2 EH @ MEDICA Experts outline European infrastructure AI in health imaging: computational power isn’t everything intelligence What will the future structure for artificial in health imaging across Europe look like? While the algorithms show great promise in collect- ing, storing, analysing, and using data to advance healthcare, dele- gates to a session on the topic at ECR 2023 in Vienna also heard that it was important for the use of AI to move from research and more ap- plications for patients. toward practical distributed big data harmonization and structure, while offering an ap- preciation of how federated learn- ing can be used to construct clini- cal prediction models. While there are opportunities for precision im- aging and cancer, he also address- ed the challenges: ‘Images are highly variable and data from Elec- tronic Health Records is mainly non-structured and difficult to extract,’ said Martí-Bonmatí, who is EUCAIM’s Scientific Director. Dr Nikolaos Papanikolaou from the Champalimaud Research Foun- dation in Lisbon, Portugal, looked at the basic concepts of AI and radiomics, the challenges in a multi-centric setting, and on best practices to increase translation from research to clinic. He dis- cussed the ProCancer-I project, an AI platform integrating imaging data and models, supporting preci- sion care for prostate cancer. The major challenges in AI/radiomics include a lack of standardisation in image representation in the data and that radiomics features are highly sensitive to variations in image acquisition, he said. While access to increased com- putational power is crucial, he also stressed the importance of the availability and accessibility to well curated high-quality data. He pointed out that medical images often incon- sistent, and heavily dependent on the way they have been acquired. non-harmonized, Intent on clinical translation Papanikolaou said inconsistencies in feature extraction may deliver unreliable and non-reproducible results. This challenge should be addressed by applying harmon- ization methods, with AI models exposed to real world big data to learn invariant features. ‘But at the end of the day, the AI should not be only a research exercise – it should be developed towards an intention to be applied in the clinics,’ he said. Areas of validity, usability and util- ity need to be ‘seriously addressed’ to convince people to start translat- ing the technology into the clinic, he urged. ‘We need to prospec- tively, and consecutively, validate AI models into the clinical environ- ment and organise randomised controlled clinical trials to docu- ment the impact on the clinical outcomes and to assess cost effec- tiveness.’ From fragmented to harmonized and structured data Professor Luis Martí-Bonmatí, who co-chaired the session with Gabriel Krestin from Rotterdam, presented details and the goals of the EU- CAIM (EUropean federation for CAncer IMages) project, which supports researchers to perform re- search on data. He looked at how fragmented health data silos can be linked and efforts made towards Addressing the “innovation chasm” ‘We need a state-of-the-art platform for AI imaging to beat cancer but there is an innovation chasm,’ he said. To address this, EUCAIM aims to deploy a pan-European feder- ated infrastructure to power up AI imaging to beat cancer; provide a research platform to develop and benchmark AI tools toward preci- sion medicine; address the frag- mentation of existing cancer im- aging a federated data warehouse ap- proach to allow the construction of observational studies and populate a central repository; and allow the construction observational studies. There is also the need to develop and foster standardization and harmonization tool via AI, the expert concluded. repositories; create of Several other projects were also discussed during the session. Mar- tin Starmans from the University Medical Center in Rotterdam, the Netherlands, discussed the “EuC- anImage” project and looked at the role of the platform for streamlin- ing European AI research in cancer imaging from data to deployment, with a focus on liver, colorectal and breast cancers ’to address real- world unmet clinical needs.’ With the CHAIMELEON project, Professor Ignacio Blanquer from the Technical University of Val- encia, Spain, talked about the con- cept of in-situ access to data and examined the pros and cons of centralised repository models on harmonized images from patients with breast, lung, colorectal and prostate tumours. Delegates also were presented de- tails on the INCISIVE project, which looks at ongoing research efforts for developing AI services for decision-support of clinical ex- perts. Senior analyst and INCISIVE co-ordinator Gianna Tsakou under- lined the importance of imaging and clinical data sharing, while ac- knowledging the benefits and hurdles of health data sharing and the role of clinical experts in this process. In a further presentation, Angel Al- berich-Bayarri from Quibim, Val- encia, outlined the PRIMAGE pro- ject with a specific focus on the architecture of an imaging platform for a paediatric cancer imaging bio- bank. ■ Report: Mark Nicholls DON‘T MISS! Connected Healthcare Forum MONDAY Connected Medical Things Advancing future healthcare with IoT technologies 15th Healthcare Innovation World Cup pitch and award ceremony Alternative Care Delivery Models Balancing at-home technology, outpatient and clinical healthcare Mobile Health Improving healthcare at home and at the point of care TUESDAY Robotics Advancing surgeries, rehabilitation and processes to the next level Healthcare Accelerators Scaling up future health innovations AI, Big Data & Machine Learning Thriving, surviving and discovery in the data age 12th MEDICA Start-Up Competition pitch and award ceremony WEDNESDAY Sustainability in Healthcare Creating green healthcare initiatives for a positive impact on the environment Brain, Mental Health and Neuroscience Understanding the brain and mental health Health Metaverse Creating the future of immersive healthcare through AR/VR, digital twins and more Future of Therapy Managing diseases with therapeuticals and new treatment approaches THURSDAY Diagnostics and Health Monitoring Pushing the frontiers of diagnostics Future Hospitals and Care Centers Advancing outpatient and clinical processes and experiences Health Start-Up Innovation Hubs I 15 Start-ups from Taiwan Health Start-Up Innovation Hubs II Digital health hubs in Germany MEDICA Start-Up Park Accelerating the future of digital health » Hall 12 / E37 EH @ MEDICA 2023

4 An overview EH @ MEDICA DON‘T MISS: Hot issues, current trends and innovations at the Labmed Forum n n a m l l i T e z n a t s n o C , f r o d l e s s ü D e s s e M © Cancer and coronary diseases, infections and new anti-bacterial active substances, digitalisation and artificial intelligence – these are some of the top issues dis- cussed this year at the MEDICA Labmed Forum. Laboratory medicine forms a bridge between clinical practice, research and patient care. Together with the life sciences, it is therefore an essential driver for a progressive healthcare system. Over the last years, the forum has developed into an especially noted part of the programme at the inter- nationally leading trade fair for the health and medical technology in- dustry, and will be held on all four days of the event in the trade fair Hall 1 from 10.30 a.m. to 4.00 p.m. Though the topics are complex, it is a hallmark of the MEDICA Labmed Forum that all presenta- tions are short, to the point and easy to understand, and can be ad- dressed in further depth in panel discussions. Like last year, the sophisticated programme was organised by Prof. Stefan Holdenrieder and Prof. Georg Hoffmann (German Heart Centre at the Technical University of Munich). During each lunch break, exhibiting companies are given the opportunity to introduce themselves with short presenta- tions about their company. MONDAY: IVDR and AI in Laboratory Management On Monday, MEDICA starts with two “scandalous” issues which cur- rently cause heated debates throughout the field of laboratory medicine: the potential threat to the existence of small IVD com- panies and specialised labs posed by the “In-Vitro Diagnostics Regu- lation” (IVDR) and the use of artifi- cial intelligence (AI) with new possibilities and also risks. Led by Prof. Astrid Petersmann (University of Oldenburg), in the morning there will be a pro- fessional discussion concerning the challenges posed by the new EU directive for the quality assurance of diagnostic tests, and how these can be overcome. In the afternoon, an equally excit- ing discussion will follow, concern- ing how artificial intelligence and machine learning are about to change the way we work in labora- tories. One of the most advanced ap- plication areas currently is the automatic evaluation of micro- scopic images and complex data sets, for example in the diagnosis of leukaemia. n n a m l l i T e z n a t s n o C , f r o d l e s s ü D e s s e M © TUESDAY: Advances in Lab Diagnostics in Oncology and Cardiology On the second day, led by Prof. Ste- fan Holdenrieder, German Heart Centre Munich, there will be a dis- cussion of new developments in laboratory medicine within the fields of oncology and cardiology. Over the last years, research has re- vealed the enormous potential of blood examinations for the diag- nosis, prognostication and therapy management of different types of cancer. For example, circulating tu- mour cells and nucleic acids are becoming established as a second methodological pillar, which opens up new perspectives beyond the classic examination of tissue for the field of oncology. A change of perspective is visible in cardiology as well: Molecular diagnostic tests allow for the in- creasing improvement of risk as- sessment for arteriosclerotic car- diovascular diseases, and thanks to advances in heart surgery, the im- portance of genetic examinations in the case of congenital heart de- fects is also on the rise. Other than that, thromboinflammation pres- ents a new pathophysiological con- cept for understanding thrombo- genesis. WEDNESDAY: The Young Scientists‘ Perspectives The third day of the Forum tradi- tionally belongs to the next scien- tific generation within laboratory medicine. PD Dr Verena Hasel- mann, senior physician at the Uni- versity Hospital Mannheim, invites young colleagues every year to re- port on their current research and thus give an outlook on the future of the scientific field. The leitmotif for 2023 is taken from the “data sciences”, which naturally exert a special attraction for young people due to the intelligent evalu- ation of large amounts of lab data. The presentation subjects in the morning run the gamut from AI- supported image evaluation to the analysis of complex lab data to the automated generation of reports on diagnostic findings. In the after- noon, there will be a discussion of practical applications in hospitals, in doctor’s offices and within the diagnostics industry, among other subjects. THURSDAY: Innovation from an Industry Perspective The last day of the event at the MEDICA Labmed Forum starts with an overview of diagnostic solutions that noticeably shorten the time it takes to identify a pathogen, thus allowing physicians to make the most effective therapeutic response at an early stage instead of turning in risky diagnostic circles and los- ing time. Special attention is given to managing septicaemia through quick identification of the pa- thogen and the targeted use of antibiotics. More thorough research into scien- tific basics and possible ap- plications yields a perspective for future options beyond classic anti- biotic therapy, with the goal of countering the problematic devel- opment of resistances through in- novative approaches. The spectrum tablished tradition at MEDICA is the presentation of future trends from the point of view of the diag- nostics and life science industry – a part of the forum programme that has for years been realised by Dr Peter Quick, member of the board of the Diagnostics Industry As- sociation (Verband der Diag- nostica-Industrie, VDGH). Present for the first time as a co-chairman this year is his colleague in the as- sociation, Dr Jan Gorka. Both have chosen infectious diseases as a focus for 2023, because ‘bacterial n n a m l l i T e z n a t s n o C , f r o d l e s s ü D e s s e M © resistances to antibiotics are a seri- ous and growing health problem that is accepted as the new normal in some health systems, among them Germany, and which will therefore cost the lives of thou- sands of people in future,’ accord- ing to Quick. ■ of possible approaches under dis- cussion ranges from the use of small molecules against bacterial toxins or specific transporters in the bacterial wall to phage therapy. rounds out A look inside the world of “Next Generation Sequencing” (NGS) and bioinformatics the event. The focus here is on char- acterising the microbiome of new- borns, a very vulnerable patient group. Another es- Hall 1 / G37» EH @ MEDICA 2023

6 EH @ MEDICA Confirming initial positive findings First-tier rapid serology testing for Lyme disease Lyme disease, the most common tick-transmitted bacterial infec- tion in the world, is challenging to diagnose. Initial early stage symptoms may include skin rash, fever, headache, fatigue, swollen lymph nodes, and/or body and joint aches. However, these symptoms are also as- sociated with many other dis- eases and medical conditions. In many cases, Lyme disease can be diagnosed based on clinical findings and a history of a tick bite or probable exposure. Laboratory testing is problematic, both with respect to confirming and ruling out the disease. Lyme disease sero- logic testing measures the levels of antibodies generated by the body in response to the infection. How- ever, these antibodies may take several weeks to develop to a level where they can be reliably de- tected. Consequently, both false negative tests and false positive tests are a problem with first-tier Lyme serological assays. For this reason, a second-tier laboratory test is needed to confirm initial positive findings. An on-site, point-of-care, rapid test- ing system that produces first-tier testing results within 3-15 minutes alleviates delays associated with in- itial analysis by an external labora- tory. This rapid test, utilizing an ad- vanced immunofluorescence-based lateral-flow (Quidel Sofia 2 Lyme+Fluorescent Im- munoassay with CE Mark), has been available for clinical use in technology m o c . e b o d a . k c o t s - s u e l i m S © Immunoassay Europe since 2018, and also in the United States (Quidel Sofia 2 Lyme Fluorescent Immunoassay) (FIA). Treating early stage localized Lyme disease with antibiotics Positive test results help reinforce a physician’s decision to prescribe antibiotics while awaiting the re- sults of a second-tier test, es- pecially if the physician believes that a patient may have been ex- posed to ticks. Antibiotics are very effective in treating early stage lo- calised Lyme disease, and to pre- vent it from developing into sec- ond and third stages that are more difficult to cure and can cause seri- ous medical problems. The rapid test is also useful for pa- tients who presented with Lyme disease symptoms but had negative test results, and who have returned weeks later for a follow-up test to definitively confirm the initial re- sults. ‘In my opinion, the rapid FIA test’s primary benefit is actually to rule out Lyme disease, not diagnose it, because it has a high negative pre- dictive value (NPV),’ says Professor of Laboratory Medicine and Pathol- ogy Elitza S. Theel, PhD, who also co-directs Mayo Clinic’s Vector- Borne Diseases Laboratory Service Line in Rochester, Minnesota, US. it with Researchers at Massachusetts Gen- eral Hospital in Boston are the first to formally evaluate the perform- ance of this single-use cartridge- based assay using lateral flow tech- nology with an instrument reader, comparing a next- generation polyvalent enzyme im- munosorbent assay (EIA) testing system (Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM (Zeus VlsE, Zeus Scientific), currently in use at the hospital. They report in the American Journal of Clinical Pa- thology that both of these first-tier serology assays show excellent agreement when combined with Lyme Test Cassette. © Quidel second tier immunoblot tests as a part of a standard two-tier testing protocol. Rapid first-tier testing at a hospital, clinic, or doctor’s office may be very good news for the estimated 600,000 individuals who annually contract Lyme disease. Central and Eastern Europe as well as Eastern Asia have the highest incidence, led by Scandinavian and Baltic countries, Austria, the Czech Re- public, Germany, and Slovenia, ac- cording to statistics from the US National Institutes of Health (NIH). ‘The test is well suited for labora- tories and settings that wish to per- form rapid Lyme testing on de- mand in a random-access mode as opposed to many Lyme assays that require batching,’ writes the study’s principal investigator, Elizabeth Lee Lewandrowski, PhD. No refrigeration needed The Sofia 2 analysers also offers additional benefits to healthcare providers. Testing materials do not require refrigeration. The test ana- lyser is compact and portable, in- terfaces directly with most labora- tory information systems (LIS) and may be configured for either single tests or batch testing to accom- modate fluctuating volumes. Un- like most EIA testing systems, it provides differentiated IgM and IgG results, the FIA will generate differentiated IgM and IgG anti- body results in a single test. (IgM antibodies are associated with early-stage Lyme disease; IgG anti- bodies appear later after infection). who presented For the comparative evaluation, the researchers tested serum speci- mens from 179 patients experienc- ing potential Lyme disease symp- toms at Massachusetts General Hospital. The researchers reported that posi- tive predictive agreement (PPA) was 78.8% and negative predictive agreement (NPA) was 94.5%, which they said demonstrated clinically acceptable performance. Results of first-tier Lyme diseases tests differ, based on manufacturer, a key rea- son why a two-tier testing system for positive findings is a necessity. Additionally, the first-tier tests had a 96.2% PPA and a 100% NPA with the second tier immunoblot test performed at Mayo Medical Lab- oratories in Rochester, MN. Elizabeth Lee Lewandrowski Elizabeth Lee Lewandrowski, PhD, is an Assistant Professor of Pathology at Harvard Medical School and Research Faculty and a Clinical Laboratory Scien- tist in the Department of Pathology at Massachusetts General Hospital in Boston. Her primary research interests are in laboratory markers of cardiovas- cular disease, Lyme disease, and out- comes research in point-of-care testing. Dr Lewandrowski is a member of the Advisory Board of Harvard Medi- cal School Harvard Health Publishing Lyme Wellness Initiative and the Re- search Director of Invisible Inter- national, an organization which offers free online courses about diagnosing and treating vector-borne diseases. research Global initiatives are underway to develop direct diag- nostic tests able to detect all major Borrelia species known to cause Lyme disease. The challenges to overcome are significant. ‘Accurate and timely diagnosis of Lyme disease, particularly during infection, remains one of the grea- test unmet needs in the realm of in- fectious disease diagnosis,’ com- ments Theel. ‘As pathologists and microbiologists, we have been moving our diagnostic capabilities for Lyme disease incrementally for- ward, with the development of in- creased sensitivity or novel direct detection methods. But we are still far from closing this diagnostic gap.’ ■ Report: Cynthia E. Keen Elitza S. Theel Elitza S. Theel, PhD, is Director of the Infectious Diseases Serology Labora- tory, Co-Director of the Vector-Borne Diseases Laboratory Service Line, and Professor of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, Minnesota, US. She is a clinical microbiologist specializing in infectious disease serologic testing. Her specific interests and clinical focus include de- veloping and evaluating novel sero- logic assays for the detection of vector-borne diseases, viruses, and di- morphic fungi. User experience: simple and smart AutoLumo A1860/A1800 is the new generation of Autobio Auto- Lumo Series with compact struc- ture and innovative design, pro- viding simpler, smarter and better user experience for small and medium size labs. According to the manufacturer, the device is characterized in particular by its simple operation and by enormous time savings and is in- tended to lead laboratories into a new generation of immunoassays. station ensures low carryover, which is particularly advantageous for infectious diseases. An integrated RIDE module that combines reading, injection, dis- carding and elution achieves a low error rate. It is also characterized by the iconic management of consum- ables and the automatic switching of dual substrate. Highlighted is the low carryover: the wash the vacuum around The bi-directional floating mag- netic separation reduces non- specific absorption. 25 reagent marketing and service of clinical diagnostic products. Focusing on immunoassay, mol- ecular, microbiology and POCT fields, Autobio helps healthcare professionals tailor treatment with fast, reliable and accurate diag- nosis solution for various diseases and dysfunctions. Currently, Auto- positions meet various clinical de- mand. With a throughput of 180 tests/hour, the instrument is a ga- mechanger in the stressful daily laboratory routine. Autobio is a leading provider of comprehensive solutions for medi- cal laboratories. The company specializes in R&D, production, Hall 1 / F17» The AutoLumo A1860/A1800 © Autobio Diagnostics bio has 529 product registration certificates, 322 CE marked and 528 patents. ■ EH @ MEDICA 2023

8 EH @ MEDICA Sustainability in medical imaging Reducing environmental pollution after contrast-enhanced scans Radiologists called for action to reduce the release of contrast media in the hospital’s waste- water after contrast-enhanced examinations in a dedicated session at ECR 2023. An estimated 300 million CT exam- inations are being performed each year in the world. This number is expected to grow, and with it, the amount of iodinated contrast media (ICM) used in radiology, ac- cording to Professor Olivier Clém- ent, Head of Imaging at Georges Pompidou European Hospital in Paris, France, and Chair of the vironment. In a paper published in the Science of the Total Environ- ment in 2021, a team of Indian re- searchers found that, whatever the contrast media used, a large amount was found not just in hos- pitals’ sewage waste water but also in surface, ground and drinking water in North America, Asia and Europe. ‘It’s a global problem, a world issue of contamination of surface and drinking water due to contrast media release,’ he said. The contribution of ICM to water pollution can be as high as 80% in the mass loading of phar- maceuticals in a hospital’s effluent, lution linked with ICM use. ‘First we should inject less contrast media and respect the indication, i.e., always inject dose which is re- lated to weight, especially for on- cologic imaging,’ he suggested. ‘We should reduce waste and use the adequate vial for the patient, i.e., open a vial of 100 ml when we use 90 and not a vial of 150. We should also recycle the residue in the vial.’ Taking steps is also important be- cause of the high demand for ICM all over the world. ‘Vendors can produce a certain amount of ICM per year that isn’t even sufficient Twelve million litres of iodinated contrast media (ICM) are being injected in patients and then evacuated in the sewage world- wide every year. © pangoasis - stock.adobe.com a undergone cuits linked with specific plants, in- stalling dry toilets for patients who have contrast- enhanced examination, and collect- ing urine in bags to be incinerated, since incineration is less polluting than using ICBPs to purify the water. ‘The radiology community should be aware of the huge amount of iodine contrast media released in the environment,’ he concluded. inject wisely, know about toxic IDBPs in plants and take specific measures to decrease the effluence.’ ‘We should Surprisingly high ‘green sensitivity’ in patients Iodine contrast media are not the only source of concern when it comes to residuals in hospitals’ wastewater. About 50 million of ga- dolinium-based contrast agents (GBCA) doses are being injected per year and then evacuated in the sewage, according to Professor Francesco Sardanelli, Director of the Department of Radiology at the Research Hospital (IRCCS) Poli- clinico San Donato in Milan, Italy, where the Greenwater study was recently launched. As previously reported, the project aims to evalu- ate the extent of retrievable ICM and GBCA from the urine collected after CT and MRI scans, and to as- sess patient acceptance to par- ticipate in the study – the ‘green sensitivity’. patients wanted to cooperate in the project is very good news for manufacturers and hospitals, he added. ‘It shows patients are highly sensitive to sustainability. Even in a hectic city like Milan, people took the time. We have to use this avail- ability.’ The future is to recycle both and gadolinium agents, by creating virtuous cycles in which the product comes back to the producer after it has been in- jected in the patient. ‘That would make sense,’ he concluded. ‘Recyc- ling is the solution.’ ■ iodine Report: Mélisande Rouger Olivier Clément Olivier Clément is Professor of Radi- ology at Descartes Paris University and Head of Imaging at Georges Pompidou European Hospital in Paris, France. He is also Chair of the contrast media safety committee of the European So- ciety of Urogenital Radiology (ESUR). contrast media committee of the European Society of Urogenital Radiology (ESUR). ‘If you assume that 40% of CT scans are being car- ried out with an average of 100ml of contrast media, you end up with 12 million litres of ICM that are being injected in patients and then evacuated in the sewage,’ he told the audience in Vienna. This con- tamination of the aquatic environ- ment is being increasingly studied. In Germany, for example, about 200 kg of contrast media are re- leased in the Rhine river every day. ‘That means 70.9 tonnes per year. It’s a lot and it means that we can really recover ICM from the aquatic environment,’ he said. because of the amount of ICM that is being injected, he went on. ‘When we inject antibiotics, we in- ject up to three grammes per pa- tient. But when we inject ICM, we inject up to 45 g per patient so the mass of CM is much higher.’ The expert stressed that in themselves, ICMs are not dangerous – the danger comes from the disinfection process in the treatment plants, which use chemicals such as chlor- ine and chloramine. These prod- ucts create toxic iodinated disinfec- tion by-products (IDBPs) that can be found in the aquatic environ- ment and drinking water. ‘This is really the environmental problem of using contrast media,’ he said. There are also review studies about contrast media’s effects on the en- Radiologists should be aware of the issue and work to decrease pol- Advertisement for all the examinations,’ Clément said. ‘So, we must think of how we use these products and find new ways to inject less contrast, with low kV and AI for example.’ Al- though software solutions are being trained to reduce ICM dose, a small amount of contrast media remains necessary to actually cre- ate contrast in the image, he be- lieves. ‘We will still need contrast media in radiology for a long time.’ Strategies to reduce pollution in- clude releasing ICM in hospital cir- the The study was carried out with urine collection within 60 minutes of administering contrast agent, so about 30 minutes after the examination. Results have been both surprising and encouraging, Sardanelli explained. ‘The first un- expected finding to me was the high acceptance from patients,’ he said. ’94% of them agreed to take part in the study and stay half an hour more in the department. That means that we can go in this direc- tion quite effortlessly.’ The fact that Francesco Sardanelli Francesco Sardanelli is Professor of Radiology at Milan University and Di- rector of the Department of Radiology at the Research Hospital (IRCCS) Poli- clinico San Donato in Milan, Italy. Eco-sustainable Medical waste treatment ding action to sterilize the waste at the same time without the emision of persistent organic pollutants (POP) emission into the atmos- phere according to the Stockholm Convention. weight reduction and a 75% vol- ume reduction. The sturdy design allows the sterilizer to work for several shifts, each lasting 35-40 minutes. The power inverter allows to reduce energy consumption. It is a patented technology specific for the treatment of solid infectious healthcare waste, including sharps, dialysis filters, PPEs, non-woven materials and fab- rics. There is a 25% The sterilizing unit is designed for on-site installation up to 600 beds hospitals and external centralized plants. ■ Newster’s Frictional Heat Treat- ment enables hospitals to pro- cess hazardous solid waste on- site sustainable and cost-effective way. It is a sustain- able alternative for the treatment of medical waste. in a The equipment is tailored to the needs of the healthcare facility and can be installed onsite in a small sized room. The running costs in- clusive of energy consumption, maintenance, operating staff and consumables allows a significant reduction of the cost of disposal. The patented technology employs the heat generated by the shred- » Hall 11 / G67 EH @ MEDICA 2023

10 Non-invasive EH @ MEDICA High-intensity focused ultrasound ablation treatment for benign thyroid nodules High-intensity focused ultra- sound (HIFU) ablation is a non- invasively treatment for benign thyroid nodules that are causing distress to patients. Brian Lang, a preeminent investigator, pro- ponent, and pioneer of this tech- nique, talks about this still novel thermal ablation treatment. is a safe, tolerable, less expensive, outpatient procedure that does not require general anaesthesia. Organ function is preserved and kept in- tact, compared to surgery, which removes portions of the thyroid. Size matters (and so does growth) ‘HIFU ablation is appropriate for fessor in the Department of Sur- gery at the University of Hong Kong, and chief of the Division of Endocrine Surgery at Queen Mary Hospital, said that the HIFU treat- ment utilizes multiple high-energy ultrasound waves focused at one particular area to cause intense vi- brations of tissue, generating heat m o c . e b o d a . k c o t s - k c o K l e x A © Up to 60% of the world’s popu- lation has thyroid nodules, most of which are benign and cause no problems. However, between 10% to 15% can progress and grow to a size that causes discomfort, cos- metic disfigurement, and/or ob- structive symptoms. In these cases, surgical resection or thermal ab- lation is required to shrink the vol- ume and size of the nodule. Types of thermal ablation include HIFU ablation, radiofrequency ab- lation, laser ablation, microwave ablation, and ethanol ablation, all of which are non-invasive. Ablation patients with small-to-medium sized, benign solid nodules greater than 40 mm in size or which are experiencing nodule growth greater than 20% in one year. interval that causes necrosis at the target location. Thermal injury occurs when tissue temperature reaches 56°C for a duration of one second or more, causing protein denatu- ration and coagulation necrosis. The distance from the skin to the center of the nodule should not be less than 7 mm or greater than 30 mm, because HIFU can cause skin burns if too close and the ultrasound energy will dissipate and not be as effective if too far,’ explained Lang, who has per- formed more than 600 of these procedures. Lang, Clinical Pro- Acoustic cavitation – the formation of microbubbles which expand and collapse – causes mechanical da- mage to nearby cells, resulting in coagulative necrosis and apoptosis. Cell arrest also occurs, activating immune cells that detect and de- stroy tumour cells. The total on- beam HIFU treatment time for a 3 cm nodule takes between 30-45 minutes, with a patient spending 4–6 hours at an outpatient clinic. Two sequential treatments six months apart are recommended for larger nodules. Shrinkage may vary Thyroid nodule shrinkage follow- ing HIFU ablation is not uniform, and the reasons for this are still being investigated. ‘HIFU can gen- erally achieve a volume shrinkage between 45% to 70%, with the smallest nodules having the grea- test shrinkage,’ said Lang. ’80% of my patients had a greater-than-50% shrinkage at six months. Also, the number and severity of pressure symptoms tend to be significantly reduced at 12 months.’ The extent and duration of shrinkage beyond two years is not yet known and is also currently being investigated. Preventing heat injury Great care must be taken to pre- vent heat injury to the carotid ar- tery, trachea, and recurrent laryn- geal nerve. Skin burns are the most commonly reported side effect; transient vocal cord palsy occurs in less than 5% of patients. Lang and his colleagues at the Uni- versity of Hong Kong have con- ducted numerous research investi- gations of the usage and efficacy of HIFU as a treatment for benign thy- roid nodules. Noteworthy clinical trial findings include: The addition of percutaneous ethanol injection (PEI) in com- bination with HIFU ablation in benign thyroid nodules is as- sociated with a significantly better six-month efficacy then HIFU alone and has a com- parable safety profile. HIFU ablation is a feasible treatment in patients take an anti-coagulation or anti-platelet agent during It might be preferable to surgery in patients who continuously require an anti-coagulation or anti-platelet agent. treatment. Brian Hung-Hin Lang Brian Hung-Hin Lang, MD, is the Li Shu Fan Medical Foundation Professor in Surgery at School of Clinical Medi- cine at the University of Hong Kong, and also serves as its Director of the Surgical Skills Training Center. He is the chief of the Division of Endocrine Sur- gery at Queen Mary Hospital in Hong Kong, specializing in thyroid, parathy- roid, adrenal diseases, and ablation of thyroid nodules. Lang has pioneered the use of high intensity focused ultra- sound (HIFU) in the treatment of be- nign thyroid disease. For the 85% of patients who ex- perience pain during HIFU ab- lation, the additional adminis- tration of a perithyroidal lignocaine infusion (PLI) in conjunction with intravenous doses of a sedative and an opioid provides greater pain re- lief. A randomized 205-person study identified lower body mass index (BMI) and older age as independent indicators of experiencing less pain. Two sequential HIFU ablation treatments six months apart generate more nodule shrink- age than a single treatment of large thyroid nodules (with a volume of at least 20 mL and up to 50 mm in diameter). Patients undergoing two treatments are not at greater risks of treat- ment-related side effects. ■ Report: Cynthia E. Keen Publisher mgo fachverlage GmbH & Co. KG E.-C.-Baumann-Str. 5 95326 Kulmbach/Germany Phone +49 (0) 9221 949-311 Fax +49 (0) 9221 949-377 Managing Directors: Walter Schweinsberg, Eva-Maria Bauch, Bernd Müller Editor and Production Manager: Sonja Buske (SB) Phone: +49 201 17755092 E-Mail: s.buske@mgo-fachverlage.de Editor: Wolfgang Behrends (WB) Founded by Heinz-Jürgen Witzke Spain: Mélisande Rouger (MR) GB, Scandinavia, BeNeLux: ISSN 0942-9085 Correspondents Austria: Michael Krassnitzer (MK) Belgium: Bernard Banga (BB) Germany: Cornelia Wels-Maug (CWM) Dr Christina Czeschik (CC) Great Britain: Mark Nicholls (MN) USA: Cynthia E. 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