A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Zamboni
Paolo
P
Vascular Diseases Center, University of Ferrara, Ferrara, Italy. zmp@unife.it
Galeotti
Roberto
R
Menegatti
Erica
E
Malagoni
Anna Maria
AM
Gianesini
Sergio
S
Bartolomei
Ilaria
I
Mascoli
Francesco
F
Salvi
Fabrizio
F
D000328:Adult; D000368:Aged; D000556:Ambulatory Surgical Procedures; D000800:Angioplasty, Balloon / Q000009:adverse effects; D002561:Cerebrovascular Disorders / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D002908:Chronic Disease; D003251:Constriction, Pathologic; D004185:Disability Evaluation; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020528:Multiple Sclerosis, Chronic Progressive / Q000150:complications* / Q000503:physiopathology / Q000628:therapy; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000150:complications* / Q000503:physiopathology / Q000628:therapy; D009460:Neurologic Examination; D016017:Odds Ratio; D010690:Phlebography; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012008:Recurrence; D018570:Risk Assessment; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency; D014689:Venous Insufficiency / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D014690:Venous Pressure