Despite the media focus on the professional divide sparked by the CCSVI controversy, most in the scientific community agree that more research is needed before interventional surgery for CCSVI can be routinely recommended.
In a position statement, the Society of Interventional Radiology stated that at present, the published literature is "inconclusive on whether CCSVI is a clinically important factor in the development and/or progression of MS, and on whether balloon angioplasty and/or stent placement are clinically effective in patients with MS" (J. Vasc. Interv. Radiol. 2010;21:1335-7).
Additionally, in a commentary on the treatment of CCSVI, representatives of the Cardiovascular and Interventional Radiological Society of Europe acknowledged that although several centers worldwide are promoting and performing balloon dilatation, with or without stenting for CCSVI, "no trial data are available, and there is currently no randomized controlled trial [RCT] in progress." Further, anecdotal evidence and patient testimonies on the Internet are not a sound basis to offer a new treatment "which could have possible procedure-related complications to an often desperate patient population," they wrote. "We believe that until real scientific data are available for CCSVI and balloon dilatation, this treatment should not be offered to MS patients outside of a well designed clinical trial" (Cardiovasc. Intervent. Radiol. 2011;34:1-2).
Toward that end, the National Multiple Sclerosis Society of the United States and the MS Society of Canada have pledged $2.4 million in support of seven CCSVI research studies, including projects designed to evaluate venous abnormalities in children and teens with MS, patients with early and late stage MS, and those at risk for MS. An international review panel comprising radiologists, vascular surgeons, and neurologists evaluated research applications via an expedited review process and chose those that "combined the strongest science with the research goals necessary to most quickly determine the scope and meaning or reported abnormalities in blood drainage from the brain and spinal cord in MS," according to the societies. "It is hoped these findings will provide clarity regarding the need for next-step therapeutic trials to correct such blockages as MS societies around the world pursue this CCSVI lead."
In a presentation at the annual International Symposium of Endovascular Therapy in January, Dr. Burks outlined the critical issues related to crafting a united CCSVI message with multidisciplinary support, which include the best CCSVI diagnostic tests and outcomes; treatment standards and successful outcomes; diagnostic criteria; standards for qualified CCSVI specialists and treatment centers; uniform institutional review board requirements; standards, by discipline, for follow-up care; and criteria for retreatment and procedural standards.
Additionally, "we need to establish a CCSVI patient registry that documents outcomes and adverse events, as well as other relevant data, and disseminate that document widely to all groups," Dr. Burks said. Doing so will go far toward mending the fractious community and directing energy toward optimal patient care, he stated.
Dr. Burks disclosed financial relationships with Acorda, Allergan, Avanir, Bayer, Biogen Idec, Novartis, and Serono. Dr. Baracchini disclosed having no relevant financial relationships.