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New device provides early diagnosis for cardiac tamponade

Written by Louise Stanley on . Posted in Early diagnosis and detection.

A new diagnostic device, developed to monitor against post-surgery heart strangulation risk, has been introduced by a company formed by Birmingham cardiothoracic surgeon Hazem Fallouh.

Patients recovering from heart surgery can be at risk from a life-threatening condition – cardiac tamponade – where fluid builds up around the heart, strangling its ability to beat properly.

Fallouh Healthcare is developing the device to monitor cardiac patients after surgery, which is when cardiac tamponade usually strikes – and has received a £500k grant from Innovate UK.

Typically, cardiac tamponade happens late at night when the patient is in intensive care. Blood clots accumulate and compress the heart, reducing its ability to pump blood around the body.

Around 45,000 patients in the UK undergo cardiac surgery each year, and it is usually safe. However cardiac tamponade can come on quickly, and diagnosis is difficult as it can be confused with other causes of heart failure. As high as 3 in 10 of all deaths that immediately follow post-cardiac surgery are thought to be due to cardiac tamponade.

If missed, cardiac tamponade can lead to cardiac arrest which is resistant to CPR and requires immediate opening of the patient’s chest in the uncontrolled environment of the intensive care unit – a procedure that has a mortality rate (30-70%), and poor outcomes for those patients who survive.

Consultant surgeon Mr Fallouh, who has worked in many centres of excellence in the UK, invented the device to provide early diagnosis of tamponade, allowing a planned return to surgery to drain fluid and clots around the heart.

Called PerDeCT (Pericardial Device to monitor Cardiac output and diagnose Tamponade), it is the only device to diagnose cardiac tamponade, and provide cardiac monitoring at no extra cost.

In 2021, Dr Fallouh, who has previously commercialised two award-winning inventions in cardiac surgery, received the prestigious Techno-College Innovation Award at the 35th Annual Meeting of European Society of Cardiothoracic Surgery for PerDeCT, by panels of expert surgeons, cardiologists and medical devices and investment specialists.

The device consists of a probe and a balloon, which is placed in the pericardium (the sac around the heart) during initial surgery, and measures cardiac efficiency (cardiac output) as well as predicting the development of tamponade, by looking at the trend in the relationship between balloon inflation and cardiac efficiency. It can be withdrawn through the skin after the patient is recovered.

The intellectual property in the form of a patent is assigned to Fallouh Healthcare Limited.

Fallouh Healthcare is a startup with a mission to deliver smart solutions to unmet needs in order to deliver safer and more effective cardiothoracic surgery.

The company has now taken up residency in Unit 9, a short-term medical technology incubator funded by University of Birmingham Enterprise, the Greater Birmingham & Solihull Local Enterprise Growth Hub and the West Midlands Combined Authority to provide flexible, low-cost facilities for medical research, proof of concept and prototyping activity.

The delivery of the Innovate UK project is in collaboration with University Hospitals Birmingham NHS Foundation Trust (UHB) and the University of Sheffield. The funding from Innovate UK will allow Fallouh Healthcare to build a prototype and conduct a usability study at UHB’s Queen Elizabeth Hospital site, the Medical Device – Testing and Evaluation Centre (MD-TEC).

researcher in laboratory

Birmingham BRC receives £30m boost to improve treatment of inflammatory diseases

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials, Early diagnosis and detection, Experimental medicine, Inflammation and chronic disease.

Increased funding for the renewed NIHR Birmingham Biomedical Research Centre will enable continuation of major developments around inflammatory diseases and new technologies and systems

The NIHR Birmingham Biomedical Research Centre (BRC) has been awarded more than £30 million in funding from the National Institute for Health and Care Research, a major funder of global health research and training, to support world-leading research into inflammation – including the development of new diagnostic tools and treatments for those with cancer, liver and heart disease, and many more illnesses.

The centre brings together multiple BHP members – including leading NHS providers led by the University Hospitals Birmingham NHS Foundation Trust and academic institutions led by the University of Birmingham – as well as other organisations working closely with charities and businesses. Its aim is to support research into inflammation which causes or worsens many common long-term illnesses including arthritis, liver disease and cancer.

This new investment represents an almost threefold increase in funding for the NIHR Birmingham BRC and will enable researchers to focus on eight areas of illness including heart disease, women’s health, and common complications from inflammation. Researchers will also be empowered to consider new tests and biomarkers for disease, health technologies including stem cells and gene therapy, patient experiences and data science.

Professor Phil Newsome, Director of the NIHR Birmingham BRC, said: “Inflammation plays a central role in many health conditions, with millions of people in the UK alone experiencing inflammatory diseases such as arthritis and bronchitis. This significant increase in funding will enable us to provide an outstanding environment for world-leading clinical research and allow us to make a step-change in our work tackling different forms of cancer, trialling new drugs for liver disease, and dealing with antimicrobial resistance.”

Patients will benefit from the increased funding thanks to the BRC’s collaborative research that has seen nearly 1,000 clinical trials and informed UK clinical guidelines.

Researchers will look at eight themes to continue to understand and help patients manage inflammation-based diseases including cancer, arthritis, and liver disease. The investment of the NIHR funding in biomedical research will enable clinicians, researchers, patients and supporters to find new treatments such as the development of new immunotherapies, which are types of cancer treatments to support the body to fight cancer.

Professor David Adams, Director of BHP, commented: “The investment from NIHR is hugely important for researchers working across the BRC partner institutions, to continue to tackle some of the critical health themes that affect our region. The funding will allow us to deliver new therapies and diagnostic tests for a range of chronic inflammatory diseases for which we currently have few effective treatments.”

Professor Lucy Chappell, Chief Executive of the NIHR, said: “Research by NIHR Biomedical Research Centres has led to a number of ground-breaking new treatments, such as new gene therapies for haemophilia and motor neurone disease, the world-first treatment for Creutzfeldt–Jakob disease, a nose-drop vaccine for whooping cough, and the first UK-wide study into the long-term impact of COVID-19.

“This latest round of funding recognises the strength of expertise underpinning health and care research across the country and gives our nation’s best researchers more opportunities to develop innovative new treatments for patients.”

The Birmingham Biomedical Research Centre is made up of the following BHP member organisations:

  • University Hospitals Birmingham NHS Foundation Trust
  • University of Birmingham
  • Sandwell and West Birmingham NHS Trust
  • Birmingham Women’s and Children’s NHS Foundation Trust
  • Aston University

Working closely with partners:

  • Birmingham Community Healthcare NHS Foundation Trust
  • Keele University
  • University of Oxford

First Midlands research collaboration to focus on patient safety

Written by Louise Stanley on . Posted in Early diagnosis and detection, Health inequalities, Maternal health.

Expectant mums and anyone needing emergency treatment will both benefit from funding for new research to improve patient safety and reduce the risk of harm.

BHP founder-members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust will be establishing the first research collaboration focused on patient safety based in the Midlands, thanks to new funding from the National Institute for Health and Care Research. The announcement made today by the Department for Health and Social Care will see £3.4m invested in world-leading research that supports patient safety in maternal and acute care settings.

The newly announced NIHR Midlands Patient Safety Research Collaboration (PSRC) will bring together NHS trusts, universities, and private business to evaluate how digital tools can support clinical decision making and reduce risks for patients.

Professor Alice Turner is a Professor of Respiratory Medicine in the Institute for Applied Health Research at the University of Birmingham, Honorary Consultant Respiratory Physician at University Hospitals Birmingham, and Co-Director of the NIHR Midlands Patient Safety Research Collaboration along with Professor Richard Lilford, Professor of Public Health at the University of Birmingham.

She commented: “Patient safety is at the forefront of every clinician’s mind and runs at the heart of the whole healthcare system. The power of new technology available to us means that we can address one of the ongoing areas of risk for patients, which is effective communication and clinical decision making.

“Thanks to the new funding from NIHR and with the support of partners, the new collaboration will be looking at how digital tools can make a real difference to reduce risks and support patient safety in the key areas of acute medicine and maternal health.”

Acute Care

Patients requiring emergency medical care in acute services will benefit as new digital decision-making tools could improve prescribing and personalised management.

Thanks to the funding, the NIHR Midlands PSRC will trial digital clinical decision support tools which will provide smoother flow of information between healthcare professionals in acute care. Working with acute care hospitals, primary care providers and the West Midlands Ambulance Service, the researchers will review how the digital tools can reduce risks of patient harm at key points in acute care management.

Professor Elizabeth Sapey, Director of the Institute of Inflammation and Ageing at the University of Birmingham and an Honorary Respiratory Consultant at the University Hospitals Birmingham said: “The vision is that every healthcare professional involved in a patients journey in acute care has access to the same information, the same decision-making support, and is able to both spot and flag any point where patients might be at increased risk of harm.

“We know that a disproportionate number of medical errors happen in acute services, and around half of patients experience a clinical error in what can be a complex journey. As acute care becomes more heavily relied on, it is critical that we use technology available to us to ensure that our patients are kept safe and risk is managed.”

Maternal Health

Mothers and babies will benefit from the new research collaboration to look at how digital tools can support antenatal decision making.

The collaboration will examine the effectiveness of clinical decision-making tools to recognise risks among expectant mothers, particularly among marginalised groups who experience worse outcomes and quality of care compared to the general population.

Professor Shakila Thangaratinam, Co-Director of WHO Collaborating Centre for Global Women’s Health at the University of Birmingham and Consultant Obstetrician at the Birmingham Women’s Hospital said: “Maternal and perinatal mortality reports in the UK have highlighted that there are real issues when it comes to identifying and responding to risk. One of the key priorities is identifying early in pregnancy those mothers who need the extra support and care, thereby ensuring that women receive individualised care during pregnancy.

“With this new funding from the NIHR, we can evaluate how digital tools can help clinicians ensure that no mum falls ‘through the net’ in identifying risk, and ensure every family receives the right level of support.”

Partners involved in the NIHR Midlands Patient Safety Research Collaboration

  • University Hospitals Birmingham NHS Foundation Trust (BHP)
  • University of Birmingham (BHP)
  • Birmingham Women’s and Children’s NHS Foundation Trust (BHP)
  • Health Innovation West Midlands (BHP)
  • NHS Birmingham and Solihull Integrated Care Board
  • University of Warwick
  • University of Aberdeen
  • Clevermed Limited
  • West Midlands Ambulance Service University NHS Foundation Trust
  • Shrewsbury and Telford Hospital NHS Trust

Experts at Birmingham Women’s and Children’s develop new test to spot rare eye cancer in unborn babies

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

Experts from BHP members Birmingham Women’s and Children’s Hospitals have developed a life-saving test that allows doctors to spot a rare form of eye cancer in babies in the womb.

The test, which is being rolled out by the NHS in England this week, means that babies identified as being at risk of developing retinoblastoma can be monitored and treated sooner – increasing the chance of saving their eyesight and potentially their lives.

Symptoms of retinoblastoma are hard to detect and a diagnosis can normally only be made once the tumour has progressed and the eye can’t be saved.

The new non-invasive test can detect changes in the genes in DNA and is likely to identify around 50 infants with retinoblastoma each year, in the latest example of the NHS harnessing the power of genomics to diagnose and treat patients faster and more effectively.

Non-Invasive Prenatal Diagnosis (NIPD) also means parents can be informed early in pregnancy if their child is at risk.

The blood sample test is taken from the mother before birth and tested and analysed for mutations, which can determine with almost 100% accuracy if the baby will develop retinoblastoma.

Treatment can then start on the affected eye as soon as the baby is born, with doctors closely monitoring the other eye for any signs. The test can also predict if the disease might develop in their siblings and will be offered to families where there is a confirmed case of retinoblastoma in the family.

In addition to the cutting-edge new test, Drs Trevor Cole and Amy Gerrish, who have been part of our specialist retinoblastoma service, are also developing a non-invasive post-natal cancer test for retinoblastoma patients using eye fluid – which can also identify if a patient is at risk from other cancers later in life. It’s hoped that in the future, this could be eventually done by a simple blood test.

Dr Amy Gerrish said: “The introduction of this technology of cell free DNA analysis will revolutionise the management of all aspects of retinoblastoma from early detection, selection of the best treatments, identification of family members at risk of retinoblastoma and early detection and treatment of associated adult onset cancers.

“We also believe it will help address the huge discrepancy in retinoblastoma outcome for individuals in high income and low and middle income countries which has been highlighted by the World Health Organisation (WHO)”.

NHS Chief Executive Amanda Pritchard said: “The introduction of this pioneering new test is fantastic news for babies and their parents and has the potential to save hundreds of lives over the coming years.

“Cancer is such a terrible illness and a baby being born with it can have a huge impact on parents and families during what should be an incredibly happy time, but backed by world-class innovation and services like the NHS Genomic Medicine Service, through the Long Term Plan the NHS is developing and delivering more cutting edge treatments like this one to help save lives and keep families together”.

Mum Siani Bainbridge, 22, from County Durham, had retinoblastoma herself as a child and feared her baby boy, Oscar, might carry a faulty gene known as RB1 which causes the potentially deadly cancer.

But she was relieved when she took part in a new trailblazing test, where doctors were able to spot the previously hard-to-detect disease and allay her concerns with a programme of treatment straight after his birth.

Siani said: “This took away a lot of stress, knowing that if there was going to be anything wrong then he would be helped straight away.

“Given that the tumours were quite severe when he was born, the fact he could be treated straight away definitely affected his outcome. It was nice to know the day he was diagnosed it was ready, set go”.

Just a week after being born, Oscar started his cancer treatment, which involved chemotherapy and then laser therapy.

While doctors could not save the sight in one eye, they did avoid having his eyeball removed and crucially, he kept his perfect sight in the other eye – as well as avoiding the disease potentially spreading to the brain.

Consultant Clinical Scientist Stephanie Allen, at Birmingham Women’s Hospital, said: “An early diagnosis will allow clinicians to manage, monitor and prepare treatments much earlier which can transform the prognosis for the baby.

“It will also give the family certainty and allow them to prepare for the birth knowing the support the clinical team will give them”.

The NIPD is one of more than 15 new tests and amendments being added to the National Genomic Test Directory (NGTD), which outlines the genomic tests available via the NHS in England through the NHS Genomic Medicine Service (GMS).

The directory, which is the only one of its kind, covers more than 3000 rare diseases and over 200 types of cancer – demonstrating how the NHS is a world leader in harnessing the benefits of genomics, the study of the genes in our DNA and their function, to deliver better patient care.

Among the other additions to the directory are tests for gene mutations that cause forms of breast and endometrial cancer, acute myeloid leukaemia and several rare diseases. A genetic test for a particular type of advanced lung cancer has had a matching treatment recently approved by The National Institute for Health and Care Excellence (NICE), meaning more effective treatment for patients.

Professor Dame Sue Hill, Chief Scientific Officer and Senior Responsible Officer for Genomics in NHS England said: “This new test is a perfect example of how the NHS Genomic Medicine Service is harnessing cutting-edge technology to deliver genomic tests for cancers like this and many other conditions through the National Genomic Test Directory – meaning more comprehensive and earlier diagnoses and more targeted treatments sooner for all our patients”.

Patrick Tonks, Chief Executive of The Childhood Eye Cancer Trust (CHECT): “Any developments such as this new diagnostic test which has the potential to allow treatment to be started much sooner and therefore the real potential to improve patient outcomes is very exciting news for babies and for the families of anyone affected by retinoblastoma. We watch with interest as this new development is rolled out across the country”.

Health and Social Care Secretary Sajid Javid said: “Despite the unprecedented pressure put on the NHS because of the pandemic it is incredible to see continued life-saving innovation taking place, enhancing cancer care and diagnosis even before birth.

“Early diagnosis is vital to ensure these babies are given every opportunity to see, and the best chance of survival. New tests such as these will help clear the COVID backlog, ensuring patients are seen at the right time and provided the right care.

“Our 10-Year Cancer Plan will set out how we will lead Europe in cancer care, improving outcomes for patients across England”.

Urine test for bladder cancer could replace thousands of invasive procedures each year

Written by Louise Stanley on . Posted in Cancer outcomes, Clinical trials, Early diagnosis and detection.

Birmingham researchers funded by Cancer Research UK and liquid biopsy company Nonacus have developed a new urine test for bladder cancer, which could reduce the need for invasive and time-consuming procedures to diagnose the disease.

The test will use highly sensitive liquid biopsy technology developed by Nonacus in conjunction with  a panel of biomarkers developed and validated by Mr Rik Bryan and Dr Douglas Ward from the Bladder Cancer Research Centre at BHP founder-member the University of Birmingham, to detect the presence of bladder cancer by finding DNA from tumour cells present in the urine.

The biomarker panel, which consists of 443 genetic mutations that are common in bladder cancer has been validated in a deep sequencing study recently published in European Urology Oncology.

In this study, which was funded by Cancer Research UK and the Medical Research Council, the researchers used the test to analyse urine from 165 people with bladder cancer that had experienced haematuria (blood in the urine), and successfully detected the disease in 144 of them (87%).

The researchers also looked at using the test in 293 patients who had already been treated for bladder cancer and were being monitored for the cancer returning. In this setting, the test returned a higher proportion of false positive results compared to when used in the haematuria clinic (37.5% vs 15.2%), with 99 positive urine tests without a tumour being seen by cystoscopy on the same day. However, during their follow up monitoring, the patients who had those positive results had almost 3-times higher (11% vs 4%) rates of the cancer returning within 24 months indicating that the test could help detect recurrent disease before it is visible by cystoscopy (the camera inspection of the bladder). Further research is needed for the test to be used for surveillance.

Lead researcher Mr Richard Bryan said: “Even though cystoscopy is good at detecting bladder cancer, it’s invasive and time consuming for patients, so we need a better way to diagnose patients. In the future our test could be an easier way to get people with bladder cancer diagnosed faster, and could mean that tens of thousands of cystoscopies on healthy patients can be avoided each year.”

Iain Foulkes, Executive Director of Research and Innovation at Cancer Research UK said “These findings show that this urine test could help diagnose bladder cancer more easily. Early detection of cancer is key for improving patient outcomes and research like this could help identify the patients that need treatment soonest, while easing the pressures of diagnostic procedures on the NHS. We look forward to seeing how the test performs in the next clinical trial.”

The researchers are working in partnership with Nonacus, a provider of genetic testing products for precision medicine and liquid biopsy, to turn their approach into a clinical test for patients to be used within the NHS, and will start a clinical study funded by Cancer Research UK and involving over 3000 patients to evaluate just how powerful the test is at reducing the number of cystoscopies.

Each year, over 300,000 cystoscopies are carried out in England, however, around 80% of patients with haematuria who’ve had cystoscopy are found to have no cancers or abnormalities1,2.  The researchers believe that using the urine test in haematuria clinic could reduce the number of patients requiring a cystoscopy by at least 45%.

Funding boost to help improve ovarian cancer survival rates

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection, Health inequalities.

BHP’s newest member NHS Trust has been given a charity grant of £100,000 to help improve survival rates of women with ovarian cancer.

The Pan-Birmingham Gynaecological Cancer Centre, based at SWBH’s City Hospital, is working jointly with University of Cambridge to boost the uptake in genetic testing, especially in Black, Asian and Minority Ethnic communities (BAME) where survival rates are low.

The project, called the Demonstration of Improvement for Molecular Ovarian cancer testing (DEMO), will create information about genetic testing in various languages both in leaflet and video format. The project will also improve the quality of the sample taken to aid diagnosis when there is suspicion of ovarian cancer by establishing a guidance document for all healthcare professionals involved in the process.

Dr Elaine Leung, Clinical Lecturer and Specialist Registrar at the Pan-Birmingham Gynaecological Centre which is run by Sandwell and West Birmingham NHS Trust, said: “This is a much-needed project reaching those diverse communities in the area.

“With the support of our patient representatives, the materials we co-create will be in an easy-to-understand format in both written and video form, which will give women a better understanding of the link between cancer and genetic testing.

“It’s important to ensure women know that genetic testing is similar to early detection and can help prolong life – we have already seen evidence of this through other studies.

“It helps to provide tailored treatments for patients and ultimately can mean surviving an ovarian cancer diagnosis.

“The lack of informed decision-making resources for women whose first language is not English could be a contributor to the low rates of testing within these communities. The team will co-produce information in multiple languages, as well as exploring why some groups of women are more likely to decline genetic testing.”

The project has been funded by health charity Ovarian Cancer Action and is part of a wider national initiative which includes funding for five other NHS cancer centres.

The Pan-Birmingham Gynaecological Cancer Network delivers cancer care to more than two million people in the West Midlands.

The project also builds on the team’s previous experience with the genetic testing studies, looking at BRCA testing in women with a new diagnosis of ovarian cancer before it became mainstream practice.

Lisa Bird, a former cancer patient who is part of the project, said: “When I was in my thirties I was diagnosed with ovarian cancer, which was a large shock.  My first line treatment successfully got me into remission but I wanted to know what options would be available to me if I came out of remission.

“I investigated treatment options and found that there were some treatments only available to those that have the BRCA 1 and 2 genes.  I also wanted to know if other family members were at an increased genetic risk of also getting ovarian cancer, so that I could warn them of the symptoms and ensure that they received better monitoring by their GPs.

“I’m really pleased to be part of the DEMO project team that will encourage more patients to have these same tests. I’m passionate that anyone affected by ovarian cancer should be able to have this genetic knowledge so that their healthcare teams can give them the best treatments available to them as quickly as possible. I really believe that the results of this project will help to provide patients with ovarian cancer, with a greater chance of an extended life.”