Petrov et al. Safety profile of endovascular treatment for chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Endovasc Ther. 2011 Jun;18(3):314-23.
The purpose of this study was to evaluate the safety of endovascular treatment of chronic cerebrovascular insufficiency (CCSVI) in patients with MS. In a 1-year period 461 MS'ers underwent endovascular treatment of 1012 venous lesions during 495 procedures. Although balloon angioplasty was preferred, 98 stents were implanted in 76 patients for lesion recoil, restenosis, or suboptimal dilation. There were no deaths, major bleeding events, or clinical deterioration of MS. Complications at the site of venous access included limited groin hematoma (5, 1.0%); there were no arteriovenous fistulas or puncture site infections. Systemic complications included 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. The average x-ray or fluoroscopy time was 22.7 minutes, and mean contrast volume used was 136.3 mL. The investigators concludes that endovascular therapy appears to be a safe and reliable method for treating CCSVI.
"Do you think it is safe?"
"I am amazed that so many patients are undergoing this procedure; particularly when CCSVI has yet to be established as a disease entity or cause of MS and that endovascular treatment has yet to be shown to work in appropriately designed randomised controlled trials."