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V O L 3 1 I S S U E 1 / 2 2 • M a r c h 2 0 2 2 T H E E U R O P E A N F O R U M F O R T H O S E I N T H E B U S I N E S S O F M A K I N G H E A L T H C A R E W O R K DIGITAL PATHOLOGY 4-6 EH @ ECR 2022 7-13 • The rocky (but worthwhile) road to digital pathology • Digital pathology switch bears fruit • Going digital: no reason to delay • Women in interventional radiology take center stage • Spinal imaging in trauma • Predicting Covid-19 death risk Radiotherapy: Nuclear waste as a potential source? Molecular radiotherapy shows great potential in becoming a more mainstream treatment for cancer, but the field is being hampered by a limited radio- nuclide supply. Report: Mark Nicholls Delegates to the virtual NCRI (National Cancer Research Institute) festival session “How do we make the most of molecular radiotherapy? Novel radiotherapeutics and indi- vidualised therapy” heard details of the rapidly advancing area of molecular radiotherapy with pres- entations covering clinical devel- opments, radiation physics and radiochemistry. The session was co-chaired by Dr Glenn Flux, Head of Radioisotope Physics at the Royal Marsden Hospital and Institute of Cancer Research in London, and Professor Jon Wadsley, a Consultant Clinical Oncologist at Sheffield Teaching Hospitals NHS Foundation Trust and the Weston Park Cancer Centre in the UK. In his opening remarks, Professor Wadsley attested to molecular radi- otherapy being a growth area on its way from the treatment of rare niche cancers to a more mainstream therapy. However, he conceded: ‘There is still a lot we don’t know about how we make best use of molecular radiotherapy.’ these Among areas, high- lighted by the NCRI Clinical and Translational Radiotherapy Research Working Group (CTRad) to develop the field in the UK, are the need y e l s d a W n o J r o s s e f o r P © Molecular radiotherapy with Lutathera www.healthcare-in-europe.com access to these radionuclides if we want to work with alpha therapies, which is really where most of the research interest is focused at the moment.’ In the UK, the lack of domes- tic supply sources complicates the issue. Creating radionuclides from nuclear waste is a potential solution, which is currently being explored by the National Nuclear Laboratory, Sosabowski reported. She expressed hope for the industry to find addi- tional ways to increase production, putting an end to this issue and paving the way for further advances in molecular radiotherapies. Beyond this, the expert urged the nuclear medicine community to be ready for upcoming new therapies: ‘We will see some expansion in PET to be able to see if patients are eligible for treatments, but also to follow response to therapy, so these diagnostics and therapeutic radionu- clides go hand in hand.’ Due to the critical shortage in the UK, advances associated with alpha particle emitters are mainly seen in the US and Europe, where availabil- ity is better. However, there remains an ambition in the UK to expand the field in terms of research, clinical trials, commercial interactions, and patient access and create opportuni- ties in the area of personalised med- icine, Dr Sosabowski concluded. The session also heard from Dr Anna Sundlöv, a senior consultant in oncology at Skåne University Hospital in Lund, Sweden, who dis- cussed dosimetry in clinical trials with molecular radiotherapy, exam- ining “what’s in it for patients?”; and Dr Jonathan Gear, Principal Physicist at the Royal Marsden NHS Foundation Trust, who gave a presentation on the potential for personalised treat- ment with patient-specific dosimetry. Jane Sosabowski Dr Jane Sosabowski is Reader in Molecular Imaging in the Centre for Cancer Biomarkers and Biotherapeutics, Barts Cancer Institute, Queen Mary University of London. She leads the Cancer Imaging Laboratory at BCI, with a team of researchers working on the application of radiolabelled peptides, antibodies, and other carriers for imag- ing and molecular radiotherapy in pre- clinical models and translation to the clinic, with a particular interest in bring- ing novel therapy radionuclides into clin- ical use in the UK. Jon Wadsley Professor Jon Wadsley is a Consultant Clinical Oncologist at Sheffield Teaching Hospitals NHS Foundation Trust in the UK with clinical interests are in thyroid cancer, neuroen- docrine tumours and pancreatic/biliary tract cancers, with a particular emphasis on molecular radiotherapy. His research mirrors these clinical interests, with a particular focus on thyroid cancer and neuroendocrine tumours. He is Clinical Director of the Sheffield Cancer Clinical Trials Centre, Cancer Specialty Lead for the Yorkshire and Humber Clinical Research Network and NIHR National Specialty Lead for Radiotherapy and Imaging. www.healthcare-in-europe.com CONTENTS IT DIGITAL PATHOLOGY EH @ ECR SURGERY LABORATORY MANAGEMENT & RESEARCH INFECTION PREVENTION 2-3 4-6 7-13 14-15 16-17 18 19-20 k c o t S i – h c i t s o K k r a M © for an appropriate infrastructure in terms of equipment and work- force; the importance of developing an evidence base for these treat- ments; and optimising molecular radiotherapy treatments, particularly through dosimetry and being able to personalise treatments. While some progress has been made in these regards, ‘there is still a lot of work to be done,’ he added. Advances were also being hampered by an insuffi- cient supply of radionuclides in the UK, and funding issues for studies in this field. The potential of molecular radiotherapy Dr Jane Sosabowski, from the Barts Cancer Institute (BCI) at Queen Mary University of London, looked at the future growth and potential of molecular radiotherapy. During her presentation “Novel radiothera- peutics and the growth of molecular radiotherapy,” she reported on the field’s unprecedented expansion, with much excitement generated around radionuclides. Cytotoxicity of these alpha particles had been cause for concern – however, these appear to have alleviated and made way for a new prospect of wider use of molecular radiotherapy, Dr Sosabowski said. ‘There is also some exciting work going on in moving from beta particle emitters to alpha particle emitters, which seem to have some really remarkable thera- peutic effects.’ However, she point- ed out ongoing availability issues for radionuclides, which threaten to hold back further progress: ‘We cannot do anything unless we have
2 I T Cloud security issues Critical infrastructures: targets of cyberattacks even be so that people die because of ransomware. For instance, in Alabama, USA, a baby might be the first-ever death caused by a ransomware attack. According to Pandasecurity.com, there is a law- suit against a hospital where a new- born baby ended up with severe brain injury. The mother did not receive all necessary tests when admitted to a hospital to deliver her organisation always has the most up-to-date information, fully auto- mated and continuous. Also, the assets found are at once scanned for any risks, allowing a security professional to know what is wrong and to prioritise.’ Shadow IT is a big problem A major and often unrecognised problem in many companies is categories. For example, a certifi- cate is not up-to-date, or a patch is required. In our system you can see the software you are using and whether you need to protect it. We indicate the risks on a scale from A to F. ‘While an “A” is okay, an “F” means that the issue urgently needs to be addressed by the company's IT department. Step 3 is the man- agement of all data. What should be Some ten years ago, it was unthinkable that virtually all company data was stored in the cloud. Now it’s what almost every company does. However, the increasing complexity of corpo- rate IT infrastructures also comes at a price. Report: Madeleine van de Wouw The sheer size and complexity of the systems makes it difficult to keep track of everything that is going on digitally. And this leads to more and more successful cyber- attacks. With all the consequences this entails. All companies and institutions in Europe have to deal with European regulations such as AVG and GDPR, which must guarantee privacy. Each country may decide for itself what falls under critical infrastructure, but for most that includes health- care, financial institutions and gov- ernment. And what counts as critical must comply with all European standards, which are constant- ly being tightened along the way. The fines for non-compliance are very high and the consequences of a cyberattack can be huge. That is why companies and institutions need to take a preventive approach to secure their IT in order to avoid getting into trouble afterwards. But how do you know exactly what is going on in your company? How can you gain insight into all the systems you have running and what the weak spots are? Identify and manage Seamless management of your IT’s digital “attack surfaces” is an important step towards cyber-resil- ience. This attack surface refers to all the possibilities that an unau- thorised user can have to bring in or steal information. To manage and control that, Dutch cybersecurity company Cybersprint B.V. devel- oped the Cybersprint Attack Surface Management platform: a SaaS solu- tion with continuous monitoring of all possible attack surfaces. For example, by entering a brand or company name, the system searches for anything related to that brand name and the vulnerabilities and misconfigurations associated with it. Sebastiaan Bosman, Product Marketing Manager at Cybersprint, explains: ‘Our platform maps the individual digital components of an organisation. Let me explain the three major developments which make control of the digital attack surface necessary. 1. Digital transformation: Certainly during Covid, online and cloud working has accelerated and systems have become larger and more complex. And so companies are increasingly outsourcing digital- ly. You must therefore take stock of what is housed with third parties. Remember, your company is always responsible for your own data, even if you hire a supplier who makes a mistake, has a leak or whether there has been a successful hacking attempt. 2. Increasing threat: Threats are becoming more fre- quent and more sophisticated. Ransomware attacks and phishing are a big problem, and they are increasingly starting in the supply chain. A while back this happened, for example, with the Microsoft mail exchange. Criminals were able to get into a large software com- pany and send their own piece of malicious software along with its updates. This gave them access to many more companies at once. In addition to securing your own infrastructure, it is therefore also necessary to know exactly where and which third-party software is running so that you can act imme- diately in the event of an incident. 3. Rules and laws: Various authorities such as govern- ments and umbrella bodies within sectors are increasingly prescribing how organisations should run their business, for example in the field of data privacy. Organisations must have control over their own attack surfaces and be able to prove that they know what is going on. If they can not, heavy fines can be issued. At the end of 2020 an ambulance with a patient had to be diverted because of ransomware. The hack- ers had gotten in by abusing a Citrix environment (at the end of 2019, a major vulnerability had been dis- covered in this Citrix product). We were on top of this at the time and advised several customers. Also, the U.S. Department of Homeland Security has issued advisories to highlight the impor- tance of cybersecurity in healthcare (https://info.publicintelligence.net/ NCCIC-MedicalDevices.pdf) It might baby because of an ongoing cyber- attack. The tests she missed would have shown that the baby’s umbil- ical cord was wrapped around the fetus’ neck, with eventually caused brain damage. The baby died nine months later. What we think is important is the way in which all this information is collected. When you, from with- in your organisation, start making an inventory of the digital assets you have, you only see what you already knew you had. But what if, for example, created subdomains haven’t all been neatly passed on to the IT security team? This cre- ates blind spots which you cannot secure. That is why our platform works from the outside in, without spe- cial access or an imposed IP range in advance – just as an advanced hacker would see it. This way, an shadow IT. Not only specialists and the IT department can build web- sites and platforms. A marketing department, for example, can set up a web page for a campaign and link it for instance to a page on Facebook without telling it. Identifying assets: 4 steps Bosman: ‘Our platform identifies between 30 and 50 percent of assets that companies and institutions did not even know they had. Take for instance a hospital. Step 1: we start searching on brand name and everything relat- ed, such as hosting etc. An over- view of all domains and underlying infrastructure automatically follows. Especially in larger organisations, there are tens of thousands of assets, also from suppliers. This means an enormous attack surface. Step 2 is the rating of the risks in U P C O M I N G E V E N T S • HIMSS Global Health • DMEA 2022 • Digital Healthcare Show • e-Health Conference and Conference 14. – 18.03.2022 Orlando, USA www.himss.org/global-conference 26. – 28.04.2022 Berlin, Germany www.dmea.de/en/ 18. – 19.05.2022 London, UK www.digitalhealthcareshow.com • Digital Health – • Medical Informatics Europe • MD&M West 12. – 14.04.2022 Anaheim, United States https://www.mdmwest.com/en/ home.html World Congress 2022 17. – 18.05.2022 London, UK https://digitalhealthcareworld congress.com/ conference 27. – 30.05.2022 Nice, France https://efmi.org Tradeshow 01. – 02.06.2022 virtual https://www.e-healthconference.com/ • CARS 2022 Computer Assisted Radiology and Surgery 07. – 11.06.2022 Tokyo, Japan https://www.cars-int.org/ k c o t s r e t t u h s – t e r o c e d s © tackled first? If there is a problem, the system can help assign own- ership to solve it. Finally, step 4 is reporting. How can you track risks, measure performance, and perhaps adjust processes?’ According to Pieter Jansen, found- er of Cybersprint, there is a dif- ference with other companies in working methods. ‘Our system maps everything continuously. You can hire a company to draw up a report, but these are snapshots and the next day it can all be different. We have automated the process and you only have to log in to see all the infor- mation you need. We don't change anything ourselves, we only signal what is wrong, we don't go “deeper” in search. The data from our plat- form serves as a starting point for other security methods, such as red teaming and penetration tests. Knowing your critical points is also an advantage if you are audited for NEN certification, for example. Regulations and the need to com- ply with standards (NEN 7510 for information security) are particu- larly important in the healthcare sector. Our platform also ensures that, within that framework, both the loose ends and the overall pro- cesses and security governance can be examined. What about our own security? Good question! Yes, we also comply with the highest requirements and standards, and of course we monitor ourselves!’ EUROPEAN HOSPITAL Vol 31 Issue 1/22
I T 3 Underestimated risk for heart failure patients Cybersecurity threat to remote monitoring devices k c o t s r e t t u h S – i o d u t s 2 a r © • using proper authentication • creating and adopting local cyber- security regulations. While he acknowledged the role of public video conferencing plat- forms, especially during the first phase of the pandemic, the IT expert stressed that going forward, only products specifically assigned for healthcare video conferencing with adequate cybersecurity should be used. To illustrate his point, Ben Gal expanded on devices used to mon- itor heart failure patients. Covering a range of parameters, such as haemodynamic and clinical data, pulmonary artery and left atrial pressure, bodyweight, and lung water content, these devices trans- mit captured data to a healthcare centre. This data is potentially vital, he explained, as it can initiate a change in therapy, if, for example, a certain threshold in one of the parameters is crossed. Therefore, the data must be protected, not only from transmission-related corrup- tion, but also ransomware attacks encrypting the medical data and demanding payment to unencrypt the information withheld. Any such damage to the data’s integrity can Ovid® Synthesis Clinical Evidence Manager have serious consequences such as interrupting device performance, impacting patient management and potentially causing harm, Dr Ben Gal pointed out. Manufacturers and companies therefore carry a great responsibility to ensure appropriate security of the monitoring device and should be encouraged to pub- lish data on security tools for open review. Establishing a (safe) remote kill switch for ICDs Newer pacemaker models, which can transmit data by unidirection- al communication for remote fol- low-up, are equally vulnerable to cyberattack, the expert cautioned – although he noted that fortunately, no cyberattacks have been reported on pacemaker technology so far. During the Covid-19 pandemic, another issue has emerged: At a certain point, ICDs must be deacti- vated for increasingly frail cardiac patients or those developing termi- nal illness, to prevent the implant from automatically administer- ing dangerous shocks. However, most devices require the patient to be transported to a hospital for the deactivation – a considerable risk, especially for terminally-ill patients. Dr Ben Gal said therefore pointed out the need for remote deactivation functionality of the devices, with strict security proce- dures in place. ‘New pacemakers should include enhanced cyber- security properties, enabling bidi- rectional communication between the patient and the medical team,’ he said. The benefits outweigh the risks The expert also stated the need to enhance cybersecurity properties in LVADs, which use bidirectional communication for remote device adjustments to help reduce compli- cations and hospital visits. While there was a risk of cyberat- tack, Dr Ben Gal concluded that the benefits these sophisticated devices bring for heart failure patients still significantly outweigh the draw- backs, greatly helping upgrade the quality of care. However, he added: ‘Medical agencies should provide clear regulations for cybersecurity in the manufacturing process of every medical device.’ Tuvia Ben Gal Dr Tuvia Ben Gal is the director of the Heart Failure Unit of the Cardiology Department at Rabin Medical Center, Petah Tikva, and Tel Aviv University, Israel. He is author of multiple peer-re- viewed scientific papers and speaker at many national and international conferences. Workfl ow solution for clinical practice improvement NEW Ovid® Synthesis Clinical Evidence Manager is a workfl ow management solution that organizes, standardizes, and accelerates quality improvement, evidence-based practice, and research projects across your institution. No other solution will take your clinical practice improvement projects to the next level to ensure they are of the highest quality and based on the latest research insights and evidence. To learn more about Ovid® Synthesis, scan the QR code. wltrsklwr.com/ovid-synthesis europe@ovid.com Remote monitoring devices and pacemakers supporting patients with cardiac conditions such as heart failure could be vulnera- ble to cyberattacks, according to leading expert Dr Tuvia Ben Gal. While acknowledging the over- all therapeutic benefits of such devices, he remains concerned that not enough attention is given to addressing the potential cyber- security risk. Report: Mark Nicholls Major issues are manufacturers often not factoring in cybersecuri- ty, medical guidelines overlooking the matter, and healthcare provid- ers being uninformed about the security risks and unfamiliar with the methods for evaluating those risks, he pointed out during a session at the ESC Digital Summit 2021. devices, Focusing on telemedicine, mon- itoring pacemakers, implantable cardioverter-defibrilla- tors (ICDs), cardiac resynchroniza- tion therapy (CRT) devices, and left ventricular assist devices (LVADs), he explained that modern commu- nication technologies for the moni- toring and management of patients improve outcomes and reduce costs. The devices allow for moni- toring and assessment of a patient’s condition by both unidirectional data transmission from the patient to the healthcare provider and bidi- rectional communication features. The latter are designed to facilitate active intervention or electronical manipulation of the device with the aim of improving the clinical condition of the patient. However, bidirectional communication is not yet being applied due to unresolved security issues, since the feature would also open potential gateways for unauthorised access. Dr Ben Gal cautioned: ‘While healthcare providers are aware of the clinical benefits and downsides of medical devices, they are frequently unin- formed of the security risks and unfamiliar with the methods for evaluating those risks.’ As a result, many patients remain uninformed because they rely on information supplied by the medical team. Gap in guidelines Expressing concern that cyber- security is not addressed in guide- lines, Ben Gal posed the question of whether the security risk outweighs the clinical benefit of the device. During the ESC presentation, he outlined what is needed for protec- tion against these security risks to ensure safe telemedicine implemen- tation. These included: • collaboration between all parties using remote technology; • awareness of cybersecurity issues in telemedicine among the medi- cal team; • establishment of institution-wide security standards, such as for data encryption; • frequent software updates and antivirus data scanning; www.healthcare-in-europe.com
4 D I G I TA L PAT H O LO G Y Experience report AI implementation: Digital pathology switch bears fruit Fully digitising pathology operations has led to greater efficiency, cost savings, and quicker diagnosis for the Laboratory of Pathology East Netherlands (LabPON). The move, made six years ago, is showing measurable benefits and now, the institution is beginning to explore the potential of deep learning computational pathology algorithms, which might push the efficiency gains even further. Report: Mark Nicholls Details were outlined to the 8th Digital Pathology and AI Congress in London by Alexi Baidoshvili, Professor of Pathology, who spe- cialises in digital and computation- al pathology at LabPON. He report- ed that LabPON had completely digitised its diagnostic routines for clinical cases in July 2015 and has continued to evolve the technology and processes ever since. Additional milestones were the development and introduction of AI software for image analysis in 2018 and a new Image Management System (IMS) in 2021, with further AI develop- ment and integration planned for 2022. In his presentation, the expert discussed the investments neces- sary to introduce digital pathology. Areas to be considered include flow analysis in the laboratory, storage, scanners, the need for a robust IMS, training of staff, consultation workflows, software and enabling remote working. On average, setting up a laboratory for digital pathology requires at least 1.5 million euros per year, he calculated, with AI sys- tems not included. However, invest- ments might be a bit lower for insti- tutions which already have a robust IT infrastructure in place. ‘It is very important to choose the right IMS,’ he added, pointing out desirable features such as open architecture, integration with commonly used scanner types, robustness, scalabil- ity, support for external consultation and – not least – a user-friendly interface. Lung tissue with special Grocott staining and more efficient internal consulta- tions and better support for multidis- ciplinary teams (MDTs). Digitisation also facilitated remote consultations, improved access to information and images, and better means to organ- ise education and research. Data from LabPON backs up these perceived improvements: for exam- ple, an experienced digital patholo- gist can diagnose faster via digital methods than with the conventional microscope. Time savings are signif- icant, reported Baidoshvili, reducing the workload of pathologists and releasing time to perform other tasks, such as participation in multi- disciplinary meetings. The expert noted that all staff segments benefit from this; lab personnel, techni- cians, and pathologists. Additionally, the switch from subjective to objec- tive diagnosis led to savings on immunohistochemistry, improved service delivery to the clinic and patient, and yielded financial advan- tages. ‘The digital transition saves on archive time and the work of secretaries and of technicians,’ he added. Current and future AI benefits After transition to digital diag- nosis, and the seamless integra- tion of interoperable AI, Baidoshvili noted an ‘impressive’ accuracy of the system, for example in cancer detection and Gleason grading of cases. Referencing the lab’s expe- rience with prostate AI solutions Concentriq from Proscia and Galen from Ibex, he praised their seam- less and intuitive workflows, with initial results showing the potential Alexi Baidoshvili in Alexi Baidoshvili is a Professor of Pathology at DT Medical University, Georgia. He specialises digital computational pathology at and the Laboratory of Pathology East Netherlands (LabPON), an institution with 120 employees, 18 pathologists and 90 lab technicians. Furthermore, Prof Baidoshvili is an active board mem- ber of several international organisa- tions and organiser of conferences. At LabPON, he and his team are working on the development of various image recognition programs. to reduce immunohistochemistry costs, subject to further validation. The expert also pointed out the potential of automatic report gen- eration with AI assistance. ‘Thanks to AI, we can save 1:18 minutes of diagnostic time in every colon diagnosis.’ Applying this to the 500+ cases LabPON processed in 2020, Baidoshvili calculated more than 11 hours of saved diagnosis time for pathologists. Overall, the switch to digitisation had widespread benefits with much improved logistics, handy tools in IMS resulting in high efficiency, flexible and remote working, easy access to computer archives, better and more efficient diagnostic qual- ity and improved diagnostic logis- tics, leading to a happier pathology workforce. Lung tissue with Pas-D staining Safer, happier, more productive Despite these initial hurdles, Prof Baidoshvili found the benefits from going digital to be well worth the effort for LabPON, which handles 55,000 histology, 20,000 cytology, 10,000 molecular and 12,000 immu- nohistochemistry cases per year: ‘What we have achieved from our investments is high efficiency and quality improvement,’ he said. Working with glass slides is a thing of the past, reducing the burden on logistics, streamlining workflows, and opening new possibilities for external consultations. Pathologists’ workplaces also saw subsequent improvement, for exam- ple in enhanced safety, better ser- vice, and more flexibility, continued Baidoshvili. ‘In the future, there will be a move from subjective diagnosis to objective with AI applications.’ He emphasised how streamlined work- flows were important in creating a ‘happier workplace’, leading to quicker replies to inquiries, faster NPIC network Pathology in North England goes digital Reaching out across 15 hospitals and a population of six million people, a network established by the National Pathology Imaging Co-operative (NPIC) is an ambi- tious move to advance digital pathology in the north of England. The project, led by the Leeds Teaching Hospitals, will see digital pathology services operate across a network of over 20 NHS trusts and 238 pathologists, scanning over 2.4 million images and generating 3 Petabytes of image data per year. In addition, 48 scanners will feed into a single, scalable, vendor neutral archive (VNA) with DICOM compat- ibility. Progress on the network was outlined by NPIC operations direc- tor, Dr Daljeet Bansal, at the 8th Digital Pathology and AI congress in London. The aspiration of NPIC is to cre- ate a globally leading infrastructure for digital pathology and AI. The groundwork for this has been laid as far back as September 2018, with the complete switch to digitisation of slides at the Leeds Teaching Hospitals, and the introduction of next generation scanners in 2021. Dr Bansal explained that NPIC’s aims are to drive clinical use of digi- tal pathology, create an environment for development and evaluation of AI and support further research and innovation. The project – which involves additional academic and industry partners working with cli- nicians – includes processing scan- ners, reporting, storage, data access and research elements and comes with £50 million of investment to fully deploy digital pathology. Focus on image analysis automation The network connects the regions of West Yorkshire, Harrogate, York, Hull, and North East England, ena- bling shared knowledge and proce- dures as well as research partner- ships. Areas of focus are the devel- opment and validation of automated image analysis and AI tools for the diagnosis of cancer with existing exemplars in breast cancer, skin, and lung cancer. ‘Research partner- ships in AI diagnostics and clinical trials will be of benefit for patients and the public,’ added Dr Bansal. The scale-up of the NPIC network will also include two national spe- cialist networks; one in paediatric tumours, the other focusing on bone and soft tissue tumours. ‘There will be a national knowledge and train- ing centre, customised data sets for AI and research, and research partnerships in AI diagnostics and clinical trials,’ the expert went on. ‘Training will be a key component with hands-on workshops and train- ing for pathologists and biomedical scientists, a centre for industry/NHS collaboration, and a multiple scan- ner platform for research and AI.’ In cooperation with Genomics England, a company of the UK Department of Health and Social Care, NPIC will also create an image library to complement the genomic and clinical data for each patient and develop patholo- gy-genomic correlation. Dr Bansal stressed the importance of the net- work as the first and largest-scale project in terms of digitisation, calling the project a ‘key element of a national digital pathology vision in the UK’. She concluded: ‘It will be a platform for many applica- tions: clinical diagnosis, digital pathology and life cycle of AI to establish ourselves as the national digital pathology system platform for use in the NHS and AI research, supporting clinical trials and diag- nostic innovation.’ (MN) Daljeet Bansal Dr Daljeet Bansal is Operations Director of NPIC (National Pathology Imaging Co-operative), overseeing the scale-up of digital pathology across hospitals across the North of England and two national networks. NPIC is a unique collaboration between NHS, Academic and Industry partners, in a network that will also develop artificial intelligence tools to help diagnose cancer and other diseases. EUROPEAN HOSPITAL Vol 31 Issue 1/22
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6 D I G I TA L PAT H O LO G Y AI introduction into clinical workflows The rocky (but worthwhile) road to digital pathology Close liaison between pathologists and data scientists is pivotal in the successful introduction of dig- ital pathology and artificial intelli- gence (AI) into clinical workflows, according to one of France’s lead- ing pioneers in the field. Professor Catherine Guettier out- lined the advantages of digital pathol- ogy to the 8th Digital Pathology and AI Congress in London at the beginning of December, but also highlighted obstacles and difficul- ties, particularly when coupling AI projects with the transition process. She discussed the experiences of creating a single department of dig- ital pathology for three hospitals in the Saclay University hospital group in Paris – a transition in which it was important to acknowledge the demands placed on data scientists. For many pathologists, the tran- sition towards digital patholo- gy and AI is marked with mixed feelings, Guettier observed. The Professor of Pathology at Paris- Saclay University and Head of the Department of Pathology at the Hôpitaux Universitaires Paris-Sud illustrated the challenges of this process by example of her depart- ment in her presentation ‘Artificial Intelligence and the pathologist’. Main topics of the session were the work with data scientists, and the new role of digital slides in health- care data. ‘Pathologists’ expectations include screening of lesion patterns in frequent samples, quantification of tumour cells, mitosis count, auto- mated scoring of cancers, quanti- fication of cellular biomarkers and also beyond the usual task of the pathologist, prognosis, theranostic or molecular prediction.’ Guettier also pointed out the difficulties data scientists face, such as the large dimension of digital slides; diffi- culties to obtain large enough, bal- anced and annotated sets; pre-an- alytic variability; and the issue of interpretability. The meeting of two worlds Looking at the practicalities of creating a single department of pathology for the Saclay University hospital group, the expert explained how AI projects have been integrat- ed into the transformation process. ‘I am convinced most pathologists will be using AI in their practice,’ she said. ‘But this is the meeting of the two worlds: of the pathologist and the data scientist.’ The new digital pathology net- work covers three hospitals in Paris, Methodology: From image labeling to model deployment (Tribun Health) with a shift in focus from teaching to full digital pathology in the work- flow. In this constellation, AI has become an important component from the outset. Implementation of the new technology has opened new automation possibilities, for example in quantification of epi- dermal nerve fibres; screening of prostate and breast cancer foci; and screening of colonic polyps. Some of the difficulties and obsta- cles in implementing AI arise from the fact that, currently, very few pathology departments in France are digital. Issues range from lack of compatibility in digital slide shar- ing between hospitals, different AI companies or academic structures, to regulation issues, medical time for annotation, and GDPR constraints. Prof Guettier said: ‘Digital patholo- gy requires the participation of the pathologist – and many pathologists are already participating – but chal- lenges remain in implementation of AI algorithms into routine workflow.’ High investment, high benefits As the impact of AI in pathology is not yet clear, implementation of the technology is still lacking a via- ble business model. This means that managers and pathologists need to work closely to find a financially acceptable solution for hospitals, the expert explained. This aspect should not be under- estimated, Guettier pointed out, because the inclusion of AI comes with the need for considerable investments: Solutions to tackle 30,000 cases per year are priced around the million-euro-mark, with an additional 100,000 euros for maintenance, software upgrades and an imaging engineer. However, Catherine Guettier Catherine Guettier is Professor of Pathology at Paris-Saclay University and is also Head of the Department of Pathology Hôpitaux Universitaires Paris- Saclay - Assistance publique – Hôpitaux de Paris (AP-HP). A pioneer of digital pathology in France, her expertise is in liver pathology and her department and team collaborates with several compa- nies and academic structures for the development of AI-based algorithms in pathology. these expenses must be careful- ly weighed against the expected benefits of AI in pathology, espe- cially time savings and improved diagnostic quality. ‘These benefits include sparing technician time for distribution of glass slides, cost sav- ings on microscopes and glass slide storage, earlier and faster second opinion request, and productivity improvement through organisation of pathology labs and telework,’ the expert said. ‘The role of the pathol- ogist in this is to guide the choice of algorithms to be deployed, to provide annotated digital slides, to clinically validate algorithms, to test the implementation of AI algorithms in the digital workflow, and to be customers of AI companies’, she concluded. (MN) Going digital: no reason to delay Experience report from Portugal The future of pathology is digi- tal – for many departments, the transformation requires major modifications but promises sig- nificant advantages. Speaking to the 8th Digital Pathology and AI Congress in London, Professor Catarina Eloy outlined the vital elements for successful trans- formation towards full digital pathology implementation. Report: Mark Nicholls For her presentation, the expert shared insights from the successful and effective introduction of digital pathology at her own institution; the Institute of Molecular Pathology and Immunology of the University of Porto (IPATIMUP) in Portugal. The efforts, though considerable, had led to a ‘new standard for pri- mary histological diagnosis’ and ‘a relevant improvement in healthcare,’ she emphasised. Highlighting the importance of adopting a new approach, with a focus on workstations and work- flow within the implementation pro- cess, Prof Eloy said: ‘Digital trans- formation for primary diagnosis has to be a holistic concept that com- plements innovative interventions in all areas of the pathology labora- tory.’ To create optimal pre-analytic conditions of the sample, optimi- sation, and automation of the lab workflow with strict quality control and validation policies and opera- tions centres on the LIS (Laboratory Information System) are critical, she elaborated. Getting started Digital pathology, while being a cost-effective model with significant, direct, and parallel achievements, must be backed by a safe and effi- cient methodology, Professor Eloy stated, referencing the initial stages of the four-year digital transforma- tion process at IPATIMUP in 2016. First steps involved optimisation of scanners, workstations, and work- flows as well as re-design of the lab layout with an assessment area. ‘All areas converge to the scanning area which is located in the heart of the lab,’ she said. ‘That required some extensive reorganisation of space. The tracking system was proba- bly the most relevant measure we adopted through these first years to have a good digital pathology workflow.’ Once fully digital and paper-free, the laboratory retained the same turnaround times with everything standardised to ensure no errors or lost specimens, Prof Eloy reported. A key ingredient for the success- ful digitisation of the department was the involvement of the whole team, particularly in the training of technicians and pathologists, along with improvements and automation of the pathologist and technician workstations in terms of equip- ment, environment, ergonomics, space and workload management. The team at IPATIMUP consists of 14 pathologists (with six not using digital pathology), 11 technicians and five administrative staff, work- ing on 38,000 samples a year with a turnaround time of two days and no fall in quality of diagnosis, the expert said. single reason that justifies delaying in the adoption of the digital man- agement of the pathology laborato- ry, since it represents a relevant improvement in healthcare.’ The road to AI implementation The next big step for the depart- ment is the implementation of artifi- cial intelligence (AI) to assist in rou- tine workflow challenges. Professor Eloy detailed the roadmap of the process, showcasing a paper from her department. Its mission state- ment reads as follows: ‘The model of digital workflow implementa- tion at IPATIMUP demonstrates that careful planning and adoption of simple measures related to time, spaces, and sample management can be adopted by any pathology laboratory to achieve higher quality and easy digital transformation.’ In summary, Professor Eloy told the congress: ‘After understanding how simple it may be to increase efficiency, quality, and safety in the laboratory workflow, there is not a Catarina Eloy Professor Catarina Eloy is Head of the Pathology Department and a researcher at IPATIMUP, Porto, Portugal, and Professor at the Faculty of Medicine of Porto University. She is also President of the European Society of Digital and Integrative Pathology and Vice-President of the Portuguese Society of Anatomic Pathology. EUROPEAN HOSPITAL Vol 31 Issue 1/22
ECR @ W W W . H E A L T H C A R E - I N - E U R O P E . C O M 2022 S P E C I A L I S S U E F O R T H E E U R O P E A N C O N G R E S S O F R A D I O L O G Y O N L I N E E V E N T • M A R C H 2 - 6 2 0 2 2 V I E N N A • A U S T R I A • J U L Y 1 3 - 1 7 2 0 2 2 ECR 2022 is building bridges This year’s European Congress of Radiology (ECR 2022) consists of two parts: an online warm-up event on March 2-6 and the actual onsite congress in July. Multidisciplinarity and interactivity are cornerstones of both events. “Building Bridges” will be the theme of this year’s ECR. ‘This rep- resents my vision for the future of radiology’, Professor Regina Beets- Tan, president of the congress, explains to Michael Krassnitzer and adds that ‘In this future, radiol- ogists will embrace a new role, one where we will work more closely with our clinical and diag- nostic partners, with scientists and industry in order to deliver the best outcome for the patients.’ The ECR is supposed to be not only a congress from and for radiol- ogists, but a convention where radiologists can learn from other disciplines. Professor Beets-Tan has invited over 100 speakers from various disciplines. ‘I believe if we team up, we can improve our per- formance and ultimately increase the outcome for the patients’, she emphasises. Multidisciplinarity, however, is only one cornerstone of the upcoming ECR 2022. Another pri- ority is interactivity. The number of parallel tracks was reduced and the lectures were shortened to give room for discussions. ‘Quality above quantity,’ Professor Beets- Tan summarises. There will be ses- sions with speakers from several disciplines discussing cases just like in daily practice. ‘Instead of sitting in a classroom and listening to the teachers, the participants will interact with the speakers,’ the president explains. Onsite, there will also be low-threshold “open forums” outside the rooms where the audience can listen to speakers and engage in lively discussions. At ECR 2022, a lot of other new fea- tures will be tried out, for example the industry partners will get more space in the congress centre itself in addition to the exhibition hall. ‘ECR is continuously adapting to the changing world. It is certain that after Covid-19 ECR will not be the same as before; it will be a con- gress of the modern times, yet not less exciting,’ Professor Beets-Tan is convinced. The most obvious change of the annual congress are the two sepa- rate events: the ECR 2022 on July 13-17 in Vienna and the so-called ECR 2022 Overture online on March 2-6, at ECR’s usual pre-Covid-19 date. The warm-up event in March will feature a series of trailer ses- sions offering a glimpse of some of the major highlights to be held at ECR 2022. In addition, there will be a scientific and educational pro- gramme, table sessions streamed live from a studio with presentations by radiology leaders and industry partners as well a stu- dio dedicated to interventional edu- round The ECR is the annual meeting of the European Society of Radiology (ESR), the European Federation of Radiographer Societies (EFRS) and the European Society for Hybrid, Molecular and Translational Imaging (ESHIMT). The ECR is one of the largest medical congresses in the world, attracting more than 28,000 participants. With 300 companies showcas- ing their products across more than 25,000 m², ECR hosts one of the largest medical exhibitions in Europe. Regina Beets-Tan Professor Regina Beets-Tan is President of the European Society of Radiology (ESR) and Chair Department of Radiology at the Netherlands Cancer Institute, Amsterdam. cation and technology. The actual ECR 2022 in Vienna in July will heed the calls for a return to the congress format with opportunities for a more personal exchange of knowledge as Professor Beets-Tan says: ‘Nothing compares to an on site experience.’ (MK) Cancer imaging PET/MRI offers significant benefits for cancer patients PET/MRI is offering new imaging opportunities for cancer patients at various points along the care pathway with its ability to assess different biological processes and its increased specificity. Report: Mark Nicholls The growing clinical role of the hybrid modality was discussed by Professor Vicky Goh during the Sir Godfrey Hounsfield lecture at the British Institute of Radiology virtual annual conference in November. In her presentation, Professor Goh highlighted the benefits of the com- bination, but also acknowledged significant challenges. Professor Goh outlined how early evidence has established that PET/MRI using the radiotracer 18F-fluoro-deoxy-glucose (FDG) is non-inferior to PET/CT. ‘Over the last two decades there have been significant strides toward personal- ised cancer care to improve cancer www.healthcare-in-europe.com outcome,’ she said. ‘But in order to ensure that patients receive the best treatment at the right time, imaging has had to evolve to meet these needs. The introduction of clinical PET/MRI in 2010 has been another step change in terms of imaging capabilities for personalised cancer care.’ More than the sum of its parts The imaging expert pointed out the key advantages of integrated PET/MRI systems: the high sen- sitivity and the ability to provide molecular information from PET; combined with the high contrast-to noise-ratio and spatial anatomi- cal resolution that MR imaging offers. These strengths, she added, make PET/MRI a comprehensive and powerful tool for tumour phe- notyping. ‘Furthermore, with PET/ MRI, physiological imaging such as vascularisation, oxygenation or diffusion can be easily integrated with anatomical sequences.’ Vicky Goh Professor Vicky Goh is Head of Department of Cancer Imaging at the School of Biomedical Engineering and Imaging Sciences of King’s College London, and Honorary Consultant Radiologist at Guy’s and St Thomas’ Hospital. Her translational research focuses on functional and advanced imaging in gastrointestinal, genito-uri- nary, haematological and lung cancers. She is currently chairing the Academic Committee at the Royal College of Radiologists. Continued on page 8 Gallium 68-PSMA PET/CT (top row) and PET/MRI (bottom row) images showing the higher contrast and anatomical information that is provided by MRI compared to CT.
8 E H @ E C R NewTom 7G Multi-Scan Body CBCT: the next level of 3D X-ray imaging ) 3 ( a l f e C © Bilateral hip dedicated protocols is available for all disciplines: • Orthopaedics – osteo-articular study with multiplanar view • • Otorhinolaryngology – ear and airways volume analysis Dentistry, implant and orthog- nathic surgery – dental-maxillo- facial and bilateral TMJ analysis- For further information: www.newtom.it/en/ medicale/ Precision, speed and simplicity of use. Safety for patient and X-ray technician. Reduced total cost of ownership. These are the benefits of the first Multi-Scan Body CBCT developed by NewTom. Suitable for radiologists and orthopaedic, otolaryngology and dentistry specialists, NewTom 7G lets you capture accurate informa- tion on bone tissues – micro-struc- tures included – to gain an in-depth understanding of the overall clinical Intramedullary PIN knee picture. Compared to conventional procedures, the system optimises analysis of treatment outcomes (by using low X-ray doses, always in proportion to build) and lowers costs. Automatisms optimise work- flows and avoid the variability and uncertainty inherent in manual examination control, especially dur- ing patient positioning and actual exposure. From in-depth detail to the big picture With the arrival of 7G, NewTom Cone Beam technology examina- tions can be carried out on all areas of the body, including the spine, shoulder, and hip. System functions and automatisms adapt FOVs and X-ray doses to the patient’s build (especially those of paediatric age). From a minimum of 4x4 cm to a maximum diameter of 29 cm, and a length that can be extended up to 62 cm, adaptive FOVs let users examine the area of interest or a portion of it. A resolution of up to 90 µm means small complex structures such as the inner ear can be analysed with precision. Select the most suitable FOVs, also for large anatomical areas NewTom 7G system automatisms allow for acquisition of an extended FOV on the hori- zontal plane. Developed to acquire bilateral hip images, the NewTom 7G can capture a 40x17cm FOV. The horizontally extend- ed FOV allows comparative assessment of hip bones via reconstruction into a single volume. The acqui- sition will therefore show a single volume on which users can modify the display plane to better adapt to clinical needs. NewTom 7G allows the acqui- sition of extended FOVs on the vertical (longitudinal) plane too. The length of the extended FOVs on this plane can be modulated: users can therefore select FOVs with lengths from 22 cm up to 62 cm. Extended FOVs allow better morphological assessment of long bones and extensive bone struc- tures (e.g. spine). Wide gantry and motor-driven patient table In addition to a 77 cm gantry, the 7G can accommodate very heavy patients thanks to a bed with a load-bearing capacity of up to 215 kg. Lying-down patient positioning ensures simple, accurate alignment of the FOVs and makes results more certain by weighting X-ray exposure. Broader diagnostic range The NewTom 7G can perform numerous types of investigation, including those with intra-articular contrast agents (e.g. arthro- grams with Cine-Scout positioning). A broad series of exams with NewTom7G PET/MRI offers significant patient benefits Benefits in staging and restaging Professor Goh emphasised the clear benefits of lower radiation dose by replacing CT with MRI, particularly in paediatric or young adult populations, where reductions of 50 – 80 % can be achieved. MRI can also outperform CT in local- ising the PET signal, and the inte- gration of PET and MRI results in More than just MRI accessories www.allmri.com Continued from page 7 increased specificity and improved quantitation. Due to these benefits, PET/MRI has become increasing- ly established across the clinical pathway in oncology in terms of detection, characterisation, stage and risk stratification, therapy planning and therapy assessment over the last decade. In particular, the use of PET/ MRI in detection and characterisation for prostate cancer has been a success story, the expert reported. The hybrid modality has also proven its worth in staging or restaging for several tumour types, including gynaecological cancers, resulting in greater accuracy and diagnostic confidence. This versatil- ity has been certified in five studies, which assessed the performance of FDG for primary staging and found that PET/MRI enhances local region- al staging and therapy planning. Professor Goh added: ‘For suspect- ed recurrence, PET/MRI has been shown to offer greater diagnostic accuracy and diagnostic confidence, particularly for nodal disease.’ Further studies have highlighted the superiority of PET/MRI in detecting, localising and characterising bone and liver metastases. Additionally, the technique can improve patient selec- tion for therapy, such as for neuroen- docrine tumours. ‘A number of stud- ies have also shown the added value for PET/MRI in terms of sensitivity for disease and better characterisa- tion of lesions,’ said Professor Goh. With respect to therapy assess- ment, she suggested PET/MRI may have a role in clinical trials, while its advantages also apply in some clinical scenarios, for example in the evaluation of myeloma patients undergoing induction chemotherapy and stem cell transplantation. The expert attested to the emerging clin- ical impact of PET/MRI, referencing two recent prospective studies with different tracers, which demonstrated higher accuracies as well as a change in management due to additional findings. Beyond oncology, PET/MRI has also made its way into the clini- cal routines in neurology and cardiol- ogy, Professor Goh reported. A more expensive option (that still pays off in the end) While PET/MRI may be more expensive than PET/CT, the imag- ing expert believes that the benefits outweigh the increased costs: high- er overall image quality may obvi- ate the need for additional scans and lead to faster management decisions. Regarding the financial impact, treatment costs may even be reduced due to better patient selection for therapies. Professor Goh concluded: ‘With increasing personalisation of care, PET/MRI offers the opportunity to transform care delivery for patients and, in particular, to improve patient experience.’ EUROPEAN HOSPITAL Vol 31 Issue 1/22
1 0 E H @ E C R Assessing infection severity CT severity score predicts Covid-19 death risk Radiologists at the Hôpital Européen Georges-Pompidou in Paris have developed a standard- ised simple visual lung damage CT severity score for Covid-19 patients who do not have symp- toms of severe acute respiratory syndrome (SARS) at the time of initial treatment. Report: Cynthia E. Keen This visual score of lung alveolar opacity aids in decision-making to admit a patient into the hospital rather than treating them and send- ing them home to recover, and to admit inpatients to an intensive care unit (ICU) directly or upgrade them to ICU treatment. Diffuse lung infection with a very poor prognosis The severity score is based on the presence and extent of ground-glass opacities (GGO), consolidation opac- ities, or both, seen on the CT images of lung lobes. Each lung lobe extent is classified with a numeric score as mild, moderate, or severe, ranging from 0 (not present in any lung lobe) to 20 (> 75% in all five lung lobes). The number of lung lobes involved per patient by GGO or consolidation opacities is also estimated as a first visual CT score to assess the extent of the damage. A score of 7 or higher is the threshold indicating greater risk of death within 30 days from Covid-19, independent of other commonly accepted risk factors, including patient age, respiratory rate, oxygen saturation levels, comorbidities, and hs-troponin I level at admission. The score also helps predict discharge rates among inpatients. The study to develop the severity score Principal investigator Professor Elie Mousseaux, MD, PhD, and col- leagues developed the score by assessing the initial chest CT exam of 210 consecutive patients hos- pitalised for at least 24 hours who were not directly admitted to an ICU between March 13 and April 8, 2020. CT images of all patients were assessed by pairs of radiologists working independently who were blinded from all clinical data, biol- ogy, and initial chest CT analysis. In cases of differing assessments, a cardiothoracic imaging specialist would provide a consensus reading used for the final analysis of the relationship between the visual lung CT scores, 30-day mortality, and other outcomes. The researchers analysed rates of all-cause mortality at 30 days according to the number of affected lung lobes by either GGO, consol- idation, or both, and according to the visual lung damage CT score. All of the patients were initially admitted to Covid-19 wards, but 72 patients were transferred to an ICU during their hospital stay. As of May 8, 2020, when follow-up ended, 147 had been discharged, 15 remained hospitalised, and 48 died. The total CT severity score com- bining GGO and consolidation was a mean of 6.3 in survivors and 9.5 in non-survivors. The 30-day mortality increased threefold if the visual lung damage CT score was 7 or greater. The more frequent and significant features in non-survivor patients were dyspnoea (shortness of breath), higher respiratory rate, and lower oxygen saturation. The researchers reported that there also was a significant increase in creatinine levels, in cardiac bio- markers and in inflammation bio- markers in non-survivors compared to survivors. Additionally, the pres- ence of pleural effusion and of peripheral distribution of lesions was more frequent in non-survivors. Patients with a CT severity score of 7 or higher were also twice as likely to be transferred to an ICU during hospitalisation.’ Survivors with high scores also had longer hospital stays. Scoring system aids hospital clinicians ‘The scoring system has helped the hospital staff in their deci- sion about admitting a patient whose Covid-19 symptoms might not be considered severe enough for an inpatient stay,‘ Mousseaux explained during our European Hospital interview. ‘If a patient has a CT score greater than 7, we keep that patient in the hospital to be sure their clinical condition will not change during the next few days. In this situation, the CT is essential.’ Publisher Mediengruppe Oberfranken – Fachverlage GmbH & Co. KG E.-C.-Baumann-Str. 5 95326 Kulmbach/Germany Phone +49 (0) 9221/949-311 Fax +49 (0) 9221/949-377 Editor-in-Chief: Mareike Scholze (MaS) Production Manager: Sonja Buske (SB) Editorial team: Wolfgang Behrends (WB) Sonja Buske (SB) Sascha Keutel (SKE) Senior Writer: Mark Nicholls (MN), Great Britain Mélisande Rouger (MR), Spain Publishing Director: Mareike Scholze (MaS) Managing Directors: Walter Schweinsberg, Bernd Müller © CT detected lung lesions in Covid-19 infection: the form is limited to only 2 lobes The researchers explained that ‘to evaluate prognosis, the short-term mortality seems to us as a more objective criterion than a composite endpoint including mortality. Given the magnitude of the epidemic from one location to another, at near-peak the number of patients transferred to intensive care and conversely sent home were more complex to analyse because of the obvious lack of available space in many institutions, particularly regarding ICUs. ‘We have confirmed here that the proportion of patients discharged was lower and that transfers to the ICUs were greater when the lung severity CT score on admission was 7 or greater,’ they added. Writing in European Radiology, the authors recommend that their score should be incorporated into risk stratification algorithms and in structured chest CT reports requir- ing a standardised reading by radi- ologists. Mousseaux also advises that the severity score also accurate- ly predicts Covid-19-related deaths six months following initial treat- ment. 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E H @ E C R Experts discuss gender issues Women in interventional radiology take center stage Gender-specific benefits of women should have a greater impact in interventional radiology (IR). But also, the field should see more women practicing the craft. These were among the main take- home messages of the annual meeting of the French Society of Radiology ( JFR). Speakers focused on the benefits brought by IR to women’s health and the global shortage of women interventional radiologists. Interventional radiology offers significant benefits in the treatment of infertility, post-partum issues and symptomatic uterine fibroids, reported Professor Maureen Kohi, chair of the radiology department at the University of North Carolina in Chapel Hill, USA. According to recent figures, infer- tility is a global problem that affects 15% of couples trying to conceive. Roughly a third of cases are caused by diseases concerning the fallopi- an tube. IR can help many of these couples procreate, Kohi explained: ‘10 to 25% of tubal disease are due to proximal tubal inclusion,’ she said. ‘Fallopian tube recanalisation is an effective treatment that can be provided in a minimally invasive fashion to address this problem.’ Recanalisation is less aggressive than surgery and may help women avoid potential emotional turmoil caused by other options like in vitro fertilisation, adoption, or surrogacy, Kohi noted. Saving a woman’s life Another important issue is the high number of women who die while giving birth, often caused by post-partum haemorrhage. Here, uterine artery embolisation (UAE) has proven an effective treatment option. ‘When you see a pseudoan- eurysm or some sort of uterine artery anomaly, going ahead and performing a uterine angiography and embolisation can be an amazing way of saving a woman’s uterus and her potential for getting pregnant in the future,’ the expert said. Success rate with UAE in post-partum bleed- ing is well above the 90% thresh- old, Kohi reported, with delayed treatment being the most common cause for failure. ‘The key is hav- ing better communication with the obstetrics haemorrhage team and tell the obstetricians to call as soon as possible to improve patient prog- nosis.’ Morbidly adherent placenta, another abnormal condition after birth, has increased over the last decade. Patients quickly lose a lot of blood, with 40% requiring more than ten units of packed blood cells – a quantity that many hospitals are not able to provide. Different solutions exist to manage the con- dition, but most recommendations point to a caesarean, followed by hysterectomy. Catheterisation helps reduce blood loss during those com- plex interventions, Kohi explained. ‘We can place occlusion balloon catheters before or after delivery to minimise blood loss during hys- terectomy,’ she said. However, the procedure exposes the foetus to radiation and is subject to contro- versial discussion. Kohi performed a registry study to assess the out- comes of balloon occlusion. She found the procedure was associated with decreased estimated blood loss (EBL), transfusions, ICU admissions and adverse events compared to internal artery ligation or no adjunc- tive interventions. Bilateral uterine embolisation can also be performed after caesarean delivery and before hysterectomy whenever a hybrid OR is available. Embolisation is also highly recom- mended in the treatment of symp- tomatic uterine fibroids, the most common reason for hysterectomy in the US. ‘It’s a great treatment and it’s been tested with excellent level of evidence and over time,’ she concluded. Underrepresentation of women Tackling another aspect, Rana Tarek Khafagy, an IR consultant at Ain Shams University Hospital in Cairo, Egypt, highlighted the global shortage of female interventional radiologists. ‘Although the preva- lence of women in radiology has increased over the past few decades, there’s still a remarkable lack of women interventional radiologists all over the world,’ said Khafagy. She also described the situation in Egypt, where female physicians have traditionally been underrep- resented, at a current 5.9% of IR consultants. ‘Interest has been grow- ing for the past few years,’ said the Maureen P. Kohi Dr. Maureen P. Kohi is professor of radiology and chair of the radiology department at the University of North Carolina in Chapel Hill, USA. Dr. Kohi is a well-known leader in Vascular and Interventional Radiology in clinical care, education, and research, as well as a nationally recognised women’s health advocate. She has received many hon- ours recognising her commitment and service to academic radiology and major areas of advocacy in medicine. Rana Tarek M. Khafagy Dr. Rana Tarek M. Khafagy is an inter- ventional radiology consultant at Ain Shams University Hospitals, Cairo, Egypt. She currently heads the Residents Fellows and Students (RFS) Committee of the Pan Arab Interventional Radiology Society (PAIRS). Dr. Khafagy is also an editorial board member of the Arab Journal of Interventional Radiology (AJIR) and the main author and co-au- thor in several peer reviewed publica- tions. Her main areas of interest include women’s health, embolisation and onco- logical interventions. expert. Radiation exposure and its potential consequences on pregnan- cy were identified among the main impediments to a career in IR, along with the nature of the profession and its associated stress, she said. ‘We should now address those con- cerns and insist that interventional radiology can be practiced safely,’ she concluded. (MR) Left picture: uterine embolisation being performed on the left side following caesarean delivery of the foetus. Right picture: successful bilateral embolisation with no blood flow to the uterus. This results in minimal blood loss during the hysterectomy. www.healthcare-in-europe.com 1 1 Advertisement 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. 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1 2 E H @ E C R Watch your back! Spinal imaging in tr Spinal trauma imaging is considered one of the most challenging areas radiologists face as they seek to assess the extent of injuries to patients under high pressure. The issue was tackled in detail at the British Institute of Radiology virtual congress by Professor Elizabeth Dick. Radiology approaches Report: Mark Nicholls spinal imaging The specialist focused on different approaches and protocols for a range of levels of spinal injury and discussed how best to assess and image them, which modalities to use, and the key factors to consider. In her presentation “Watch your back! – an approach to spinal imaging in trauma,” Professor Dick explored imaging of thoracolumbar and cervical spine injuries. One of the major challenges, she said, was assessment of the spine’s stability, a crucial prerequisite for safe removal of the cervical collar. Misjudging stability can result in severe con- sequences, such as progression of skeletal deformation or neurological Brust fracture retropulsed fragment deficits. Generally, spinal imaging should be performed on patients who have undergone a relatively high-energy mechanism of injury, Professor Dick said. ‘But there is also a need to be cautious if there is another injury or altered level of consciousness. It is important to get the patient to CT as quickly as possible, ideally within half an hour of arriving in the emergency depart- ment.’ She stressed the importance of this timeframe since delays often result in a higher risk of neurolog- ical injury. Number of affected columns as a predictor of stability To determine spinal stability in thoracolumbar injuries, several clas- sification systems may be applied. For many clinicians, the Denis sys- tem is the preferred option, based on its division of the vertical body into anterior, middle, and posterior columns. ‘Put simply, if two col- umns are injured, it is quite likely the patient has an unstable spine,’ Professor Dick said. Another aspect that has gained rel- evance in recent years is the posteri- or ligamentous complex. Consisting of the posterior bony ring and adja- cent soft tissues, the structure acts like a tension band which holds the whole spine together, the expert explained. For this reason, injury to the ligamentous complex is asso- ciated with a high risk of spinal instability. The four thoracolumbar spinal Central Cord syndrome injury patterns are: 1. compression fracture 2. burst fracture, which may be a 2 or 3 column injury, with or without retropulsion and neu- rological damage 3. flexion-distraction or Chance injury, an unstable three-col- umn injury which may have an associated abdominal injury, and usually needs intervention 4. fracture dislocation, such as from someone falling from height, with unstable spine and a high likelihood of neurologi- cal deficit Professor Dick added: ‘Burst frac- tures can be stable or unstable. If a patient has a neurological deficit, that would indicate the need for surgery. The radiologist can help by identifying various signs on CT, such as severe loss of height of the vertical body, retropulsion, kyphosis and rotational malalignment.’ The ‘golden rules’ of spinal MRI For MR imaging, the expert also gave two “golden rules”: the impor- tance of a T2 fat saturated imaging sequence, and imaging of the whole spine; ‘because if someone has one spinal fracture, they are likely to have a second one as well, so it is important to make sure all of the injuries are detected,’ she stressed. These rules are especially important since patients with severe injuries are difficult to get into the scan- ner in the first place, so any scan should be performed properly the first time. Professor Dick also outlined the TLICS (Thoracolumbar Injury Classification and Severity) score for determinants of injury cover- ing fracture morphology, integrity of posterior ligamentous complex and the neurological status of the patient. ‘It is useful to be aware of this as two out of the three compo- nents are based on radiology,’ she added. Furthermore, she stressed the importance of early imaging for patients with thoracolumbar spine injuries, with CT being the primary modality, followed by MR whole spine imaging. For children, different rules apply For patients with cervical spine injuries, Professor Dick advised moving from the anterior to pos- terior during the examination. Additionally, routine CT in major trauma should be chosen over plain film, with imaging of the entire cervical spine in all planes being of great importance as well. ‘In major trauma in general, a routine whole- body protocol should be performed to image the entire patient each time,’ she said. ‘That way, all the injuries will be included, and the image can be reviewed in a very structured and disciplined fashion, to maximise chances of picking up every injury.’ She concluded that promptly and thoroughly executed whole-body CT has in important role in improving patient survival. JVCKENWOOD announces functional enhancements and new monitor Remaining active in 2022 ACCUTRON® CT-D VISION. SIMPLY MORE. The diagnostics specialist that can do more. More comfort, more mobility, more operating safety. More integration through Injection Data Sharing with RIS/PACS connection. View now at medtron.com In the second year of the pan- demic, JVCKenwood draws a pos- itive conclusion despite all diffi- culties. ‘We were able to welcome some highlights in 2021, both on the part of new monitors and new customers,’ says Marcel Herrmann, Marketing Manager Medical Imaging. ‘Nevertheless, the situation remains tense here and there.’ The two new displays CL-S600 and CL-S1200 have received consist- ently positive reactions from users. Both can display medical images of different modalities such as CT, CR/DR, MR, ultrasound and pathol- ogy side by side, the 12-megapix- el monitor additionally displaying images of mammography. The two large screens without a centre bar create a comfortable environment for radiological diagnostics. For this purpose, they are equipped with the latest technology. ‘The patented Dynamic Gamma function, for exam- ple, analyses the entire screen con- tent and selects the correct gamma curve for each individual pixel in real time. This applies to all images – whether ultrasound, endoscopy, pathology or nuclear medicine – and always results in an optimal display,’ explains Herrmann. This succeeds without problems even with moving images, although millions of opera- CL-S600 monitor tions per second are necessary here. Another important feature: lumi- nance and colour temperature are adjusted automatically and in real time. ‘The built-in colour front sensor on the screen constantly measures the colour temperature and adjusts changes over a long period of time,’ says Herrmann. This is easy on the eyes of the person making the findings – as is the built-in lighting on the back of the monitor and the indirect lighting of the keyboard and mouse. JVCKenwood has installed the first CL-S1200s in a hospital in Switzerland. Spain also reports a large project: Here, the Japanese company has equipped all clinics in the Asturias region around Gijón EUROPEAN HOSPITAL Vol 31 Issue 1/22
our back! Spinal imaging in trauma E H @ E C R 1 3 Cerebrovascular diagnostics and treatment Stroke: The benefits of multimodality imaging When a patient suffers a stroke, speed in treatment can mean the difference between successful recovery, permanent disability, or death. Often encapsulated in the phrase ’time equals brain’, the ability to act quickly and with greater certainty enables physicians to bring a higher quality of life for those who survive. For Christopher Hess, MD, PhD, success in stroke diagnosis and impactful treatment therefore is a question of workflow and efficient care delivery. Elizabeth Dick Report: Sascha Keutel Professor Elizabeth Dick is a consult- ant radiologist and Professor of Practice at Imperial College NHS Healthcare Trust with expertise in body MRI, emergency, trauma, and musculoskeletal radiolo- gy. At Imperial College Healthcare she was Head of Trauma radiology and is Associate Director of Medical Education. She is past-President of the European Society of Emergency Radiology and of the British Society of Emergency Radiology. Her research interests include trauma imaging, medical education, and digital learning. The use of CT angiograms may also be considered to identify inju- ry of the vertebral artery early, so patients can be anticoagulated to decrease the risk of stroke. However, the aforementioned guidelines only apply for adult patients, Professor Dick cautioned, as the rules on imaging the spine in children are very different: if possi- ble, CT imaging should be avoided because of the long-term radiation risk and should only be considered if there is a strong suspicion of injury. with more than 400 different dis- plays. Innovations for 2022 2022 will be marked by function- al expansions of the i3 monitors. ‘They will also be equipped with a turboluminance function as well as the so-called Visual Point Mode, which users of our 6 and 12 MP displays are already familiar with,’ says Herrmann. The turbo luminance function can increase the brightness and contrast of the screen for a maximum of 30 seconds to magnify recognisable greyscales. This enables the radiolo- gist to reliably assess even the finest calcifications. The effect is further enhanced by the Visual Point mode. This increases the contrast in cer- tain areas controlled by the mouse pointer. With both technologies, the DICOM characteristic curve is main- tained or dynamically adjusted. In addition, the launch of an 8-megapixel monitor is planned for the summer. ‘However, due to the pandemic, we are still facing chal- lenges that also affect the supply situation. Therefore, we unfortu- nately cannot exclude the possibility of delays. However, we will do everything we can to be ready in time. After all, the European Congress of Radiology ECR is planned as a presence event in July – with us as an exhibitor,’ says Marcel Herrmann, looking forward to a relaxed summer. www.healthcare-in-europe.com treatment of ‘Effective stroke depends critically on workflow and the overall strategy for how patients are evaluated and treated,’ the Chairman of the Department of Radiology and Biomedical Imaging at the University of California, San Francisco (UCSF), said. For Hess, new and emerging mul- timodality angiography suites that include MRI and cone-beam CT hold significant promise for stroke patients. ‘We have a closely locat- ed MRI and angiography suite at Zuckerberg San Francisco General Hospital that we use to decide in real-time how to process with embolectomy. Our other imaging resources like effective hub-and- spoke imaging transfer tools, fast emergency department CT and cone-beam CT in the angiography suite are essential to rapidly make sure the patient doesn’t have a hemorrhage before embolectomy proceeds,’ he reported. This technological advantage directly affects workflow at UCSF, because it can allow patients with large vessel occlusion to avoid going through the ER, the expert explained. ‘Patients are transferred directly into the the hands of our neurointer- ventionalists to start the procedure. ‘This is important, because the clock is always ticking in stroke therapy.’ Time is also of the essence when thrombolysis is performed using tis- sue plasminogen activate (tPA) in patients with large-vessel occlusion. The tPA protein, which is used to dis- solve the clot, must be given intrave- nously within a four-and-a-half hour window from the onset of symptoms to ensure treatment success. Mobile Stroke Units Deployment of Mobile Stroke Units (MSUs) is another approach to shorten stroke-to-embolecto- my time. Equipped with compact CT scanners, point-of-care labora- tories, and real-time bidirectional audio-video communications, these ambulances allow for initial diag- nostics and even treatment while the patient is on the way to the hospital. Clinical staff onboard typi- cally include a paramedic, CT tech- nician, and physician plus a regis- tered nurse trained in stroke med- icine. Researchers at the Medical University of South Carolina recent- ly tested an ultra-low field portable MRI machine that would not only cost a fraction of the CT scanner but would also bring the advantages of MRI scanning to the MSUs. ‘Mobile Stroke Units offer signif- icant promise. Studies show that they improve patients’ outcomes by decreasing the time to treatment,’ Hess said. ‘However, with costs often exceeding $1 million per unit, MSUs are a very expensive resource to deploy and their overall effec- tiveness remains to be determined. It is critical that these resources are directed to actual stroke patients, and not in circumstances where other neurological disorders like seizures, headaches or drug over- doses cause stroke-like symptoms.’ Embolectomy is available at only a few centres, so the distinction between stroke and stroke-like syn- dromes impacts where the MSU should drive. ‘We have to see how effective it is at triage, but I expect that for large vessel strokes, MRI in MSUs will be very effective and cost-efficient,’ Hess said. ‘Especially with late-onset strokes, the question often is how much tissue is still viable. The extent of whether an MRI scanner could answer that question prior to the arrival at the hospital would allow a more precise targeting of therapy,’ he explained. Outlook Envisioning the future of stroke imaging, for Hess, it all boils down to workflow. ‘The future lies with multimodality systems. At UCSF, we are very excited about our combined angiography-MRI units and using them to make real-time decisions about how to best treat patients,’ Hess said. ‘We need to Christopher Hess Christopher Hess, MD, PhD, is Alexander R. Margulis Professor and Chairman of the Department of Radiology and Biomedical Imaging at the University of California, San Francisco. Hess earned his medical degree at the University of Illinois College of Medicine. He obtained a master’s and a doctorate in electrical engineering at the University of Illinois at Urbana-Champaign working in the field of MRI. His primary research interests lie in brain degeneration, epi- lepsy, and neurovascular disease. push for more multimodality imag- ing.’ Furthermore, he envisions new software will help the diagnosis and treatment of stroke. ‘There will be advances in numerical quanti- fication of a stroke’s effect on the brain, some of which use MRI, and these will increase our ability to more effectively select patients who will benefit from treatment,’ he predicted. New NEWTOM 7G www.newtom.it WIDE.VISION NEW IMAGING HORIZONS. Featuring a large gantry aperture, the NewTom 7G is the most advanced CBCT device on the market. From in-depth detail to the big picture. ULTRA-DETAILED MULTI-DIAGNOSTICS Localised analysis over the entire body. Ray2D and 3D imaging up to 90 µm, also with radiocontrast agent. Artifact reduction and movement analysis using CineX and Cine-Scout. The eXtra Functions protocol extends the field of view longitudinally to analyse anatomical structures such as the spine and limbs. 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1 4 R O B OT I C S U RG E RY Robotic ‘mini-tank’ to enhance colonoscop Endoculus A miniature colonoscopy robot developed to collect images and biopsies could have clear benefits for both patients and endoscopists. The device, which carries a camera and uses other small surgical tools, uses tank-like treads to proceed along the patient’s colon under the control of a gastroenterologist, instead of the current ‘pushing’ technique to propel the endoscope manually through the colon. This means advantages for the patient in terms of less friction and discomfort, as well as having ergonomic benefits for surgeons. Report: Mark Nicholls The device, called the Endoculus, has been designed by a team at the Advanced Medical Technologies Laboratory (AMTL) at the University of Colorado in the United States. Professor Mark Rentschler, director of the AMTL, who leads the project, explained the current version of the device began in earnest in 2016 with PhD students Greg Formosa and Micah Prendergast advanc- ing the mechanical and electronic design. It has now reached the stage of adding more autonomous capa- bilities and features to further the understanding of its capabilities as the team look to transition the pro- ject into a commercial product that is affordable and tested clinically. Reducing the strain on endoscopists and patients The robot is the size of a small film cannister and can be used on patients without causing discomfort, but the team is looking to make it smaller still. ‘The idea was originally to make a capsule device that can be tethered and can propel itself around to ena- ble remote endoscopy,’ explained Professor Rentschler. ‘There are a few things tied to that: one is just capability and ease, but also a lot of the mental energy and effort from surgeons are focused on getting to where they need to go with the scope, rather than just focusing on visualisation. So, if you can have less of a manual approach, the upside for the physician is that they e c n e i c S d e i l p p A d n a g n i r e e n i g n E f o e g e l l o C r e d l u o B o d a r o o C l f o y t i s r e v i n U ) 2 ( © The robot with a model of an intestine can focus on diagnostics and treat- ments, not just access.’ With chronic shoulder and elbow problems being a well-known strain on endosco- pists related to this heavy manual work over long periods of time in theatre, this is not just a matter of enhanced convenience. Familiar, yet different As a motorised colonoscope, the Endoculus has all the standard capa- bilities of an endoscope, with an onboard camera and lighting, chan- nels for irrigation, inflation and suc- tion, and a port for conventional tools. ‘Our device needed to have visualisation and tool access, but we want the device to focus on mobil- ity, traction, and manoeuvrability,’ Rentschler added. ‘Ultimately, we wanted to approach this as a remote device that the physician can control and get to where they want it to go.’ The group is looking at options to design portions of the device for sin- gle use, with motors off board and the power transfer through its teth- er. ‘We are trying to add new capa- The ‘Endoculus’ miniature robot bilities to the physician suite but not radically change their approach from an operational standpoint,’ the robotic expert added. From push to pull The device offers benefits to sur- geons and patients. ‘The patient benefit is more comfort and less pain,’ Rentschler said. ‘With endos- copy, distension of the wall from endoscope pushing is where dis- comfort occurs for the patient. The key for us is to transition away from Greater precision, reduced exposure to radiation Robotic surgery procedures bring great benefits to cardiac interventions Interventional cardiology is entering a new era with the wider introduction of robotic procedures which bring significant benefits to the medical team and the patient. The benefits for interventional cardiology were outlined to the ESC 2021 Digital Summit by consultant cardiologist Professor Dariusz Dudek, while cardiac surgeon Professor Nikolaos Bonaros discussed the advances in robotic cardiac surgery. Relying on robotic assistance ben- efits precision and brings additional options for remote procedures. This, in turn, results in less direct contact with the patient, and reduced expo- sure to radiation for interventional cardiologists. While interventional cardiol- ogy and percutaneous coronary (PCI) had seen interventions significant progress in recent years, Professor Dudek, from the Department of Clinical Cardiology and Cardiovascular Interventions at the University Hospital and the Jagiellonian University in Krakow, Poland, expressed his confidence that robotic techniques would take these fields even further, ushering in a new era. Having adopted the technique for patients at his centre in March 2021, he outlined the benefits for the cardiologist, medi- cal team, and the patient. More precision, less fatigue The robotic instruments are con- trolled via a cockpit console in the operating theatre, the cath lab or a separate control area. Only one assistant is needed close to the patient to change devices and wires with headset communication between the two areas. For aspects such as wire manipu- lation and balloon or stent delivery, robotics also allow for a degree of automation, Professor Dudek explained. ‘The benefits we see is that there is almost no radiation exposure, and a dramatic reduction of operator fatigue due to not having to wear heavy aprons. There is also precise evaluation of coronary artery lesion length, which is much more precise than colleague assessment, and precise positioning The robotic system in the cath lab Dariusz Dudek at the robotic console of stents, especially for ostial lesions and for long lesions with minimal overlap.’ Precision is also increased in comparison with the manual tech- nique, the expert continued, par- ticularly with guidewire navigation. ‘With this technology, it is time to change the traditional cardiology era and make the next step,’ he said. Professor Dudek envisions the ‘cath lab of the 21st century,’ as he put it, with a greater focus on image- based pre-procedural planning via CT, robotic-assistance, and the abili- ty for remote procedures. ‘We are going towards a new era that is a paradigm shift in interven- tional cardiology, with less radiation exposure, artificial intelligence and more precision.’ Professor Bonaros from Innsbruck Medical University, Austria, reflected on advances in robotic cardiac surgery, and devel- opments in techniques, equipment, and instrumentation, over the last two decades. Available systems range from fully human-controlled procedures through partial automa- tion with human back-up, to ful- ly-automated smart vehicles capable of operating in any circumstances, he explained. The expert showcased the bene- fits of automation with examples of cases, demonstrating the degrees of manipulation of the instrumenta- tion, particularly with the flexibility of the endowrist technology, and levels of 3D visualisation. However, while robotic assistance brings ben- efits in cardiac surgery procedures EUROPEAN HOSPITAL Vol 31 Issue 1/22
R O B OT I C S U RG E RY 1 5 to enhance colonoscopy techniques push endoscopy where the physi- cian is pushing, to pull endoscopy, where device at the end of the tether is pulling it softly through the colon.’ With the surgeon, the reduced physical effort helps avoid common injuries associated with the task. For populations with a tortuous, or strange, colon pattern, it can be challenging for physicians to reach the cecum at the beginning of the colon to get a full colonoscopy, so consistently getting a complete pro- cedure is also a strong upside for the device, he said. From testing to clinical practice The device is a few years away from use in clinical practice but has been tested on animal tissue laid out in the form of human anatomy. The plan is to launch a company to establish the product, with a view to procedures in humans within three years. ‘We have focused long and hard on the clinical aspect, but we really need to make sure of the commercialisation aspects of it to keep it moving forward,’ said Professor Rentschler. The team believes the Endoculus could eventually replace traditional endoscopes used in colonoscopies and endoscopies and lead to earlier detection of cancers enabling better outcomes. Mark Rentschler Mark Rentschler is Professor of Biomedical, Mechanics of Materials, Robotics and Systems Design and director of the Advanced Medical Technologies Laboratory (AMTL) at the University of Colorado in the United States. His research is focused on intelli- gent medical devices and surgical robot- ics for patient-specific medical care and includes design of novel surgical tools, devices, and robotics, and characteriza- tion and modelling of how these interact with the patient. y procedures bring entions such as coronary surgery, mitral valve surgery and procedures for congenital conditions, human par- ticipation remains a necessity, for example a perfusionist operating the heart-lung machine. Professor Bonaros concluded: ‘I think the future of robotic cardiac surgery is very interesting, but it is important to support it with training, with sim- ulators. There are difficulties in implementation, such as costs, and this is the reason why robotic cardi- ac surgery has not boomed until now, but I think it is an opening market.’ (MN) Dariusz Dudek Dariusz Dudek is President of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC). He heads the second Department of Clinical Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland, and is a Professor of the Institute of Cardiology at the Jagiellonian University in Krakow. His key areas of research are acute myocardial infarction, antiplatelet and antithrombotic drugs and complex PCI. www.healthcare-in-europe.com
1 6 L A B O R AT O RY Bringing liquid profiling to the clinic Liquid profiling is offering clear benefits in terms of cancer diagnostics and targeted therapy, but challenges remain in bringing it into the clinic. During the LabMed oncology ses- sions at the 2021 Medica/Compamed conference, Dr Verena Haselmann talked about the gaps between the possibilities of liquid profiling and the status quo in standard of care. Cancer diagnostics The expert from the Institute of Clinical Chemistry of the University Medical Centre Mannheim, Germany, also outlined the challenges with implementing the technique into standard care and routine diag- nostics in management of cancer patients. Liquid profiling, she said, brings a number of benefits; it can be used as a companion diagnostic for appropriate drug selection, provide therapeutic monitoring to detect upcoming resistance mechanisms and recurrence, and prognosis assessment for guidance of thera- peutic/diagnostic decisions. On the other hand, she conceded that it was a challenging type of diagnos- tics with a need for highly sensi- tive techniques. Its unwieldy nature made it hard to convince clinicians to integrate it into their clinical rou- tine workflows, despite the benefits, the expert summarised. lenges in a lack of harmonisation of preanalytical and analytical work- flows and reimbursement issues for most targets. Most important, how- ever, is the incorporation into clini- cal guidelines for different cancers, because ‘at the end of the day, the clinicians will decide whether this will be successfully translated into standard of care.’ Liquid profiling, the expert main- tained, is still not fully implemented into standard of care. ‘But we do see a nice correlation between the frequency we observe in liquid pro- filing and the clinical course of the disease of the patients.’ She noted that more clinicians become aware of these benefits and it is increas- ingly being integrated into work- flows. If this trend were to continue, liquid profiling should have ‘a really great future’ to match its diagnostic potential, Prof Haselmann conclud- ed. k c o t s r e t t u h s – 2 5 l u f i a S © ‘At the end of the day, the clinicians will decide’ Her unit was the first to intro- duce an external quality assess- ment scheme in 2017, which now sees 40 laboratories participat- ing. Compared with standard-of- care molecular genetic tests, liquid profiling is prone to high error rates, often depending on the meth- ods used by individual labs. Prof Haselmann identified further chal- Different strategies for different scenarios Dr Ellen Heitzer from the Institute of Human Genetics at the Medical Considerable advances University of Graz, Austria, dis- cussed the application of liquid profiling diagnostics in oncology and its unique challenges. One of these, she said, was the highly frag- mented nature of circulating tumour Ellen Heitzer Dr Ellen Heitzer is Associate Professor at the Diagnostic and Research Institute of Human Genetics and heads the Research Unit for Liquid biopsies for personalized medicine in cancer at the University of Graz, Austria. A pioneer of liquid biopsy in Europe, her scientific expertise and research focus is in cancer biomarkers, cell-free circulating DNA, tumour heterogeneity, hereditary cancer syndromes, next generation sequencing, and circulating tumour cells. Emerging technologies in POCT Considerable advances in point- of-care testing (POCT) devices are emerging from lab-on-a-chip platforms, innovations in smart- phone-based technology and wearable technology. Cloud-based deep learning systems herald a future revolution, writes Bernard Banga, MD. The World Health Organization (WHO) has endorsed bedside diag- nostics as the top research priority in response to the so-far 2-year long epidemic without let-up. The aim is to improve turnaround time and ease of use compared to the gold standard lab-based PCR test. These have included rapid antigen tests, alternate nucleic amplification methods and novel sensors in prox- imity to the patients. POCT deployed in multiple clinical contexts in 2021 POCT is being rolled out in var- ious healthcare settings in 2021. The most obvious applications are blood-glucose monitoring and preg- nancy testing. ‘Widespread POC test- ing and diagnostic devices are avail- able, including, but not limited to, glucose monitoring, pregnancy and infertility testing, infectious disease testing, cholesterol testing and car- diac markers,’ said Amit Saha, from the Stanford Genome Technology Center in California, USA. Today, blood gas analysis along with hae- moglobin, prothrombin time and infectious disease testing are the dominant applications in the POCT market. Looking to the future, tumour markers, flow cytometry (mainly for chemotherapy monitoring), endo- crine function tests and therapeutic drug monitoring will all benefit from recent technology advances in the POCT field. Technology advances change POCT applications Miniaturisation in chip technolo- gy, microfluidics and new biosen- sors have heralded the design of new systems for POCT. Lab-on-a- chip technology is one of the main drivers of POCT, especially in infec- tious disease diagnosis. This tech- nology means various bioassays, such as microbiological culture, polymerase chain reaction (PCR) and enzyme-linked immunosorbent assays (ELISA), can now be used at the point of care. Similarly, emerging microfluidic technologies include a set of minia- turised components allowing chem- POCT and Covid-19 Most promising SARS-CoV-2 POCT methods: immunoassays for antibody and antigen detection, RT-PCR as the gold standard, isothermal amplification and CRISPR-Cas9 genome editing technology as an emerging technique. Due to growing confirmed Covid-19 cases globally, rapid and reliable POCT is needed urgently for early detection. A reliable POCT device could reduce transportation, risk of spreading infection, strain on healthcare, and cost of care. Despite outbreaks caused by infectious viral diseases such as MERS, SARS, and Ebola, existing POCT platforms were not sufficiently ready to address the Covid-19 viral threat. However, in 2020, great efforts were made in POCT to improve Covid-19 detection. nosis and prognosis in conditions such as cancer, by identifying spe- cific biomarkers. The second, much more sensitive and specific, is based on PCR on a chip and isothermal amplification. Nucleic acid amplifi- cation can be used to detect a whole array of infectious diseases, such as Mycoplasma pneumonia, Bordetella pertussis, Legionella pneumonia, Influenza A virus, SARS, Legionella, Aspergillus, West Nile Virus and, now, SARS-CoV-2. A seventh format joins POCT POC device manufacturers are continually looking for ways to design products that deliver greater user comfort in a cost-effective man- ner. POCT relies on six main formats: bench-top, monitoring, transportable, portable, handheld and disposable. In recent years, the latest advances have seen the launch of a seventh: smart devices with smartphones and wearable devices. Mobile POCT uses sensors to detect signals from samples in vitro, whereas wearable POCT detects signals directly on the body. Both systems then send quan- tified results to the clinic via wireless communication. Various body fluids such as tears, urine, blood, sweat and saliva can be used to analyse metab- olites, hormones, proteins, viruses and bacteria. Smartphones act as minicomput- ers for sensitive and specific data quantification with built-in sensors, high resolution cameras, rapid wire- less connectivity and the ability to use various software and apps. This means they can function as standalone sensors and detectors in mobile POCT,’ Saha pointed out. EUROPEAN HOSPITAL Vol 31 Issue 1/22 k c o t s r e t t u h s – r e h p a r g o t p y r C © ical or biological samples to be analysed at the microscopic level. Microfluidic-based POCT devices are widely used in molecular biol- ogy as well as in chemical and biochemical analysis. They enable detection and fluid regulation in a single unit. ‘Greater sensitivity and specificity when detecting target analytes in small volumes over- comes several challenges encoun- tered when using traditional POCT techniques,’ Saha said. POCT cur- rently centres around two technol- ogies: lateral flow assay (LFA) and nucleic acid amplification. The first is used in pregnancy testing; test- ing for HIV, herpes simplex virus, hepatitis, infectious diseases (Ebola, dengue, malaria, Zika virus) and respiratory infections; and for diag-
iling to the clinic DNA (ctDNA), making it hard to discriminate between normal cell- free DNA (cfDNA) and its malignant counterpart. She also pointed out the necessity of adapting analysis strategies to different clinical scenarios; while at the time of diagnosis, testing of clin- ically actionable targets might be sufficient to tailor the patients’ treat- ment, the detection of MRD (minimal residual disease) after surgery or a Verena Haselmann Dr Verena Haselmann is Deputy Director of the Institute of Clinical Chemistry at the University Hospital Mannheim and heads the Next Generation Sequencing (NGS) Core Facility of the Medical Faculty Mannheim at the University of Heidelberg, Germany. Her research focuses on molecular genetics, ctDNA/liquid profiling, integra- tive diagnostics and quality assurance. Similarly, wearable POCT devices can be physical sensors used to acquire samples from the skin, eye or mouth with minimal invasion. They come in various forms, such as tattoos, patches, bands, watch- es, spectacles and contact lenses, and can be integrated with smart- phones for data capture. This type of testing is especially important for patients suffering from critical conditions, as they can monitor their health constantly without the need to go to hospital, or for trained personnel. Artificial intelligence and machine learning Artificial intelligence in diagnostics (AI), machine learning (ML) and neural networks are now starting to be integrated into POCT. These AI modules have demonstrated their value studies. However, the accuracy of test apps varies greatly and relying on these apps is cautioned against. The future is bright. Since samples can be dig- itised directly at the point of care (POC), advanced digital diagnostic techniques, such as sample analysis using medical AI algorithms, can be deployed outside high-end laborato- ries. ‘Hence POC digital microscopy, supported by automated digital image analysis and AI, might be deployed for routine microscopy diagnostics on samples harvested during cancer surgery, or on parasi- tology samples with an emphasis on potential areas of application in low-resource settings,’ added Oscar Holmström from the Faculty of Medicine at the University of Helsinki. L A B O R AT O RY 1 7 molecular relapse requires screen- ing for patient-specific alterations to achieve the necessary sensitivity. To analyse disease progression, larger gene panels and genome-wide anal- ysis of copy number alterations may identify resistance mechanisms or novel actionable targets. Potential alternative to tissue biopsy To illustrate this further, Dr Heitzer applied this approach to non-small cell lung cancer (NSCLC), where hard-to-access tumours are present in 31% of patients and up to one fifth of biopsies yield insufficient tissue quantity or quality for molec- ular testing. With respect to MRD, she noted that ctDNA could detect disease recurrence earlier than imag- ing in 72% of patients, adding that ‘ctDNA recurrence opens a window of opportunity to treat patients while tumour burden and heterogeneity are at their lowest’. She also pointed out the role of ctDNA as a marker of treatment response in ICI (immune-check- point-inhibitor) in NSCLC, with molecular ctDNA being predictive of long-term outcome. ‘Liquid biop- sy is a rapidly evolving and promis- ing diagnostic tool that may be an adjunct or an alternative to tissue biopsy and can be applied in many clinical scenarios.’ In addition, ctDNA testing has entered clinical routine in cases where no evidence-based treat- ment option is left and clinicians look to plasma for clinically-actiona- ble mutations. ‘However, due to the high variability of ctDNA, we still need to work on sensitivity,’ the expert cautioned. ‘Implementation of ctDNA mutation testing in routine clinical practice is envisioned in the near future, but it is necessary to standardise workflow because many by Professor steps are involved in a liquid biopsy test so it is really important to do this in a proper way.’ The session was hosted Stefan Holdenrieder from the German Heart Centre (DHM) in Munich, and also heard presentations on monitoring of conventional and immune thera- pies by molecular biomarkers from Professor Michel van den Heuvel of Radboud University Medical Center in the Netherlands; and on Exosome- associated miRNA and IncRNA diag- nostics by Professor Michael Pfaffl from the Technical University of Munich. (MN) D M C O R P 0 0 1 0 v 1 0 . From Sample to Result 1 9 - J A N - 2 0 2 2 PROVIDING INNOVATIVE MOLECULAR WORKFLOWS MolGen is a total solutions global supplier of innovative extraction DNA / RNA technology, systems, products and kits for human and animal diagnostics, agriculture, aquaculture, pharma and biotech. From sample to result, MolGen is challenging the status quo in molecular diagnostics by offering high-tech automated systems and consumables. Highly customizable, MolGen offers the perfect workflow for each customers’ specific needs. Please contact us for more information about our workflows, systems, kits and consumables. PUREPREP TUBE TRANSFER SYSTEMS The PurePrep TTR is an automated liquid handling device that transfers liquid fast, accurately, and consistently from tubes to Deep Well microtiter plates. This system is developed to decrease hands-on time, increase the laboratories’ accuracy, reduce contamination risks by decapping and capping tubes, and transfer samples from the tubes to plates. It is optimized for processing samples in the PurePrep TL+ Buffer. PUREPREP TL+ The PurePrep TL+ buffer allows the combination of safe transfer of viruses and lysis in one tube for research (including diagnostic tests and molecular biology techniques). The lysis component is optimized for further processing steps like nucleic acid extraction. The PurePrep TL+ buffer breaks down mucus-like substances in the tube to decrease prepping time and improve liquid handling. • +31 (0) 85 – 200 7431 • info@molgen.com • www.molgen.com www.healthcare-in-europe.com
1 8 M A NAG E M E N T & R E S E A RC H Eco-friendly power source ‘Greener’ mini-batteries to power medical devices More than 15 billion batteries are sent to landfill sites every year – technology that converts glucose and oxygen into electricity has the potential to reduce this waste and serve as a sustainable alternative power source for medical devices such as pacemakers, glucose monitors and pregnancy kits. with the combination of the two half-cell reactions creating the bio- fuel cell. Report: Mark Nicholls Visitors at the recent Medica/ Compamed conference were intro- duced to the innovative approach and its possibilities by French-based company BeFC at the “Powering the future – Energy generation with papers and enzymes” session. Dr Jules Hammond, CEO of BeFC, described the technology as part of a new wave of smart and connect- ed devices for patient monitoring, glucose monitoring, fertility testing and connected packaging. With an estimate of 50 billion connected units in 2020, this is expected to be a growing market within the industry. Many of these devices can oper- ate with low power consumption. Dr Hammond proposed that sus- tainable and clean energy alterna- tives can be used to power these machines, replacing conventional miniature batteries that often con- tain toxic materials. The eco-friendly paper-based fuel cells are ultra-thin, lightweight and flexible. Energy is generated via enzymatic reactions and stored using glucose and oxygen, avoiding the use of toxic materials and envi- ronmental pollution long after the batteries have been discarded. The BeFC sustainable power source batteries sustainable power cells developed by BeFC are flexible, lightweight and appropriate for wearable and implantable devices, the company’s CEO pointed out. ‘We use enzymes to convert glucose and oxygen into electricity, very much a bioinspired solution.’ The glucose and oxygen can be harvested from the blood- stream and power items such as pacemakers and insulin pumps, with the biofuel cells being activated by biological fluids such as blood, sweat, or urine. Dr Hammond also presented a “blister reservoir” as an alternative mode of activation, with the technology able to last for days or even months, depending on use case. The power source can also be sterilised with no obvious signs of degradation, he pointed out. The fuel cells are constructed as a stack of cellulose and carbon layers. Its function is based on the use of different enzymes immobilised on the electrodes. One enzyme is used to oxidise glucose, liberating elec- trons, which are harvested through the electrode. A different enzyme then reduces oxygen into water, which pulls elec- trons through the electrical circuit Wearable technology Reliable even when the lights go out The shape and size of the paper biofuel cell can be adjusted or enlarged as necessary. Current mod- els are 600 microns in thickness, with plans to reduce to 250 microns in 2022. Dr Hammond reported that his company is working with part- ners to scale up their production from a robotic sheet-to-sheet pro- cess to a roll-to-roll process. A major obstacle that prevents many green and flexible energy sources from use in wearables is their tendency to produce only unre- liable power output. As an example, photovoltaics require exposure to direct light to achieve useful power densities – this makes the technol- ogy unsuitable for devices worn underneath garments. Due to their structure, the batteries developed by BeFC are not limited in this way, the CEO pointed out. He expressed confidence in the technology developed by his team at BeFC of engineers, scientists and problem-solvers, with academic backgrounds in biosensors, print- ed batteries and paper microfluids. ‘What we are looking to do is pro- vide smart and connected devices that represent the minimal envi- ronmental amount of impact.’ Dr Hammond expressed his belief that medical application will become a major market for these low-cost, green platforms, which will com- bine metal-free and plastic-free energy solutions with printed elec- tronics. Dr Jules Hammond Dr Jules Hammond is CEO and cofounder of BeFC. Having completed his BEng and MEng degrees in electron- ic engineering, he continued his studies, completing a PhD in nanofabricated bio- sensors and then joined the group of Dr Serge Cosnier at Grenoble to develop novel biofuel cells. As a CEO, Hammond is focused on hiring talent to build an interdisciplinary team of problem-solv- ers. He develops the strategy to guide the company towards its mission of replacing conventional miniature batteries with eco-friendly technology, to provide a sus- tainable energy solution for low-power electronics. Smart textiles to help detect heart conditions Serious heart conditions such as Atrial Fibrillation (AF) are among the major causes for strokes in patients, if undetected. However, AF can be difficult to pinpoint as symptoms – irregular or rapid heart rhythms – may occur at unpredictable intervals. So, long-term monitoring of a patient’s heartbeat is required to effectively identify AF. Smart textiles with built-in sensors and transmitters present themselves as a diagnostic solution as they can monitor heart rhythm over long periods and thus pick up on potential AF. Risk of stroke is increased 3–5 times for AF patients, but because the condition can occur at irregular intervals, it may remain unnoticed by the affected person, explained Markus Sonderegger, from Austrian start-up company 24sens. Globally, 45 million people have AF, a quar- ter of 40-year-olds will develop it in their lifetime, and the prevalence increases rapidly with age, with 10 % of people over 65 10 % of people over 65 affected. With more than five With more than five million new cases a million new cases a y e a r , y e a r , global prevalence of AF has doubled in the past decade, with the World Health Organization classifying it as a global problem. ‘The challenge is to detect AF because it occurs at irregular intervals,’ explained Sonderegger. ‘This requires a long- term recording of the patient’s heart activity and subsequent analysis of the data.’ Wearable device designed Wearable device designed for all-day use for all-day use 24sens has devised a mobile 24sens has devised a mobile solution for long-term 24/7 record- solution for long-term 24/7 record- ing and visualisation of heart rates ing and visualisation of heart rates and certain heart diseases, par- and certain heart diseases, par- The SmartcorCONTROL system combines smart textiles with intelligent software. ticularly AF. The system, called SmartcorCONTROL, consists of a smart textile patch, which is fas- tened via a chest strap, and sensor technology-based software. A sen- sor located at the front of the strap and an onboard ECG monitor are used to gather data on heart activ- ity over several days. The device is connected to a mobile app, which records and documents health sta- tus, and transfers collected data to a web portal, where it is evaluated by a healthcare professional and an AI-powered software for visual- isation. The cable-free design of the smart textile facilitates use during normal daily activities, Sonderegger added. Its recording unit can store a week’s worth of collected data. A rechargeable battery and washa- ble textile component further cater ble textile component further cater to the all-day application of the to the all-day application of the device. Control and feedback options for patients Using the mobile app, patients can pause and resume the record- ing as well as give feedback on health status and activities during the recording. ‘The application vis- ualises the heart activities and the detection of areas possibly affect- ed by AF, and they can be seen through the doctor’s dashboard,’ Mr Sonderegger said. ‘The healthcare professional can access important data without reviewing the whole data stream and can provide an earlier, faster and reliable diagnosis. The dashboard integrates individual feedback by the patients about their activity, health status and health feeling during the recording and the patient management process.’ The physician can also contact the patient by sending a message through the dashboard onto the patient’s mobile app. Markus Sonderegger Markus Sonderegger is Chief Techno logy Officer with 24sens, a start- up company based in Austria which was launched at the beginning of 2021. For the development of the new product, the company has consult- ed with a medical advisory board and established a cooperation with the University of Vienna. With the product verification and usability process under way, 24sens is cur- rently preparing the market launch in line with the new Medical Device Regulations. (MN) EUROPEAN HOSPITAL Vol 31 Issue 1/22
I N F E C T I O N P R E V E N T I O N 1 9 AMR Insights platform Antibiotic resistance: a global problem in urgent need of intelligent solutions Antibiotics have been at the heart of modern healthcare since the 1950s. They are prescribed prior to an operation to minimise the risk of infection after the operation. Or antibiotics are prescribed to fight an infection. This practice, which might seem straightforward at first glance, has proven to cause a number of problems itself. Report: Madeleine van de Wouw Over the last twenty years, it has become increasingly clear that pathogenic and sometimes even life-threatening bacteria are becom- ing resistant to these antibiotics. This results in persisting infec- tions in humans and animals which cannot be controlled. Because of this, various types of medical inter- ventions such as surgery, chemo- therapy and stem cell therapy may become impossible. The development of new antibi- otics might seem the obvious solu- tion. However, most pharmaceutical industries do not see that a priority, because it is expensive and lengthy, often yields little to no profits – and more likely than not, a newly developed antibiotic will never even reach the market. ‘We are therefore waiting for a huge crisis to happen,’ says researcher Nathaniel Martin, PhD, and head of the Biological Chemistry department at Leiden University, the Netherlands. ‘That's why as academic research- ers we need to be proactive in addressing the issue of antibiot- ic resistance (AMR). We know that some bacteria become resistant because they can produce enzymes that break down antibiotics. We are trying to tackle that problem by developing enzyme inhibitors that prevent bacteria from destroying the antibiotics and thus maintaining their antibacterial activity. Another approach our research team is using to overcome resistance is by struc- turally modifying antibiotics. In this way, the bacteria are exposed to a “new” antibiotic to which they are not resistant. Now, several years into the research, we are testing how well these modified antibiotics cure infections in animals. This is still the preclinical phase, but the results so far are very encouraging. If we can show that these new antibiotics are safe and effective in animals, the next step is to test them on humans.’ Educating professionals worldwide However, Martin is convinced that there are more ways to prevent an increasing number of bacteria from developing resistance. For example, educating every prescriber of anti- biotics is high on the agenda. In fact, education and communication were the motivations for Molecular/ Medical Microbiologist Maarten van Dongen, PhD, in coordination with twelve Dutch public and pri- vate organisations, to found AMR Insights in 2017. The information platform focuses entirely on com- bating the issue of antimicrobial resistance worldwide. ‘The subject already had my atten- tion, but when my neighbour died of an infectious disease, and there www.healthcare-in-europe.com sectors; professionals in the human, animal, food, and environmental sectors can draw on the collected and tailored information to help them in their daily work. Updates on current research, such as the modification of antibiotics, which Martin’s team is working on, are also available on the platform. In addition, more than 300 ambassa- dors including researchers, doctors, veterinarians and entrepreneurs in some 60 countries work together to represent AMR Insights in the workplace. They are united under the project’s aim of maintaining antibiotic availability and effective- ness as well as preventing AMR from further threatening health and food safety. Martin sees current antibiotic management in emergency consul- tations as a main driver of AMR: ‘Here, a broad-spectrum antibiotic is often used until it is determined whether an infection is viral or bacterial and, in the latter case, what type of bacteria it is.’ To put an end to this practice, solutions are needed to view and sequence the genome of bacteria more quick- ly, determining resistance profiles before medication is applied. ‘As progress is made in diagnostics, this should also allow a more targeted approach to the use of antibiotics,’ he says. Another cause of resistance devel- opment is the widespread use of antibiotics in animals – to prevent disease or just to promote growth, the expert continues. As a result, antibiotics accumulate in humans antibiotics accumulate in humans through the consumption of meat through the consumption of meat was no antibiotic that could save him, AMR came awfully close,’ he said. There is a lot of research and information being generated on antimicrobial resistance worldwide. And that amount of information makes it difficult to determine rel- evancy and to keep abreast of the latest developments.’ While staying on top of current events might be possible with some effort in the Western world, the expert says that this is much more difficult or even impossible in developing countries. As a major cause of preventable deaths, AMR must be tackled now, Van Dongen stresses. ‘Already each day around 800,000 people world- wide die, and according to the World Bank, AMR leads to extreme poverty in many places.’ To reduce the prevalence of resistant bacte- ria in countries such as Belgium and Germany, but also in southern Europe, he advises to look to the Netherlands, where AMR is much less common. ‘This is because in the Netherlands, we are cautious about prescribing and using anti- biotics in humans and animals,’ the microbiologist says. He also compli- ments the Dutch open-mindedness for new technologies, citing a type 1 diabetes app as a major inspira- tion for the AMR Insights platform: ‘When I became involved with the app, I thought that a collection plat- form with information on antibiotic resistance should also be feasible,’ Van Dongen recalls. About the platform The online expertise platform AMR Insights informs, educates and AMR Insights informs, educates and connects experts from different dis- connects experts from different dis- ciplines worldwide. Symposia and ciplines worldwide. Symposia and innovation missions are organised, innovation missions are organised, and people can subscribe to the free and people can subscribe to the free newsletters. These contain infor- newsletters. These contain infor- mation for people from different mation for people from different Maarten van Dongen Nathaniel Martin Maarten van Dongen is a Molecular and Medical Microbiologist. After attaining his PhD in Biochemistry at the University of Amsterdam, the Netherlands, he has worked for the international Pharma and Biopharma industry in the Netherlands, Switzerland, Finland and Belgium. He has gained extensive experience as a (project) man- ager of complex, international projects. As an advisor, Van Dongen is increasing- ly involved in projects in the field of anti- microbial resistance. In 2020, he found- ed the global AMR Insights Ambassador Network. and animal products. Furthermore, antibiotics-laden wastewater from institutions like animal farms and hospitals ends up in the ground water. Van Dongen: ‘Good systems are needed to filter antibiotics and resistant bacteria from wastewa- ter.’ To this end, AMR Insights, together with medical industry association VIG and water treat- ment company EWS, established the Dutch Consortium Antibiotics and Medicinal Residues from Water in 2020. Spearheads in the fight against AMR Both Martin and Van Dongen believe that prevention of infec- tious diseases is one of the most important ways to prevent many important ways to prevent many antibiotics from working at all in antibiotics from working at all in the near future. They argue that, if the near future. They argue that, if people and animals do not become people and animals do not become ill in the first place, antibiotics are ill in the first place, antibiotics are not needed for their treatment, and not needed for their treatment, and further resistance does not develop. further resistance does not develop. y y a a b b a a x x i i p p © © Nathaniel Martin obtained his PhD degree in 2004 from the University of Alberta, Canada, after which he per- formed postdoctoral studies at the University of California, Berkeley, USA. In 2007, Martin moved to the Netherlands, where he started an independent research career at Utrecht University. In 2018, Martin accepted a professorship at Leiden University where he currently holds a chair in Biological Chemistry. In Leiden, the Martin group works on developing new molecular strategies to address antibiotic resistance. With a firm foundation in bioorganic chemistry, the approaches used by the Martin lab include the design and synthesis of new antibiotics as well as developing small molecule inhibitors of different resist- ance mechanisms. To this end, they point to the impor- tance of good hygiene standards and Antibiotic Stewardship, which is crucial in monitoring the use of antibiotics in humans and animals, and the reduction of unnecessary antibiotic use through better and quicker diagnostics and tests. Besides the development of new antibiotics and modification of exist- ing types, the experts see the search for alternatives such as phages as another vital strategy. These are viruses that selectively attack bac- teria and render them harmless. To fully exploit the potential of these fully exploit the potential of these solutions, Van Dongen says that this information must be made availa- ble worldwide to effectively tackle ble worldwide to effectively tackle the antibiotic resistance problem. the antibiotic resistance problem. The platform aims to provide this The platform aims to provide this information in a targeted manner, as relevant aspects are different for a veterinarian than, for example, for a general practitioner. Even though there is much to be done, Van Dongen remains optimis- tic about the future of AMR Insights: tic about the future of AMR Insights: ‘Now, our income consists of project income, contributions for participat- ing in events and from sponsors. The objective is to change from The objective is to change from short-term, project-related funding to long-term, programme-related to long-term, programme-related funding. Then we will be able to set and realise our own objectives. With sustainable funding, AMR Insights can go one step further to become a global information and knowledge platform with even more searchable information.’ Martin adds: ‘A lot of money is needed for further research and clinical studies.’ But while a current focus area is on the modifi- cation of antibiotics, it is certainly not the only way to tackle AMR, he concludes.
2 0 I N F E C T I O N P R E V E N T I O N Infection management New sepsis marker speeds up detection and therapy Sepsis is the cause of one in five deaths worldwide, killing nearly 11 million people each year, many of them children. It is also a major cause of disability, affecting millions more. To combat the condition, many hospitals have implemented sepsis performance improvement programmes. A meta-analysis of 50 observational studies showed that these programmes are associated with better compliance with sepsis resuscitation and management bundles as well as a reduction in mortality* in patients with sepsis and septic shock. Report: Dr Jean Patel Rapid and accurate profiling of infection-causing pathogens remains a significant challenge in modern healthcare. Most hospitals use blood cultures and other microbiological tests to detect sepsis, while blood culture analysis remains the diag- nostic gold standard. However, this method is too slow and cumber- some to significantly influence the initial management of patients. In addition, antibiotic resistance – one of the greatest global challenges of modern time – has become worse with the advent of Covid-19 because it increases the challenge for doc- tors to differentiate patients who need antibiotics from those who don’t. It is estimated that 72% of Covid-19 patients receive antibiot- ics when only 8% of patients have co-infection. Time is of the essence Blood culture is the most com- mon laboratory method used to identify pathogens responsible for an infection. Cultures obtained with- k c o t s r e t t u h s - n o K a n y r e t a K © Illustration of sepsis in the blood in three hours and other diagnostic tools such as PCT and lactate can help identify the risk for sepsis. However, physicians, especially in emergency departments, cannot wait for the results of a microbial culture before pursuing treatment for a potentially septic patient. In fact, delaying intervention is known to increase mortality. recognise Laboratorians that shortening the time at which path- ogens are identified will result in improved patient outcomes in cases of sepsis. Over the last decade, MALDI-TOF (matrix-assisted laser desorption ionisation time-of-flight) tion consistently increased sepsis probability. Used early in emer- gency department patients, MDW enhances the odds of early sepsis detection approximately 6-fold uti- lising Sepsis-2 and ~4-fold based on Sepsis-3 criteria. The FDA-cleared MDW in-vit- ro diagnostic (IVD) parameter is intended for use with adult patients presenting to the emergency depart- ment. A complete blood count (CBC) with differential has been ordered to aid in the early detection of patients with or developing sep- sis. Together with other laboratory findings and clinical assessments, it provides a qualitative assessment of sepsis from whole blood venous samples. Moreover, the results are automatically available as part of CBC-Diff results for adult patients entering the emergency department with no impact on laboratory or emergency department workflow and no additional tests to order. *OR: 0.66; 95% CI 0.61-0.72 mass spectrometry has emerged as an important tool in the quest to speed up microorganism identifica- tion. Whereas traditional biochem- ical microbial identification meth- ods may require days to complete, MALDI-TOF mass spectrometry can provide answers in minutes. These results, integrated with an Antibiotic Stewardship Programme, significantly improve time to opti- mal therapy while decreasing the length of stay and total costs. A rapid identification combined with accurate antimicrobial susceptibility testing ensures patients get the right antibiotic to treat a life-threatening infection. A new sepsis marker In addition to diagnostic tools such as blood culture, PCT and lactate, monocyte distribution width (MDW), a novel sepsis biomarker, is emerging as a valuable resource enabling physicians to make deci- sions regarding their patients who may be at risk for severe infection. New analysis from a study confirms that abnormal MDW at presenta- Cutting-edge study Dr Jean Patel scientist, Dr Jean Patel currently serves as the principal scientific affairs, at Beckman Coulter. Prior to her role at the company, Patel served as the science team lead, antibiotic resistance coordination and strat- egy unit, at the Centers for Disease Control (CDC), where she led imple- mentation of its Antibiotic Resistance Laboratory Network and the CDC and FDA Antibiotic Resistance Isolate Bank. Patel has served as chair and vice chair of the Clinical and Laboratory Standards Institute Subcommittee for Antimicrobial Susceptibility Testing and worked with the World Health Organization (WHO) to develop technical guidance for detect- ing resistance and strengthening global surveillance of antimicrobial resistance. Stay sharp, surgeons – your patients depend on it Researchers at Auckland Uni- versity of Technology’s BioDesign the University of Lab and Auckland’s Department of Surgery have uncovered a link between the sharpness of surgi- cal implements and the risk of post-surgery infection. The study, published in PLOS ONE, determines that keeping tools sharp is essential to avoiding cross-contamination. ‘Bone surger- ies are some of the most common surgeries, with approximately 9,000 hip replacements and more than 8,000 knee replacements happen- ing in New Zealand every year,’ says Lecturer Lorenzo Garcia. ‘Post- surgery infection not only reduces the patient’s quality of life; it also significantly increases healthcare costs. Reducing cross-contamination and possible infection will improve patient outcomes.’ The osteotome is a surgical tool commonly used to chip, cut, and sculpt bone during various surgical procedures such as orthopaedic, plastic, and dental surgeries. This tool resembles a chisel, beveled on both sides of the cutting edge and is like many bone-cutting sur- gical tools usually manufactured ) 0 . 4 Y B C C ( 2 2 0 2 E N O S O L P , . l a t e e t i h W © As-supplied osteotome cutting edge at x1000 magnification (left). Energy-dispersive x-ray spectroscopy (EDS) points for as-supplied osteotome (right). Mechanical wear and damage can be seen across cutting edge. from either heat-treated Martensite, Austenite, or Martensitic Stainless Steel. These materials allow surgical tools to withstand impact forces without fracturing. They also pos- sess excellent properties of cor- rosion resistance, biocompatibility, and cost-effectiveness. Osteotomes are re-used in surgical procedures however lack of regular mainte- nance can lead to a dull or damaged cutting edge being used. Three different osteotomes The research performed at AUT showed that dull osteotomes, used in surgical procedures including common operations like knee or hip replacements, retain bone con- taminants even after sterilisation. The BioDesign Lab’s study tested three different commercially avail- able osteotomes with different sur- face coatings. After four cutting and sterilisation cycles, contaminants including calcium and phosphorous (evidence of bone contaminants), chromium, magnesium, silicon, alu- minium, carbon, and nickel (base material of stainless steel) and trac- es of chlorine (used in autoclave sterilisation water) were found. ‘Thanks to our commercial part- ner Sheffmed we were able to test a l y g o o n h c e T f o y t i s r e v i n U d n a l k c u A © An osteome used for bone cutting range of different commercially available osteotomes with different coating treatments, to measure what affect the different coatings had on reducing cross-contamination. Our testing detected bone contaminants in each osteotome,’ says Dr Garcia. ‘However, the PVD (physical vapor deposition) coated osteotome demonstrated significantly less bone contamination the as-supplied or electroless nickel coated tool. According to the results, than either there is an association between blade sharpness and post-sterilisa- tion bone contamination, so if hos- pitals can maintain sharp tools, it follows the risk of cross-contamina- tion will be reduced. Or alternative- ly, the use of disposable osteotomes could be recommended.’ Source: Auckland University of Technology EUROPEAN HOSPITAL Vol 31 Issue 1/22