Thursday, June 30, 2011
CCSVI Trials in Canada
Late yesterday afternoon Hon. Leona Aglukkaq health minister nnounced the Canadian federal government would fund phase 1 and phase 2 trials for the controversial procedure discovered by Dr. Zamboni. She requested that the involved parties commence the trials as soon as possible. Apparently she was touched by the stories and interactions with patients who had received this treatment and the results attained.
I have no doubt this issue will remain controversial, the vast majority of MS neurologists are against this procedure, most were from the very beginning.
The MS Society was certainly against it in the beginning yet bowed to public pressure and announced a request for funding sometime last year, personally I believe this was too little too late.
As far as I know these studies are being funded by the federal government due to the minister's request.
Trials are normally categorized by phases with phase one's primary endpoint to evaluate the safety of this or any proposed procedure/medication approved for a trial. I received the following information regarding the results of a phase 1 trial conducted in Bulgaria. Wouldn't it be nice if we didn't have to repeat this process with the expenses involved only to obtain the same results?
I will forward this to the minister although I believe the torch has now been passed to the medical community so only time will tell.
For one thing it opens the door for communication and a proper evaluation of this procedure, the end is in sight we will know one way or another whether this procedure is beneficial for people with MS. My only hope is that the trials are not limited to people with relapsing remitting MS or are based on the criteria which exists today to evaluate the effectiveness of treatment.
Those of us who need it the most would again be left out however I suspect many doors would open that were previously closed.
1. J Endovasc Ther. 2011 Jun;18(3):314-23.
Safety profile of endovascular treatment for chronic cerebrospinal venous insufficiency in patients with multiple sclerosis.
Petrov I, Grozdinski L, Kaninski G, Iliev N, Iloska M, Radev A.
Cardiology Department, Tokuda Hospital Sofia, Bulgaria.
Abstract 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.
PMID: 21679067 [PubMed - in process]