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CCSVI Statement: Dr. Ernie Willoughby, MS Specialist Neurologist

Chronic Cerebro-Spinal Venous Insufficiency or CCSVI was described in a paper in 2009 by Prof Paulo Zamboni, a vascular surgeon from Ferrara, Italy.   He reported that 100% of 65 MS patients studied had obstruction of major veins in the neck and chest that drain blood from the brain and spinal cord, while similar abnormalities were seen in none of 235 controls (including normal persons and persons with other neurological disorders).   The obstructions were thought to be developmental abnormalities of vein structure and although pressure in the veins was not increased in MS patients compared with normals, it was suggested that ill-defined slowing of venous flow caused leakage of blood with deposition of iron into brain and cord tissue and triggered the inflammatory reaction characteristic of MS.   In a later report Zamboni reported in 65 MS patients that dilatation of the obstructed veins using balloon catheters led to improvement in symptoms in some patients, although the study did not include untreated control patients, and many of the obstructions reappeared after a year or more.   In the past 18 months Prof Zamboni and his collaborators have published 15 further papers on various aspects of CCSVI in MS.

These unexpected reports suggesting a new and potentially treatable cause for MS have generated tremendous interest in the MS community, particularly among patients, while there has been considerable scepticism about the occurrence and significance of CCSVI among MS neurologists.    That has led to a good deal of tension and extensive comment (much of it web-based) that neurologists have not paid sufficient attention to CCSVI because of vested interests related to immune-modulatory therapy.   There have been public demonstrations (in Canada), a petition to Parliament for accelerated access to the “Liberation Therapy” (in the UK), and the formation of a splinter MS Society (in the US).   Numerous medical centres in many countries (particularly Eastern Europe, India and Latin America) now offer the diagnostic procedures and treatment of obstructed veins by balloon dilatation and/or insertion of stents to keep the vein open.    The indications are that perhaps hundreds of MS patients in North America and Europe have had these procedures done.   Unfortunately, most treated patients do not have systematic neurologic follow-up and past experience indicates that anecdotal reports of dramatic improvement cannot be relied on as measures of definable effect on the MS disease process.

There are sound reasons for the continuing widespread doubts among MS neurologists about the relevance of CCSVI and concern about the appropriateness and safety of procedures on major veins.    Although it has long been observed that the inflammatory patches in MS are concentrated around small veins, there has been no evidence of venous obstruction with enlargement of small veins, and recognised disorders due to obstruction of veins have different features from MS.   Additionally, a recent report using MR brain scans has shown reduced rather than engorged veins in MS.   Most controlled detailed studies of the veins in MS have not confirmed Zamboni’s results.   The most extensive reports have been from Zivadinov in Buffalo, NY.  who recorded occurrence of CCSVI in 62% with established MS, 45% with other neurological disorders, 42% with early MS and 25% in normals.   Doepp in Germany reported CCSVI in none of 56 MS patients and Baracchini from Padua, Italy found CCSVI in 16% of 50 persons with early MS.    These markedly inconsistent results have produced much discussion on the most appropriate techniques to use to assess venous flow in MS, particularly ultrasound vs. MR venography and catheter venography.       At this stage it seems unlikely that CCSVI is a significant factor causing MS.   It is possible that secondary changes in venous flow may result from established MS but not clear if procedures on the veins have a beneficial effect on the disease process, or are sufficiently safe.      Of 35 MS patients treated for CCSVI at Stanford in California, one died of a cerebral haemorrhage and another needed urgent cardiac surgery to retrieve a stent that had dislodged from the vein.  

Despite its doubts, the neurologic community has addressed the issue of CCSVI actively.   At the annual meeting of the American Academy of Neurology in April 2010, Prof Zamboni was invited to present a paper and a live web forum on CCSVI which included Zamboni was held with 4200 registered participants from around the world.   The annual meeting of the European Committee on Treatment and Research in MS (ECTRIMS), in October 2010, included a symposium on CCSVI.   The US MS Society has committed $2.4 million to fund 7 research studies on CCSVI in Canada and the US.    Those are focussed on the best means to demonstrate CCSVI and to determine its significance.   Reliable evidence of benefit and safety will come only from double-blind controlled treatment trials, and most neurologists (and also Prof Zamboni) believe MS patients should have venous dilatation procedures only as part of such trials.