BACKGROUND: We designed a prospective case-control study of patients with clinically isolated syndrome (CIS) and Relapsing-Remitting Multiple Sclerosis
(RRMS) with an Expanded Disability Status Score (EDSS) of ≤2, compared
with age-and-sex-matched healthy controls, to test the hypothesis that
chronic cerebrospinal venous insufficiency (CCSVI) is more prevalent in
patients with CIS or mild MS.
METHODS: All subjects were
examined using a Siemens Antares duplex ultrasound machine. The internal
jugular, vertebral and intracranial veins were studied in subjects in
both supine and sitting postures. The sonographer was blind to the
subject's clinical status. Measures included the criteria proposed by
Zamboni and volume flow. Presence of CCSVI was defined as ≥2 Zamboni
criteria.
RESULTS: Seventy patient-control pairs were
recruited, with 11 males and 59 females in each group. Only one subject,
a control, satisfied the Zamboni definition of CCSVI; however, 19
patients and 13 controls had abnormalities as defined by Zamboni, the
difference largely caused by a higher prevalence in patients of internal
jugular vein (IJV) stenosis, defined as a cross-sectional area
≤0.3cm(2). This difference disappeared with a more rigorous stenosis
definition. Further analysis revealed there was IJV valve variation in
seven patients and one control.
CONCLUSIONS: Our findings
indicate that CCSVI, as defined by the Zamboni ultrasound criteria, is
not present in CIS and mild RRMS (EDSS ≤2), providing further evidence
that CCSVI does not have a causal role in MS; however, we found an
apparent increase in IJV variation in patients with CIS or mild MS that
would warrant further investigation.
The conclusions suggest that as CCSVI was not present in all early MSers, it is very, very unlikely to be causal. The evidence is stacking up against the Zamboni theory, but this largely matters not as studies are going ahead with venoplasty in Msers.
We wait to see what the trials of venoplasty will bring......a placebo effect or real therapeutic advantage?