The latest work of Prof Zamboni and colleagues on the surgical approach to chronic cerebrospinal venous insufficiency has been published in the Journal of Vascular Surgery (2009;50:1348-1358).
This research has been avidly awaited worldwide, as interest continues to grow in the possibility that a definitive cause for MS may have been found.
The abstract is shown below, and the full paper can be downloaded via the pdf link above right. In brief the procedure is a short day-case procedure in which a catheter is inserted in the groin and threaded up into the venous system.
Narrowings of the veins exiting the brain are dilated via this route. The researchers found the procedure was safe, but with quite a high rate of re-narrowing of the veins at 18 months: about half the internal jugular vein narrowings that were dilated had narrowed again.
People with relapsing-remitting disease did best, with twice as many relapse-free after the operation than before, although half the patients who had the procedure still relapsed afterwards during follow up; the most worrying result reported was that there was no difference in the group's relapse rate after the procedure. The number of people with new MRI lesions was considerably lower after the procedure.
People with progressive disease did not do as well as those with relapsing-remitting MS, and didn't seem to get much benefit at all. All in all, the results look promising, although not nearly as dramatic as had been hoped, and warrant further study. It should be noted that this was not a controlled trial, and its main aim was to assess the safety of the vascular dilating procedure.
Many people with MS still had ongoing problems and new lesions after the procedure, and overall, the procedure had no effect on the annual relapse rate of the group.
How it compares to other available treatments will become more clear with time, and after randomised controlled trials are conducted. In contrast to this technique, most of the other available treatments have been shown to make a difference to relapse rate in randomised controlled trials.
For instance in a randomised controlled trial (Weinstock-Guttman B, Baier M, Park Y, et al. Low fat dietary intervention with omega-3 fatty acid supplementation in multiple sclerosis patients. Prostaglandins Leukot Essent Fatty Acids 2005; 73:397-404) of a low fat diet supplemented with fish oil, there was a 69% reduction in relapse rate after starting the diet. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency by Paolo Zamboni, Roberto Galeotti, Erica Menegatti, Anna Maria Malagoni, Sergio Gianesini, Ilaria Bartolomei, Francesco Mascoli, Fabrizio Salvi
Chronic cerebrospinal venous insufficiency (CCSVI) is characterized by combined stenoses of the principal pathways of extracranial venous drainage, including the internal jugular veins (IJVs) and the azygous (AZY) vein, with development of collateral circles and insufficient drainage shown by increased mean transit time in cerebral magnetic resonance (MR) perfusion studies. CCSVI is strongly associated with multiple sclerosis (MS). This study evaluated the safety of CCSVI endovascular treatment and its influence on the clinical outcome of the associated MS.
Sixty-five consecutive patients with CCSVI, subdivided by MS clinical course into 35 with relapsing remitting (RR), 20 with secondary progressive (SP), and 10 with primary progressive (PP) MS, underwent percutaneous transluminal angioplasty (PTA). Mean follow-up was 18 months. Vascular outcome measures were postoperative complications, venous pressure, and patency rate. Neurologic outcome measures were cognitive and motor function assessment, rate of MS relapse, rate of MR active positive-enhanced gadolinium MS lesions (Gad+), and quality of life (QOL) MS questionnaire.
Outpatient endovascular treatment of CCSVI was feasible, with a minor and negligible complication rate. Postoperative venous pressure was significantly lower in the IJVs and AZY (P < .001). The risk of restenosis was higher in the IJVs compared with the AZY (patency rate: IJV, 53%; AZY, 96%; odds ratio, 16; 95% confidence interval, 3.5-72.5; P < .0001). CCSVI endovascular treatment significantly improved MS clinical outcome measures, especially in the RR group: the rate of relapse-free patients changed from 27% to 50% postoperatively (P < .001) and of MR Gad+ lesions from 50% to 12% (P < .0001). The Multiple Sclerosis Functional Composite at 1 year improved significantly in RR patients (P < .008) but not in PP or SP. Physical QOL improved significantly in RR (P < .01) and in PP patients (P < .03), with a positive trend in SP (P < .08). Mental QOL showed significant improvement in RR (P < .003) and in PP (P < .01), but not in SP.
PTA of venous strictures in patients with CCSVI is safe, and especially in patients with RR, the clinical course positively influenced clinical and QOL parameters of the associated MS compared with the preoperative assessment. Restenosis rates are elevated in the IJVs but very promising in the AZY, suggesting the need to improve endovascular techniques in the former. The results of this pilot study warrant a subsequent randomized control study.