Vol 32 ISSUE 2/23 • June 2023 THE EUROPEAN FORUM FOR THOSE IN THE BUSINESS OF MAKING HEALTHCARE WORK Cancer patients at risk Blood test detects risk of neurotoxicity from CAR T-cell therapy Evidence of a stroke (red arrows) is seen on this MRI scan of a brain of a patient who developed neurotoxic side effects after CAR T-cell therapy. © Dr Omar H. Butt of Washington University at St. Louis is an therapy Chimeric antigen receptor (CAR) T-cell im- munotherapy treatment that re- engineers a patient’s own T-cells to help them attack malignant tumour cells. It has been very ef- fective in the treatment of blood cancers, including certain types of leukaemia and lymphoma. However, two serious side effects are common as a result of the treatment: cytokine release syn- drome (CRS) and immune effec- tor cell-associated neurotoxicity syndrome (ICANS). ICANS Researchers in Germany and in the United States have separately de- termined that high levels of serum neurofilament light chain (NfL), a protein in the blood indicative of neuroaxonal injury, are associated with complications. A simple blood test identifying NfL levels can help identify cancer pa- tients who are at risk of developing ICANS following CAR T-cell ther- apy. ICANS represents a broad spectrum of neurologic symptoms ranging from mild confusion, tremor, headaches, difficulty read- ing, difficulty concentrating, lethar- gy, and memory problems to se- vere brain swelling, seizures, coma, and even death. Between 40% to 60% of patients receiving CAR T-cell therapy develop ICANS. Two independent studies, one con- ducted at the Washington Univer- 2 In lab, a virus “infects” T cells with CARs. 1 Patient donates blood to get T cells. www.healthcare-in-europe.com Harnessing the Power of the Immune System to Fight Cancer Chimeric antigen receptor (CAR) T-cell therapy uses the child’s own immune cells to seek out and kill tumor cells. 3 CAR T cells muitiply. 4 Tests ensure safety and purity. sity at St. Louis (WUSTL) and the other by a multi-institutional Ger- man team led by researchers at Ludwig Maximilian University (LMU) of Munich, have identified that higher NfL levels in cancer pa- tients’ pre-CAR T-cell treatment correlate with the severity of sub- sequent ICANS. German multi-institutional study Principal investigator Prof Louisa von Baumgarten, MD, of LMU’s co- University Hospital, researchers that and hypothesized neuroaxonal integrity might have an important role in determining the severity of ICANS. Their hy- pothesis was based on numerous studies demonstrating that NfL serum levels correlate well with cerebrospinal fluid levels, mirror the extent of neuroaxonal injury, and predict outcomes for severe neurologic conditions, including multiple sclerosis, neurodegener- ative disorders, traumatic brain in- jury, and ischemic stroke. their serum NfL Ninety-six patients being treated at CAR T-cell therapy centres at LMU and University Hospital Heidelberg had levels measured five days before treat- ment, the day of treatment, and on the day that maximum ICANS symptoms were exhibited. NfL pre- levels were significantly higher in patients who developed moderate to severe ICANS after CAR T-cell transfusion than in patients repor- ting no or mild ICANS. Both post- treatment and pre-treatment NfL le- vels correlated with the severity of the subsequent neurotoxicity. l a t i p s o H h c r a e s e R s ’ n e r d l i h C e d u J . t S . 0 2 0 2 t h g i r y p o C © 6 CAR T cells HUNT for cancer cells, BIND to them and DESTROY them 5 CAR T cells infused into patient. Predicting severe neurotoxicity Writing in Blood Advances, the re- searchers said, ‘These findings sug- gest that measuring the level of NfL – alone or in combination with known risk factors such as tumour burden, CAR T-cell expansion, sys- temic inflammation, and immune system activation – might be useful to predict severe neurotoxicity after CAR T-cell transfusion […]. Our data imply an increased risk for more se- vere ICANS as a result of neur- oaxonal injury if NfL – pre-treatment is greater than 75 pg/ml.’ They are currently validating the predictive value of NfL levels in a prospective setting, and correlating findings with EEG, fMRI, and comprehensive neuropsychologic testing. USA study Armin Ghobadi, MD, and Beau M. Ances, MD, PhD, both of WUSTL, led a similar study, published in JAMA Oncology. They measured plasma NfL levels of 30 patients re- ceiving CAR T therapy at WUSTL and Case Western Reserve Univer- sity in Cleveland at seven time- points, starting at baseline pre-CAR T infusion to 30 days after. They analysed NfL levels in patients who developed each severity grade of ICANS and those who did not, as well as age, sex, tumour burden, history of neurologic disease, and history of neurotoxic therapies. ‘Patients who developed any grade ICANS had significant elevations in baseline NfL level,’ they write. ‘Baseline NfL level correlated with ICANS grade. No association was observed with demographic, onco- logic, neurologic, or exposure to neurotoxic risk factors, such as CRS. The risk of developing ICANS is associated with pre-existing neuroaxonal injury that was quan- tifiable with plasma NfL level in a subset of patients.’ Ongoing prospective trial WUSTL lead author Omar H. Butt, MD, PhD, tells European Hospital that the team is scaling up to wide scale testing in the near future. ‘We are also trying to determine where in the brain this injury originates, how this injury interacts with the immune system to develop symp- toms, and how long the injury lasts after symptoms along with its lin- gering consequences. All these questions are under active investi- gation with an ongoing pros- pective trial integrating advanced neuroimaging with blood and spi- nal fluid biomarkers and neuro- physiological testing in patients undergoing cellular therapy.’ ■ Report: Cynthia E. Keen CONTENTS LABORATORY ROBOTICS RADIOLOGY 1-4 5-7 8-12 www.healthcare-in-europe.com

LABORATORY Pre-eclampsia Detecting high-risk pregnancy with heart attack test 3 an require About five percent of all women develop so-called pre-eclampsia during pregnancy, which in se- vere cases can become life- threatening for mother and child and emergency caesarean section. Until now, the risk has been determined rather unspecifically on the basis of fac- tors such as diabetes, obesity or the mother‘s age. Using commer- cially available troponin tests, high-risk patients could be ident- ified much earlier and more ac- curately than before, an ap- proach from Freiburg, Germany, shows. diagnosis much more difficult. A reliable test that can indicate the development of pre-eclampsia at an early stage would be a great help,’ says Prof. Dr. Ingolf Juhasz- Böss, Medical Director of the De- partment of Gynaecology at the Freiburg University Medical Center. In the next step, the Ger- man researchers want to check their results in a prospective study and combine the data from the troponin test with other risk fac- tors. In this way, the safety of pregnant women and their unborn children could be creased. ■ further in- Source: Medical Center – University of Freiburg SAFETY AND VALUE. It's in our blood. Prof. Dr. Dirk Westermann, Medical Director of the Department of Car- diology and Angiology at the Medi- cal Center – University of Freiburg presented this completely new ap- proach at the Congress of the American College of Cardiology (ACC) in New Orleans, USA. Predicting severe courses Troponin tests have long been used in acute diagnostics for sus- pected heart attacks. ‘We were able to show that the troponin level in the blood is very closely associated with the risk of later pre-eclampsia. In particular, severe courses of the disease can presumably be pre- dicted very well. This could make early and targeted prevention poss- ible in the future,’ says Wester- mann. The numerous risk factors for pre- eclampsia include being very over- weight, diabetes, previous multiple pregnancies and a very young or old age of the mother. If several of these factors come together, the pregnant women are closely moni- tored and receive prophylactic medication with aspirin. But: ‘By far not all women with risk factors actually develop pre- eclampsia. We were able to show that women with a low troponin level did not develop pre- eclampsia despite risk factors. TAKE CARE, STAY SAFE WITH VACUETTE® SAFETY PRODUCTS We know how much your daily work takes from you. The least we can do is keep you and your patients safe. Prof. Dirk Westermann © University of Freiburg It's why every detail of our VACUETTE® Safety Products are designed to make a difference to nurse, patient, and lab safety. ‘Thus, about 40 percent of the women would not have needed closer care,’ says Westermann. For their study, the Freiburg physicians examined 3,080 blood samples from four international studies of a total of 2,293 pregnant women. ‘We can already treat women with pre-eclampsia very well today. So far, however, the causes of the dis- ease are unknown, which makes www.healthcare-in-europe.com Let us take care of blood collection. Greiner Bio-One GmbH / Kremsmünster, Austria / E-MAIL office@gbo.com We are a global player / Find the contact details of your local partner on our website.

ROBOTICS 5 State of the art and latest advances in technology Robotic assistance in the operating room Surgical robots are becoming widespread in operating the- atres, delivering accuracy and safety. An overview of the main systems, principal operators, the market and European initiatives in this field. of procedures. Modern surgery has come a long way in the past decades, thanks to improved techniques, tools and medical equipment. However, traditional surgery still has some limitations, including accuracy as well as fatigue and hand tremors in surgeons, which can impact the quality For example, with spinal surgery, accu- racy of movement must be better than 2 mm to avoid spinal cord in- jury. The threshold for errors is very low too, with a rate lower than 3% being necessary to avoid serious com- plications. In brain surgery, these margins become even smaller, with movement accuracy > 1 mm and error rates > 2%. Ophthalmic sur- gery takes this to the extreme, with an accuracy than 0.5 mm to avoid corneal damage, and error rates less than 1%. postoperative limit better 1.5 million robot-assisted procedures each year These limitations have led to the emergence of robot-assisted sur- gery, which has dramatically in- creased the accuracy of surgical procedures while reducing hospi- talisation times and postoperative complications. Surgical robots have been designed for use in a wide variety of surgical procedures across multiple fields, including cardiology, gynaecology, and urol- ogy. The latter has seen an especially pronounced surge in robotic use; while in 2008, only 1.5% of urology surgery was performed with robot assistance, this has skyrocketed to over 43% today, according to vari- ous hospital sources. In total, some 1.5 million surgical procedures are performed worldwide using sur- gical robots. The advantages of this are manifold, including access to difficult areas through the use of slender, flexible robotic arms and on-board cameras, stable navi- gation of surgical instruments, sig- nificant reductions in operating times and hospital stays, as well as a reduction in postoperative com- plications infections, etc.). (bleeding, According to the colloquium paper “The state of the art of robotic sur- gery”, presented in October 2022 in Lyon, France, at the French As- sociation of Biomedical Engineers congress, 71 technology options for automation and assistance with surgical gestures are currently available companies around the world. from 63 The procedures that have bene- fited most from surgical robotics include prostate removal and renal ureter repair, gastrectomy, chole- cystectomy and colectomy, plus heart valve surgery and coronary bypass surgery, along with total hip and knee replacements. This is www.healthcare-in-europe.com hip. This advanced robotics for op- timised orthopaedic surgery pro- ject has been awarded a €3.5 mil- lion grant. Since its inception in 2018, the French startup has rapidly validated its proprietary al- gorithm based on pre- and intra- operative data collected via an ob- servational study on 100 patients. ‘We aim to offer the first compact, intuitive and cost- ergonomic, effective says Cahen. This next generation of robot introduces computer vision- driven intelligence and perception into the operating theatre, allowing contactless localisation of the pa- tient’s anatomy and opening the way to data-driven operating the- atres. robotic device,’ Microsure, based in Eindhoven, the Netherlands, is a spin-off from Eindhoven University of Tech- nology (TU/e), and has developed the world’s first clinically available CE-marked microsurgery robot. The Meet MUSA project, funded by the EU to the tune of more than €2.6 million, will tackle the ob- stacles to successful product roll- out, including scaling up and opti- mising manufacture. Mechanics, electronics engineers, software de- velopers and control engineers at Microsure have designed a system where surgeons look through 3D glasses at a large screen connected to a digital microscope positioned above the patient. The movements made by the surgeon using joys- ticks are detected and transformed into highly accurate movement of the small, lightweight robot at- tached to a platform fitted with arms able to hold and manipulate microsurgical instruments. In a 2020 study, surgeons reported using MUSA to treat breast cancer lymphoedema, a chronic condition that commonly occurs as a side ef- fect of cancer treatment and is characterised by a swelling of body tissue as a result of a build-up of fluids. To perform the surgery, the robot sutures tiny lymph vessels measuring just 0.3 to 0.8 mm in di- ameter to nearby veins in the af- fected area. ‘Given this large unmet need in microsurgery, we are con- vinced that the time is right to launch MUSA on the market,’ said Sjaak Deckers, CEO of Microsure. The company will introduce MUSA across Europe by 2029, confident that that it will achieve major social and economic impact. ■ Report: Bernard Banga MUSA, the world’s first clinically available CE marked microsurgery robot © Microsure BV a burgeoning market expected to be worth $14.9 billion by 2028. Three robotic systems The top five surgical robot manu- facturers by market share in 2020 were Intuitive Surgical, Stryker, Medtronic, Zimmer Biomet, and Smith & Nephew. Intuitive Surgical supplies four robots for urology, ENT, abdominal and gynaecology surgery – the Da Vinci and Ion platforms. These have a market share of more than 69% between them. Stryker has the Malo plat- form, with a motorised arm hold- ing cutting instruments (oscillating saw, acetabular burr) linked to an infrared stereoscopic system for partial knee replacement surgery. Medtronic has developed two sys- tems: a semi-automatic navigation assistant named the Mazor X Stealth Station, for rectifying spinal deformity, and the Hugo RAS multi-port remote guidance sys- tem. Zimmer Biomet markets a semi- automatic navigation assistant for partial and total knee replacement, its Rosa Knee robot. Finally, Smith & Nephew has the Navio FPS plat- form, a manual navigation assistant using a handpiece combined with an optical navigation system de- signed for partial and total knee arthroplasty. Faced with the emerg- ence of numerous surgical robots, the biomedical and equipment de- partment at Geneva University Hospitals in Switzerland, together Five generations of surgical robots 1980 – neurosurgery. The first generation of surgical robots was developed for neurosurgery. The robot was used to position a probe in the brain with great precision. This first generation of robots were manufactured by AESOP Medical (US) and ZEUS Robotics (Canada). The AESOP robot was controlled by a remote surgeon, while the ZEUS robot had a more advanced interface, allowing the sur- geon to control the robot’s movement. 1990 – remote control. The second generation of surgical robots saw the intro- duction of robotic laparoscopy surgery. The robot was able to control the surgical instruments remotely, allowing the surgeons greater precision and ease of use. The manufacturers of this generation of robots were Intuitive Surgical, Computer Motion, and SRI International, all from the US. The Intuitive Surgical robots were the most advanced, offering surgeons greater dexterity, accuracy, and stability. 2000 – more indications. The third generation of surgical robots was characte- rised by the extension of robotic surgery to include cardiac and orthopaedic sur- gery. Robots from this generation were more compact, easier to use and more precise than previously. The manufacturers here were Intuitive Surgical, MAKO Surgical, plus Mazor Robotics from Israel. Intuitive Surgical robots dominated the market with their advanced technology, high precision, and ease of use. 2010 – the limits of precision pushed back. The fourth generation of surgical ro- bots saw the introduction of precision robotic surgery, with robots capable of even more precise movements and control of surgical instruments. The robots in this generation were also smaller and more portable than before. Manufacturers included Intuitive Surgical, TransEnterix and Verb Surgical, all from the US. 2020 – artificial intelligence enters the operating theatre. Surgical robots use ar- tificial intelligence (AI) to improve the precision, speed, safety, and reliability of surgical operations. For instance, the French company Robocath has developed R One, a robotic system for assisting cardiac surgery which uses AI to learn a sur- geon’s exact movements in order to optimise the pathways taken by surgical in- struments. with the Swiss Foundation for In- novation and Training (SFITS), have just published a guide listing and classifying all automation and assistance technology options for surgical gestures. This collabor- ative effort is the result of a year- long survey of robots on the mar- ket. ‘The process of choosing and introducing these high-tech sys- tems into the complex environ- ment of the hospital must be sub- ject to a structured and complete methodological ex- plains Hervé Jacquemoud. approach,’ His team distinguishes between guidance assistants, laparoscopy devices and telesurgery systems. ‘Depending on whether the guid- ance assistants have a motorised arm, an instrument holder and whether they perform the pro- cedure autonomously, we classify these into visualization assistants and manual, semi-automatic or automatic guidance assistants,’ the expert continues. Within the cat- egory of automatons, robots are sub-classified as motorised or non- motorised augmented instruments, or motorised endoscope holders. Finally, telesurgery systems are said to be single-port when only one incision is required, and multi- port for several. Future generations of surgical robotics supported by the EU The number of knee replacement procedures in OECD countries is expected to increase from 2.4 mil- lion procedures today to 5.7 mil- lion by 2030. ‘Currently, 95% of procedures are performed with no robotic assistance and with a very high patient dissatisfaction rate of more than 20%,’ observes Sophie Cahen, co-founder and CEO of Ga- nymed Robotics. Her med-tech company, based in Paris, France, has been selected by the EU for in- clusion in a project which hopes to develop a compact robot to make joint replacement surgery more precise and less invasive. The in- itial focus is on total knee replace- ment, though Ganymed is looking to expand this to other joints in- cluding the shoulder, ankle and

ROBOTICS 7 More quality time for patients Transport robots help care staff base of the cart to be transported,’ Graf explains. ’The transport robot can move in any direction and is thus suitable even for confined spaces. A 360° safety system with sensors makes sure that the robot does not present a danger to people.’ Moreover, the system can be preprogrammed to execute cer- tain tasks at certain times or be used spontaneously as required. out during the shift the nurses can order replacements on their mobile phone. The robot then brings the restocked cart to the room where it is needed. At the end of the shift the robot takes all carts back to the storage room. Thus the nurses can stay with the patients while new material is being fetched; due to its mobility, the robot can support several team members. Robot, fetch! A possible scenario could be as fol- lows: at the beginning of a shift the robot places the required number of carts – let’s say with bed linen or care utensils – to predefined lo- cations. When that cart‘s stock runs While the robot takes over the transport, restocking the carts still needs to be done manually by human colleagues. But Dr Graf’s team had an idea how to solve this problem: modular baskets at an automated changing station. Graf explains that ‘each modular basket contains the items necessary for a certain task, for example taking blood samples or changing wound dressing. When all items in the basket are used up, the robot auto- matically moves to the changing station and replaces the baskets – without human intervention.’ Sensors scan each item taken from the shelves to facilitate stock management. © Fraunhofer IPA sent to the staff,’ says Graf. ‘Since the system is linked to the facility‘s material management system, an order can be placed immediately.’ Each cart can be equipped with this technology but it is par- ticularly simple to implement with patient care carts featuring a screen that provides access to the documentation system. ready robot could be developed rather quickly. The economic bene- fits have already been verified in a sample calculation. ‘In a 100-bed facility, a robot that takes on the entire transport of fresh and soiled laundry has paid off within three years. If it takes on more tasks, that period is even shorter.’ ■ Report: Sonja Buske Care staff can direct the robot via app. © Fraunhofer IPA Sensors for stock management are particularly helpful. ‘Each item taken from the stock is scanned. When the available stock has reached a certain level and needs to be replenished, a message is The prototype of the transport robot has been extensively tested in the Fraunhofer labs. ‘Now would be a good point in time for an in- dustry partner to come on board,’ Graf points out, since a market- Surveys and studies regularly ar- rive at the same conclusion: care staff, particularly in hospitals, want more time to spend with the patients. Persistent staff shortages, however, continue to increase the staff’s workload and thus render this wish well-nigh impossible. But there might be help around the corner: the Fraunhofer Institute for Manu- facturing Engineering and Auto- mation IPA developed a flexible transport robot to support care staff in hospitals. Being a hospital nurse entails con- siderable footwork: moving be- tween patient rooms, departments, the lab and different storage rooms, nurses can chalk up several kilometers during a single shift. The time spent in the hallways means less time for bedside patient care. Engineer Dr Birgit Graf and her team at Fraunhofer IPA ad- dressed this issue in their MobDi project by developing a transport robot that can lift any cart with suf- ficient ground clearance and take it to the desired location – be it laun- dry or meal carts, garbage or bev- erage carts. ‘Length and width of the robot chassis can be adjusted according to the size and wheel Improving accuracy Robots push the door of interventional radiology in tumour Long confined to surgery, robots are making their first steps in in- terventional radiology. Those de- vices could help improve ac- curacy targeting during needle insertion and help radiologists less experienced perform lead- ing French interventional radi- ologist showed at the Spectrum conference in Miami. ablations, a Robots have gone a long way ever since they were introduced to the field of neurosurgery in 1985. Many devices are available today, and some have the potential to boost interventional procedures, according to Thierry De Baère, professor of medicine at Paris Sa- clay University and Head of Inter- ventional Radiology at Gustave Roussy Cancer Centre in France. For over a year, his team has worked with the Epione robot sys- tem from French manufacturer Quantum Surgical, which has shown promising early clinical re- sults in more than 100 patients for ablation procedures and other needle guided procedure at Gus- tave Roussy. The team has used the robot for various types of pro- cedures including cryoablation, RFA and MWA in the liver and kid- www.healthcare-in-europe.com ney, as defined by the device’s CE mark. But the French group also used the robot off-label in bone re- construction and lung thermal ab- lation. Their experience has been very positive, De Baère ex- plained. ‘The robot is giving you the needle trajectory and placing the needle on track,’ he said. ‘The robotic system of needle insertion is safe, highly feasible and requires only a few needle adjustments. It provides efficient thermal ablation.’ Steps for robotic needle insertion include image acquisition, needle trajectory planning, robot place- ment, needle insertion and image verification. ‘You align the centre of the ablation to the centre of the tu- mour, then you’re all set and ready to send the robot,’ he said. ‘You send the arm to the location estab- lished in the treatment planning. And all you have to do is to push the needle in a single step from the skin to the target, which is some- thing that we’re not used to.’ After the insertion, radiologists can see where the needles are and correct the position if needed. An interest- ing possibility with the system is how it can expedite needle inser- tion in procedures where multiple needles are required, De Baère ex- plained. ‘Tumour ablation in the kidney can be complex and time Prof. Thierry Jacque De Baère at work with Quantum Surgical‘s Epione robot. jectory, offering a new way to ap- proach the tumour.’ Last but not least, there is a short learning curve for the system and beginners can start working very fast with the equipment. ‘Everybody can do the same. For a beginner it’s great,’ said De Baère, who com- pared the performance of three ex- perts with ten years’ experience with that of a novice without prior experience in sticking needles. ‘In just a few days, the beginner was doing as good as we have done for the past 20 years,’ he said. Another significant benefit with the robot is its respiratory monitoring function. ‘It’s better to work under apnea, be- cause the target is moving with the breathing, so you need to monitor that. If you cannot reproduce your breath hold, you might get the wrong target,’ he said. Future development will need to take into account footprint, com- parison of set-up time vs. manual adjustment. ■ Report: Mélisande Rouger consuming if we have to stick many needles,’ he said. ‘With the robot, insertion of one additional needle was below one minute in most of our patients, and below two minutes for the rest. Once we decide our trajectory, we can go faster with the device.’ There are several areas where the system could help advance inter- ventional radiology, he went on. ‘The robot increases the degree of freedom for needle insertion in any plane. This could offer more stable guidance and accuracy at the time of placing the needle tip at the centre of the target,’ he said. A second benefit concerns dose re- duction. ‘As interventional radi- ologists we get a lot of radiation when we are working and dose matters to both patients and phys- icians,’ he said. ‘With a robot, it’s obvious that you can decrease radi- ation to physicians because they are no longer inside the room.’ One more thing De Baère hopes to achieve with the robot is more ho- mogeneity in axial and oblique plan needle insertion. ‘In oblique plan puncture, you don’t see the whole plan during the entire needle placement,’ he said. ‘With the robot, there should be no vari- ation, as it gives you angle free tra-

RADIOLOGY Disaster victim identification Radiology in DVI: distressing insights and “hidden gems” 9 Advertisement Identifying victims of major dis- asters remains a significant chal- lenge for investigators. Often, identification can take weeks or longer, but new approaches are paving the way for greater ac- curacy and quicker identification whilst preserving the body with- out unnecessary invasive investi- gation. In mass casualties or terrorist at- tacks, many victims need to be identified despite the possible ex- tensive destruction of the bodies. Radiology has become essential in this process. More recently, greater use of 3D reconstruction which is harnessing CT to add a non-invas- ive dimension to disaster victim identification (DVI) might help overcome some of the challenges of DVI. A session dedicated to DVI at ECR 2023 in Vienna heard how 3D im- aging technology is building up pictures of victims and re-assem- bling body parts – often while the remains are still in the body bag – while also conducting investi- gations in a way that preserves the dignity of the victim. In turn, that offers reassurance to relatives that the investigation is being con- ducted in a humane and sympath- etic manner. Pathology Unit Forensic pathologist Dr Mike Biggs, from the East Midlands Forensic in Leicester in the UK, has been in- volved in a range of high-profile investigations. These included the MH17 the UK nationals involved); Shoreham Air- show crash; and the Grenfell Tower fire in London (where mobile CT scanning was used). incident (with In cases where coroners specifi- cally request non-invasive investi- gations, 3D imaging offers benefits. Biggs suggests there are ‘hidden gems’ of information contained in the DICOM data but that accessing it can at times be problematic, par- ticularly where mobile scanners are used. ‘You can answer specific questions if you are willing to extract data from DICOM,’ he said. The 3D application has value in reconciliation of body parts, which may even be in different bags. ‘The anatomy is not always in the right place and with fragmented bodies it can take time to work out what is going on. This is where the 3D ap- plication can be very helpful,’ said Biggs. He outlined how CT scanning of body bags can identify victims from distinctive jewellery or cloth- ing and then start answering spe- cific questions, with reliance on comparison of ante-mortem and post-mortem data to reach an identification. The standard Interpol approach for DVI body reconciliation was out- lined to delegates, with pink post- mortem paperwork and yellow ante-mortem data (fingerprints, dental records, DNA samples) fol- lowing scene investigation to bring the elements together to obtain a positive identification. In addition, pathologists are in- creasingly being asked by police to produce physical 3D prints for the courtroom, particularly when cor- oners want scan-only autopsies rather than invasive examinations. Biggs said the 3D software can clean-up images, removing veg- etation, degradation, and insects, and produce sanitised colour im- ages that are less distressing for ju- rors. Powerful reconstruction and analysis possibilities With fragmented bodies, the avail- able tools can produce inventories of the bones that are present and absent, arrange them in presenta- tion form, and reassemble them. The expert recalled one example, where there were no dental rec- ords, and the individual was ident- ified from a Facebook profile pic- ture, with the help of a 3D print of 3D imaging technology is used to build up pictures of victims and re-assembling body parts. © pangoasis - stock.adobe.com www.healthcare-in-europe.com the teeth which matched the vic- tim. In another case, the tech- nology reassembled the skull of an unidentified person to create a fa- cial reconstruction and use that to put out an appeal for witnesses. It is also possible to show the way forces propagated through a bone to identify what happened to cause a fracture. ‘There is the potential for doing very useful analysis,’ he added. Preserving the integrity of the body In introducing the session, radi- ographer and co-chair Mark Viner said DVI sat within the congress theme of “The Cycle of Life” and the medico-legal process of iden- tifying the person who died ‘so loved ones can grieve and begin the healing process.’ This, he said, can be complex, particularly in mass fatality incidents with trauma, body fragmentation or decom- position and where reliance is on the hard tissues of bone and teeth that survive long after the soft tis- sues have gone. Radiology was first proposed for human identification as early as 1896 and first used in a mass fatal- ity incident in 1949, with the non- invasive tool of CT coming to the fore more recently. ‘This means we can we use technology to answer question of identity less invasively, preserving the integrity of the body for the loved ones. In recent years, mobile multidetector CT (MDCT) has become the gold stan- dard for DVI investigations,’ said Viner. Shift from x-ray to CT imaging The session also heard from Dr Arne Stray-Pedersen from Oslo, Norway, who discussed the role of radiology on victims of the 2011 terror attacks in Norway with a bomb explosion followed by mass shootings at a youth camp. Thomas Ruder from Berne, Swit- zerland, meanwhile discussed the use of radiology in DVI, highlight- ing how whole-body CT in a post- mortem setting makes all struc- tures of the body available to compare to ante-mortem images. ‘The use of radiology for identifica- tion and DVI has seen a transition from x-ray to post-mortem CT, as we have seen in the clinical side of radiology. CT is much more versa- tile for identification.’ The scenario and the conditions of an incident determine imaging modalities and roles as a biological and medical profile is established. ‘Comparative radiologic identification is based on visual pattern recognition, which also plays a central role in clinical radiology,’ said Ruder. ■ Report: Mark Nicholls Comfortable and secure: The swivelling handle system helps patients to position themselves on the examination table with as little assistance as possible – even when transferring from a wheelchair. Febromed provides support for everyday radiology work Safe and hygienic: ‘Get up®’ tomography Whether in magnetic reso- nance imaging (MRI), com- puted (CT), diagnostic radiology, or ra- diation therapy: in radiolo- gy, it’s all about the details. Highly specialised equip- ment in a professional en- vironment helps to make exact diagnoses and im- plement precise therapies. Everything else needs to be just as professional. 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RADIOLOGY Project EU-JUST-CT CT scans: systematic evaluation of benefits and risks 11 When is a CT scan justified, i.e. when do the benefits of a CT scan for the patient outweigh possible risks associated with radiation Justification has been a major issue among radiologists ever since CT has become widely available and widely used. With regard to dose the answer is the well-known ALARA principle: ‘As low as reasonable achievable‘. Now, the European coordinated action on improving justification of computed tomography (EU- JUST-CT) has a closer look at the process of justification. At ECR in Vienna, initial results were presented. According to the EU legal frame- work, the use of radioactive sub- stances or ionizing radiation in human beings requires a justified indication that must be provided by a medical expert. This principle is confirmed in the EU Basic Safety Standards Directive (BSSD) which demands that any imaging examin- ation that causes radiation ex- posure has to be justified in a stan- dardized process prior the exam. to The EU member states were asked to adopt appropriate regulations. ‘Appropriate justification and opti- mization of all procedures invol- ving patient ionizing exposure are essential elements of good and safe clinical practice,’ underlines EU- JUST-CT’s lead researcher Pro- fessor Dr Boris Brkljačic of the School of Medicine at the Univer- sity of Zagreb. At this year’s ECR, Professor Brkljačic presented inter- im results of the project which started on 7 April 2021 and is scheduled to run until March 2024. to collect up-to-date Two project goals have already been reached Two of EU-JUST-CT’s four goals have already been reached. A sur- vey in- formation about justification of CT examinations in Europe was con- ducted in 145 centers in seven EU countries. And indeed the survey results confirmed the need for ac- tion. In Luxembourg, for example, a study showed that 39 percent of the CT scans requested by referring physicians were uncalled for. In 35 percent of the cases, the clini- cal justification was so vague or in- complete that the necessity of the requested CT scan could not be properly assessed. The second goal, the development of a common methodology for au- diting justification of CT examin- ations, has also been completed. A third goal will be achieved shortly: coordinated pilot audits of justifi- cation of CT examinations in a minimum of five different Euro- pean countries. Discussion with the Member States The fourth and final phase is ahead, namely the discussion of the status of justification of CT examinations with the member states and identifying oppor- tunities for further action. This en- tails im- plementation of the justification audits that were developed. One focus will be CT scans of children and adolescents. ‘The role of CR initiating the legal It must be considered very carefully whether the benefits of a CT scan outweigh the potential dangers to the patient due to radiation. © pressmaster - stock.adobe.com examinations is undisputed, thanks to the diagnostic information pro- vided in countless clinical con- ditions. However, in the past years a few epidemiological studies raised concerns about its use in children, as CT studies were linked to an increase in the risk of brain tumours,‘ Brkljačic points out. This includes an analysis of the EPI-CT cohort study which was re- cently published in Lancet Oncol- ogy. It found that one of 10,000 young patients developed a brain tumour five to fifteen years after a head CT scan. Major impact on the healthcare system Brkljačic is convinced that these re- sults will have a major impact on the healthcare systems and on the debate of the justification of CT scans. ■ Report: Michael Krassnitzer EU-JUST-CT is led by the European Society of Radiology (ESR) and has received funding from the Euro- pean Commission Contact: ESR Office Am Gestade 1 AT – 1010 Vienna Phone: +43 (1) 533 40 64 –20 http://www.eurosafeimaging.org/ eu-just-ct Publisher mgo fachverlage GmbH & Co. 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