhibitor therapy reduces mortality by 15 percent compared to tamoxifen therapy. bisphosphonates are being used to counteract the osteoporosis risk associated with anti-hormone treat- ment of breast cancer. the sec- ond meta-analysis co-conducted at ccc vienna confirmed the efficacy of bisphosphonates over a period of two to five years post-surgery in postmenopausal breast cancer patients since the occurrence of bone metastases was reduced by 28 percent and breast cancer mor- tality was reduced by 18 percent. in pre-menopausal breast cancer patients no positive effect could be identified. ‘these two meta-analyses will also redefine the standard treatment of breast cancer. in addition, they prove that, with our knowledge and our performance, we are at the forefront of international cancer research,’ professor gnant happily concludes. the top performance does not go unrecognised: abcsg will play a crucial role in the new pallas study, which seeks a new strategy for follow-up treatment of female as well as male breast cancer patients. worldwide around 4,600 breast cancer patients at 500 centres are expected to participate in the study and abcsg will coordinate the international – i.e. non-us – part of the study with 2,300 patients. professor gnant is understandably pleased: ‘for a small country, such as austria, that’s quite remarkable.’ the study looks at patients diagnosed with a stage ii or iii hormone-dependent breast cancer without her2 characteristics. after the standard initial therapy (sur- gery, radiation and chemo therapy) they receive the usual anti-hormone therapy over a period of two years to block metastases or an additional agent: palbociclib. this substance has been success- fully used in he treatment of patients with breast carcinoma metastases (stage iv). professor michael gnant directs the university clinic for surgery at vienna’s medical university and is deputy director of the university‘s comprehensive cancer centre (ccc). the vienna-born researcher also presides over abcsg, the austrian breast & colorectal cancer study group. additionally, he is visiting professor at the mayo clinic in rochester, usa, and a board member of several national and international professional societies. his research focus is surgical oncology, particularly breast, colorectal and pancreatic. the professor is also interested in antibody immunotherapy, endocrine intervention, tumour dormancy, therapies targeting bones in order to halt tumour micro-metastases and therapies targeting pathways such as mtor or cdk 4/6 inhibitors. serena nik-zainal md is a career development fellow (cdf) group leader in the cancer genome project at the sanger institute in cambridge and an honorary consultant in clinical genetics at nearby addenbrookes hospital. having qualified in medicine from the university of cambridge in 2000, trained as a physician and subsequently specialised in clinical genetics, she undertook a phd at the wellcome trust sanger institute in 2009 and her research focuses on pursuing biological understanding of the mutational signatures that have been identified in primary human cancers. dr ewan birney is director of embl-ebi (the european bioinformatics institute, which is part of the european molecular biology laboratory). his main research areas include functional genomics, assembly algorithms, statistical methods to analyse genomic information and compression of sequence information. found: 5 new cancer associated genes and 13 new mutational signatures that influence tumour development in view: customised breast cancer care oncology 22

path0logy in her keynote address at the forth- coming digital pathology congress (london. 1-2 december) dr fiona carragher, the deputy chief scientific officer for nhs england will discuss ‘personalised medicine - the next dimension for digital pathology’, in the context of the nhs england personalised medicine strategy, and how digitisation, com- bination and analysis of diagnos- tics is central to personalised care. ahead of the congress, she shared her views exclusively with mark nicholls of european hospital. ‘the combination, correlation and analysis of information are the cor- nerstone of personalised medicine,’ dr carragher pointed out. ‘it is the ability to digitise results from patient samples that has been one of the key enabling technologies that make personalised medicine possible now. through digitising information in this whole-scale way we can apply new analytical tech- niques, such as machine learning and cluster analysis that open up possibilities for new diagnoses and characterisation that weren’t pos- sible with the previous approaches.’ is nhs england close to embrac- ing personalised medicine through these means? ‘in the nhs we already have the foundations in place to bring the science and data together through our integrated informatics and genetic laboratory infrastructure. the nhs has spearheaded this new in the 21 years since its launch in germany, kugel medical has become a leading manufacturer of histopathology equipment on a global level, with a presence in labo- ratories, forensic centres, universi- ties, anatomical institutes, pharmacy firms and veterinary pathologies. the products include almost every- thing used in a modern laboratory. ‘our specialties are the integrated exhaust units for dissection and autopsy tables,’ explains ceo robert karl. ‘we also offer a complete range of stainless steel furniture, morgue refrigeration units and transport and storage equipment, which are distinguished by their ease of use, installation and maintenance, high reliability and long service life.’ recently, robert karl has been consistently asked not only to pro- vide equipment, but also to perform entire laboratory planning. ‘it makes no difference whether you’re look- ing for a partner for sophisticated furnishing of an entire building complex or a partial fit out. ‘we are your point of contact for all questions concerning design, development, planning and imple- menting,’ adds claudia karl, cfo at kugel medical. in such cases, robert karl and team work closely with architects and engineers to arrive at a perfect arrangement of workspac- es and compliance with government regulations and limits for alcohol, formalin and xylol concentration. based on extensive discussions with their international customers, the company designs a tailored concept that suits their customers’ needs. modern 3-d drawings enable cus- tomers to gain a realistic impression of their future laboratory. ‘on the technical side, exhaust and ventila- tion technology has never been more important than now, especially energy recovery and filtration of pollutants play a main role,’ robert karl points out. kugel now exports to 72 coun- tries, assisted by about 130 business partners. thus the firm’s advanced solutions are internationally – in the renowned medical faculty of the university of melbourne, australia; our lady of maryknoll hospital in hong kong; hospital no. 4 in olympic city, sochi, russia; the charité in berlin, one of europe’s biggest university hospitals, and more. the firm reports that it has worked with some of its business partners for over a decade. ‘something we way of working by establishing 13 nhs genomic medicine centres. these are pioneering and multidis- ciplinary network structures that require input across many clinical specialities. they are a step change in the processing of information, as they capture data from multiple systems and bring this together to analyse against common datasets and standards. thanks to this infra- structure, by 2020 we aim to be offering whole genome sequencing for specific conditions; improved diagnosis of rare conditions and a better understanding of cancer; and comprehensive linked diagnostics data coupled with effective infor- matics analysis to give a full picture to patients.’ the next stage ‘we are continuing to develop the building blocks currently in place, with a focus on improving con- nectivity; educating, informing and supporting commissioners; quality and accreditation, and developing informatics and analysis capacity. more specifically, we are developing our specialist genetic and molecular pathology laboratories; investing in the data and informatics infrastruc- ture for the nhs genomic medicine centres; and working with health education england to develop the workforce capability and expertise to deliver genomic and personalised medicine. ‘by 2025 we hope to achieve a new taxonomy of medicine based on underlying cause and person- al response; an integrated clini- cal service taking a “whole body approach”; and tailored, optimised and more effective therapies for bet- ter outcomes.’ how much investment is needed? ‘there are many external factors that will influence the success of this vision and it’s vital that we develop a shared ambition and com- mitment to deliver this with part- ners across the system and beyond. one key investment is in building partnerships between the nhs, aca- demia, industry and patient groups – as maximum patient benefit will come where all these groups work together. ‘the future of digital patholo- gy can only be delivered through enduring collaborative relationships and networks that ensure national consistency whilst delivering local responsiveness. to achieve this we need to invest in meeting the training, education and workforce planning challenges; facilitate the uptake and adoption of new sci- entific advances and technology; understand funding flows; develop commissioning information and education tools with commission- ers; develop new models of care, and ensure quality and assurance.’ how will its worth and success be quantified? ‘high quality diagnostic services are crucial to both patient outcomes and in determining success of other targets and measures for the whole system. this is because they are at the front line of screening and assessment to diagnose disease and determine severity, functional impact and response to therapeutic intervention. as they form such an integral part of clinical decision making, digital pathology is a key driver in successful and sustainable delivery of a&e targets, referral to treatment times for elective and out-patient care, reduction in hospi- tal admissions and in length of stay.’ the nhs personalised medicine strategy ‘personalised medicine is a move away from a “one-size-fits-all” approach to the treatment and care of patients with a particu- lar condition, to one which uses new approaches to better manage patients’ health and target therapies. the nhs personalised medicine strategy is changing the way medi- cine will be delivered to follow a tar- geted treatment approach enabled by integrated informatics. it turns on its head the traditional approach built around clinical teams special- ising in a particular organ system, who work back from a patient’s symptoms to arrive at a diagnosis. ‘personalised medicine recognises that complex diseases should no longer be considered as a single entity. as we integrate and analyse genomic and other data, we can find common factors and causes of variation, resulting in the discovery of new pathways of disease, which changes how diseases are thought of and treated. it enables us to recognise that the same underlying change in our dna or genome can lead to problems in very different parts of the body, which would not have been previously identified with a more traditional care approach.’ central to personalised care: dig- itisation, combination and anal- ysis ‘an integrated characterisation of individuals, based on the diagnostic and clinical data the nhs generates, is central to personalised medicine. we have more data about people, their habits and their health than we’ve ever had. to maximise the true value of the available infor- mation, we need to bring together genomic, clinical and diagnostic, medicines, and lifestyle data. it’s the integration and analysis of this information that forms the power- digital pathology advanc professional histopathology solutions and services creating a data powerhouse everything a modern laboratory dr fiona carragher is the deputy chief scientific officer for england, supporting the head of the profession for the 50,000-strong healthcare science workforce in the national health service (nhs) and associated bodies. this covers more than 50 separate scientific specialties. with a clinical background, and as a fellow of the royal college of pathologists, she has a broad portfolio of policy responsibilities across nhs england and the wider nhs and provides professional leadership and expert clinical advice and particularly for pathology within nhs england. a significant part of her role involves working across government, with partners in the department of health, the nhs, public health england, health education england, and others to help inform policy, influence legislation, deliver strategic change and introduce new ways of working. designs for specific work spaces and thier devices 24 european hospital vol 25 issue 5/16

26 european hospital vol 25 issue 5/16 path0logy digital pathology advances personalised medicine successful digital pathology denmark has been highlighted as a world-leader in creating a hugely successful national digital pathology system, mark nicholls reports advanced computer software under- pins a service - coupled with a countrywide database, which ena- bles denmark’s pathologists to opti- mise the assessment of patients’ specimens. in turn, the digitisation of the system in recent years has led to sig- nificant improvements in pathology services, delivering greater efficien- cy and advances in patient safety. professor ben vainer, who will highlight the progress his country has made in this field at the digital pathology congress (london. 1-2 december), believes other nations can learn from the danish experi- ence. ahead of his presentation, ‘how digitisation can improve pathology service - the danish experience,’ he told european hospital: ‘in large pathology labs, the high number of specimens is often a hindrance to efficient handling and ensuring patient safety without time-consum- ing steps, but those steps can be turned digital, releasing valuable staff resources. ‘most important, though, is that digitisation opens up opportunities for the implementation of the new imaging techniques, which are nec- essary to provide each patient with the correct assessment of diagnosis and biomarker expression profile.’ vainer, a consultant in the department of pathology at rigshospitalet, at the university of copenhagen, will focus on the danish civil registry database and other national databases connected to this, and the use of the same laboratory information system (lis) in all pathology departments in the entire country, with access to the national pathology database of all pathology reports in denmark since at least 1998. he believes this gives danish pathologists unique opportunities to interact with each other and to study diseases from an epidemio- logical point-of-view. his talk will focus on the advan- tages of these national initiatives, giving an overview of computerisa- tion and digitisation in routine labo- ratory operations, from the clini- cian’s ordering of a service via tissue sectioning and staining, to speech recognition and report presenta- tion to the ordering clinician and to research-related national cancer databases. vainer will also discuss the impor- tant links between lis and patient medical records in hospitals and in private practice (e.g. general practi- tioners), and how computerisation of the entire laboratory flow, from ordering of the pathology service to presentation of the specimen to the ordering physician, has helped ensure patient safety and eliminate time-consuming manual steps. ‘pathology departments in denmark have, through close col- laboration, been able to build a national pathology system, where each individual pathology depart- ment serves as a sort of “branch office”,’ he added. ‘all steps of the specimens are followed through the pathology department, which gives a good global view of the departmental activities and the possibility to trace individual specimens. for the man- agers, this also provides good meas- ures of operational objectives.’ the “users” – the ordering physi- cians – are provided with a clear overview of their patients’ speci- mens during the assessment pro- cess, and the patients have full access to reports on their own tis- sue,’ he added. digitisation of the laboratory pro- cesses and the link to the pathology lis and the national pathology data- base opens up the opportunity for image automation, including digi- tal image analysis and transfer of whole slide images in cases where a second opinion is needed, without compromising patient safety or the international data acts. patients in denmark are also seeing clear benefits from digital pathology with a significant reduc- tion lost specimens. ‘the risk of specimen mix-ups are minimised, and application of national pathol- ogy databases linked to nation- al person-identification databases ensures that the pathologist always has access to previous tests per- formed on the patient,’ vainer point- ed out. ‘this increases the quality of the pathology assessment and hence the final diagnosis.’ the process within denmark is constantly evolving with the intro- duction of the new digitisation pro- cedures, such as automated image analysis, and substitution of conven- tional light microscopies with whole slide images. ‘automated image analysis,’ he said, ‘will further increase the pathology assessment quality by eliminating subjective readings of biomarker expression, for example, in addition to eliminating the risk of patient case mix-up.’ * ben vainer, professor of pathology at copenhagen university, will discuss developments on 2 december during the digital pathology conference, to be held at london’s heathrow marriott hotel. ben vainer is professor of pathology at the university of copenhagen and consultant pathologist at department of pathology, rigshospitalet, the university of copenhagen’s main teaching hospital. his primary area of interest is digitisation of pathology in terms of education, research and diagnosing. grossing. each person has his/her own screen, which shows specimen details and other software can be opened, for example a surgery report or laboratory tests. two people are always present, one for the grossing and for packaging etc. the latter ensures patient identification and use of the correct capsules/blocks block cutting. the screens to the technicians’ right are used to ensure patient identification. each block and glass slide are to be ‘beeped’; if the block and glass are not from the same specimen the system will make a sound and show a big red x; then it becomes impossible to proceed unless the technician corrects the mistake patobank is the national pathology database, which includes all pathology reports since at least 1998 (and diagnosis back to around 1988). this is the homepage, also including the detailed snomed coding database (in denmark this has more than 7,000 entries). registration of incoming specimens (in the plastic bag in front of the technician). tubes are suction (to avoid formalin fumes) the system in action; the technician is scanning the barcode, which is on the side of the tissue block whole slide image workstation: right screen for microscopy, middle for lis, left for other software, e.g. radiology, patient record or laboratory workup digital image analysis of her2 in a breast cancer case. the software provides a semi-quantitative score according to international guidelines (0,1+,2+ or 3+)

surgical led lamp starled3 nx acem s.p.a. medical company division bologna – italy ph. +39 051 721844 info@acem.it − www.acem.it medical lighting system medica düsseldorf 14- 17 nov 2016 hall 10 stand e 31 28 european hospital vol 25 issue 5/16 surgery report: marcel rasch cognition-guided surgery aims to enable surgeons to make knowl- edge-based computer-aided deci- sions during surgery – with the help of computers. this requires the crea- tion of a database that is filled with factual and practical knowledge that a machine can process and use. the underlying idea is for a sur- geon to be able to call up suitable actions when planning or perform- ing an intervention. ‘you can com- pare it to a cognitive vehicle. while we are in the car driving along the road we often don’t notice that there are technologies in the background that control traction or chassis or whatever. when problems occur, a warning is displayed. as an advanced development, the cogni- tive car is autonomous, entirely dis- connected from the human driver,’ professor beat müller explains. the human brain can process or access a maximum of about seven pieces of information at a time. however, large amounts of data are not a problem for a computer. the challenge for the machine is not data volume but data interpretation. ‘in surgery we are dealing with mas- sive data volumes. every day, new knowledge is published in thou- sands of books and articles, new insights are culled from diagnostics, which is an increasingly complex discipline. a few decades ago x-ray images were all we had; today we are looking at ct and endoscopy images, at lab and histology param- eters previously unknown. ‘to collect these data and chan- nel them into a sound decision – that’s the complex art of medicine. unfortunately humans do make poor decisions every once in a while. thus cognition-guided sur- gery wants to create a system that helps to make good decisions.’ initial results that’s a long way to go. it won’t suffice for scientists to access big data and to design analytical tools; they must consider a very special factor, as müller points out: ‘the ability to learn is a crucial feature of the machine. the computer must be able to process not only factual knowledge, or book knowledge, but also practical knowledge gathered over time in the course of our every- day work. all these types of knowl- edge are input for the knowledge base. what we are aiming at is a system that does not suggest certain procedures anymore, because of the negative outcomes this procedure yielded in the past. instead the sys- tem suggests only procedures with a higher probability of success.’ such a system might indeed work, as was demonstrated by an initiative funded by the german research fund (dfg) between 2012 and 2016. ‘in the special research area cognition-guided surgery, teams from a consortium of research- ers, including the german cancer research centre and the karlsruhe institute of technology, looked at several key aspects of this idea,’ müller reports. in the course of the project an adaptive autonomous camera-guidance robot was devel- oped. ‘when the computer correctly guided the camera during an inter- vention, this experience was stored as “positive”. ‘but when the camera-guidance robot was corrected, it stored the correction,’ he explains. thus the system learns the correct camera positions step by step. the road ahead however, many challenges lie ahead. ‘don’t forget – we are at the very beginning of our research,’ says müller, dampening unrealistic expectations. ‘on the one hand we have to make the required data available in a machine-compatible way. when, as trained physicians, we look at an x-ray image and can read it – we understand what we are seeing. the more x-ray images we read, the more we learn. the computer must also go through this phase of gathering experience and knowledge.’ on the other hand, müller explains, ‘a computer can easily do statistical analyses, but semantic assessments are a major obstacle. we are talking about mod- el-based or pattern-based action. it’s not only about gathering data but about the way these data are per- ceived and evaluated.’ a third difficulty is system valida- tion. ‘the computer has to show that its suggestions, which are based on the learning process, are indeed bet- ter. human beings learn from suc- cess and failure. machine learning happens in smaller increments. if an error made by the system is not corrected, the system will store it as “positive”, no matter whether there might have been specific reasons for not correcting the error in this particular case. in short: we must ensure the system not only gath- in more than 21% of complex ana- tomical osteosynthesis procedures, an intraoperative improvement of the implant position or a revision of reduction has to be performed (recum von, j. et al., unfallchirurg 2012, 115:196-201, die intraopera- tive 3d-c-bogen-anwendung. state of the art). image-guided surgery is gaining relevance as a method to increase confidence in these com- plex procedures. the goal is to enable clinicians to deliver high-quality care and manage less-invasive approaches to shorten hospital stays, which poten- tially improve patient outcomes. by utilising preferred, navigation-ready instruments from different implant companies, automatic registration of images for navigation and intraoper- ative 3-d control scans allow quick progress checks and documentation at all times. this, in turn, ensures efficient clinical workflows, con- tributing to increased accuracy and reduced x-ray exposure (richter et. al., cervical pedicle screws: con- ventional versus computer-assisted placement of cannulated screws. spine (philapa 1976). 2005 oct 15;30(20):2280-7. and, gebhard et al., does computer assisted spine surgery reduce intraoperative radi- ation doses? spine (philapa1976). 2006 aug 1;31(17). for these demanding procedures in areas such as the cervical and upper thoracic spine, as well as for pelvic or minimally invasive surger- ies, ziehm imaging partnered with leading surgical navigation provid- ers to develop an interface that combines navigation systems and intraoperative 3-d imaging with the ziehm vision rfd 3d mobile c-arm. the ziehm naviport navigation interface connects the c-arm seam- lessly with the navigation system. a high-resolution 3-d dataset can be transferred automatically; real- time visualisation of the surgical instrument position can then be performed on the acquired dataset. this allows more accuracy during orthopaedics, trauma, and spinal procedures compared to conven- tional surgical techniques. with the combination of advanced intraoperative 3-d imaging and navigated surgery, these complex procedures for accurate screw and implant positioning can be han- dled with greater confidence thanks to visual guidance requiring less fluoroscopic control. with image- guided surgery and intraoperative control scans, post-operative ct scans become obsolete. ‘moreover, the ability to perform intraoperative seeking the gateway towards deeper computer intelligence adapting to image guided surgery cognition-guided surgery surgery will change – with all the challenges that developments such as big data create there are no two ways about it. however, how deep those changes run remains to be seen. in a rather young field of research, scientists look at the ways all components used during surgery can be interlinked. professor beat müller, co-initiator of the project ‘cognition-guided surgery’, explains results achieved so far and coming challenges increase confidence in the operating theatre control scans enables us to signifi- cantly reduce the need for postop- erative ct scans,’ says professor christoph josten, orthopaedics, trauma, and reconstructive surgeon at leipzig university hospital ph. +39051721844

biotronik home monitoring reduces mortality meta-analysis of home monitoring trials trust, ecost and in-time shows the reduction of all-cause mortality in an unselected patient population * hindricks g et al., daily remote monitoring of implantable cardioverter-defibrillators: pooled individual patient data from in-time, ecost, and trust trials suggest a mechanism of clinical benefit, esc congress 2016, rome. truecoin* study demonstrates again: www.biotronik.com european hospital vol 25 issue 5/16 surgery mechanical ventilation and sub- specialisation are key aspects of modern anaesthesia and critical care practice according to dr javier garcia fernandez, head of critical care and anaesthesiology at university hospital puerta de hierro in madrid. interview: mélisande rouger prior to his current role at madrid’s university hospital puerta de hierro, dr javier garcia fernandez practiced as a paediatric anaesthesiologist. asked what differences need con- sideration in anaesthesiology and ventilation of children compared to grown-ups, he explained: ‘paediatric anaesthesia is totally different from the rest of anaesthesia. evidence shows that specialising even only one year in paediatric anaesthesia reduces mortality. ‘the patient’s age is crucial. if he or she is six years or older, dif- ferences will not be that important and general anaesthesiologists can handle the patient. but little children and neonates require training at a dedicated paediatric hospital. ‘you need specific skills to place something as simple as an intrave- nous line or connect an electrode on a neonate’s thorax. ‘ventilation is also completely dif- ferent in children and they respond differently to anaesthetics. it’s eas- ier to predict reactions in adults. fentanyl is a commonly used drug in all patients, but you cannot intro- duce it as rapidly in a neonate as you would in an adult. ‘and, you can absolutely not miss regarding dose; you need to calcu- late it perfectly according to the size and weight of the patient. ‘accuracy and precision are man- datory in children. there is no mar- gin of error.’ congenital cardiovascular dis- ease surgery and transplants are the most common settings for paediatric anaesthesia. are there enough anaestheiists in spain to properly care for these patients? ‘all studies show that paediatric anaesthesia in these settings should only be done at paediatric hospitals. there should not be more than three or four hospitals offering paediatric transplants in the same country. these procedures are complex and you need to treat enough patients to obtain good results. ‘la paz in madrid was one of the first hospitals to offer paediatric transplants. but, in spain, healthcare is divided in 17 different areas and all are trying to get their own paedi- atric hospital. the british model is excellent in my opinion for transplants and run- ning the extracorporeal membrane oxygenation (ecmo) programme. six centres are authorised to per- form transplants and run ecmo. they are evaluated every year and only the most efficient can continue their activities. ‘nevertheless there should be enough paediatric anaesthesiologists everywhere to perform routine pro- cedures such as imaging examina- tions or ambulatory surgeries.’ spain is the leading country in organ donations worldwide. what are the main issues for the anaesthesiologist in this context? ‘my hospital is among the first three hospitals in europe to perform lung transplants; we carry out 50 opera- tions a year and have treated 700 patients so far. ‘spain performs a lot of trans- plants and there is an impulse to open new centres; this is quite con- troversial. if you want to maintain a high level of care, you should only have a low number of centres carry- ing out transplants.’ do you programme a ventilator individually for each patient? ‘after 20 years’ teaching and giving training all over the world, i have come to realise that most countries do not have deep knowledge of mechanical ventilation. ever since siemens introduced the “green points” on the screen of ventilators to help anaesthesiologists and inten- sivists, we have been setting all the ventilators exactly the same way for everybody. furthermore parameters are not changed every day according to the state of patients’ lungs. ‘in europe, things are changing. we have to set ventilators individu- ally because patients are unique. a smoker’s lungs are not the same as a non-smoker’s. programming ventila- tion also depends on the position of the patient. ‘ventilators now offer much more information. they deliver volume, pressure and flow time curves in real time breath-by-breath, pressure volume loops, etc. all these tools give you specific information on respiratory function. we now have to interpret and analyse this informa- tion to know how to ventilate each patient individually. ‘we have to train our colleagues accordingly. this is one of the big- gest challenges in our field.’ what are the latest developments in anaesthesiology and critical care? ‘intensive care technology has devel- oped rapidly over the past dec- ade and these advances have made their way to anaesthesia practice. ventilators are just as good in both fields, but most anaesthesiologists are not familiar with these tools yet. ‘cardiorespiratory mechanical sup- port devices provide heart and lung function artificial support. these machines are coming to the market; there are two or three new cases per month. they are the future. ‘neural adjusted ventilation assist (nava) technology enables mechan- ical adaptation of ventilation to the patient’s diaphragm; this will play a significant role in the years to come.’ does automation or learning soft- ware play any role in your disci- pline? ‘everybody has been looking into automating everything for the past decade. the problem is that mechan- ical ventilation is a disregarded field. efforts have focused on creating software that everybody can use, so that no one has to do mechanical ventilation any more. ‘software is helping clinicians, but is not solving problems. so far this has not been working at all. using software requires programming for each patient; software cannot run on its own. some patients will want to breathe in two seconds, others in three or more. clinicians need to adapt to each individual patient. ‘we have to see what the future can offer and whether automation can help us in complex situation like asynchronies, recruitment manoeu- vres, weaning, etc.’ ‘to maintain high level care, you should only have a low number of transplant centres’ top anaesthesiologist stresses automation limits in late 1996, javier garcia fernandez gained his phd in medicine and surgery (cum laude) at complutense university of madrid. after specialising in paediatric anaesthesia and critical care in la paz children’s hospital for 14 years, from 2011 he has chaired the anaesthesia, critical care and pain department at puerta de hierro university hospital in madrid. today he is professor of anaesthesia and critical care in the surgery department at madrid’s autonomous university. he is also president of the research and ethics committee (rec) of puerta de hierro hospital and associate editor of several international anaesthesiology, resuscitation and ventilation journals. among the first three european hospitals to perform lung transplants, puerto de hierro performs fifty of these operations annually, so far treating around seven hundred patients specialization is needed because ventilation is different in children and they respond differently to anaesthetics from left: paediatric anaesthesiologist patrice bourgeois, javier garcia fernandez and a resident at la paz hospital 30 european hospital vol 25 issue 5/16

comparison between triclosan impregnated suture and two non- impregnated sutures. after 12 hours, the non-impregnated sutures were colonised with an initial biofilm, which developed its full growth after 24 hours. 32 european hospital vol 25 issue 5/16 surgery report: bettina döbereiner wound infections after surgery are not uncommon and can be fatal. in germany, postoperative wound infections are now the most common type of hospital acquired infection (hai), with a proportion of 24%. an expert on infection prevention and control, professor axel kramer, who directs the institute for hygiene and environmental medicine at the university of greifswald, germany, believes that suture material may be an underestimated aspect of prevention. postoperative wound infections are typical complications that occur after surgery. they typically develop through entry of pathogens, mostly bacteria, via the skin or mucous membranes into the surgical site. according to the hospital infection surveillance system kiss, 1.6 out of 100 surgical interventions in german hospitals lead to surgical site infections; this results in some 267,000 postoperative wound infec- tions annually (2014 figure). these are only estimates – precise data is lacking. however, the fact is that some of these nosocomial infec- tions could be prevented – between 20-60% of them, kramer estimates. in terms of the total number of post- operative wound infections annu- ally this would represent between 53,000 – 160,000 fewer cases. how best to prevent ssis is one of kramer’s specialist research areas. at the 4th forum on infection prevention and control held by the german medical technology association (bvmed), in berlin last december, he explained his recom- mendations for the best options of prevention. his urgently recommended strate- gies to tackle ssis include eradica- tion of existing infections before elective surgery, standardised pre- operative skin antiseptics, sterile covering of the surgical area, no shaving (if required then clipping instead of shaving), aseptic, tissue- conserving working methods, sterile clothing, surgical hand disinfection, intact surgical gloves (if necessary double gloving), surgical masks and perioperative antibiotic prophylaxis (pap) and – to complement all this – the respective suture material. underestimated implants the surface of a conventional, ster- ile suture (braided vicryl) with a length of 150cm has, kramer calcu- lated, the same surface area as the side of a cd cover. ‘this means that, during the formation of a biofilm, around 325 billion pathogens can colonise this area and, in the case of multi-layer biofilms even up to a tril- lion pathogens,’ he explained. ‘the suture material is in fact an implant, but unfortunately often not recog- nised as such,’ kramer points out. this implant bears the same risks as other implants. the number of pathogens required to cause infec- tion is far lower around the suture material. therefore, the probability of infection via the suture material, particularly in body areas with high bacterial colonisation, such as the colon with its complex intestinal flora, is markedly high. it is also possible, kramer says, that a biologi- cal film may form around the suture and thus protect the pathogens from immune defence. the suture can almost act like a ‘slide’ into deeper layers of tissue and cause infection there. triclosan coated sutures kramer therefore recommends the use of antiseptic-impregnated suture material, particularly for visceral surgery. the number of ssis here is significantly higher than the average 1.6, at 9.36 per 100 surgical inter- ventions. however, even if all meas- ures of prevention are adhered to, invasion of pathogens, such as from the intestine, can never be complete- ly prevented even with antimicrobial suture material, kramer emphasised. currently, the only antimicro- bial suture material available is coated with the antimicrobial substance triclosan. impregnation with triclosan prevents the bio- film development on the suture material. however, there is a gap in effectiveness against the fourth most common cause of ssi, p. aer- uginosa. however, irrespective of this, the benefits of antimicrobial suture material continue to be con- troversial. for abdominal surgery, four meta analyses now confirm a reduction in the ssi rate through the use of triclosan-coated sutures. however, a proud study showed no significant impact on superficial (a1) or deep (a2) surgical site infection after elec- tive, median abdominal laparotomy. however, says kramer, after con- solidating the data from the proud study with data from four further studies it was possible to document clear superiority of the antiseptic suture material (diener et al 2014). potentially positive results have so far also been achieved in breast can- cer surgery and heart surgery. for kramer the trend, at least for abdominal surgery, is obvious, even though more proof is still required. he is convinced by the benefits. the university hospital greifswald has therefore been using antibacterial suture material since 2005. self-control with checklist reduces ssi rate irrespective of the research situation it is obvious that only a combination of a whole bundle of measures will lead to success in the prevention of wound infections. kramer therefore suggests specific bundles of meas- ures to combat ssis, which each surgical department should estab- lish, train its staff in and then moni- tor. at the centre for colon cancer, in greifswald, this has been suc- cessfully implemented since 2009. surgeons control adherence to all- important measures of prevention via a checklist prior to commencing surgery. this has led to a stable reduction of superficial (a1) and deep (a2) ssis by an average of 60% in the period between 2011 and 2015, kramer says. conclusion: if postoperative wound infection was to be reduced by more than half through suitable measures of prevention, such as seen in this example from greifswald, based on the aforementioned prevalence rate in germany this would save a total of €1.8 billion – but most impor- tantly it would spare many patients the unpleasant and sometimes even deadly effects of wound infections. professor axel kramer md is a specialist in hygiene and environmental medicine and former head of the institute for hygiene and environmental medicine at the ernst-moritz-arndt university greifswald, germany. in this role he combines teaching with research, as well as the management of infection prevention- and control for the university hospital greifswald. he is a member of the commission for ‘hospital infection prevention- and control at the robert koch institute’ and a founder member of the german society for hospital hygiene (dgkh), having been its president from 1990 to 2010. the best prophylaxis against post-surgical wound infection the importance of suture material source/copyright axel kramer