2 RADIOLOGY Photon-counting CT, strain imaging, 4D flow MRI How new technologies shape the future of cardiovascular radiology New approaches to cardiov- ascular radiology are evolving to help clinicians gain an increas- ingly better insight into heart conditions. Latest developments in cardiovascular radiology in- clude myocardial strain imaging, 4D flow and photon-counting CT technology. An ECR 2024 session shone the spotlight on these areas of cardiov- ascular imaging with expert speak- ers outlining the pros and cons of each. Dr Hatem Alkadhi, Vice Director of the Department of Diagnostic and Interventional Radiology at Univer- sity Hospital Zurich in Switzerland, explained that photon-counting CT offers two advantages: spectral in- formation and ultra-high resol- ution. He said the inherent spectral in- formation is always available, thanks to the dual source principle of the scanner, at the highest avail- able temporal resolution. ‘That means we can do several post- processing issues – reconstruct vir- tual monoenergetic images, sub- tract calcium from iodine and look at the myocardium at high quality. The ultra-high-resolution mode is very interesting for dense calcifi- cations, plaque imaging and visual- isation, stenosis quantification and coronary stents imaging.’ PCCT: Promising, but not without flaws Alkadhi said one of the biggest benefits of spectral data ac- quisition is the images are virtual mono-energetic. He pointed to study results comparing patients scanned with a third-generation dual source conventional energy integrating detecting CT machine and then with a photon-counting detector CT, which showed clear benefits of the new technology. With matched protocols, radiation dose and contrast media, the photon-counting CT delivered ‘a net increase in contrast to noise ratio (CNR) of up to 70% when you look at vascular imaging.’ That translates into improvements in image quality with lower contrast media. characteristics He concluded: ‘We have excellent performance for photon-counting detector CT for cardiovascular imaging in regard to signal, noise and CNR, which we can use to improve image quality and/or save contrast media, which may be important in vulnerable pa- tients.’ There do, however, remain issues over which scan mode to apply in which patient – spectral or ultra-high-resolution acquisition – or both, and which is best for as- sessing the stenosis. He noted that the PureLumen algorithm for vir- tual calcium removal still needs to be more robust to be applied in clinical routine. m o c . e b o d a . k c o t s . w w w – a l l e n u m a s © Cardiac MRI Myocardial strain imaging: hearts in motion Radiologist Dr Tilman Emrich from the Department of Diagnostic and Interventional Radiology at the University Medical Center in Mainz, Germany, highlighted the benefits of myocardial strain im- aging, its applications and how it can be used as an imaging biom- arker. ‘Strain imaging is all about de- formation, the alteration of shape or volume of body by a force,’ he said. ‘This is happening in the heart while it contracts. We see the alteration of volume by the con- traction and we can measure this deformation in several parameters.’ This, he continued, can connected to different layers of the heart muscle which have different prop- erties and are responsible for cer- tain motion aspects in the heart. ‘The 3D motion pattern can be di- vided into longitudinal, circum- ferential (rotation) and radial pat- terns and we can look at these deformation patterns and try to connect which layer of the muscle is affected,’ said Emrich. Strain images enables cardiac radi- ologists to conduct segmental analysis, such as in myocardial in- farction, and the detection of sub- clinical changes of the left ven- tricle, e.g. in genetic diseases or after treatment with chemotherapy. In addition, strain imaging offers insights into prognostic effects of various cardiomyopathies. While acknowledging that myoc- ardial strain imaging offers a number of insights and is highly promising, Emrich said there is a need to standardise the technique before it can be used as a clinical tool. 4D flow: fluid mechanics with solid potential Dr Ursula Reiter from the Depart- ment of Radiology at the Medical University of Graz in Austria dis- cussed how 4D flow is a valuable tool in state-of-the-art cardiac MRI. It provides simplified acquisition and accurate quantification as a time-resolved, three-dimensional, three-directional, velocity encoded phase contrast imaging. The four sequences enable calculation of the 3D velocity through the cardiac cycle, supported by guidelines and expert recommendations on how to adapt these protocols with re- spect to spatial and temporal resol- ution. ‘We can use these par- ameters of elevated stress as possible risk stratification,’ she added. Summarizing her insights, Reiter pointed out that 4D flow can be relatively straightforward to assess with a whole heart body flow con- ducted within 10 minutes. She added that 4D flow allows visual- isation of flow patterns and ac- curate velocity quantification and flow quantification can be per- formed through any a posteriori defined cross section. ‘4D flow allows calculation of unique fluid mechanical parameters, though the full diagnostic/prognostic potential still has to be explored,’ the expert concluded. ■ Report: Mark Nicholls Professor Hatem Alkadhi Professor Hatem Alkadhi is Vice Director of the Department of Diag- nostic and Interventional Radiology at University Hospital Zurich in Swit- zerland. His specialist areas are multimodal cardiovascular imaging, emergency radiology and computed tomography. Dr Tilman Emrich Dr Tilman Emrich is working as an attending radiologist specializing in cardiovascular imaging at the Univer- sity Medical Center Mainz, Germany. In parallel, he serves as an Adjunct Assistant Professor of Radiology and Director of Photon Counting CT Re- search at the Department of Radiol- ogy and Radiological Science, Division of Cardiovascular Research, Medical University of South Carolina, USA. EUROPEAN HOSPITAL Vol 33 Issue 2/24

4 RADIOLOGY Technology applications in diagnostic imaging How digital twins will support the radiologist of the future twin Digital technology can transform clinical practice by aiding patient-specific prediction and supporting personalized treatment models. Expert speak- ers at an ECR2024 session in Vienna focussed on how radiol- ogy will play a leading role in the advance through data ac- quisition via a range of imaging modalities. The session was chaired by radi- ologist Professor Valeria Panebian- co from the Sapienza University of Rome, who also outlined her de- partment’s work with digital twin technology. To set the stage, she provided a rough definition of what a digital twin can be: • an evolving digital profile that helps optimise digital perform- ance; • a dynamic digital representation; or • a virtual representation of a physical object or system across its lifecycle. The key concepts are that the two systems – physical and digital – should exist side by side on a real time basis. Panebianco said: ‘As simulation models, digital twins will transform clinical practice as they will pro- vide patient-specific prediction for the prevention, screening and dis- ease diagnosis as well as person- alization and assessment of re- sponse to therapy.’ ways, noting that it is ‘where the real clinical world meets digital’. How- ever, the complexity and prognostic heterogeneity of diseases make it necessary to apply computational tools and precision medicine. ‘However, ‘The data for digital twins’ devel- opment can be derived from many different medical specialities,’ she continued. radiology stands out for multiple factors as radiologists make diagnoses and as- sess therapy response, which are the main predictive clinical questions to which digital twins have to reply.’ Bridging the human-digital divide The expert delivered insights on the future development of digital twins in radiology through clinical, com- putational, digital and virtual path- Radiology produces large amounts of data from different modalities such as CT, MRI and ultrasound, providing a rich foundation for quantitative and in- functional NEWS ∙ REPORTS ∙ INTERVIEWS ∙ VIDEOS ∙ SOCIAL MEDIA K e p u p - - d a e n h e l a e s n e w s f r m h s p i a l - r e l a e d f i e l d s ! a l Subscribe to our bi-weekly newsletter and conveniently receive selected medical articles and background information. For more information, visit healthcare-in-europe.com formation. To achieve the goal of making viable predictions, the data fed to the digital twins must be ac- curate as well, Panebianco said. She pointed to current examples of digital twin applications, such as in cardiology to inform on clinical decisions, in orthopaedics to main- tain musculoskeletal health of sol- diers, and in multiple sclerosis for simulation models for treatment outcomes. Outlining the work to develop digi- tal twin technology at the Univer- sity of Sapienza, she said her focus is on validating wearables, liquid biopsy and imaging biomarkers in prospective studies to construct the digital twin. She concluded: ‘Radiology is able to provide a bridge between the human being and the digital twin by shortening the gap and enhanc- ing the development of this inno- vative digital solution.’ Efficiency, personalization, research Meanwhile, Huan Xuan Nguyen, Professor of digital communication in engineering at Middlesex Uni- versity in London and Director of the London Digital Twin Research Centre, went into more detail on what he called the “three pillars” of digital twins in healthcare: • models developed for healthcare facilities and organizations, de- signed to improve efficiency of hospital or departments; • digital twins of the human body for personalized diagnosis, treat- ment planning, treatments and interventions; and • models geared towards disease research, medicine and device development. However, he cautioned that im- plementation of digital twins in healthcare come with high deploy- ment and maintenance costs, with significant investment needed in technology platforms to achieve vi- able results. ) e g a m i d e t a r e n e g I A ( m o c . e b o d a . k c o t s – a k s n i m e r K a n a i t a T © patient digital twins and determine which option is likely to be the most effective. to twin ‘Digital technology offers great opportunities revol- utionize healthcare systems, and ethical issues should not prevent development of such technologies but should integrate with it.’ However, the expert warned that conflicts of interest must be regu- lated by adopting an ethical ap- proach, with the new technologies governed by the law. She said it was necessary to adopt an ap- propriate regulatory framework, especially regarding the allocation of responsibilities between the dif- ferent actors involved in the pro- duction and use of digital twins. The framework should also intro- duce ethical principles of auton- omy, responsibility and transparen- cy in codes of conduct and training courses for engineers, computer scientists and developers, with par- ticular reference to ethics in the de- sign of technologies. ■ Report: Mark Nicholls Nguyen also outlined technical challenges, with notable issues around data collection and inte- gration, computational resources, model accuracy and validation, as well as privacy and security con- cerns. The effort needed to over- come these challenges might still be worth it, he added: ‘The benefit in healthcare and radiology is that you can have greater predictive ac- curacy with a digital twin, treat- ment plan optimisation and can test scenarios without interfering with real patients. ‘It can also be used for research and training and to familiarise pa- tients with equipment. Finally, per- sonal care and treatment is one of the most important potential bene- fits of the digital twin.’ Need for a regulatory framework Dr Ilena Rapisarda, a private law researcher from the Department of Law at the University of Catania in Sicily, explored ethical and legal issues of digital twin technology. the While technology’s devel- opment might still be in its infancy, the field is rapidly evolving, she said: ‘Clinicians will be able to simulate aspects of treatments on Huan Xuan Nguyen Valeria Panebianco Huan Xuan Nguyen is Professor of digital communication in engineering at Middlesex University in London and Director of London Digital Twin Research Centre, with research inter- ests include that include digital twin modelling, digital transformation and machine learning. Valeria Panebianco is Full Professor of Radiology at the Sapienza Univer- sity of Rome with a specialist interest in diagnostic imaging focused on GU, screening programmes and precision medicine. She is scientific co-ordi- nator of a range of projects on digi- tal medicine applications in healthcare. EUROPEAN HOSPITAL Vol 33 Issue 2/24

6 RADIOLOGY Delivering more efficient healthcare How teleoperations is changing radiology for opportunities As tele- operations rapidly expand with- in radiology, the concept is being deployed across an array of mo- dalities to deliver more efficient healthcare. A range of speakers covered the topic at ECR 2024. However, challenges remained: radiographers and radiologists were initially slow to accept and adopt the concept, there were cost and technical obstacles, and concerns over a loss of direct contact with patients. range of With a real-world examples within clinical practice and education, speakers high- lighted how teleoperations is mak- ing a difference in the way they op- erate and deliver care to patients. In his introduction to the session, chair Borut Marincek pointed to the World Health Organization definition of telemedicine as ‘de- livery of health services using digi- tal technologies to overcome dis- tance that teleradiology now accounts for at least 50% of telemedicine usage. barriers’ and A former chairman of the Depart- ment of Diagnostic Radiology at Zurich University Hospital, he said recent radiology and health con- gresses had highlighted the value of teleoperations in solving per- sonnel shortages. But he also pointed to challenges to implemen- tation: a lack of worldwide regula- tory standards; costs; and a chang- ing work culture. ‘It is paramount that the view of radiographers is taken into consideration when im- plementing this new technology,’ said Marincek, adding that a survey among tele- operations is planned. radiographers on Cautious approach Anton Sheahan Quinsten, senior radiographer at University Hospital Essen, Germany, outlined his centre’s experiences of remote MRI – Advertorial – n e s s E l a t i p s o H y t i s r e v i n U © Remote scanning in the cockpit at University Hospital Essen. scanning, noting that ‘remote scan- ning is the most discussed topic among radiographers.’ While radi- ographers are adaptive to new technologies, he conceded an el- ement of caution remains within the profession on the subject. The backdrop is also challenging: increased demand for imaging, an ageing demographic, and a lack of radiographers with vacancies across most hospitals in Germany and an expectation that half of radiographers will retire between 2030 and 2040. In addition, his hospital is spread across a large campus with 50 institutes and clinics and patients meaning time spent having to get to different areas if colleagues need support. That needed a software solution all scanners remotely with MR oper- ations separated into three processes: patient management, exam manage- ment, and quality management. Given the serious shortage of radi- ographers in Germany, it was real- ised that highly-qualified radiogra- phers were not required for patient management (i.e. patient position- ing) and staff could be better de- ployed, leading to a ‘cockpit sol- ution’ with radiographers in a separate room with screens locked in to all the modalities across the campus. ‘Today, our radiographers routinely work from home, with three screens and able to perform three scans simultaneously,’ added Quinsten, who during the Covid pandemic became the first person to perform an MRI examination re- motely from home. The system is so flexible, he added, that the MRI scanners can be operated from any location at any time. There were initial ‘human and techni- cal’ challenges when remote scan- ning was introduced. Some senior staff resigned, though they have since returned as remote technologists. His department has now scanned 50,000 patients remotely and since 2023 has deployed a cloud-based solution. ‘We have seen that remote scanning has huge potential in the hospital,’ he said. ‘We can operate all our modalities with fewer radi- ographer than in the past.’ A technologist in a cockpit centre can share their knowledge, training time for new radiographers has been reduced by half, radiographers can scan from home and experienced older personal who are less mobile can return to their profession. Quinsten added that on-site radiogra- phers have more time to prepare pa- tients, images can be shared live with other departments and research can be supported. Patients benefit be- cause they do not have to travel for specialist exams and can go to a radi- ology department closer to home. Ultrasound teleoperations Professor Vita Cantisani, Vice-Dean of Medicine and Dentistry at the University of Sapienza in Rome, fo- cused on teleoperations in ultra- sound and how it can help remove geographical barriers and resolve staff shortage problems in hospitals. ‘Radiologists working in a central hospital can interpret the images ob- tained in an elevated number of re- mote patients, thus increasing effi- cacy, while reducing transport costs,’ said Cantisani, who emphasized the importance of specialized training and formal certification and the need for high-end technology. He concluded: ‘Telerobotic ultra- sound may successfully answer clinical questions in most cases, allowing patients to receive im- aging in their home community and in remote and rural areas where hospitals or imaging centres are not available.’ He said it also helps in areas lacking experienced radiologists, while pre-hospital tele-ultrasound may reduce time to diagnosis and improve patient treatment or referral times. Expanded applications The session also heard how tele- operations are supporting the mili- tary. British Army radiologist Dave Muchena examined the pros and cons of teleradiology in defence medicine, acknowledging it as an ‘excellent and cost-effective tool for clinicians in austere environ- ments’, but there can be a lack of Anton Sheahan Quinsten Anton Sheahan Quinsten is senior radiologist at University Hospital Essen and Deputy Chairman of the Radiographers Board in Germany. He studied business informatics and his field of research is Artificial Intelli- gence in radiography. He is author of the book Information Technology and Artificial Intelligence in Radiology. Vito Cantisani is Professor of Radi- ology at the University La Sapienza in Rome with specific interests in multiparametric ultrasound, contrast media and in abdominal and vascu- lar imaging. He is also President- elect of the EFSUMB (European Federation for Ultrasound in Medi- cine and Biology). face-to-face contact and issues of miscommunication. Dr Ricardo Teresa Ribeiro from the University of Applied Sciences and Arts (Western Switzerland) dis- cussed remote imaging as a means to support radiographer and radi- ologist education, while Patrizia Cornacchione from the Catholic University of Sacro Cuore highlight- ed experiences of implementing a televisits system for cancer patients during the Covid-19 pandemic. She said: ‘The swift deployment of a telemedicine system, even in the context of a pandemic emergency, is both feasible and well-received by patients. Initial experiences pave the way for expanded tele- medicine applications within radi- ation oncology.’ (MN) ■ The right solution for every challenge If images, videos and audio are to be distributed, recorded and man- aged in the operating theatre and beyond, SMART OR is the right sol- ution – from the individual work- station, where local sources are to be documented, to distribution, archiving and streaming in com- plex networks. With SMART OR‘s web ap- plications, authorised users can ac- cess available media material and related information at any time and from any location. „Thanks to the technology used, the WEB CLIENT is secure, fast, robust and flexibly configurable. An auto- logoff function also provides ad- ditional security,“ says Michael Heuer, Head of Development and Product Manager Software at Rein Medical. With SMART OR‘s web applications, aut- horised users can access available me- dia material and related information at any time and from any location. Patient data can be created and edited manually via the web ap- plication or automatically imported from the DICOM worklist or via HL7. Users can view, crop or upload and download media with a click of the mouse. All-in-one PC offers flexibility and maximum security With the SILENIO, Rein Medical offers a powerful all-in-one (AIO) PC that is designed as a fully equipped workstation computer. The monitor with a screen diagon- al of 24 inches can be used in the central sterile supply department, the emergency room, in the shock room, at the documentation work- station or on a trolley for mobile ward rounds. The SILENIO is a medical PC that offers the ap- propriate device safety for use in a patient-centred environment. A special feature of the AIO PC is its intelligent presence detection. „If an unauthenticated person at- tempts to access the screen con- tent, the monitor is automatically switched off. This ensures that only authorised employees can ac- cess confidential patient data,“ says Fabian Wischet, Product Man- ager SILENIO and CLINIO at Rein Medical, explaining tech- nology. the Another special feature is the three hot-plug battery packs. They en- sure that the device can be oper- ated reliably for up to eight hours without a power connection. Ready for use in hygienically sensitive areas The AIO-PC CLINIO, a Class I medi- cal device according to MDR with EUDAMED listing, ensures a hy- gienic working environment in the operating theatre and can be used both as a thin client and as a fully- fledged PC system. The system allows users to retrieve and process data from medical information and imaging systems such as HIS, RIS, PACS, PDMS, OR image manage- ment and others. Users can log into the system easily and securely using an ID card. As an option, the PC can be supplied with a barcode reader with acoustic read confirmation and adjustable reading field, an RFID reader and a 10-finger PCAP-TOUCH front protective screen. ■ www.reinmedical.com/en EUROPEAN HOSPITAL Vol 33 Issue 2/24

8 AI is key Lung cancer screening initiatives across Europe RADIOLOGY Artificial Intelligence will be a critical component in ensuring a Europe-wide lung cancer screen- ing programme can achieve its potential, according to speakers at a special ECR2024 session. Delegates heard that the SOLACE projects (Strengthening the screen- ing of Lung Cancer in Europe) will be supported by AI in terms of workflow, diagnostics, and image and data analysis. Presentations in the session also focused on prog- ress on the initiative in Croatia, France, Hungary and the Czech Re- public, in reaching out to under- represented vulnerable groups. and In her introduction to the session, chair Dr Oyunbileg von Stackel- berg from the University Clinic Heidelberg in Germany said that while there was evidence that screening with low-dose CT (LDCT) reduces lung cancer mor- tality, few countries in Europe had lung cancer screening (LCS) as a national programme their healthcare systems. in SOLACE, a multi-national project to boost LCS in Europe, includes 33 institutions from 15 countries with ongoing projects and pilot trials. Reducing mortality by 20% Radiologist Professor Helmut Prosch from Vienna General Hos- pital outlined the vision of SOL- ACE, which is an EU4Health funded initiative within Europe’s Beating Cancer Plan, and the chal- lenges it faces. He said 55% of patients with lung cancer present in the advanced tu- mour stage, 22% in the regional stage, and 19% with a localised tu- mour, with 4% unknown. ‘Only pa- tients presenting with localised tu- mour stage have a fairly good five-year survival of 61%, but with more advanced stages, the prog- nosis is bad,’ said Prosch. ‘This translates into overall survival of 20.5%. What we are trying to do with LCS is increase the number of patients diagnosed in the localised tumour stage as the smaller the tu- mour the better the prognosis.’ Fig- ures suggest screening with LDCT can reduce lung cancer mortality by 20%, saving a life for every 320 people screened. Challenges include a lack of Euro- pean guidelines, limited cost effec- tiveness data, concerns about reaching groups who would bene- fit most, and LCS training. ‘We know women under- represented in lung cancer screen- ing, even though they would bene- fit more cancer screening,’ Prosch continued. ‘Vul- nerable and marginalized commu- nities smoke more and have higher lung cancer incidence but are dif- ficult to reach. The people who would profit the most are under- from are lung m o c . e b o d a . k c o t s i k z t i l u a K n a i t s a b e S © represented. That is why we have work packages specifically focuss- ing on females and hard-to-reach individuals.’ SOLACE is also working with the European Society of Thoracic Im- aging on a unified training system for healthcare professionals in- volved in LCS. Digitisation makes workload manageable As the first EU country with a na- tionwide LCS programme, Croatia has 20 centres in 14 cities, is fully reimbursed and integrated into the healthcare system, and aims to re- duce lung cancer deaths by 20% within 10 years. Professor Miroslav Samaržija from the Department of Pulmonary Dis- eases at the Clinical Hospital Center in Zagreb said the pro- gramme hopes for a 50% response rate from eligible and high-risk populations and promote an early therapeutic approach. He also em- phasized the role of AI. ‘It is not possible to perform volume analy- sis in 20 centres on thousands of participants without the use of AI,’ he said. ‘Another problem is how to approach high-risk populations and we decided to do that through the GP network. But if you want to connect 2000 GPs with 20 radiol- ogy centres and six centres for ad- ditional diagnostic procedures and surgery, you need digitalisation.’ For 2024, the plan is for digital in- tegration of LCS with breast and prostate cancer screening and im- prove data sharing in the SOLACE project. The session also heard from Pro- fessor Marie-Pierre Revel from Co- chin Hospital, Université Paris Cité, on the French experience focusing specifically on women through the CASCADE study (Lung Cancer Screening in French women using low-dose CT and Artificial Intelli- gence for Detection), launched in March 2022. Underlining the im- portance of a woman-only cohort, she said a key driver was because women are under-represented in LCS studies and that the portion of women among lung cancer pa- tients has increased from 16% in 2000 to 34.6% in 2020 with 41% under the age of 50. A Hungarian pilot project reached out to deprived populations, while the Czech Republic is focusing on very high-risk participants. Appeal for more scientific evidence Biomedical engineer Dr Colin Jac- obs outlined the role AI can play in national LCS programmes across Europe in assessing the probability of malignancy, automated detec- tion of lung nodules, and in work- flow. ‘It determines the type of nodules, measures the size of the nodule and the malignancy prob- ability,’ said Jacobs, from Radboud Pippa Powell from Lungs Europe – a collaboration of the European Respiratory Society and the Euro- pean Lung Foundation – discussed the participant’s perspective and outreach, pointing to a SOLACE stakeholder forum, a lung cancer advisory group, a website (Home- page – SOLACE (europeanlung. org) and social media platforms as well as advice material and newsletters disseminate information. ■ to Report: Mark Nicholls University Nijmegen. Medical Center, He said there are 17 AI products related to pulmonary nodule detec- tion and/or characterization CE- approved for clinical use in Eu- rope. ‘Screening programmes and trials are increasingly using AI, though there is no or little re- imbursement for AI support,’ said Jacobs. He called for more scien- tific evidence by continuous moni- toring of real-world AI perform- ance in running installations, new research and a need to find good models on how to pay for AI in LCS, as well as creating reference databases for quality control and quality assurance on AI products for LCS. Colin Jacobs Research scientist Dr Colin Jacobs is from the Diagnostic Image Analy- sis Group in the Department of Medi- cal Imaging, Radboud University Medical Center, Nijmegen with a specific interest in AI, Chest/Thoracic imaging and computer applications. Helmut Prosch Radiologist Professor Helmut Prosch is from the Medical Univer- sity of Vienna and the Department of Biomedical Imaging and Image- guided Therapy at Vienna General Hospital in Austria. A chest/thoracic specialist, his fields of interest in- clude AI, Clinical IT, Hybrid imaging and principles of imaging technology & molecular imaging. EUROPEAN HOSPITAL Vol 33 Issue 2/24

10 LABORATORY/PATHOLOGY Challenges and opportunities Molecular pathology in Europe: in search of standardization Tackling standardization of mol- ecular pathology at a European level remains a major challenge, according to speakers at the 35th European Congress of Pathology in Dublin. One leading expert warned it would be ‘very difficult’ to achieve, though the session also heard about potential solutions such as educational steps to con- sistently train future pathologists at a high and consistent level. In his presentation, Giorgio Stanta, Professor of Pathology at the Uni- versity of Trieste, said: ‘Everything is changing continuously and we have to follow these changes, but standardization of molecular pa- thology is not an easy task. We have an urgent need for standard- ization of the molecular analysis, exchange- reproducibility, ability among in- stitutions to obtain safety and effi- cacy of treatment for the patient. European and ‘The necessity of molecular pathol- ogy standardization in Europe is related to a more precise diagnosis, prognosis, and prediction of the most suitable therapy and basis of choices of treatment.’ Stanta, an expert in molecular pa- thology and diagnosis for oncology, outlined the work conducted so far, and challenges still to be overcome. He highlighted how the European Society of Pathology (ESP) Molecu- lar Pathology Working Group is QC at AACC 2023 pre-analytical working with the Organisation of European Cancer Institutes (EEIC) towards standardization in het- erogeneity, con- ditions, and clinical evaluation of NGS (next generation sequencing) in breast and colorectal cancer. ‘All these projects are very important for clarity,’ said Stanta. Ensuring reproducible results through standardization A central issue is irreproducibility of clinical research, he pointed out. At the root of this, he pointed out, lie problems of experimental de- sign and interpretation, the com- plexity of biological and medical information, the pre-analytical con- dition, sophisticated methodologies, intra-tumour het- erogeneity, and institutions using similar, but different biomarkers. highly and specification Solutions, however, include design and analysis support, medical tu- mour boards, CEN (European Com- mittee for Standardization) tech- nical ISO standards, internal and external control, and new sampling tech- niques such as liquid biopsy. Stanta underlined the need for an expert steering committee, suggesting that those driving the European Masters on Molecular Pathology would be best placed for this task. ‘We have huge difficulties in stan- dardization because of continuous development of diagnostic molecu- gives very specific requirements for a diagnostic assay, not only if it is manufactured by a company and CE marked but also when we do it in our own laboratory.’ IHC biomarkers and LDT – still alive and kicking Frédérique Penault-Llorca, pro- fessor of pathology at the Univer- sity of Clermont-Ferrand, focused on standardization of the thera- nostic immunohistochemistry (IHC) through the preanalytical, analyti- cal, and postanalytical phase. She stressed that IHC biomarkers will be around for a while, despite sug- gestions of their declining import- ance. Regarding the quality of the tissue and the results, she under- lined the need for education and training as well as providing guide- lines for scoring, reporting, and monitoring internal quality. She also examined implementation of new biomarkers safely into clini- cal practice, emphasizing the need for a sufficient number of cases; testing, training, and monitoring; and standardized reports that are clear for clinicians in line with cur- rent guidelines. ‘Heterogeneity still exists, despite major progress in the last 20 years,’ she said, adding that standardization of the pre-ana- lytical phase is the cornerstone of the subsequent analysis. The use of lab-developed tests (LDTs) will re- main important in Europe because of economic issues and equipment constraints, despite IVDR regu- lation. She also pointed to the value of education and the Molecu- lar Pathology Masters course, out- lined in detail by Marius Ilié as the final presentation of the session. During his lecture on standard- ization through training, Ilié, Pro- fessor of Pathology at the Nice Medical School and co-chair of the congress session, outlined the benefits of the course: • delivering objective evaluation of knowledge and competences of the new professionals in the field; • facilitating movement of young molecular pathologists within the EU; • improved harmonization and standardization of clinical and molecular pathology; and • providing support for the con- tinuously increasing use of diag- nostic, prognostic and predictive biomarkers directly related to treatment choices. Ilié said of 87 applications, 23 stu- dents from 18 countries were ad- mitted on the two-year course. With an array of modules, candi- dates will be certified molecular pathologists on the course, which will reinforce a standardized ap- proach to molecular pathology. ■ Report: Mark Nicholls m o c . e b o d a . k c o t s – m o c . l e x i p w a R © lar pathology, so the standardization must be plastic with continuous cor- rections,‘ the expert summarized. IVDR: No time to waste Kurt Zatloukal from the Institute of Pathology at the Medical University of Graz discussed reference materi- als for standardization, guiding delegates through the IVDR (in vitro diagnostic medical devices regulation) and its associated chal- lenges, particularly with calibration of devices and control materials. Even though the window for im- plementation has been extended until May 2026 due to the chal- lenges of the Covid-19 pandemic, he warned that time was of the es- sence as the process could take several years: ‘The new regulation New risk-based quality control assessment for clinical labs Juggling the cost of quality con- trol (QC) resources versus the risk of testing error is a bal- ancing act no clinical laboratory manager enjoys. It is an inexact process, itself prone to error, which can impact the operations of hospital labs and independent clinical testing companies. In the current resource-constrained healthcare environment, there is pressure to improve the cost ef- fectiveness of QC programmes and reduce the considerable re- sources spent on them by clini- cal labs. A new method in development to more accurately determine the level of acceptable risk was intro- duced at the 2023 Association for Diagnostics and Laboratory Medi- cine (formerly the AACC) Annual Scientific Meeting held in July in Anaheim, California, USA. The Precision QC (PQC) model offers more precision than the one-size- fits-all models currently in use in many clinical hospital laboratories, according to its developers from the University of Utah in Salt Lake City. It is dynamic and flexible, and can be adapted to a wide range of QC monitoring methods, QC be- haviours, and clinical scenarios. test (FP) and A watchful eye on systemic and measurement errors In spite of best efforts, errors in laboratory results occur, caused by systemic error, measure- ment error, or both. This results in false positive false negative (FN) events. FP events incur costs associated with troub- leshooting to identify their cause, reagent use, downtime, repeat test- ing, and recalibration. Identifying the reason for a FN event can stretch lab financial and staff re- sources, hinder lab operations, and potentially can have significant health consequences to a patient. cause QC settings that are too strin- gent may be just as problematic for a lab as those that are too lax. ‘We view an assay as a dynamic system that evolves from state to state over time. It will shift and the question that needs to determine risk is frequently of shift and shift size distribution,‘ says Robert Schmidt, MD, PhD, formerly a pro- fessor of pathology and principal investigator of the Utah team. The expert compared these shifts in laboratory equipment to change in performance in other equip- ment, such as cars or bikes. Only in the former, there are countless components that are subject to change over time that can manifest itself as a change in performance, he explains. QC systems are designed to detect when systemic errors start occur- ring. How stringently parameters are set has a direct impact on the number of FPs that occur. Assess- ing risk of error is important, be- Assessing the “problem potential” of lab tests Incorporating risk can be benefi- cial for a QC programme. Some as- says are reliable, robust, and stable, with few errors. For others, measurement error will not result in immediate clinical harm, or, the results of the tests being per- formed have a low impact on clini- cal outcome if an error occurs. At the other extreme are “problem” assays, with known performance volatility, or whose results have critical cut points, and which have a high cost when failures occur. The researchers define risk as an event equal to the probability and cost of the event. It’s also import- ant to factor in intuition, ideally without from prior experienced events. introducing bias where it remains, until the QC monitoring system raises a detec- tion signal, at which it is restored to the IC state. The overall behaviour of the system is determined by the proportion of time spent in each state (a level of system systematic error), which determines the risk. One of the key features of the PQC model is that it explicitly includes the shift probability, which links the rates of FP and FN events. This feature makes it possible to con- struct trade-off curves between FP risk and FN risk, which characterise the performance of the QC moni- toring system.’ ‘The PQC model views an assay as a dynamic system that evolves through various states over time, and is not necessarily a single shift that remains constant until dis- covered,‘ explains Joseph W. Ru- dolf, MD, an assistant professor and medical director in the Clinical Pa- thology Division’s Automated Core Lab. ‘The system starts in the In Control (IC) state and at some point moves to an out of control (OCC) ‘This model will help you quanti- tatively assess if QC resources spent on each assay to maintain its testing accuracy is appropriate, too little, or excessive,‘ Schmidt and Rudolf advise. ‘By mixing and matching parameters relating to different assays, you will be able to clearly visualize the results and make informed decisions.’ ■ Report: Cynthia E. Keen EUROPEAN HOSPITAL Vol 33 Issue 2/24

12 Compared to laparoscopy Robotic surgery improves colorectal surgery outcomes SURGERY . c n I , s n o i t a r e p O l a c i g r u S e v i t i u t n I © When colorectal surgery was first performed with robotic as- sistance in 2014, the procedure was questioned about safety, effi- cacy, and outcomes. Today it is an established option. Well- trained surgeons use robotic sur- gical systems confidently. Nu- merous clinical studies have verified its intraoperative bene- fits for patients and surgeons alike, as well as very positive outcomes for patients. from recent Findings clinical studies conducted in Europe and the United States comparing the outcomes of patients having ro- botic colorectal surgery with those having conventional laparoscopic surgery and the surgical costs re- inforce that the use of robotic sur- gery produces improved outcomes for patients during both with re- spect to the surgery and recovery. Surgeons also benefit. However, robotic surgery takes about 20-30% more time in the op- erating room to perform and is much costlier than conventional la- paroscopy. However, the com- bination of increased use of the ro- botic platform for surgeries will reduce per procedure cost, and in- creasingly sophisticated integrated AI technology integrated into it is expected to reduce operative time. These factors would lower barriers to adoption and implementation by hospitals and motivate surgeons to invest in the lengthy and extensive training program to become skilled in its use. Robotic surgery systems offer the advantages of an immersive 3D magnification to enhance depth perception, a stable camera plat- form, articulating wrists with seven degrees of freedom, bimanual im- proved dexterity and instrument control, and improved ergonomics. A robotic system provides easier access to narrow places, enables more precise and complex move- ments, and facilitates the perform- ance of complex procedures. Colorectal cancer is the third most common cancer in the world. Over 1.9 million new cases were esti- mated in 2020 and 2022, based on the GLOBOCAN database of 185 countries.1 Researchers estimate an increase to 3.2 million new cases by 2040.2 More “textbook outcomes” Researchers at UT Southwestern Medical Center in Dallas, Texas, US, evaluated the perioperative outcomes of patients having right colectomy (RC), left colectomy (LC), and rectal cancer surgeries based on “textbook outcomes”, criteria that includes the absence of 30-day complications, a length of stay (LOS) less than five days, and hospital They matched rectal surgery patients having rectal surgery 1:1 with re- spect to having laparoscopic versus robotic surgery. Patients having right or left colectomies were matched 2:1. A total of 26,133 pa- tients from a cohort of 53,209 were selected from a national database. readmission. Principal investigator Patricio M. Polanco, MD, and colleagues com- pared baseline preoperative char- acteristics, intraoperative outcomes (such as number of lymph nodes harvested, unplanned conversion to open surgery, and operative time), and postoperative outcomes. The latter included textbook out- come, anastomotic leak, post- operative ileus (the inability to contract), LOS five days and long- er, readmissions within 30 days, complications, and mortality. They reported in the World Journal of Surgical Oncology3 that robotic surgery was associated with a higher rate of all “textbook out- comes” compared to laparoscopy in RC and LC, at 71% versus 64% respectively in RC, and 75% versus 68% in LC. Robotic resection also had a lower conversion rate to open surgery. Overall complication rates, the number of bleeding transfusion oc- currences within 72 hours, major anastomotic leaks, . c n I , s n o i t a r e p O l a c i g r u S e v i t i u t n I © morbidity, and 30-day mortality were comparable. tations in TME, requiring a higher intraoperative conversion rate to open surgery than RC and LC. to make this an equitable com- parison. To date, none have been published. Both approaches produced near comparable results for rectal sur- gery, although robotic resection had a significantly lower con- version rate of 3.9% compared to 10.4% for laparoscopic surgery. However, robotic surgery had a higher rate of major morbidity, postoperative an- astomotic leak. ileus, and Robotic surgery took a much long- er time to perform for all procedur- es, with a mean operative time of 225 minutes compared to 177 min- utes in laparoscopy. robotic A small comparative study of 83 colorectal cancer patients having 46 robotic and 37 laparoscopic re- sections performed at University Medical Centre Ljubljana in Slove- nia showed that none of the pa- tients having surgery required any transfusions or con- version to open surgery, compared to five (13.5%) and six (16.2%) pa- tients respectively in the lapar- oscopy group. Patients in the lapar- oscopy group also stayed in the hospital one additional day. Com- plication rates were comparable. According to first author Jan Gro- sek MD, and colleagues, this study was unique because two highly ex- perienced surgeons performed all the surgeries using both surgical techniques.4 radical Comparing clinical and financial outcomes Rectal cancer represents 28% to 35% of all colorectal cancer cases. The surgery – resection by sphincter-preserving rectal resection with total mesorectal excision (TME) – requires a meticulous surgical technique with little margin of error. The instruments used in lapar- oscopic surgery have inherent limi- that Researchers at Charité University Medicine Berlin, Germany, a refer- ral centre for colorectal surgery, hy- pothesized robotic-assisted surgery would reduce the open sur- gery conversion rate, shorten LOS, and improve the quality of TME. First author Jasper Max Gebhardt, MD, and colleagues retrospectively analyzed data from 125 consecutive patients, 66 undergoing robotic sur- gery. Patients had been selected for either procedure based on equip- ment (Da Vinci X Surgical System, Intuitive Surgical, Mountain View, California) availability. References 1. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 4 April doi.org/ 2024. 10.3322/caac.21834 2. Morgan E, Arnold M, Gini A, et al. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLO- BOCAN. Gut. 2022 72:2 doi. org/10.1136/gutjnl-2022–327736. The study’s primary endpoint fo- cused on the rate of 30-day post- operative complications, as well as operative time, rate of conversion to open surgery, LOS, and quality of TME. 13.6% of robotic surgery cohort experienced severe post- operative complications, compared to 30.5% of the laparoscopic sur- gery cohort, more than double the amount. Intraoperative adverse events were comparable, but more laparoscopic patients had follow- up surgery, at 22% versus 13% for the robotic group.5 As expected, operative time was longer, with robotic surgery taking a median 379 minutes versus 302 minutes for laparoscopic surgery. Surgical costs were also higher, a median of 17663 euros versus 14,883 euros. A trade-off exists: perform a sub- stantially more expensive colo- rectal cancer surgery or subject a patient to a much higher level of severe Further studies are needed to compare sur- gical cost plus the cost to treat se- vere post-operative complications complications 3. Farah, E, Abreu AA, Rail B, et al. Perioperative outcomes of robotic and laparoscopic surgery for colo- rectal cancer: a propensity score- matched analysis. World Journal of Surgical Oncology. 2023 21:272 doi.org/ 10.186/s12957–023–03138-y. 4. Grosek J, Kosir JA, Sever P, et al. Robotic versus laparoscopic sur- gery for colorectal cancer: a case- control study. Radiation and Oncol- ogy. 2021 55(4): 433–438. doi: 1 0.2478/raon-2021.0026. 5. Gebhardt JM, Werner N, Stroux A, et al. Robotic-Assisted versus La- paroscopic Surgery for Rectal Cancer: An Analysis of Clinical and Financial Outcomes from a Tertiary Referral Center. Journal of Clinical Medicine. 2024 13, 1795. doi. org/10.3390/jcml13061795. ■ Report: Cynthia E Keen EUROPEAN HOSPITAL Vol 33 Issue 2/24