A multi-centre cohort study comparing health outcome data from Holter monitoring to 14 day Zio monitoring in people where ambulatory ECG monitoring is required.

In 2020 an independent evaluation of the Zio service as part of the Digital Health Technologies programme at NICE was conducted. From the available clinical and economic evidence, the evaluation was concluded that further evidence is needed to estimate the resource use associated with Zio compared with standard care, particularly the number of outpatient visits and repeat testing needed. Additionally, it recommended further evidence is needed of outpatient visits and repeat testing consequences such as anticoagulant uptake and other changes to treatment related to the results from monitoring. Therefore, this study aims to address these uncertainties and identify whether the Zio service could be used in the health and social care system in England. This existing standard of care cohort using Holter monitor (cohort 1) will be collected from 6-month retrospective pre-covid date, and, for the Zio service cohort (cohort 2), data will be collected retrospectively over a 6-month period. Each cohort will include two separate populations recruited from cardiology clinics and stroke/TIA clinics. The main objective of this study is to analyse quantitative date collected from participating sites and complementary qualitative data on Zio utilisation from questionnaires, with the purpose of answering the following research questions:

1. Does the Zio service reduce the number of outpatient visits and repeat tests needed compared with standard of care (Holter monitor)?
2. Is there a difference in resource utilisation in cohort 1 receiving standard of care compared with cohort 2 receiving Zio service?
3. What are the cost-consequences of using Zio service in cardiology and stroke/TIA populations compared to current standard of care?
4. Is there a difference in the time to treatment decision for anticoagulants or other clinical intervention for AF or other clinically significant arrhythmia?
5. Are there any factors identified during this study at the participating centres that should be considered if Zio monitor compared to a population receiving Holter monitor?
6. Is there a shift in the spectrum of patients using Zio monitor compared to a population receiving Holter monitor?
7. What is the patient and clinician experience with the Zio service in comparison with the standard of care (Holter monitor)?
8. Is there greater utilisation of the Zio patch in hard-to-reach populations living in rural areas who may have difficulty travelling to clinics?

Chief Investigator – Dr Anna Barnes

Principal Investigator – Dr Philip Clatworthy

Cavernomas A Randomised Effectiveness (CARE) pilot trial, to address the effectiveness of active treatment (with neurosurgery or stereotactic radiosurgery) versus conservative management in people with symptomatic brain cavernoma.

A cavernoma is a cluster of blood vessels that form blood-filled ‘caverns’ in the brain that look like a raspberry. Cavernomas can bleed into the brain and cause a stroke. Cavernomas can also cause a seizure or epilepsy. About 160 people in the UK each year are diagnosed with a cavernoma that has caused symptoms. Stroke and seizure may lead to disability, handicap and occasionally death. In standard practice in the UK, most people with cavernomas have medical management (which may involve scans, drugs, or rehabilitation) to manage these symptoms. About one fifth also have ‘surgical management’ with either brain surgery to remove a cavernoma or stereotactic radiosurgery to stabilise it with radiation. Surgical management can cause death, disability, and handicap.

The pros and cons of medical management versus medical and surgical management are finely balanced. The most reliable way of finding out which management is best to do a randomised trial, in which suitable patients are allocated to medical management or medical and surgical management at random. This has never been done with cavernomas, and this was the top priority identified by a Priority Setting Partnership for cavernoma. The NIHR wants research to be done to find out whether enough patients can be found for a randomised trial comparing ‘medical management’ with ‘medical and surgical management’ of symptomatic cavernomas. We need to know this because cavernomas are rare and we do not know whether patients and doctors will take part.

In three years, we will:

1. Create a network of specialists to do this study. We will include the UK and Ireland patient support organisations for people with cavernoma and doctors representing the relevant specialities at all the major hospitals specialising in decisions about cavernoma treatment in the UK and Ireland.
2. Invite newly diagnosed patients to join a pilot phase of a randomised controlled trial. Of 190 people diagnosed with brain cavernoma in 18 months, we estimate that 60 of them will enrol in the randomised trial. We will study why some patients take part in the randomised trial and others don’t. We will use this information to change the methods of the trial if recruitment to the randomised trial goes slowly.
3. Estimate whether enough patients can be found for a full-scale randomised trial to be done to find out whether medical management or medical and surgical management of symptomatic brain cavernomas is best.

Chief Investigator – Professor Rustam Al-Shahi Salman

Principal Investigator – Mr Mario Tao

Key study findings:

• Majority of patients hospitalised with COVID-19 have not fully recovered after 5 months
• Those who experience more persistent symptoms tend to be middle-aged, white, female, with at least two ‘co-morbidities’, such as diabetes, lung or heart disease
• Cognitive impairment, also referred to as ‘brain fog’, occurs as a predominant symptom in a sub-set of patients who tend to be older and male
• A biological marker associated with inflammation, C-Reactive Protein (CRP), is elevated in all but the most mild of post-hospital cases

The majority of survivors who left hospital following COVID-19 did not fully recover five months after discharge and continued to experience negative impacts on their physical and mental health, as well as ability to work, according to results released by the PHOSP-COVID study today. Furthermore, one in five of the participant population reached the threshold for a new disability.

The UK-wide study, which is led by the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre – a partnership between Leicester’s Hospitals, the University of Leicester and Loughborough University - and jointly funded by the NIHR and UK Research and Innovation, analysed 1077 patients who were discharged from hospital between March and November 2020 following an episode of COVID-19.

Researchers found that each participant had an average of nine persistent symptoms. The ten most common symptoms reported were: muscle pain, fatigue, physical slowing down, impaired sleep quality, joint pain or swelling, limb weakness, breathlessness, pain, short-term memory loss, and slowed thinking.

Patients were also assessed for mental health. The study reports that over 25 per cent of participants had clinically significant symptoms of anxiety and depression and 12 per cent had symptoms of post-traumatic stress disorder (PTSD) at their 5-month follow-up.

Of the 67.5 per cent of participants who were working before COVID, 17.8 per cent were no longer working, and nearly 20 per cent experienced a health-related change in their occupational status.

Professor Chris Brightling, a professor of respiratory medicine at the University of Leicester and the chief investigator for the PHOSP-COVID study, said:

“While the profile of patients being admitted to hospital with COVID-19 is disproportionately male and from an ethnic minority background, our study finds that those who have the most severe prolonged symptoms tend to be white women aged approximately 40 to 60 who have at least two long term health conditions, such as asthma or diabetes.”

The researchers were able to the classify types of recovery into four different groups or ‘clusters’ based on the participants’ mental and physical health impairments.

One cluster group in particular showed impaired cognitive function, or what has colloquially been called ‘brain fog’. Patients in this group tended to be older and male. Cognitive impairment was striking even when taking education levels into account, suggesting a different underlying mechanism compared to other symptoms.

Dr Rachael Evans, an associate professor at the University of Leicester and respiratory consultant at Leicester’s Hospitals, said:

“Our results show a large burden of symptoms, mental and physical health problems and evidence of organ damage five months after discharge with COVID-19. It is also clear that those who required mechanical ventilation and were admitted to intensive care take longer to recover. However, much of the wide variety of persistent problems was not explained by the severity of the acute illness - the latter largely driven by acute lung injury - indicating other, possibly more systemic, underlying mechanisms"

The pre-print, title, which is yet to be peer-reviewed, is now available to view on Med Archives.

An experienced Consultant Neuro Interventional Radiologist and their team will perform the procedure in the radiology department.

The Interventional Radiology nurses and the Stroke Nurse Practitioner will keep in close contact and keep you updated after the procedure.

Patients who have been transferred to Southmead Hospital will be reassessed when they arrive, and they may also need further CT scans.

Please be aware that patients may no longer be suitable for treatment once they arrive, if further damage to brain tissue has happened.

Occasionally after thrombolysis the clot may have dissolved, or moved to an artery further away that is not suitable for a thrombectomy. In this case the patient will be transferred back to their local hospital for ongoing care and investigations.

In some cases, patients may have had worsening of their stroke symptoms, and the area of damage (ischaemia) has become larger. In these cases, the procedure is unlikely to be helpful.

Patients may need to stay at Southmead for observation if they are unwell or may transfer directly back to their local stroke centre or hospital.

The procedure has been shown to significantly improve chances of surviving and preserving quality of life, if done within the first twelve hours of symptoms starting. This will be alongside other specialist medical treatment and care.

The aim is to prevent stroke symptoms getting worse, but does not reverse the damage that has already occurred to the brain.

The procedure can be done up to 24 hours after a stroke, depending on the level of damage in the brain. Every patient is different, and some patients may experience irreversible damage to the brain quicker than others.

The brain is fragile following a stroke, and there is risk of causing bleeding by puncturing a vessel during the procedure. This can cause severe disability or death.

There is also a risk of groin site bleeding, abdominal internal bleeding, or disrupted blood supply to the lower limbs which may need further surgery.

There is a small risk of infection at the groin site.

• After the procedure, patients go to the recovery unit where staff closely monitor blood pressure and groin site.
• Occasionally patients may need to go to the intensive care unit if specialist blood pressure treatment is required for a short time.
• Otherwise, patients will go to the hyperacute stroke ward (Ward 34B).
• Patients will have close monitoring and observations, which will include heart monitoring, frequent measurements of blood pressure, heart rate, and oxygen saturation levels.
• Staff will test the strength in arms/legs, speech, and level of consciousness.
• Any signs of neurological deterioration will be detected quickly and patient will have further CT scans as necessary.
• Patients will usually stay in this area for 48-72 hours before being moved to the acute stroke unit area of the ward.

• If your friend or relative came from another hospital then they will stay with us until they are stable to return to their local hospital. This is normally 24-48 hours.
• It will depend on the type and severity of your stroke.
• It will depend how well they are recovering and whether they need rehabilitation.

Strokes affect everyone differently and recovery from depends on many factors:

• Where the stroke occurred in the brain.
• The severity of the stroke.
• The age of the patient and their medical history.

If you have any questions about the procedure or care following the procedure, do not hesitate to speak to any of our stroke team. This leaflet is only a starting point for discussion and our doctors and nurses can answer any of your queries during your friend or relatives stay.

You can contact the Hyperacute Stroke Unit on: 0117 414 3600.

The Stroke Association

0303 303 3100

Stroke Association / Finding strength through support

Stroke association information about thrombectomy

What is Thrombectomy? | Stroke Association

Bristol Area Stroke Foundation

0117 964 7657

Bristol After Stroke | Home