Development of a research agenda for evaluation of interventional therapies for chronic cerebrospinal venous insufficiency: Proceedings from a multidisciplinary research consensus panel

The committee came to the general consensus that the mechanisms for evaluating patients with MS for jugular and azygous venous compromise and the value of treating these lesions with angioplasty warrant careful, well designed additional study. The committee believed the specific parameters needed for a large-scale, pivotal multicenter trial were not necessarily available at this time, but that these types of trials are the mandatory goal for study of CCSVI. Prospective safety and efficacy trials should be conducted in well defined and potentially smaller controlled populations under institutional review board approval. In addition, it is critical to support and continue the basic science work under way to better understand the relationship between venous stenoses and hypertension and the subsequent contribution of CCSVI to patients with MS. Animal models will likely prove useful, though inflammatory mediators may be assessed with serum sampling in the context of human trials. There will be many practitioners who will offer endovascular therapy to patients with MS in advance of the availability of definitive peer-reviewed data in support of that practice. It was the general hope of the committee that this work would lead to additional peer-reviewed studies generating data that clarify the role in MS of treating venous disease with angioplasty and possibly stent placement and the potential adverse events associated with these interventions (65). If additional studies confirm the initial reports in favor of CCSVI diagnosis and treatment, and appropriate study cohorts and standardized procedural technique and reporting are developed, it will be appropriate to pursue prospective multicenter trials. Enrollment in these trials will require the following: (i) confirmation of the diagnosis of MS based on currently accepted criteria; (ii) assessment of disease activity with conventional MR imaging; (iii) determination of clinical and functional status; (iv) listing of previous treatment for MS or other significant medical issues; (v) noninvasive screening documentation of venous disease with US and/or MR imaging/venography; and (vi) catheter-based venographic documentation of venous stenoses. Randomization against catheter venography without angioplasty would be required, with blinding of research personnel and examining neurologists. The potential role of stents would emerge from discussions of trial design. Imaging follow-up and clinical assessments might occur at 3, 6, 9, and 12 months after treatment, with a crossover permissible after a period yet to be defined. This type of study defines an ultimate goal in determining the contributory role of CCSVI and catheter-based interventions in patients affected with MS.