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eric593 wrote:

Cece wrote: It is so hard to draw conclusions. Can't wait for registry data.

I don't know if the registry data will be more detrimental than illuminating given the heterogenous skillset, techniques and treatment methods, experience and expertise among a diverse group of IR's. I fear the same or worse problems will result as Dr. Sclafani envisaged with a premature clinical trial, exacerbated by different IR's involved as well with treating patients recorded in the registry.

The best clinical trials are ones that are multi-center, this is why Dr. Dake's study includes patients treated in FL by Dr. Katzen, specifically because of the variables in different IR's skill set, techniques, etc as you laid out. If results can show despite those differences, it will be stronger support for the effectiveness of CCSVI treatment than if it was only one IR's set of patients. Plus the data can be looked at in subsets by which IR was treating, what type of MS, what treatment, etc etc....

Cece wrote: The best clinical trials are ones that are multi-center, this is why Dr. Dake's study includes patients treated in FL by Dr. Katzen, specifically because of the variables in different IR's skill set, techniques, etc as you laid out. If results can show despite those differences, it will be stronger support for the effectiveness of CCSVI treatment than if it was only one IR's set of patients. Plus the data can be looked at in subsets by which IR was treating, what type of MS, what treatment, etc etc....

That might be the case where a standard of care has been established already.

But when "best practices" have yet to be known, it only leads to disparity of results which make those results inconsistent and unreliable.

The registry may end up showing that treatment is ineffective when it is not the treatment but the skill or type of treatment provided that is the cause.

I agree with Dr. Sclafani that the doctors need to figure out how best to treat before results can be relied upon in the aggregate. Having such a diversity of IR skill, method and experience only skews the results even more, making them less reliable. Multi-center clinical trials normally don't have problems with inconsistent standards of care practices to contend with like this does. We are not treating like problems in all patients either nor treating in the same way either...the variables become too great in this situation where IR diversity only complicates it even more. IMO we need to eliminate as many variables as possible before trying to collate data. It may cause more harm in the meantime.

Great conversation, Eric, thank you.

I'd nominate what he did for my procedure as "best practices" although I might also be judging it based on results.

Dr. Sclafani, I have a question, actually, and it is a serious one. I showed signs of MS or CCSVI in childhood. Fatigue, cogfog, some other things as well. Of my three children, my oldest has fatigue. My middle child has fatigue, cogfog, irritability, a poor memory, wakes up at night in hysterics about his legs hurting (been to a specialist and was told it was nothing), and sometimes tells me his neck hurts. He is only five. (My youngest child is not a consideration to this, he is so healthy and active, it shocks me.) I may pursue doppler ultrasound scanning for them, just to know. But at what age would CCSVI treatment begin to be an option? What are the increased risks in venoplasty in a child and at what age might those risks diminish? My son is struggling with all these symptoms.

My thought is that he has to reach adult size first, which would be sometime in his teenage years, but I haven't much to base that assumption on. I would also want CCSVI to be further investigated than it is currently.

LauraV wrote:Dr. Sclafani,

A friend with MS told me about this talk that Dr. Hewett (UBC MS Clinic) gave in Seattle a few weeks ago.

http://www.facebook.com/note.php?note_i ... 940&ref=mf

My understanding is that he said that there will always be re-stenosis and the only question is when it will occur, suggesting that we should expect to get repeat angioplasties. He also spoke about the importance of the azygous vein (affecting walking, bladder and bowel - things that many of us are dealing with) and it's diagnosis and treating. And I think you would agree with his take on the use of stents, as well.

Is this the kind of information that doctors are learning as more and more I'd love to get your take on all of this. Laura

These statements are not new laura, they have been stated for the past year.

We have decided that restenosis as described by dr zamboni was too high a rate and two high a frequency. it occurs too early. we are trying various methods to treat by different techniques that described by dr zamboni because we want to reduce the restenosis rate and delay restenosis. The methods in vogue right now are higher pressures and larger balloons. but there is no published data yet.

The azygous is part of the problem from the original zamboni articles. we havent really added anything to this yet. We remain challenged by recognition of all of the azygous abnormalities. the treatment is fairly straightforward though.

so, we are still rehashing old stuff looking at different ways to see things.

Cece wrote:

drsclafani wrote:this is not proven but i have noted that in general terms, patients with the most long standing symptoms tend to have the most dilatation above the stenoses.

Ok, that's an interesting observation. With all the imaging studies that show CCSVI is worse in patients with advanced MS (or, in the Beirut study, RR of over 10 years duration), perhaps they are seeing this increased dilatation and measuring the stenosis against the dilatation, so the stenosis gets measured as being more severe.

yes, that is interesting as we calculate percentages

however i was noticing tighter stenoses, more difficult to get a catheter across.

bluesky63 wrote:So Cece, what they may actually have is a degree of both stenosis and diltation? Am I misinterpreting? (Basically resulting in a larger degree of difference in size between the adjacent areas -- one narrow and considered a "stenosis," one larger and dilated -- so in general many people with CCSVI have the same degree of stenosis, but the people with worse disability get dilatation too?) Could this indicate a higher degree of "stretchiness" in the blood vessels of the people who have more disability? A collagen defect?

actually patients are thought to have too stiff a collagen in the outer layer of the wall of the vein.
when there is obstruction, it is not uncommon for the vessel above to ddilate. i dont think that what we are seeing is greater than expected.

On a different area -- Dr. Sclafani, my apologies if this had already been asked. But I don't remember seeing this anywhere. Have any of your patients had vasospasm during a procedure? Is this a normal risk of angioplasty? Why would it happen?

vasospasm is caused by constriction of the muscle in the wall of the blood vessel. i do not think this is common but on rare occasion i have seen it. it is far more common in arteries.

eric593 wrote:

Cece wrote: It does all get to the question raised by the other studies, does CCSVI worsen with time, why is CCSVI worse in patients with more advanced MS, etc.

That's interesting. Neither I nor the two people I met also being treated,all of us each with MS for close to 20 years, had anything more than "routine" stenoses, nothing complicated or unusual, no collaterals, no severe stenoses or complicated problems, no correlation to extent of azygous stenoses and mobility, bowel, bladder, etc problems, in fact one of the people in a w/c for many years with no azygous issues found at all.

lets not all get ahead of ourselves.

i noticed an anecdotal observation. something worthy of further analysis
we cant confirm or disprove with more anecdotal experiences of fewer patients.

Cece wrote:Great conversation, Eric, thank you.

I'd nominate what he did for my procedure as "best practices" although I might also be judging it based on results.

Dr. Sclafani, I have a question, actually, and it is a serious one. I showed signs of MS or CCSVI in childhood. Fatigue, cogfog, some other things as well. Of my three children, my oldest has fatigue. My middle child has fatigue, cogfog, irritability, a poor memory, wakes up at night in hysterics about his legs hurting (been to a specialist and was told it was nothing), and sometimes tells me his neck hurts. He is only five. (My youngest child is not a consideration to this, he is so healthy and active, it shocks me.) I may pursue doppler ultrasound scanning for them, just to know. But at what age would CCSVI treatment begin to be an option? What are the increased risks in venoplasty in a child and at what age might those risks diminish? My son is struggling with all these symptoms.

My thought is that he has to reach adult size first, which would be sometime in his teenage years, but I haven't much to base that assumption on. I would also want CCSVI to be further investigated than it is currently.

first of all, you need to maintain a healthy skepticism.
i think i am moving in a logical direction but i dont have even three months followup on the way I have treated you.

This childhood thing really gets to me. if symptoms are really bad, perhaps treatment is appropriate but first we have to get it right in adults. children are just too vulnerable.

but screening is probably closer. we will need to image cohorts of healthy children first to understand the hemodynamics and then we can image sick children....
what to do with what we find????
we need to be concerned with radiation exposure in the child, more vulnerable than adults to radiation.
we need to understand how the child's veins will react

Hi, Dr. Sclafani,

I heard a radio interview with Dr. Code that said over 12,000 people have been treated.

As you and your colleagues work to quantify the "recipe" for a CCSVI venogram, how many treatments are part of your data base?

Are these reports from the few "first responders" like Siskin and yourself, or do they come from a much wider pool of physicians?

Thanks!

Thanks for the answer, Dr. Sclafani. Radiation, lack of knowledge of how the child's veins would result, children being more vulnerable, and the treatment not yet being refined in adults, let alone children.

It would make sense to me that the presence of a pediatric MS diagnosis might be helpful too in choosing whether to intervene or not.

Someday when we hear about Sardinian children, it'll be about them being treated for jugular abnormalities and growing up MS-free.

Rosegirl wrote:Hi, Dr. Sclafani,

I heard a radio interview with Dr. Code that said over 12,000 people have been treated.

As you and your colleagues work to quantify the "recipe" for a CCSVI venogram, how many treatments are part of your data base?

Are these reports from the few "first responders" like Siskin and yourself, or do they come from a much wider pool of physicians?

Thanks!

I wonder what his source is, rosegirl. No one has asked me to pool my data. Nothing i know of has had this type of data. i am not hearing a lot of reports actually.

to date, my experience plus my discussions have led me to my current recipe. In truth, I havent really noted a bullseye yet. I feel more confident in how i treat and what i treat, but i must admit i have no clarity about who i treat. improvements have come in all flavors in many difference patients over variable and unpredictable time courses. I still cannot predict who will be a nonresponder.

My group database is winding its way through irb approval, so that data is not robust yet.

drsclafani wrote:
but screening is probably closer. we will need to image cohorts of healthy children first to understand the hemodynamics and then we can image sick children....
what to do with what we find????
we need to be concerned with radiation exposure in the child, more vulnerable than adults to radiation.

Saw a familiar name in the New York Times this morning at the coffee shop!

http://www.nytimes.com/2011/02/28/healt ... ation.html

A different article, from a few years back:

http://tinyurl.com/6l59prn

But Sclafani's passion is and always has been working with trauma patients, and he has no plans to leave Kings County Hospital.

"Trauma is one of the most exciting aspects of radiology, because it's life and death, in the moment," he said.

"I always wanted to be part of a community, and watch it develop and grow. If you move around, there's more advancement and financial reward, but you don't have that same relationship with the people you work with and the people you help."

Thanks for taking care of Nunzio today.

And for being part of our community!

From the article Cece linked:

Twelve years ago, he performed another groundbreaking operation that saved the life of a city cop, Harry Ortiz.

Ortiz, who was shot in the head by a thug, was bleeding from his mouth. After Sclafani determined that the bullet had severed an artery to Ortiz's brain, the doctor threaded a catheter from the cop's leg up to the base of his skull. There, he inflated a tiny balloon that stopped the bleeding and allowed the wound to heal.

'It works'

Not surprisingly, Ortiz, 54, is a big fan of Sclafani's and his techniques.

Wow! I never heard about this. I'm a big fan, too. This technique must be saving thousands of lives.

zap wrote:

drsclafani wrote:
but screening is probably closer. we will need to image cohorts of healthy children first to understand the hemodynamics and then we can image sick children....
what to do with what we find????
we need to be concerned with radiation exposure in the child, more vulnerable than adults to radiation.

Saw a familiar name in the New York Times this morning at the coffee shop!

http://www.nytimes.com/2011/02/28/healt ... ation.html

that article was a bait and switch, if you ask me

i cannot talk, obviously, about the article details, but sometimes i feel like a got a raw deal and look bad trying to do some good.

o well, i can live with myself

i love what i do now