the european forum for those in the business of making healthcare work v o l 2 6 i s s u e 4 / 1 6 • a u g u s t / s e p t e m b e r 2 0 1 6 laboratory 4-6/19-20 • biobank develops research standards • testosterone and male heart problems • in reprocessing qualifications are vital surgery 21-23 • reconstruction or amputation? • gaining a suite for 3-d printing • procedures in your pocket contents news & management 1-3 lab & pathology 4-6/19-20 cardiology special 7-18 surgery 21-23 events 24 www.healthcare-in-europe.com exuding the aroma of hi-octane fuel, the glamour of multi- coloured racing leathers, flashy sponsored brands and the glitz of the circuits, motorcycle racing can be an irresistible fast-action sport. amid the roar of engines, the world’s leading motorcycle aces, such as marc marquez, valentino rossi or jonathan rea, hit around 300kmh on tracks across the globe. interview: daniela zimmermann high-speed duals thrill the crowds, but clearly the risk of accident and injury remain high, despite improve- ments over the last three decades in equipment, machines, safety fea- tures and medical facilities. at the core of these is the renowned clinica mobile, a fully equipped medical and physiother- apy centre ‘on wheels’ to treat riders and the wider motor- cycle racing entourage. since the 1970s, clinica mobile has grown from a group of car- ing and enthusiastic practitioners carrying medi- cal boxes to race circuits into a mobile diagnostic and treatment facility with 50 employees attending superbike world championship and motogp races. in 2015, for example, the facility performed 2,966 interventions for motogp alone, of which about 1,245 their own permanent medical facili- ties, but clinica mobile is still a critical resource for care and treat- ment. the unit constantly upgrades its equipment, the latest being an additional carestream drx-1 flat panel from medical imaging systems and it solution specialist carestream health. installed at the back of the truck this produces immediate radiographic images; the console captures images and a detector forwards exposures wire- lessly to the console for processing and display, and then onward to printing and archiving systems. the digital detector reduces expo- sure to x-rays compared to conven- tional systems and the light weight of the system makes this a versatile tool to conduct a range of tradi- tional tests, e.g. general and trauma radiography and orthopaedics. ‘carestream’s drx-1 is a high-tech w e r e for driv- ers and 1,721 for paddock staff. ‘very often it helps diagnose and treat minor injuries, but sometimes - 359 times in 2015 - an x-ray is required. all this must be carried out within our 65-metre square facility, which can treat up to eight patients simultane- ously,’ medical director dr michele zasa explains. circuits now have continued on page 2 ace motorcyclists gain instant radiographic imaging from a flat panel system clinica mobile’s drx-1 delivers high-speed care system, able to meet the diagnostic needs of the specialisms that we serve, allowing us to provide more timely and accurate support,’ zasa points out. ‘it’s a very important and extremely reliable tool, useful in case of falls and ascertained frac- tures. in diagnostics, you need to have good machines that produce excellent diagnostic images. i need to provide a good quality service to the top riders, so the quality of all our equipment is very impor- tant. in terms of diagnostics the carestream drx-1, is a very good system. for traumatology, we can diagnose more and more fractures and it’s important to see, if the rid- ers are in pain, whether there are minor fractures. dr michele zasa is the medical director of the clinica mobile, a fully equipped medical and physiotherapy centre ‘on wheels’, and sometimes riders’ refuge. checking for minor fractures is important – they will race anyway, but they can relax knowing what the pain is 7-18 esc special reports and more v o l 26 i s s u e 4 / 16 • a u g u s t / s e p t e m b e r 2016

x - r a y s y s t e m s s o l u t i o n s a s i n d i v i d u a l a s y o u a r e d i g i t a l r a d i o g r a p h y c o m p u t e d r a d i o g r a p h y r a d i o g r a p h y s o f t w a r e m o b i l e x - r a y c l i n i c a l s p e c i a l i t i e s at carestream, we understand that everyone is unique – from patients and clinicians, to support staff and managers. that’s why we’ve created an award-winning portfolio of x-ray solutions that can be tailored to your individual needs. whether you’re a small clinic, large hospital, a regional or national health system, our solutions will help improve workflow, reduce costs and enhance patient care, now and into the future. to see how our solutions are a perfect match for your needs, visit our website or contact your local carestream representative. x - r a y s o l u t i o n s c a r e s t r e a m . c o m / x - r a y © carestream health, inc., 2016. carestream is a trademark of carestream health carestream_european_hospital_print_ad_a4_xrs_individual_2.indd 1 09/08/2016 14:20 3 www.healthcare-in-europe.com news & management to already made unprecedented sav- ings in hugely challenging circum- stances. the uncertainty following the brexit vote is likely to com- pound financial concerns. “now is an important time for the government and national bodies to assure nhs leaders that a focus on stability does not come at the expense of transformation. “this is critical to improve care for patients at a local level and will ultimately deliver sustainability for the future.” the department of health responded by saying the nhs is “performing well and delivering safer, more compassionate care.” “we know some providers are under financial pressure caused by big rises in demand and our age- ing population, but are investing an extra £10bn a year by 2020 to deliver the nhs’s own plan for the future,” said a spokesman. however, the patients association rejected the plan to ease targets. “this is the slippery slope back to the bad old days of never-ending waiting times and uncertainty - with patients left endlessly on a&e trol- leys and waiting for life-changing operations,” said chief executive katherine murphy. “we are calling on government to urgently reconsider this deci- sion and put the patients safety and wellbeing first. patients should not be punished for years of financial waste in the nhs.” stephen dalton a nurse by background, stephen dalton has been a nhs provider services chief executive for 17 years, holding posts in merseyside, cheshire and cumbria where, for nine years, he was ceo of cumbria partnership nhs foundation trust. he is also former chief executive of the mental health network. ng off mechanical ventilation raises mortality ed more attention of recording the conscious state of a person for initial and subsequent assessment – at the start of weaning, were more likely to have prolonged weaning, meaning that the patient’s consciousness level and mental sta- tus affect the success of weaning. ‘higher paco2 levels at the initial sbt were independently related to prolonged weaning in our study,’ xi pointed out, ‘most patients under- going weaning still have consider- able gas exchange disturbances dur- ing the weaning process and may develop hypoxemia, hypercapnia, or both, during an sbt. ‘patients who experience failed weaning are frequently unable to increase their minute ventila- tion in response to a high paco2 because of weakness of the res- piratory muscles, altered respira- tory mechanics, and other factors.’ the study follows a proposal at the international consensus conference to classify weaning of patients in intensive care units from mechanical ventilation into ‘simple’, ‘difficult’, and ‘prolonged’ weaning, based on the difficulty and length of the weaning process. for the prospective cohort study, the beijing team examined the inci- dence and outcome of weaning according to the new categories. three hundred and forty-three patients were included in the final analysis. the prevalence of simple, difficult, and prolonged weaning was 200 (58%), 99 (29%), and 44 dr xiu-ming xi, from the department of critical care medicine, fuxing hospital, capital medical university, in beijing, is one of china’s leading critical care prac- titioners and also president of chinese association of critical care physicians. continued on page 5 carestream_european_hospital_print_ad_a4_xrs_individual_2.indd 109/08/201614:20

ab sciex is doing business as sciex. © 2016 ab sciex. for in vitro diagnostic use. not available in all countries. the trademarks mentioned herein are the property of the ab sciex pte. ltd. or their respective owners. ab sciex™ is being used under license. ivd-mkt-13-4537-a 08/2016 you’re on a mission to provide accurate data that clinicians can rely on. at sciex diagnostics we share your passion. we understand that delivering accurate and timely patient test results, under increasing regulatory and financial pressure, is of paramount importance. our in vitro diagnostic mass spec solutions help you deliver data quickly and adhere to current compliance standards. with the added flexibility to expand your test menu, be confident you can support clinicians with the right results so they may make reliable patient diagnosis and treatment decisions for years to come. it’s time to see the future differently. sciexdiagnostics.com it’s time to embrace the future of diagnostic accuracy 5 www.healthcare-in-europe.com laboratory & pathology (13%) patients, respectively. ‘patients who experienced pro- longed weaning had a significant increase in both 60-day and hospital mortality compared with patients who experienced either simple or difficult weaning,’ said xi. ‘we found that a lower glasgow score, and hyercapnia at the beginning of the weaning pro- cess, were independent risk fac- tors for prolonged weaning.’ in the prolonged weaning group, patients were more likely to be from the medical ward and to have pneumonia as the cause for ini- tiation of mv; they were also older and had a higher apache ii score (acute physiology and chronic health evaluation ii) - one of sever- al icu scoring systems to asses icu patients - on admission to the icu. the study was performed at med- ical-surgical icus of 13 municipal hospitals in beijing and all patients who had been intubated and mechanically ventilated for more than 24 hours were screened. continued from page 3 these patients need more attention the würzburg biobank aims to sup- port the research projects of the uni- versity’s medical school. therefore, it collects a broad range of samples for oncology, cardio-vascular dis- eases and endocrinology. samples from cancer patients usu- ally encompass tumour core tis- sue, tumour margin tissue and non- tumour tissue. these samples are the basis for personalised therapies, since they allow examination of different tumour-specific molecular changes on the genetic level and molecular tumour signatures may be decoded. today, different mutations can be treated in a highly specific man- ner. certain tumour dna can be new analytical methods ‘there will be new analytical meth- ods such as proteomics. high- resolution protein analysis has not yet arrived in lab routine, but it will do so because it yields a lot more information. it not only shows that something is docking onto the antibody but also shows the protein fragment itself – its modifications and much more. it creates informa- tion on an entirely new level.’ cooperation with medical colleagues and patients ‘it’s very important for us to stay in touch with our medical colleagues, because this is the only way to ensure we have an uninterrupted flow of information. in the future, we will be playing an increasingly important role as consultants. the added value we create in medicine is often under-appreciated. we are sit- ting in the backseat, without direct contact with patients. nevertheless, 70 percent of all diagnoses can be correctly made based on lab results. this is an extremely high level of performance – at a mere three per- cent of healthcare spend. ‘diagnostic imaging is much more time consuming and expensive than lab diagnostics. lab medicine has become so efficient and so quiet that it’s now not noticed and taken for granted. our contribution to the diagnostic process should not be underestimated and maybe even be more appreciated. laboratory medi- cine connects! in the future we will be open to organise our congress jointly with other disciplines.’ after receiving his doctoral degree at the university of würzburg, germany, professor berend isermann was research fellow at the blood research institute in milwaukee, wisconsin, usa. subsequently, he then joined the department of internal medicine at the university of heidelberg where in 2008 he obtained his qualification for university professorship. one year later he was appointed director of clinical chemistry at the institution’s department of internal medicine. since 2011 he has been heading the institute of clinical chemistry and pathobiochemistry at otto von guericke university, magdeburg, germany. professor isermann focuses his research on coagulation proteases, chronic vascular diseases, diabetic nephropathy and sterile inflammation. ibdw’s bio ii lab for automated processing of liquid biosamples x continued on page 6 © all images: pieruschek

r o m e • i ta ly 2 7 a u g - 3 1 a u g 2 0 1 6 n e w s a n d t e c h n o l o g y u p d a t e s f o r c a r d i a c c a r e cardiology 2016 www.healthcare-in-europe.com www.healthcare-in-europe.com research by a team at john hopkins university (jhu) in baltimore, usa highlights the patients who are most likely to face lethal arrhythmias. when patients suffer arrhythmia, cardiologists often respond by fit- ting a small defibrillator implant to sense the onset of arrhythmia and jolt the heart back to a nor- mal rhythm. however, the ques- tion remains over how they decide which patients need the implant and the invasive surgery needed to fit it. aiming to address this, a team from the department of biomedical engineering and institute for computational medicine at jhu has developed a non-invasive 3-d virtu- al heart assessment tool to help doc- tors determine which patients face the highest risk of a life-threatening arrhythmia and would benefit most from a defibrillator implant. early evidence suggests the new digital approach yielded more accu- rate predictions than the current blood pumping measurement used by most physicians. ‘our virtual heart test significant- ly outperformed several existing clinical metrics in predicting future arrhythmic events,’ professor natalia trayanova, the university’s inaugu- ral murray b. sachs professor of biomedical engineering, said. ‘this non-invasive and personalised virtu- al heart-risk assessment could help prevent sudden cardiac deaths and allow patients who are not at risk to avoid unnecessary defibrillator implantations.’ a pioneer in developing personal- ised imaging-based computer mod- els of the heart, she has worked on the project with cardiologist katherine c wu, associate profes- sor in the johns hopkins school of medicine, whose research has focused on mr resonance imaging approaches to improving cardiovas- cular risk prediction. for the study, trayanova’s team formed its predictions by using the distinctive magnetic resonance imaging (mri) records of patients who had survived a heart attack but were left with damaged cardiac tissue that predisposes the heart to deadly arrhythmias. the study involved data from 41 patients who had survived a heart attack and had an ejection fraction – a measure of how much blood is being pumped out of the heart – of less than thirty- five percent. patients in this range are usu- ally recommended implantable defi- brillators, however, with the jhu team concerned about this measur- ing score system, they invented an alternative to these scores by using pre-implant mri scans of the recipi- ents’ hearts to build patient-specific digital replicas of the organs. using computer-modelling tech- niques developed in trayanova’s lab, the geometrical replica of each patient’s heart was brought to life by incorporating representations of the electrical processes in the cardiac cells and the communication among cells. in some cases, the virtual heart developed an arrhythmia, and in others it did not. the new non-invasive way to gauge the risk of sudden cardiac death due to arrhythmia has been named the varp (virtual-heart arrhythmia risk predictor). subsequent tests showed that patients who tested positive for arrhythmia risk by varp were four times more likely to develop arrhythmia than those who tested negative. varp predicted arrhyth- mia occurrence in patients four- to-five times better than the ejec- tion fraction and other, invasive and non-invasive, existing clinical risk predictors. ‘we demonstrated that varp is better than any other arrhythmia prediction method out there,’ trayanova confirmed. ‘by accurately predicting which patients are at risk of sudden cardiac death, the varp approach will provide the doctors with a tool to iden- tify those patients who truly need the costly implantable device, and those for whom the device would not provide any life-saving benefits.’ wu said that the early results indi- cate the more nuanced varp tech- nique could be a useful alternative to the one-size-fits-all ejection frac- tion score. trayanova is hopeful the new risk prediction methodology could also be applied to patients who had prior heart damage, but whose ejection fraction score did not tar- get them for therapy under current clinical recommendations. the next step is to conduct fur- ther tests involving larger groups of heart patients. the virtual-heart arrhythmia risk predictor natalia trayanova phd is the john hopkins university’s inaugural murray b. sachs professor of biomedical engineering in the department of biomedical engineering and institute for computational medicine. she received her doctorate at the bulgarian academy of sciences in sofia (1986) and post-doctoral training in biomedical engineering at duke university. her research focuses on understanding the normal and pathological electrophysiological and electromechanical behaviour of the heart. the virtual heart arrhythmia risk predictor. patient-specific heart models are constructed from clinical imaging data. a virtual-heart model is then used to predict the patient risk of lethal arrhythmias. identifying patients with cardiac injury at risk for lethal arrhythmias using a combination of cardiac imaging and computational simulations. from the patient’s scan (blue), a virtual heart is constructed and the presence of arrhythmia, indicated by the non- uniform electrical activation (red-yellow), is revealed. researchers have developed a personalised 3-d virtual heart that can help predict the risk of sudden cardiac death. mark nicholls reports r o m e • i ta ly 27 a u g - 31 a u g 2016

syngo.ct cardiac function – enhancement1 and syngo.ct myocardial perfusion1 with a coronary ct angiography, the diagnosis of a coronary stenosis is done easily within clinical routine. but what about the functional relevance of an intermediate lesion? will the patient actually benefit from an intervention? with syngo.ct cardiac function – enhancement you can choose from the full spectrum of myocardial perfusion: from first pass enhancement in both rest and stress assessment to late enhancement for the evaluation of scarred tissue. with its evaluation of dynamic myocardial perfusion, syngo.ct myocardial perfusion takes you to a new level in measuring the myocardial blood flow and allows you to use actual quantitative assessment for the hemodynamic relevance of intermediate stenoses of the coronaries.2 this enables you to choose the right diagnostic approach for every patient. 1 optional application 2 rossi a, pugliese f et al., eur heart j cardiovasc imaging. 2014 jan;15(1):85-94. a9ct-9425-a2-7600 siemens.com/ct-cardio-vascular-engine driving progress with the full spectrum of myocardial perfusion assessment. get further. with the ct cardio-vascular engine. 3934_ct_ad_a9ct-9425-a2-7600_a4_dd.indd 1 09.08.16 09:10 cardiology 9 www.healthcare-in-europe.com the document, which brings a series of tables providing parameters, cri- teria, and new algorithms. ‘although relatively rare, valve dysfunction does occur with prosthetic heart valves in the forms of structural valve deterioration or non-structural problems,’ he explained. ‘though often challenging, establishing the exact cause of phv dysfunction is essential to determine the appro- priate treatment strategy. the new algorithms to help clinicians diag- nose and quantify prosthetic valve dysfunction are easy to use.’ ‘in clinical practice, a compre- hensive approach that integrates several parameters of valve mor- phology and function assessed with echocardiography is key to appro- priately detect and quantitate phv dysfunction. other imaging modali- ties are complementary tools for the diagnosis and management of phv complications.’ ‘nuclear imaging currently has very limited application in the eval- uation of phv, other than in the setting of suspected infective endo- carditis,’ lancellotti explained. the chinese society of echo- cardiography, the inter-american society of echocardiography and the brazilian department of cardiovascular imaging have already endorsed the recommendations in multimodality imaging assessment hms define tic valve dysfunction nce of all imaging modalities – including ate prosthetic heart valves in a new series nigma patrizio lancellotti is head of the intensive care cardiology unit at the university of liège hospital centre and professor of clinical medicine at the university of liège. a pioneer in cardiac imaging techniques, his research has led to significant progress in the care of patients suffering functional mitral insufficiency. a former president of the european association of cardiovascular imaging (eacvi) and the author of 330 peer-reviewed publications, he was also co-chair of the task force that drafted the esc guidelines for endocarditis, promoting the need for an approach based on a multimodal imaging. er the weekend faced a higher risk of dying over the prosthetic heart valve implantation ©beerkoff/www.shutterstock.com 3934_ct_ad_a9ct-9425-a2-7600_a4_dd.indd 109.08.1609:10

intuitive. intelligent. innovative. meet aplio™ i900. engineered to help you get the information you need to make confident decisions quickly, aplio i900 elevates cardiovascular imaging to a new level of imaging precision, diagnostic performance and productivity. intelligent design intuitive workflow support ibeam architecture www.toshiba-medical.eu cardiology 11 www.healthcare-in-europe.com austrian viktor mayer-schönberger, professor of internet governance and regulation at the oxford internet institute, university of oxford, england, founded ikarus software in 1986, which focuses on data security. given his interest in ‘big data’, he researches the role of information in a networked economy. he has authored numerous articles and seven books including ‘delete: the virtue of forgetting in the digital age’. r with 7-t magnetic field-strength cardiomyopathy pared to 3-t,’ the professor added. ‘this translates into being able to acquire the same quality data in five minutes that previously took 30 minutes, or into being able to use a finer spatial resolution, or into being able to measure other metabolites, such as inorganic phosphate which occur at lower concentrations in the body and were not visible in our scans.’ in the healthy heart, the con- centration ratio of phosphocreatine (pcr) – the primary energy buffer of heart muscle cells - to adenosine triphosphate is approximately 2:1. ‘in the failing heart,’ rodgers added, ‘the concentration ratio drops to around 1.5:1. we measured this change in our group at 3-t and 7-t. the more sensitive 7-t experi- ment, in theory allowed us to detect changes in less severe cases of dilated cardiomyopathy than in the cohort we studied.’ whilst still at the basic research stage, rodgers believes the primary impact on patient treatment is that these more sensitive measurements facilitate trials of new treatments such as new drugs, devices, or lifestyle modifications, because the imaging can detect smaller improve- ments or deteriorations in the heart’s metabolic status than were previously visible. ‘it ought to be possible to detect earlier improvement in response to treatment, and to quantify the rela- tive merits of different treatments more accurately,’ he said. ‘we are also planning studies to understand the interplay between heart disease and disease in other organs, e.g. type ii diabetes, or obesity. ‘having treatments that have been based on a more rigorous under- standing of the heart’s biochemis- try will hopefully mean they will be more effective at treating heart disease.’ research centres and teaching hospitals will also benefit, with the new approach helping improve understanding of the heart’s metab- olism in clinical studies. big data: a revolution that will transform how we live, work, and think by viktor mayer-schönberger and kenneth cukier; published by hodder & stoughton, uk 2013; price 7,99 euro. isbn: 9781848547926 © rogers/radiology

sonosite, and the sonosite logo are trademarks and registered trademarks of fujifilm sonosite, inc. in various jurisdictions. fujifilm is a trademark and registered trademark of fujifilm corporation in various jurisdictions. all other trademarks are the property of their respective owners. copyright © 2016 fujifilm sonosite, inc. all rights reserved. subject to change. 2504_ 07/16 the way ultrasound is used at the point of care can help drive and change patient care every day. ahead lies a continuing demand and desire for increased standards of quality for healthcare delivery, for everybody. and so too does the demand for ultrasound: more available, more connected, more at the patient’s side. we share your desire to overcome the obstacles standing in the way of patient care, constantly evolving ultrasound technology to help you get the right answers at the right time. with you we break down the barriers. you make us what we are. see why we continue to put ultrasound machines in your hands. contact your local customer representative or email eraf-sales@sonosite.com for further information. breaking the barriers cardiology 13 www.healthcare-in-europe.com in the fast-evolving field of left atrial appendage closure a new study has delivered data that could ben- efit thousands of patients at risk of stroke. led by professor martin bergmann, head of interventional cardiology at cardiologicum hamburg in germany, the ewolution study was conducted to evaluate the watchman left atrial appendage (laa) closure device from manufacturer boston scientific. ‘the laa field is evolving very quickly for stroke protection, mainly in the elderly.’ professor bergmann explained. ‘anti-coagulants are a great step forward yet have left many patients with bleeding compli- cations, so these drugs are not the solution for all patients.’ the laa is believed to be the source of more than 90% of stroke- causing clots that come from the left atrium in people with non-valvular atrial fibrillation. in recent years laa closure has been seen as an alternative, though progress has been held back because of hesitancy among gps, neurologists and non-interventional cardiologists to refer patients for the procedure because there was no clear data on success rates. however, the recently pub- lished three-month results from the ewolution registry found that laa closure with the boston scientific watchman device has a high success rate in complete laa closure with low peri-procedural risk. ‘we can now say that, irrespec- tive of post procedural drug regi- men, the risk of thrombus on the device is quite low, even in patients that have not received any oral anti- coagulation because of their bleed- ing risk,’ bergmann confirmed. the success of the trial, he added, will see more patients becoming candidates for laa closure. in europe, two laa closure devic- es are currently available - each with a different approach - but bergmann said the watchman device – which is anchored in the distal part of the laa and closes laa right at the entrance leaving the ridge to the pulmonary vein free – is the only one now underpinned by prospec- tive data. watchman is a catheter-delivered heart implant designed to close the left atrial appendage to prevent the migration of blood clots from the laa, and thus, reduce the incidence of stroke and systemic embolism for higher risk patients with non- valvular af. many patients are still being denied anticoagulation, he pointed out, because there are compliance issues, leaving them with a high stroke risk. however, he added: ‘ewolution should pave the way in europe to solidly establish laa closure in routine practice as one of the options that is available.’ dual antiplatelet therapy (dapt) following the implant also appears to be safe. data from the prospective multi- centre registry show that the implant procedure was successful in 98.5% of cases; 99% of implanted devic- es presented no or minimal peri- device leakage at the first follow-up, assessed by peri-procedural trans oesophageal echocardiogram (tee); device or procedure related seri- ous adverse events (sae) rates at 92 days were similar if patients were treated with warfarin or dapt; rates for bleeding sae were also simi- lar if warfarin or dapt was used post-implantation (4.8% vs. 3.6%, respectively). following watchman implan- tation, bergmann added, 6% of patients received no anticoagula- tion, 27% received oral anticoagula- tion (16% warfarin and 11% novel oral anticoagulants - noacs), 60% received dual antiplatelet therapy (dapt) and 7%of patients were on single antiplatelet therapy. stroke (0.4%) and bleeding (4.1%) rates were low overall and did not vary by post-implantation medica- tion. the study, the professor said, is a significant step forward in the treatment of such patients and in the field of stroke preven- tion. ‘we especially see the procedure being adapted in rising numbers in the inter- ventional field because we see a lot of patients who have no indi- cation for pulmonary vein isolation but have a problem with stroke pre- vention based on atrial fibrillation.’ one factor to emerge from the trial was with the 11% of patients treated with noacs, who post-pro- cedurally had the best data. ‘to be able to use noacs for this therapy, which has the advantage of very short half-life,’ bergmann added, ‘means that it may be even better than dual anti-platelet therapy, but this is something we will have to test in randomised trial or larger numbers.’ more at risk patients will become candidates for laa closure device trial could benefit stroke patients transmission success rate of 93.8pc, which is really exceptional. ‘biotronik has invested heav- ily over the years in its home monitoring system and that is borne out in this trial. the most important aspect with the devices is the abil- ity to make a diagnosis, that comes first and foremost, as well as the implantation procedure being not too invasive,’ ooi pointed out. biotronik home monitoring trans- mits patient heart data automatically on a daily basis, rapidly detecting deterioration in a patient’s clinical status. early detection of clinically rel- evant events, in particular paroxys- mal and asymptomatic arrhythmias, such as atrial fibrillation, enables the physician to adapt patient therapy at a very early stage. an interventional cardiologist, professor martin bergmann md heads interventional cardiology at cardiologicum hamburg in germany, a high volume pci centre. his focus is on structural heart work including tavi, mitral clip, laa, pfo and asd procedures. more than 1,000 patients are part of the ewolution registry across 45 centres. sze-yuan ooi md is a coronary inter­ ventionist and cardiac device implanter at the eastern heart clinic and prince of wales hospital in sydney, australia. his research interests include new coronary stents and implantable device technology, coronary inflammation, coronary physio­ logy and pressure wire technology. laa with watchman device device held by physician continued on page 14

headquarters: schiller ag, altgasse 68, ch-6341 baar phone +41 41 766 42 42, fax +41 41 761 08 80 sales@schiller.ch, www.schiller.ch designed for users who value state-of-the-art technology, schiller’s cardiovit ft-1 offers: easy 1-2-3 steps outstanding signal quality for adult and paediatric ecg bidirectional wi-fi communication improved interpretation algorithm with etm sport for athletes maximum performance in a compact electrocardiograph explore the new ecg world: schiller’s cardiovit ft-1 visit us at the esc in rome 27.8.-31.8.2016 e4-0200 eh_2016-08_ft-1_210x297_en.indd 1 11.08.2016 10:41:59 cardiology 15 www.healthcare-in-europe.com rom page 12 d versatility increase hospital zurich, who discussed how earlier management of atrial and ventricular arrhythmias is enabled by detection with icms, and dr niraj varma, from the cleveland clinic, who spoke about improving out- come of icd and crt-d patients by continuous remote monitoring. ‘efficient workflow and robust transmissions are critical to leverag- ing the benefits of remote monitor- ing,’ varma said. biotronik home monitoring facilitates this with daily automatic transmissions that pre- serve the highest order of data integrity, and are yet easy to handle. ‘this is a key reason why this system has been associated with improved clinical outcomes in sev- eral trials and why the current remote monitoring guidelines are based largely on home monitoring data,’ varma explained.’ professor josep brugada is medical director of the cardiovascular institute, at hospital clínic, university of barcelona, spain, and a past president of the european heart rhythm society. with his brothers, pedro and ramon, he identified brugada syndrome, a genetic disease characterised by abnormal electrocardiogram (ecg) findings and an increased risk of sudden cardiac death. the group of patients treated with sonr was 75%, compared to 70.4% in the echo group. it also emerged that optimisation with sonr resulted in a significant improvement in clini- cal response for patients with atrial fibrillation and renal dysfunction. professor brugada from the cardiovascular institute, hospital clinic, university of barcelona, said: ‘in order to deliver the very best crt treatment to our heart failure patients, there has been a real need for an optimisation solution that is both automatic and efficient. ‘the results of the respond-crt trial have shown that sonr perfectly meets this need. the high rates of responders together with the ben- eficial improvements in clinical out- comes indicate a significant advance- ment in crt therapy, one that will allow us to better treat a larger num- ber of heart failure patients. ‘automatic optimisation with sonr was as effective as echo-guided opti- misation - 75% v 70.4% – so the primary efficacy end point was met, that a clinical response was in favour of sonr but especially patients with history of af and renal dysfunction, and optimisation, using the sonr contractility sensor, showed signifi- cant reduction of 35% in rates of heart failure hospitalisation during long-term follow up.’ implanted cardiac resynchronisa- tion devices resynchronise the con- tractions of the ventricles of the heart by sending tiny electrical impulses to the heart muscle, helping the heart to pump blood more efficient- ly throughout the body. the sonr sensor uses measurements of car- diac contractility to optimise cardiac resynchronisation therapy. singh, from massachusetts general hospital, boston, explained that although echo-guided optimisation was considered the gold standard in terms of reducing the number of non-responders to crt, it was not widely used because of the com- mitment of time and resources it requires, as well as patients needing to attend the clinic. he added that the sonr can optimise av and vv intervals on a daily basis and on weekly basis for both rest as well as for exercise so patient do not have to come into the clinic or have echo guided optimisation. ‘the device using the sensors can automatically optimise the heart, overcoming the inadequacies of existing optimisation strategies and logistical issues with echo-guided optimisation strategies.’ respond-crt was a prospective, multicentre, randomised, double- blind study designed to evaluate the safety and efficacy of the sonr system. 1,039 patients were enrolled at 125 sites in europe, the usa and australia, who were implanted with a crt-d (cardiac resynchronisation therapy and defibrillation) device, which combines the function of an implantable cardiac defibrillator (icd) with cardiac resynchronisation therapy (crt). patients were randomised 2:1 to receive either av or vv optimisation with sonr or echocardiography, with the study meeting all of its primary safety and efficacy end points. continuous cardiac resynchronisation reduces hospitalisation ng af and renal ion care nce of all imaging modalities – including ate prosthetic heart valves in a new series phone +41417664242, fax +41417610880 eh_2016-08_ft-1_210x297_en.indd 111.08.201610:41:59

cardiology 17 www.healthcare-in-europe.com 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. user reports on working with new siemens equipment 55% of heart recipients now survive for 10 years 3-d transducers prove their mettle in cardiology transplants – a much neglected topic the 3-d tee transducer is fast and offers high volume a small report in the press prompt- ed examination of a much neglected topic. the report read ‘heart centre at university hospital no longer carries out transplants’, and referred to the university hospital frankfurt, one of the 22 heart centres that perform these transplantations. so what happened? only four trans- plants were carried out there between 2010 and 2013, and in 2014 and 2015 only two to three were performed per year. why? the same report also men- tioned that around thirty patients per year wait for donor hearts at this hos- pital. donor hearts continue to be in short supply, and organ donation is the problem. there have bee n no improvements in that situation, not only in frankfurt, or all of germany, but also across europe and globally. the ratio between those who received donor hearts and those waiting for donor hearts is increasingly unfavourable. figures from switzerland show an ‘average’ european example: when 33 people received donor hearts in 2005 not even double that number. i.e. 63, were waiting for donor hearts at the time. ten years later, in 2015, the number of transplants‘only’ increased to 40, whilst the number of patients on the waitlist increased to 134. in germany, says professor f w mohr, president of the german society for thoracic and cardiovascular surgery, more than 1,000 patients are currently one of the first facilities to pur- chase a complete set of the 3-d tee transducer, including the equipment, was the department of cardiology and angiology at university hospital magdeburg, as thomas groscheck, specialist physician for internal medicine at the echocardiography lab explains. since july 2015 he has worked with the new siemens transducer – and is enthusiastic. ‘in our department we treat all types of cardio-vascular disease, from cardiac insufficiency to hyperten- sion, valve repair and aortic valve replacement,’ thomas groscheck explains. ‘we perform all neces- sary studies prior to an intervention and do the follow-up for all car- diac patients, particularly those who underwent valve surgery or received a valve replacement.’ this is where the 3-d tee transducer comes in very handy. ‘what’s so special about this 3-d probe is that it is fast and offers high volume’, the specialist explains. this allows live images with a high frame rate, particularly in 3-d, which is very interesting during valve interventions. ‘i found the hardware and the software in the equipment to be very fast. thus you get high temporal and spatial waiting for donor hearts. however, only 320 hearts were actually transplant- ed. ‘the average patient has very little chance of receiving a donor heart. the organs donated are only allocated to particularly urgent cases,’ mohr explains. at the beginning of the 1990s still more than 420 heart transplants a year were carried out. the allocation of donor hearts in eight european countries (germany, belgium, netherlands, luxembourg, austria, slovenia, hungary and croatia) is coordinated by eurotransplant based in leiden, netherlands. the allocation is based on medical criteria, with no consideration given to national or any other criteria. eurotransplant works with a catchment area of 135 million people across europe. there are simi- lar organisations in scandinavia, cover- ing about 25 million people, or for eastern europe, along with the inter- nationally active society for heart and lung transplantation based in addison (texas, usa). a look at international figures and developments helps to better under- stand the situation. as is known, the first ever heart transplantation was carried out by professor christiaan barnard and a 31-strong team in south africa in 1967. the number of operations increased to 100 transplants (worldwide) in 1980 and to 4003 in 1990, with reported figures of 4203 in 1992, 4364 in 1993, 4429 in 1994 and 4396 in 1995. according resolution with regard to valve visu- alisation in 3-d. this translates into much better quality than our previ- ous transducers delivered.’ length of examination in terms of time spent on exami- nations the new tool also offers benefits. ‘the prep examination for a valve intervention takes ten min- utes on average,’ according to mr groscheck. ‘image acquisition and patient handling pre- and post-exam take about twenty minutes. after to the society for heart and lung transplantation, a total of 80,106 heart transplantations were carried out in 300 officially designated centres between 1967 and 2007. from the mid-1990s the numbers decreased continuously to around 3,000 per year. significantly better and more effective prophylaxis and major advanc- es in treatment, along with the lack of donor organs, are considered the rea- sons for this decline. in january 2016 more than 10,000 patients were waiting for donor hearts across the eight european countries coordinated by eurotransplant. if it had not been for advances in treatment the number of those waiting for donor hearts would be much higher still, say the specialist medical societies. however, documenting advantages and disadvantages with statistics does not do justice to the topic of heart trans- plantations. the history of heart transplants is also one of particular success. as is known, the first person to receive a donor heart, transplanted by prof. christiaan barnard in 1967,‘only’ survived the operation for 18 days. in those days the prospects of a ‘longer’ life after the operation were also generally not particularly rosy. however, over the course of the years and decades not only the surgical pro- cedures and the expertise and routines improved but also the direct care and aftercare for patients. that time all images are available, including the valve models.’ data acquisition is fast and the analysis can be speeded up when all tools for automatic valve assessment are used. the raw data that are gener- ated and which, theoretically, can be read by any machine, are turned into dicom images, which in turn can be viewed with any dicom viewer.’ handling transducer handling has been one of the main problems was, and remains, rejection of the donor organ. not least through the discovery and development of the immune suppres- sor cyclosporine has it been possible to achieve major success in this field. this ring-shaped, small protein which con- sists of 11 amino acids was discovered by the swiss biologist hans peter frey in 1969 and was publicised in the 1970s. it then led to the development of other, very effective drugs. it is assumed that the current, five- year survival rate is around seventy-five percent and the ten-year survival rate is still at around fifty-five percent to conclude, there are three things we can hope for: firstly, that the num- ber of those requiring donor hearts will continue to fall due to improved medical knowledge and prophylaxis, along with healthier lifestyles in large parts of the population. secondly, that the number of organ donors increases rather than decreases, and lastly that the survival rate con- tinues to increase closer towards the 100% mark through more experience, knowledge, routine and capabilities of the surgeons, along with advances in technology and aftercare. improved. with its plastic grip it is lighter than metal models. ‘this makes the transducer easy to handle,’ the physician reports. ‘nevertheless it takes some to get used to the new probe. the head is a bit more angular, not quite as round as we were used to. the loca- tion of the function buttons and the two knobs to control transducer head movement could be improved ergonomically. the control elements are no longer centred, which means the probe has to be held in a certain way in order to use it in an optimum way.’ however, these are the only handling issues thomas groscheck encountered with the new trans- ducers. temperature advantages there is one feature groscheck is particularly enthusiastic about: ‘with this transducer, temperature issues are a thing of the past. finally! although the device does have a cooling mode with reduced trans- mission performance, i have never been compelled to us it. despite the fact that in 3-d mode the trans- ducer heats up to about 40 °c, i always could easily complete longer sequences.’ thus interruptions due to overheating – a common prob- lem in longer examinations with high sound intensity, particularly in 3-d – are no longer required. ‘in 3-d mode, the 3-d tee transducer works for minutes without any tem- perature problems. that makes life much easier for patient and physi- cian alike. obviously, patient safety has been considerably improved with this device,’ groscheck points out. hand in glove the overall interaction of all ele- ments and components of the new transducer convinced the expert. ‘with a bit of training using the transducer is no problem. transducer, software, and process- ing programmes for the valve mod- els – they are all well aligned and integrate easily in any daily work- flows. even though the device with all its functions and settings might seem a bit technologically intimi- dating at first, actually using it is a real pleasure particularly because it works without a hitch and the individual components work hand in glove,’ groscheck sums up. thomas groscheck is an internal medicine specialist in the echo­ cardiography lab in the cardiology and angiology department, university hospital magdeburg. following his initial training as a nurse he attended medical school at charité – university hospital berlin. he is currently completing his doctorate. walter depner, writer and consultant specialising in the laboratory field 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

19 www.healthcare-in-europe.com laboratory & pathology jane macdougall the increasing numbers of bacteria resistant to the newer generations of antibiotics is a public health problem on a global scale. bacteria have an extraordinary capacity for adaptation, mutating permanent- ly to overcome the action of our increasingly impotent antimicrobial armamentarium. a situation further aggravated by the use of the pow- erful ‘large spectrum’ antibiotics, creating further pressure towards acquired resistance. extended-spectrum beta-lacta- mases (esbl) are enzymes that con- fer resistance to most beta-lactam antibiotics; these include penicil- lins, cephalosporins and aztreonam. community and hospital-acquired esbl-producing enterobacteriaceae are prevalent worldwide and include common gut microflora, such as escherichia coli. infections with esbl-producing organisms are asso- ciated with poor outcome and high mortality rates. however, because the reliable identification of esbl- producing organisms is challeng- ing, their prevalence is likely to be underestimated. the first esbl-producing organ- isms were isolated in the 1980s; today there are hundreds of differ- ent esbl-producing strains result- ing from successive mutations. the emergence, particularly in hospital, of resistant e. coli creates a vicious circle; the use of large spectrum antibiotics essentially leads to the emergence of greater numbers of resistant bacteria. christian cattoen, from the valenciennes hospital group in france, explained how this occurs ‘… the antibiotics are excreted from the body via the liver, therefore arriving in the digestive tract in bile. the normal gut microflora sensitive to the antibiotics is wiped out and in the void that is left, the resist- ant strains of e. coli, even if only present in very low numbers can now rapidly multiply. nature abhors a vacuum!’ to combat these bacteria a fam- ily of antibiotics, now nearly 20 years old was developed – the car- bapenems. the original molecule with anti-b-lactamase activity was derived from gram-positive bac- terium streptomyces clavuligerus. however, by the 2000s the first car- bapenem resistant strains had been isolated. resistance to carbapenems is now appearing at regular intervals worldwide from different mutations. the discovery of new producers of carbapenemases, a form of b-lac- tamase, is a worrying trend. ‘while still highly effective against esbl- producing organisms and other multi drug resistant organisms, both gram-negative and gram-positive, the use of these antibiotics must only be considered as a last resort,’ cattoen insisted. in 2015, the world health organisation issued a warning about the spread of bacteria resist- ant to carbapenems, drawing atten- tion to the fact that they were now a global phenomenon. this rapid increase and spread of dangerous bacteria turns the spotlight on the clinical laboratory. firstly, in helping to reduce the use of broad-spectrum antibiotics by concentrating on new methods for returning an antibiogram in a timely manner, so the clinician can initi- ate appropriate treatment for the isolated pathogen. recently devel- oped rapid antimicrobial suscepti- bility testing methods include clas- sical agglutination assays, molecular testing methods, e.g. qpcr, dna microarrays, luminex xmap assays and next generation sequencing. additionally, there are fluorescence in situ hybridisation (fish) and mass spectrometry-based meth- ods, e.g. phyloproteomics, assays using stable isotope labelling of amino acids, mass spectrometric beta-lactamase assays, pcr/electro- spray ionisation-mass spectrometry (pcr/esi ms), mini-sequencing and mass spectrometry-based compara- tive sequence analysis (mscsa) all aiming to rapidly identify and deter- mine the susceptibility profile of pathogens. while, not immediately available to all laboratories, clinical labora- tories should certainly think about incorporating techniques, such as dna chips, to more easily iden- tify carbapenem resistant bacteria, so that infected patients can be quickly isolated and the hospital’s contingency plan for containment implemented. ‘the clinical biologist should be fully implicated in this procedure,’ cattoen advised. the reliability of our results is primor- dial, the better the techniques we have, the sooner we can raise the alert and put processes in action, that the clinical laboratory needs to be at the heart of.’ * source: jib – journées internationales de biologie. press conference and scientific session. 24 june 2016 will antimicrobial resistance finally overcome us? carbapenem resistant strains the superbug known as carbapenem- resistant enterobacteriaceae as men appear to have higher risk of cardiovascular disease (cvd) than women of a similar age – with vas- cular calcification a strong predictor of mortality and morbidity from cvd – a team from the university of edinburgh hopes that exploration of a link between gender and calcifica- tion could help unlock the pathway to new therapies. the researchers have been look- ing at whether sex hormones could be the common ground, focusing on testosterone as the primary and most well-recognised androgen in men. they hypothesised that exog- enous androgen treatment induc- es vascular calcification and could explain this gender disparity and that testosterone may be key in explaining why men have a greater risk of heart attack. initially the study focused on the effects of testosterone on blood ves- sel tissue from mice and found that the hormone triggers cells from the blood vessels to produce calcifica- tion, which causes blood vessels to harden and thicken. in addition, when the mouse cells were modified, by removing the testosterone receptor so that they could no longer respond to testos- terone, the cells produced far fewer calcium deposits. the researchers also looked at blood vessel and valve tissue from humans with heart disease who had undergone surgery for their condition. they found that cells from these tissues contained bone- like deposits and also carried the testoster- one receptor on their surface, suggesting that testosterone may trigger calcification in humans. the work was co-ordi- nated by dr vicky macrae, group leader and reader at the roslin institute and royal (dick) school of veterinary studies at the university of edinburgh. ‘vascular calcification, a pathological process which involves the deposition of hydroxyapatite crystals in cardio- vascular tissues, powerfully predicts mortality and morbidity from car- diovascular disease’ she said. ‘this study addressed the hypothesis that testosterone induces vascular calci- fication. our in vitro studies found that testosterone increases the cal- cification of vascular s m o o t h muscle cells (vsmcs). furthermore, testosterone-induced calcification was reduced in vsmcs lacking the androgen receptor (ar) through which the biological actions of tes- tosterone are predominantly medi- ated.’ with androgens playing a role in inducing vascular calcification through the androgen receptor (ar), researchers suggest that androgen signalling may represent a potential therapeutic target for clinical intervention. ‘the prevalence of vascular cal- cification is sexually dimorphic, showing a relative increase in men compared to women, suggesting a hormonal influence,’ dr macrae added. ‘our data showing a direct effect of testosterone on accelerat- ing vascular calcification may there- fore be key to explaining why men have a greater risk of heart attacks.’ at present, there is no compre- hensive pharmaceutical treatment to inhibit the development of vas- cular calcification. however, the edinburgh team say this study fur- thers existing knowledge of the basic mechanisms underpinning this pathological process, and high- lights androgen signalling as a novel potential therapeutic target for clini- cal intervention. research is on going to under- stand the pathways behind the pro- cess and whether the results have implications for patients with heart disease. ‘calcification is particularly dif- ficult to treat, as the biological processes behind the disease are similar to those used by our body to make and repair bone,’ dr macrae explained. ‘by finding this link between tes- tosterone and calcification we may have discovered a new way of treat- ing this disease and also reducing heart disease.’ funded by the british heart foundation (bhf) along with the biotechnology and biological sciences research council (bbsrc), this research focused on testosterone was a collaborative study across a number of different research groups within the university of edinburgh in scotland. cardiovascular disease research testosterone clue to male heart deaths new research suggests that testosterone could be involved in explaining why men have a greater risk of heart attacks than women, mark nicholls reports vicky macrae phd is group leader and reader at the roslin institute and royal (dick) school of veterinary studies at the university of edinburgh. her group undertakes research on bone formation and vascular calcification, examining the mechanisms of differentiation and calcification in growth plate chondrocytes, osteoblasts, vascular smooth muscle cells and valvular interstitial cells. in vitro studies found that testosterone increases the calcification of vascular smooth muscle cells (vsmcs) ©lyricsaimay/www.shutterstock.com ©aunt spray/www.shutterstock.com

21 www.healthcare-in-europe.com surgery report: mark nicholls ‘amputation v. reconstruction’ – a vital issue – was debated by two leading surgeons during the microsurgical lower limb reconstruction session at the advances and controversies in reconstructive microsurgery (acrm) 2016 conference, held in the united kingdom this may. consultant plastic surgeon umraz khan, from north bristol nhs trust presented a plastic surgeon’s view, while ben davis, a consultant orthopaedic surgeon at the norfolk & norwich university hospital, dis- cussed the perspective of an ortho- paedic surgeon. during our european hospital interview, khan explained that an important question is ‘what consti- tutes a useful limb?’ and any deci- sion to amputate or salvage a trau- matised lower limb depends on a ‘since its foundation materialise has providing leading-edge, 3-d visuali- sation and printing solutions to its extensive list of hospital, academ- ic and medical device customers,’ explains the belgium-based manu- facturer materialise. ‘the new open and flexible platform of software and services forms the foundation of certified medical 3-d printing, in clinical as well as research environ- ments, enabling medical profession- als to revolutionise patient treat- ment,’ the firm explains.’ ‘the platform includes plan- ning and design software tools, 3-d printed anatomical models and number of requisites being in place. ‘an important requisite is that there must be no chronic pain,’ he continued. ‘the difference with the lower limb is that it bears weight and if every time a patient puts their foot down it hurts, they will limp and that will have a detrimen- tal effect on the more proximal joints, the hip joint or the back, for example. ‘the patient then becomes addict- ed to painkillers and they are bet- ter off losing the limb. pain is an important consideration and a reconstructed limb really should be pain free.’ he also stresses that ‘reconstruc- tion should be within the realms of possibility’ and, whilst surgery may be technically possible, if it leaves the patient with significant morbidity the solution is not to do reconstruction. surgical guides, and patient-specific implants,’ the company reports. ‘launched during the american association of orthopaedic surgeon’s annual meeting (aaos), the suite also introduces material- ise mimics inprint, a new software solution that enables surgeons to create accurate medical models for 3-d printing in hospitals without the need of advanced clinical engineer- ing support. ‘with this suite, we have drawn together medical software and ser- vices, both established and new, into a single, neutral platform that facilitates the further integration scoring systems are available to help a surgeon to decide, although he said the clinical experience of the surgeon remained the critical factor. advances in technology and surgical practice have changed the approach to lower limb trauma, and the pros- pect of limb transplantation is also on the horizon. ‘we are able to grow bone, which we could not do reli- ably before,’ khan pointed out. ‘if someone had bone loss it was almost certain amputation in the past, whereas now we can grow bone in a frame and the plastic surgeon is involved in providing microsurgery for that.’ the demographic of patients is changing, shifting away from young adult males involved in road acci- dents towards older active early retirees. amputation rates are falling and, khan explained, ‘while there are of 3-d planning and printing into hospitals. for example, the system allows clinicians to 3-d print by connecting data from all modern imaging systems to the ever-expand- ing range of 3-d printers now on the market. ‘the system also includes soft- ware for predictive planning and communication; patient-specific guides that transfer a co-created sur- gical plan to the operating theatre (ot); and patient-specific models and implants that enable surgeons to treat complex cases. ‘for more than 25 years, materialise has been identifying meaningful applications some patients who have a futile reconstruction and have a delayed amputation either through infection or pain, which used to be up to 30 percent two decades ago, but has come down to about three to four percent because we are making the right decisions about the patient – and it is the surgeon’s experience and decision making that has a massive impact for the patient in the long-term.’ davis, who believes that salvage of a limb, or as much as circumstanc- es allow, is the preferred option, highlighted the bespoke nature of every case. ‘there is a tendency for surgeons to assert very blunt and incorrect conclusions about the rapidity with which patients can be mobile and active after amputation, but those conclusions are generally wrong,’ he suggests. ‘amputation is, by definition an all or nothing event that should be reserved until it is clearly necessary.’ during the acrm session, davis highlighted how the ‘decision regarding amputation and salvage of the lower limb is complex and there is no algorithm, formula or protocol that can be applied to an individual patient.’ both surgeons acknowledge the significant development of pros- thetics, however, davis warns that of 3-d printing and developing the backbone of software and solutions needed to successfully bring them to market,’ said wilfried vancraen, materialise founder and ceo. ‘we see incredible potential for 3-d printing in hospitals, but have also recognised that many existing solu- tions have slowed adoption of the while the success of the paralympic games and publicity surrounding the rehabilitation of military person- nel highlights the amazing potential of prosthetics, the level of rehabili- tation and the motivation of these individuals is not representative of the general population. ‘at the same time as prosthetics advance, so does the technology and understanding of tissue engi- neering and implants, creating sal- vage options where previously none existed,’ davis added. in terms of salvage, 3-d printing and tissue engineering are likely to enable the bespoke creation of mechanical and biological implants for individual problems and more reliable and sophisticated implants for limb lengthening are already available and being used with great success, he pointed out. ‘in prosthetics, the use of osseo- integration is under-going a resur- gence of interest and the possibili- ties created with computerisation, robotics and power assistance will continue to drive forward prosthetic possibilities,’ davis explained. but, he warned that, when look- ing to amputate or salvage, the patient’s wishes and perspective are paramount in the decision-making. ‘from a patient’s perspective, hav- ing your own stable functional limb is unlikely to ever be bettered,’ he said. ‘if, however, a patient is living with a chronically painful, poorly functioning limb and has reached the end of the salvage options, or has reached the decision him or her self that they no longer wish to continue with the salvage, then amputation can be a very positive step forward.’ technology. therefore, we devel- oped the materialise mimics care suite to help hospitals to better integrate 3-d printing and begin unleashing the benefits it offers, which include potential cost savings and patient care improvement.’ lower limb trauma – the critical choice belgian firm designs platform specifically for hospitals reconstruction or amputation medics gain a suite for 3-d printing umraz khan is a consultant plastic surgeon at the north bristol nhs trust. he publishes regularly on different aspects of patient trauma with a specific area of research focused on ways of improving functional outcome. ben davis is consultant trauma, ortho­ paedic and limb reconstruction surgeon at the norfolk & norwich university hospital. his research interests lie in outcomes in trauma surgery, non-union, fracture healing and external fixation. 3-d printed anatomical bone model by materialise ©wavebreakmedia/www.shutterstock..com

23 www.healthcare-in-europe.com surgery why the scepticism? ‘we are caught between the tech- nological viability of these inno- vations – their use and potential benefits – and their economic via- bility,’ explains surgeon andreas kirschniak, at tübingen university hospital. ‘in countries with case- based reimbursement schemes, par- ticularly in germany, the fact that using these systems frequently does not make economic sense is the major obstacle,’ he points out. if the use of a robot-assisted surgery system costs more than the insur- ers will reimburse, hospitals quickly question the legitimacy of such technologies. the current robotic versus laparoscopic resection for rectal cancer (rolarr) study (https:// c l i n i c a l t r i a l s . g ov / c t 2 / s h ow / nct01736072study) was expected to offer renewed hope that the robotic industry can deliver systems which indeed will improve onco- logical outcomes. ‘unfortunately the study did not yield the expected results. there are indications of a trend towards improved outcomes, but statistical significance could not be reported,’ kirschniak says. the bottom line for physicians is sim- ple: does it makes sense to acquire such expensive equipment – with the total cost of ownership going beyond the acquisition price and including substantial amounts for training and operating costs. ‘we are smack in this tension between economics and viable healthcare innovation,’ he regrets, although still convinced that robot-assisted surgery will prevail: ‘particularly with interventions that require closures in minute spac- es through minute accesses, such as d’hoore rectopexy, a robot is unbeatable.’ enter haptic feedback ‘when your fingers touch the tissue you feel how strong it is, you feel its elasticity, the pressure you are exert- ing,’ kirschniak explains, ‘and, even with forceps and a needle holder, you do get haptic feedback to a cer- tain degree.’ but on the next level, in laparoscopic interventions when long instruments are used, haptic feedback is close to non-existent. ‘this is where the robot enters the stage. it can exert far more force than a human surgeon. when the surgeon at a workstation asks the robot to pull the tissue, it executes the command, no matter what,’ says kirschniak. today, robotic systems do not provide feedback on the force they apply in vivo. ‘but, two systems are scheduled for launch in the course of the next two years that offer precisely this type of haptic feedback.’ for kirschniak this is a major benefit since any intervention, be it with or without robotic assistance, has to be as gentle as possible on the patient. ‘in a joint project with darmstadt technical university (financed by the german research fund), we developed such a robot. and it works very well,’ kirschniak is pleased to report. the force applied in the new robot is not measured at the tip of the instrument in the sterile area but in the adjacent non- sterile area and the values are fed back to the surgeon. we will see… ‘imagine your tests have shown precisely how much force you can apply on a certain tissue with- out causing micro-trauma!’ that, kirschniak believes, would be major progress because, in almost all sur- gical interventions, tiny and often invisible ruptures occur, mostly because every patient is d i f f e r e n t , every tissue is different. ‘i’m truly convinced that this new technology will be used in numer- ous indications particularly due to the robot’s ability to move ‘around the corner’ and in minute spaces,’ kirschniak emphasises. ‘true, robot- ic surgery still has to prove its met- tle, but once the first robots with haptic feedback are commercially available i am sure the market will react and new applications will be developed.’ robotic surgery still has to prove its mettle haptic feedback is a possibility robot-assisted surgery still meets with considerable scepticism even though intuitive surgical’s da vinci system has been around for more than a decade. however, few surgeons and researchers are seeking ways to expand the surgical toolbox. not so the members of the working group ‘surgical technology and training’ at the general, visceral and transplantation surgery department, university hospital tübingen: they are particularly interested in haptic feedback for robot-assisted systems. ‘several systems are about to be launched. these are exciting times,’ says andreas kirschniak, head of the tübingen working group and surgeon by training. made in italy, the starled7 nx design is naturally handsome, practi- cal, compatibility with laminar flows and provides excellent light qual- ity. ‘the special optics of its leds generates a shadow-less, clear and homogeneous light assuring visual comfort and best working condi- tions,’ acem spa confirms. the 57 next generation leds are circularly placed and split into seven,’ and, the manufacturer adds, the device gener- ates an ir-free light, excellent colour temperature and a practically endless life cycle at low consumptions. with high illumination level of 160.000 lux, a colour rendering index of 95 and colour temperature of 4.500 °k the exact chromatic scale of human body colours can be achieved, acem points out. ‘the lamp is provided with acris, an innovative system realised by acem that ensures, by the use of a microprocessor, the control of electrical curves typical of leds to remain unaltered over the time but maintaining a long life cycle (about 50.000 hours),’ the firm adds. other assets include light field dimension adjustment through opti- cal-electronic management, i-sense control panel, adaptable and adjust- able illumination levels for different tasks, and more. ‘this light allows visualisation of the operating field as well as the sur- rounding environment clearly and is particularly suitable for minimal invasive surgery and for preparation and treatment during an operation, monitoring of the patient and micro- scope operations,’ acem adds. on demand, the removable and sterilisable central handle can house a video camera to record surgical operations accurately and the video camera can also be placed on a separate arm. details: www.acem.it shadow-less clear homogenous lighting andreas kirschniak md heads the ‘surgical technology and training’ working group at the general, visceral and transplantation surgery department at tübingen university hospital. his clinical focus is colorectal and pelvic floor surgery, robot-assisted surgery and the surgical treatment of chronic inflammatory bowel disease.