Don't know if this will answer any questions that some may have or not. Haven't been able to read much about this, but my husband did e-mail Dr. Dake. So I am posting both here. I for one certainly appreciate the efforts of the good Doctor. I think it would be wise to guard against speculation and finger pointing. We are all adults here and have to take responsibility for our decisions and choices. We don't live in a risk free world. My decision was based on quality of life and I was okay with the possibilty of death . As a Christian I must remember O death where is thy sting, O grave where is thy victory? 1 Corinthians 15:55
The e-mail and Dr Dake's response is as follows:
I know you are inundated with e-mails but we heard (read) the disturbing news that all procedures have been stopped seemingly out-of-the-blue. We knew that this would occur at some point prior to the clinical trials, but the “seemingly out-of-the-blue” action raises the possibility that a major complication has occurred in one or more patients. Many CCSVI patients were obviously aware of the one situation where a stent actually moved to the heart, but I am still stunned by that revelation as it is new to me today and wondering if there are other serious issues. Also wondering if a fall or other jarring of the body could increase the risk of a stent moving and should one therefore limit one’s activities until the stents have had time to “settle in” so to speak. My wife feels great and is trying to do too much in my opinion already, and now this really concerns me as her walking has not improved much if at all.
This procedure has such great potential and the patients that have already had it done need to take every precaution possible to make their results positive. I am sure that the drug companies and possibly some neurologists will point to any problem to stop this procedure.
This probably also explains why we have not heard from Alex yet about a return visit as I know she is swamped trying to cancel everyone scheduled for the procedure. This brings us to the obvious question, will you continue to see my wife in January as planned? We do not need to buy airline tickets if you are unable to see her and treat what you find if something is a problem. What is the status of those who have already had the CCSVI procedure from this point forward?
I am not one to give you advice, but here goes. If at all possible, it would be a great help for our (all CCSVI patients and loved ones) nerves and hopes if you e-mailed (or posted on ThisIsMS) an explanation of the immediate stopping of all procedures and a synopsis of the successes and problems to-date. Something needs to be done to stop the speculation and fears swirling in the CCSVI Forum on ThisIsMS
Dr. Dake’s response is as follows:
Please be assured there is nothing to worry about in terms of stent migration as far as your wife is concerned--I am completely confident of this. There are no other complications besides our one stent migrtion two weeks ago. Obviously, we will certainly be pleased to see your wife for follow-up. One reason you haven't heard from Alex is because of the 630-odd emails we have received in the last 12 days from patients, family members, physicians, physician/patients, etc., inquiring about how to receive evaluation and possible treatment. Indeed, I have decided to suspend further therapies until we can secure the appropriate infrastructure to deal with the staggering number of requests, including the approval of a protocol which is the natural progression of scientific investigtion to follow our initial open label observational phase. This will insure that the next phase of study is taken seriously by a wider medical community as a formal protocol will dictate specified patient enrollment criteria, pre procedure testing and post procedure analysis with specified clinical, imaging and quality of life endpoints. I firmly support this approach as the most appropriate next step in our process of understanding what role this therapy should play in the overall management of patients with MS. The current wave of interest and the obvious resultant democratization of endovascular procedures will soon find local/regional hospitals offering the procedure. Now is the time when it is most important to establish the scientific merit, if any, before this becomes a widespread practice. It is my hope that our trial will contribute to our understanding and help others know any benefits and limitations. This is a voluntary decision and although there is high skepticism by many neurologists regarding any merit of endovascular therapy of extracranial venous obstruction, I was not forced by anyone to suspend procedures. Rather, it is the recognition that we have now accumulated enough clinical experience to understand how to create the appropriate protocol for a rigorous scientific study. Please feel to share these comments with any friends or forum readers, as you feel they may prove explanatory or helpful.