PURPOSE: To evaluate the safety of endovascular treatment of chronic 
cerebrovascular insufficiency (CCSVI) in patients with multiple sclerosis (MS).
METHODS: In a 1-year period, 461 MS patients (261 women; mean age 45.4 years, 
range 21-79) with CCSVI underwent endovascular treatment of 1012 venous lesions 
during 495 procedures [34 (6.9%) reinterventions]. While balloon angioplasty was 
preferred, 98 stents were implanted in 76 patients for lesion recoil, 
restenosis, or suboptimal dilation. The procedures were analyzed for incidences 
of major adverse events (death, major bleeding, or clinical deterioration of 
MS), access site complications, procedure-related complications, and procedural 
safety-related variables (fluoroscopy and contrast times). The complication 
rates were compared to published data for similar endovascular methods.
RESULTS: There were no deaths, major bleeding events, or clinical deterioration 
of MS. Access site complications included limited groin hematoma (5, 1.0%); 
there were no arteriovenous fistulas or puncture site infections. Systemic 
complications included only rare cardiac arrhythmias (6, 1.2%). 
Procedure-related complications included vein rupture (2, 0.4%), vein dissection 
(15, 3.0%), acute in-stent/in-segment thrombosis (8, 1.6%), and acute recoil (1, 
0.2%); there was no stent migration or fracture or distal embolization. Mean 
fluoroscopy time was 22.7 minutes, and mean contrast volume was 136.3 mL.
CONCLUSION: Endovascular therapy appears to be a safe and reliable method for 
treating CCSVI. Innovations such as purpose-specific materials and devices are 
needed, as are case-controlled and randomized data to establish efficacy in 
ameliorating MS symptoms.