NICE IPG420 - CCSVI Procedure allowed in UK - 28Mar12

[MarkW]

Revision of NICE submission begins here.........................MarkW

I love the work and activism you've put into this.

A – Entry is best made through the saphenous vein rather than the femoral vein. This reduces the patient’s risk of a thrombosis in the femoral vein. Local anaesthesia is used. The puncture site is compressed manually at the end of the procedure, which is generally more successful than if the femoral vein was used.

This one is Dr. Sclafani's technique. I have not heard any of the other IRs pick up on it. It seems logical because we are likely to repeat procedures over a lifespan of managing our venous malformations and this protects the femoral vein from injury. If the saphenous vein is injured, it is of less consequence. Using the saphenous instead of the femoral might be minor in comparison to some of the more major differences in technique, such as doctors not checking the left renal vein.

D – Treatment is largely confined to venoplasty of vein valves in leading practice, which follows Prof Zamboni’s recent paper. This reduces, probably eliminating, vein dissection and vein rupture. This area requires future research before any CCSVI syndrome treatment procedure is finalized.

Septums too. Dr. Fox's autopsy study found more septal abnormalities than valvular abnormalities. I am curious about this because we don't hear much talk about septums or about how the treatment of a septum differs than a valve. Septums may be more resistant to treatment. 'Intraluminal abnormalities' would be a more encompassing term than vein valves for this point. And vein dissection and rupture can be due to overaggressive ballooning such as oversizing or excessively long or repeated balloonings. I believe this can happen as easily at the area of the valves as anywhere else in the vein. They have always been treating the area of the valves, even if they did not know it was the valves that they were treating.

D - Correct sizing of the balloon in relation to the vein value being treated is best evaluated using IVUS. Pressure in the balloon of up to 20 atmospheres may be required, although lower pressure of up to 5 atmospheres is often sufficient.

In Dr. Sclafani's abstract on high pressure balloons, the range went as low as 4 atms, which surprised me. I do not think 5 atms is sufficient for most of us.
http://www.ccsvicare.org/outreach_update03.html
His conclusions were that high pressures are required to completely dilate the lesions of CCSVI and that IVUS reduces the risk of vein injury.
And who wants incomplete dilation of the lesions of CCSVI or vein injury.[/quote]

[MarkW]

My submission was written with Prof Sclafani's words imprinted on my brain. Does it need changing or more explanation? I am not concerned that few Interventionalists are using the saphenous vein at the moment. All I am seeking to document is leading practice.
MarkW

A – Entry is best made through the saphenous vein rather than the femoral vein. This reduces the patient’s risk of a thrombosis in the femoral vein. Local anaesthesia is used. The puncture site is compressed manually at the end of the procedure, which is generally more successful than if the femoral vein was used.

This one is Dr. Sclafani's technique. I have not heard any of the other IRs pick up on it. It seems logical because we are likely to repeat procedures over a lifespan of managing our venous malformations and this protects the femoral vein from injury. If the saphenous vein is injured, it is of less consequence. Using the saphenous instead of the femoral might be minor in comparison to some of the more major differences in technique, such as doctors not checking the left renal vein.

[MarkW]

I submitted this to NICE last October. Suggestions please for improvements.
B – A guide tube (called catheter tube in UK, sheath in USA) is advanced through the heart into the superior vena cava. The tube remains in place during the procedure and catheter, balloons and intravascular ultrasound (IVUS) are introduced, removed, and re-introduced many times through the tube.
On language I should explain that in the UK the word 'sheath' can be used for a condom. In the same way that 'rubber' is used in the USA. In the UK an eraser is called a rubber, so it is OK for a six year boy to ask his teacher for a rubber in Oxford but not in USA.
The reason for using a guide tube is simple. If catheters/balloons/IVUS are introduced through the heart many times it may cause irregular heartbeats. This was pointed out (by Neurologists?) as a negative for the procedure in the NICE initial document so I submitted that good practice is to use a guide tube. They are relatively cheap and I hope they are used in most CCSVI procedures.
Comments please,
MarkW

[MarkW]

Any thoughts/improvements/comments on part C..................MarkW

C – Diagnosis of CCSVI syndrome requires the use of both catheter venography and intravascular ultrasound (IVUS). Latest research shows that some problems are missed if catheter venography is used alone (Abstract of CIRSE presentation attached, ref 1).

Ref 1:
Presentation Time: 2:00 PM
Pres. No.: P-492 - Usefulness of IVUS in diagnosis of chronic cerebrospinal venous insufficiency and multiple sclerosis
M. Stefanini, S. Fabiano, C. Del Giudice, C.A. Reale, S. Marziali, V. Cama, R. Gandini, G. Simonetti
Rome/IT
Purpose:
Chronic cerebrospinal venous insufficiency (CCSVI) is a cerebrospinal venous disease that recently has been considered related to multiple sclerosis. Diagnosis may be performed by Doppler ultrasonography and angiography. One limit of angiography is the lack of visualization of venous wall aspects. We investigated in our study the usefulness of IVUS to detect CCSVI anomalies.
Material and Methods:
From September 2010 and January 2011, 13 patients with multiple sclerosis and CCSVI, evaluated by Doppler US, were enrolled in this study. Venography was performed through a left transfemoral retrograde access with 5 Fr introducer sheet. Venography and IVUS control was performed at ileo-lumbar level, bilateral jugulars and azygos vein.
Results:
All patients showed a stenosis of at least one vein. In all cases IVUS confirmed flebographic control. IVUS allowed to evaluate anomalous valve movement that was not evident at flebographic control in 5 patients (38%). 4 patients (31%) had an anomalous membrane of azygos vein. Moreover, a double lumen aspect was present in some cases.
Conclusion:
IVUS is a useful device to detect venous anomalies in CCSVI. Particularly it allows a complete evaluation of valve movement that could not be performed with flebographic control. Moreover, it is fundamental to evaluate the Azygos vein structure that could not be showed clearly with US Doppler.

[Brightspot]

Wonderful work Mark!

In my discussions I tend to put a strong focus on CCSVI as a vascular disorder that has been demonstrated to affect many persons with MS.

I note the symptoms attributed to MS which are also symptoms of compromised oxygen perfusion to the brain.

I sometimes focus on the hemodynamics of CCSVI, and the resultant damage to blood vessels.

I downplay any need to tie the conditions to each other. To me it is irrelivent for the time being, except that having MS is a indicator that you may have CCSVI.

In my mind there is no need to "prove" causitive relationship. This is in fact a distraction from the main point. Persons with MS are at increased risk of having CCSVI. They ought to have access to screening and treatment by vascular specialists, for a vascular problem.

I wish we had something like NICE in Canada, with a mandate to respond in a transparent and public process to the conderns of citizens.

Lately I have become involved as much as possible in the health care reform process in Canada, in hopes of preserving and expanding our publicly funded, universal health care sysytem...and implimenting some meaningful mechanism for ensuring that the intersts of citizens are not swept under the carpet by more powerful interests.

In this country, my discussions with Health Authorities, Ministers of Health (federal and provincial) and others in power, always lead back to the reliance of the policy makers on the advice of the neurological department of the medical associations for advice regarding CCSVI. (This was what I was told by the office of the Provincial Health Minister, who did not reply to my next communication expressing concern that advice on vascular issues was sought for physicians in a different field.) Thus my sensitivity to separating the conditions of MS (clearly the "turf" of neurologist) and CCSVI (a vascular health condition).

(In Canada the Canada health act legislates the availability of medically necessary treatment to all Canadians. In Canada there is also Human Rights legislation which specifies that a service cannot be denied to a person on the basis that they are disabled.)

Any progress that you make will have wide reaching effect.

Thanks for all your work.

[MarkW]

If you like reading official guidelines:
http://guidance.nice.org.uk/IPG420
NICE did pretty well in their description below. I have informed them chest is incorrect, it should be trunk as the left renal and iliac veins are not in the chest. (I did check this as pharmacists study very little anatomy)
NICE Description
It is possible that there is a link between blocked veins in the head, neck and chest and progression of multiple sclerosis. This procedure aims to open blocked or narrowed veins by inflating a small balloon in the vein, allowing for better blood flow and a reduction in the symptoms of multiple sclerosis.
MarkW
PS Thanks for your support Brightspot.

[MarkW]

Please volunteer for the Sterling trial if you live close to Sterling University. MarkW

[triciacollick]

I just found this discussion.
I have been in correspondance with Mark recently (some months ago) and found our discussions very helpful.
I was one of the respondants to the NICE document last year, Mark, and would be happy to join any campaign about discrimination if they refuse to allow treatment for all.
Then there may still be a 'postcode lottery' depending where you live !
Even if CCSVI is not a cure, if it improves quality of life (which it seems to) then it should be offered, the earlier in life with MS the better !
This is a low cost procedure compared to the expensive drugs which are currently offered to those in pain, with apparently horrible side effects, may hold off progression.
LDN is another low cost possibility which helps some.
I have tried both and both seem to work for me. I am not the 'old' me but I found these things help a lot, after 10 years of progression, no-one will ever know if they would have helped more if I had been offered them by the NHS earlier.
I have also got my vitamin D levels normalised and I am taking Omega 3 supplements which seems to be redressing the balance.

(ps, I just tried to access ccsvi.co and can't get to it, does anyone know where it went to ?)

[MarkW]

Hello Tricia and other UK CCSVIers,
The site you are looking for is, but the back pages are not functioning. No idea why.
http://www.ms-ccsvi-uk.org/home/
I feel that NICE understands that UK CCSVIers will not allow themselves to be discriminated against, but if this happens many of us will take them on.
I am not campaigning to have CCSVI on the NHS at the moment. There is insufficient published data to support the economic case. I find this frustrating as so many CCSVI syndome procedures have been performed over the world. Yet there is no standard for diagnosis and therapy, which pwMS can demand from the NHS. EHC are working on this in the UK but I had hoped for global co-ordination of research.
In the short term I am working on collecting other peoples' ideas on diagnosis and therapy and compiling them in a concise document.
Best wishes,
MarkW

[triciacollick]

Thanks Mark, you can count on my support if you find you need to take on NICE.
I had my procedure through EHC, was very happy and have just been for the 6month check, everything still seems to be flowing ! The check-up is feeding into UK research as EHC input and I have moved my LDN prescriptions to them too so everything private is in 1 place , I am trying an increase in LDN slowly to see if that helps, I know it takes a while to stabilise.
I generally seem to be walking better but can't help over-doing it sometimes....still its good to push the boundaries !
I'll let you know how it goes
Tricia

[MarkW]

In contrast to the FDA, in the UK NICE has translated its guidance into Welsh, Not sure if that is a good use of UK taxpayers money as I am sure all IRs in Wales read English.
MarkW
Thanks for your offer of support Tricia.