About CCSVI - National Multiple Sclerosis Society

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What is CCSVI?

Some studies have indicated that a phenomenon called CCSVI (chronic cerebrospinal venous insufficiency), a reported abnormality in blood drainage from the brain and spinal cord, may contribute to nervous system damage in MS. This hypothesis was put forth by Dr. Paolo Zamboni from the University of Ferrara in Italy in 2009, and is now being pursued by other investigators as well.

Based on the results of initial preliminary findings, Dr. Zamboni and others state that this pilot study warrants a subsequent larger and better controlled study to definitively evaluate the possible impact of CCSVI on the disease process in MS. There have been additional studies published, some of which showing results that conflict with the original findings. This amplifies the need for larger, well-controlled studies that can quickly provide answers regarding next steps.

National MS Society research leaders first met with Dr. Zamboni in February 2010 at New York University’s Society-funded MS Center of Excellence and again in April when the Society hosted, along with the American Academy of Neurology, a live Web forum on CCSVI. Based on the results of preliminary research which has been published in respected peer journals, Dr. Zamboni and others have recommended larger scale studies to determine if CCSVI may be treated through an endovascular surgical procedure, which involves inserting a tiny balloon or stent into blocked veins in order to improve the flow of blood out of the brain and spinal cord.

Dr. Zamboni suggests that if further evidence supports the link between MS and CCSVI, that its treatment may ultimately add to the arsenal of therapies available for MS. He emphasized the need for more research on his hypothesis, and noted that people with MS should remain on their immunomodulatory therapies as has his wife after her endovascular surgical procedure.

The Society shares in the public urgency to expeditiously advance any lead that has the potential of stopping, repairing or preventing MS. 

Recent Findings related to CCSVI

Should people with MS seek treatment for CCSVI?

Like all important medical decisions, the question of whether individuals should undergo any procedure is a personal one that should be discussed with their health care providers. There is urgency for more effective MS treatments, particularly for more progressive forms of MS. Each of us varies in our ability to tolerate risks; an intervention that may seem far too risky to one who is doing relatively well with his or her current treatment strategy may not feel very risky at all to someone whose MS is obviously progressing in spite of everyone’s best efforts. Each individual must make this decision in conjunction with a trusted health care provider.

Endovascular surgery, like any surgical procedure, carries some risks. This does not mean that it would not be considered as a potential treatment in the future if further research provides evidence of its possible benefit. We need to determine if treating CCSVI improves symptoms or changes the course of the disease in any way. That is why the Society is leading research efforts to determine how CCSVI may be involved in the MS disease process. To get the quickest answers and most reliable results about benefits and risks of any surgical procedure that might attempt to address blood flow in or out of the brain, it is prudent that such surgery be performed as part of controlled trials, especially in light of adverse events reported to date.

Prospective candidates should know that there have been reports of CCSVI surgical procedures resulting in adverse events, including deaths. According to the Annals of Neurology and the Wall Street Journal, a person died of a hemorrhage in the brain while taking a blood thinner (anti-coagulant), which is commonly prescribed when stents are inserted into blood vessels. In another individual, a stent dislodged and moved to the heart, requiring emergency open heart surgery to remove the device. MS endovascular surgery was halted at Stanford University after these two adverse effects occurred. In another instance, a Canadian man is reported to have died from complications during follow-up surgery after having a stent inserted in Costa Rica. Other possible risks include: infection at the puncture site; damage to the blood vessel, which could lead to the formation of clots; and internal or external bleeding if anti-coagulants are used.

In May 2012, the U.S. FDA issued a safety communication about procedures to treat CCSVI in people with MS. Read more

Virtually all FDA approved disease-modifying MS therapies have their own risk/benefit profiles. The difference is that these therapies have been shown, through large-scale, controlled clinical trials, to significantly reduce MS disease activity in certain individuals. Dr. Zamboni, who originated the CCSVI hypothesis, has emphasized the need for carefully controlled research on CCSVI, and has noted that people with MS should remain on their disease-modifying therapies, as has his wife after her endovascular surgical procedure.

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