DrSclafani answers some questions

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Postby MS_mama » Wed May 12, 2010 1:45 pm

Not sure if this has been addressed, but I have a question from Dr. Simka's article. (link: http://www.ncbi.nlm.nih.gov/pubmed/20351666 )

In the abstract it says:

The most common pathology in our patients was the presence of an inverted valve or another pathologic structure (like membranaceous or netlike septum) in the area of junction of the IJV with the brachiocephalic vein.


Any comments on this? Are you seeing this frequently as well? Also, what would be an appropriate solution to this abnormality? Does angioplasty destroy the valve/septum? Are those valves supposed to be there but in a different form, and do you forsee a future research area in valve repair? Does such a thing already exist?
dx RRMS Jun. 2009...on Copaxone and LDN and waiting for my turn to be "liberated"<br />
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Postby Zeureka » Wed May 12, 2010 2:24 pm

MS_mama wrote:Not sure if this has been addressed, but I have a question from Dr. Simka's article. (link: http://www.ncbi.nlm.nih.gov/pubmed/20351666 )

In the abstract it says:

The most common pathology in our patients was the presence of an inverted valve or another pathologic structure (like membranaceous or netlike septum) in the area of junction of the IJV with the brachiocephalic vein.

That's my case in exactly that location!
Have heard that ballooning is generally applied, but also wonder what then happens to the pathologic valve, if it's then destroyed or squeezed to the wall? And heard that cases of restenosis frequent?

Is the normal valve function at this location (junction with the brachiocephalic vein) crucial? Meaning, if that valve (or its function) would be missing, is there a big impact of its missing function at this location?

Dr Sclafani, in addition to MS_Mama's questions, would be very interested in your views on the impact of the location of the affected valves. Thank you!
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valves

Postby Rosegirl » Wed May 12, 2010 5:18 pm

How timely that the topic of valves has come up. When I was first diagnosed 20 years ago, the doctor asked me to keep a journal of my symptoms. I had to create a chart that showed how symptoms appeared and disappeared, usually in less than 20 minutes.

Then, for more than 10 years, I had no problems. One day in 2000, my left leg just stopped working. Not completely, but over the years, things have gotten worse. Now I "wall walk" at home, and use a scooter whenever we go out.

But twice in the last five years, suddenly, I could walk perfectly. I could stroll, swinging my arms, you'd never know anything was wrong. Then in a minute or two, the magic went away.

So is this a valve problem? And should I make a point of telling the IR about it before being "liberated"?
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Postby fogdweller » Wed May 12, 2010 6:18 pm

To Dr. Sclafani and all those wrestling with designing a study:I personally think this is VERY IMPORTANT. The righ test done as soon as possible will either unleash the flood gates or put this very hot issue to bed if it is not the real deal.

I have personal experioence; I was Sr. staff for a medical device start-up company in the endovascular space. We did an overly optomistic study. It came back, "negative; no significant differnece." The company ran out of money, went bankrupt, and stopped what it was working on.

The technology is now doing fine in the market, (for others) but it is 6 years behind where it would have been and is not as good as what we had develeped.

We need to do the trial right and carefully or we will set back the process of finding an answer to the question of whether CCSVI is for real by years. We should chose as simple measures as possible and as many measures as possible (Relapses ... I know, not the real issue but that is what the drug companies have used as justification for all the treatments so far), new lesions, brain volume, and anything else that can easily be measured. We should try to get a HUGE study group, both treatment and non-treatment arms. We should define sucess as slight as possible.

I also think we can use historical progression data if we use lesion numbers and maybe even brain volume. There should be a good data base in the MRI records. The best MRI maven I know is Dr. Peltier at UCSF and he is on the MS society peer review panel. Tallying the data would make a good graduate study project. Here is his info from the MS society:

Daniel Pelletier, M.D.
Department of Neurology
The School of Medicine
University of California, San Francisco
San Francisco, CA
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Postby drsclafani » Wed May 12, 2010 7:38 pm

people have privately asked if i detuning, since i hadnt responded in a couple of days.

I was finding the discussion fascinating and helpful but have been inundated with work responsibliites, etc, thus havent devoted as much time to the thread as i would like.

Please continue the discussion about how to design trials from your perspectives. I have already incorporated some of your ideas into my plans for the study to follow the safety study. I will share your thoughts when our physician colleagues discuss a multicenter trial

but for the moment, you guys should take the lead for a while.

maybe we should change the name of the thread, for the moment, into DrSclafani asks some questions.[b/]
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See folks, it's working !!!

Postby larmo » Wed May 12, 2010 8:10 pm

drsclafani wrote:I have already incorporated some of your ideas into my plans for the study to follow the safety study. I will share your thoughts when our physician colleagues discuss a multicenter trial

but for the moment, you guys should take the lead for a while.


Can everyone see how this is helping out the entire CCSVI issue. 8O

Keep up the great work everyone. :D
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Postby 1eye » Wed May 12, 2010 9:23 pm

1 eye, I also at first read "psychological" and was wondering what he meant, but Nunzio meant "physiological" Smile
I noticed when tired my eyes stimes turn/swap letters when read on the screen and if I type I also sometimes miss out a letter without noticing - simply don't see it. Wink

Absolutely. Sorry Nunzio. I thought only my fingers transposed letters. Oh, boy...:roll:
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
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Postby costumenastional » Thu May 13, 2010 12:03 am

Dear Dr Sclafani.

http://www.fightforccsvi.blogspot.com/

Check these pics out if possible. Maybe a good example for others?
Click on them and they ll get bigger.
I am just glad this doesnt happen in my neck anymore. At least i hope cause i cant find an after capture in my operation cds :(

The video would be much better but the GENERAL ELECTRIC software is not compatible to upload :(

Have you ever encounter a situation like this ???
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Postby Nunzio » Thu May 13, 2010 2:49 am

Hi 1eye, do not worry, we know you are visually challanged; after all 2 eyes see better than 1 eye.
Going back to Thirdday question the only problem I see is the presence of reflux.
Usually that indicate a blockage below the area where the reflux was noted.
If the occlusion was a thin membrane is possible that passing the catheter was enough to open it up.
Have they repeated the doppler after the venogram?
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Postby Zeureka » Thu May 13, 2010 4:29 am

costumenastional wrote:Dear Dr Sclafani.

http://www.fightforccsvi.blogspot.com/

Check these pics out if possible. Maybe a good example for others?
Click on them and they ll get bigger.
I am just glad this doesnt happen in my neck anymore. At least i hope cause i cant find an after capture in my operation cds :(

The video would be much better but the GENERAL ELECTRIC software is not compatible to upload :(

Have you ever encounter a situation like this ???
Wow, costumenastional, this is impressive! Thank you for this blog!
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Postby AlmostClever » Thu May 13, 2010 4:53 am

Dr. S.,

Contrast in MRV - Is it necessary?

Thanks a million!

A/C
If you can't explain it simply, you don't understand it well enough. - Al Einstein
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CONGRATULATIONS Dr. Sclafani - 100,000 views

Postby HappyPoet » Thu May 13, 2010 8:38 am

.
CONGRATULATIONS Dr. Sclafani,

100,000 views

Thank you for taking CCSVI another leap forward and for touching so many people's lives...

Patients
Patients' Families and Caregivers
Doctors
Medical Technologists
MS Associations
Hospitals
Researchers
Big Pharma
Medical and Biomedical Device Manufacturers
Investors
Internet:
...MS forums - TIMS (wonderful research, friendships and support), and others.
...Facebook - CCSVI Alliance: www.facebook.com/pages/CCSVI-in-Multipl ... 96282297?v
...Blogs:
......Wheelchair Kamikaze: www.wheelchairkamikaze.com/
......Enjoying the Ride: www.enjoyingtheride.com/
...Other web sites - patient advocacy groups, foundations, doctors
...Web radio - www.blogtalkradio.com/omario/2010/05/09 ... bout-ccsvi

and this list goes on and on and on...
.
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Postby bretzke » Thu May 13, 2010 2:36 pm

drsclafani wrote:Please continue the discussion about how to design trials from your perspectives. I have already incorporated some of your ideas into my plans for the study to follow the safety study. I will share your thoughts when our physician colleagues discuss a multicenter trial

but for the moment, you guys should take the lead for a while.


Dr. Sclafani asked for suggestions on how a trial might be designed. Here's my two cents:

KISS: Keep It Simple Scalfani.

Drug companies approach MS trials from two different categories: 1. Disease Modifying Drugs and 2. Symptomatic Management Drugs.

Symptom management trials are the easiest. You simply test for the efficacy of a drug or treatment based on a single MS symptom. The FDA recently approved Ampyra, a drug that it says helps people with the symptoms of multiple sclerosis walk more rapidly.

The National MS Society reports that 35 to 43 percent of those who took the drug in Acorda's two phase III clinical trials had improved walking ability. The increase in function was 10 to 30 percent of baseline compared with those taking a placebo.

Amphyra Use and Side Effects?

Ampyra is intended to be taken as a pill twice a day. Side effects experienced by study participants included back pain, dizziness, insomnia, fatigue, nausea, balance disorder, urinary tract infection, falls and headache, according to the MS society.

Ampyra’s Cost?

Acorda Pharmaceuticals has announced a wholesale price of $1,056 for a 30-day supply (60 pills), or $12,850 annually. That pencils out to $17.60 a dose, or $35.20 for each day’s two doses.

Is Ampyra Worth the Cost?

It will be up to individuals and their physicians to determine whether Ampyra’s benefits justify its steep price. David Phillips, in a commentary on Bnet, is not sure that they do. He suggests that regulators may have downplayed safety issues and ignored the relatively light efficiency of the drug because of pressure from the MS society which, he points out, funded early stages of Ampyra research.

43% of patients taking this drug had function increase from 10-30% over baseline.

Can we find an MS symptom that Liberation will improve better than this in a trial?
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Postby ozarkcanoer » Thu May 13, 2010 3:53 pm

The one symptom that many MSers say is their worst symptom is FATIGUE. I have read a lot of anecdotal reports here that say after liberation the fatigue goes away, the cog-fog is gone, minds go from low-def to hi-def. Surely there can be some way to measure this. Some sort of a neuropsych test ? When I go to BNAC one of the tests they will give me besides all of the imaging (doppler, MRI, MRV) is a 2 hour neuropsych test.

So if fatigue is many MSers worst symptom, then measure fatigue pre and post procedure.

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Postby fogdweller » Thu May 13, 2010 5:01 pm

bretzke wrote:Symptom management trials are the easiest. You simply test for the efficacy of a drug or treatment based on a single MS symptom.


I think this is exactly correct. Here is my 2 cents worth.

Pick a single symptom. The anctedotal stories here by those who have had the treatment should give some good candidates. Cold feet, fatigue, and even Relases come to mind.

Enroll as study subjecs only those who have that symptom, the ore pronounced the better. (I have none of those three. My suggestion would cut me out. Drat.)

Randomize the patients, treat a portion and do not treat the other portion.

Follow the prevalance of the symptom at certain periods post randomization (2 weeks, 10 weeks, and six months for example.)

Blind the person doing the symptom evaluation. (difficult with a procedure, but maybe a bandage over a non-existant incisson or something.)

Compare the treated and un treated groups.

If there is a significant difference, then you can justify treating anyone with that symptom with the liberation procedure. You can also follow all the treated patients for effect on other symptoms, and if the procedure is approved, doctors can use it on other MS patents on a compassionate use basis, and continue to study it.

We only need one symptom, and then the use will expand.


This is very different than drugs or new medical devices. I do not think you need FDA approval, just hospital or IRB approval. But a good scientific study gives a basis for insurance coverage.
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