Grant awarded to new risk score for heart rhythm monitoring to prevent second strokes

Heart Research UK has awarded a research grant of £115,000 to a project at the University of Glasgow for developing a risk score to help guide investigation for atrial fibrillation. This will allow more people to benefit from anticoagulant drugs to prevent second strokes.

After a stroke, heart rhythm monitors are worn for three days to look for an abnormal heart rhythm called atrial fibrillation (AF) that increases the risk of blood clots forming and second strokes.

If the monitor shows that a patient has AF, then blood thinning drugs, called anticoagulants, can greatly reduce the risk of a second stroke. However, there are often long waits for these tests and only four out of every 100 people who have a three-day heart rhythm monitor are found to have AF.

New heart rhythm monitors that are worn for longer find many more people with AF, but these tests are not necessary for everyone who has suffered a stroke. It has also been difficult to implement them in the NHS, as a lot of time and resources are already required to perform the three-day heart rhythm monitors.

The new project, led by Professor Jesse Dawson (above), aims to develop a risk score that identifies people who are unlikely to have AF after stroke and therefore do not need heart rhythm monitoring for three days or longer. This would free up resources so that longer heart rhythm monitoring can be focused on people who are more likely to have AF.

675 people admitted with a stroke to the Queen Elizabeth University Hospital Glasgow will take part in the study. The team will collect clinical and genetic information, heart rhythm recordings, and blood to measure levels of a new blood marker.

All participants will have a 30-day heart rhythm monitor to test for AF and the data will be analysed to develop a risk score that identifies people who do not have AF after the 30 days of monitoring.

The results have the potential to improve care for people affected by AF and stroke by developing a more personalised model of care. This could help to avoid unnecessary tests for people who are unlikely to have AF, during what can be a challenging time for stroke survivors and carers.

It would also mean that longer heart monitoring can be focused on people who are more likely to have AF. This would increase AF detection rates and allow more people to benefit from anticoagulant drugs to prevent second strokes.

Kate Bratt-Farrar, Chief Executive at Heart Research UK, said: “This is an exciting project where a successful outcome would enable the healthcare system to focus resources for heart rhythm monitoring after a stroke, on those who really need it.

“Anticoagulants are vital in preventing people from suffering a second stroke and we are proud to be able to support Professor Dawson and team in helping more people to benefit from them.”

You can read more about Heart Research UK’s Research Grants here.

‘Game-changing’ Stroke pilot procedure launched at RIE

A new, pilot mechanical thrombectomy service for stroke patients in the East of Scotland has been launched today.

The pilot will be based at the Royal Infirmary of Edinburgh and will help pave the way for an eventual national service set to benefit hundreds of people who have been struck with a life-threatening stroke.

John Watson, Associate Director of the Stroke Association in Scotland said: “This service is long awaited, overdue, but very welcome indeed.

“Thrombectomy is a remarkable procedure.  It involves inserting a long tube into an artery in the leg, which is then fed through the body to reach the blood clot in the brain. The blood clot is then captured in a mesh and pulled out.

“The removal of the clot allows blood flow to resume and oxygen to reach the brain, halting the damaging effects of the stroke. These are blood clots which are too big to be broken down by clot-busting drugs and are usually associated with severe strokes and the worst outcomes for patients.

“Around one in every three people who receive a thrombectomy following their stroke will be less disabled as a result. Around one in five will be able to function completely independently afterwards.

“Thrombectomy has the power to save lives and reduce disability for around one in every ten people who have a stroke.

“The Edinburgh-based pilot is an important milestone on the road to a national 24/7 thrombectomy service for Scotland.  A pilot service for the North of Scotland based in Dundee, has been underway since November last year, and we look forward to a third thrombectomy centre in Glasgow coming online next year.”

In addition to improving quality of life, thrombectomy generates substantial savings for the NHS by reducing the need for other interventions or care in the future. Research indicates that, on average, every thrombectomy procedure saves the NHS £47, 000 over a 5-year period.

A stroke is a brain attack. The effects can be devastating. Stroke is a leading cause of severe adult disability. Almost two thirds of survivors leave hospital with a disability. Many have problems with speech and communication, thinking and vision. It can also affect peoples’ emotions and personality.

Alison Maclean, 72, from Dundee had her stroke just before lockdown in January 2020. It was a massive stroke that could have taken away her independence, but following a thrombectomy, she regained full function and has gone back to the life she had before her stroke, almost unchanged.

Angela said: “I am back to doing all the things I did before my stroke: seeing friends and family, reading, watching telly, going on my exercise bike and for walks.” 

See foot of article for Angela’s story

John continued: “We want all eligible patients to have access to this game-changing treatment, as quickly as possible. But thrombectomy cannot deliver in isolation. It needs to be part of a new, re-shaped service covering the whole pathway from 999 call, to hospital treatment, recovery and rehabilitation. 

“The Scottish Government recognises the need for stroke improvements, which is extremely encouraging. It already has a draft framework of what its own advisors, stroke clinicians and the wider stroke community including the Stroke Association want to see. This is the result of good work by all involved.

“We look forward to seeing the final report and recommendations at the end of the year. But of course, it is the delivery of change and improvement that really matters so we look forward even more, to a commitment early next year to publish a plan to deliver on it.”

Alison Maclean’s stroke story of receiving a thrombectomy

Alison Maclean, 72, from Dundee had her stroke during lockdown in January 2021. It was a massive stroke and she received a thrombectomy resulting in enormous success. The stroke could otherwise have left Alison unable to talk or walk.  

I had an accidental fall on 21 Jan 2021. I rang NHS24 in complete agony. Two days later I was in hospital getting it checked out. 

I had a fractured femur which was put in a plaster-cast and an operation was planned on 26th Jan 2021. On the morning of my operation, I suddenly developed left sided weakness, vision difficulties and problems speaking.

The doctor in the orthopaedic ward called for help. I don’t remember very much other than being asked to lift my arm and lift my leg and answer questions. 

I thought I was ok, but the next thing I remember is the doctor telling me that he thought I might have had a stroke. I believe I was rushed in to a room to get a brain scan following which I underwent a thrombectomy.  Apparently some blood had leaked from my femur bone causing a clot thereafter the stroke.

The next thing I remember was being in ICU.  A nurse came up to me and told me that I’d had a stroke and had just received a procedure to remove a blood clot to help with my recovery. 

I was quite relaxed about being told about the fact that I’d had a stroke, but my son called me and he was very distressed about it.   I guess he had had to deal with the stress of seeing his Mum in a life-threatening situation making decisions on my behalf. I was unaware of how ill I was at the time, so there are big gaps in my recollection of what happened.

I felt fine following the procedure and apart from my hand shaking uncontrollably for the first day, everything else seemed normal.  I was discharged on 2 February 2021. I feel great, just the same and I am back to doing all the things I did before my stroke: seeing friends and family, reading, watching telly, going on my exercise bike and for walks.

Lockdown has been absolutely fine.  I’ve been in a bubble, so have had some company and when lockdown eased briefly last summer, I met a few friends and we’d have a cup of tea and biscuit together.

I am very positive about thrombectomy and the fact it probably saved my life. It should be available to everyone who needs it.  My life is back to normal and that may never have happened if I had not received a thrombectomy.

COVID Vaccination: Changed advice for under-30s

Under 30s in the UK should be offered an alternative to Oxford-AstraZeneca vaccine

The benefits of vaccination continue to outweigh any risks but the MHRA advises careful consideration be given to people who are at higher risk of specific types of blood clots because of their medical condition.

  • The MHRA is not recommending age restrictions in COVID-19 Vaccine AstraZeneca vaccine use.
  • The MHRA’s scientific review of UK reports of extremely rare and unlikely to occur specific blood clots with lowered platelets has concluded that the evidence of a link with COVID-19 Vaccine AstraZeneca is stronger but more work is still needed.
  • By 31 March 20.2 million doses of the COVID-19 Vaccine AstraZeneca had been given in the UK meaning the overall risk of these blood clots is approximately 4 people in a million who receive the vaccine.
  • Anyone who did not have these side effects should come forward for their second dose when invited.
  • The data suggest there is a slightly higher incidence reported in the younger adult age groups and the MHRA advises that this evolving evidence should be taken into account when considering the use of the vaccine.
  • The MHRA is now issuing updated guidance for healthcare professionals on how to minimise risks, as well as further advice on symptoms for vaccine recipients to look out for 4 or more days after vaccination.
  • Vaccines are the best way to protect people from COVID-19 and have already saved thousands of lives. Everyone should continue to get their vaccination when asked to do so unless specifically advised otherwise.

The Joint Committee on Vaccination and Immunisation (JCVI) have also published a statement (see below) following reports of an extremely rare adverse event after vaccination with the first dose of the AstraZeneca COVID-19 vaccine.

This includes information on the use of the vaccine in those under 30.

Updated information is being provided for people and healthcare professionals on the possible risk of extremely rare and unlikely to occur specific types of blood clots following vaccination with the COVID-19 Vaccine AstraZeneca, the Medicines and Healthcare products Regulatory Agency (MHRA) said today.

The MHRA has undertaken a thorough review into UK reports of a very rare and unlikely to occur specific type of blood clot in the brain, known as cerebral venous sinus thrombosis (CVST) occurring together with low levels of platelets (thrombocytopenia) following vaccination with the COVID-19 Vaccine AstraZeneca. It is also considering other blood clotting cases (thromboembolic events) alongside low platelet levels.

These reports have been analysed by the Government’s independent advisory body, the Commission on Human Medicines (CHM) and its COVID-19 Vaccines Benefit Risk Expert Working Group, which includes lay representatives and advice from leading haematologists.

Up to and including 31 March 2021, the MHRA had received 79 UK reports of blood clotting cases alongside low levels of platelets following the use of the COVID-19 Vaccine AstraZeneca:

  • 44 of the 79 cases were of CVST with thrombocytopenia
  • 35 of the 79 cases were of thrombosis in other major veins with thrombocytopenia
  • 79 cases occurred in 51 women and 28 men, aged from 18 to 79 years. It should be noted that more women have been vaccinated with COVID-19 Vaccine AstraZeneca than men.
  • Sadly, 19 people have died out of the 79 cases – 13 females and 6 males. 11 out of the 19 people who died were under the age of 50, 3 of whom were under 30. 14 of these 19 cases were of CVST with thrombocytopenia and 5 were of thrombosis with thrombocytopenia.
  • All 79 cases occurred after a first dose of the vaccine.

This risk, based on reports up to and including 31 March, is slightly higher than the risk calculated from the reports published up to and including 24 March. However, likelihood of these blood clots occurring is still extremely rare.

As a precaution, administration of COVID-19 Vaccine AstraZeneca in people of any age who are at higher risk of blood clots because of their medical condition should be considered only if benefits from the protection from COVID-19 infection outweighs potential risks.

Anyone who experienced cerebral or other major blood clots occurring with low levels of platelets after their first vaccine dose of COVID-19 Vaccine AstraZeneca should not have their second dose. Anyone who did not have these side effects should come forward for their second dose when invited.

Pregnancy predisposes to thrombosis, therefore women should discuss with their healthcare professional whether the benefits of having the vaccine outweigh the risks for them.

The MHRA recently confirmed that the evidence to date does not suggest that the COVID-19 Vaccine AstraZeneca causes venous thromboembolism without a low platelet count.

It is important to note that this type of blood clot together with lowered platelets can rarely occur naturally in unvaccinated people as well as in people with COVID-19 disease.

While the MHRA continues to investigate these cases, as a precautionary measure, anyone who has symptoms four days or more after vaccination is advised to seek prompt medical advice, such as:

  • a new onset of severe or persistent headache, blurred vision, confusion or seizures
  • develop shortness of breath, chest pain, leg swelling or persistent abdominal pain,
  • unusual skin bruising or pinpoint round spots beyond the injection site

Dr June Raine, MHRA Chief Executive, said: “Over 37 million doses of vaccines against COVID-19 have now been administered in the UK, saving thousands of lives through the biggest vaccination programme that has ever taken place in the UK.

“No effective medicine or vaccine is without risk. We continually monitor safety during widespread use of any vaccine. This is to ensure vaccines are performing as expected, to identify any new side effects that may arise, and to ensure the benefits continue to outweigh the risks.

“The public’s safety is always at the forefront of our minds and we take every report of a suspected side effect very seriously indeed. We thoroughly analyse each and every report as we receive it and although the number of reports of CVST and other thromboembolic events has increased over the last week, so has the overall number of vaccinations administered, therefore these blood clots remain extremely rare and unlikely to occur.

“We ask anyone who suspects they have experienced a side effect linked with their COVID-19 vaccine to report it to the Coronavirus Yellow Card website.

“It is still vitally important that people come forward for their vaccination when invited to do so.”

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said: “The independent Commission on Human Medicines (CHM) and its COVID-19 Expert Working Group, together with leading haematologists, has conducted a rigorous scientific analysis of all available evidence regarding reports of thromboembolic events occurring together with low platelets and COVID-19 Vaccine AstraZeneca and usage of the vaccine in different age groups.

“We have a rich source of data – the best data there is – and the MHRA and CHM will continue to keep this under close observation. The public deserve nothing less.”

JCVI statement on use of the AstraZeneca COVID-19 vaccine: 7 April 2021

Since the start of the pandemic over 4 million COVID-19 infections have been confirmed in the UK causing more than 120,000 deaths. Over 30 million people have received their first dose of COVID-19 vaccine since the start of the programme, which Public Health England (PHE) estimate has prevented at least 6,000 deaths in the first 3 months of 2021. Analysis of infection data since the introduction of the COVID-19 vaccines in the UK demonstrates that vaccination is highly effective and substantially reduces the risk of infection and severe COVID-19 disease.

There have been reports of an extremely rare adverse event of concurrent thrombosis (blood clots) and thrombocytopenia (low platelet count) following vaccination with the first dose of AstraZeneca ChAdOx1 nCoV-19 vaccine (AZD1222).

There has been no signal for thrombosis/thrombocytopenia following receipt of other COVID-19 vaccines approved for use in the UK (Pfizer-BioNTech and Moderna).

Given the very low numbers of events reported overall, there is currently a high level of uncertainty in estimates of the incidence of this extremely rare adverse event by age group.

However, the available data do suggest there may be a trend for increasing incidence of this adverse event with decreasing age, with a slightly higher incidence reported in the younger adult age groups.

In contrast, the risks of severe disease associated with COVID-19 increases steeply with age, with the youngest adults at lowest risk.

There are currently no known risk factors for this extremely rare condition, which appears to be an idiosyncratic reaction on first exposure to the AstraZeneca COVID-19 vaccine.

Alternatives to the AstraZeneca COVID-19 vaccine currently approved for use in the UK include the Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273 vaccines. 

JCVI has weighed the relative balance of benefits and risks and advise that the benefits of prompt vaccination with the AstraZeneca COVID-19 vaccine far outweigh the risk of adverse events for individuals 30 years of age and over and those who have underlying health conditions which put them at higher risk of severe COVID-19 disease. 

JCVI currently advises that it is preferable for adults aged <30 years without underlying health conditions that put them at higher risk of severe COVID-19 disease, to be offered an alternative COVID-19 vaccine, if available.

People may make an informed choice to receive the AstraZeneca COVID-19 vaccine to receive earlier protection.

There are some adults <30 without underlying health conditions who are in phase 1, who were prioritised due to an increased risk of exposure and/or to reduce the risk of passing the infection on to vulnerable individuals.

This includes health and social care workers, unpaid carers and household contacts of immunosuppressed individuals. Acting on a precautionary basis, if these persons are still unvaccinated, it is preferable for them to be offered an alternative COVID-19 vaccine, if available. 

JCVI is currently finalising its advice on phase 2 of the programme, particularly for healthy people under 30 years of age, and this will be published in due course.

To date, there are no reports of the extremely rare thrombosis/thrombocytopenia events following receipt of the second dose of the AstraZeneca COVID-19 vaccine. All those who have received a first dose of the AstraZeneca COVID-19 vaccine should continue to be offered a second dose of AstraZeneca COVID-19 vaccine, irrespective of age. The second dose will be important for longer lasting protection against COVID-19.

JCVI advises that all individuals offered a COVID-19 vaccine should be fully informed about the benefits and risks of vaccination. This should include clear information on the extremely rare thrombosis/thrombocytopenia adverse event, how to monitor for symptoms that might be related to the adverse event, and what action should be taken by individuals and health professionals in the event of such symptoms arising. 

PHE is preparing updated information for those being offered COVID-19 vaccines, and for health professionals, which will be available through the GOV.UK website.