Diagnosis And Treatment Of Chronic Cerebrospinal Venous Insufficiency In Multiple Sclerosis

Chronic cerebrospinal venous insufficiency (CCSVI) may be associated with multiple sclerosis (MS), although this is controversial and an active area of research. Correction of CCSVI in patients with MS has been attempted using percutaneous venoplasty. The intent of this procedure is to relieve MS symptoms by improving venous drainage of the central nervous system. For individuals who have MS who receive ultrasound with or without magnetic resonance imaging to diagnose CCSVI, the evidence includes systematic reviews and controlled observational studies. Relevant outcomes are test accuracy, test validity, and other test performance measures. Systematic reviews have generally found a statistically significant association between CCSVI and MS, but a 2014 meta-analysis that excluded studies by Zamboni (who proposed criteria for defining CCSVI) and associated research groups found no significant association. Moreover, systematic reviews have reported significant heterogeneity among studies. Recent observational studies have not found that Zamboni criteria or updated criteria proposed by the International Society for Neurovascular Disease can discriminate between patients with and without MS. The association between CCSVI and MS, especially as a causative factor, remains unclear. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have MS and CCSVI who receive treatment for CCSVI with percutaneous venoplasty, the evidence includes 1 randomized controlled trial (RCT) and several case series. Relevant outcomes are overall survival, symptoms, quality of life, and treatment-related morbidity. The RCT was double-blind and sham-controlled. It found no statistically significant differences in venous outflow characteristics or improvements in clinical disease scores between groups treated with venoplasty and a sham intervention. The results of this RCT are limited by the potential for underpowering, and we did not identify any other RCTs on the efficacy of percutaneous venoplasty. Data on adverse events are available from the Food and Drug Administration (FDA) as well as larger published case series (ie, with several hundred patients). The case series found that adverse events were uncommon following venoplasty, but serious adverse events have been reported to FDA. FDA issued an alert in May 2012, noting the existence of serious complications, including death, and the need for ongoing monitoring. It is not currently possible from the available literature to estimate with confidence the rate of serious adverse events (eg, death, major bleeding). The evidence is insufficient to determine the effects of the technology on health outcomes. <a id="