a single center study of 50 patients

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

a single center study of 50 patients

Postby Cece » Mon Oct 22, 2012 6:39 pm

http://content.onlinejacc.org/mobile/ar ... s.facebook
Carotid and Neurovascular Disease and Intervention
Published online October 23, 2012

TCT-196 Chronic Cerebrospinal Venous Insufficiency: The Association Between the Extent Of Extracranial Venous Anomalies and Clinical Severity and Duration of Multiple Sclerosis

Juraj Madaric; Andrej Klepanec; Rastislav Bazik; Marek Toth; Terezia Urlandova; Jana Margitfalviova; Juraj Mikulas; Erika Drangova; Daniela Hladikova; Tibor Balazs; Vladimir Neuschl; Ivan Vulev

J Am Coll Cardiol. October 23, 2012,60(17_S): doi:10.1016/j.jacc.2012.08.217

BACKGROUND
Chronic cerebrospinal venous insufficiency (CCSVI) characterized by stenoses or obstructions of the internal jugular veins (IJV) and/or azygos vein (AZY), has been reported to be associated with multiple sclerosis (MS). However, such association is a matter of debate. The aim of our retrospective analysis was to determine the relationship between the extent of extracranial venous pathology and clinical severity of MS.

METHODS
We analyzed 50 consecutive patients (pts) with relapsing-remitting (32 pts) and secondary progressive (18 pts) clinical course of MS (age 38±10 years, M:F=15:35) scheduled for duplex ultrasound (DUS), invasive phlebography, and eventual endovascular procedure of IJV and/or AZY. The extent of stenotic/obstructive process of IJV, and AZY, or IJV reflux, were graded by combination of invasive phlebography and duplex ultrasound as negative (group A), unilateral/focal stenosis/regurgitation (group B), or bilateral/multifocal stenoses/regurgitation (group C). The clinical severity of MS was evaluated by expanded disability disease scoring (EDSS). The study was approved by the local scientific and ethical committee.

RESULTS
Out of 50 analyzed pts (mean EDSS 3.7±2.4) there were 10 pts with negative DUS and venous phlebography pathology (20%), 16 pts with unilateral/focal venous pathology (32%), and 24 pts with bilateral/multifocal pathology (48%). The 20 cases were treated by balloon angioplasty alone, whereas the stenting of at least one vein was required in 14 pts. Importantly, there was significant difference in MS clinical severity of group A versus group B (EDSS 1.8±1.3 vs 3.0±2.2, p<0.05), as well as compare to group C (EDSS group B vs group C 3.0±2.2 vs 5.0±2.2, p<0.005). Similarly, there was significant difference in MS duration in group A versus group C (4±3 years versus 9±5 years, p<0.005).

CONCLUSIONS
The clinical severity of multiple sclerosis as well as duration of disease seems to be associated with the extent of pathological venous drainage of the central nervous system. To answer the question if CCSVI is only the accompanying secondary process, or the underlying condition of MS, the blinded randomized studies are needed.

Of concern is the 14 out of 34 patients who received stents, when some other clinics are stenting in approximately 2% of patients. 14 out of 34 is approximately 40%. Also of concern is that 10 out of 50 patients were found to have no pathology.

Without having confidence in the doctors' ability to diagnose all stenoses, I cannot have confidence in the conclusion that the more severe or greater duration of MS was associated with more severe CCSVI. But this has been suggested before, in the Beirut study. More research will shed more light on this. I am appreciative that the authors of this study collected their data and published. We benefit if all doctors are doing likewise.
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Re: a single center study of 50 patients

Postby 1eye » Mon Oct 22, 2012 9:50 pm

You have to understand: this was published in a peer-reviewed journal, the Journal of the American College of Cardiology. We have jumped a discipline. These guys practically invented ballooning and stenting. They do it in their sleep. Five stents before breakfast. Dr. Paulo and others have been too frightened by the bad press and mouthy neurologists who want to protect their turf. I say this is demonstrably a cardiac/vascular condition; jugulars lead directly to the heart. If some doctors are afraid of stents, let the other doctors install them. If they could not find CCSVI in 20%, that might be because these were the first 50 they ever looked at.

If a stent is required, I'll take it. I have three in my arteries already, and Mr. cheerleader and a number of others are doing quite well with theirs. You might get a clot that fouls one, but the vein can't close very easily. I'd bet there are more patency problems without than with.

Without having confidence in the doctors' ability to diagnose all stenoses, I cannot have confidence in the conclusion that the more severe or greater duration of MS was associated with more severe CCSVI.
Hokum. That's what statistics are for, and why this is not an anecdote. If they had been able to find more pathology, that could just as easily strengthen an already strong conclusion. Dr. Zivadinov found the same thing. It only stands to reason that a self-worsening blood oxygen problem would get worse with time, and we already knew that's what "MS" severity does. I think they were saying the cause/effect issue is the only one left. :!: This one does NOT require any further study; the association between "MS" and CCSVI severity has been proven.
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Re: a single center study of 50 patients

Postby PointsNorth » Tue Oct 23, 2012 8:41 am

I've PM'd you, 1eye.

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Re: a single center study of 50 patients

Postby ErikaSlovakia » Tue Oct 23, 2012 8:53 am

The study was done in this hospital in Bratislava, Slovakia:
http://www.nusch.sk/en

These were their first 2 patients in March 2010: http://www.angio.sk/sk/skleroza-multiplex-a-ccsvi/

I visited them in September 2009 after having CCSVI diagnosis from Dr. Simka but as I was probably their first CCSVI patient they could not find it so clearly so I had my procedure in Poland.

Yes, I think these were their first 50 patients.

Btw, they used the first bioabsordable stent in an artery aprox. 2 weeks ago. So far successful. The patient is OK.
This is the best hospital for Cardiovascular diseases in Slovakia.

Erika
Aug. 7, 09 Doppler Ultras. in Poland, left Jugul. valve problem, RRMS since 1996, now SPMS,
- Nov.3,09: one stent in the left jug. vein in Katowice, Poland, LDN, never on DMDs
- Jan. 19, 11: control venography in Katowice - negative but I feel worse
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Re: a single center study of 50 patients

Postby Cece » Tue Oct 23, 2012 9:35 am

Thanks, Erika, I was wondering where this was from.
If a stent is required, I'll take it.

That's exactly the rub: figuring out when a stent is required and when it is not. I too would take a stent if it were required. A stent that keeps a vein open is good; a stent that closes off a vein once intimal hyperplasia or clotting or stent fracture or bone compression occur is not at all good. We have heard from people on both sides of that equation.
I'd bet there are more patency problems without than with.

But when patency problems occur with a stent, they are harder to treat or potentially untreatable; when patency problems occur after ballooning, it is in general easier to treat by reballooning.
Hokum. That's what statistics are for, and why this is not an anecdote. If they had been able to find more pathology, that could just as easily strengthen an already strong conclusion. Dr. Zivadinov found the same thing. It only stands to reason that a self-worsening blood oxygen problem would get worse with time, and we already knew that's what "MS" severity does. I think they were saying the cause/effect issue is the only one left. This one does NOT require any further study; the association between "MS" and CCSVI severity has been proven.

It's a little tricky when it's not linked to age, it's linked to duration of disease. You can be 50 with a 1 year duration of disease or 30 with a 10 year duration of disease. But I am still intrigued by the idea of super IVUS and if this tool would show if the luminal abnormalities are present early on but are not easily seen until they have thickened further. If CCSVI causes MS, we would see it in all MS patients at all stages of the disease.
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Re: a single center study of 50 patients

Postby 1eye » Tue Oct 23, 2012 11:30 am

That's exactly the rub: figuring out when a stent is required and when it is not. I too would take a stent if it were required. A stent that keeps a vein open is good; a stent that closes off a vein once intimal hyperplasia or clotting or stent fracture or bone compression occur is not at all good. We have heard from people on both sides of that equation.
If it ain't balanced, it ain't an equation. I think in those cases it is not the stent that has closed off the vein. I don't know what you mean by bone compression. Stent fracture shouldn't happen very easily. I don't get enough exercise to fracture one. I would have to have a bad biking accident or something. I had one last year (not really too bad), and my helmet would have taken care of a high stent. All that being said, if problems occur they can ruin the vein with or without a stent. Blood flow being slower and under less pressure, veins are more likely than arteries to have problems (regardless of stents). I think some doctors will lean on the side of what they think the patient wants, which may not be what is required. Yes, stenting is more risky, but if it remains patent, a stent can be a good thing.

That's why IRs etc. get the big bucks. I'd expect a good explanation before accepting stenting. We have to be strong, and demand proper and sufficient explanations before letting some hot-dog do the wrong thing with our veins.

It's a little tricky when it's not linked to age, it's linked to duration of disease. You can be 50 with a 1 year duration of disease or 30 with a 10 year duration of disease. But I am still intrigued by the idea of super IVUS and if this tool would show if the luminal abnormalities are present early on but are not easily seen until they have thickened further. If CCSVI causes MS, we would see it in all MS patients at all stages of the disease.
To sort that out, let me remind you that this is not a disease. It is a congenital condition (CCSVI). I do not want to wade into what causes what. I think the conclusions of this paper are clear, and current severity of MS is linked with current severity of CCSVI. We can argue about durations and ages, but a fact is a fact. All I was saying is it stands to reason given the self-worsening aspect of CCSVI, and the known course of "MS", from bad to worse. The association has been proven. The connection between them is thought to be related to severity. It also makes sense given "MS" is thought to be genetically determined.

We can now break into buzz groups and assign "stages" to the common associated combination of the two entities.

clinical severity of multiple sclerosis as well as duration of disease seems to be associated with the extent of pathological venous drainage of the central nervous system


I don't think anyone can get away for long with saying only that "more study is needed".
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
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Re: a single center study of 50 patients

Postby Cece » Tue Oct 23, 2012 5:30 pm

http://www.ncbi.nlm.nih.gov/pubmed/21866063
This is what I mean by bone pressing on the jugular. As it says in the article, stenting can make this outflow obstruction worse when the bone compresses the stent, which has happened to CCSVIers. There was the most awful picture of a bone-crushed stent, where the tip of the stent was funneled down and bent like a tip, and it was from someone here at TiMS, but a google search didn't turn it up.
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