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Sunday, September 15, 2013 5:07 AM | CCSVI in Multiple Sclerosis Volg link
Dr. Salvatore Sclafani has been at the forefront of CCSVI research, diagnostics and treatment.  Here is a truly thought-provoking post he made on the This Is MS.com  forum earlier today.  Thanks, Dr. S.  We appreciate your contnued effort.  Dr. Sclafani will be the keynote speaker at the NCS CCSVI conference in Sherbrooke, Quebec later this month.  I look forward to meeting him, and hearing his thoughts. 
https://www.facebook.com/notes/ncs-the-national-ccsvi-society/dr-sclafani-to-present-the-many-reasons-of-failure-to-improve-or-hold-on-to-impr/611147215572812
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I have been thinking sadly about the loss of the Albany trial. It was such a heroic effort by one man to create a study that would prove whether treatment of CCSVI provided a treatment for MS. 

The issues have been distorted to such a great degree that neurologists have elected to negate the entire concept of CCSVI. 
the first issue is whether CCSVI causes MS. This issue is irrelevant to me at this point in time. This issue will take years to assess, evaluate, research and conclude. 

We have spent three years evaluating whether ultrasound proves an association. In reality what we have tested is whether the technique of ultrasound described by Zamboni is a practical one. The literature suggests that it is not. It requires clear understanding of the concept of interpretation, proper technique needed to validate that concept, and general acceptance of that interpretation. Unfortunately, the ultrasound, while the ultrasound works very well in my practice, is not well reviewed in a variety of peer reviewed papers. Poor correlations have been reported and reproducibility is certainly at question at this point. 

The wide variability in results speaks loudly that this is not a good screening test. Most of the randomized studies using ultrasound have really been a test of whether standard jugular ultrasound, or ultrasound done by Zamboni protocol and/or MRI are effective tools of screening. It is clear from the existing literature that Ultrasound requires adherence to a special technique, quite unique and different from standard ultrasound. This makes it a poor screening test. The wide variation in interpretations of ultrasounds in patients with MS indicates that it is not adequate to address the question of whether CCSVI is associated with MS. 

We have allowed a suboptimal screening test to take center stage while obvious venographic abnormalities are amply and routinely seen in the peer reviewed literature. These venographic findings, reported in an adequate number of studies, have been largely ignored. The limitations of venography, inherent in a luminal imaging study of an intraluminal disease, only emphasize the degree of significance of these abnormalities. When augmented by an endoluminal imaging study such as intravascular ultrasound, the prevalence of venous abnormalities in patients with MS cannot be rejected. 

But proving this association is only of secondary importance. What is most important is that some patients with venous outflow obstructions have symptoms that improve after angioplasty, and at a higher rate than that described for placebos in trials of medications and other therapies. This is the most important thing that we have learned in three years. 

It is with deep regret that the entire concept has been politicized, discredited, misunderstood, denigrated, slandered and rejected out of hand. The techniques of treatment, the reasons for recurrence, complications, and failure must be understood in order to discover the role of venous outflow obstruction in neurological conditions. . Why some patients get better must be discovered. Failure to do so, would insult the good memory of Charcot and many others. 

The issue here is not about MS, it is about whether venous outflow obstructions can result in neurological symptoms. It is about whether opening venous outflow improves some clinical manifestations often seen in MS.

We need to put MS on the back burner and focus on the symptoms.

s



Dr. Sclafani believes that the future of CCSVI depends on education of physicians and patients alike. He is a Founding Member of the International Society for Neurovascular Disease, the primary society dedicated to education and research of CCSVI. His column on THISISMS.COM, DrSclafani Answers Some Questions, has been viewed more than half a million times in the last year by patients and physicians alike. Dr. Sclafani directs the CCSVI Workshops at the annual meetings of the Society of Interventional Radiology. 

His research focus is on the development of best practices in preparation for randomized prospective trials. His groundbreaking use of Intravascular Ultrasound (IVUS) since the beginning of his treatments has lead to important break-through in our understanding of the nature of the venous obstructions. He treats patients at American Access Care offices in Brooklyn and Staten Island.
http://www.ccsvicare.org/sclafani.html