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Middle meningeal artery embolisation (MMAE) can be used in the NHS during the evidence generation period as an option to treat non-acute subdural haematomas:
with surgery to remove the haematoma
alone when surgery is not suitable or not clinically indicated.
There must be enhanced informed consent and auditing of outcomes.
More research is needed on MMAE alone when surgery to remove the haematoma is suitable but not chosen to treat non-acute subdural haematomas before it can be used in the NHS.
This procedure should only be done as part of formal research and a research ethics committee needs to have approved its use.
MMAE with surgery, or alone when surgery is not suitable or not clinically indicated
There are uncertainties around the safety and efficacy of this procedure when used with surgery to remove the haematoma, or alone when surgery is not suitable or not clinically indicated. It can be used if needed while more evidence is generated. After this, NICE will review this guidance and the recommendations may change.
Healthcare professionals do not have to offer this procedure and should always discuss the available options with the person with a non-acute subdural haematoma before a joint decision is made.
Hospital trusts will have their own policies on funding procedures and monitoring results. NHS England may also have policies on funding of procedures.
Enhanced informed consent
Because there are uncertainties about the procedure's safety and efficacy, there must be an emphasis on informed consent. Healthcare professionals must make sure that people (and their families and carers as appropriate) understand the uncertainty and lack of evidence around a procedure's safety and efficacy using NICE's advice on shared decision making and NICE's information for the public. Healthcare professionals must also inform the clinical governance leads in their organisation if they want to do the procedure.
Auditing of outcomes
Healthcare professionals doing this procedure should collect data on the safety and outcomes of the procedure. Details about everyone having this procedure should be entered into an appropriate registry. If there is no data collection method already available, use NICE's interventional procedure outcomes audit tool. Healthcare professionals should regularly review the data on outcomes and safety.
Who should be involved with the procedure
Patient selection should take a multidisciplinary approach. Relevant disciplines include interventional neuroradiology, neurosurgery, geriatrics and trauma care. MMAE should only be done by an interventional neuroradiologist with specific training in this procedure.
MMAE alone when surgery is suitable but not chosen
There is not enough evidence to know whether this procedure is safe and efficacious. MMAE alone when surgery to remove the haematoma is suitable should only be done as part of formal research.
Auditing of outcomes
Healthcare professionals doing this procedure should collect data on the safety and outcomes of the procedure. Details about everyone having this procedure should be entered into an appropriate registry. If there is no data collection method already available, use NICE's interventional procedure outcomes audit tool. Healthcare professionals should regularly review the data on outcomes and safety.
Who should be involved with the procedure
Patient selection should take a multidisciplinary approach. Relevant disciplines include interventional neuroradiology, neurosurgery, geriatrics and trauma care. MMAE should only be done by an interventional neuroradiologist with specific training in this procedure.
Healthcare professionals must collect data specifically around the safety and efficacy of MMAE with surgery to remove the haematoma, or alone when surgery is not suitable or not clinically indicated, especially in the form of registry data relevant to the NHS. The data should be compared with data from people who did not have the procedure. This can include historical controls with statistical matching.
For people having MMAE with surgery, data includes:
longer-term efficacy outcomes including:
functional outcomes such as cognitive function
change in neurological symptoms such as headaches
quality of life
patient selection, including:
symptom severity
whether the procedure is done for a new or recurrent haematoma.
For people having MMAE alone when surgery to remove the haematoma is not suitable or not clinically indicated, data includes:
intermediate and longer-term efficacy outcomes including:
symptomatic recurrence
need for further intervention
functional outcomes such as cognitive function
change in neurological symptoms such as headaches
quality of life
intermediate and longer-term safety outcomes including:
mortality
stroke or myocardial infarction
patient selection, including:
symptom severity
frailty status
whether the procedure is done for a new or recurrent haematoma.
For MMAE alone when surgery to remove the haematoma is suitable but not chosen, more research is needed. This should be in the form of randomised controlled trials and real-world evidence, and in populations relevant to the NHS. It should include:
intermediate and longer-term efficacy outcomes including:
symptomatic recurrence
need for further intervention
functional outcomes such as cognitive function
change in neurological symptoms such as headaches
quality of life
intermediate and longer-term safety outcomes including:
mortality
stroke or myocardial infarction
neurological complications such as visual loss
procedure or device-related adverse events or complications
patient selection, including:
symptom severity
whether the procedure is done for a new or recurrent haematoma.
There is good quality evidence on the efficacy of MMAE with surgery to remove the haematoma for some outcomes up to 12 months. It shows that MMAE with surgery reduces the recurrence or worsening of non-acute subdural haematomas compared with surgery alone or no surgery. But there are some uncertainties about whether MMAE with surgery:
leads to better functional outcomes and quality of life
reduces disability and mortality in the long term.
The evidence on the safety of MMAE with surgery is limited, but does not raise any major safety concerns.
The evidence for MMAE alone when surgery to remove the haematoma is not suitable or not clinically indicated is more limited compared with the evidence for MMAE with surgery. But it suggests that the procedure is safe and effective. Also, there is a greater unmet need for people who cannot have surgery because standard medical treatment alone could lead to poor health outcomes.
So, for these populations, MMAE can be used while more evidence is generated on its efficacy and safety.
There is very little evidence on the efficacy and safety of MMAE alone when surgery to remove the haematoma is indicated but not chosen. So, more research is needed for this population.
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