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, as well as to further the overall understanding of CCSVI and how it may affect people diagnosed with MS, it is important 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.
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.