Oct 3, 2010
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Pretty controversial subject, but quite fascinating. Will be discussed at length at the SIR annual meeting in Chicago. Looking forward to DR. Gary Siskin's Double blind randomized clinical trial evauating this.

http://www.timesunion.com/local/article/MS-treatment-put-to-test-in-Albany-721816.php


"It's almost an underground railroad right now, " she said. "It's not widely accepted. Neurology is so against it."
Despite the growing number of patients that say it works, there is no scientific evidence that proves the effectiveness of treating CCSVI, or even whether CCVSI is associated with MS.
In 2009, a vascular physician in Italy named Dr. Paolo Zamboni reported that 43 of 65 MS patients he studied had signs of narrowed veins. It was a breakthrough moment for study of the disease. Zamboni also performed balloon angioplasty in the patients' veins to widen the constricted vessels; many reported feeling better, although half the patients' veins went back to having restricted blood flow.
A follow-up study conducted at the University of Buffalo Medical Center delivered conflicting results. Buffalo researchers examined 499 volunteers, 289 of whom had MS. Preliminary numbers from the study show that 56 percent of the MS patients had CCSVI and 23 percent of the healthy people also had the condition.
Meanwhile, Zamboni's work was circulating on the Internet. Siskin said patients started calling his practice to see if doctors there performed the procedure. The physicians were skilled at breaking up blockages in the arteries of the heart, so it wasn't difficult to learn the pathways to reach blockages in veins. "The patients did really well," Siskin said.
CCSVI critics in the neurology community say that MS is an autoimmune problem, not vascular, and argue the vein abnormalities seen in MS patients are found in many healthy people with no symptoms.
The National MS Society is spending $2.4 million on seven studies to figure out the mechanics of CCSVI and determine if there is a link to MS.
"It's really important to address new ideas and find out if they are going to fulfill their early promise," said Nicholas LaRocca, the society's vice president of health care delivery and policy research, "rather than let people wait and hope and not really know."
In Albany, Siskin's study leapfrogs the research around the link between MS and the narrowed veins and zeroes in on the treatment of the damaged veins.
Siskin will enroll 130 patients in a double-blind, controlled study. All of the patients will undergo a venogram, in which a tube is placed into the veins to assess the width of the vessels. Half the patients will also get a balloon angioplasty to widen any restricted vessels. Since all patients will be sedated and have a puncture in their groin, the patients will not know whether they received the angioplasty, and the neurologist who assesses the patients will not know which treatment the patient received -- hence the "double-blind."
The patients will pay for the venogram, but Albany Med and Community Care Physicians will pay for the balloon angioplasty. Though the risks of the procedure are low, there are possible complications such as infections at the site of the groin wound, abnormal hearth rhythm, a puncture in a vessel, blood clots and veins that become narrowed again. "It's not something that someone would undertake lightly," LaRocca said.
Siskin's study will last about 18 months.
 

Charles_Carmichael

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Are there any results from phase III trials? Or is one in the process?
 
OP
G
Oct 3, 2010
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not aware of any. Interesting concepts, but really no solid data yet to suggest it is safe or effective treatment.
 

gonogo

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Do general IRs put stents in the cerebral circulation? I thought it was neuroIRs.
 
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Oct 3, 2010
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So for CCSVI , I believe that they may angioplasty/stent the internal jugular veins or central veins and perhaps the azygous vein. This is something that tends to be done by peripheral IR. We in the peipheral IR are also often involved in carotid stenting and some of us are also involved in cerebral angiography and stroke thrombolysis.
 
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What I thought was interesting was the difference in outcomes between the different forms of MS, i.e. Relapsing-Remitting vs. Secondary Progressive vs. Primary Progressive MS, in Zamboni's study. Patients with RRMS were shown to benefit while it had no long-term effect on the other forms. Of course, with such a small patient sample size (10 PPMS and 20 SPMS) you can't draw conclusions. It's interesting though. The difference in outcomes between those with azygos vs. IJ stenosis was also interesting.

If you search youtube for "CCSVI," it brings up over 2,100 videos including many patient before/after videos and testimonials, as well as a couple of videos (supposedly?) posted by Dr. Zamboni, geared for patients. It's amazing how far patients are traveling to get treatment...Poland, Bulgaria, etc.

Dr. Zamboni's wife has MS and he did her angioplasty in 2006. Apparently, she's doing very well.

Definitely interested to see how Dr. Siskin’s study turns out. It would be awesome if this proves beneficial for MS patients, they need something better than the injectables/other treatments they have now.
 

jake2

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To say this hypothesis is controversial is a vast understatement. Most neuroradiologists at my program do not believe the venous congestion theory is valid, but are open to being proven wrong. Hopefully properly powered studies will come out in the near future going one way or another before too many more patients fly to remote locations to get a therapy with currently questionable efficacy.
 
Oct 3, 2010
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To say this hypothesis is controversial is a vast understatement. Most neuroradiologists at my program do not believe the venous congestion theory is valid, but are open to being proven wrong. Hopefully properly powered studies will come out in the near future going one way or another before too many more patients fly to remote locations to get a therapy with currently questionable efficacy.

I know there've been mixed results regarding the imaging CCSVI findings. For example, against the theory is http://www.ncbi.nlm.nih.gov/pubmed/21490322 which is larger but several smaller studies (for ex. http://www.ncbi.nlm.nih.gov/pubmed/21490322) show a definitive relationship... I know there were several sessions regarding this topic at SIR...anyone have any more information on how these trials are going?
 
OP
G
Oct 3, 2010
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I believe what they have noted from initial results is that in the right hands it is fairly safe procedure.

The caveats are that some are using intravascular ultrasound to identify the narrowings or webs and then performing angioplasty.

There are no properly designed stents for the veins and there have been cases of stents migrating centrally.

There was a great town hall meeting at the ISET meeting (International Society of Endovascular Therapy) in Miami this last January. It was interesting when one of the heads of neurology discussed some of the shortcomings of the study designs that are being developed including inclusion criteria of defined MS patients.

At SIR there was a great debate between Dr. Gary Siskin pro and Dr. Jim Reekers against the treatment of MS etc.

Fascinating topic. Hopefully more data will start to come out.