This Is MS Multiple Sclerosis Knowledge & Support Community

girlgeek33 wrote:

ThisIsMA wrote:

drsclafani wrote:
a treatment clinic could be built for a six figure sum using good used equipment and could actually be profitable as long as insurers choose to pay for procedures. and i will bet we find that sleeping giant waking up soon.

Cece replied: Worrisome!

Hi Cece,

I thought doctor Sclafani's statement above meant that the sleeping giant of insurance companies might soon figure out that paying for CCSVI treatments could save them big money in the long run, so they might soon start covering it, but maybe I've got that wrong. Sigh...

More likely that they will figure out a way to not pay, call it research... They have a tendency to look for reasons not to pay, instead of looking at the upside...

My MS care, including my 13 infusions of Tysabri per year (I have gotten much worse since I started Tysabri 3 1/2 years ago, but I'm afraid to stop it and take the chance of getting even worse), my Ampyra (which does very little), my doctor's visits, MRI's, etc. is costing my insurance company about $100,000 per year in a good year when I have no complications (falls, broken bones, physical therapy). I, too, have wondered if insurance companies wouldn't be happy to learn of this treatment which could potentially save them hundreds of thousands per year.

Maybe the insurance companies will crunch the numbers or do a focus group...there are many many MSers who are quitting their drugs post liberation...that has to add up...but yes this is a new worry that I hadn't had before.

drsclafani wrote:they mention increased ijv flow on the other side. THIS IS NOT A SIGN OF CCSVI. i guess i really do need to do the study of the imaging tests (specifically ultrasound) you have had taken to see if they follow the protocol. Tonite i shall start a request for an irb exemption. However if anyone can anonymize their cd, i can look at it now.

Did everyone catch this? I think our good doctor is back in the saddle.

drsclafani wrote:its really not a pressure phenomenon. its a flow phenomenon.

But there must be some interplay between pressure and flow? I am thinking of the barrel, where the out-flow is blocked so the in-flow is lesser, but if you turn up the inflow and force more in (higher blood pressure) it's still not going to get past that blockage but there will be more going around it and through the collaterals and leaking out the sides? Which is not a good thing?

fogdweller wrote:I guess there really isn't anything right now that leads a dr. to do the venograms that show CCSVI except MS.

I googled this yesterday and came up with: neoplasms (tumor); jugular aneurysm; pulsatile tinnitus or right carotid abnormalities; early morning headache and vomiting; this one: http://www.ncbi.nlm.nih.gov/pubmed/19540711; persistent left superior vena cava; and jugular bulb venous thrombosis caused by mild head injury. None of which I have.

(You know, if no one else is here, my post is just going to get longer and longer.... ;) )

Dr Sclafani
appreciate your reply.

Wonderfulworld wrote:
Dr. Sclafani
thank you for this thread. I have read the different user experiences on TIMS with valve issues (Erika, LR1234, Rici) and I realise searching for answers on how to treat valve issues is less 'looking for a needle in a haystack' and more 'do I need a needle, and will it be what I'm looking for if I do find it' Laughing .

I had a Doppler scan done, it showed a diminished flow in the left Internal Jugular Vein (IJV), with an immobile valve at the IJV-innominate junction. Increased right IJV flow. I have not yet had any CCSVI treatment.

again....this would be a negative doppler ultrasound as you only mentioned one of the five findings of ccsvi and a diagnosis requires two for zamboni
they mention increased ijv flow on the other side. THIS IS NOT A SIGN OF CCSVI. i guess i really do need to do the study of the imaging tests (specifically ultrasound) you have had taken to see if they follow the protocol. Tonite i shall start a request for an irb exemption. However if anyone can anonymize their cd, i can look at it now.

The colour Doppler did not include any analysis of the Azygous veins, so I don't know if there is any problem there - I realise the scan I had was more to see if there were any abnormailities prior to travelling to continetal Europe (Poland perhaps) so at least knowing I had some abnormaility was helpful. Unfortunately the scan was sent on CD to my GP and I did not receive a copy, except for a short summary written report. I am living in Ireland so I'm not sure if you can exempt overseas people?!! - not sure what IRB is but suspect it is an approvals board of some type..........I intend seeing my GP in the next month to discuss it but I can't imagine I'll have the smarts to anonymise the CD itself when I do get a copy.............

drsclafani wrote:i would suspect that this would have no bearing on the United States.
I could try and get rejected again or i could try to accomodate their concerns.
its all about risk benefit.......risk of shut down vs treatment of half the enrollees in a randomized trial.

plan A...ccsvi stands on its own. what are the symptoms?
headache? fatigue? spasticity? how does one differentiate that from MS? anyone other than MSers get ccsvi? Can't differentiate it? need a trial for ms patients. because it is a vulnerable patient population. anyone know of a treatment option for ccsvi that is proven? no? need a treatment protocol and trial.
standard of care: what is the standard of care ? where? not in the US? Italy? where is that? when did they set the standard of care in the US? need a trial, treat vs no treat.

see the problems

I fully understand that it may be difficult in your situation to get approval for your trial on this basis - and also understand the financial aspect and immense costs for a clinic

But in Italy in order to get general green light for making treatment a possibility upon private payment it seems the Ministry of Health accepted - or is at least now considering - not necessary to show/prove symptoms, but to prove the CCSVI condition in itself. The Ministry had expressed/concluded in this meeting that as long as the stenosis is quantifiable in a patient and as long as it is found that the type of stenosis leads to an alteration of the hemodynamic balance taking into account vene and artery components, that treatment should be a right for a patient to ask for in a hospital(..."se questo tipo di stenosi comporta ad alterazione del equilibrio emodinamico che tiene conto di due componenti venosa e arteriosia").

The symptoms and in particular the potential MS was pointed out to be secondary...as for those, the Ministry expressed first proof would be needed by clinical trials underway.

However, it was pointed out by the Ministry that this new aspect to be proposed for CCSVI treatment would not happen over the summer...and lets wait and see now...I hope we see and do not wait tooo long...as Italian summers are usually long...and this winter was far too long as well!

drsclafani wrote:its all about risk benefit.......risk of shut down vs treatment of half the enrollees in a randomized trial.

Isn't it actually risk of shutdown vs treatment of half and delayed treatment of the other half?

It's a little brighter way to look at it?

Especially if the reality is 'certainty of shutdown vs treatment of half and delayed treatment of the other half.'

What happened to the good ol' Case Report? There are thousands that have been published but I've yet to find one for a treated MS patient. What would happen if every physician who has treated CCSVI submitted one Case Report each? I know it doesn't count for much, but if they were coming from everywhere wouldn't it be something at least to show improvement or overlapping symptoms between MS and impaired cerebral circulation?

Speaking of Case Reports, I read one on dural sinus thrombosis and the surgeon stated the cause of the thrombosis was IJV stenosis, citing that venous stenosis promote turbulence and progressive thrombosis and should be treated with safe and effective balloon angioplasty. It was published in 1996. Symptoms included lethargy, blurred vision, balance and coordination issues, sensory and motor dysfunction, to name a few.

Since my sister has been treated (RIJV only as the azygous was never checked and the left is still a big question mark) she has felt on nine separate occasions a sensation of something slithering across the inside of her forehead, to the temporal bone, behind the ear and down the neck, all the while accompanied by pressure as it moves. Each time she feels it get 'stuck' behind the ear (stenosis was ballooned), the pressure becomes painful, and with diaphragmatic breathing it finally continues its path down her neck and no longer feels it once it passes below the clavicle.

I have heard similar stories from 2 other people, and Denise Manley of the US was found to have a calcified clot in one of her IJVs. Do you agree with the statement (application of Virchow's Triad?) that venous stenosis promote turbulence and progressive thrombosis?

Thank you so much for your time and compassion.

Cece wrote:

drsclafani wrote:its all about risk benefit.......risk of shut down vs treatment of half the enrollees in a randomized trial.

Isn't it actually risk of shutdown vs treatment of half and delayed treatment of the other half?

drsclafani wrote:plan A...ccsvi stands on its own. what are the symptoms?
headache? fatigue? spasticity? how does one differentiate that from MS? anyone other than MSers get ccsvi? Can't differentiate it? need a trial for ms patients. because it is a vulnerable patient population.

what about people awaiting a diagnosis? I was mis-diagnosed for 10 years, and then when I went to a new neuro, he had a strong suspicion it was MS, but I did not get the diagnosis until after an MRI. Could you grab patients "suspected" of MS and first test them for CCSVI; instead of the MS defining tests such as MRI?

Hi Dr. Sclafani,

Happy Monday to you! I hope your weekend was full of rest and relaxation.

A question for you: Did you have an opportunity to speak with Dr. Zamboni about malformations of the dural sinuses?

Thank you very much.
~HP

drsclafani wrote:

mshusband wrote:Dr. S ...

If someone had a problem with their leg, couldn't you do a venogram for MayThurner ... and then explore a few other veins?

depends upon what the problem was.
but there is no association between may thurner and ccsvi that i know

Okay I'm confused again. I thought the whole left vs right femoral vein thing was related to this? Different disease, same veins?

drbart wrote:

drsclafani wrote:

mshusband wrote:Dr. S ...

If someone had a problem with their leg, couldn't you do a venogram for MayThurner ... and then explore a few other veins?

depends upon what the problem was.
but there is no association between may thurner and ccsvi that i know

Okay I'm confused again. I thought the whole left vs right femoral vein thing was related to this? Different disease, same veins?

I think it's this: no association means you are not more likely to have May Thurner disease if you have MS or more likely to get MS if you have May Thurner disease. (Optic neuritis and MS are associated; Kidney cancer and MS are not.)

That being said, if by unfortunate chance you happen to be stricken with CCSVI and May Thurner out of the general randomness of life (just as you might be stricken with MS and kidney cancer but not consider them related diseases), then having May Thurner is probably making your MS worse and so both the May Thurner and the CCSVI need to be treated, separately.

Dr. Sclafani's explanation earlier was that May Thurner disease causes reflux around the blockage in the lumbar veins and so blood tries to reroute through the azygous, which is a no-go if CCSVI has also blockaded the azygous. Hope this helps.

Article in today's NYTimes... Good Exposure!
http://www.nytimes.com/2010/06/29/health/29vein.html
Nice quote from Dr. S!

Good article!

I especially love that our Dr. Sclafani was quoted. ^5, Doctor.

Also, I'm glad I learned about the nonprofit CCSVI advocacy organization Reformed Multiple Sclerosis Society--I love their name! Being in this article will be terrific for them.

Thanks for posting this, CharW--you'll find this post on your other thread, too.

~HP

Wonderfulworld wrote:Dr Sclafani
appreciate your reply.

Wonderfulworld wrote:
Dr. Sclafani
thank you for this thread. I have read the different user experiences on TIMS with valve issues (Erika, LR1234, Rici) and I realise searching for answers on how to treat valve issues is less 'looking for a needle in a haystack' and more 'do I need a needle, and will it be what I'm looking for if I do find it' Laughing .

I had a Doppler scan done, it showed a diminished flow in the left Internal Jugular Vein (IJV), with an immobile valve at the IJV-innominate junction. Increased right IJV flow. I have not yet had any CCSVI treatment.

again....this would be a negative doppler ultrasound as you only mentioned one of the five findings of ccsvi and a diagnosis requires two for zamboni
they mention increased ijv flow on the other side. THIS IS NOT A SIGN OF CCSVI. i guess i really do need to do the study of the imaging tests (specifically ultrasound) you have had taken to see if they follow the protocol. Tonite i shall start a request for an irb exemption. However if anyone can anonymize their cd, i can look at it now.

The colour Doppler did not include any analysis of the Azygous veins, so I don't know if there is any problem there - I realise the scan I had was more to see if there were any abnormailities prior to travelling to continetal Europe (Poland perhaps) so at least knowing I had some abnormaility was helpful. Unfortunately the scan was sent on CD to my GP and I did not receive a copy, except for a short summary written report. I am living in Ireland so I'm not sure if you can exempt overseas people?!! - not sure what IRB is but suspect it is an approvals board of some type..........I intend seeing my GP in the next month to discuss it but I can't imagine I'll have the smarts to anonymise the CD itself when I do get a copy.............

not to worry about anonymization. I would never reveal any personal information. While I await my own liberation (to treat), i want to make myself useful. I would be happy to look at your ultrasound

Cece wrote:

drsclafani wrote:its all about risk benefit.......risk of shut down vs treatment of half the enrollees in a randomized trial.

Isn't it actually risk of shutdown vs treatment of half and delayed treatment of the other half?

It's a little brighter way to look at it?

Especially if the reality is 'certainty of shutdown vs treatment of half and delayed treatment of the other half.'

i like your sunny way of looking at it.