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]


Karen said...

It will be interesting to see the outcome of the Canadian trials.

MikeH said...

While I'm not sold on this I certainly wouldn't mind getting tested to see if I have the condition.
The problem I fear is it will be certainly very limited in phase 1 possibly a dozen or so patients that will be monitored after the procedure and for several months i.e. years before they go to phase 2. I hope they include persons with primary progressive MS in their initial phase 1 study yet I doubt it since most if not all neurologists I know are against this procedure.
Time will tell

PS: did you ever try that program for your photos?

nicole said...

Very intriguing. I'm guarded, yet optimistic.

MikeH said...

Honestly I'm not certain where I stand with this procedure. On one hand I think it's great that there is something new yet on the other hand I know at least half a dozen persons who have had the procedure and they haven't shown that much improvement. And that's according to me, I'm certain they would have an entirely different opinion.

I'm disappointed at the length of time it will take before the procedure would be available if the trial is in fact successful. In my estimation we are looking at something that may be available 10 years down the road which is a long time.

I'm keeping my fingers crossed but also keeping a realistic outlook.
Thanks for stopping in and sharing your thoughts.

Wes said...

I had the procedure about 8 weeks ago at Emory hospital in Atlanta, Ga. I would love to give you guys a positive report but I haven't noticed a difference in my progression. The results for the phase 1 trials in America are suppose to be given around December 2011 I'll keep my fingers crossed and hope for the best.

My name is Wes Smith, I was diagnosed with MS October 2001.

Jan-Michael said...

I am male age 60, diagnosed PPMS 10 years ago. I have followed CCVSI procedures and results as I hoped to have it myself. However in checking Zamboni's own blog or articles published it seems for PPMS, it is not done generally. One reason, I suspect is that CCVSI is expected to require doing every few years! As such, being age 60 and finding a way to ensure activity or movement to Cardio-Vascular blood flow, I am doing better that way and will no longer pursue CCVSI. I have been pro-active before and was one of those to write Bayer AG when they needed to distribute Sativex. In Cabada we already had medical marjihuana legislation and so I get great pain relief now from Sativex sublingual spray.
Jan-Michael Toronto Canada

MikeH said...

Jan -- Michael
Thank you so much for your post I only wish I could contact you to ask you about the new medication you are on.
I have a friend who smokes marijuana to ease the spasticity he has. Believe me I've seen him during one of his attacks and would not want anyone to go through this. Unfortunately in the province of Québec is not recognized or covered so unless a person has private insurance well there's not much they can do.
Thanks for stopping by

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