Comments & a CCSVI Update

I want to take a moment to thank everyone who has left a comment on this blog!  It is so amazing to know that people are reading and that my blog has an impact.  I think I had forgotten that, to some extent, until my last post (Too Long).  In response to that post, I got two very kind, very supportive, very positive comments.  It reminded me of why I started this blog and it reminded me that everyday is a blessing and that I need to stay optimistic.  Your comments lift my spirit and I appreciate your words!  I am so lucky to have such an amazing support system, from my family to my friends to the readers of my blog.  It warms my heart to know that people whom I have never met support me.  It is also always great to hear about other people's experiences with MS; it helps me remember that I am not alone in this fight and that there are so many people to be fighting for.  I hope and pray that someday soon we will have a cure.  Thanks again for your continued support and for your always appreciated comments!

And now . . . a CCSVI update from the MSAA:

Background Information on CCSVI and MS

Many questions still surround the possible connection between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS). CCSVI is a complex condition involving changes in blood flow from the brain back to the heart, which some researchers theorize could possibly lead to activation of the immune system, excess iron deposits, loss of myelin, and other nervous system damage. With CCSVI, the veins located on the outside of the brain (extracranial cerebrospinal veins) - those designed to transport blood from the brain back to the heart - collapse and/or become blocked, a condition known as "stenosis." Studies have shown that when the normal blood flow is altered, especially when the flow of blood is reversed, the body may react with an inflammatory response.
Two years ago, Paolo Zamboni and others published the results of a pilot study in the December 2009 edition of the Journal of Vascular Surgery. In this article, lead investigator Dr. Zamboni describes an experimental procedure to widen the narrowed or blocked veins in a study of 65 MS patients. Some refer to this as the "liberation procedure," where angioplasty is performed using a tiny balloon inserted into an affected vein. From this small, open-label study, Dr. Zamboni noted that a portion of the patients with relapsing-remitting MS (RRMS) experienced fewer relapses and improvement in function.
Since these results were published, the CCSVI theory in MS has received a great deal of attention. While a small number of studies are underway, some MS patients are seeing vascular surgeons or interventional radiologists on their own to undergo speculative diagnostic and corrective procedures. Additionally, vascular specialists and neurologists are not always in complete agreement about the presence of this condition in patients with MS and the procedures.
Anecdotally, some individuals with MS who have undergone a procedure feel that they are experiencing some improvement in certain symptoms. Typically, these might include improvements in fatigue, heat sensitivity, sleep, concentration, and balance. Over time, some even attribute improvements in bladder issues, mobility, flexibility, and other symptoms to the procedure. Conversely, some patients did not see any improvement following the procedure.

Research Challenges with CCSVI and MS

The problem faced by the medical community in researching the CCSVI theory is two-fold. First, researchers need to prove whether or not CCSVI occurs more often in individuals with MS versus the general population, and if so, how it may be related to the disease. Further complicating the issue is the fact that no single procedure or protocol has been identified for its diagnosis, and a wide range of results can occur when using different imaging equipment, techniques, and technicians.
The second problem in researching the CCSVI theory involves treating the condition. Dr. Zamboni and others have used an angioplasty-type of treatment for opening closed veins with a tiny balloon that is inflated several times and then removed. Possible adverse events can include bleeding, heart arrhythmias, and rarely an allergic reaction to the dye used to illuminate the veins. Additionally, veins sometimes close (restenosis) in the months following the procedure. A second option is to insert a stent into the closed veins, which poses additional risks - such as the stent dislodging and moving to another area of the body - requiring immediate surgery. Even with the stents, scar tissue can sometimes form and clog the stent. Finally, doctors will still need to determine if and to what extent MS patients may benefit from such a procedure, and if the benefits outweigh the risks.
More than 50 articles on the subject have appeared in peer-reviewed publications over the past two years, although many present conflicting results - with some finding significant proof of CCSVI in MS patients, and others finding no evidence - a problem often blamed on the lack of a protocol for specific diagnosis. Doctors are also looking at possible relationships between CCSVI and known risk factors for MS, including Epstein-Barr virus, genetic factors, Vitamin D deficiency, and cigarette smoking.
Experts agree that a strict protocol for testing will need to be developed, that a combination of tests may be required for a confirmed diagnosis of CCSVI, and that the operators performing these tests will need specialized training for consistent results. Another impressive hurdle in these studies is the issue of blinding. The researchers, doctors, and operators performing the diagnostic tests and evaluating the patients after the procedures need to be blinded as to who has MS and who received the active treatment, or the results could be biased.

Current Studies and CCSVI Registry

Studies may be found by visiting www.clinicaltrials.gov and searching for "CCSVI and multiple sclerosis." Many of the studies are listed as still recruiting participants, but interested individuals should check with the contact person listed for the most current information on recruitment. Currently, seven studies are listed, with locations in New York, Texas, California, Poland, and Italy. In June 2011, the Canadian Institutes of Health Research announced that they will be proceeding with a Phase I/II clinical trial.
One of the studies listed is sponsored by the Hubbard Foundation, titled, "Multi-center Registry for CCSVI Testing and Treatment." Located in San Diego, California, the purpose is to develop a registry of patients evaluated and treated for CCSVI, looking at changes in quality of life. The Hubbard Foundation is looking for doctors and medical facilities that perform CCSVI testing and treatment to register under their IRB (Institutional Review Board) approval to conduct research and provide the outcome of those tested and treated for CCSVI.
In June 2010, the National MS Society and the MS Society of Canada committed more than $2.4 million to support seven new research projects focusing on the role of CCSVI in MS.

Closing Remarks

As with any unproven theory and treatment, interested patients are strongly encouraged to talk with their doctor, and if appropriate, participate in an approved clinical trial. Without a tested and proven protocol for the diagnosis and treatment of CCSVI, individuals could be putting themselves at risk. In July 2011, news arrived of a second individual with MS from Canada who sought treatment outside of the country and died due to complications. Although such tragic results are not common, individuals considering these types of procedures should be aware of the risks involved.
MSAA enthusiastically but cautiously supports the investigation of potential causes and treatments for MS, striving to communicate such research to the MS community as soon as any information becomes available. However, MSAA's policy is to consider patient safety as the top priority - recognizing that all prospective theories and experimental treatments need to be thoroughly studied through rigorous clinical trials.

For more information on CCSVI from the MSAA, visit the MSAA's news center.

Thanks for reading!