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The EVTMS trial is studying angioplasty by comparing people who are treated immediately to those whose treatment is delayed. Initial results indicate a possible effect of the treatment on relapse rate and lesions.
Dr. Zivadinov gave an overview of his research results to date. CCSVI has been found more often in MS cases than in people with other neurological diseases, and more often in people with a first MS-like symptom (clinically isolated syndrome or CIS) than in healthy controls. There is no difference in CCSVI frequency in adults vs. children. Based on the available evidence, Dr. Zivadinov feels that CCSVI probably does not play a causative role in MS.
He then presented some work being done to standardize and validate CCSVI investigations using multiple imaging techniques. One imaging technique is MR venography, which in a previous study using a 3T machine detected no significant differences in internal jugular vein morphology between 57 MS and 21 healthy control subjects. Doppler sonography is better than MRV in terms of giving more specific and sensitive CCSVI results; it also can image people in an upright position which MRV cannot. Catheter venography is the gold standard for investigating vein morphology, but it's invasive and also can't be used in people who are sitting upright. A study is being conducted to compared MRV, CT venography, and Doppler sonography with invasive techniques to try to establish standards of CCSVI imaging. CCSVI characteristics also need to be compared with other common MS imaging measurements.
Dr. Zivadinov also mentioned two treatment studies that are underway. The EVTMS trial is studying angioplasty by comparing people who are treated immediately to those whose treatment is delayed. Initial results indicate a possible effect of the treatment on relapse rate and lesions. The PREMISE study will attempt to control for the placebo effect by comparing balloon angioplasty to sham angioplasty. Since the placebo effect is real and can be very strong with invasive procedures, this type of study is necessary to measure the true effect of treating closed or blocked veins in MS.
At this meeting, Dr. Zamboni and Dr. Zivadinov and colleagues presented results of a small pilot safety trial of endovascular treatment of venous lesions in patients with MS. A first small pilot study was published in December 2009 and reported by Medscape Medical News at that time (J Vasc Surg. 2009;50:1348-1358).
In the current trial, called the EVTMS study, 15 patients with relapsing-remitting MS and evidence of CCSVI were enrolled and randomized to receive either immediate endovascular treatment (8 patients) or treatment delayed for 6 months (7 patients), and these were compared with 8 healthy controls.
Treatment of significant stenosis was with angioplasty alone, and patients were prospectively followed up at 3, 6, 9, and 12 months with sonography, MRI (at 6 and 12 months), and clinical examination.
No serious adverse events were seen, with the exception of 1 transitory vasovagal syndrome 1 hour after the intervention, they report.
"No significant clinical or MRI differences have been seen, although there were less relapses in the immediate treatment group, 1 vs 4, and a decrease in T2 lesion volume in the immediate group, about 10%," Dr. Zivadinov noted. Restenosis did not occur in any of the azygous veins treated but was seen in 29% in the internal jugular veins.
"I think based on this study that we can't say more than there is no deterioration of the patients who are getting this type of treatment, and we need to do more specific placebo-controlled trials to understand whether this treatment is useful or not, but I would add that no remarkable differences have been seen in this first study," he said.
Featured Masters Questions and Answers
Robert Zivadinov
June 2010
My view at this point is that CCSVI is associated with MS; however it is yet to be determined whether CCSVI is among the risk factors that, along with others, increase a person’s susceptibility to developing this disease. The fact that CCSVI prevalence is about 38% in patients with a first clinical attack of MS and almost 90% in those with secondary progressive MS and a disease history of 20 years suggests to me that venous insufficiency has a high likelihood of affecting people with MS over time.
really proving that last statement wrong is kind of the objective for me right now. Why would simka find the exact opposite? Ever since the first buffalo results came out I've sensed an agenda to make ccsvi a thing caused by ms.
The best results to the contrary are dake's 20 patients who are progression free after a year. Clearly the problem is that people with rrms have hard to find ccsvi. ziv can't find it, simka cam.
...Our bigest program is CTVD. We presented results from 500 subjects....
Conclusions are:
First: CCSVI certainly and definitely is not the cause of the disease,
Second: CCSVI may help to further progression of the disease,
Third: To operate or not? To answer that question further research of the effectiveness of the procedure are required.
...
Billmeik wrote:The best results to the contrary are dake's 20 patients who are progression free after a year. Clearly the problem is that people with rrms have hard to find ccsvi. ziv can't find it, simka cam.
Billmeik,
Where you are getting your facts? I am one of Dake's early stent patients treated September 2009 with secondary progressive MS. I can't say the procedure has stopped my MS progression, but I can say that it has helped lessen certain symptoms. I had a new area of numbness pop-up about 9 months after the procedure, and at its worst, physical fatigue and dizziness are worse now than before the procedure.
(I'm probably over-reacting to your statement, which on second read was in reference to rrms. I get a little defensive about the question of whether CCSVI treatment will stop progression. It hasn't in my case.)
--Tracy
CCSVI Procedure 9/16/2009 at Stanford
Stent in left and right IJVs
SPMS
Copaxone
Former Ampyra User
Regular Botox Bladder Injections
300mg d-Biotin / day
concerned wrote:So he's saying that CCSVI+TIME doesn't equal MS, but MS+TIME might equal CCSVI?
You can't just pull stuff out of thin air ... he DID NOT say that.
MS IS NOT A DISEASE ... PLEASE SHOW ME THE DISEASE OF MS ... is it a germ, virus, what is it? EVEN NEUROLOGISTS WITH A LOT MORE TRAINING AND EXPERTISE SAY "WE DON'T KNOW" AN AWFUL LOT WHEN TRYING TO ANSWER THAT QUESTION ...
Okay, I guess it would be more accurate to sum up what I've understood from Zivadanov as "CCSVI doesn't seem to be the cause of ms, but it might be a co-morbidity factor, or it might be a secondary disease process of ms."
questor wrote:Where you are getting your facts? I am one of Dake's early stent patients treated September 2009 with secondary progressive MS. I can't say the procedure has stopped my MS progression, but I can say that it has helped lessen certain symptoms. I had a new area of numbness pop-up about 9 months after the procedure, and at its worst, physical fatigue and dizziness are worse now than before the procedure.
Sorry to hear you're doing worse. We don't have solid facts yet, I wish we did.
