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I hope someone produces a cheap and simple test to show venoplasty changes something for CCSVI syndrome. Next that all research includes this test. Best not to call this an endpoint Cece it is just a measurement. We should remember that neuros use lesions in MS research, without proving that the number/size/brightness of lesions is related to MS disability. However they are united in using this flawed measurement, a lesson for IRs.

MarkW

NICE received over 400 submissions concerning its draft guidance, which was unusual for them. NICE has agreed a final document which is going through a quality control process. This includes sending it for factual corrections to named people on a confidential basis. If you are consulted and would like assistance with your reply please feel free to contact me on a private & confidential basis via e-mail (mark@walkerm.com).

MarkW

NICE has resent their weblink http://guidance.nice.org.uk/IP/891. No final guidance so far.
MarkW

I cannot share with you the final draft of NICE's guidance as I signed a non disclosure agreement. However I can say that I noted many factual errors in the document and pointed out that the guideline discriminated against disabled people (pwMS), which is contary to UK law.

I also sent a constructive letter to NICE, which I may share with you...................MarkW

PS I realise that this is not of much interest to non Brits, except that you can see the game being played.
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In my former consulting world, re-use of material was commonplace. Hence, IP 409 ‘Balloon dilatation of the Eustachian tube’ has been used in this instance. Management consultants often focus on the core of the subject and avoid using contentious terms. In this case, Chronic Cerebrospinal Venous Insufficiency (CCSVI) is not used as the term and symptom has not been agreed between Neurologists and Interventionalists. I offer this proposal in the hope that this novel treatment can still be offered, in the UK, to this sizable group of disabled people.

1 Guidance for IP 891 (MAW proposal)
1.1 Current evidence on the efficacy and safety of balloon dilatation of Extra-cranial Venous Stenoses for people with Multiple Sclerosis is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research, which should address the efficacy of the procedure in the short and longer term, and also document safety outcomes. Research studies should clearly describe which veins have been treated and report objective measurements of venous or related function and/or subjective measurements of symptom improvement.

Mark Walker – 21st December 2011

Please Mark, keep posting on the developments. I think this is all very important for anyone interested in CCSVI and especially for Europeans like me...in Germany we are still very far from anything that comes close to this. However, I am sure that if nice considers CCSVi favourably for the UK in the end, we will come one step further in other European countries, too.

Thank you very much for your great work!

sumsum

It may also help us here in Canada where we seem to go around in circles!

As an ex pat. Brit I am extremely interested in the NICE process in the UK.

Thanks to sumsum and Hooch for your comments.

Its not official from NICE but EHC says:

..................... The full report was due for publication in December but has been put back to Spring 2012 apparently due to the large number of patients reports, over 400, that the committee have received on the subject. We are delighted to have contributed to the evidence considered by the committee particularly on the issue of safety.

We are moving into a new and exciting phase in the development of CCSVI treatment throughout the world. The initial euphoria that greeted the discovery of this condition has been gradually replaced with a more pragmatic approach which will help to scientifically assess the importance of this condition in MS and other neurological conditions. We hope that the NICE guidance will result in an increase in research activity in the UK and its eventual adoption as a standard treatment for MS available on the NHS. There have been many hurdles to overcome in order to establish CCSVI treatment in the UK and there will be many more before our aim of having this available as an NHS treatment is achieved.


MarkW

NICE has published its final guidance:
http://www.nice.org.uk/nicemedia/live/1 ... /58610.pdf
My question is - will Essential Health Clinic meet the standard of a 'robust controlled clinical trial' demanded by NICE???
My interpretation is that their offering is not a controlled trial as their work is open on patients prepared and able to pay for the procedure.
If the NICE guidance restricts access of pwMS to EHC or increases the cost, then NICE is discriminating against pwMS (a group of disabled people). Let's see how this plays out but a complaint against NICE on the grounds of discrimination could be a future idea. Any other UKers up for it ?
Kind regards,
MarkW

This seems to position the Saskatchewan study to provide the needed input on QoL. It does not sanction any of the existing for-pay treatments. However, this is inevitable and ongoing, due to the positive anecdotal evidence in great quantity, and the lack of better solutions either for pw"RRMS", or other "phenotypes". It seems to sanction the assumption that percutaneous venous angioplasty (PVA), with or without stenting, is a treatment for "MS", which is still ill-defined. If it exists, it still has an origin about which nearly nothing is known. It currently defined and diagnosed with symptoms, imaging, and clinical course, often due to known other conditions, frequently mis-diagnosed as "MS". I agree that it is better to think of it as a proven treatment for the CCSVI syndrome, with its well-known effects on QoL, less well-established effects on the onset of disability, and little known effects on the lesions previously characterized as being due to "MS".

Thanks for the offer of the domain name. I hope to use it in the coming months..........MarkW

On careful reading and discussion I conclude that NICE allows the CCSVI procedure in a research setting. I was reminded that the setting is one for a surgical procedure not a double blind placebo controlled drug trial. I am pleased that NICE removed the requirement for sham trials. Those of us who have had the procedure know that a sham procedure would be very difficult to achieve, if not impossible.
More info later, next step is to contact NICE with my thanks. Then we need a clinic in south east England to start offering the procedure. Eventually it will move to the NHS, but that could take years as budgets are very limited at the moment.
MarkW

Well done Mark! I think I was one of the 400 who wrote in as I certainly sent off a form. But I've had preggers brains for the last few months so everything is a bit of a blur. Getting better now.
Regards,

Alex Gibbs

Great to hear the outcome. First time I've participated with NICE this way. I put my dual citizenship to good use for once.

Thanks to everyone who wrote to NICE supporting CCSVI. Most of the 400 submissions supported CCSVI. Gibbledygook and Bluesky have indentified themselves, who else wrote to NICE ?
MarkW

My letter to NICE written on 16-Apr-12......................MarkW
To:
Prof. Carole M. Longson – Director, Centre for Health Technology Evaluation.
Prof. Bruce Campbell – Chairman, Interventional Procedures Advisory Committee.

IPG420 - Percutaneous venoplasty for chronic cerebrospinal venous insufficiency in multiple sclerosis
Comments from - Mark A. Walker
Charity Address - Chair, Oxfordshire MS Therapy Centre, 37E Milton Park, Abingdon OX14 4RT
 
Introduction
I welcome IPG420, a significant improvement in the Institute’s final guidance, when compared with the draft document. Many people with Multiple Sclerosis (pwMS) who made submissions to NICE will also welcome IPG420, as it permits us to obtain percutaneous venoplasty in the UK.
I am particularly relieved that NICE has removed any reference to sham trial for CCSVI. I am aware that NICE received comments from pwMS, similar to mine made on 20th Sept 2011: - Trials comparing venoplasty against sham is a research dream. Real life patient experiences, including my own, report that balloon venoplasty (inflation of the balloon) is felt during treatment. In some cases pain is reported and local pain killers (eg Fentanyl via catheter) are used. Heavy sedation of patients in order to facilitate a sham trial would place trial subjects under increased risk, due to the sedative drug. I doubt that heavy sedation of patients would be accepted by any UK ethics committee and it is certainly not in the best interests of the trial subjects (people with Multiple Sclerosis).
My objective remains to ensure that pwMS can access the procedure using current guidance and based on leading practise. In order that NICE is aware of errors or ommisions in your published guidance, I detail these below. Also, I await the letter indicated by Prof Longson’s paragraph:

Comments on IPG420:
My current comments use the paragraph points of IPG420. I document these at the current time so that there can be no doubt to my current view on NICE’s document IPG420.
In section 1, IPG420 states that further research is encouraged ‘in the form of robust controlled clinical trials’:
1.1 Current evidence on the efficacy of percutaneous venoplasty for chronic cerebrospinal venous insufficiency (CCSVI) for multiple sclerosis (MS) is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research.
1.2 NICE encourages further research on percutaneous venoplasty for CCSVI for MS, in the form of robust controlled clinical trials. Studies should clearly define selection criteria and patient characteristics. They should also clearly define technical success which may include measurement of pressure gradients across treated vein segments before and after venoplasty. Outcomes should include clinical and quality of life measures.
I applaud that the NICE guidance (IPG420) and comments by Prof Campbell have focused on the technical success of surgical procedures, rather the data generated from placebo controlled double blind drug trials usually used by the pharmaceutical industry. Additionally, the phrase ‘quality of life measures’ used by NICE should reassure pwMS that our real life experiences will not be dismissed as ‘placebo’ following a CCSVI procedure. NICE’s phrase should permit pwMS to decide the appropriate level of benefit for themselves. Slowing progression of MS may not be ‘substantial’ in the eyes of MS Neurologists but was the primary reason I sought the procedure in June 2010 and it is a goal of most pwMS, living with this life-long disease.
IPG420 should result in the increase of ‘patient financed open trials in private medicine’ in the UK. It is clear from the NICE IPG420 that this type of trial is sanctioned. Patient’s ‘real life’ experiences thankfully challenged the logic of blinded trials. It is relief that patients’ voices were acted upon in this case, and a challenge to NICE, on equality grounds, was avoided.
PwMS still struggle to finance open label procedures of percutaneous venoplasty for CCSVI in the UK. Unfortunately, many travel abroad for treatment, instead. I hope that IPG420 means that other centres in the UK offer percutaneous venoplasty during 2012. I expect that initial studies will be open trials in private medicine but hope that the National Health Service will also consider trials very soon.
In section 2.2.1, IPG420 has been amended but inaccurately. Unfortunately the renal and iliac veins are outside the definition of ‘head, neck and chest’ used in IPG420. Treating the renal veins has been reported at the SIR 2012 conference, as well as numerous reports on the internet. I am concerned that IPG420 includes such an error as it could misguide interventionalists who may use this technique. I am unclear why NICE used the term ‘trunk’ in its first document, but says the term is inappropriate now?

IPG420 contains three sections which have become out of date already, when presentations at recent conferences (ISNVD/CIRSE/SIR) are considered.
These sections would need regular updating if IPG420 seeks to remain current and a source of leading practice:
2.3 Efficacy
2.4 Safety
2.5 Other comments
Prof Longson’s letter of 270312 said:
Although NICE amended section 2.3.5 (above), it is apparent to those of us who have studied Multiple Sclerosis and CCSVI syndrome for many years that the ‘Specialist Advisors’ in the main lacked detailed knowledge of CCSVI syndrome. Maybe, a panel selection error was made by NICE, when many Neurologists were included as Specialist Advisors for an interventional procedure.

I am focussed on achieving the best solution for pwMS. My study of MS and CCSVI leads me to agree with NICE that “the aim of percutaneous venoplasty is to relieve MS symptoms by improving cerebrospinal venous drainage”. I remain certain that MS is a multi-factorial disease and the approach of safely treating symptoms is the only logical one to adopt, currently.
Insert - Letter of Oct 2011 gave details on steps for percutaneous venoplasty
I am not aware of published documents that give future practitioners of percutaneous venoplasty any basic instructions, which I assembled but only just understand. The importance of the best methods and tools is emerging at conferences, example ref A. Such developments are vital to pwMS who seek percutaneous venoplasty, so that the safest procedure is offered in the UK .
I remain available to discus any points of IPG420 with NICE personnel, in order to assist NICE in providing fair and accurate guidance to pwMS.

Mark Walker

Ref A
Society of Interventional Radiology 2012
Sun, 3/25: 11:26 AM - 11:34 AM
Abstract No: 47
Authors: S. J. Sclafani1, 2, K. Zhang2
Institutions: 1. American Access Care, Brooklyn, NY, United States. 2. Radiology, SUNY Downstate Medical Center, Brooklyn, NY, United States.
Author(s)
Professor Salvatore Sclafani, MD, FSIR - View Disclosure
American Access Care
Brooklyn, NY
Purpose:
The nature of Internal Jugular Vein (IJV) obstructions associated with chronic cerebrospinal venous insufficiency (CCSVI) is not well established, but it appears to be different from those stenoses caused by thrombotic recanalization, scarring, tumor encasement and access intimal hyperplasia. We sought to determine the balloon sizes and pressures that were necessary to attain complete distension of IJV obstructions in CCSVI.
Materials:
The records of all patients undergoing endovascular treatment of the IJV for CCSVI were reviewed. Angioplasty was based upon venographic findings such as stenosis >50%, stasis, reflux, collaterals or upon intravascular ultrasound (IVUS) findings, such as cross sectional area stenoses (CSA)>50%, immobile valves, septa, membranes,or webs. Balloon sizing was initially calculated by visual estimation, but converted to IVUS measurement of CSA. Inflation endpoints were elimination of balloon waist without recoil or exceeding rated burst pressure. Balloon size and maximum pressure were recorded. Complications were reviewed.
Results:
93% of 150 treated patients underwent angioplasty of 239 IJVs. 82% received bilateral IJV angioplasty. Balloons used were slightly larger in diameter on the right (avg. 15.8mm, range 10-20mm) than on the left (avg 14.4mm range 8-20 mm). Endpoint pressure requirements averaged 12.7 Atmospheres (range 4-25 atm) on the right side and 13.2 atm (range 6-23 atm) on the left side. There were three balloon ruptures, two occurred during removal from the sheath.There were three dissections, two perforations and ten thromboses (6.3% of treated veins). All but one dissection and one thrombosis occurred prior to using IVUS CSA for balloon selection. Complication rate of 16% using visual estimation was reduced to 1.3% using IVUS CSA measurements.
Conclusions:
High pressures are required to completely dilate the lesions of CCSVI. IVUS reduces risk of vein injury.