This Is MS Multiple Sclerosis Knowledge & Support Community

Happy Birthday and Best wishes!

I hope you had a pleasant birthday!

You've got a question that landed in this thread: http://www.thisisms.com/forum/chronic-c ... ml#p205902

The worst news this week, or any week, was that we've lost the Greek from the D. Wheelchair Kamikaze has a memoriam up: http://www.wheelchairkamikaze.com/2013/ ... oriam.html

Cece wrote:I hope you had a pleasant birthday!

You've got a question that landed in this thread: http://www.thisisms.com/forum/chronic-c ... ml#p205902

The worst news this week, or any week, was that we've lost the Greek from the D. Wheelchair Kamikaze has a memoriam up: http://www.wheelchairkamikaze.com/2013/ ... oriam.html

Thanks Cece for posting both of these.

Dr S I have been reading up on the research that shows infection is an early co-incident factor in heart attacks and strokes and I find that there is lots of talk about spasms in arteries.

*Does this also effect veins?

The work being done regarding vein health is indicating that the valve issues are more related to general vascular health. The research on diet, vit D, stress etc is really an extension of after the fact issues through life that have negative cumulative effects that create the problems you are treating. For instance endothelial health improvement is a must for CCSVI success!

My talking around the traps tells me that the doppler findings of CCSVI are actually changing over time (month by month), not fixed or only worsening. They are transient which makes sense for some of the findings.

The 'possibility' that plaque build up due to infection causing the fluctuating stenosis findings is very realistic. The process of build up and leakage of fluid plaque and then clots is a strong possibility for the waxing and waning post PTA. The collagen changes are an indication of healing from inflammation, which is likely to be caused by infections by pathogens such as Lyme and CPn bacteria.

*Do you see similarities in vein walls that correspond with artery spasms?

*And is there research and studies indicating vein wall spasm?


Nigel

Nigel wrote:My talking around the traps tells me that the doppler findings of CCSVI are actually changing over time (month by month), not fixed or only worsening. They are transient which makes sense for some of the findings.

I interpret that as the doppler being unreliable, not as the CCSVI abnormalities changing. It might also be due to the doppler technicians looking at vein wall narrowing, which could be physiological or transient depending for example on hydration, instead of looking at intraluminal abnormalities, which are fixed? I agree that infection if it is present would be bad for endothelial health.

I am waiting for Dr. Sclafani to return to see if he has any thoughts about the ASTRAL trial, which is not directly related to CCSVI! The ASTRAL trial was a trial on endovascular treatment of renal artery stenosis. It was a big randomized trial and it got negative results. In the ASTRAL study, during patient selection, they skimmed off the worst cases and did not include them because it was known that they needed to get endovascular treatment and so it would not be ethical to include them in a randomized trial. So the entire trial was only on the borderline cases and it got negative results, so maybe borderline cases of renal artery stenosis don't need to be treated or maybe more research is needed.

What if including borderline cases in the CCSVI trials is going to result in negative results? Would it be possible or practical for the selection criteria for CCSVI trials to use only people like me and Tiltawhirl who had nearly complete bilateral jugular stenosis? The up side would be that improvements might be more easily captured; it might be a proof-of-concept which is taking so so long to happen. The down side would be that the results might only apply to those of us with severe bilateral jugular stenoses.

Also if the need for funding is what is holding everything up, then how do we make that happen? Do you know what the NIH needs to see before it will fund CCSVI research?

Thanks Cece,
I think that same operator, same machine will decide the question. From what I understand the example I showed you in the PM is how there will be more definitive answers.

Question for Dr S,
** if people have atherosclerosis of arteries does that also effect capillary beds and then veins down stream?

The variety of findings from IVUS is very broad and I wonder what is the reason for the findings such as valve leaflet hardening and thickening as a group finding. Collagen involvement and fibrin increase points more to infection from my reading.

So there may be a subset of findings that relate to for instance infection and other subsets as well that are categories such as genuine malformation from birth like webs and septums.

The outcome (aka lesions of brain tissue) from impeded flow could generally speaking be from reflux within the outflow system which breaches the vein wall integrity.

The examples of less rapid reflux and impeded flow would also cause ischemia and low oxygen levels.

The repetitive damage at a cellular level will cause inflammation which will increase a cyclical pattern and that in turn will create a cascade effect as the repeating inflammation effects more tissue. Then that inflammation area is ripe for infection by opportunistic infection (bacteria) and also spread of any pre-existing infection such as atherosclerosis (CPn co-incidence finding in atherosclerosis) up stream of the new inflammation site.

Various diseases are the outcome of the variety of pieces in the matrix of 'causing factors' which require time, then once Medical Science decides on the label for the symptom expressions you have a name for the de-generation disease.

Does this sound like your findings?

Nigel

Hi Doc,

Premise study show bad results....makes me think of a statement you made once; 'all coming trials miss an experience ccsvi-treating doctor, so results will not be good'...or something like that.
Is this trial an example?

On the other hand; Zivadinov, Zamboni, Simka, Sclafani.....i would expect that Zivadinov would 'use' an experience doc as he knows 'those' docs...

Opinion??

Rgds,

Robert

Robnl wrote:Hi Doc,

Premise study show bad results....makes me think of a statement you made once; 'all coming trials miss an experience ccsvi-treating doctor, so results will not be good'...or something like that.
Is this trial an example?

On the other hand; Zivadinov, Zamboni, Simka, Sclafani.....i would expect that Zivadinov would 'use' an experience doc as he knows 'those' docs...

Opinion??

Rgds,

Robert

The flaw with using someone that knows what they are doing that has been involved in the theory and treatment from an early stage is the need for transparency and for results that can be replicated by others. These are the two biggest requirements of any study of this nature. They are also the most difficult to overcome.

Unlike a drug trial which is generally funded and run by the manufacturer of the product being trialed who can then chose which data or parts of data they want published.

It's not a level playing field.

The argument from the other side is that the experienced CCSVI IRs are inherently biased. Only inexperienced ones can be trusted as being independent.

Anyone heard from Dr. Sclafani lately? It's been awhile.

Interesting findings from the latest BNAC study with no improvement measured by the systems they used to test outcomes. So that in itself is interesting to hear yet again that 'the measure of MS' disease and the 'treatment for CCSVI' doesn't link.
Doesn't mean in any way, shape or form that there is or isn't a link as well!

;)
Nigel

Cece wrote:The argument from the other side is that the experienced CCSVI IRs are inherently biased. Only inexperienced ones can be trusted as being independent.

Anyone heard from Dr. Sclafani lately? It's been awhile.

So if experienced docs do it it's biased, if non-exp docs do it it means bad results......great choice

Robnl wrote:

Cece wrote:The argument from the other side is that the experienced CCSVI IRs are inherently biased. Only inexperienced ones can be trusted as being independent.

Anyone heard from Dr. Sclafani lately? It's been awhile.

So if experienced docs do it it's biased, if non-exp docs do it it means bad results......great choice

In a nutshell yes.

It's rather unpalatable.

EJC wrote:

Robnl wrote:

Cece wrote:The argument from the other side is that the experienced CCSVI IRs are inherently biased. Only inexperienced ones can be trusted as being independent.

Anyone heard from Dr. Sclafani lately? It's been awhile.

So if experienced docs do it it's biased, if non-exp docs do it it means bad results......great choice

In a nutshell yes.

It's rather unpalatable.

So what does it mean when a patient gets well! Placebo is one excuse to be well, but is it the reason!

http://www.thisisms.com/forum/chronic-c ... ml#p191658

drsclafani wrote:As I said from the beginning, i thought it was premature for trials last year. Given the experiences i have had in treating patients previously treated by others with underdiagnosis, under- and overtreatment, excessive usage of stents, etc, i am quite confident that i made a correct decision.

I am ready now. All i need is about $5M.

bumped from a year ago

Cece wrote:http://www.thisisms.com/forum/chronic-c ... ml#p191658

drsclafani wrote:As I said from the beginning, i thought it was premature for trials last year. Given the experiences i have had in treating patients previously treated by others with underdiagnosis, under- and overtreatment, excessive usage of stents, etc, i am quite confident that i made a correct decision.

I am ready now. All i need is about $5M.

bumped from a year ago

I want to apologize for not responding to the last few emails. I did not receive any notices that there was any messages. I happen to respond to a notification regarding discussion of this vagal nerve thing and noticed that there was a message for me.

I also received an email in the past couple of days that I was missed on TIMS.

i never meant to ignore questions. I was actually pretty sad that none had been asasked for such a long time.

Regarding trials, notably the negative BNAC trial, it is noteworthy that in a first phase, they performed ten non-randomized procedures to familiarize themselves with techniques and IVUS in the jugular veins. That would put them where I was in experience back in february 2010. Then they treated nine of nineteen patients. Their results are not surprising to me. as you can see from my prior posts.

I look forward to the published results to better understand how this surprising development could have occurred. The findings are quite disturbing, nonetheless. At the risk of insulting friends and colleagues, should we reach a conclusion that treatment without significant experience leads to a high rate of relapses and no significant reduction in lesional volume or changes in function measures? of should we just abandon the idea that venous problems should be treated?

I guess we will have to wait for the large Italian multicenter trial to get a better sense of what is what.

Cece quoted Dr. S. saying (a year ago):

I am ready now. All i need is about $5M.

Thank you Cece for bumping this. I think this should be our goal for the next two years: figuring out how to make this trial happen. If we could pool the resources of Direct MS, the Annette Funicello Foundation, donations from individual celebrities with MS (and/or hollywood star events to raise money hosted by or on behalf of these celebrities) and lots of small donations from people who have MS, we could theoretically raise these funds. If we had an official campaign and an easy way to donate on-line, those of us on ThisIsMS who are able could attend all the MS support groups within their area and give a presentation on why we should all donate to this cause. Materials for the presentations could be created and made to be downloadable so that they could be printed out from home. Those of us who can't get to support groups could fan out across the internet and spread the news through online MS forums and support groups.

If we could get even half the money needed, then perhaps some medical study funding sources might pitch in through grant applications to them. Also I wonder if the $5M figure could be reduced at all by making the study smaller, asking medical facilities to donate part or all of the cost of using their facility, or any other means that are legitimate (don't threaten the integrity of the results of the trial).

Is this something that the CCSVI Alliance has the capacity to champion?

It seems like we desperately need a well designed blinded clinical trial where the person or people conducting the CCSVI procedures are CCSVI-experience IR's using the gold standard methods, and the outcome measures include a blinded assessment of the types of benefits typically seen after CCSVI PTA.

M.A.