Transvenous embolisation can be used in the NHS during the evidence generation period as an option to treat spontaneous intracranial hypotension caused by a cerebrospinal fluid (CSF)–venous fistula. There must be enhanced informed consent and auditing of outcomes.
There are uncertainties around the safety and efficacy of this procedure. It can be used if needed while more evidence is generated.
After this, NICE will review this guidance and the recommendation may change.
Healthcare professionals do not have to offer this procedure and should always discuss the available options with the person with spontaneous intracranial hypotension caused by CSF–venous fistula 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 safety and outcomes of the procedure. Enter details about everyone having this procedure into an appropriate registry. If there is no data collection method already available, use NICE's interventional procedure outcomes audit tool. Regularly review the data on outcomes and safety.
Who should be involved with the procedure
Patient selection and post-procedure follow-up should be done by a multidisciplinary team including a neurologist, neurosurgeon and interventional radiologist. This procedure should only be done in specialist centres by healthcare professionals (usually interventional radiologists) with specific training and experience in this procedure.
Healthcare professionals must collect data specifically around the safety and efficacy of this procedure.
This includes:
patient-selection criteria, including:
the location of any leak
the number of leaks
which nerves are involved
whether alternative procedures are suitable
evidence on procedure success, complication rates and long-term durability of repair
comparative data on safety and efficacy between different treatment options.
Evidence on the efficacy and safety of transvenous embolisation is limited but it is already widely used for other embolisation procedures. The embolisation liquid used in the procedure has been used by healthcare professionals for a long time and its safety profile is well understood. The available evidence for the procedure has not raised any major safety concerns.
Spontaneous intracranial hypotension caused by CSF–venous fistula is a highly debilitating condition that substantially impacts quality of life. Treatment options are limited, but include more invasive surgery or off-label CT-guided fibrin glue injection. The availability of transvenous embolisation along with other alternatives would improve access to treatment. So, it can be used with evidence generation.