CCSVI and MS: a statement from the European Society of neurosonology and cerebral hemodynamics

Abstract

To systematically review the ultrasonographic criteria proposed for the diagnosis of chronic cerebrospinal venous insufficiency (CCSVI). The authors analyzed the five ultrasonographic criteria, four extracranial and one intracranial, suggested for the diagnosis of CCSVI in multiple sclerosis (MS), together with the references from which these criteria were derived and the main studies that explored the physiology of cerebrospinal drainage. The proposed CCSVI criteria are questionable due to both methodological and technical errors: criteria 1 and 3 are based on a scientifically incorrect application of data obtained in a different setting; criteria 2 and 4 have never been validated before; criterion 2 is technically incorrect; criteria 3 and 5 are susceptible to so many external factors that it is difficult to state whether the data collected are pathological or a variation from the normal. It is also unclear how it was decided that two or more of these five ultrasound criteria may be used to diagnose CCSVI, since no validation of these criteria was performed by different and independent observers nor were they blindly compared with a validated gold-standard investigation. The European Society of Neurosonology and Cerebral Hemodynamics (ESNCH) has considerable concerns regarding the accuracy of the proposed criteria for CCSVI in MS. Therefore, any potentially harmful interventional treatment such as transluminal angioplasty and/or stenting should be strongly discouraged.

Mystery of Chronic Cerebrospinal Venous Insufficiency: Identical Venographic and Ultrasound Findings in Patients with MS and Controls

“…The European Society of Neurosonology has published a position statement declaring that there is no scientifically sound validation for each of the 5 criteria quoted by Zamboni et al for the diagnosis of chronic cerebrospinal venous insufficiency. 37 The problem of a lack of blinding of the sonographer in this area of research has been widely discussed. 38 One of the subcriteria of Zamboni et al 9 is high-resolution B-mode evidence of IJV stenosis.…”

No Evidence for Impairment of Venous Hemodynamics in Children or Young Adults with Pediatric-Onset Multiple Sclerosis

“…4 Our study adds to the growing number of studies that have not replicated a high prevalence of CCSVI in RRMS. [19][20][21][22][23] In the largest venous sonography study to date, 56% of adult patients with MS met the criteria for CCSVI, compared with 42% of patients with other neurologic disorders and 22% of healthy adult controls. 24 In 2011, a meta-analysis supported a higher prevalence of sonographic features of CCSVI in MS compared with controls, but it highlighted numerous methodologic challenges, including a lack of blinding in some studies.…”

Observational case-control study of the prevalence of chronic cerebrospinal venous insufficiency in multiple sclerosis: results from the CoSMo study

“…Most of these criteria have been criticized both for conceptual and technical reasons. 9,32 The absence of an abnormality is easily recognized, but the presence of a change is not uniformly evaluated by ultrasound readers. In this context, it is worth noting that results variability in the literature, but also within a single multicentric study, and the very low presence of CCSVI when confounders are controlled through central reading, pose the basic question of whether CCSVI does exist as a syndrome, 33 i.e.…”

“…Moreover, many factors influence the results of the ultrasound examination of neck veins, including hydration status and level of compression by the ultrasound transducer. 32 Therefore, blinding of the rater is fundamental. Some involuntary unblinding may have occurred in the local analysis, because the examiner may have perceived some level of disability in patients with MS or ONDs; on the contrary, the central reader was completely blind.…”