NICE IPG420 - CCSVI Procedure allowed in UK - 28Mar12

[MarkW]

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 The draft guidance has been published today (24 August) for public comment.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Following a public meeting last month, NICE's independent committee is proposing in its draft guidance that the procedure should be used in the context of research so that further evidence on its safety and clinical efficacy can be developed; for example to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

MarkW's Previous Posting

http://www.thisisms.com/ftopict-17666.html
http://www.thisisms.com/ftopict-16450-nice.html
http://www.thisisms.com/ftopict-16434-nice.html
http://www.thisisms.com/ftopict-16239-nice.html


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.

MarkW

[silverbirch]

markW

I have posted your link about NICE on the Action CCSVI FB .....

MarkW do you do FB ?

[silverbirch]

Whilst MS-CCSVI-UK is pleased that the treatment of CCSVI is being considered for guidance by NICE, we would like to make it clear that this is not us which made this application.

Not only were there several things that we did not agree with (stents, connections with MS, terminology,) but also we were aware that without the backing of a professor the application was likely not to be taken seriously.

We also knew that if the application was rejected, (according the NICE's process of consideration) another similar application could not be considered for two years.

[Cece]

Is this new?
www.mstrust.org.uk/news/article.jsp?id=4690

Timetable for NICE guidance on CCSVI

Author: MS Trust

NICE (the National Institute for Health and Clinical Excellence) has announced the timetable for its guidance on treatment for CCSVI.

Chronic cerebro-spinal venous insufficiency (CCSVI) is a theory that stenosis (an abnormal narrowing or obstruction) in blood vessels can cause inflammation and damage to cells in the central nervous system, leading to MS symptoms.

It has been proposed that CCSVI can be treated by surgical procedures to open the narrowed veins by inflating balloons (balloon angioplasty) or by inserting a stent (mesh tube) to support the vein.

The NICE Interventional Procedure Programme is about to start and as a stakeholder in this guidance the MS Trust has been given the following summary of the schedule:


10 June 2011
■First Interventional Procedures Advisory Committee (IPAC) meeting the evidence will be discussed and provisional recommendations drafted
21 July - 18 August 2011
■Consultation on the Draft recommendations
13 October 2011
■Second IPAC meeting The committee will consider the consultation comments and make changes to the guidance if necessary

www.mstrust.org.uk/news/article.jsp?id=4690

[MarkW]

The latest dates are below, but they are always subject to change. I suspect a high volume of evidence could delay these dates.

■14 July 2011
First Interventional Procedures Advisory Committee (IPAC) meeting
The evidence will be discussed and provisional recommendations drafted
■24 August - 21 September 2011
Consultation on the draft recommendations
■10 November 2011
Second IPAC meeting
The committee will consider the consultation comments and make changes to the guidance if necessary

MarkW

[MarkW]

The whole press release is at the top of thread.
Adds to Cece's post - www.thisisms.com/ftopict-17666.html

MarkW

[MarkW]

L posted:

Is open for you to add your comments

http://guidance.nice.org.uk/IP/891/DraftGuidance

[MarkW]

Submissions close on Wed 21/9/11. Speak now or forever hold your peace.
MarkW

[cheerleader]

MS Trust reports final day:

http://www.mstrust.org.uk/news/article.jsp?id=4950

[MarkW]

Just the EXECUTIVE SUMMARY
 NICE’s consideration of Percutaneous venoplasty for chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) is welcome.
 Professor Paulo Zamboni’s recent publication (ref 1) defines CCSVI as a syndrome. NICE’s provisional recommendations miss the point that the procedure is to treat CCSVI syndrome, not the disease of Multiple Sclerosis.
 The primary question for NICE should be, ‘Does this procedure open restricted veins?’
 15,000 procedures have been conducted globally (ref 2). These have been mainly patient financed.
 Trials comparing venoplasty against sham is a research dream.
 Leading practice through personal communications should be adopted.
 Treating syndromes remains an established medical and pharmaceutical practice and must be adopted for CCSVI syndrome.

MarkW

[PointsNorth]

 Treating syndromes remains an established medical and pharmaceutical practice and must be adopted for CCSVI syndrome.

I find this to be especially compelling. N'est pas?

[MarkW]

Hello PointsNorth,
I use this argument cos it is impossible for Neuros to argue against it. Treating an overactive immune system is treating symptoms, even if Neuros like to call them DMDs (disease modifying drugs). I encourage the use of this slogan in Canada rather than liberation treatment, which is easy to argue against.

"Treat my CCSVI syndrome - it is an established medical and pharmaceutical practice".

MarkW

[Cece]

The most encouraging aspect of the whole proceedings was the strength of response from the consultees, (as they called the people who wrote to give them the benefit of their experience and their suggestions). Four hundred and forty (440) people wrote in, most of them in support of PTA for the treatment of CCSVI.

440 people wrote in!! Those are numbers.

The issue of equality was discussed extensively and the committee had to agree that the procedure could not be described as anything but safe and that there was no reason why people with an MS diagnosis should not be treated via a venoplasty procedure, however they felt that the most important question not answered so far was whether this was an effective treatment for MS symptoms. Although there was plenty of evidence about the safety of the procedure, no one had published anything regarding its efficacy.

It is considered safe, but is it effective....
It is not accurate to say that no one has published anything regarding efficacy. We have long-term results from Zamboni that have been published. It's not enough, but it's not nothing.

[MarkW]

Hello Cece,
The public meeting was not a consultation session, just the committee meeting in public to show NICE is open in its processes. The truth is the real work goes on behind the scenes (I am a cynic, so decided not to attend).
The "safe procedure" statement is very important as the UK neuros said this procedure is dangerous (people die) and would like to stop the procedure in the UK.

A logical discussion on efficiecy goes like this:
1 - treating CCSVI syndrome is balloon venoplasty is safe.
2 - valve issues are treatable by balloon venoplasty.
3 - do valve issues remain resolved after the procedure ????
There is no published paper which show that the vein valves treated remain treated after 1 or 3 or 6 or 12 months. This is the simple step wise research which needs to happen. Personally I know that my veins which were treated in Athens (June 2010) remain patent because Dr S checked them in Jun 2011. Unless I have missed a paper this data is not available.
If I were to advise on designing a trial I would:
1 - use a non invasive measurement of CSF flow in pwMS and controls (upright MRI, BOLD techniques etc).
2 - diagnose vein valve problems in pwMS/ people with redured CSF flow using catheter venograms and IVUS
3 - treat all instances of vein valve problems
4 - use IVUS to verify treatment.
5 - repeat step 1 after 1 day, 1, 3, 6, 9, 12 months.

I expect that CSF flow would be shown to be slower in pwmS (research is emerging). I expect that CSF flow would be improved in pwMS by the procedure (step 3). Depending at the techniques used for step 3, CSF flow would remain at same as 1 day level in most cases. Results would show the efficiecy of the procedure after certain time periods. I hope such basic data will be published by the Hubbard group and various Italian groups during 2012. Basic efficacy trials are normal in drug development and bodies like NICE expect to see them for CCSVI syndrome. Jumping ahead to the impact on MS symptoms is a waste of time until basic efficacy is demonstrated.

I keep feeding info into NICE. It is interesting to read Prof Cambell's comment on trials as I wrote a section summarised as:
Trials comparing venoplasty against sham is a research dream.

Let's keep watching, they release some of the comments.

MarkW

[Cece]

A logical discussion on efficiecy goes like this:
1 - treating CCSVI syndrome is balloon venoplasty is safe.
2 - valve issues are treatable by balloon venoplasty.
3 - do valve issues remain resolved after the procedure ????
There is no published paper which show that the vein valves treated remain treated after 1 or 3 or 6 or 12 months. This is the simple step wise research which needs to happen.

Back in January, around ISET time, Dr. Dake talked about his planned trial in the press. It is exactly what you are asking for here. He is going to look at flow as an endpoint, namely if flow is improved or not improved as a result of the angioplasty.