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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    1 Recommendations

    1.1

    More research is needed on transvenous embolisation for spontaneous intracranial hypotension caused by a cerebrospinal fluid (CSF)–venous fistula before it can be used in the NHS.

    1.2

    This procedure should only be done as part of formal research and a research ethics committee needs to have approved its use.

    What this means in practice

    There is not enough evidence to know if this procedure is effective. Transvenous embolisation for spontaneous intracranial hypotension caused by a CSF–venous fistula should only be done as part of formal research.

    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 and regularly review the data on outcomes and safety.

    Who should be involved with the procedure

    Patient selection should be done by a multidisciplinary team. This procedure should only be done in specialist centres by healthcare professionals with specific training and experience in this procedure.

    What research is needed

    More research, including randomised controlled trials or a registry, is needed. The research should:

    • report patient-selection criteria, including the location of any leak, the number of leaks, which nerves are involved, and whether alternative procedures are suitable.

    • include UK-based evidence on procedure success, complication rates and long-term durability of repair.

    Why the committee made these recommendations

    Evidence on the efficacy and safety of this procedure comes from small observational studies done in the US and France. The evidence shows that transvenous embolisation can relieve symptoms of spontaneous intracranial hypotension and prevent future episodes. But there is no evidence directly comparing transvenous embolisation with any other procedure for closing a CSF–venous fistula. There is also not enough evidence on its long-term effectiveness and no published evidence from the UK.

    The available evidence has not raised any major safety concerns with the procedure.