'Liberation procedure' for treatment of venous stenoses (CCSVI) in the brain of MS sufferers

What is it about?

Multiple sclerosis (MS) is an inflammatory disease of the nervous system and the most frequent cause of neurological disability in young adults. Myelin, the material that wraps around and protects the nerves becomes damaged and this results in scarring and the formation of scar‐like plaques. MS is considered to be an immune‐mediated disease in which the person's own immune system attacks the nervous system and most of the current drug therapies are based on this hypothesis. However, a new theory has been recently proposed with a suggestion that impaired blood flow in the veins draining the central nervous system, so called chronic cerebrospinal venous insufficiency (CCSVI), may play a role in the cause of MS. CCSVI is thought to be congenital and it may result in iron deposits which in turn trigger the immune system to attack the central nervous system thus damaging the myelin. The proposed treatment for CCSVI is balloon angioplasty which entails the widening of narrowed (stenosed) veins, the commonly named 'liberation procedure'. We searched the relevant literature but found no studies that matched the criteria of methodological quality necessary for their inclusion in this review. There is currently no evidence to support or refute the efficacy and the safety of angioplasty for CCSVI in people with MS. Well‐designed and robust studies are warranted.

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Why is it important?

BACKGROUND: Multiple sclerosis (MS) is a leading cause of neurological disability in young adults. The most widely accepted hypothesis regarding its pathogenesis is that it is an immune-mediated disease. It has been hypothesised more recently that chronic venous congestion may be an important factor in the pathogenesis of MS. This concept has been named 'chronic cerebrospinal venous insufficiency' (CCSVI) and is characterised by stenoses of either the internal jugular or azygos veins, or both. It is suggested that these stenoses restrict the normal blood flow from the brain, causing the deposition of iron in the brain and the eventual triggering of an auto-immune response. The proposed treatment for CCSVI is percutaneous transluminal angioplasty, also known as the 'liberation procedure', which is claimed to improve the blood flow in the brain thereby alleviating some of the symptoms of MS. OBJECTIVES: To assess the effects of percutaneous transluminal angioplasty for the treatment of CCSVI in people with MS. SEARCH METHODS: We searched the following databases up to June 2012: The Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Specialised Register, CENTRAL in The Cochrane Library 2012, Issue 5, MEDLINE (from 1946), EMBASE (from 1974), and reference lists of articles. We also searched several online trials registries for ongoing trials. SELECTION CRITERIA: Randomised controlled trials assessing the effects of percutaneous transluminal angioplasty in adults with multiple sclerosis, that have been diagnosed to have CCSVI. DATA COLLECTION AND ANALYSIS: Our searches retrieved 159 references, six of which were to ongoing trials. Based on assessment of the title or abstract, or both, we excluded all of the studies, with the exception of one which was evaluated following examination of the full text report. However, this study also did not meet our inclusion criteria and was subsequently excluded. MAIN RESULTS: No randomised controlled trials met our inclusion criteria. AUTHORS' CONCLUSIONS: There is currently no high level evidence to support or refute the efficacy or safety of percutaneous transluminal angioplasty for treatment of CCSVI in people with MS. Clinical practice should be guided by evidence supported by well-designed randomised controlled trials: closure of some of the gaps in the evidence may be feasible at the time of completion of the six ongoing clinical trials.