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NICE encourages research for MS operation in draft guidance

The National Institute for Health and Care Excellence (NICE) is encouraging further research into a procedure which could relieve symptoms for some people who have multiple sclerosis (MS). The draft guidance has been published today (24 August) for public comment.

The procedure, called percutaneous venoplasty, aims to improve blood flow from the brain by using a small inflatable balloon or stent to widen narrowed veins in the neck, which carry oxygen-depleted blood. It has been suggested that there could be a link between narrowed veins (called chronic cerebrospinal venous insufficiency, or CCSVI) and the progression of MS.

Following a public meeting last month, NICE's independent committee is proposing in its draft guidance that the procedure should be used in the context of research so that further evidence on its safety and clinical efficacy can be developed; for example to explore its impact on quality of life.

Professor Bruce Campbell, Chair of the independent committee that develops NICE's Interventional Procedures guidance said: "Multiple sclerosis can be a distressing and disabling condition with a lack of effective treatments This means that it is really important to find out whether percutaneous venoplasty is clinically effective and safe for use in the NHS.. Based on the existing evidence, we believe that clinicians should only consider offering percutaneous venoplasty as a treatment option for people with MS who fir the diagnostic criteria for CCSVI, as part of structured clinical trials.

"In particular, we would welcome controlled research comparing percutaneous venoplasty against “sham venoplasty”, in the same way that drug treatments are compared to a placebo. This is so that we can learn more about whether venoplasty works and for how long. Further research could also improve the understanding of the relationship between MS and CCSVI which is very unclear at present."

"We encourage anyone with a special interest or experience of the procedure to comment on our committee's provisional advice for the NHS during this consultation period. This is so that all views can be considered appropriately, and so that NICE's final guidance can be of the greatest benefit for the future treatment of patients with MS who have CCSVI and the wider NHS."

NICE will publish its final guidance for the NHS in December, after its committee has reviewed the comments received and held a further public meeting in October.

The final guidance will advise the NHS on what the latest evidence and specialist opinion say about the safety and efficacy of percutaneous venoplasty, and what doctors should do if they wish to consider it as a treatment option for their patients with MS who have CCSVI.

The final guidance will not determine whether or not the NHS should offer the procedure: these decisions will continue to be made at a local NHS level and usually on a case-by-case basis.

Ends

Notes to Editors

1. The draft guidance will be available from 00.01 Wednesday 24 August 2011 at: http://guidance.nice.org.uk/IP/891. Contact the NICE press office for embargoed copies. The consultation period closes at 5.00pm on Thursday 21 September 2011.

2. Chronic cerebrospinal venous insufficiency (CCSVI) has been described as when the veins in the neck that carry oxygen-depleted blood away from the brain and spine become narrower, thus reducing blood flow. It has been proposed that there may be a link between CCSVI and multiple sclerosis (MS). Percutaneous venoplasty aims to open these narrowed veins by inflating a small balloon inside of them, or by using a stent, to improve blood flow and improve the symptoms of MS.

3. Concerns raised by NICE's independent committee regarding the current evidence included; that there is a lack of controlled trial data (e.g. the evidence submitted included a news article from a peer-reviewed journal), a lack of long term data (the longest follow up was 18 months), and different measures of efficacy (e.g. EDSS or MS-QOL). There are also safety concerns as the evidence reported one death following the procedure, as well as complications including stents becoming dislodged, internal bleeding and heart rhythm problems.

4. This type of NICE guidance considers evidence on safety and clinical efficacy; it does not consider cost effectiveness. For further information about NICE's Interventional Procedures guidance, please read the factsheet: www.nice.org.uk/newsroom/factsheets/InterventionalProcedures.jsp

5. Multiple sclerosis is a disease of the brain and spinal cord, characterised by scarring on the nerve fibres. This scarring disrupts the transfer of messages from the brain to the rest of the body, thus affecting the actions and activities, such as movement and balance. Symptoms can include: muscle weakness and tightness, fatigue, pain, blurred vision, numbness and tingling, and problems with mobility and balance. For further information, visit NHS Choices: www.nhs.uk/Conditions/Multiple-sclerosis/Pages/Introduction.aspx

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

2. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 24 August 2011

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.