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Knee surgery: Applying the latest advances

Article-Knee surgery: Applying the latest advances

Recently, Dr. Herve Ouanezar presented innovative clinical results based on his research at the International Congress for Joint Reconstruction Middle East 2019 and the 7th Emirates International Orthopaedic Congress in Dubai.

“We want to improve patients’ overall care before, during and after surgery,” explained Dr. Ouanezar.

For this Consultant Orthopaedic Surgeon, the prerequisite for successful surgery is a technique that preserves the patient’s biology to the greatest possible extent and that best reproduces the biomechanics of the knee combined with a personalised multidisciplinary approach that takes the specifics of each case into consideration.

“Many people think that if their knee is affected, they will suffer for a long time, if not for the rest of their lives,” he said.

In the past five years, there has been considerable progress in anterior cruciate ligament (ACL) reconstruction, and Emirates Hospital Day Surgery and Medical Center, Motorcity, has integrated these advances into its care protocol.

Native ACL preservation and meniscal repair

To reconstruct the torn ACL – the ligament that stabilises the knee in rotation – the surgeon uses an autograft by taking tissue from the patient’s thigh or patellar tendon. The torn native ACL, which would have been removed in the past, is now preserved to facilitate the new transplant’s biological integration by serving as a tutor.

“Thanks to my former mentor Dr. Sonnery-Cottet in Lyon, France, this technique has been popular in Europe since 2014,” said Dr Ouanezar. “Thanks to him, I am part of the Scientific ACL Network International (SANTI) study group, which is performing research on the pathology of the anterior cruciate ligament.”

 The second advancement is the improved diagnosis and repair of unstable meniscal lesions known as meniscocapsular tears.

Dr. Ouanezar said, “Two or three years ago, in two out of five patients, these lesions were not visible using an MRI or even during the surgical procedure”.

This advancement allows for better preservation of the menisci, which act like shock absorbers and play a major role in stabilising the knee. Now patients can hope to delay the onset of early osteoarthritis.

A ‘new’ ligament

Dr. Steven Claes, a Belgian surgeon who is part of the SANTI group, contributed to the third major evolution of this subspecialty in orthopaedic surgery. In 2013, based on previous work and collaboration with other specialists, he highlighted the existence of a ‘new’ knee ligament – the anterolateral ligament (ALL). Reconstructing this ligament at the same time as the ACL increases knee stability and protects the ACL graft.

“With ACL, this ligament plays an important role in the rotational stability of the knee. The rate of re-rupture of the ACL after surgery is usually 10 per cent,” Dr. Ouanezar explained. “Based on an analysis of 600 patients with a minimum of two years’ follow-up, the combined reconstruction of these two ligaments substantially reduces the rate of re-rupture. Currently, surgeons face the challenge of deciding when it is necessary to undertake ALL reconstruction in the interest of avoiding unnecessary surgeries.”

Repair vs reconstruction: Save the ACL

Last January, the Arthroscopy Journal published an article about a promising new arthroscopic technique for primary ACL repair combined with ALL reconstruction. As one of the authors, Dr. Ouanezar believes that the preservation of the native ACL using this arthroscopic primary repair technique can achieve short-term clinical success in a carefully selected subset of patients. If ACL repair is possible, patients undergo a minimally invasive arthroscopic procedure that focuses on maintaining the patient’s native tissue and avoiding the use of grafts. Shorter, less invasive and less painful than reconstruction, this procedure has fewer complications. The patient regains their range of motion more rapidly with minimal atrophy, dramatically reducing the recovery time.

“I was very lucky to have been trained by one of the world’s leading surgeons in ACL repair during my fellowship,” said Dr. Ouanezar. “At the world-renowned Hospital for Special Surgery in New York, Dr. DiFelice taught me how to apply a daily advance ACL repair philosophy to help some patients avoid unnecessary major surgery.”

Athlete in first line

In the UAE today, athletes between 16 and 32 years of age are most likely to experience knee injuries. “Footballers are most likely to be affected, and those who practice other sports such as basketball, volleyball, CrossFit, squash and martial arts,” said Dr. Ouanezar.

Although age has long been an important criterion for operations – these were not usually performed on patients aged 40-45 years. This is less likely to be the case today. A discussion with the patient makes it possible to determine their level of activity and to suggest surgery based on the patient’s interest in continuing to engage in a sporting activity. “Except for cases involving a very degenerative knee with advanced osteoarthritis, there is no major contraindication to surgical treatment,” Dr. Ouanezar explained.

Attenuated pain

For several years, surgical management has involved the use of arthroscopy or keyhole surgery, a minimally invasive technique performed under loco-regional or general anaesthesia that involves making very small incisions, introducing a camera into the knee and using miniature instruments to treat the lesions. At Emirates Hospital Day Surgery and Medical Center, the length of stay is one day, with a significant reduction in post-operative pain thanks to the new compressive cryotherapy system.

“Surgery is not everything,” Dr. Ouanezar emphasised. “We integrate the patient into a personalised rehabilitation programme with physical trainers, sports physicians and physiotherapists. After using crutches for one month and adapted physiotherapy for three months, the patient can return to a pivoting sport after six to eight months. The post-surgery results are very promising; more than 90 per cent of the patients report that they are satisfied, and more than half are able to play their preferred sports at pre-injury levels.” 

References available on request.

Towards a learning system for Enhanced Recovery After Surgery (ERAS)

Article-Towards a learning system for Enhanced Recovery After Surgery (ERAS)

Contemporary colorectal surgery was often associated with long length of stay (eight days for open surgery and five days for laparoscopic surgery), high costs, and rates of surgical site infection approaching 20-30 per cent. During the hospital stay for elective colorectal surgery, the incidence of perioperative nausea and vomiting (PONV) may be as high as 80 per cent in patients with certain risk factors. After discharge from colorectal surgery, readmission rates have been noted as high as 35.4 per cent.

The concept of Enhanced Recovery After Surgery (ERAS) was initially proposed by Kehlet who explored the possible determinants of post-operative morbidity in the late 1990s. He identified potential risk factors that need to be recognised and treated perioperatively to minimise the effects of surgical stress on the patient. Kehlet also championed the idea of working within a multidisciplinary team framework. Together these have led to a series of interventions, which have been formulated into standardised mutli-disciplinary integrated protocols to span a patient’s entire journey through the surgical process with distinct elements in the pre-operative, intra-operative and post-operative phase.

The outcomes of interest to patients and providers include freedom from nausea, freedom from pain at rest, early return of bowel function, improved wound healing, and early hospital discharge. The basic premise is that the impact of surgery on the metabolic and endocrine response is reduced leading to earlier recovery. Successful implementation of ERAS leads to reduced length of hospital stay and earlier return to productivity. Systematic reviews of ERAS for various types of surgery have shown that the intervention has the potential to enhance patient outcomes, but that consistent implementation is required. In this paper, we describe how the concepts drawn from the field of implementation science can be used to improve consistency and quality of ERAS implementation.

Management of surgical risk and quality improvement

It is widely understood today that the first step towards implementing ERAS is to assure patient safety and quality of care and addressing several factors that are external to the surgical process itself. Scaling up in new hospitals and countries requires attention to much more than the surgery and requires an appreciation for introducing standardised processes in complex systems, and appreciation of the implementation contexts. These steps involve: (a) developing a standard set of activities that are needed to deliver ERAS within a health system (over and above the clinical steps themselves); (b) identifying the operational factors (e.g. political will, resources, schedules, supplies, equipment, etc.) that affect the implementation of ERAS within the system; (c) identifying the organisational factors (e.g. staff motivation, organisational culture, climate for innovation) that affect the implementation of ERAS, and (d) developing tailored, locally appropriate strategies to address the organisational and operational factors based on systematic local experiments. In essence, effective hazard reduction and risk management requires a reframing of care from one that is task-oriented at the level of the practitioner, to a systems-based, patient-centred one that looks to the actual relationships within the socio-technical microsystems, and the operational and organisational characteristics of the meso- (and possibly macro-) system in which care is conceived and delivered.

At the most basic, this involves a re-conceptualisation of the patient from the passive object of medical intervention to an active ‘consumer’ or ‘user’ of health services who co-produces and “owns” their own health. Standardisation can lead to more seamless process, which the patient and family experience as high quality service. The risks and hazards of healthcare are known to frequently be the result of an ineffective systems design rather than poor performance by surgeons and other individual providers. Preventable errors occur in healthcare because of the interaction between “latent” organisational system failures and “active” errors by frontline actors, possibly in ignoring or responding inappropriately to those system failures. Multiple latent conditions, or “organisational pathogens”, may be designed into the processes and structures of care thereby increasing the likelihood/risk of failure/error at the patient-provider interface, sometimes because of unforeseen interactions between pathogens.

Continuous learning and systems improvement

It should be clear by now that successful implementation of an ERAS programme requires not just the clinical studies showing that the intervention works in controlled study settings, and supportive culture but is also supported by a continuous organisational learning platform to understand what actually works in practice. Evaluation methods for assessing the effectiveness of ERAS therefore need to not only determine whether patient outcomes have been achieved, but also under what mechanism(s) were they achieved, for whom and in what context. This requires the creation of an internal learning system that can document the results of the Plan-Do-Study-Act (PDSA) cycles (15), harvest learning and share with other facilities and systems so that knowledge about implementation becomes as pervasive as the knowledge about the intervention itself.

Learning is the acquired, relatively permanent or persistent change of behaviour or behaviour potential resulting from instruction, training, and practice (intentional learning) or experience (incidental learning). In 1984, Kolb described an experiential learning model, which argued that learning occurs through a cycle of reflective observations of concrete individual or team experiences in order to gain an understanding of what can be learned from each specific experience. This adaptive learning approach supports new ideas, which are applied to future experiences, renewing the cycle and supporting the professional joy and practice of the clinicians.

What is next for ERAS?

Effective implementation processes are essential in achieving desired outcomes of health system initiatives. Whereas many approaches to Enhanced Recovery After Surgery (ERAS) implementation may seem straightforward, careful advanced planning, mapping out multiple stakeholder involvement, and addressing other contextual constraints needed for programme scale up and sustainability are complex. Interventions tend to have components beyond just clinical care, implementation activities are diverse, and contexts dynamic and complicated.

Diffusion of ERAS into mainstream surgical practice has been hindered due to minimal evidence of successful ERAS under routine conditions for management and resourcing ERAS. This makes meaningful ERAS improvement initiatives challenging to describe and evaluate as matching evaluation and programme designs can be difficult, requiring collaboration, trust and transparency. If this does not take place, results may be highly variable and lack credibility because the association between interventions implemented and outcomes achieved is obscure and attribution uncertain. Aligning the interests of all specialty stakeholders is the largest organisational challenge in implementing successful ERAS.

The lack of clarity and descriptions of the implementation strategies, report on implementation variables, and the context under which the implementation occurs hinder successful spread. Without the detailed context in which it was implemented one is often led to disappointment or outright failure of spread and scale-up efforts. The input of imbedded researchers into the design and conduct of ERAS improvement initiatives is essential in mitigating these potential problems.

Meaningful application of mixed health services research methods can serve as powerful tools for studying the impact of ERAS in diverse clinical settings, both for prospective studies about implementation and the analyses of retrospectively collected data. This can provide the means for transforming ERAS practice into evidence, and practice within uncertainty into deep knowledge. The process of learning is iterative and typically incremental, constantly being infused by everyday work experience and hard-earned lessons by clinicians providing clinical care.

The real challenge remains how to translate these findings into new settings. Introducing and implementing ERAS practice is a complex challenge requiring what Deming calls the “profound knowledge” of improvement. This involves four key components: (a) deep knowledge of the system through which ERAS is delivered; (b) understanding variation, and the aspects of variation that can be tolerated or even required (as in adaptations) and those that need to be eliminated; (c) willingness to experiment to continually improve and be bold in advancing testable theories of improvement and (d) engaging in the improvement process with transparency, truth telling and trust building.

While, emerging data is showing that thoughtful implementation of ERAS improves the opportunity for rapid, uncomplicated recovery after surgery with both short-and long-term benefits for patients, decrease patient readmission rates and leads to significant cost savings, the benefits can never be realised at scale without a rapid diffusion of ERAS into mainstream using timely and robust methods for systems improvement and clinician engagement.

The nature of complex systems such as ERAS is that small changes to inputs may produce large changes in results across the system. Thoughtful implementation with an eye on key system leverage points reinforced by engaged learning communities may result in rapid acceleration of ERAS uptake once a “tipping point” is reached. By the same token, negative feedback loops may result in rapid deterioration of uptake from which systems may find it difficult to recover. The ERAS implementation tools require thoughtful application, preferably bottom up, led by front line clinicians: they are not a hammer that can be universally employed in all circumstances. They are not an end in themselves. Instead they provide a starting place for systematic reflection, staff engagement, deepening trust and staff support, and supporting a culture of continuous improvement. The process of implementing ERAS should promote team engagement among clinicians, staff, administration, and patients. It is must be systematic and based upon measurement and consultation with all stakeholders involved in the process.

Even if initial outcomes are achieved, the practice could determine how to produce an even better outcome or achieve it more efficiently and with less cost.

 Lasting surgical quality improvement is necessary and requires significant change in how surgical care is delivered. It explicitly seeks to be not only better, but the best that the team can deliver under these care circumstances. The staff ownership of the ERAS improvement process and adaptability of the intervention to address future quality outcomes are considered strengths.

Key messages

1. The standardisation and integration of the multidisciplinary protocols should be based upon evidence-based medicine, quality enhancement, service improvement, simplification of processes and cost-efficacy.

2. Implementation of ERAS is difficult and requires a mental mindset change and respectful cooperation of many involved specialties, who all have their own needs and personal goals.

3. It is important to assign champions from each involved speciality who are charged by that specialty to make decisions on the multidisciplinary protocol on behalf of their specialty.

4. Compliance to the protocol is the best way to measure successful implementation of ERAS. Compliance on the postoperative protocol has proven to be the most difficult part.

5. Initiating ERAS works best by bottom-up initiatives of a few champions followed by top-down support to speed-up and strengthen implementation and to support uptake by other services.

6. Good preparation (assigning champions, making protocols and patient info materials, visiting ERAS team courses, and training teams) and adopting a an implementation process, preferably with ERAS-teacher is crucial to success.

References available on request.

Utilising genomic medicine to improve the care of children with cancer

Article-Utilising genomic medicine to improve the care of children with cancer

With the advent of genomic technologies, the treatment of cancer is rapidly evolving. Advances in the understanding of the biological drivers of certain cancers have led to the development of targeted therapies, designed to disrupt abnormal disease pathways and lead to the death of cancer cells while sparing healthy cells.

Many of these remarkable advances are applicable in the treatment of children and adolescents with cancer. Still, much about cancer, particularly relapsed and resistant disease, remains unknown. At Children’s Mercy, genomic medicine is considered a critical aspect of the care of every patient treated for cancer.

Offering sequencing to paediatric patients

The Center for Pediatric Genomic Medicine (CPGM) at Children’s Mercy was the first of its kind to be housed within a paediatric hospital. Shortly after its founding in 2011, the CPGM gained national attention for detection of pathogenic genomic abnormalities in neonates by rapid whole genome sequencing. Since then, the CPGM has become a centre for innovation in translational genomic medicine. It offers novel technologies, such as epigenomic, transcriptomic, and single cell sequencing, to patients with malignant and non-malignant diseases.

The centre’s flagship initiative, Genomic Answers for Kids, integrates clinical findings, family history, and biological samples from children and their family members with rare diseases, including cancer. The CPGM is leading the way in advancing genomic medicine for the care of children by collaborating and sharing data with researchers in the medical community.

Clinical testing

The Cancer Genomics Program at Children’s Mercy consists of paediatric providers from the Division of Hematology/Oncology/Bone Marrow Transplantation, the Department of Pathology, and the CPGM. Molecular testing and sequencing are performed in-house, providing the distinct advantage to be able to assess diagnostic clinical data in conjunction with germline (constitutional) and somatic (cancer-specific) variants.

 A team of dedicated cancer bioinformaticists and molecular oncologists analyse the variants and the findings are discussed in a multi-disciplinary tumour board, which includes the clinical paediatric oncologists. Treatments are then tailored to each patient’s needs, resulting in uniquely personalised medicine.

Biobanking and research

Patients and their immediate family members are also given the option to enrol in a biobanking protocol, approved by the Children’s Mercy Institutional Review Board. Patients who opt in agree to donate left-over blood, bone marrow, and tissue samples for long-term storage and research. Each sample is annotated with detailed clinical information regarding the patient’s diagnosis, treatment, and outcome. The Oncology Biorepository is housed within the Children’s Research Institute (CRI) at Children’s Mercy and de-identified samples are available to investigators at Children’s Mercy and in partnering research institutions.

Thanks to the generous support of philanthropic donors and the CRI, the biobank routinely performs sequencing of DNA, RNA, and single cells from each patient’s tumour sample at diagnosis, remission, and if the patient experiences a relapse. Thus, the biobank at Children’s Mercy is generating an enormous resource consisting of invaluable sequencing data, generated prospectively from all types of paediatric cancer samples.

Improving outcomes for infants with ALL

Acute lymphoblastic leukemia (ALL) with KMT2A gene rearrangement is a rare and devastating cancer. Only about one in three infants survives the disease, despite very intensive chemotherapy. Bone marrow transplant and immunotherapies have not improved survival outcomes. At Children’s Mercy, we are working to find targeted cures for this heart-breaking cancer. We have partnered with researchers at Johns Hopkins University School of Medicine to study the genomic biomarkers of infant ALL, by performing genome, exome, transcriptome, methylome, and single cell sequencing of samples from more than 40 infants at the time of initial diagnosis, at remission, and at relapse.

This is the largest study of its kind in infant ALL and the sequencing is being exclusively performed in the CPGM. We hope to uncover new targets for cancer-directed therapies, to improve remission and long-term cure rates for infants with ALL.

Comprehensive care

Children’s Mercy is a full partner and the primary paediatric cancer provider in the National Cancer Institute (NCI)-designated University of Kansas Cancer Center Consortium and is a member of the NCI’s Children’s Oncology Group (COG) Cooperative Group. Children’s Mercy Cancer Center employs 27 paediatric faculty subspecialists with expertise in paediatric cancers, blood disorders, immunotherapies, and stem cell transplantation. The Cancer Center integrates disease-focused programmes, including the leukaemia and lymphoma, brain tumour, and solid tumour programmes, with comprehensive care-focused programmes, such as the Cancer Genomics, Cancer Predisposition (SPoT), Survive & Thrive, Adolescent and Young Adult (AYA), and Spanish-Speaking (HOPE) programmes.

Children’s Mercy Cancer Center offers enrolment in national and international clinical trials, including experimental therapeutics trials, and was one of the first sites in the U.S. to participate in clinical trials of chimeric antigen receptor T-cell therapy (CART) for paediatric acute lymphoblastic leukemia. Every patient treated at the centre receives care from a multi-disciplinary team of paediatric subspecialty providers, with support from nursing, child life, nutrition, pharmacy, psychology, physical and occupational therapy, palliative care team, and social work. 

The biology of recovery

Article-The biology of recovery

A brain injury is often called the most complicated injury in the most complicated organ in the human body. The almost unlimited variations of the human mind can create huge barriers for caregivers and researchers on how to approach treating a brain injury. Having a robust team approach to manage both the biologic and psychologic factors is critical, as is having access to the latest research and scientific approaches. For patients at Spaulding Rehabilitation Hospital in Boston, that convergence of novel science and excellence in care is available each day.

As a world-recognised leader in research and innovative physical medicine and rehabilitation, Spaulding believes in fully integrating research into the care environment via the work of clinicians and therapists who work directly with patients and researchers in labs. Through its Spaulding Research Institute, there are over 100 active studies in a wide variety of diagnoses from stroke, brain injury, spinal cord injury, musculoskeletal injury, chronic pain and more, and the hospital’s clinicians and researchers are some the most prolific in the field.

New ideas and a passion for discovery are part of the daily work at Spaulding, the principal teaching hospital of the Harvard Medical School Department of Physical Medicine and Rehabilitation. This academic affiliation combined with its connections to world-renowned centres of healing such as Massachusetts General Hospital and leading innovators of science such as MIT, help Spaulding maintain a vigorous research agenda and operate ongoing clinical trials.

Spaulding’s work in brain injury, led by Dr. Ross D. Zafonte, the Earle P. and Ida S. Charlton Professor and Chairman of the Department of Physical Medicine and Rehabilitation at Harvard Medical School, can best highlight this forward thinking integrated approach to care. Dr. Zafonte also serves as Chief of Physical Medicine and Rehabilitation at Massachusetts General Hospital and Brigham and Women’s Hospital, as well as Senior Vice President of Medical Affairs, Research and Education at Spaulding Rehabilitation Network. His textbook is considered one of the standards in the field of brain injury care. The doctor brings a focus on looking at ways to discover new approaches to care that combine science and personalised medicine.

“What we see in so many of areas of healthcare now is the understanding that individuals are multifactorial, and we have to look at customised approaches to care and science to enable the best recoveries. This is more illustrative than ever when we look at the brain injury population, on why those methods can produce the greatest outcomes,” said Dr. Zafonte.

Often referred to by Dr. Zafonte as “The Biology of Recovery” is the acknowledgement that each person’s unique biological profile contributes to their type of injury and in turn what they may need to recover. The idea of personalised medicine is expanding in everything from wellness programmes to mental health. Applying it in rehabilitation medicine often requires the skill of clinicians to evaluate a patient on who they are and design a unique care plan based on their factors to achieve the greatest outcomes.

Spaulding’s Brain Injury Rehabilitation Programme provides cutting-edge rehabilitative care for adults and children recovering from an acquired brain injury as a result of trauma (such as an accident) or from non-traumatic causes.

An area that is informing brain injury research is sports. In the U.S., collision sports such as American Football and Ice Hockey have garnered attention for new advances and understanding of a type of brain injury – concussion.

Concussions are the sudden displacement of the fluid surrounding the brain causing impact of the brain against the inside of the skull. This damage can be immediately evident or cumulative over time, but often the lasting impacts are devastating resulting in memory loss, loss of function, mental health issues, and more. However, what is so challenging for clinicians is that there are many factors, some societal and unique to each person, that require individualised treatment.

The Harvard Health Football Players Study, which is the largest study of its kind, examines the long-term impacts on retired professional American football players in a multifactorial way. From examining everything right from mental health to biologic profiles of players, researchers hope to learn new methods and models that can help more accurately diagnose and support those with brain injuries from collision sports.

The study has already yielded high impact studies published in major journals including one that showed that mortality rates varied based on the collision rates in sports, and one published in JAMA in Neurology on the loss of sexual health function in men based on sports in which they participated.

Global awareness

The work of Spaulding and Dr. Zafonte has gained global notoriety on two fronts in the world of sports and entertainment in the past year. In the 2018 Champion’s Cup Final, Liverpool goalkeeper Loris Karius suffered a horrific collision on the field in the 3-1 loss to Real Madrid, in front of an audience of millions around the world. It was later learned that he had suffered a concussion and was able to get the support and treatment needed with a team from Spaulding and Mass General.

In the Spring of 2019, renowned actress Emilia Clarke, best known for her portrayal of Daenerys Targaryen on Game of Thrones, revealed to the world she was a brain injury survivor. As part of that broadcast, she announced the launch of her SAMEYOU Foundation to fund brain injury research and education. Clarke also announced that Spaulding would be the first U.S. based charity partner and immediately launched an online campaign to raise over US$1 Million for new studies into brain injury led by Dr. Zafonte.

Brain injury 1.jpg

Actress Emilia Clarke, a brain injury survivor, partnered with Spaulding to launch the SAMEYOU Foundation to fund brain injury research and education.

As a U.S. News and World Report highly ranked Best Hospital (#3 in 2019), Spaulding recognised an ever-increasing global need for rehabilitative medicine and the opportunity to provide support and expertise in areas such as traumatic brain injury.

For Spaulding, that commitment to creating partnerships overseas began over six years ago with a consulting project with a group looking to create a new rehabilitation facility in the UAE. It became evident very quickly to the leadership at Spaulding that there was a dearth of rehabilitation medicine expertise and a significant growing need internationally. However, before diving in fully, Spaulding collaborated with other leading institutions to identify the best approach and locations where experts from Spaulding could make an impact.

Among the many pitfall’s healthcare organisations have found is trying to recreate or “set up shop” with an owner/operator model. This method becomes a labour and resource intensive exercise. Also, a classic traditional consulting model has a focus on the short-term and is generally project based. Rather, Spaulding leaders decided to take a collaborative model approach with an emphasis on long-term commitment, knowledge transfer and sustainable outcomes.

This approach serves to allow for local ownership, where organisations could tap specific expertise to apply it to the needs that best work within their culture and population. To lead these efforts to evaluate, create, and foster productive relationships internationally, Spaulding International, LLC was established.

“What we have found is a real desire to look for collaborators who can provide clinical expertise but also the openness and flexibility to understand that there is no one size fits all approach, and this is a different situation than in the U.S.,” said Bob McCall, Senior Vice President of Network Development. “What is rewarding is we feel that we have found emerging rehabilitation markets that can truly benefit from our clinical expertise and cutting-edge research to improve the lives of people. This also helps us create new revenues that support new pathways of research. We are just scratching the surface of the need across the globe.”

Services and approaches offered by Spaulding include hosting clinicians on-site for mentoring and training, virtual training via video conferences, tailored sharing of best practices, and more. In many areas internationally, there are massive acute care campuses of many thousands of beds; however, there are no formal home care services, limited outpatient programmes and a severe shortage of rehabilitation beds.

“For our team what has been very exciting is learning new ideas and best practices we take back to Spaulding. In many ways the technologies and processes for patient support, hospital wayfinding, and family response are outstanding,” said McCall. “Our goal is to build true collaborations that result in a productive sharing of ideas, culture and resources that ultimately enable all of us to better serve the populations entrusted to our care.”

Daily Dose

How is Malaffi accelerating the delivery of better-quality healthcare?

Article-How is Malaffi accelerating the delivery of better-quality healthcare?

Created as a Public Private Partnership between the Department of Health – Abu Dhabi (DOH) and Injazat Data Systems, a subsidiary ultimately of Mubadala Investment Company, Malaffi is the region’s first Health Information Exchange (HIE) platform.

Being a universal, Emirate-wide initiative, Malaffi will safely and securely connect all public and private healthcare providers in the Emirate of Abu Dhabi, enabling the meaningful, real-time exchange of important patient health information between healthcare providers – ultimately creating a centralised database of unified patient records.

Previously, providers operated on individual Electronic Medical Records (EMR) systems, which meant patient information remained in silos within the boundaries of each provider’s EMR and was not accessible to other attending providers.

Through Malaffi, providers – and the industry as a whole – now have unmatched opportunities to continue improving care in a way that has never been feasible on such a scale before. This means the platform allows providers to source crucial healthcare data that will be used to improve the coordination of care and allocate healthcare resources more efficiently to ultimately advance patient outcomes and support the provision of world-class care across the Emirate.

Benefits to healthcare providers

Through Malaffi, almost 2,000 Abu Dhabi providers will be able to access crucial patient medical information; ultimately enhancing the quality of healthcare and improving patient outcomes. The safe, secure and meaningful exchange of important patient health information brings many benefits to providers, including increased workforce satisfaction as a result of easier access to comprehensive, timely health information.

Most importantly, the platform brings together key patient data, including patient demographic information, medication, allergies, laboratory and radiology results, procedures and much more; all recorded at the different providers across the Emirate of Abu Dhabi. As such, Malaffi facilitates better care coordination and transition of care, better-informed decision making at the point of care, and improved management of chronic illnesses and emergencies.

With providers having more information about their patients, they can reduce the unnecessary duplication of diagnostic and treatment procedures, which in consequence increases efficiency, patient experience and satisfaction. For example, in the U.S., the implementation of a HIE system resulted in a 12 per cent reduction in consultations by multiple physicians, a 7 per cent reduction in the emergency department length of stay, a 4.5 per cent reduction in readmission odds within 30 days1 , and a 25 per cent decrease in the odds of imaging procedures being repeated2.

Similarly, in Finland – over a five-year period – there was a reduction of over 43 per cent in primary care referrals to specialist care, and a 16 per cent reduction in the number of radiology examination within primary care3.

Malaffi’s benefits are countless and elevate healthcare standards across Abu Dhabi, as essentially, a patient’s medical information is critical to making all the difference between a correct diagnosis or an incorrect one, and it can ultimately save lives, especially in an emergency.

Elevating healthcare standards across Abu Dhabi through Malaffi

H.E Mohammed Hamad Al Hameli, Undersecretary of the Department of Health – Abu Dhabi, said: “We are firmly committed to providing the very best healthcare solutions and technologies to the people of Abu Dhabi. In line with our future-forward vision, we are proud to see a series of milestones for Malaffi in its journey to utilise technology to improve patient outcomes. This is a shared goal across the Emirate, evident through the active participation of leading healthcare providers, both private and public, to adopt the new Malaffi system. We look forward to more milestones in the coming months as we create a better-connected healthcare system and ultimately a healthier Emirate.”  

Malaffi’s progress update

At present, the Malaffi database contains more than 38 million patient records for more than 3 million patients, who are being treated and their care managed through Malaffi by over 15,000 doctors and care teams utilising the platform. To date, 1,732 facilities in Abu Dhabi have signed the Participant Agreement, and 406 facilities have been onboarded, with many more in the pipeline. Some of the onboarded providers include Abu Dhabi Health Services Company (SEHA), Mediclinic Al Noor Hospital, Kanad Hospital, UEMedical Group, Cleveland Clinic Abu Dhabi and Healthpoint.

During 2020 Malaffi will be launching a patient mobile application to help patients better manage their health. Once logged onto the portal or by downloading the app, patients will have their own medical information at their fingertips.

To learn more about Malaffi and preview the patient app, visit the Department of Health – Abu Dhabi stand (Hall 5, Booth H5.B10) or log on to https://www.malaffi.ae/en/.

References

1. Janakiraman, R. et al. (2017) The Effects of Health Information Exchange Access on Healthcare Quality and Efficiency: An Empirical Investigation. Mays Business School Research Paper No. 2915190.

2. Vest, et al (2014), Health Information Exchange and the frequency of repeat medical imaging, Am. Journal of Managed Care,

20: 16 –24

3. Maenpaaet al. (2011) Outcomes assessment of the regional health information exchange a five‐year follow‐up study. Methods of Information in Medicine, USA, Rochester, New York ↓ 25%Odds of Imaging Procedure being Repeated *Vest, et al (2014), Health Information Exchange and the frequency of repeat medical imaging, Am. Journal of Managed Care.

Increased hope for patients with life-limiting heart disease

Article-Increased hope for patients with life-limiting heart disease

Cardiovascular disease (CVD) remains one of the leading causes of fatality in the Middle East. Faulty heart valves are a common cause of CVD and can be a result of age-related changes to the heart. In the UK, experts at Royal Brompton and Harefield Hospitals Specialist Care have led the way in recent years to develop new lifesaving alternatives for patients with faulty valves. These innovative options are suited to patients who are at increased risk from conventional open-heart surgery, or who might benefit from a minimally invasive approach.

The transcatheter valve service was established in 2007, which means it is now 12 years since the first transcatheter aortic valve implantation (TAVI) at Royal Brompton and Harefield Hospitals. The service brings together a multi-disciplinary team, including surgeons, cardiologists, anaesthetists, imaging experts and specialist nurses to ensure patients of all ages have access to innovative treatments for the two most common heart valve conditions, aortic stenosis and mitral regurgitation, which between them account for well over 75 per cent of all patients with valve disease.

The transcatheter programme is led by consultant interventional cardiologists’ Dr. Simon Davies and Dr. Robert Smith and is unique in the UK in terms of volume of TAVI activity, the complexity of cases treated, for the range of catheter-based procedures used to treat the mitral valve, pulmonary valve, and tricuspid valve.

Dr. Davies explains: “For many high-risk patients’ conventional open-heart surgery is not an option, however, the expertise available at Royal Brompton and Harefield Hospitals ensures that patients have access to the most suitable alternative procedure.”

Which patients benefit most?

Due to an ageing population and the ever-increasing number of patients requiring heart valve repair or replacement later in life, the minimally invasive procedures available at Royal Brompton and Harefield Hospitals are particularly beneficial to older patients, who often have co-morbidities and are at high-risk for conventional surgery.

Some of the techniques being used by Royal Brompton & Harefield Hospital experts were pioneered at our hospitals, with the very first patients in the country – or sometimes even the world – benefitting from new revolutionary procedures.

Patients from across the globe are benefiting from greater choice than ever before and have access to world-class specialist treatments that are not widely available elsewhere. Whilst each patient is individually assessed to ensure the best treatment path and procedure. Here we describe some of the novel techniques our team has undertaken.

Aortic stenosis

The aortic valve is the outlet valve from the main pumping chamber, and it controls the blood flowing out of the heart and to the body. Aortic stenosis is the most common and serious form of valve disease. With advancing age, the valve can become progressively stiff and narrow as a result of calcium deposits, making it more difficult for blood to leave the heart. As blood flow through the valve becomes significantly restricted, symptoms can include breathlessness, chest pain, fainting and palpitations.

Procedure: TAVI

Royal Brompton and Harefield Hospitals specialists run the largest programme in the UK for transcatheter aortic valve implantation (TAVI). The only effective long-term treatment for aortic stenosis is to replace the aortic valve, therefore, TAVI is a lifesaving non-surgical alternative for many patients. 

For those suffering from aortic stenosis, one of the only options in the past for treatment was open heart surgery to replace the valves that are failing. The TAVI procedure is a less invasive form of aortic valve replacement that can be offered, whereby a new aortic valve can be implanted either via the arteries in the groin, the arm, directly into the aorta or via a small cut in the chest.

During the procedure, which can be performed under general or local anaesthetic, a catheter is guided through an artery to the patient’s heart using special scanning equipment. The new valve is then placed within the narrowed aortic valve and expanded to relieve the obstruction.

Since none of these methods require the breastbone to be cut or open-heart surgery to be performed, they are less traumatic than conventional surgical aortic valve replacement. This procedure should cure aortic stenosis, so reducing the risk of heart failure and any shortness of breath, chest pain or fainting.

The Royal Brompton & Harefield Hospital team has expertise with many of the different TAVI devices currently available. They have considerable experience in using TAVI to treat previously implanted surgical aortic valves that are showing signs of degeneration.

Mitral regurgitation

The mitral valve is the inlet valve to the main pumping chamber. It separates the upper left heart chamber from the lower left chamber and helps control blood flow through the heart. 

Mitral regurgitation (MR) occurs when the valve becomes damaged and fails to close properly. This results in blood flowing backwards or leaking, through the valve when the heart contracts.

There are several conditions that can lead to MR, but most commonly it is the valve becoming weaker over the years from ‘wear and tear’ or persistent high blood pressure. Symptoms can include shortness of breath, tiredness, dizziness and chest pain.

As every patient is different it is important to have a variety of treatment options. These include MitraClip, mitral valve-in-valve and valve-in-ring implants with different devices, transcatheter mitral valve implantation with the Tendyne system, and transventricular mitral neochordal implantation utilising the Neochord system. The Royal Brompton & Harefield Hospital team has an international reputation in these fields.

Procedures

Tendyne

In late 2014, a 68-year-old patient with mitral regurgitation became the first person in the world to have the ‘Tendyne Transcatheter Mitral Valve (TMVR)’ system, which was implanted at Royal Brompton Hospital. 

The tissue valve replacement is placed into a patient’s beating heart without the use of cardiopulmonary bypass, commonly known as a heart-lung machine. It is implanted via a catheter through a small incision between the ribs. During the procedure, the novel Tendyne device can be repositioned as necessary, allowing the surgeon to precisely place the device during implantation, which improves patient outcomes.

MitraClip®

Royal Brompton and Harefield Hospitals is one of the most experienced centres in the UK for this minimally invasive procedure to treat MR, having undertaken more than 250 cases to date, more than double any other UK hospital. MitraClip is a relatively new ‘keyhole’ technique that offers a less invasive approach to conventional surgery.

A catheter is inserted through the top of the patient’s leg and via the femoral vein, and a small hole is made to enable the catheter to cross from the right to the left side of the heart.

The MitraClip device is a small clip that is attached to the mitral valve. It treats MR by allowing the mitral valve to close more completely, helping to restore normal blood flow through the heart. The MitraClip procedure is guided by both x-ray and transoesophageal echocardiogram (TOE) to ensure the best possible outcome. The MitraClip device is then steered into the left atrium and can literally ‘clip’ the leaking portions of the valve leaflets together. The procedure immediately reduces MR.

NeoChord

The NeoChord procedure is an innovative approach used for beating heart mitral valve repair. Using a minimally invasive technique, implantation of transventricular neochordae (artificial chordae) under live echo guidance enables treatment of severely regurgitant mitral valves. The procedure provides real-time confirmation of mitral valve repair without the need for an incision through the breastbone or temporarily stopping the heart.

Royal Brompton Hospital is one of the only centres in Great Britain with expertise in beating heart mitral valve repair with NeoChord. High-risk patients with MR who have been declined treatment at other UK centres have been offered successful treatment at the hospital with this procedure.

Expert team approach

The multi-disciplinary approach adopted by the transcatheter valve team has led to Royal Brompton and Harefield Hospitals experts pushing boundaries and routinely carrying out increasingly complex operations with excellent outcomes.

Dr. Davies comments: “For most patients with heart valve disease, conventional surgery is still the standard treatment. However, for many patients this is not an option because of their advanced age, frailty, or other medical problems.

Over the last three decades the average life-expectancy in the Middle East has steadily increased, the international expertise of the Royal Brompton and Harefield Hospitals multi-disciplinary team can be invaluable in ensuring that patients have access to an alternative life-saving procedure. The Royal Brompton and Harefield Hospitals team carefully review each individual patient and advise which of the above procedures may be suitable.”

Lowering cholesterol with injectable medicine to decrease cardiovascular disease

Article-Lowering cholesterol with injectable medicine to decrease cardiovascular disease

Every second one person will die from cardiovascular disease somewhere in the world. There are more than 17 million people who die every year from heart disease.

The big question is why do people have a heart attack?

In spite of extensive research all over the world, the definite answer is not available yet, but these researches showed the “risk factors” which include hypertension, dyslipidemia, diabetes, smoking, obesity, lack of exercise, unhealthy diet, too much of stress, genetic factors, ageing, hormonal factors, among others. Many of those risk factors are modifiable. The study showed that the stricter there is control of the modifiable risk factor, the more likely there is a chance of decreasing having cardiovascular disease including heart attack.

For controlling cholesterol, Statin has been the gold standard treatment for lowering the bad cholesterol (LDL). Many studies confirmed that lowering LDL decreases the chance of developing cardiovascular disease, and if it was given to the people who already have cardiovascular disease it significantly decreases the chance of having recurrence of cardiovascular events.

For those patients who already sustained heart attack, stroke, gangrene or other cardiovascular atherosclerotic event, it is very crucial to have stricter control of the risk factors because they have a significantly higher chance for those events to reoccur again. For those patients it is recommended to have maximal dose Statin to bring the LDL below 70 and even research and guidelines suggest bringing the LDL below 55 on those patients who are at very high-risk atherosclerotic disease.

Most patients tolerate Statin well and many of them reach the target by using the maximal dose of Statin with or without Ezetimibe. However, there is still significant number of patients who cannot tolerate Statin. In addition, there are fewer patients who are on maximal dose of Statin and Ezetimibe but are still not reaching the target (less than 55) in high risk patients. For those patients there is a new group of medicine called PCSK9 inhibitors, which works to lower the cholesterol through a different mechanism.

The two that are commercially available are Alirocumab and Evolocumab. Those medicines are strong and safe; they can lower LDL about 60 per cent. It used as an injectable form, one injection every two weeks.

Major studies

Two major studies, Fourier and ODYSSEY outcome studies, which include close to 45,000 patients, showed that using those new medication “PCSK9 inhibitors” can lower the LDL about 60 per cent and may bring LDL to 25 or even less than 15. This translated to lowering the cardiac event close to 15 per cent extra to the maximum treatment with the standard of care.

Evolocumab, or the brand name Repatha, comes with an injection of 140mg twice a month or it can be 420mg once a month. Another medicine is Alirocumab (Praluent) that is 75 mg or 150 mg and can be given twice a month.

Results

Short term and intermediate terms of up to five years showed using those medicines are safe despite of lowering the LDL to very low level, down to 25 or even to 15 mg. There was a concern that very low LDL may increase the risk of hemorrhagic stroke, diabetes, liver disease or other complications but it turned out that there is no increase in any of the side effect if LDL is lowered to a very low level.

Now with the new medications available, we can almost bring the LDL to the target, which is less than 55 mg in very high-risk patients.

The main concern of those medications is the cost because the monthly cost is about US$600. If the price came down and there was more widespread use of these medications, there will be a much higher percentage of patients achieving the targeted LDL and that will hopefully be translated to significant lowering of incidents of heart attack, stroke or death.

Bariatric Endoscopy: From development to daily practice in obesity care

Article-Bariatric Endoscopy: From development to daily practice in obesity care

“Mrs. ABC, 50 years old, visited our clinic seeking advice for the management of obesity. Her weight was 95Kg and the body mass index of 39 Kg/m2. She had diabetes mellitus on insulin, hypertension requiring two medications, and obstructive sleep apnea. She started gaining weight after her second pregnancy 10 years ago. She has changed four jobs in the last five years because of difficulty in walking. She has tried several measures to lose weight but has failed. She has heard unpleasant stories about bariatric surgery and is afraid of going under the knife. She underwent endoscopic sleeve gastroplasty and lost 25kg in two years. Her life has transformed drastically now….”

Obesity is a disease that has reached epidemic proportions in the Middle East and across the globe. The healthcare cost involved in treating obesity has inflated exponentially. Compared to people with normal weight, it has been shown that overweight and obese are at increased risk of developing diabetes mellitus, hypertension, cardiovascular disease, stroke, and obstructive sleep apnoea. They are also at higher risk of 13 different types of cancers and increased mortality. Besides, the quality of life and productivity of obese individuals are shown to be very low.

Obesity is a multifactorial disease with a complex pathophysiology. There exists a strong link between genetic, environmental and social factors, and obesity development. However, among the public and healthcare professionals, it is often considered as a self-inflicted problem, and people with obesity are generally stigmatised and discriminated against.

This has considerably discouraged patients from discussing their weight during the consultation or even seek medical attention for obesity. Studies have demonstrated that individuals delay at least six years before consulting a physician for obesity. More often, these patients are eschewed away with “eat less and exercise more” advice than having a concrete long-term care plan.

It is high time that we change our practice and healthcare policy and start recognising obesity as a chronic disease and design treatment with clear outcome goals similar to other chronic diseases. Currently, several treatment options are available to treat obesity. This includes the modestly effective medical therapy to the most effective surgeries. Despite the availability of such effective treatment options for several decades, we have not been able to penetrate and treat more obese patients successfully. To date, studies have demonstrated that only 1-2 per cent of obese patients undergo surgery because of fear of complications, invasiveness of the procedure, cost, and irreversibility. This has created a big void in obesity treatment.

What is new in obesity treatment?

The field of interventional endoscopy has experienced a monumental change in the last decade where the course for many gastrointestinal diseases has been changed dramatically. A new discipline called bariatric and metabolic endoscopy is evolving with numerous innovations and treatment options targeting different pathways of obesity and its comorbidities. We have several space-occupying devices to restrict the food intake, change the motility of the stomach, and induce weight loss. More than ever, we are now able to reduce the gastric volume similar to surgery without resecting a portion of the stomach.

The endoscopic sleeve gastroplasty (ESG) and the primary obesity surgery endoluminal (POSE-2) narrows and shortens the size of the stomach significantly and induces weight loss. From our extensive experience performing these procedures, we have demonstrated that the total body weight loss is significant and sustained with continued follow-up.

Other researchers have also shown improvement in metabolic comorbidities after these gastroplasty procedures. The beauty of the endoscopic procedures are it’s a) effective, b) minimally invasive in nature, c) leads to short hospital stay (24hours), d) negligible complication rate, and e) repeatability. Recently, techniques like the duodenal mucosal resurfacing and duodenal-jejunal bypass liner are being studied to treat diabetes mellitus, and the early results are promising.

How can we enhance results?

The endoscopic treatment options now open the door for many obese patients to seek treatment at a lower risk. However, the patients should not approach it as a “one-stop and done” attitude. The success of the procedure depends on regular follow up, setting up realistic goals and expectations, and adhering to the multidisciplinary advice. From our research, we have repeatedly demonstrated that the weight loss is augmented and sustained with long term follow up and sub-optimal in those who take less responsibility in adhering to the post-procedure instructions.

How to train in Bariatric and Metabolic Endoscopy service?

Training in obesity management requires a three-pronged approach – 1) understanding the basic concepts of obesity and its pathogenesis, b) building a multidisciplinary collaboration to manage obesity, and c) becoming proficient and well-versed in different endoscopy techniques. Unlike general endoscopy training, there are only a handful of centres around the world that can offer in-depth fellowship training in obesity. Most of these advanced endoscopic procedures have a steep learning curve and requires dedicated training to understand the concepts, and learn to manage the complications. Our dedicated bariatric endoscopy unit in HM Sanchinarro University Hospital, Madrid, offers a multitude of bariatric procedures including intragastric space-occupying devices, endoscopic gastroplasty (ESG and POSE-2), and bariatric surgery revision procedures.

Our high-volume unit performs 30-40 procedures per month. The centre has a well-established and experienced multidisciplinary (Nutrition, Psychology, and Endocrinology) team that has a standardised follow-up protocol to achieve the best results. In addition, we organise the annual Madrid International Bariatric Endoscopy meeting bringing together world experts to discuss the new developments in obesity.

We also host small group, didactic bariatric endoscopy master class series, three to four times a year, to assist interested physicians in learning the principles of bariatric endoscopy. We strongly believe in education, training, and collaboration to disseminate the knowledge and strive to fight the obesity pandemic successfully.

It is not possible to curb the rise of obesity if we do not recognise and approach it holistically in our daily practice. Let us start taking obesity seriously and embark on treating it at an early stage using newer effective therapies to prevent the development of complications and to improve the quality of life and productivity.

From the design thinking perspective, it is a win-win situation both for the individuals and policymakers. 

References available on request.

Double trouble: Fatty liver in people with diabetes

Article-Double trouble: Fatty liver in people with diabetes

Fatty liver is the accumulation of fat in liver cells, which is otherwise not a normal place for fat storage. Long standing fat in liver can damage the organ in some people and gives rise to fatty liver disease. Fatty liver can arise from excessive alcohol consumption, in that case it is called alcoholic fatty liver disease. But here we are discussing another type of fatty liver disease, which occurs in people who do not consume significant amounts of alcohol. This is called non-alcoholic fatty liver disease and is related to unhealthy lifestyle and excessive body weight (obesity). This is the most common liver disease worldwide. In the U.S., fatty liver disease is the second most common reason for liver transplantation.

What is the connection between fatty liver and diabetes?

Diabetes is another disease that is linked to unhealthy lifestyle and obesity. That is the reason fatty liver is strongly related to diabetes as well. Not only this, diabetes accelerates the progression of simple fatty liver to more severe liver diseases such as inflammation of liver (technically called non-alcoholic steatohepatitis, NASH), fibrosis, cirrhosis (scarring of liver) and even liver cancer in some patients. These are the long-term liver-related consequences of fatty liver disease.

Fatty liver individuals who have progressed to fibrosis stage are more prone to develop cardiovascular disease (heart attack and stroke) and chronic kidney disease. These are the long-term non-liver-related consequences of fatty liver disease.

How common is fatty liver in diabetes patients?

Fatty liver disease in patients with diabetes is a public health problem. Let’s see the burden of this disease in India. There are more than 72.9 million individuals living with diabetes in India (IDF 2019 data). Among these individuals, 60-70 per cent, that is approximately 50 million, have fatty liver disease. Twenty-five per cent of 50 million individuals, that is 12.5 million, have inflammation of liver (NASH). Among these NASH patients, 1.25 million have cirrhosis (scarring of liver) without significant symptoms. Among these cirrhosis patients, 375,000 patients have decompensated cirrhosis, that is with bleeding through mouth, water retention in the abdominal cavity (ascites) and other liver-related symptoms. Seven per cent of this population, that is 87,500, have liver cancer. The worst thing is that most of these patients remain undiagnosed till they develop severe complications. This is because we have no nationwide screening programme for this condition.

What causes fatty liver disease?

Fatty liver disease, like type 2 diabetes and obesity, is a lifestyle disorder. It stems from long-term over-nutrition and under-activity. When there is unhealthy lifestyle and obesity in individuals with predisposing genetic background, the free fatty acid pool expands in the liver. Free fatty acids are at the central of fatty liver disease. The liver gets free fatty acids mostly from fat depot (adipose tissue). It also gets free fatty acids from diet, by converting glucose and fructose to fatty acids. These fatty acids are partly utilised by the liver for energy production and partly packaged into VLDL (a type of vehicle for triglyceride) to put back into circulation.

When there is no substrate overload (therefore little free fatty acids), these two processes are enough to dispose of all the fatty acids that the liver receives. When there is substrate overload, a good proportion of free fatty acids are esterified and converted to triglyceride, which are then stored in the liver cells as fat droplets. This is simple fatty liver and helps in accommodating excess fatty acids in a benign manner. When these disposal mechanisms are overwhelmed, harmful lipid species (modified free fatty acids) are formed which lead to inflammation in the liver by activating several inflammatory processes. Unbridled inflammatory processes damage liver cells and when the liver repair mechanisms are overwhelmed, liver stellate cells are activated that give rise to fibrosis of the liver. The good news here is that even if there is significant fibrosis, if the initial processes are reversed, for instance by reducing free fatty acid load by lifestyle measures, the fibrosis is reversible.

But when the unhealthy processes remain unchanged and unchecked, the overwhelming fibrotic processes lead to cirrhosis and further complications. The condition is irreversible once it has progressed to the cirrhosis stage.

How should doctors identify high risk patients?

As already mentioned, only a small proportion (10-20 per cent) of patients with simple fatty liver progress to more advanced liver conditions, such as inflammation stage, fibrosis stage or to the cirrhosis stage. In other words, a large number of patients with simple fatty liver remain as such for their whole life without developing other stages of fatty liver disease. So, to tackle this disease at the simple fatty liver stage, beyond lifestyle changes, would not be cost-effective.

Now the million-dollar question is how to identify those patients who are at high risk for progressing to higher stages of the liver disease. A simple answer to this question is that we do not know. A number of studies have revealed that the individuals who have already progressed to fibrosis stage are at higher risk for developing complications, both liver-related (cirrhosis and liver cancer) as well as non-liver-related (heart attack, stroke, chronic kidney disease, etc.).

As fatty liver disease is so prevalent, we can’t do invasive testing (such as liver biopsy) or expensive testing (such as magnetic resonance elastography) for detecting fibrosis stage among all fatty liver disease patients. One doable approach is to apply serological scoring systems that have been developed for this purpose. Two useful scores are fibrosis-4 (Fib-4) and NAFLD-fibrosis score (NFS). We are using fib-4 score for sorting out high-risk fibrosis patients in our facility.

The screening protocol works as follows: Fib-4 scoring is done for all patients with diabetes, which uses four simple parameters, such as age, two liver enzyme levels (SGOT, SGPT) and platelet count. An online calculator gives a score. If the score is less than 1.45, there is 90 per cent probability that this individual has no significant fibrosis.

For this individual, we prescribe standard diabetes care including lifestyle measures (category 1 management). For those patients with Fib-4 score 1.45 or more, we send them for fibroscan. Fibroscan is a non-invasive method for measuring liver stiffness (a surrogate marker of liver fibrosis). When the score is less than 8.0 kPa, they receive category 1 management. When the score is between 8.0 to 12.0 kPa, they are sensitised for liver complications, are motivated to reduce weight by at least 10 per cent, and the anti-diabetic drugs such as pioglitazone, SGLT-2 inhibitors or GLP-1 receptor agonists are prescribed whichever feasible. This is category 2 management.

When the score is more than 12.0 kPa, they receive category 2 management plus they are referred to specialised care (hepatologist) for screening for oesophageal varices, ascites, and liver cancer. This is category 3 management and are kept under specialist surveillance.

Using the above protocol, almost 80 per cent of patients with benign fatty liver are sorted out and only the high-risk patients are identified and further managed.

What should we advise these patients at present?

It should be kept in mind that there is no medication that is approved for fatty liver disease. This is because for approval of a drug for this disease, it has to show significant benefit in reversing fibrosis.

The research is ongoing. However, like type 2 diabetes and obesity, patients with fatty liver disease are encouraged to lose weight by eating healthy and enhancing physical activity. They are also encouraged to avoid alcohol and get vaccinated against preventable Hepatitis A, Hepatitis B and Hepatitis C.

These healthy lifestyle measures are by far the most economical way of managing the condition. The use of pioglitazone, SGLT-2 inhibitors or GLP-1 receptor agonists are only adjunctive for fatty liver disease in patients with diabetes. In these patients, these anti-diabetic drugs are basically prescribed for managing type 2 diabetes.

All the three classes of drugs are also helpful in reducing cardiovascular diseases. SGLT-2 inhibitors and GLP-1 receptor agonists also help in reducing body weight. 

References available on request.

Ultrasound interventional pain management during pregnancy

Article-Ultrasound interventional pain management during pregnancy

Non-obstetric painful syndromes are a common problem during pregnancy, It has been estimated that 90 per cent of women would experience some form of pain during the gestation period. The main reason for the occurrence of pain is musculoskeletal changes that accompany pregnancy. With the start of pregnancy, there is a release of a large number of certain hormones namely, oestrogen, progesterone, relaxin and prolactin, which have a known effect on the collagen remodeling and increase joint laxity and hyper-mobility.

Furthermore, weight gain, fluid retention, the position of the gravid uterus and anterior pelvic tilt during pregnancy will lead to additional mechanical effects on the musculoskeletal system, which intensify the painful syndromes.

The most common pain syndromes that happen because of pregnancy may include low back, pelvic girdle and radicular leg pain. It also includes abdominal cutaneous nerve entrapment, carpal tunnel syndromes and De Quervain’s tenosynovitis. Parturients may complain from neuralgia of the occipital, intercostal, pudendal, obturator and lateral femoral cutaneous nerves.

Furthermore, pregnant women may present with small joint arthralgia and foot pain secondary to tarsal tunnel syndrome or plantar fasciitis. Moreover, physiological changes with pregnancy may exaggerate already existing chronic painful conditions such as migraine, cervical or lumbar disc disease, lumbar spondylosis and facet joint arthropathy.

Conservative treatment with non-pharmacological remedies such as physiotherapy and body supports are the first line to treat pregnancy-induced pain. However, many of the patients may not be contented and require pharmacological treatment. It is well known that an untreated painful condition might constitute a higher risk to the foetus compared to medications.

Careful assessment of the parturient condition should be performed before prescribing medications as nearly all medications given to the mother will cross the placenta and reach the foetus. The effect of the drug on the foetus depends on the drug category, gestational age and duration of exposure. Possible side effects of the medications may include congenital anomalies, growth retardation, intrauterine foetal death, neonatal intoxication and neonatal abstinence syndrome. Therefore, the non-systemic administration of medications is considered a safer solution.

Interventional pain management is a relatively new specialty. The basic principle for interventional treatment is to identify precisely the source of pain, whether nerve, muscle, tendon or joint, and deliver the medications directly to the diseased part through a minimally invasive procedure.

This procedure gives permanent or long-term pain relief and at the same time, avoids systemic administration of the drug. This treatment method hypothetically matches the requirement for pain relief during pregnancy. Procedures can be done under CT, X-Ray or ultrasound. However, during pregnancy, only ultrasound-guided procedures are performed. Common painful pregnancy conditions and their interventional treatments include:

Sacroiliac joints dysfunction

Back pain during pregnancy is considered one of the most common problems. The patient can suffer from mild, moderate or severe pain. Previous works showed that one-third of the parturients would present with severe back pain (pain score > 6/10). Pain typically started during the second or third trimester; however, some patients will have severe pain from the beginning of pregnancy. There are multiple pain generators in the back, yet, the sacroiliac joint is the source of pain in 50 per cent of the patients. If parturient is complaining of sacroiliac joint pain, she may present with one or all of the following: (1) Low back pain with maximum tenderness over the posterior superior iliac spine, (2) Groin pain, (3) Hip and lateral thigh pain and/ or (4) posterior calf pain. The patient might present with unilateral or bilateral pain, and the pain could be axial or radiating to the legs. Clinical diagnosis can be made when there are > three positive provocation tests. In general, there is no need for imaging to support the diagnosis of sacroiliac joint dysfunction unless it is absolutely indicated. In case refractory pain did not respond to conservative management, interventional treatment should be offered to the patient.

An ultrasound-guided sacroiliac joint injection can be safely done during pregnancy. The procedure can be performed in a prone, lateral or sitting position (Figure 1) based on the pregnancy duration and operator experience. As the pain is mainly due to the laxity of the supportive ligaments, the majority of the medications should be deposited extra-articular rather than intra-articular. Medications consist of local anaesthetic, either lidocaine or bupivacaine and corticosteroids, which usually administered during pregnancy for foetal lung maturation.

pain management during pregnancy Figure 1.JPG

Fig 1: Injection of the left sacroiliac joint injection in 32 weeks patient patients in sitting position.

 

Carpal tunnel syndrome

The compression of the median nerve at the wrist below the flexor retinaculum is another pregnancy related painful condition. It has an incidence of between 2.3 to 35 per cent. Parturient usually present during the second or third trimester with numbness, tingling and throbbing sensation, which may worsen at night. If the condition becomes severe, additionally, there will be a difficulty for hand gripping and performing fine motor hand skill. The pain ranges from mild to severe, and the patient may complain from one or both hands. Fluid retention is the main reason for the occurrence of carpal tunnel syndrome. Predisposing factors include obesity, gestational diabetes and hypertension as they may lead to more fluid retention.

Carpal tunnel syndrome can be diagnosed clinically by positive Tinel’s sign and Phalen’s manoeuvre. The diagnosis is usually confirmed by nerve conduction and electromyography (EMG); however, recently, a simple bedside test using ultrasound can be used. The measurement of the cross-sectional area (CSA) of the median nerve could be diagnostic. The typical CSA of the median nerve is up to 0.09 cm2, and it had been documented that a CSA of the median nerve ≥ 0.13 cm2 confirms the diagnosis of carpal tunnel syndrome.

The interventional injection will be offered to the patient if she has two positive diagnostic tests with a documented enlarged median nerve by ultrasound (in case of failure of medical treatment). The injection of local anaesthesia with corticosteroids is done under ultrasound either in a longitudinal or transverse plane approach. The author prefers to use the in-plane transverse ulnar approach as this ensures the placement of injectable below the flexor retinaculum with less chance of injury to the median nerve (Figure 2).

pain management during pregnancy Figure 2.jpg

Fig 2: Injection of the right carpal tunnel in transverse ulnar approach.

Besides, during pregnancy, there is no inflammation and adhesion between the median nerve and the flexor retinaculum, and there is no need for further dissection above the wrist.

Meralgia paresthetica

Pregnant women present with a painful burning sensation in the lateral or anterolateral aspect of the thigh. This condition appears during pregnancy due to compression of the lateral femoral cutaneous nerve (LFCN) below the fascia lata, at the level of the inguinal ligament. It is a pure sensory nerve with the absence of any motor symptoms. The pain is usually aggravated by prolonged sitting, standing or sleeping on the affected side. A clinical neurological examination will demonstrate loss of sensation in the affected area with normal reflexes and motor function.

Ultrasound-guided injection of the LFCN can be conveniently done in pregnant patients. The nerve and its branches will be located above the sartorius muscle when the high-frequency ultrasound probe inserted above the inguinal ligament with the heal of the probe just lateral to the anterior superior iliac spine. A small volume of local anaesthetic and corticosteroids are sufficient to alleviate the pain.

Conclusion

Pregnancy is associated with multiple painful conditions secondary to hormonal, musculoskeletal changes and fluid retention. Interventional procedures are safe and effective treatment modalities. Awareness among healthcare professionals with this new management approach will improve patients care and decreases the side effects of medications during pregnancy.