This thread combines other threads with nearly the same title/subject:
Press Release on 24 Aug 2011:
The National Institute for Health and Clinical 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 The draft guidance has been published today (24 August) for public comment.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Following a public meeting last month, NICE's independent committee is proposing in its draft guidance that the procedure should be used in the context of research so that further evidence on its safety and clinical efficacy can be developed; for example to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.
End of NICE Press Release
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I contacted NICE and this is an extract from my comment:
MAW Comment – This is not one but two different procedures. Percutaneous Transluminal Angioplasty (PTA) is widely used in the UK. Balloon angioplasty (also called balloon venoplasty to distinguish the fact that veins are treated) is being performed in the UK currently. Use of stents in veins as CCSVI treatment has not been performed in the UK. For NICE to consider these two procedures as one procedure would be detrimental to rational debate. I urge NICE to exclude the use of stents in the consultation document, or as a minimum to consider them as two procedures.
NICE has amended the proposed title to:
Percutaneous venoplasty for chronic cerebrospinal venous insuffciency (CCSVI) in Multiple Sclerosis
Posted on - http://guidance.nice.org.uk/IP/891
This change could have been entirely unconnected with my comments but I am happy with the new title. The published data does not include use of stents and Prof Zamboni has not mentioned stents in his papers. I will advise NICE of their typo.
Excluding the use of stents will, no doubt, annoy some of the 'liberation activists' in the UK. However, 'no stents' prevent Neurologists from presenting the issues with stents seen in two patients to IPAC.
I will not give details of my submissions to NICE as this is a public site. I would be grateful if any CCSVI activists would contact me if you make any submission to NICE or are considering doing so.