NICE encourages research for MS operation
Final guidance from the National Institute for Health and Care Excellence (NICE) out today (28 March) encourages further research into an operation which is claimed to relieve symptoms for some people who have multiple sclerosis (MS).
The procedure, called percutaneous venoplasty, aims to improve blood flow from the brain by using a small inflatable balloon 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.
NICE's guidance advises the procedure should be only performed on these patients in the context of clinical research. This is so that more evidence on its safety and efficacy can be developed; for example to explore the impact that the procedure could have on quality of life in the long term.
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 fit the diagnostic criteria for CCSVI, as part of structured clinical trials.
"This is so that we can learn more about whether venoplasty works and if so for how long. Further research could also investigate the relationship between MS and CCSVI, as this is very unclear at present".
NICE's guidance outlines what NHS healthcare professionals should do if they wish to consider percutaneous venoplasty as a treatment option, based on its safety and efficacy only. Cost is not considered in this type of guidance.
Notes to Editors
1. The interventional procedures guidance will be available from Wednesday 28 March 2012 at: www.nice.org.uk/IPG420. Contact the NICE press office for embargoed copies.
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 is a technique to widen narrowed veins by inflating a small balloon inside of them, which can improve blood flow.
3. NICE's independent committee considered that the 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), are a concern. 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. The final guidance was originally expected to publish in February; however, NICE postponed this to the following month, in order to fully consider comments and requests submitted by some of its consultees. This feedback was received as part of NICE's resolution process - a final quality-assurance step for NICE's interventional procedures guidance. This gives stakeholders a final opportunity to comment on the factual accuracy of NICE's draft guidance following its public consultation, and to highlight any potential areas where NICE may have appeared to have not followed its process. The resolution process is independent of NICE and the guidance committee. It resulted in a few minor changes to the wording of the guidance for clarification, but the recommendations for the use of the procedure remain as “research only”. Other requests (i.e. regarding NICE's process) have not been upheld by the independent resolution panel. For further information about NICE's resolution process, please read pages 32-38 of the guide.
6. 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
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: 28 March 2012