Second Annual CCSVI update Symposium

[DrSnyder]

Cece - I will post a summary after the meeting.
G

[marcstck]

Dr. Simka presented all of their data from Poland.
Dr. Petrov presented their data from Bulgaria.

Again consensus is that the procedure is safe and that over time as experience has developed, the use of stenting has reduced.

Dr. Ponec presented some data that will be published about the current state of the Hubbard registry. This was very informative.
His point is that we still don't have enough idea about how we treat this process to make a solid randomized study reasonable. With such variables in treatment we cannot even enter into a randomized study as we don't have consensus on how to treat. The results from the study are from outcomes on the MISI-29 which show positive outcomes at 1 and 6 months. This data looks comprehensive and as Dr. ponec points out, this is The first data to report a benefit from the procedure since Zamboni's original publication.

Thanks again for all of the vital info, Dr. Snyder. It's very much appreciated.

Dr. Ponec also related his outcome data during the patient information day, but I wonder how strong the actual statistics are, given that it's all patient reported data, which, I believe, is known to skew towards the positive. Patients with negative outcomes are less likely to report. Indeed, I asked him about this during his Q&A, and he agreed that this could be problematic. At the six month point, a full 40% of his treated patients did not respond to the surveys, which could indicate that these nonresponders would have reported lesser efficacy. Then again, one never knows, do one (to quote Fats Waller)…

[Cece]

It was the MSIS, wasn't it? I am pretty sure the MSIS has correlated well with what is found on neuro-administered tests. Not 100% sure.

[cheerleader]

thanks for the updates, Dr. Snyder!
cheer

[Cece]

Karen Marr, RVT
Presented thoughts on how to do a proper ultrasound. Showed some pictures. No questions yet. Most interesting to me was the need for WARM gel. I don't think we did that at my facility. We will now...

This doesn't sound like it is just for comfort...what difference does the warmth of the gel make?

Discussion of difficult hypothetical cases.

I'd love to hear more about this. What were the hypotheticals? Were the IRs divided in what they would do?

[DrSnyder]

As most presentations begin with the presenter providing details to any financial relationships with industry or product, Dr. Zivadinov started by admonishing everyone who presented by reminding them they should let the crowd  know that they are profiting from performing CCSVI treatments.  Although this is technically very true it might fall outside what is usually meant by disclosing financial relationships - but Dr. Zivadinov wanted everyone to acknowledge that point ( including himself who is now focusing his career on being a CCSVI researcher).

Dr. Zivadinov then presented a plea / challenge call to the colleagues at the meeting to modify their studies to include outcomes that are similar to the drug trials.  Although it came off as scolding and a bit preachy, I don't think that is how it was intended.  

Dr. Zivadinov makes the important point that our only ability to promote this procedure into the future needs to be based on proven efficacy.  His concern is that all of the current study protocols use "subjective improvement" via msis, etc.  To date they have not tracked decrease in white matter lesions or decreased rate of brain atrophy, etc.  He stated that the  data we collect and the primary outcomes need to parallel the outcomes that are currently being reported by the drug therapy studies.  He makes the point that absent this redefinition of what our study goals are, that we won't get buy in from the treating neurologists ( I believe they counted three in the room of about 100 people), and that we will be merely developing a treatment for clinical symptoms as opposed to a disease modifying therapy.  

He made the point that if we do determine that it is merely treating clinical symptoms, then we need to do the studies to codify what symptoms are being treated and duration of response to determine if the benefits outweigh the real risks of the procedure.  

He then discussed the PREMISe pilot study (Prospective Randomized Endovascular Therapy in Multiple Sclerosis). 
He covered his study data and how they turned away 270 patients of the 300 to get the 30 well controlled patients that they are looking for in an attempt to reduce confounding factors.  

He discussed the various phases and left with the conclusion, "We cannot just treat for quality of life, we must treat to improve Multiple Sclerosis."

A short question and answer session followed where he was beat up a bit for his stance on the current studies.   

Dr. Sclafani respectfully argued that at this early stage in our understanding of the disease and it's treatment that it was too soon for the types of study that Dr. Zivadinov was suggesting.  He reminded the audience that many radiology studies used reduction of symptoms as the outcome (and not alteration in disease status).
Many in the crowd shared Dr. Scaflani's view on this.   A few other. Doctors spoke mostly supporting Dr. Sclafani's statements.

I do think in this case Dr. Zivadinvov was being misunderstood.  I don't think his point was not to do this type of research, but rather sooner or later we would have to do the blinded studies with Treatment modality outcomes that mimic the endpoints of neurology clinical drug trials in MS or our data won't be relevant to them and neurologists will continue to 'denounce' this possible treatment choice.  
He continued to make the point that there are already validated tools with which to measure outcomes and that any future studies should attempt to utilize those tools.

Dr. Siskin presented the study design for the Albany study and went over the inclusion and exclusion parameters.  His outcome was improvement in quality of life as defined by MSQol-24.

Finally, Dr. Sclafani did a wrap up, did a quick review of the weekend, thanked the speakers and the attendant and dismissed the meeting.

I am going to work on my notes and post a final summary tomorrow with answers to the questions that I was asked.  I hope someone found this useful.

[Cece]

This has been a valuable firsthand early report of the symposium! You got linked to over at the facebook CCSVI in MS page too.

Three neurologists...Dr. Hubbard and Dr. Zivadinov and Dr. Salvi?

I have to disagree with Dr. Zivadinov. This does not have to be studied the way a neurologist would study it.

"We cannot just treat for quality of life, we must treat to improve Multiple Sclerosis."

that quote is nearly the opposite of when we hear, "I do not treat MS, I treat CCSVI."[/quote]

[MrSuccess]

Dr. Snyder ... thanks for the information . You may find it helpful to read Dr.Sclafani's initial description of Dr. Zivadov ..... at the founding meeting of [ can't remember the name ] at his house . All the Who's Who of CCSVI were there. Dr.Sclafani described Dr. Zivadov ... as gruff.

Okay .... so the guy's not a teddy bear ...

I very much respect and admire Dr.Zivadov ..... and understand his point ..... that the CCSVI treatment MUST show measureable improvements ....... lesion load ..... grey matter loss ..... and so on ....

BUT .

Quality of life ........[ How do you measure that ? ]........ is also important.

I don't see how you can argue with the outcome of a person that is of the opinion that they seem to be better ..... post CCSVI treatment ?

And I have a question : Are male veins larger and longer than female veins ? Could you evaluate the difference in a blinded study ?




Thanks


Mr.Success

[drsclafani]

This has been a valuable firsthand early report of the symposium! You got linked to over at the facebook CCSVI in MS page too.

Three neurologists...Dr. Hubbard and Dr. Zivadinov and Dr. Salvi?

I have to disagree with Dr. Zivadinov. This does not have to be studied the way a neurologist would study it.

"We cannot just treat for quality of life, we must treat to improve Multiple Sclerosis."

that quote is nearly the opposite of when we hear, "I do not treat MS, I treat CCSVI."

[/quote]

cece
dr zivadinov is focused on ms and i am focused on quality of life. Both are valid and valuable.

my point was an objection that we have to perform our studies to conform to the way neurologists do drug trials. We are interventionalists doing minimally invasive PROCEDURES and there is a difference. We use registries. we focus first on safety, reproducibility and optimization of the techniques.

premature trials render results suspect too

[leetz]

Thank you so very much for the up-dates!

[MegansMom]

I very much appreciated this thread.

I wonder why they don't quantify changes
in signs ( objective/ measurable things seen by physician/ nurse ) vs symptoms ( things described by patients).


Vision changes are an example of a
sign and statements that fatigue disappeared would be a symptom.


Thanks to all that contributed. And I like you avatar photo. It looks very professional.

[pklittle]

I have always wondered too why physical outcomes were not tracked using the type exams we are used to... such as:

balance
tandem walk
timing the 25' walk
reflexes
clonus
eye checks incl. peripheral vision and color tests
leg, arm and hand strength and coordination
testing numbness with the pin prick, and that instrument that buzzes
spasticity

It seems to me that gathering these measurable facts pre and post, along with the subjective ones ("how depressed are you on a scale 1-10", etc), is a no brainer (no pun intended ) and would clarify just how effective or not ccsvi treatment is.

------

**Thank you very much Dr. Snyder for your recaps.

[munchkin]

My guess would be that would require a neuro to do the testing. Would the neuro's accept testing from anyone other than themselves?
Physical testing of our symptoms is not what I thought of as the IR's role. What would be nice is if we could get appointments with our neuro's prior to procedure and have them do the tests and then follow-up at the same time the IR's follow-up.
The test results could be sent to the IR's, exactly the same as when the neuro's send follow-up letters to GP's, to be included with the data the IR's are tracking.

[pklittle]

My guess would be that would require a neuro to do the testing. Would the neuro's accept testing from anyone other than themselves?
Physical testing of our symptoms is not what I thought of as the IR's role. What would be nice is if we could get appointments with our neuro's prior to procedure and have them do the tests and then follow-up at the same time the IR's follow-up.
The test results could be sent to the IR's, exactly the same as when the neuro's send follow-up letters to GP's, to be included with the data the IR's are tracking.

PA's have done these tests on me too. Even a scaled back version would be better than nothing.

[Cece]

I think we are missing collaboration by neurologists and adequate funding. Those two things would enable better trial design, with both quality-of-life measures and disease-modifying measures.

You also need a trial with local patients, not travelling patients, if you are going to capture follow-up data.

cece
dr zivadinov is focused on ms and i am focused on quality of life. Both are valid and valuable.

my point was an objection that we have to perform our studies to conform to the way neurologists do drug trials. We are interventionalists doing minimally invasive PROCEDURES and there is a difference. We use registries. we focus first on safety, reproducibility and optimization of the techniques.

premature trials render results suspect too

This makes a lot of sense.

All of us patients too are accustomed and familiar with how drug trials are run. Phase I, Phase II, Phase III.... It makes sense that procedure trials are different.

Registries, safety, reproducibility, optimization of techniques.... In drug trials, safety is dealt with in Phase I, but optimization of techniques is more along the lines of if you take one dose or two and what time of day do you take it! Compare that to the hundreds of variables in a surgical procedure: what size balloons, what pressure, what side to enter on, duration of ballooning, what lesions not to treat, how to diagnose, what anticoagulation and when, etc, etc.