Potential of Endovascular Treatment of CCSVI in MS Patients Studied

December 3, 2009—Paolo Zamboni, MD, et al have published findings from a prospective open-label study of the endovascular treatment of chronic cerebrospinal venous insufficiency (CCSVI) in the Journal of Vascular Surgery (2009;50:1348-1358). This study was first presented in April 2009 at the Charing Cross Symposium in London.

The investigators stated that CCSVI is strongly associated with multiple sclerosis (MS). Therefore, they conducted this study to evaluate the safety of CCSVI endovascular treatment and its influence on the clinical outcome of the associated MS. CCSVI is characterized by combined stenoses of the principal pathways of extracranial venous drainage, including the internal jugular veins (IJVs) and the azygous vein (AZY), with development of collateral circles and insufficient drainage shown by increased mean transit time in cerebral magnetic resonance (MR) perfusion studies.

As detailed in the Journal of Vascular Surgery, 65 consecutive patients with CCSVI were subdivided by MS clinical course: 35 with relapsing remitting (RR), 20 with secondary progressive (SP), and 10 with primary progressive (PP) MS who underwent percutaneous transluminal angioplasty (PTA). The mean follow-up time 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) as measured by the MS questionnaire.

The investigators reported that 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.

The investigators concluded that PTA of venous strictures in patients with CCSVI is safe, and the clinical course positively influenced clinical and QOL parameters of the associated MS compared with the preoperative assessment, especially in patients with RR. Restenosis rates are elevated in the IJVs but are 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, the investigators advised.