Another false promise?
There has been a lot of excitement over CCSVI (Chronic Cerebrospinal Venous Insufficiency), because of the hope that we needed a paradigm shift in the understanding of MS.
The line of thinking was that thinned veins draining blood from the central nervous system (CNS), causes a back-up of blood and iron (one of its components) gets deposited in brain and spinal cord tissue. Instead of MS being a primarily autoimmune disease, the thinking was that perhaps MS is structural (based on the venous thinning) and that this anatomic anomaly causes a back-up of iron, which in turn provokes an immune response (trying to "clean up" the iron).
This notion is attractive because everyone with any lifetime diagnosis, wants to know why it is occurring to them, and wants to find a novel way of thinking about it -- so that an actual cure can be found.
It is easier to understand a vein problem than to grasp the notion of autoimmunity. In fact, autoimmunity raises many philosophical questions about self and non-self and what separates us from the other.
Unfortunately (or fortunately), the CCSVI hypothesis needs to be tested just as any other (and there have been many) new theory is tested -- through rigorous scientific and clinical studies and trials.
For everyone reading, please understand that neurologists want to help their patients and we are not wed to the idea that MS is primarily autoimmune, in fact many of us are leaning towards it being a neuro-degenrative or astrocytic mediated disease.
As neurologists, we appreciate budding sites, such as Liberating CCSVIcuresMS.com, Understanding CCSVIforMS.com and CCSVIliberation.com -- but we also need to act responsibly in order to protect the health of our patients. With that in mind, I recently attended a meeting of MS neurologists, where we had frank discussions about the data surrounding CCSVI.
The great hope of CCSVI research, is not that it is a simple association or even causation, but that treating (liberating) the CCSVI would treat the MS itself (some have gone so far as to say, cure). Leaving the question of what percent of patients with MS actually have CCSVI (Dr. Zamboni is quoted to have said at some point that he found evidence of CCSVI in 100% of MS patients -- but we know that no diagnostic test -- be it lab, ultrasound or MRI -- is perfect), an open-label study in the Journal of Vascular Surgery was supposed to help lead us in the right direction:
I truly wish their data had been more promising, but in this open-label, uncontrolled trial, they did not meet their endpoints for SPMS or PPMS (there was some QoL [quality of life] improvement) and in RRMS, they did not meet their annualized relapse rate outcome.
If you look at their data (open-label) "Patients free of relapse, %" venoplasty went from 27% to 50% (18 months). Now, if you look at prior clinical trials, such as the AFFIRM (Tysabri vs. placebo) placebo arm, it went from 2% pre-treatment to 60% at year 1 and 46% at year 2.
This highlights that the rate or number of pre-study relapses and in-study relapses, even in an untreated group is different. One of the reasons for this, is that in a clinical trial patients and physicians are more careful about what they call a relapse. So, no matter what you do (unless you are causing more relapses with a dangerous intervention), the number of relapse free patients will go up during a trial.
MRIs were not performed in a standard way at a standard time point and it is very possible that patients enrolled because their disease was somewhat active at that moment in time, and when the MRI was repeated they were not in close time proximity to a relapse.
In terms, of "Patients with MRI Gad+ lesions, %," venoplasty went from 50% to 12% and in the placebo AFFIRM arm, it went from 46% to 32% at year 1 and 28% at year 2.
So, you may be saying -- well this was a small study and it warrants further research with larger numbers of patients in more Centers. This is a good idea, but we are far from what some have called a cure -- there is even a group on FaceBook called "Dr. Paolo Zamboni for Nobel Prize."
So, why wait -- why not go somewhere and get the Liberation procedure performed?
Stanford University recently had 2 patients with very severe adverse events from venous stenting for CCSVI: one patient died from bleeding in the brain (after the procedure you go on blood thinners) and another patient had migration of one of the stents into their heart and required surgery to remove them). Needless to say, these are very concerning adverse events and the surgeon at Stanford will no longer be performing this procedure.
With CCSVI, I was hoping for the best, but please don't allow hope to endanger safety
- Dr. Daniel Kantor, MD BSE
Medical Director
Neurologique
info@neurologique.org
www.neurologique.org
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The adverse reaction of two stent procedures is catastrophic to the two patients involved, but surely two anecdotes about failed operations is within the normal range of the course of post-operative events.
ReplyDeleteThis is correct, however in a relatively uncommon procedure (part of the problem), 2 serious adverse events are a lot. We always weigh risks vs. benefits of any procedure (or drug we prescribe), and these occurred in a procedure with questionable (and, as of yet, unproven) benefit.
ReplyDeleteThank you for an objective view. You surely know the desperation embodied within the MS community and to have a drug free treatment that makes sense from a layman's view grabs everyone's attention. It makes sense to open up twisted veins regardless of the MS factor. The clock is ticking and it is difficult sit and wait for many. People are only seeing the positive.
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