I S S U E 55
2022
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NEW NORMAL, NEW FUTURE Reshaping the Future of Health through MedTech Innovation Ashley McEvoy Executive Vice President and Worldwide Chairman Medical Devices Johnson & Johnson
Associate Partner
IMPLICATIONS OF COVID-19 ON HEART HEALTH
A DIGITAL REVOLUTION IN PATHOLOGY
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Foreword MedTech Innovations Shaping the future of healthcare Healthcare is shifting from the traditional provider-centric, in-patient setting to patient-centric, virtual consultations with increased remote care monitoring. This transition has prompted the need for MedTech industry to relook at the products they develop and enhance value in care delivery.
extend and expand this adoption to improve the health outcomes across regions and populations. However, this increased demand calls for a careful evaluation of the shift to digital infrastructure and proper regulations in place to ensure the industry is better prepared for managing health emergencies.
The COVID-19 pandemic has increased the use of digital health technologies, and the need to develop innovative devices or systems that support virtual health. The last couple of years have seen increased use of wearables, mobile and app-based technologies along with data and analytics have been transforming healthcare delivery.
MedTech companies would do well to innovate and develop advanced diagnostics & monitoring tools with a focus on agility, affordability and effective outcomes. Asia-Pacific will become the second-largest regional market for MedTech, contributing 35 percent of the growth over the next two years, according to McKinsey & Company. Driving MedTech innovation calls for collaborations and partnerships between MedTech and healthcare organisations and the region has the potential to guide the world towards digitisation of MedTech for enhanced care delivery.
Advancements in healthcare technologies like Artificial Intelligence (AI), Virtual Reality and Augmented Reality 3D-printing, robotics and nanotechnology are shaping the future of healthcare. This technology boom is helping address disease and medical conditions through provision of cheaper, faster and more effective solutions for diseases. The pandemic has forced organisations to rethink their strategic planning understanding the need to go the digital route and patients have understood the importance of teleconsultations and the advantages mobile health applications bring forth. From increasing productivity to driving operational efficiency with automation of mundane tasks and gaining a 360-degree perspective through 3D rendering, the likes of Robotic Process Automation AI, 3D systems and the cloud are in focus for the medical devices industry. The pandemic has created a need for loosening regulations in offering clearances to address the medical device demand-supply needs of the sector. MedTech companies and healthcare organisations have to collaborate and work in sync for implementation of digital technologies. There lies a huge opportunity to
This issue features an interview with Ashley McEvoy, Executive Vice President and, Worldwide Chairman, Medical Devices, Johnson & Johnson. Ashley shared her views on how the pandemic has changed the shape of healthcare and MedTech in the Asia-Pacific region. She also talks about how collaborations and partnerships will drive MedTech innovation in the future. Hope you find this issue insightful. Please also use this as an opportunity to share your perspectives for the upcoming special issue ‘Executives Special’. Write to me - prasanthi@ochre-media.com.
Prasanthi Sadhu Editor
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HEALTHCARE MANAGEMENT 06 Behavioural Health Gurrit K Sethi, Founder, Miindmymiind
08 Healthcare Technology Entrepreneurship in China Caiwei Chen, Yongqi Zheng and Pradeep Ray Centre For Entrepreneurship, University of Michigan-Shanghai Jiao Tong University Joint Institute
MEDICAL SCIENCES 14 Keep Calm and Reconsider Graft Revision The impact of coronary stenosis for beating heart coronary artery bypass grafting Frank R Halfwerk, Assistant Professor, Cardiac Surgery Innovations Lab, University of Twente
NEW NORMAL, NEW FUTURE
COVER STORY
CONTENTS Reshaping the Future of Health through MedTech Innovation
Ashley McEvoy Executive Vice President and Worldwide Chairman Medical Devices Johnson & Johnson
19 Addressing the Osteoporosis Care Gap in The Asia-Pacific
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M Chandran, Senior Consultant and Director, Osteoporosis and Bone Metabolism Unit, Singapore General Hospital M Chadha, Consultant Endocrinologist, P.D. Hinduja National Hospital and Medical Research Centre Q Cheng, Chief Physician and Doctoral Supervisor, Department of Osteoporosis and Bone Disease, Huadong Hospital
24 Understanding and Predicting Progression to Hepatorenal Syndrome in Cirrhotic Patients Roula Sasso, Ahmad Abou Yassine, Department of Gastroenterology Staten Island University Hospital
38 The Health Impact of Nudges, Influence and Community Kent Bradley, Chief Health and Nutrition Officer, Herbalife Nutrition
42 Implications of COVID-19 on Heart Health Audditiya Bandopadhyay and Gyaneshwer Chaubey Cytogenetics Laboratory, Department of Zoology, Banaras Hindu University
INFORMATION TECHNOLOGY 50 Global Certification for Telehealth Services K Ganapathy, Member Board of Directors, Apollo Telemedicine Networking Foundation & Apollo Tele Health Services
56 A Digital Revolution in Pathology Suresh Vazirani, Founder Chairman, Transasia-Erba International Group of Companies
28 Management of Cerebrovascular Steno-Occlusive Disease Contemporary multidisciplinary approach Benjamin Wai Yue Lo, Neurosurgeon & ICU Specialist
34 Chronic Disease Management Challenges and opportunities Prasad Narayanan, Senior Consultant & Director – Medical Oncology Cytecare Cancer Hospitals
Advisory Board
Beverly A Jensen President/CEO Women's Medicine Bowl, LLC
EDITOR Prasanthi Sadhu EDITORIAL TEAM Grace Jones Rohith Nuguri Swetha M
K Ganapathy Director Apollo Telemedicine Networking Foundation & Apollo Tele health Services
ART DIRECTOR M Abdul Hannan PRODUCT MANAGER Jeff Kenney
Pradeep Kumar Ray Honorary Professor and Founder WHO Collaborating Centre on eHealth UNSW
SENIOR PRODUCT ASSOCIATES Ben Johnson David Nelson Peter Thomas Susanne Vincent
Nicola Pastorello Data Analytics Manager Daisee
PRODUCT ASSOCIATE John Milton Veronica Wilson CIRCULATION TEAM Sam Smith SUBSCRIPTIONS IN-CHARGE Vijay Kumar Gaddam
Gurrit K Sethi Founder, Miindmymiind
HEAD-OPERATIONS S V Nageswara Rao
Pradeep Chowbey Chairman Minimal Access, Metabolic and Bariatric Surgery Centre Sir Ganga Ram Hospital
Associate Partner
In Association with
A member of Confederation of Indian Industry
David A Shore Adjunct Professor, Organisational Development Business School, University of Monterrey
Gabe Rijpma Sr. Director Health & Social Services for Asia Microsoft
Peter Gross Chair, Board of Managers HackensackAlliance ACO
Malcom J Underwood Chief, Division of Cardiothoracic Surgery, Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital
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BEHAVIOURAL HEALTH Our behaviours define what we consume and how. The pandemic has had deep rooted effects on our psyches and this is bound to impact consumer behaviours. We all need to closely watch the changes wrought about during this time and re-strategise what we do and how, as we reach out to strengthen and expand our businesses. Gurrit K Sethi, Founder, Miindmymiind
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e are all defined by our behaviours, quite literally so. Our behaviour affects how we engage with not only the external world, but also reflects on how we engage with ourselves. It is this engagement that drives the world around us… Yet we hardly ever consider this fact. Ain’t this true? I am neither a behavioural health expert, nor a mental health expert. However, there are many who practice without many credentials. In fact, the rulings and regulations around the required credentials for counselling in India is still nascent. But since I have been a business professional, and worked through people behaviours and also suffered business behaviours, and because I now work in the mental health and well-being space, I am taking the liberty of expressing the opinions of a minion from this field. As per Wikipedia, the word ‘behaviours’ extends itself to not just individuals and human beings but also to all other living beings, systems or artificial entities in conjunction with themselves or their environment. How we react or our mannerisms, as they play out have been ensconced under the apparel of behavioural sciences.
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This ‘science’ of behavioural sciences is studied not only with respect to human beings, but also cultures, systems etc. So much so that a lot of research today happens on the behavioural side of economics as well. Ironically our behaviour’s are being studied for their effects on the growth of economy, and for many business professionals, for how to use these behaviours for economic gains for the business. To understand what created these behaviours, I researched various elements of our environment that surrounds us. And hence I came upon the need to understand culture and if it shaped our behaviours. The discovery that both cultures and behaviours do get driven and impacted by each other came upon with some apprehension. It is so said that human behaviour is affected by both genetic inheritance as well as experience. This is quite a deep-seated aspect. And a very critical part of our mental frameworks. This leads to the belief that to support our behavioural health, it is important to understand the culture to which one belongs and, maybe, similar aspects need to be applied to the behaviours of other abstracts of our environment – our work culture especially. The culture
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and employee behaviours impact productivity of the organization. Many studies ascertain that work life imbalances and work stress impact mental health of the employees and this leads to loss of productivity. The WHO statistics to this effect are overwhelming. And these ‘effects and loss of productivity can definitely be minimized by the right interventions. If we look at the world as one large community and one large economy, it is invariably driven by basic human instincts and colored by the effects of the various cultures. These in turn are determined by the geography, the resource availability, the climate and many other natural factors and how overcoming challenges arising of these for survival have evolved over centuries. As the world got knitted together, not just by the expanse of the earth, but more through transportation and communication channels. As a result, new patterns of expected behaviours have evolved. Many of us in the corporate world undergo trainings on managing cultural diversity for better work output. As the global communities have come together to expand the economic gains, it is imperative to understand the different cultures of different geographies, and
to keep the sensitivities in mind as we connect across different countries. Each place has its own unique way of living and environment driven by resources and other elements of this environment. One thing is for sure, communication is key, and, if one looks deeper, the key aspects and strains of human behaviour do remain the same, albeit with some differences But one thing remains sacrosanct through all of this: behaviours are the defining factors for humans, systems and cultures – for output, end result, and the final product. It is well understood that the environment affects, rather shapes these behaviours and vice versa. And, thus it becomes important to understand the environment to be able to shape the behaviours. Especially when we all exist in such a volatile, uncertain, complex, ambiguous (VUCA) world! This is true not just for our day to day living, as behaviours add to the quality of it, but also true for our business environments, our political environments as well as the social fabric which is an essential core of our survival. The ongoing pandemic has made our already VUCA world more so. The effects of these on people’s health, homes, and other behaviours are telling. There is an increased focus on behavioural and mental health today. This heightened focus has been driven by the widened need supply gap hugely as a key after effect of the pandemic. There are an enormous number of mental health start-ups that have sprung up across varied geographies – some serious players, some fly by night operators. The need of the hour today is not just better regulations and governance by the respective authorities but by our own selves as well to recognize our issues well in advance and nip the evil in the bud. Awareness about mental health and mental well-being needs to be given due importance by educators, employers, and by each one of us. While we all
AUTHOR BIO
HEALTHCARE MANAGEMENT
Gurrit K Sethi, Founder, MIINDMYMIIND, contributes to healthcare by bringing to life new concepts which enhance accessibility, helps providers re-engineer businesses, works with Global Challenges Forum (a Swiss Foundation) on sustainable health initiatives. An avid traveller and voracious reader, these attributes provide her with incisive insights about people and systems and what drives them.
look out for developmental anomalies and mental disease evidences, the focus needs to also shift to creating strong mental frameworks in the first place. With strong mental frameworks driven right through our developmental years, we will all be better equipped to handle our emotional ups and downs largely motivated by our VUCA world. Perhaps a focus on creating a mentally strong human force actually leads to a less toxic and a less VUCA world. While we work around the above challenges through research-based
methodologies, let us all focus on looking after our behavioural health today and give it the requisite attention – recognize and understand our own pain points, address those pain points by seeking professional help, in time. Ironically enough, the same can be said for systems, businesses etc. Let me conclude by saying that if health is wealth, our behaviours are the cornerstones or the tombstones of everything around us, be these of our lives, our health, our work or the overall economy.
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Healthcare Technology Entrepreneurship in China Entrepreneurship in healthcare is growing rapidly all over the world. Thanks to the explosion in the Internet and mobile technologies and the cooperation among technologists and medical professionals, China is seeing some great progress in this field. This article discusses some cutting edge technology entrepreneurship in China, using the technique called Business Model Canvas. Caiwei Chen, Yongqi Zheng and Pradeep Ray Centre For Entrepreneurship, University of Michigan-Shanghai Jiao Tong University Joint Institute
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ntrepreneurship in healthcare technology is one of the fastest growing investments in the startups in the world today as seen from the reports from the venture capital industry. China is a country of entrepreneurs with nearly 25 per cent of the Chinese technology professionals becoming entrepreneurs. Therefore, it is not surprising that entrepreneurship
HEALTHCARE MANAGEMENT
in healthcare technology is growing rapidly in China. The Centre For Entrepreneurship (CFE) at the University of Michigan-Shanghai Jiao Tong University Joint Institute (UM-SJTU JI) is a premier institution in Asia training engineering students for entrepreneurship through courses and practicum projects in collaboration with local startups and the corporate businesses. Since the Business Model Canvas (BMC) is the de-facto standard method of presenting and validating entrepreneurship ideas, this article uses BMC to analyse healthcare entrepreneurship in China through case studies in projects that CFE has been involved in. The article starts with an introduction of BMC followed by two case studies; one involving the Haiyang Group, the largest private sector aged care provider in China (that started with the entrepreneurial vision of the founder and
CEO Mr. Max Xu) and a new startup called MiDIVI (led by Chen Liang) that is involved in the deployment of cuttingedge Mixed Reality (MR) application in surgery in China. The case studies discuss the business model of each of these sectors using BMC, followed by brief comments from the leader of each company. Business Model Canvas1
Business model canvas (BMC) is a systematic way to present the developing plan of a company’s product with nine building blocks. BMC helps the company in keeping the major decisions consistent with the product positioning. At the initiation stage of an idea, it is done with guesses, which enables the company to clarify the whole developing strategy. Then later during validation 1 A. Ostenwalder and Y. Pigneur, Business Model Generation. USA: Wiley, 2010. ISBN: 9780470876411.
phase, the company can evaluate and improve its plan based on BMC. Value propositions are the core values of a product, namely how it provides a solution to the problems from each specific Customer Segment. • The Customer Segments describe the target customer groups, to whom the Value Propositions are designed for. Channels indicate through which media the product will reach the Customer Segments, and how each of them is integrated. • Customer Relationships refer to the strategies to get, keep and grow customers based on designated Customer Segments. • Revenue Streams are strategies the company adopts to gain profit from each Customer Segment. These include the major revenue sources and pricing model. • Key Resources include the most important things to keep the BMC
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work, mainly from financial, physical, intellectual and human perspectives. • Key Partners can be strategic alliances to jointly provide a complete product or service, suppliers of Key Resources, and so on. • Key Activities usually consist of development, maintenance and promotion of the product. Cost Structure is the plan for expenditure on each Key Resources and Key Activities. Case Study of Haiyang Group2
Shanghai Haiyang Internet Elderly Services Co., LTD. (hereinafter referred to as ‘Haiyang’) is a leading company which provides comprehensive pension service in China. Haiyang focuses on developing an integration of digital technology, new business forms and new 2 Z. Hao, M. Xu, L. Li and P. Ray, “Role of Technology in Aged Care in China,” in Digital Methods and Tools for Healthy Ageing. U.K.: IET, 2021, ch. 11. ISBN: 978-183953-462-1.
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models in pension industry. Their main product is Continuing Care Homebased Community (CCHC), which is a smart pension model supported by multiple digital technologies. Haiyang group is now the largest private sector aged care provider in China and it has been a partner of UM-SJTU JI CFE led by Pradeep Ray in the recently concluded project (2019-2021)“Digital Health for the Elderly” that led to the publication of the book “Digital Methods and Tools for Healthy Ageing”, (2021) eds Pradeep Ray, Siaw Teng Liaw and Artur Serrano, published by IET (UK). 1 Analysis based on BMC
The value proposition for Haiyang is to provide a comprehensive pension chain service integrated with digital technologies, which enables the elderly to have a better life and relaxes their children. Most of the competitors in the industry are system or software service
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suppliers and Haiyang is the only single company in China which covers three pension models which is institutional pension, community pension and home pension. The main customer segment is the elderly who need to be taken care of but lack all-day-long face-to-face care. These “new Chinese seniors” are more open to digital technologies and are also concerned about their own health. Channels for Haiyang can be divided into two parts: healthcare applications or programmes which can be downloaded directly online, and specialised wearable electronic devices which can be bought from both online and physical stores. In order to strengthen customer relationship, Haiyang provides multiple high-quality products and makes good connection between customers and caregivers. The revenue streams can be formed in two parts: direct earning from multiple telehealth products and funds from investment cooperation.
HEALTHCARE MANAGEMENT
Raw material of the products and software providers are the key resources for Haiyang. Chinese government and medical centers are Haiyang’s key partners. The former offers supporting funds and policies and the later provide the best user experience, share the data and do rapid assessment. Key activities of Haiyang include effective production, training for the elderly to use the products and high-quality maintenance. The cost mainly goes to three areas: raw materials, software support, and community workers’ salary. 2 Interview excerpts
UM-SJTU JI CFE team interviewed the CEO of Haiyang Group, Max Xu (Chao Xu) in 2021 as he has been an awardwinning entrepreneur and the founder of the Haiyang group. In his view the nine building blocks of BMC is ranked in the following order (from important to less important): value proposition, revenue streams, customer relationship, key partners, customer segments, channels, key activities, cost and key resources. Apart from the elements in BMC, he believes that people in the core entrepreneurial team are also important for a start-up. The whole team should have a clear division of work, avoid homogeneity, and be brave to face failure. Case Study of MiDIVI
MiDIVI is a digital health technology startup in Shanghai, China and MiDIVI has been a partner of the UM-SJTU JI Centre For Entrepreneurship (CFE) in offering practicum courses like VX423 for which Caiwei Chen was an intern in this company in 2021. One main product of MiDIVI, Jinshu, is a surgery navigation system integrating medical image processing and Mixed Reality (MR) technique based on MR goggle — Microsoft HoloLens. It is supposed to assist Healthcare Practitioners (HCPs) before, during and after operations, currently supporting percutaneous puncture biopsy (PPB) for cardiothoracic
surgery and neurosurgery department, to name a few. Jinshu consists of three parts, the MiDIVI smart holographic cloud platform (MSHCP) on personal computer, the J-MRview on HoloLens, and J-control on an iPad. 1 Analysis Based on BMC
The value propositions of Jinshu vary with customer segments. For HCPs, Jinshu provides assistance throughout the whole surgery process. Before surgery, MSHCP builds a 3D hologram model of operative field from 2D images (such as CT images), then generate the preoperative plan (such as to determine the precise position of puncture) with deep learning algorithm. During surgery, J-MRview superimposes the hologram model on real-time view according to predefined feature points on the patient’s body. Following the model HCPs can precisely position the surgical tools without further measurement. HCPs can also ask remote experts for help using the meeting module. After surgery, HCPs can review the recorded operation video filmed by HoloLens. For patients, Jinshu clearly illustrates their conditions and the expected operation procedure with the 3D holograms. Besides, more accurate surgery lead to better therapeutic effect. For hospitals, Jinshu helps to lower surgical error rate and thus prevent potential medical disputes. Besides, the remote guiding module promotes fair treatment through the society, equalising accessibility to high level medical resources for people from all segments of society. For traditional medical device enterprises, Jinshu as a representative of information technology advancement facilitates the growth of their competitiveness in the market. The first step to build strong customer relationships is to get customers, which closely relies on the chosen channels. In general, customers are obtained through direct contact with targeted customers. Since the products apply promising
technology advancement, collaboration cases with medical departments are reported by local satellite television channel, while collaborative projects are propagated on partners’ websites. Besides MiDIVI actively attends conferences and exhibitions to present its ideas. To keep and grow customers, products are continuously upgraded in response to clients’ feedback. Since MiDIVI is a relatively small enterprise, it is possible to tailor project for specific needs, providing better customer experience. Beyond the cutting-edge products, free trials of supplementary services (such as a remote meeting module) are also offered to current customers. Key activities include software development, marketing and after-sales service, each corresponds to several Key resources. MiDIVI focuses on developing medical image processing algorithm and operational navigation application. Jinshu also incorporates surgery aid devices based on HoloLens and the optical measurement and electromagnetic (OME) tracking device from NDI. For research and development (R&D), MR and deep learning technicians are major human resources. To protect intellectual property and to distinguish from competitors, patents are also of key importance. The particularity of medical devices segment leads to a special financial resource structure. Sale and application of medical devices is strictly controlled by government because they are closely related to human life and health. For the same reason, the productisation commonly takes more than one year, and licensing takes even longer. Therefore, financing, instead of profiting from common trade, is the vital R&D funds. MiDIVI being one of the small and medium-sized enterprises (SMEs), marketing is a crucial part to obtain customers and expand market share. Consistent with Channels, MiDIVI
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and business. The former needs to solve the pain of doctors and patients and the latter means to put ideas into practice. Besides, Chen Liang thinks that it is hard to conclude any element in BMC as a less important one. He would rather describe it as a dynamic process and judgement should be made on how to allocate people and one’s energy during different periods. Conclusion and future
Entrepreneurship in healthcare technology is now booming all over the world. This article has provided a brief overview of healthcare technology entrepreneurship in China through two case studies; one large group (Haiyang) and one new startup (MiDIVI), using a
AUTHOR BIO
provides demonstrations to investors and employ online media to promote products like Jinshu. Key partners are mainly of three types. First, companies such as Microsoft and NDI are key suppliers that provide MiDIVI with necessary hardware. Second, strategic alliance is set up with Jingteng Tech, to name a few, with whom projects are co-launched to make the most of each company’s strength. Third, several medical experts provide both professional surgical aids and practical suggestions as users. The revenue streams include direct sale and investment. There are two possible ways for Jinshu’s sale. Hospitals usually purchase the whole set of device and service, while some medical device companies may pay for cloud service on use basis. Yet as described, there are strict restraints on the transactions. Currently the expenditure is mainly covered by investor funding. As an IT product, the cost structure of Jinshu consists of software development and maintenance. To take the remote meeting module as an example, R&D expenses include purchase of resources such as software development kit. Hardware production also takes a considerable portion. Apart from HoloLens and OME tracking device, surgical tools and human anatomical models are needed for simulation and tests. In addition, there are expenses of administration, including rent, business trip and consumables.
conceptual model called Business Model Canvas (BMC), now extensively used for modelling and validating startups. BMC is also used to teach entrepreneurship to students all over the world and these case studies would help summarise startup ideas. However, students of entrepreneurship also learn (while doing projects) that much more details need to be added to the BMC for a real startup business and that is the subject of courses like VX420 (Entrepreneurship Basics) taught in the UM-SJTU JI. More research is needed to fill the gaps in BMC as discussed in the forthcoming book “Technology Entrepreneurship for Sustainable Development” by Springer in 2022 with Pradeep Ray and Rajib Shaw as co-editors.
Caiwei Chen is a member of the University of Michigan (UM)-Shanghai Jiao Tong University (SJTU) Joint Institute (JI) Center For Entrepreneurship (CFE) and chairs the IEEE Technology and Engineering Management Society (TEMS) student branch in JI. She is interested in interdisciplinary development in business field, with major interest in entrepreneurship and business analytics. Yongqi Zheng is the current treasurer of the IEEE-Technology and Engineering Management Society (TEMS) Student Branch at the University of MichiganShanghai JiaoTong University Joint Institute. He is a member of the UM-SJTU JI CFE and particularly particularly interested in industrial engineering, product innovation and entrepreneurship.
2 Interview excerpts
UM-SJTU JI CFE team interviewed the CTO of MiDIVI, Chen Liang in 2021 as he has been an entrepreneur and the founder of the MiDIVI. Chen Liang believes that the value proposition is the most important element among the nine building blocks. He regards it as the origin which makes an entrepreneur clear about his goal and decides the eight rest elements. From the perspective of MiDIVI, the value proposition should include both the innovation of product
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Pradeep Kumar Ray is the Founder Director of the Centre For Entrepreneurship (CFE) at the University of Michigan-Shanghai Jiao Tong University Joint Institute and is currently leading an international research initiative called Technology Entrepreneurship for Sustainable Development (TESD) involving more than twenty partners from all over the world. He is the founder of the WHO Collaborating Centre on eHealth in the University of New South Wales (UNSW)-Australia (2013).
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MEDICAL SCIENCES
KEEP CALM AND RECONSIDER GRAFT REVISION The impact of coronary stenosis for beating heart coronary artery bypass grafting Preoperative angiography in combination with intraoperative graft flow measurements may improve durability of coronary artery bypass grafts. However, native coronary flow might impair bypass graft flow based on stenoses’ severity, leading to inferior long-term outcomes. Intraoperative routine snaring of a coronary artery detects significant competitive flow, possibly intercepting unnecessary perioperative graft revisions. Frank R Halfwerk, Assistant Professor, Cardiac Surgery Innovations Lab University of Twente
The heart, inadequate blood supply, and revascularisation
The coronary arteries supply the heart itself with oxygen and nutrients. Severe narrowing of these coronaries (stenosis) might lead to chest pain or a heart attack. Myocardial revascularisation by either percutaneous coronary intervention or
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coronary artery bypass graft (CABG) improves symptoms, quality of life and survival in these patients. A stenosis with a diameter reduction < 50 per cent is considered a mild stenosis, 50 – 70 per cent as moderate, and > 70 per cent as severe. Unfortunately, the degree of coronary stenosis can easily
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be overestimated and impacts short and long-term outcomes of CABG. A heart lung machine takes over the heart’s pumping function and gas transfer of the lungs during heart surgery. Major drawbacks, however, are a systemic inflammatory response, acute kidney injury or brain infarctions. For
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CABG, the heart lung machine can be abandoned by performing off-pump coronary artery bypass grafting where the heart keeps beating during surgery. Intraoperative choices and challenges lead to postoperative complications
Patients’ own arteries from the chest or lower arm can be used to create these coronary bypasses. These arterial grafts have excellent long-term functionality, and low redo revascularisation rates. Arterial grafts require proper handling to avoid early technical failure. Competitive flow from native coronaries that are not narrowed enough impacts long term success of the coronary bypass. Detection of competitive flow for arterial grafts as early as possible after making the anastomosis might predict the longterm patency.
Intraoperative assessment of graft flow can be measured with transit time flow measurements (TTFM). European guidelines on myocardial revascularisation suggest routine use of intraoperative bypass graft flow assessment. Unfortunately, this quality control technique is not always used, nor handled upon adequately during surgery. The first signs of a failed graft are heart rhythm changes, postoperative new onset of chest pain and a potential myocardial infarction might occur. Often, the patient already left the operating theatre, and bypass graft revision is not possible, or should be considered for another surgical procedure. Cut-off values for TTFM to indicate graft failure are still debated, and are not uniform between clinical studies. In a recent study conducted at Thoraxcentrum Twente of Medisch
Spectrum Twente (Netherlands), preoperative angiography findings were combined with intraoperative TTFM in 50 CABG patients without the use of a heart lung machine (off-pump CABG). All patients had significant coronary artery disease as established by heart team discussion between a cardiologist and heart surgeon. Temporary closing of a severely narrowed coronary artery
During off-pump CABG, a bypass graft was made with the left internal thoracic artery (LIMA) on the largest coronary artery on the front side of the heart (left anterior descending artery, LAD). This coronary artery was then temporarily closed and the bypass graft flow was measured with TTFM. Hereafter, a new measurement was performed with the coronary artery reopened. After the
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This increase might indicate an open, and functional anastomosis affected by competitive flow from the native coronary artery. Here, surgical graft revision will not likely improve baseline TTFM values such as mean graft flow or graft patency, resulting in a useless or even harmful procedure. Is snaring safe?
Snaring the LAD is a widespread method to obtain a bloodless operative field, and is well tolerated by patients. Indeed, this technique is comparable to intracoronary shunting regarding postoperative heart enzyme rise. Atherosclerotic plaques or calcified coronary arteries make shunting technically more tough. Prolonged snaring might induce blood vessel injury, and arrhythmias, but are reversible up to 20-30 minutes of snaring. Patient-specific decision making before and during surgery
Figure 1: Mean LIMA graft flow (mL/min) increased with LAD snared compared to open LAD stratified to degree of stenosis. A third of all patients shifted from a low mean graft flow ≤ 20 mL/min with LAD open, to higher flows with LAD snared. Whiskers show the 25th and 75th percentile ± 1.5 times interquartile range in the Tukey box‐and‐Whiskers plot. LAD, left anterior descending coronary artery; LIMA, left internal mammary artery.
initial bypass graft, arterial grafts were placed to other parts of the heart. As expected, higher values of bypass graft flow were observed with the coronary artery snared, effectively preventing any competitive flow. More interestingly, the mean graft flow increased from 20 mL/min with open LAD to 30 mL/min with snared LAD and differed between severity of coronary stenosis groups (Figure 1). In more than half of the patients (52 per cent) the mean graft flow was lower than clinical relevant TTFM cut-off values with the LAD open. Graft flow increased in 16 patients after snaring the LAD, and shifted to acceptable TTFM values.
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Adequate intraoperative quality control improves patients postoperative quality of life, reduces life-events such as myocardial infarctions or unnecessary graft revisions, and therefore reduces hospital costs of prolonged treatments.
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Patient-specific decision making is performed daily in heart team discussion between cardiac surgeons and cardiologists according to international guidelines. Here patient characteristics determine decision making for a surgical, percutaneous or conservative treatment. Combining patient characteristics with procedural characteristics could further tailor treatment and thus improve outcomes for patients. Professional information for decision making is scattered. Direct comparison between competing treatments or diagnosis modalities is often lacking. For assessing coronary artery stenosis, visual eyeballing by a cardiologist is most common, although high intra-and inter-observer variability exists for many years with low concordance around clinical relevant cut-off points. Some centres use quantitative coronary analysis (QCA) with 2D or 3D reconstruction using cardiac angiography to analyse degree of stenosis for research purposes, but are rarely used for heart team discussions. To predict graft patency, it is no match
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Figure 2: The degree of left anterior descending (LAD) coronary artery stenosis is quantified with quantitative coronary analysis. A left internal thoracic/mammary artery (LIMA) bypass graft was made on the LAD with beating heart coronary artery bypass graft surgery. Intraoperative graft flow measurements were performed with the LAD open, and snared. Regardless of preoperative coronary stenosis, the LIMA graft flow increased with LAD snared, but was more substantial in mild to moderate stenoses.
AUTHOR BIO
compared to functional assessment using the more invasive fractional flow reserve (FFR). Here, clinical cut-off values are also debated and might even differ between percutaneous coronary intervention or CABG. Future studies
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should investigate the cut-off values of FFR or QCA for PCI and CABG to optimise outcome for patients. Implications for daily practice
Heart time discussions should carefully,
Frank R Halfwerk is Assistant Professor and leads the Cardiac Surgery Innovations Lab at the University of Twente and is Technical Physician in cardiothoracic surgery at Thoraxcentrum Twente, Medisch Spectrum in Enschede, the Netherlands. His focus is on personalized treatments for patients with predictable surgical outcomes. Underlying study: Halfwerk FR et al. Intraoperative transit time flow measurements during off-pump coronary artery bypass surgery: The impact of coronary stenosis on competitive flow. Journal of Cardiac Surgery, 2021. https://doi.org/10.1111/jocs.16103.
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and objectively evaluate the functional degree of coronary stenosis to determine revascularisation strategies. Because preoperative visual estimation proves to be difficult, intraoperative evaluation of a stenosis is pivotal. Routine snaring of the LAD during off-pump CABG demonstrated an increase in mean graft flow among all coronary stenosis groups. A third of clinical cut-off TTFM values for graft failure shifted to acceptable values. Therefore, regular use of TTFM and careful analysis of competitive flow according to the method described in the underlying study can be useful to identify competitive flow in case of intraoperative borderline TTFM parameters. Adequate intraoperative quality control improves patients postoperative quality of life, reduces lifeevents such as myocardial infarctions or unnecessary graft revisions, and therefore reduces hospital costs of prolonged treatments. Clinical studies should establish definitive evidence regarding routine snaring of the LAD during off-pump CABG. These studies should focus on the prevention of unnecessary intraoperative graft revisions and postoperative heart attacks. References are available at www.asianhhm.com
MEDICAL SCIENCES
Addressing the Osteoporosis Care Gap in The Asia-Pacific In the Asia-Pacific there are significant inconsistencies in clinical practice guidelines for the management and prevention of osteoporosis and fragility fractures. These guidelines vary in scope and recommendations. To address this, in early 2021, APCO launched The APCO Framework – the first pan-Asia-Pacific clinical practice standards for the screening, diagnosis, and management of osteoporosis. M Chandran, Senior Consultant and Director, Osteoporosis and Bone Metabolism Unit, Singapore General Hospital M Chadha, Consultant Endocrinologist, P.D. Hinduja National Hospital and Medical Research Centre Q Cheng, Chief Physician and Doctoral Supervisor, Department of Osteoporosis and Bone Disease, Huadong Hospital
A significant challenge to overcome
The survival of those who sustain an osteoporotic fragility fracture is significantly compromised for up to six years, with patients facing twice the risk of death within the first year. Furthermore, a prior fracture at any site doubles a person’s risk of refracture. In the Asia-Pacific alone, an overwhelming 319 million people aged 50 years and over are projected to be at risk of osteoporotic fracture over the next three decades. More than 50 per cent of the world’s hip fractures are expected to occur in the region by the year 2050. The Asia-Pacific is home to 4.5 billion people, a rapidly ageing population, and vastly different healthcare systems. Given the anticipated, exponential growth in fragility fractures due to
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the region’s ageing population, mass urbanisation and increasingly sedentary lifestyles, recognition of the monumental human and socio-economic burden of osteoporosis, and the severe impact of fractures on a patient’s independence and quality of life, is critical. Osteoporosis must become an urgent priority on regional and global health agendas. Despite alarming osteoporosis and fragility fracture statistics worldwide and the extensive availability of safe and effective osteoporosis therapies, more than 80 per cent of fragility fracture patients are neither assessed, nor treated, thereby placing a substantial, but importantly, preventable burden on already strained healthcare systems. Osteoporosis is vastly underdiagnosed and under-treated. Disturbingly, millions of people worldwide at high risk of fracture remain unaware of this underlying, silent disease. Sadly, people often only discover they have osteoporosis after sustaining a first fracture. A fragility fracture, which occurs every three seconds worldwide, compromises quality of life and loss of independence. Worryingly, one-in-four patients who sustain a hip fracture die within a year, and less than half of those who survive, regain their previous level of function.
Osteoporosis can compromise a person’s quality of life through loss of independence and productivity, chronic pain, disability, emotional distress, reduced social interaction, and selflimitation caused by a fear of falling. Less than a third of hip fracture patients regain their pre-fracture level of mobility, while more than 80 per cent are restricted with their daily activities, such as driving or grocery shopping. Importantly, osteoporosis not only affects those living with the disease, but also their family, and the community at large. Among all osteoporotic fractures, hip fractures incur the greatest morbidity, mortality, and social and financial costs. An analysis of nine Asian countries and regions from the Asian Federation of Osteoporosis Societies (AFOS) revealed the number of hip fractures will more than double from 1.13 million in 2018, to 2.54 million in 2050.5 In 2018, the estimated cost of hip fractures obtained from nine Asian countries or regions was USD 7.5 billion. By 2050, projections suggest this will rise to approximately USD 13 billion.5 Overwhelmingly, the costs for treating a single hip fracture represents approximately 19 per cent of APAC’s regional per-head annual gross domestic product (GDP).
China and India contribute to the highest absolute number increase in hip fractures in the region. In fact, the two countries constitute approximately 37 per cent of the world’s population, and therefore, largely account for the anticipated hip fracture epidemic expected in the Asia-Pacific. Between 2025 and 2050, the population of India is projected to grow from 1.4 billion, to 1.88 billion, with those aged over 50 who are more susceptible to osteoporosis, expected to constitute 33 per cent of the population by the middle of the century. In India alone, the direct medical costs of hip fractures was an estimated USD 256 million in 2018, the costs for which are projected to increase to USD 612 million by 2050. In 2013, 50 million people in India were either osteoporotic, or considered to be living with low bone mass. The 2018 AFOS study predicted the number of hip fractures in India would more than double, from approximately 332,000 in 2018, to 792, 000 in 2050. Importantly, compared to Western populations, hip fractures occur a decade earlier in the Indian population. Similarly in China, the projected direct cost of hip fractures is expected to rise from USD 1,690 million in 2018, to USD 4063 million by 2050, while the number of hip fractures is projected to increase from almost 485,000, to more than 1.17 million between the same period. Projections suggest the total number of osteoporosis-related fractures in China will increase from 2.33 million in 2010, to 5.99 million in 2050. In recent years, several paramount themes that profoundly impact strategies employed for osteoporosis management have emerged. These emerging concepts in osteoporosis care should be astutely considered and incorporated into new and revised guidelines, following careful deliberation of their applicability to local health care practices.
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One of the emerging osteoporosis themes is the importance of AsiaPacific-wide systemic integration of case identification and management at all levels of health systems, including acute care services, when patients present with fractures through Post Fracture Care Coordination Programs, such as Fracture Liaison Services (FLS). These coordinated systems of care aim to identify, treat and monitor patients presenting with a fragility fracture. Intervention can halve the incidence of fragility fractures, deliver significant financial savings, and most importantly, save lives. Furthermore, FLSs compared with usual care, have been shown to increase bone mineral density (BMD) testing, improve initiation of osteoporosis care, and adherence to treatment, and reduce mortality rates.
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Fracture Liaison Services (FLS) compared with usual care, have been shown to increase bone mineral density (BMD) testing, improve initiation of osteoporosis care, and adherence to treatment, and reduce mortality rates
In the Asia-Pacific, there are currently 111 FLS centres, 19 of which have been awarded a gold star rating, based on evaluation of achievement against the International Osteoporosis Foundation’s (IOF) Best Practice Framework standards for four key fragility fracture patient groups – hip fractures, other in-patient fractures, outpatient fractures and
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vertebral fractures – and organisational characteristics. Another important emerging theme is the urgent need to employ health economics to inform intervention thresholds and indications for specific classes of osteoporosis therapies. For example, a significant body of evidence obtained through analysis of nine active interventions across 14 countries, has demonstrated antiosteoporosis therapies are cost-effective in women at high risk of fracture. When compared with no treatment, active osteoporotic drugs were generally cost effective in postmenopausal women aged over 60-65 years with low bone mass, especially those who had sustained prior vertebral fractures. While vast heterogeneity exists in epidemiologic and economic characteristics of
MEDICAL SCIENCES
A much-needed solution
The Asia-Pacific Consortium on Osteoporosis (APCO)1 was launched in May 2019. The overarching goal of APCO is to stem the tsunami of osteoporotic fractures in the AsiaPacific, and to promote quality care in osteoporosis. There are significant inconsistencies in clinical practice guidelines in the Asia-Pacific for the management and prevention of osteoporosis and fragility fractures. These guidelines vary extensively in scope and recommendations. There is also a lack of information available on adherence to national guidelines in daily clinical practice. Minimum clinical standards for the assessment and management of osteoporosis are therefore urgently required in the Asia-Pacific, to inform clinical practice guidelines, and improve osteoporosis care. After employing a comprehensive 5IQ analysis and the well-established Delphi Consensus process to analyse the 18 clinical practice guidelines existing in the Asia-Pacific region, in early 2021, APCO launched The APCO Framework2 – the first pan-Asia-Pacific clinical practice standards for the screening, diagnosis, and management of osteoporosis, targeting a broad range of high-risk groups. Implementation a set of minimum 1 https://apcobonehealth.org/ 2 https://apcobonehealth.org/apco-framework/
clinical standards care for the screening, diagnosis, and management of osteoporosis is expected to significantly reduce the burden of osteoporosis not only in the Asia-Pacific region, but also worldwide. To further support the HCP community in the Asia-Pacific in the implementation of minimum clinical standards, APCO recently developed the APCO HCP Peer to Peer Educational Modules 3 – a 17-module educational series designed to arm osteoporosis champions in the AsiaPacific, with information, supporting data, topical literature summaries, and best practice examples that support and emphasise each of The APCO Framework’s 16 minimum clinical standards and address emerging themes in osteoporosis care. 3 https://apcobonehealth.org/apco-education-modules/
AUTHOR BIO
countries undoubtedly influencing recommendations included in national and regional clinical practice guidelines, health economic analysis is playing an increasingly important role in informing the relative value of osteoporosis therapies, and helping determine how to best allocate finite health care resources and determine the cost effectiveness of interventions.
The development and launch of peer to peer educational resources for the HCP community designed to encourage wide scale implementation of minimum clinical standards, demonstrates APCO’s ongoing commitment to achieving greater consistency in national and regional clinical practice guidelines for the screening, diagnosis, and management of osteoporosis in the Asia-Pacific, wide scale implementation of FLS and calling for due consideration of health economics by guideline developers and policy makers in the Asia-Pacific.
For more information visit www.apcobonehealth.org. References are available at www.asianhhm.com
Manju Chandran, who is the International Osteoporosis Foundation 2021 IOF Olof Johnell Science Awardee, is an internationally renowned Endocrinologist. She is a Senior Consultant and Director of the Osteoporosis and Bone Metabolism Unit at Singapore General Hospital, and the inaugural Chairperson of the Asia-Pacific Consortium on Osteoporosis (APCO). Manoj Chadha is Consultant Endocrinologist at P.D. Hinduja National Hospital and Medical Research Centre, Mumbai, India. He is Immediate Past President of the Indian Society of Bone Mineral Research (ISBMR), Past President of the Endocrine Society of India, Regional Representative at the International Osteoporosis Foundation (IOF), and APCO member. Qun Cheng is Chief Physician and Doctoral Supervisor, Department of Osteoporosis and Bone Disease, at Huadong Hospital affiliated with Fudan University, Shanghai, China. She is Director of the Shanghai Medical Association of Osteoporosis, Deputy Leader of the Chinese Medical Association - Geriatric Society of Bone Metabolism, and APCO member.
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Understanding and Predicting Progression to Hepatorenal Syndrome in Cirrhotic Patients Hepatorenal syndrome is a severe complication in cirrhotic patients associated with high mortality. Diagnosis of difficult and often delayed due to diagnostic criteria. Understanding the pathophysiology, predictors, and precipitators of hepatorenal syndrome can aid clinicians in making the diagnosis and early initiation of therapy.. Roula Sasso, Ahmad Abou Yassine Department of Gastroenterology, Staten Island University Hospital
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atients with liver cirrhosis often present with acute kidney injury (AKI) which is a cause of high morbidity and mortality. Cirrhotic patients are at an increased risk of intravascular volume depletion secondary to certain medications (such
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as diuretics or lactulose, which are commonly used in this population), gastrointestinal bleeding and decreased effective arterial blood volume secondary to splanchnic vasodilation, all of which result in decreased renal perfusion and renal injury.
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Hepatorenal syndrome (HRS) is a form of AKI in decompensated cirrhotic patients and is mainly caused by a hyperdynamic circulatory system resulting in renal vasoconstriction and systemic inflammation. HRS is the only form of AKI in cirrhotic patients
MEDICAL SCIENCES
that results from liver dysfunction, yet it is often difficult to differentiate from other causes of AKI in cirrhotic patients. As such, this often leads to a delay in diagnosis, management, and worse patient outcomes. Based on the current International Club of Ascites (ICA), the previously known HRS- type 1 has been renamed HRS-AKI and diagnosis requires AKI based on the current KDIGO guidelines in the presence of cirrhosis and ascites, 48 hours or appropriate resuscitation, diuretic withdrawal, and exclusion of other causes of AKI. Establishing predictors for development of HRS in cirrhotic patients with AKI could aid clinicians in establishing a diagnosis of HRS sooner rather than later and allow them to initiate goal-directed management. Some studies have attempted to describe predictors of HRS in this population of patients, however many of these studies have been limited by small sample sizes and poor generalizability. Additionally, the definition and diagnostic criteria
of HRS has evolved over the years, necessitating the reevaluation of older studies in the field. The evidence
A recent retrospective case-control study conducted by Sasso et al. evaluated 529 cirrhotic patients admitted with AKI across multiple Northwell-health hospital sites in New York City. The primary outcome was development of HRS-AKI during hospital stay. Patient variables including demographics, past medical history, laboratory data, medication history and hospital complications were evaluated to determine predictors of the development of HRS-AKI in this cohort of patients. This study compared outcomes of patients who developed HRS-AKI to those who did not and found that those who did develop HRS-AKI were more likely to have a history of alcoholic cirrhosis, evidence of portal hypertension and large volume ascites, a diagnosis of spontaneous bacterial peritonitis, lower sodium levels and platelet count as
well as higher bilirubin, creatinine and INR levels. Mortality was also higher in patients who developed HRS-AKI compared to those who did not. This study found that a history of ascites, baseline serum creatinine >2.5 mg/dL, albumin < 2g/dL, bilirubin >2 mg/dL and spontaneous bacterial peritonitis to be independent predictors or progression to HRS-AKI (Figure 1). Treatment of HRS-AKI
Treatment of HRS-AKI is challenging and restoration of baseline kidney and liver function is rare. Treatment is usually directed towards avoiding irreversible renal injury by increasing effective intravascular volume and renal perfusion. Albumin infusions for volume expansion is often used to prevent worsening of kidney dysfunction at the earlier stages of AKI in attempt to prevent progression to HRS-AKI. Albumin might also provide some antiinflammatory benefits. Pentoxifylline has also been evaluated as a possible
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agent in the prevention of progression to HRS-AKI, however further studies are needed to determine efficiency. Vasoconstrictor therapy increases renal perfusion and is the main approach to treatment in HRS-AKI. Terlipressin, a synthetic vasopressin analogue is available in Europe, Australia, New Zealand and parts of Asia and is the firstline treatment option for patients with HRS-AKI. Clinical trials have shown improved kidney function and patient survival with the use of Terlipressin and even better outcomes with the combined use of Terlipressin and albumin. Other vasopressor therapies such as Norepinephrine have been used for treatment of HRS-AKI with some studies showing equal efficacy In countries where Terlipressin is not available, the combination of midodrine and octreotide is often used, however, convincing data on the efficiency of this combination is lacking. Other treatment options include hemodialysis and transjugular intrahepatic portosystemic shunt (TIPS). Hemodialysis is often used as a bridge
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to liver transplant or for patients with no evidence of improvement in renal function who are not eligible for liver transplantation. TIPS results is shunting of blood from the portal vein to the hepatic vein, essential decreasing portal pressures which can lead to improvement in renal function. While some studies suggest that TIPS might be an effective method of improving renal function, is it often not feasible in patients with high MELD scores (as is the case for many patients with HRS-AKI) given the high risk of hepatic encephalopathy. Liver transplant is the only definitive and most effective treatment option for HRS-AKI, resulting in restoration of kidney function in up to 80 per cent of patients. However, at the time of diagnosis of HRS-AKI, patients are often poor candidates for transplantation based on MELD scores. Discussion
Prognosis of patients with HRS-AKI is poor, with several studies demonstrating higher mortality in patients with HRS-AKI compared to other forms
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of AKI. In the study by Sasso et al., mortality was 40 per cent among those with HRS-AKI. Understanding the pathophysiology and precipitating factors for development of HRS-AKI is critical. In the setting of high portal pressures (often seen in decompensated cirrhotic patients), the renal vasculature eventually becomes vasoconstricted in response to splanchnic vasodilation and activation of the renin-angiotensin-aldosterone system. This results in a reduction of glomerular filtration and retention of sodium and water. Additionally, systemic inflammation as a result of bacterial infections has been suggested to play a role in the progression of HRS-AKI (figure 2). Furthermore, several clinical conditions have been linked to the development of HRS-AKI. Worsening ascites can cause elevated intra-abdominal pressures leading to compression of the renal vasculature and worsening kidney dysfunction. Some studies have demonstrated that large volume paracentesis may be associated
with HRS-AKI secondary to intravascular fluid shifts and potentiation of the renin-angiotensin-aldosterone system. Spontaneous bacterial peritonitis results in a hyperinflammatory state that has been suggested to precipitate HRS-AKI and cardiogenic shock results in decreased effective intravascular volume, contributing to renal dysfunction. Additionally, certain medications such as diuretics, non-steroidal anti-inflammatory drugs and lactulose may contribute to HRS-AKI (figure 2). By understanding the pathophysiology of HRS-AKI and integrating the clinical conditions associated with HRS-AKI and the established evidence-based predictors of progression to HRS-AKI, clinicians can stratify cirrhotic patients into high risk or low risk for HRS-AKI allowing for earlier diagnosis and management of this high mortality condition.
AUTHOR BIO
MEDICAL SCIENCES
Sasso is a medical resident at Northwell health. After completing medical school, she pursued two years of post-doctoral fellowship at the department of Hepatology at the Medical University of South Carolina. Her research interest focus on complications of portal hypertension. Sasso is going to start her gastroenterology and hepatology fellowship at the University of New Mexico
Abou Yassine is a medical resident at Northwell health. His research interest focus on critical illness in cirrhotic patients including severe infections and sepsis. Abou Yassine will complete chief-resident training at Northwell health before pursing a fellowship in critical care.
References are available at www.asianhhm.com
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Management of Cerebrovascular Steno-Occlusive Disease Contemporary multidisciplinary approach Patients with steno-occlusive cerebrovascular disease are at risk of ischemic symptoms from haemodynamic insufficiency in the presence of reversible hypoperfusion, exhausted autoregulation and impaired vasodilatory reserve. Multidisciplinary management approach includes blood pressure management, antithrombotic therapy, treatment of underlying brain-body interactions targeted at optimising cerebral blood flow and oxygen delivery, and revascularisation procedures. Benjamin Wai Yue Lo, Neurosurgeon & ICU Specialist
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atients with symptomatic stenoocclusive disease have a risk of recurrent stroke of at least 10-15 per cent within 5 years. Progressive atherosclerosis of internal carotid artery (ICA) or middle cerebral artery (MCA) is the most common cause of impaired distal cerebral perfusion with cerebral misery hypoperfusion (Figure 1, Table 1).
Cerebral Hypoperfusion & Collateral Circulation
In the setting of cerebral hypoperfusion, recurrent ischaemic events occur depending on the following factors: (1) amount of collateral cerebral circulation; (2) extent of haemodynamic impairment; (3) age; (4) cardiac status; (5) presence of metabolic syndrome of hypertension, hyperlipidemia and insulin resistance; (6) factors affecting coagulation, blood
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oxygen carrying capacity and delivery (such as anaemia and other haematology disorders, systemic infections and sepsis, renal and hepatic disorders). In addition to the traditional cerebral ischaemic symptomatology pertaining to the affected vascular territory (Table 2), orthostatic symptoms, syncope, transient global amnesia, episodic limb shaking and watershed infarction are possible. In states of misery perfusion, compensatory cerebral vasodilation is not possible as the cerebral autoregulatory capacity is exhausted and, as a result, cerebral blood flow decreases proportionally with cerebral perfusion pressure (Figure 1). Possible cerebral collateral circulation routes include: (1) contralateral internal carotid artery (ICA) through anterior communicating artery; (2) posterior circulation via posterior communicating artery; (3)
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MEDICAL SCIENCES
For patients who have been medically optimised but are still at risk of ischaemic symptoms of haemodynamic insufficiency due to ICA/MCA stenosis/ occlusion in the setting of hypotension or orthostasis, one can identify candidates with reversible hypoperfusion, exhausted autoregulation and impaired vasodilatory reserve. Consideration of extracranialintracranial bypass procedure can be reliably made to identify patients who have reasonable chances of augmentable flow-induced long-term cerebral blood flow re-organisation (collateral shift) while preventing future hypoperfusion events. Identification of these candidates is made after blood pressure management, antithrombotic therapy and treatment of underlying brainbody interactions targeted at optimising cerebral blood flow and oxygen delivery. Investigational adjuncts
leptomeningeal or pial collaterals; (4) collateral circulation from external carotid artery (ECA) with retrograde flow and connections with ophthalmic artery, extracranial connections between ECA or vertebral artery (VA) branches and distal ICA; (5) collaterals through dural meningeal arteries to cortical arteries; (6) anterior cerebral artery (ACA)-posterior cerebral artery (PCA) connections via the limbic loop; and (7) anterior spinal artery collaterals with the vertebrobasilar circulation. Medical management principles
Medical management strategies are essential to treatment of cerebral ischaemic events and prevention of recurrent strokes in face of cerebral hypoperfusion. These include: (1) cautious individualised blood pressure management (usually systolic blood pressure targets of 130-160 mmHg for those with severe bilateral carotid stenoses); (2) maintenance of fluid status to maintain appropriate plasma oncotic pressures for adequate cerebral perfusion; (3) anti-platelet and anticoagulant
therapies (single anti-platelet agent and anticoagulant for those with embolic strokes or in the setting of cardiac arrthymias; dual anti-platelet therapy, with laboratory evidence of responsiveness to these agents, for those with atherosclerotic disease or perforator events), (4) statin, and (5) glycaemic control. Treatment of underlying brainbody interactions are also essential, including attention to haemodynamic stability, cardiac status, optimising cerebral oxygen delivery with avoidance of anaemia, goal-directed therapy for sepsis, optimisation of renal perfusion and avoidance of coagulopathy and encephalopathy due to underlying multi-systemic involvement, particularly renal or hepatic impairment. Identification of surgical candidate
For patients with symptomatic severe (> 70 per cent) carotid stenosis, carotid endarterectomy or angioplasty/ stenting is considered. Thrombectomy is considered for patients with embolic strokes to large size cerebral vessels.
In addition to clinical findings on presentation and with monitoring (Table 2), other adjunctive investigations are useful in identifying such surgical candidates. CT perfusion scans demonstrate ischaemic penumbra of increased time-to-peak (TTP, time between first arrival of CT contrast intracranially and its peak concentration), increased mean transit time (MTT, average time for blood to travel through a volume of brain), with relatively preserved cerebral blood volume (CBV) due to vasodilation and recruitment of collateral flow, and decreased cerebral blood flow (CBF). As reference, an infarcted core shows increased TTP, increased MTT, decreased CBV and decreased CBF. SPECT (single photon emission computerised tomography) scan with acetazolamide (DiamoxTM) is used to identify patients with haemodynamic insufficiency who exhibit reversible hypoperfusion and decreased cerebrovascular reactivity when challenged with acetazolamide (Figure 3a-c). In those who are in the misery perfusion stage of haemodynamic insufficiency, they are already maximally
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vasodilated and dysautoregulated. In this regard, they cannot further vasodilate in response to increased carbon dioxide tension from diuretic acetazolamide, a carbonic anhydrase inhibitor. Quantitative MR angiography (q-MRA)’s non-invasive optimal vessel analysis (NOVA) is also essential to quantify and measure blood flow through large vessels of the Circle of Willis (Figure 3b). Together with formal cerebral angiography, it can be used to estimate pial and collateral flow. It gives reasonable estimates of augmentable flow to ensure appropriate blood velocity ranges after bypass, and also in anticipation of longer term collateral shift, cerebral blood flow re-organisation.
procedure can be reliably made to identify patients who have reasonable chances of augmentable flow-induced long-term cerebral flow re-organisation while preventing future hypoperfusion events. Identification of these candidates
are made after medical optimisation, including blood pressure management, antithrombotic therapy and treatment of underlying brain-body interactions targeted at optimising cerebral blood flow and oxygen delivery.
Figure 1. Stages of Cerebral Hypoperfusion.
Surgical procedure
Direct superficial temporal artery (STA) [donor] and middle cerebral artery (MCA) M4 cortical branch [recipient] bypass is generally preferred. Meticulous attention to blood pressure control, maintenance of intravascular volume and depth of anaesthesia are essential to avoid cerebral hypoperfusion during these cases with underlying steno-occlusive disease. Intraoperative end-to-side anastomoses are performed using 10-0 nylon sutures with indocyanine green (ICG) and intra-operative angiographic confirmation of anastomotic patency. Individualised blood pressure goals with gradual liberalisation of these parameters are done post-operatively with continuation of antithrombotic agents to maintain anastomotic patency and to avoid reperfusion-related injury. Conclusion
For patients who have been medically optimised but still at risk of ischemic symptoms of haemodynamic insufficiency due to steno-occlusive cerebrovascular disease, one can identify candidates with reversible hypoperfusion, exhausted autoregulation and impaired vasodilatory reserve. Consideration of extracranial-intracranial bypass
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Table 1. Cerebrovascular mean flow velocities.
Artery
Normal Mean Flow Velocity [MFV] (cm/s)
ICA Siphon
< 70
MCA M1-M2
< 80
ACA A1
< 80
BA
< 50
VA
< 60
PCA
< 50
ICA = internal carotid artery, MCA = middle cerebral artery, ACA = anterior cerebral artery, BA = basilar artery, VA = vertebral artery, PCA = posterior cerebral artery. Arterial Stenosis (50 per cent)
Mean Flow Velocity [MFV] (cm/s)
ICA Siphon, ACA (A1)
< 90
MCA M1-M2
< 100
BA-VA-PCA
< 70
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Table 2. Stroke Syndromes Carotid asymptomatic bruit TIAs (transient ischemic attacks): transient monocular blindness, weakness, numbness, speech/language disturbance sudden deficit in MCA and/or ACA territory progressive or stepwise hemispheric deficits (watershed infarction)
MIDDLE CEREBRAL ARTERY (MCA) STROKE SYNDROMES MCA - entire territory contralateral gaze palsy, hemiplegia, hemisensory loss, spatial neglect, hemianopsia (left) global aphasia
MCA – deep contralateral hemiplegia, hemisensory loss (left) transcortical motor (non-fluent aphasia, intact repetition) and/or sensory (receptive) aphasia lacunar syndromes - pure motor hemiparesis, sensorimotor stroke
MCA – parasylvian contralateral weakness and sensory loss of face and hand (left) conduction aphasia, apraxia, Gerstmann's syndrome (dys-/ a-graphia, dys-/a-calculia, finger agnosia, left-right disorientation) (right) constructional dyspraxia
MCA - superior division contralateral hemiplegia, hemisensory loss, gaze palsy, spatial neglect (left) Broca's aphasia
MCA - inferior division contralateral hemianopsia or upper quadrantanopsia (left) Wernicke's aphasia (right) constructional dyspraxia
ANTERIOR CEREBRAL ARTERY (ACA) STROKE SYNDROMES ACA - entire territory contralateral hemiplegia abulia incontinence transcortical motor aphasia or motor and sensory aphasia limb dyspraxia
ACA – distal contralateral weakness of leg, hip, foot, shoulder sensory loss in foot transcortical motor aphasia or motor and sensory aphasia limb dyspraxia
ACA – deep lacunar syndromes - pure motor hemiparesis, sensorimotor stroke
ACA - anterior choroidal hemiparesis, hemisensory abnormalities, hemianopia
MIDBRAIN STROKE SYNDROMES Midbrain basis (Weber's syndrome) PCA (posterior cerebral artery) branches, top of basilar CN (cranial nerve) 3 fascicles - ipsilateral 3rd palsy (ptosis, no eye adduction, no up/downgaze +/- dilated pupil)
Midbrain tegmentum (Claude's syndrome) PCA (posterior cerebral artery) branches, top of basilar CN 3 fascicles - ipsilateral 3rd palsy red nucleus, superior cerebellar peduncle fibers - contralateral ataxia
Midbrain basis and tegmentum (Benedikt's syndrome) PCA (posterior cerebral artery) branches, top of basilar CN 3 fascicles - ipsilateral 3rd palsy cerebral peduncle - contralateral hemiparesis red nucleus, substantia nigra, superior cerebellar peduncle fibers - contralateral ataxia, tremor, involuntary movements
PONS STROKE SYNDROMES Medial pontine basis (dysarthria hemiparesis - pure motor hemiparesis) basilar artery (paramedian branches), ventral territory corticospinal/bulbar tracts - contralateral face/arm/leg weakness, dysarthria
Medial pontine basis (ataxic hemiparesis) basilar artery (paramedian branches), ventral territory corticospinal/bulbar tracts - contralateral face/arm/leg weakness, dysarthria pontine nuclei/pontocerebellar fibers - contralateral ataxia (occasional ipsilateral ataxia)
Medial pontine basis and tegmentum (Foville's syndrome) basilar artery (paramedian branches), ventral and dorsal territories corticospinal and corticobulbar tracts - contralateral face/arm/ leg weakness, dysarthria facial colliculus - ipsilateral face weakness, ipsilateral horizontal gaze palsy
Medial pontine basis and tegmentum (Pontine wrongway eyes syndrome) basilar artery (paramedian branches), ventral and dorsal territories corticospinal and corticobular tracts - contralateral face/arm/leg weakness, dysarthria abducens nucleus/paramedian pontine reticular formation ipsilateral horizontal gaze palsy
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Medial pontine basis and tegmentum (Millard-Gubler syndrome) basilar artery (paramedian branches), ventral and dorsal territories corticospinal and corticobulbar tracts - contralateral face/arm/leg weakness, dysarthria CN7 fascicles - ipsilateral face weakness
Medial pontine basis and tegmentum (Other regions) basilar artery (paramedian branches), ventral and dorsal territories medial lemniscus - contralateral decreased position and vibration sense medial longitudinal fasciculus - internuclear ophthalmoplegia (affected eye impaired adduction)
Lateral caudal pons (anterior inferior cerebellar artery AICA) middle cerebellar peduncle - ipsilateral ataxia vestibular nuclei - vertigo, nystagmus trigeminal nucleus and tract - ipsilateral facial decreased pain and temperature sense spinothalamic tract - contralateral body decreased pain and temperature sense descending sympathetic fibers - ipsilateral Horner's syndrome
Lateral caudal pons (Other regions) labyrinthine artery - inner ear - ipsilateral hearing loss
Dorsolateral rostral pons (superior cerebellar artery SCA) superior cerebellar peduncle and cerebellum - ipsilateral ataxia other lateral tegmental structures (variable) - variable features of AICA syndrome (lateral tegmental involvement)
MEDULLA STROKE SYNDROMES paramedian vertebral artery (VA), anterior spinal artery (ASA) pyramidal tract - contralateral arm/leg weakness medial lemniscus - contralateral decreased position/vibration CN12 nucleus/fascicles - ipsilateral tongue weakness
asymptomatic sometimes vertebrobasilar (VB) TIAs (dizziness, slurred speech, faintness, imbalance)
Extracranial Vertebral Artery (VA) asymptomatic sometimes VB TIAs
Intracranial Vertebral Artery (VA) lateral medullary syndrome (Wallenberg's syndrome) medial medullary syndrome (tongue paralysis, contralateral hemiplegia) hemi-medullary infarction PICA infarction (dorsolateral medulla and lower half of cerebellum)
BASILAR ARTERY STROKE SYNDROMES Basilar occlusion often preceding TIAs at onset headaches, dizziness, paresthesia, confusion followed by CN palsies neuro-ophthalmologic abnormalities (such as vertical skew, oscillopsia, downbeat nystagmus), ataxia, quadriparesis/plegia, locked-in syndrome, coma
Lacunes pure motor hemiparesis, dysarthria-clumsy hand, pure sensory stroke, sensorimotor stroke Paramedian and short circumferential arteries crossed syndromes with ipsilateral CN palsy contralateral motor, sensory or sensorimotor deficits neuro-ophthalmologic abnormalities, dysarthria, ataxia limb ataxia, dysarthria, CN4 palsy (diplopia worse in downgaze), Horner’s syndrome, contralateral thermoanalgesia
Anterior Inferior Cerebellar Artery (AICA) limb and trunk ataxia, CN7 & 8 palsies, Horner’s syndrome, contralateral hemiplegia and hemisensory loss
Posterior Inferior Cerebellar Artery (PICA)
Lateral Medulla (Wallenberg's syndrome) posterior inferior cerebellar artery (PICA), vertebral artery (VA) inferior cerebellar peduncle, vestibular nuclei - ipsilateral ataxia, vertigo, nystagmus, nausea trigeminal nucleus, tract - ipsilateral facial decreased pain and temperature sense spinothalamic tract - contralateral body decreased pain and temperature sense descending sympathetic fibers - ipsilateral Horner's syndrome nucleus ambiguus - hoarseness, dysphagia nucleus solitarius - ipsilateral decreased taste
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Subclavian Steal
Superior Cerebellar Artery (SCA)
Medial Medulla
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pseudovestibular syndrome, nystagmus, trunk and limb ataxia, lateral medullary syndrome
Top of Basilar Occlusion abnormal pupils, convergence, vertical eye movements, CN3 palsy, hemiplegia/quadriplegia, sensory loss, ataxia, hypersomnolence, inattention, abnormal behaviour, confusion, hallucinations, memory loss, visual defects, abnormal movements
Thalamic Infarcts abulia, memory loss, dysphasia, dyspraxia (anterolateral infarction)
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hypersomnolence, coma, abnormal vertical eye movements and convergence, disorientation, amnesia, dysphasia (anteromedial infarction) pure sensory stroke, sensorimotor stroke, Dejerine-Roussy syndrome (lateral infarction) visual field defects (dorsal and lateral geniculate body infarction)
Figure 3b. Quantitative MRA showing decreased left MCA flow.
POSTERIOR CEREBRAL ARTERY (PCA) STROKE SYNDROMES PCA - deep and superficial territory part of syndrome of top of basilar
PCA - deep territory thalamopeduncular infarcts
PCA – superficial cortical blindness visual field defects (homonymous hemianopia, altitudinal hemianopia, quadrantanopia) abnormal color vision, pallinopsia, micropsia visual agnosia, pure alexia, hemidyslexia, prosopagnosia, memory deficits, topographic disorientation, amnesic aphasia
Figure 3a. MR Angiogram showing left ICA functional occlusion. Figure 3c. SPECT showing slight reversible hypoperfusion after acetazolamide challenge (right).
AUTHOR BIO
Acknowledgement: Acknowledgement is made to Dr. David J. Langer for his expertise in this clinical area.
Benjamin W Y Lo is a neurosurgeon and ICU specialist. His clinical focus is cerebrovascular disorders. His research focus characterises brain-body interactions in neurocritical care patients with cerebrovascular disorders. Dr. Lo’s qualifications include FRCSC certification in neurosurgery (2009), FRCSC certification in critical care medicine (2011), MSc and PhD degrees in clinical epidemiology and biostatistics from McMaster University. His clinical experience includes working as neurosurgeon and ICU specialist at St. Michael’s Hospital, University of Toronto; Montreal Neurological Institute & Hospital, McGill University; and Northwell Health Lenox Hill Hospital, New York.
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CHRONIC DISEASE MANAGEMENT Challenges and opportunities In this article Dr Prasad shares his views on chronic disease management based on four key principles organ focus, standardised global care guidelines, multidisciplinary approach and tumour board and patient centric cancer care. Prasad Narayanan, Senior Consultant & Director – Medical Oncology Cytecare Cancer Hospitals
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hen a disease persists for a long time, it presents different challenges. Whether it is diabetes, asthma or hypertension, chronic disease management is the key. This essentially entails helping the patient live a ‘normal’ life, despite there being no cure for the ailment. As an oncologist, I see cancer patients today live longer than ever before. We have newer and smarter treatment modalities for cancer getting approved on a regular basis. According to National Cancer Institute, USA, 67 per cent of people diagnosed with cancer have survival rates of at least five years. That’s a remarkable increase of over 20 per cent in the last four decades. The Indian Council of Medical Research (ICMR) registry also reports a similar trend in cancer survival, despite almost 60 per cent of cancer cases in India being diagnosed at an advanced stage. In other words, even when there’s no cure per se available, medical science can help patients lead a good quality of life.
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Treating cancer
Cancer is counted among the top 10 chronic diseases globally. However, the term ‘cancer’ refers not just to one disease, but a collection of more than 100 diseases – from breast cancer and colon cancer to blood cancer and skin cancer – with wide-ranging characteristics that usually call for varied treatments. Cancer management depends on multiple factors, such as type of cancer, disease response, remission or relapse, tolerance to treatment, age and overall health of the patient, to name some. Studies show that lifestyle changes, early detection and timely treatment can help prevent and cure many cancers, including breast cancer, cervical cancer, oral cancer, prostate cancer and skin cancer. Also, treating an early stage cancer is nearly 80 per cent more cost-effective and the survival rates are five times higher than at later stages. Current cancer treatments include chemotherapy, immunotherapy, radiation therapy, and surgery. However, modalities are changing rapidly. For instance, most cancers needed chemotherapy or other IV drug treatments in the past. But today an increasing number of patients – almost 30 per cent in case of lung cancer patients – are treated with targeted therapy, mostly by way of oral medications! With targeted therapies, researchers are looking at targeting the cancer-causing genetic changes in tumours – no matter where the cancer develops in the body – to combat the disease. Similarly, precision medicine can help predict targetable mutations and figure out how the body would process certain drugs even before one takes them. Precision medicine holds immense promise in cancer care.
We can no longer look at cancer treatment as a one-sizefits-all; it has to be tailored to each individual, such that the therapies work with the body’s makeup to help fight cancer in the most effective manner. Immunotherapy, also called biotherapy, is another cancer treatment, powered by one’s own immune system. There are two common types of immunotherapy. First, monoclonal antibodies, which are designed to recognise and attack cancer cells, and have an overall good response with limited side effects. Second, checkpoint inhibitors that work by blocking checkpoint proteins from binding with their partner proteins. This prevents the “off” signal from being sent, allowing the T cells to kill cancer cells. Vaccines are also a type of immunotherapy that work to boost the body’s immune system to fight cancer. There are vaccines, such as the Human Papilloma Virus (HPV) vaccine that help prevent cancers caused by a virus, and vaccines that are used to treat certain cancers, such as
prostate cancer and cervical cancer, by activating the immune cells. Researchers are in the process of testing vaccines for several types of cancer. Organ site approach
Traditionally, we have approached cancer unlike most other diseases with potential for turning chronic; not associating it with the organ that it impacts. Of course, this is no longer true for the medical fraternity. Today, we have colleagues who have spent years understanding how the disease not only impacts a specific organ but certain different parts of an organ. For instance, head and neck cancers comprise over 17 sites, including oral cavity, nasal cavity, and ear, to name some. We need to look at cancer from an organ site approach, whereby there are dedicated teams for each type of cancer. However, the awareness among patients with regards to organ site focus and how it impacts the course of their treatment, chances of recurrence, and post-treatment life is still quite low. For many of them, especially semi-rural and rural patients, all types, and stages of cancer are associated with life-limiting illness. Hence, a major area of growth as we look to effective chronic disease management would also be to educate patients and people at large about how every cancer isn’t the same in terms of its symptoms, risk, survival, and life post treatment. Disseminating a lot more knowledge about organ site-focus can go a long way in reducing anxieties around the disease. Cytecare is one of the first private hospitals in India to offer organ sitefocus-based oncology care. Our practice is based on four prominent pillars — organ site focussed and specialist oncologists, standardised global guidelines and tumour board, patientcentric culture and clinical research. The multidisciplinary team of clinicians is strongly guided by national as well as
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global protocols, such as the National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO), National Health Service (NHS), Indian Council of Medical Research (ICMR) and Tata Memorial Hospital. Way forward
Going forth, we must look at building organ site-focus capabilities that understand the varied emotional impacts associated with the difference organ-related cancers. For instance, the mental make-up of a patient with breast cancer is likely to very different than that of a patient with lung cancer. Accordingly, not just counselling, but the very nature of treatments and therapies in the future should be directed towards effectively managing the same. Right from diagnosis to posttreatment prescriptions, we need to create an environment that isn’t overwhelming and alienating but one that instils hope, confidence, and positivity. Each one of us – surgeons, doctors, therapists, radiologists, nutritionists, nurses, counsellors – need to see it as our collective and core responsibility rather than an addition to our busy schedules. Be it offering them sufficient information support and procedure-related advantages and disadvantages in a language of their choice or mind and body wellness programs, we need to go from addressing the cancer at the site to managing the disease that engulfs the mind, lives, and communities. As Suresh Ramu, Co-founder and CEO, Cytecare Cancer Hospitals, rightly puts it, "India needs to invest in more patient-centric cancer care systems, with an organ-site approach. We must adopt a holistic way of dealing with chronic diseases – that are often misunderstood and not diagnosed and treated on time. Patient-centricity has to be at the heart of chronic disease management. Right from
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pain management and rehabilitation services, to onco-nutritional support, mind-body medicine and home care support services, Cytecare was founded on the principle of ‘Fighting Cancer the Right Way’. With healthcare taking centre stage during the pandemic, this could be a truly transformative phase that changes the way we address health and chronic disease management. Lifecycle management
Once the cancer is stable during treatment or in remission and life feels normal again, it’s important to remember that the battle isn’t over yet. With chronic disease management, the road ahead is long. And there are bound to be ups and downs along the way. In order to ensure that the journey doesn’t get too uphill or lonely, it’s vital to nurture a strong support system. At Cytecare, for instance, we foster a sense
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of community to help patients cope better. Our Patient Navigator support system, a one-of-its-kind support system, encourages cancer survivors to share their personal experiences with others in similar situations. Patients find it comforting to hear survivors talk about their experience of managing pain, undergoing chemotherapy and other treatments, communicating with doctors, drawing strength from family and friends. Families of people living with cancer also need support. We have seen that when caregivers are cared for, it can make a big impact in terms of optimal outcomes for the patient. It’s prudent for cancer care centres to invest in patient support groups, wellness groups, social workers, psychologists, and counsellors as part of their work with families. Extra hands and empathetic hearts can make the journey with cancer less stressful.
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Mind-Body Wellness
It is crucial that cancer patients take care of their mental and physical health. Mental health is closely linked to physical health. A disturbed state of mind can further affect emotional and psychological wellbeing. Chronic stress is known to trigger inflammation in the body and can cause fatigue, depression, irritability, and severe headaches. Being diagnosed with a lifethreatening disease and undergoing treatment can cause much distress. And the pandemic has only further aggravated the emotional and mental impact that one experiences while navigating a chronic illness. Right from concerns about being immunocompromised to greater anxiety about an uncertain financial future, the trigger points are plenty.
At Cytecare, our team of psychooncologists help patients to navigate mental health issues and find a healthy outlet for their emotions. It is essential to help patients manage the psychosocial challenges of diagnosis and treatment of cancer. Multi-disciplinary team-based approval
The quality of care over time is critical to chronic disease management. For cancer, it is important to adopt a multi-disciplinary approach. It’s not just about cancer care, but patient care. For instance, co-existing medical conditions, if any, also need to be addressed effectively to ensure overall health and well-being of patients. As healthcare providers, our focus tends to be on new, multidimensional models of service delivery for improved patient outcomes. That’s essential – but so is patient satisfaction. We need to look at continuity of care from both perspectives – that of the patient and that of the provider. From medical, radiation and surgical oncologists to pain and palliative care experts, all cancer care centres need to be armed with a comprehensive team of professionals, who have a deep understanding of the complex disease. Cytecare’s integrated oncology works with a world-class team of 25 plus cancer specialists - One of the largest such team in India.
AUTHOR BIO Prasad Narayan is a Senior Consultant and Director at Cytecare Cancer Hospitals. With over two decades of rich experience in medical science and clinical research, Prasad has been conferred with several prestigious awards including, ‘Dronacharya Award’ for Oncology.
We also have a multi-disciplinary tumour board to ensure that each patient not only gets expert care – from the medical oncologist, the radiation oncologist, the surgical oncologist and the pathologist, among others – but also that there is strict governance of care. Remote patient monitoring
Technology can be a potent tool in bridging the healthcare gap, by moving medical care out of the traditional setting into places where people live and work. This is particularly empowering in a country like India where an overwhelming majority of patients have advanced stage of cancer at the time of diagnosis. During the pandemic, the ability to offer remote/virtual consultations has helped healthcare providers to offer suitable consultations and reduce the risks of infection, while dealing with limited hospital resources. Several cancer patients, who are at high-risk of infection, managed to get regular advice from their doctors via teleconsultations, without having to travel to the hospital. The pandemic also saw patientcentred home care being integrated with more traditional hospital-centred care. In time, the primary setting for the delivery of care to certain patients with cancer is likely to shift from the hospital to the home – courtesy better cancer treatments, advent of oral therapies, shortened hospital visits, longer survival, and most patients’ desire to be cared for at home for as long as possible. Smart technologies have further facilitated timely, evidence-based care for seamless healthcare delivery. Smart ICUs, for instance, offer valuable benefits of continuous remote surveillance, such as prevention of infections, early detection of organ failures and timely resuscitation of patients as well as helping devise disease-specific protocols and effective strategies.
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THE HEALTH IMPACT OF NUDGES, INFLUENCE AND COMMUNITY There is enough evidence available now suggesting that beyond meal plans and exercise regimes, there are more factors that impact healthy lifestyle and overall wellbeing of the society – both macro and micro. And there is merit in exploring and evaluating what different influences can help in creating aware and healthier societies. When it comes to behaviour moulding at a community level, there lies an opportunity to leverage nudges and incentives to lead the community to achieve the desired health and wellbeing status. A few of these tactics that have proven to be beneficial and further research is needed in these areas to derive ideal outcomes and impact. Kent Bradley, Chief Health and Nutrition Officer, Herbalife Nutrition
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n our busy world full of easy conveniences, many consumers choose high-sugar, high-fat foods that are low in nutrients. Leading a healthy life is easy to wish for but much harder to attain in an environment with so many unhealthy choices so readily available.
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These days, the matter of leading a healthy life is not a concern limited to just individual consumers. The ongoing pandemic, and its adverse impacts on the economic and healthcare status on the countries in Asia Pacific1, has become a significant national agenda. Many lowand middle-income Asian economies needed to spend more on health issues like obesity and non-communicable diseases (NCDs) even prior to the crisis. It is critical to ensure that economic pressures — either during or after the pandemic has ended — do not divert already limited resources away from essential health services. As these
countries have limited capacity and depend heavily on household out-ofpocket spending, the significant cost of responding to and containing the pandemic may not be fully within their financial capacity. With more and more countries and governments2 in the region expressing their concern over the public health issues and their preparedness to manage them; it is clear that a more holistic and widespread approach is needed. There is enough evidence available now suggesting that there are multiple factors, beyond medication or nutrition awareness, that impact healthy lifestyle
and overall wellbeing of the society – both macro and micro environmental level3. There is also merit in exploring and evaluating the factors that can help in creating aware and healthier societies. The ANGELO Framework defines four categories of environment to consider while evaluating an impact – physical (what is available); political (what are the rules); economic (what are the costs); and sociocultural (what are the attitudes and beliefs). When it comes to behaviour moulding at a community level, all these categories together play a significant role. There lies an opportunity
1 https://www.oecd-ilibrary.org/sites/aaa5448f-en/index. html?itemId=/content/component/aaa5448f-en\
2 https://www.oecd-ilibrary.org/sites/aaa5448f-en/index. html?itemId=/content/component/aaa5448f-en
3 https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC5129776/
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to leverage nudges, incentives, and power of community to achieve the desired health and wellbeing status – an aspect which nutrition companies, and healthcare professionals (HCPs) can help facilitate and drive. While further research is needed in these areas to derive ideal outcomes and impact, a few of these tactics have proven to be beneficial: Nudges and influence
Nutrition labeling4 is a proven potential method to encourage consumers to improve dietary behaviour. Many industries have been adopting images and labels on packaging of food items as an indicator of its calorific value as well as its impact on health. Different formats of such labelling have been experimented in the past such as coloured coding, warning imagery,
keywords indicating healthy choice, fibre rich and symbols. However, a study conducted by Duke-NUS Medical School and NUS Saw Swee Hock School of Public Health5 revealed that it is important to keep the messaging simple on food products. Multiple symbols and too much information on the pack can confuse shoppers and dilute the effect of all information shared. For example, the Government of Thailand made substantial efforts towards making this labelling simplistic, in association with Thai National Strategic Steering Committee, National Food Committee and the Public Health Ministry. Endorsements and certifications by credible authorities have a great deal of influence in helping consumers make
healthier food and lifestyle choices. Government endorsements spanning sustainable agriculture, sourcing, food quality standards and supply chain best practices have been instrumental in building the accurate and authentic perception for brands across. In another instance, Taiwan’s Symbol of National Quality (SNQ6) is a wellknown certification for wellness and health supplements. The SNQ is given by the Institute for Biotechnology and Medicine Industry, and its purpose is to let consumers know which products meet top safety and quality standards. While in Vietnam, the Golden Product for Public Health Award7 by the Vietnam Association of Functional Food is endorsed by the Ministry of Sciences 6 https://iamherbalifenutrition.com/our-products/taiwanquality-certification/
4 https://journals.plos.org/plosmedicine/article?id=10.1371/ journal.pmed.1003765
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5 https://www.asiaresearchnews.com/content/healthy-foodlabels-work-and-don%25E2%2580%2599t-work
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7 https://iamherbalifenutrition.com/our-products/vietnampublic-health-award/
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and Technology to achieve the similar objectives. Friendships and communities
As humans we are wired for social connection and these very social connections play an important role in people being able to live healthier lives - science provides evidence that social connections have a positive impact8 on people’s lives. According to researchers from the Harvard Center for Population and Development Studies9, people with meaningful social relationships tend to have better health behaviours, like eating healthy foods10 and being physically active. Group activities11 and exercises for instance, are known to enhance social bonding; and social bonding in turn leads to a proven enhanced exercise performance. Another research study published in the British Journal of Sports Medicine12 found that people who regularly walk in groups have lower blood pressure, resting heart rate, and total cholesterol. The recent Herbalife Nutrition Virtual Run successfully motivated more than 25,000 consumers to form a common-purpose community that clocked a total of 1.57 million kilometres, enough to circle the earth almost 40 times! Actions are hugely impacted by beliefs, circle of friends, and family that 8 https://iamherbalifenutrition.com/health-and-wellness/5reasons-being-social-makes-you-happier/ 9 https://www.hsph.harvard.edu/news/hsph-in-the-news/ active-social-life-longevity/ 10 https://www.hsph.harvard.edu/multitaxo/topic/healthyeating/ 11 https://journals.plos.org/plosone/article?id=10.1371/ journal.pone.0136705#sec017
AUTHOR BIO
12 https://bjsm.bmj.com/content/49/11/710 utm_source=TrendMD&utm_medium=cpc&utm_ campaign=BJSM_TrendMD-0
influence choices. Most people spend a considerable portion of their time at work and form social circles at work as well. Thus, workplace environments thrive when there is a focus on education and empowerment towards better health. Civil society, government and public policy have a significant role to play on how incentives are applied to create a healthier environment. The potential solutions call for a more holistic approach that effectively integrates the various groups mentioned. The impact of unhealthy populations is not limited to just the consumers, they run much deeper with social, political, and economic implications. The HCPs impact
Perhaps those with the greatest power to impact consumer lifestyle behaviour are the likes of coaches, experts, and HCPs. HCPs command a fair share of respect and credibility among the public as far as the nutritional information and awareness is concerned. As influential members of their respective communities, HCPs have a deeper understanding of the beliefs, practices, attitudes, awareness as well as behaviour of their audiences. This knowledge can help them spread information among their stakeholders and to nudge more people towards a healthier lifestyle. Herbalife Nutrition is on the right side of these efforts. Our commitment to improving lives and our communities has remained at the core of everything we do. Given the scale and scope of our global network, we have the capacity to make a lasting difference for people seeking a healthier lifestyle. One of
our key initiatives last year was the Herbalife Nutrition Dialogue Series 13 , a compilation of nutrition-related educational videos aimed at closing the nutrition knowledge gaps among Asia Pacific consumers and equipping them with credible nutrition information. The series featured leading experts discussing topics like diabesity, heart health, healthy ageing and the need for multi-sector collaboration to drive public nutrition education. Leading a better lifestyle is a matter of choice, commitment, and support, and at Herbalife Nutrition, we are fulfilling our mission by providing not one but multiple nudges, influences and communities such as fitness camps, mentorship programs and educational efforts to help people make smart decisions, stay active and achieve their personal goals. 13 https://www.herbalife.com.sg/apacnews/home
Kent L Bradley has worked in leadership roles in healthcare sector, strategising health related policies and business decisions, he has acted as strategic advisor for multiple health-tech companies. A retired army Colonel, he has Masters Degree in Public Health from University of Minnesota & his medical degree from Uniformed Services University of Health Sciences, Maryland.
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IMPLICATIONS OF COVID-19 ON HEART HEALTH
Profoundly straining national healthcare systems and the global economic stability, since December 2019, the Wuhan Virus exhibited diverse patterns of after-effects, especially on the cardiovascular health of an individual, thus leaving a blind spot in understanding the impacts of the disease and a huge field for research unexplored. Audditiya Bandopadhyay and Gyaneshwer Chaubey Cytogenetics Laboratory, Department of Zoology, Banaras Hindu University
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he past two decades witnessed two recorded epidemics, caused by the family of seven known coronaviruses - Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV), in 2002 - 2003, and the Middle East Respiratory Coronavirus (MERS-CoV) in 2012, before the third and also the most recent one
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started to emerge lately. It eventually turned gigantic, spreading rapidly to several countries globally, inflicting a massive jerk to health, economy, and lifestyle. The previously known virus family, comprising of HCoV- 229E, HCoV-NL63, HCoV-OC43, and HCoV-HKU1, has long been associated with respiratory distress syndromes
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and flu-like outbreaks, with minimum Cardiac involvement. However, with the ascent in the number of COVID19 confirmed cases, the recent literature survey documented accumulating data for cardiovascular complications, occurring in about 10-20 per cent of the hospitalised COVID-19 patients. Apart from the high occurrence of cases of bronchitis and severe pneumonia, a heart attack or congestive heart failure was prevalent during the pandemic, particularly among the patients suffering from pre-existing heart ailments. Reports also widely stated COVID-19 triggered myocarditis, along with systemic inflammation, necrosis of its cells, mimicking heart attacks, arrhythmias, and acute or protracted heart failure (muscle dysfunction), as a characteristic of the
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infection. In fact, these complications at times were the sole features of COVID-19 clinical presentation, and have occurred even with the cases with milder COVID-19 symptoms as well as in the asymptomatic. This deciphered a distinct set of characteristics of SARSCoV-2 in its comprehensive cardiac involvement, which also could probably be a consequence of the exposure of the virus to millions due to the pandemic. Nevertheless, the plausible cause of the COVID-19 infection in the development of myocardial injury in the patients suffering from underlying cardiovascular disease is still unknown and requires an extensive study to confirm whether or not an after-effect of the hyperactive immune response against the virus or the virus itself, that is leading to myocardial inflammation, associated with cardiac function impairment and ventricular tachyarrhythmias. Structural aspects of the COVID-19 virus
polybasic site that alters their structure and broadens the tropism of cells that the virus can infect when cleaved. Studies involving autopsy specimens quoted tropism to other organs beyond the lungs i.e. heart, kidney, and liver, with the presence of SARS-CoV-2 genomic RNA. In-vitro studies revealed the ability of SARS-CoV-2 to infect the induced pluripotent stem cells (iPSCs) derived cardiomyocytes, causing the distinctive pattern of cell fragmentation along with the complete dissolution of the contractile machinery, leading to apoptosis, and ultimate cessation of the heartbeat within 72 hours of the viral exposure. COVID-19 on systemic and cardiovascular health
Besides the direct involvement of the virus in the heart muscles, its entry into the endothelial lining of the blood vessels of the heart and multiple vesicular beds is well documented. Another potential threat is the effects of secondary immune
response on the infected heart and endothelial cells (endothelitis) which may include the dysregulation of the renin-angiotensin-aldosterone system modulating blood pressure; activation of proinflammatory responses including platelets, neutrophils, macrophages, and lymphocytes, the cytokine storm and a prothrombotic state. The degree of cardiovascular manifestations ranges from limited necrosis of cardiac cells leading to myocarditis to an oftenfatal inefficiency of the heart to pump sufficient blood, thus leading to cardiogenic shock. Myocarditis, being a diffuse pattern of inflammation of the heart, typically represents a variable admixture of injury and an inflammatory response to the injury, and often extending through all the three layers of the human heart to the pericardium, encompassing the heart, proves to be even more worrisome than the restricted pattern injury. Every one-fifth of the hospitalised COVID-19 patients, suffering from
The virus targets the angiotensinconverting enzyme 2 (ACE2) receptor throughout the body while facilitating the entry of viral genetic material by the means of its spike protein, along with the assistance of the cellular serine protease transmembrane protease serine 2 (TMPRSS2), heparan sulfate, and other proteases, which cleaves the viral spikes protein and make the entry pathway for the viral genetic contents and thus it may perturb the angiotensinrenin pathway severely. ACE2 is involved in the regulation of blood volume, systemic vascular resistance, and thus cardiovascular homeostasis. Previous studies documented its association with hypertension, stroke, dyslipidemia, and cardiovascular diseases, and kidney diseases. The heart also has a significantly high level of ACE2 expression which makes it more susceptible to the SARS-COV-2 infection. The difference between SARSCoV-2 and SARS is apparently a furin
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cardiac injury reflects an accumulation of troponin - a cardiac muscle-specific marker in blood, and the same happens with those having pre-existing heart ailments. For the kind of myocardial injury in-hospital mortality, troponin accumulation was found to be a marker for morbidity risk. Moreover, it was observed that the patients with higher troponin amounts also had increased levels of many inflammatory markers, including interleukin-6, C-reactive protein, ferritin, lactate dehydrogenase, and an increased neutrophil count, and heart dysfunction (amino-terminal pro-B–type natriuretic peptide). Involvement of myocytes, which synchronise electrical conduction can cause conduction block and malignant ventricular arrhythmias, leading to the consequential heart attacks. Besides in-hospital arrhythmias, numerous regions with high COVID-19 dissemination have observed a steep increase in out-of-hospital cardiac arrest and sudden death. There has been a reported rise of 77 per cent in the cases in Lombardy, Italy, as compared to the previous year. Due to a cluster of chest pain-like sensations, an irregular EKG, and high levels of cardiac-specific enzymes in the blood, myocarditis imitating a heart attack has been reported even in individuals as young as 16 years. Heart failure, acute cor pulmonale, and cardiogenic shock can occur in response to significant and diffuse heart muscle injury. Other possible pathways, responsible for COVID-19-related heart dysfunction, such as Takotsubo syndrome or the Broken heart syndrome, which is a transient stress-related illness that causes apical ballooning; ischemia caused by endocarditis; and related atherosclerotic plaque rupture with thrombosis were also reported. Although the children were thought to be less susceptible to COVID-19, in comparison to the adults, and the majority of them with the disease were asymptomatic or presented only milder symptoms,
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Beyond the prevention of infection, the goal of averting cardiovascular involvement is paramount.
the reports of COVID-19 associated severe inflammatory symptoms among the pediatric patients were not null. An unexpected cluster of eight children (aged 4–14 years) presenting with a hyperinflammatory syndrome with symptoms of Kawasaki Disease was reported in a case series from the United Kingdom. Other causes included the multisystem inflammatory syndrome of children (MIS-C), this time not only exclusive to children but also in the adult subjects, such as in a 45-year-old, with the same clinical. It wouldn’t be of much surprise if the
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patients present with cardiomyopathy of unknown etiology and test positive for SARS-CoV-2 antibodies in the future. However, attributing all such cardiomyopathy solely to the virus may be difficult, given the high prevalence of infections. A biopsy might be a necessity to identify any virus particle to support causality. Conversely, an immunologic basis is likely as there is a possibility of myocarditis ensuing from the hyperimmune response so as to tackle coronavirus by releasing excess cytokines. Cytokines might end in inflammation that damages the lungs and the heart alike. This condition, known as a cytokine storm, is often more pronounced in the elderly and the co-morbid population. However, it was also seen to affect the middleaged population largely during the subsequent waves of the pandemic in India being the primary reason for the severe respiratory complications that lead to death in patients suffering from coronavirus. Cytokines promote blood coagulation, thus interfering with the body’s clot-busting system. Blood clots in coronary arteries in turn can block
MEDICAL SCIENCES
Present and future directions
Previous studies have delineated the overall clinical attributes of patients with COVID- 19, and a portion of it has shown that the condition of some patients with COVID-19 deteriorates apace. In contrast to the asymptomatic, a substantial proportion of the population also suffer a long-standing, and often an incapacitating illness, called long-COVID. The marked heterogeneity of the malady, ranging from lack of symptoms to fatality, is poorly understood. The most intriguing question that followed is that why do certain individuals have a propensity for heart involvement after the SARSCoV-2 infection. We hypothesised this to be the result of genetic variability among the individuals at two tiers, modifying their risk towards the ailment. First is the entry point for the virus, that is the ACE2 receptors and their variations among the individuals of certain ethnicities, which makes them either susceptible or resistant towards
the virus. The other one includes the immunity of the individual and its effects after the entry of the virus. The reaction of the immunity towards the non-self determines its activity, and thus results in an overactive state of immune responses, that leads to systemic inflammation, which prevails for a much longer time, as compared to the symptoms themselves. And in many cases, the asymptomatic individuals are merely the result of the symptoms getting masked due to unawareness or the socio-economic background of the infected. They may have underlying inflammation-related pneumonia due to the disease and still not experience hypoxia and thus, be considered asymptomatic. On the other hand, the body of the athletes, the demographic cluster of the young and the most healthy, may demand more oxygen when in practice and experience the symptoms of hypoxia and thus, can lead to cardiac arrest due to pulmonary thromboembolism, as a consequence
AUTHOR BIO
blood flow, causing the risk for heart attacks. A tendency for clotting, both in the microvasculature and large vessels, has been reported in multiple autopsy reports and in the young COVID19 patients with a history of stroke. Another relevant possibility for the development of cardiac complications in coronavirus patients could be a consequence of the infected lungs. Insufficient oxygen increases the risk of arrhythmias. Parallelly, fever caused by the virus alters the body’s metabolism, thus increasing the cardiac output. As a result, an elevated demand for oxygen along with a reduced supply, inflicts an imbalance, thereby causing the patient’s heart to struggle, finally leading to myocardial injury. The causes of death also might often involve multiple organ dysfunctions, and therefore difficult to mark myocardial injury as the sole reason. Schematic representation of the pathways leading to post-COVID conditions is depicted in the Figure.
of dilated arteries due to the diseaserelated inflammation. They are the most common to lack the symptoms after SARS-CoV-2 infections and thus, raises the question of how many athletes may have an occult cardiac disease. Beyond the prevention of infection, the goal of averting cardiovascular involvement is paramount. Long-term Cardiac Surveillance and prospective study design on the viability of treatments, explicit for myocardial injury are of utmost significance. Genome-wide and Whole-genome study designs would reveal and map a particular population at risk, would categorise the vulnerable groups to prioritise them at first, and thus manage the casualties due to the disease. References: Rewritten from Bandopadhyay, A., Singh, A. K., & Chaubey, G. (2021). COVID-19: The cause of the manifested Cardiovascular complications during the Pandemic. Frontiers in Cardiovascular Medicine, 1481.
Gyaneshwer Chaubey – He spent most of his research career in Estonian Biocentre and University of Tartu, and also as a visiting scientist to the Sanger Centre, UK, before joining as a Professor in Banaras Hindu University, India. He is known for his in-depth expertise on the demographic history of South and Southeast Asia and their role in old world peopling, and its further application as a foundation to understand the complex disease genetics of South Asians. Audditiya Bandopadhyay - M.Sc in Zoology from Banaras Hindu University, India. Pursuing PhD under the supervision of Prof. Gyaneshwer Chaubey, with expertise in the field of Population Genetics and Disease Genomics. Area of research and interest - Cardiovascular Genetics and Genomics within the South and Southeast Asian Populations.
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NEW NORMAL, NEW FUTURE
Reshaping the Future of Health through MedTech Innovation
The pandemic stirred learnings in technology and healthcare for APAC, but consumption and ageing populations continue to grow and present newer challenges, opening up more questions on how we can hedge against future contingencies – to which Ashley McEvoy, Executive VP and Worldwide Chairman, Medical Devices, Johnson & Johnson, is here to answer. Ashley McEvoy, Executive Vice President and Worldwide Chairman, Medical Devices, Johnson & Johnson
1. How has the COVID-19 pandemic impacted the MedTech industry in Asia-Pacific? Were there any silver linings brought about by the pandemic? The COVID-19 pandemic without a doubt is the single most notable event in our recent history. It has put healthcare front and centre on the agenda for governments, healthcare companies and patients. The silver lining is that we’ve also witnessed the strength and the impetus for change when all these players come together to drive better outcomes for patients, at a scale never seen before. Above all for MedTech, COVID-19 has been a catalyst, and likewise for Johnson & Johnson Medical Devices, in hastening innovations that combine technology and medical capabilities to address the pressing needs of patients and healthcare partners. The exigency of the crisis also supercharged newer ways of thinking and working that is much needed for the sector particularly in technology investment.
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3. Is MedTech innovation more critical than ever in addressing the healthcare needs of today? Why? We’re seeing significant changes across the region in term of quality of care, as well as patient needs and expectations. Paired with burgeoning consumption and the ageing population in the region. By 2050, we are expecting one in four people in Asia-Pacific to be aged 60 or older 1, signalling a huge unmet need in healthcare. MedTech will look to fill this pressing need to reshape the way healthcare is delivered to enable patients to lead healthy and fulfilling lives. Think about lung cancer, the number one cause of mortality around the world. Innovation that enables earlier, less invasive diag1 https://www.weforum.org/agenda/2021/10/is-asia-pacific-ready-to-be-the-world-s-most-rapidly-ageing-region/
noses and more localised interventions as opposed to lung re-sectioning can completely transform the standard in lung cancer management. The sector has always been evolving and bringing in new innovative solutions. But what is clear is that we need to accelerate the innovation journey even more and it’s now more crucial than ever with rapidly evolving healthcare needs. Asia-Pacific, for instance, is estimated to be the largest patient population with chronic diseases, yet access to care remains limited in many parts of the region. 4. How can MedTech innovation future-proof the delivery of healthcare? To future-proof the delivery of healthcare, we need MedTech solutions that allow for adaptability in our healthcare systems – be it 3D printing, digital surgery, virtual consultations, virtual professional education or telementoring as well as tele-health. These are all important in helping improve access to healthcare. The future is uncertain so it’s important to bring to market solutions that can be adapted easily. We believe strengthening the industry is the way forward to step up the progress of MedTech innovation, and this means fostering a collaborative culture that in turn creates a thriving and sustainable ecosystem of startups that can hasten the sector’s stride towards stronger innovation. We’ve had a long-standing commitment to supporting start-ups and fostering a robust MedTech ecosystem in the region. We are one of the founding sponsor and supporter of MedTech Innovator, the largest accelerator of
AUTHORBIO
2. What are the challenges faced when it comes to innovation in this space? Asia-Pacific has always been ahead of the curve in creating a thriving environment for new technologies and digital solutions. A number of countries across the region are pioneering in areas such as digital and robotic surgery. I’m particularly impressed with how China is leaning into patient and clinical insights and translating that into value creation in MedTech. However, more work is needed to deepen the understanding on the benefits of these technologies to the patient, surgeon, hospital as well as to the efficacy of the healthcare system. The regulatory and reimbursement systems are also maturing. More broadly, software as a medical device is an ongoing area that is in its infancy in many markets, despite the acceleration of digital solutions during COVID-19 and will be one barrier of challenge to address in Asia-Pacific. Data standardisation and security is also another area that need more attention.
medical devices companies in the world. Opharmic, grand prize winner of its Asia-Pacific Accelerator program for 2021, is one of many start-ups that have benefited from such collaborations, having accelerated its development to bring a non-invasive alternative for eye drug delivery to the world. In addition, we are also rapidly activating our own digital products such as VELYS that is elevating the orthopaedic experience2 with robotics surgery as well as regional partnerships such as working with TINAVI to expand digital surgery footprint in China3 and Navbit to introduce a digital navigation system for hip implant in Australia4. 5. What does the future of MedTech look like? Beyond 2021, the innovation agenda is going to continue to be important. The pandemic has emphasised the importance of healthcare and as the population continues to age, there continues to be new challenges but also opportunities. Looking ahead, we are aiming to leverage collaborations and partnerships that will be integral in driving MedTech innovation and create an enhanced healthcare journey tailored for patients and healthcare professionals in the region. I am confident that Asia can lead the world in uncovering how to digitise the MedTech experience for patients and customers.
2 https://www.jnjmedicaldevices.com/en-US/velys 3 https://www.jnjmedicaldevices.com/en-US/news-events/ johnson-johnson-medical-shanghai-and-tinavi-sign-strategic-collaboration-expand-digital 4 https://www.jnj.com/johnson-johnson-medical-announces-strategic-partnership-with-aussie-startup-navbit-tobring-smartphone-inspired-tech-to-hip-replacement-surgery
Ashley McEvoy is Executive Vice President and Worldwide Chairman, Medical Devices, Johnson & Johnson. Under Ashley’s leadership, Johnson & Johnson Medical Devices has accelerated its ability to tackle the most pressing global healthcare challenges across four franchises in general surgery, orthopedics, eye health, and interventional solutions.
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EXECUTIVES SPECIAL
ISSUE 56 APRIL 2022
A special issue designed to focus on a theme or a sector trend. This issue is aimed at facilitating the industry leaders share perspectives and insights with our readers on key issues impacting and influencing the industry. The issue would also cover a few articles on trending topics in the healthcare industry.
If interested in contributing, please reach out to prasanthi@ochre-media.com or gracejones@ochre-media.com
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W
ith telehealth now becoming an integral component of the healthcare delivery system, maintaining high quality, with systems and processes, in a future ready, technology-enabled remote healthcare milieu becomes mandatory. With geography becoming history, distance has become meaningless. Various stakeholders with diversified backgrounds constitute the telehealth eco system. Cultural and socioeconomic differences notwithstanding, it is essential that the whole world talks in the same language, as far as actual deployment of telehealth is concerned. Formulating dynamic standards implies seeing the Big Picture and understanding the nitty gritty as well.
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The global ISO 13131 Certification exclusively for telehealth Services fulfils these objectives. For decades, Telemedicine/ telehealth services were not centre stage in the healthcare delivery system. Covid -19 changed this. The world has now accepted that the original forced lockdown- enforced acceptance of Remote Health Care will become the new normal even after the pandemic is de notified. Universal acceptance increases the responsibility of all healthcare providers deploying technology to ensure constant high quality while bridging the urban-rural health divide. Quality is never an accident. It is always the result of sincere effort,
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intelligent direction, and skilful execution. Henry Ford opined that quality means doing it right when no one is looking, but in the real world this is difficult to implement. ISO certification ensures that “Big Brother” is watching all the time. The necessity for re-certification is like the Sword of Damocles hanging above us. It drives home the message that quality is everyone’s responsibility at all times and not during the audit alone. One has to keep running to stay where one is. To maintain the initial global recognition, maintaining quality needs to become a habit, a unique opportunity to transform one’s DNA if necessary. Success is the sum of small efforts, repeated day-in and day-out.
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GLOBAL CERTIFICATION FOR TELEHEALTH SERVICES With Telehealth now becoming an integral component of the healthcare delivery system, maintaining high quality, with systems and processes, in a future ready technology enabled Remote Healthcare milieu becomes mandatory. This article will highlight the challenges faced and overcome to obtain a global ISO 13131 Certification exclusively for Telehealth Services and its implications. K Ganapathy, Member Board of Directors, Apollo Telemedicine Networking Foundation &, Apollo Tele Health Services
Standardising systems, processes, documentation and re-documentation alone will ensure providing quality remote healthcare for anyone, anytime anywhere. . ISO 13131 - An Overview
The International Standards Organization (ISO), TC 215 Health Informatics Committee, developed a Technical Specification, ISO/TS 13131 Telehealth Services, based on a risk and quality management approach. This standard supports healthcare planning, service and workforce planning, organisation responsibilities and financial and IT management. ISO was established in 1947 in Geneva, Switzerland. An Independent,
non-governmental international organisation, ISO develops standards that are recognised and respected globally. It brings experts together to improve quality and provide worldclass healthcare services. Experts are from 166 national standard bodies. ISO standards are developed by various advisory groups. Presently ISO has 255 technical committees, 515 subcommittees, and 2498 working bodies. Since 1947, ISO's technical experts have created more than 18,800 standards for all possible business. ISO standards ensure that administration and product/work flow systems are carried out legally, safely and effectively. ISO technical experts have developed several assessment protocols to ensure
that certified organisations apply these guidelines in their workplace. The approved protocols aid organisations to ensure that their frameworks, devices and workforce comply with ISO standards. ISO 13131 provides recommendations on guidelines for telehealth services deploying Information and Communication Technology (ICT) to deliver quality healthcare services. Implementing ISO/TS 13131 means facilitating cooperation and interoperability of its different health systems to ensure quality telehealth services. It also ensures a reliably high standard of service, irrespective of where a person lives, across the globe. This standard provides guidelines for
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developing quality plans and managing company resources, while putting the right policies in place to safeguard clients’ private data. Securing ISO 9001 for quality management and ISO 27001 for information security management reduces the complexity involved in getting the IOSO 13131 branding. Why get certified?
The decision to get a time consuming, labor-intensive and expensive certification is the determination to set a benchmark in the telehealth sector. If a leading market player faces competition, the company needs reassurance that its high-quality standards would provide a stamp of recognition distinguishing it, from its
Presently ISO has 255 technical committees, 515 subcommittees, and 2498 working bodies.
Fig 1 Apollo telehealth Servicesr eceiving ISO 13131 certifcation on Dec 102021
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competitors. Pioneers in the field, set conditions of competition, to prevent some potentially harmful practices of others, from compromising the reputation of all. Considering risks involved in securing patients’ data privacy, IT systems and processes need to be stringent conforming to security legislation. A preliminary gap analysis is initially conducted and deficits if any addressed, to fulfil specific criteria required for ISO/TS 13131. Beneficiaries draw confidence from a stringent certification process. ISO standards help organisations comply with new regulatory requirements, enhancing efficiency of internal processes and quality of remote health services provided. Documenting the
INFORMATION TECHNOLOGY
Fig 2. 24/7 Certified Medical Call Centre of ATHS @ Hyderabad, India
much needed framework necessary for supply of services, improves value of the product. The more diverse and competitive the market, the more guidance consumers need, to ensure they are purchasing an excellent cost effective service. International Standards helps maintain a healthy competition in the marketplace. Right quality metrics are identified. This information is made available to patients, health systems and providers. Consumers are helped to gauge telehealth providers. Healthcare workers and systems need feedback for continuous improvement. Best practices for virtual care need to be standardised, notified and applauded so that it will be increasingly sought.
With the pandemic disrupting in-person care, virtual healthcare needs to be prioritised. The time to define, implement and enforce quality in all aspects of telehealth is not tomorrow but today. Formal certification by an international organisation requires hundred percent fulfilment of stringent criteria . This pre supposes commitment of a very high order and the realisation that excellence is always a moving target. One can never ever rest on one’s laurels. We need to keep running to stay where we are. What is the Certification about?
ISO / TS 13131 is based on a risk and quality management approach allowing a broader approach to generate detailed
guidelines required by a particular service. The class of standards provide flexible, general guidelines supporting innovation in healthcare. These include financial management and service, workforce and healthcare planning in addition to healthcare organisation responsibilities, facilities, technology, and information management. All existing national and international standards including standards for safety, quality and risk in health are evaluated. Standards overcome barriers in knowledge sharing. Community interest is promoted ahead of sectional interests. Often local needs, conflicting business models, intellectual property and policies have to be balanced against national and global interests.
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Specific guidelines including technical standards are available for clinical specialties using telehealth. However, these are at the most national. Global Standards add credibility, standardise approaches and decrease liabilities. Guidelines in the ISO/TS 13131 specification are designed to support telehealth services offered by a healthcare organisation and healthcare professionals. The specification is used as a tool customised for each healthcare setting. The healthcare professional or healthcare third party is required to possess competencies necessary for providing healthcare remotely.
Appropriate minimum professional standards are applied in assessment of required competencies.
delivery of health services to telehealth requires managing safety and quality in a virtual environment.
Standards in ISO 13131
Role of Quality and Quality Management Systems (QMS) in Telemedicine
These specifically deal with financial, facilities, operations, technology, and information management, service and technical support, service delivery and infrastructure deployment. The ISO/ TS 13131 specification provides useful guidelines to assist the development of telehealth services, but it remains the job of each organisation to develop appropriate guidelines for each health service. Transitioning from face to-face
Key Requirements for ISO 13131 Certification for telehealth Services • Management of all telehealth processes by the healthcare organisation • Management of financial resources to support telehealth services • Processes relating to staff responsibilities • Provision of infrastructure facility for telehealth service organisations • Management of Information and Technology resources used in telehealth services
Guidelines in ISO/TS 13131 • Service planning ensures that appropriate, accessible and quality healthcare services are provided to patients. • Workforce planning ensures that managers, clinical and technical staff are qualified and skilled to provide safe and high quality services. • Healthcare planning includes planning, designing and implementation of processes, clinical and technical guidelines, risk management and medical record management. • Responsibilities of Stakeholders: Key stakeholders in the telehealth system (Healthcare providers and beneficiaries) should be competent to use technologies associated with telehealth services. Organization is responsible to provide safe and quality services.
Safety and quality risks in the use of telehealth • Financial management is required to provide sufficient funding for telehealth services. • Facilities management must ensure that adequate facilities are provided in telehealth services, including infrastructure and technical devices. • Technology management ensures that telehealth services are equipped with ICT to deliver quality healthcare. Transmitting healthcare information and procedures relating to data security and data privacy are also equally important
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Proof of quality is a precondition requested by principals, prior to placing an order. Quality of services/ products is important in all services provided by organisations. Quality should conform with requirements defined by customers.Better the service quality more the utilisation. In telehealth the focal point is always the patient. Comprehensive information about content of services provided, formal authorisation before transfer of confidential patient data to a third party and regular customer satisfaction surveys are key requirements of a QMS.Third party auditing and certification of the system, give a measurable value. Safeguarding legal compliance with priority on data safety, cost effectiveness, involvement of employees and customer satisfaction are key ingredients to fulfil needs of all stakeholders in tele-monitoring applications. Standards and Guidelines in Telemedicine and Telehealth
Guidelines and standards for telehealth is an important and valuable process to help ensure effective and safe delivery of quality healthcare. Evidence is needed to validate existing guidelines and guide revision of future versions. There is evidence supporting telehealth’s utility and benefits. However there are differences in approaches and norms for conducting telehealth. Stakeholders include clinicians, medical support and technical staff. CEOs, business development and other managers also form part of the team. In any field, improving performance and accountability depends on having a shared goal that unites the interests and activities of all stakeholders.
INFORMATION TECHNOLOGY
CHALLENGES KNOWLEDGE: Improper knowledge about ISO standards and compliance is a common problem. It is essential that the company knows their current state, what is to be achieved and processes to bridge the gap. MANAGEMENT COMMITMENT: Management's commitment to achieve ISO compliance is critical including clear understanding of benefits of ISO certification - from delivering quality service to improving business efficiency. A committed management will result in effective implementation of ISO resulting in a culture of continuous improvement. EMPLOYEE MOTIVATION: ISO implementation drive is never easy on employees. It is difficult to initiate if there is resistance. The latter is due to lack of knowledge about ISO. This is eliminated/reduced through training sessions. AUDITING PROCESS: Internal audit report is mandatory for ISO certification. Audit identifies areas where there is scope for improvement. Inexperience in performing internal audits is a major challenge in ISO standards implementations. FINANCIAL SUPPORT: Lack of funds makes implementing ISO standards difficult . Funds are required to train the staff, purchase high quality equipments if required, payments to auditors, external consultants and to procure certification. The organisation needs to ensure that all required costs are pre calculated and have been accounted for, before the compliance process
ISO/TS 13131 is an example of how ICTs can improve society by facilitating the distribution of services. Human services are not replaced. It is complemented and enhanced by codifying and formalizing best practices in quality healthcare and patient safety. ISO 13131ensures interoperability of different health systems ensuring a high
standard of service no matter where a person lives, across the globe. Guidelines ensure managing company resources, using right policies to safeguard clients’ private data. Future prospects
So what does the future hold for ISO/ TS 13131 ICT is being used in everyday healthcare through texts, e-mails and smartphone-enabled videos. It is expected that there will be an extension and intensification of their use in general practice and hospitals to manage patient health. ICT is developing at a breakneck pace. Wireless broadband Internet access, and 5G will be the gold standard sooner than later. Regulations in their application to telehealth will be tightened. ISO standards will help all players in the eco system to talk and understand the same language. Enhancing efficiency of internal processes will lead to improvement in quality of health services provided remotely . Preparation for a global certification helps improve quality of services offered and reassures patients that they are getting better than the best. Realising that excellence is always a moving target it is logical next step in a company’s journey to go (to paraphrase Captain Kirk of Star Trek) “where no Man had ever gone before”. On December 10th 2021 the ISO 13131 -2021, certification for telehealth services was obtained for the first time, anywhere, by Apollo Telehealth Services. It is the author’s belief that raising the bar and setting high standards is more important than following standards. One day the world will strive to achieve India class!
AUTHOR BIO K Ganapathy Past President, Telemedicine Society of India & Neurological Society of India Hon Distinguished Professor The Tamilnadu Dr MGR Medical University Emeritus Professor, National Academy of Medical Sciences Formerly Adjunct Professor IIT Madras & Anna University Director Apollo Telemedicine Networking Foundation &, Apollo Tele Health Services Website: www.kganapathy.in
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A DIGITAL REVOLUTION IN PATHOLOGY
Laboratory medicine is continuously evolving to provide the much needed support for disease monitoring, treatment decisions and patient safety. With a rise in the adoption of machine learning and artificial intelligence to improve turnover and optimise efficiency, pathology laboratories are transforming into predictive rather than reactive environments. Suresh Vazirani, Founder Chairman, Transasia-Erba International Group of Companies
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D
iagnostics is the critical first step in the healthcare delivery chain, as 70 per cent of the treatment decisions are based on lab results. The market for diagnostics devices is growing steadily to meet the increasing demand from hospitals and laboratories. The onus is thus on the manufacturer to provide a holistic solution that integrates automation
INFORMATION TECHNOLOGY
with analytics, training, updates, and troubleshooting. Further, the use of QR codes and RFID chips enables automated tracking of samples and laboratory materials such as reagents, chemicals and equipment. The role of AI and ML
Today, digitalisation, automation, and laboratory information software (LIS) have found a place in clinical laboratories. However, many lab processes continue to be performed manually or are partially digitised. Efforts are also being taken to improve the pre-analytic, analytic, and postanalytic processes of the clinical laboratories with the AI-support. The COVID-19 outbreak accelerated the adoption of digital technologies in laboratories. According to a recently published report, several examples of applications of Artificial Intelligence (AI) to COVID-19 are already reported such as AI-enabled outbreak tracking apps, chatbots for diagnostics, AI-powered analysis of scientific publications and triage using natural language processing (NLP) for screening potential patients and prognosis prediction tools, and using radiology CT scans to manage system capacities, among others. Also available on record are multiple examples of the role played by AI in the management of non-communicable chronic diseases such as cancer and cardiovascular disorders. AI tools aid in augmenting the accuracy of clinical decision and improving patient care. Studies reveal that AI-supported systems can predict patient waiting time in the phlebotomy unit and organise the entire blood collection process or the autoverification of test results using a Machine Learning (ML) approach. ML can also be used to predict out-ofcontrol events in internal quality control studies, detecting instrument failures before even they occur, or determining compatibility between analysers in central laboratories where
Test Management and reporting are the other two benefits of using the Laboratory Information Management System.
several instruments running the same parameters are tested. Automation of analysers
It is very interesting that the basic manual laboratory techniques and procedures have generally been adopted in principle to automated, or mechanised, fashion in automated analysers, while a wide variety of configurations can be observed in modern instrumentation in clinical laboratory. Step-by-step innovations created these ultimate configurations. There are several approaches to automated instrumentation historically. For instance, multiple samples are tested in a series in batch analysers. In contrast, in sequential analysers, the samples are tested sequentially, and the results are reported at that order. Continuousflow analysis means a form of sequential analysis with a continuous stream. In random-access discrete analysers, the most common configuration, analyses are performed sequentially on a set of specimens, and each sample can be analysed for a different test selection. In this type of analysis, an interruption can occur in routine working for spanning a stat sample in-between, permitting measurement of a number of and a variety of analytes in each specimen. Discrete term in this type of analysers means that each test of a patient (or a
sample) is analysed in a distinct chamber (in a well, cuvette, reaction vessel) The use of automated analysers has many advantages including reduction of workload, less time consumption per sample analysis, more number of tests done in less time, use of minute amount of sample, decreased chances of human errors, and high accuracy and reproducibility. Further, Total Laboratory Automation (TLA) systems use conveyor belts to connect pre-analytical specimen processing and other functions directly to an analyser. Such systems also include functions such as post-analytical storage or sorting of specimens or aliquots to be transported to low-volume testing areas—or to be sent to reference laboratories. At Transasia-Erba Group, we are looking forward to launching exciting new products by 2023. Our R&D labs in France, UK, USA, Austria and India will launch over 10 state-of-the-art analysers in CLIA, molecular, high-end haematology, AI and LIS. Also in the offing is a TLA solution aimed at midand large size laboratories. All these will make Transasia-Erba among the top-five companies globally to have ‘Total solutions in Laboratory Diagnostics. Digital data management
Modern-day cutting edge smart technologies are giving a much-needed renovation to laboratories and making them ‘smart’. A smart laboratory is nothing but an amalgam of different hardware tools and software that helps in data management, which is one of its integral parts. And when it comes to data management, one cannot ignore the concept of digital data management. The concept of digital data management generally revolves around utilising tools to store, document, and share, analyse and manage the experimental data. Among all the other software available, Laboratory Information Management System (LIMS) is extremely helpful. LIMS is a
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software solution that helps in addressing data management, regulatory challenges, and automation. This software is extremely useful in handling laboratory samples and the data. As a result, it helps maintain tests, workflows and reporting techniques that assist in standardising operations. The most significant part of the LIMS is to enhance the operational efficiency of a lab by streamlining and automating workflows. Also, it eliminates the purpose of manually maintaining information and complying with regulations. An efficient LIMS will easily be able to keep records and report them. As a result, it eliminates the possibility of any human errors. Benefits of using LIMS
The key advantage of using LIMS is that it provides sample management. It means that with the help of LIMS, it is possible to manage accurate and detailed records of every sample and securely store them. As a result, the data is not lost while it moves from one laboratory to another.
Secondly, the inventory management functionality of LIMS makes it possible to manage reagents and stock supplies. In addition, it also helps in generating automatic recorder alerts in time of depletion of the stock. Test Management and reporting are the other two benefits of using the Laboratory Information Management System. It is possible to achieve standardised testing structures with the help of LIMS that too with the bonus of providing accurate and complete testing process control. The Internet of Things
With an increasing focus on offering value-added services, manufacturers are adopting rapidly evolving technologies, such as the Internet of Things (IoT), to meet the huge demand for fully automated products and services. IoT applications are being used across all industries and healthcare is no exception. In fact, IoT has brought in a lot of ‘convenience’ to the healthcare ecosystem, becoming especially useful for medical device providers. While it
According to a recently published report, several examples of applications of Artificial Intelligence (AI) to COVID-19 are already reported such as AI-enabled outbreak tracking apps, chatbots for diagnostics, AI-powered analysis of scientific publications and triage using natural language processing (NLP) for screening potential patients.
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offers a host of solutions, it is left to the companies to leverage the potential of IoT to the fullest. Predictive maintenance
For laboratories, one of the biggest concerns is downtime. Planning for upgrading via cloud-based lab management systems and sophisticated software is a good way to future proof products and reduce the cost of maintaining the instrument. The days of preventive maintenance are long forgotten, now is the time for predictive maintenance. Devices with IoT capability can sense when components are exhibiting faults or when they near their expected end of life and communicate this back to technical support and initiate actions to resolve them – from ordering replacement parts to requesting a completely new device. Inventory management
Remote monitoring is also used to evaluate the usage and consumption of reagents for each test and their expiry to allow efficient management of lab
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inventory and utilisation. Further, by analysing actual usage data, a company can provide better customer service by pre-scheduling the delivery of consumables. This is particularly relevant for a diagnostic laboratory that is faced with a major challenge of optimising capacities of capital equipment. 24x7 remote access
While nothing can replace personalised customer service, IoT is playing the role of an adjunct to ‘smarter’ personalised customer service. In the traditional approach, a device manufacturer provides after-sales service to solve a problem with the instrument in case of a breakdown. This could result in repeated visits by the sales team to first diagnose the problem and then fix it. However with IoT, the service team can receive real-time reports. Technicians can thus remotely access the instrument and get information on the performance and repair history and other details that can help them save time. This will further help the organisation to improve their TAT and customer satisfaction. Optimising patient outcomes
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Manufacturers can utilise IoT data for compliance monitoring and to evaluate the performance of an instrument and optimise test results real time, with QC rules and calibration trends. This can be integral to making the device more useful to the end-user.
Transasia gives its customers the convenience of connected devices
Transasia’s cloud-based system, Transconnect, has helped equip labs with cutting-edge technology to improve patient treatment outcomes and enable better analytic insights. Its sophisticated software provides the team with real-time updates, prompting timely intervention to avoid a breakdown. In addition, a round the clock application support guarantees a seamless lab workflow. IoT sensors integrated in the instruments, provides extensive information on the consumption of reagents and the thus enhances the efficiency of the lab. Cloud computing used in laboratory
Cloud Computing is the method of using remote servers and networks that are hosted on the internet for saving, managing, processing the enormous data of the company or a firm. For a large number of laboratories, the data collected from various sources like experiments, research, and development activities are much more valuable. In order to keep them safe and secured, it is mandatory to keep in enormous and massive storage, and that’s where cloud computing comes into the picture. Data and files collected is a genuine record that has been performed or experimented. It is an asset to the company or a laboratory. Thus, it is necessary to safeguard and store in a safer place.
Suresh Vazirani is the Founder Chairman of Transasia-Erba International Group of Companies. He set up Transasia Bio-Medicals in 1979 to meet India’s need for reliable and affordable diagnostic systems. He has led the organisation for over four decades to becoming the largest Indian In-vitro Diagnostic Company.
Moreover, cloud computing helps a lab to prevent the loss of files and vital data. Benefits of cloud computing
Increase revenue and profits: Laboratories and healthcare management companies can make use of the robust metrics, MIS dashboards, with fingerprints metrics to have an eye on the recent trends and projections to maximise profits and revenues. Increase brand reputation: Extensive usage of cloud computing can help a laboratory or a healthcare company to give a delightful patient experience. Moreover, cloud computing provides accuracy in reports and diagnoses, which satisfies the patients and ultimately makes them happy. Productivity: With the use of cloud computing, laboratories and healthcare companies can increase the workflow and work productivity, respectively. They can maximise productivity by leveraging EM flow as well as automation across several departments of the laboratories. Cloud computing is the one-size solution that fits all the companies that boosts productivity and streamlines business workflow. With the help of cloud computing, labs can streamline business operations. Moreover, they can centralise data, strategies the company data, and safeguard the same adequately. The road ahead
Disruptive technologies will fundamentally change the way laboratory tests are going to be ordered, carried out and interpreted in the future. Data will be stored in cloud services, and a 24/7 online availability of health services will strengthen predictive medicine. This may also enable improved preventive healthcare that is supported by deep-learning algorithms for clinical decision-making not only on behalf of the physician, but also the empowered patient.
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