Considering CCSVI-Related Procedures
We respect and honour your right to make decisions for the benefit of your own health. The MS Society recently shared preliminary unpublished findings from the Canadian CCSVI trial which aimed to determine whether the CCSVI procedure would alleviate MS-related symptoms. These preliminary results suggest that the CCSVI procedure is ineffective in treating MS.
Having a Conversation with Your Doctor about CCSVI Testing or Procedures
The primary concern of physicians is safe-guarding your health, including ensuring that any treatments you take are safe (or have well-understood risks), potentially effective and ethical. If after a discussion, you decide to go for a CCSVI procedure, keep your doctor(s) informed of this decision.
CCSVI is a hypothetical condition that might be diagnosed in a variety of ways. One is through high resolution imaging technologies to view (or "image") the primary veins that carry blood from the central nervous system (brain and spinal cord) to the heart. This imaging is used to detect either one or both of what are considered key indicators of CCSVI:
- Stenoses (blockages, narrowing) and other malformations of the primary veins draining the CNS. Stenoses that impede blood flow through the vein by more than 50% are potential contributors of CCSVI.
- Abnormal venous blood flow (for example, reflux, or flow time).
You can read more about diagnostic approaches on the CCSVI Alliance website
Questions to Consider when Looking at Centres Offering Procedures for CCSVI
CCSVI-related procedure centres can be found throughout the world. If you are seeking to have a procedure done, explore all possibilities in North America prior to considering options overseas. Venous angioplasty is not major surgery but it is invasive. Complications can occur and they can be serious. Follow-up procedures are sometimes called for. If any follow-up care is needed, you are in a much better position if you have rapid access to your medical team and are able to communicate in your own language.
Ask the centre:
- What medical information would you need from me, aside from my CCSVI imaging file?
- What is the training or experience of those doing the endovascular treatments? Has the individual had radiology or interventional training? How many procedures have been done to date?
- Are the physicians members of a college of physicians that require adherence to a code of ethics?
- What is the post-operation complication rate?
- How much is the cost relative to other centres?
- Will I need to take blood thinners? If so, for how long?
- Do you advocate the use of stents? If so, why, given that they have shown to be of higher risk in venous procedures?
- How do you determine if a stent is required? Is there an additional cost for a stent?
- What are the risks associated with the procedure that is being offered?
- What benefits can I expect from this procedure?
- What kind of aftercare can I expect to receive from you? What kind of aftercare will I need to arrange in my home community?
- What documentation will you give me for my health care team at home? Will I be allowed to access and leave with a copy of my medical records from this centre?
- Will you speak to my health care professionals at home if needed?
- If something goes wrong and you have to perform additional procedures, do I have to pay extra? What are these additional procedures and how much do they cost?
- How will I know if my veins have stayed open? If they become constricted again, is it safe to repeat the operation? Will I have to pay extra to have my veins rechecked and re-opened?
You can read more about centres that offer the procedure here
- A vein in the groin area is the point of entry for the procedure. The interventionist will make an incision in the groin area. Local anesthesia is used;
- A thin, spaghetti-size catheter is inserted and threaded up through a vein that travels up near the spine and into the neck;
- A balloon on the tip of the catheter is expanded, thereby opening up the vein to allow free blood flow;
- The catheter and balloon are removed;
- After the catheter has been removed, you may be asked to remain still for a couple of hours.
Some people have stents inserted into their veins. Stents are made for use in arteries, not veins. The risks increase with the use of stents. Stents can migrate (move out of place), and there is an increased chance of blood clotting when a stent used. The reports of serious complications are especially common in those who were treated with stents. Dr. Zamboni's initial research did not involve the use of stents and he advises against their use. If you do get a stent, be sure to get all of the information you can about the stent that has been used so that your physicians at home know what material it is made of and whether or not it is MRI compatible.
There is higher risk when stents are used.
- Stent migration (stents moving out of place).
- Aneurysms forming from damage to the vessels.
- Clotting complications -- stents in the venous system are prone to clotting because of the lower flow and lower pressure in veins as compared to arteries. Therefore over time, one is likely to end up with a complete obstruction at the site of the stent.
We understand that thousands of individuals worldwide have had a CCSVI-related procedure performed. The reports from individuals range widely. Some people report that they were tested but no blockages were found in their veins. Others describe little or no change in MS symptoms. Many others report moderate or even dramatic improvement in symptoms.
According to Dr. Zamboni's initial studies, the treatment was of benefit for relapsing rather than progressive forms of MS. 47% of those in Dr. Zamboni's study re-stenosed (had blockages in their veins again) within 18 months of the procedure.
Preliminary unpublished results from the Canadian CCSVI trial confirmed that treating vein narrowing is ineffective in treating MS.
CCSVI and Disease-Modifying Therapies (DMTs)
DMTs underwent rigorous trials prior to being approved and are shown to reduce relapse rates from 33% to 68%, depending on the treatment. They are also shown to slow the progression of disability in the disease. It is highly inadvisable that you cease your current treatment without recommendation from your neurologist or physician.
Combining DMTs with the CCSVI procedures does not appear to add any additional risk, though again, more information from studies and trials, if warranted, will provide more information.
Cost of CCSVI-Related Procedures
The cost of CCSVI-related procedures varies depending on the centre. Most seem to offer the procedure for approximately $5000-$9,000 USD. You may also need to consider the cost associated with travel, accommodation, need for vaccinations etc.
Risks and Safety
While some information regarding risks and safety has been gathered, more is needed. Gathering definitive risk and safety information with respect to CCSVI-related diagnosis and procedures is complicated by the lack of standardized methodology or equipment in the testing and procedures currently being done. While there may be information on safety with respect to interventions in the arteries, we do not have much information with respect to veins and the venous system. We do know, however, that the risks are not insignificant. Prospective candidates should know that there have been reports of CCSVI surgical procedures resulting in adverse events, including deaths. According to the Annals of Neurology, a person died of a hemorrhage in the brain while taking a blood thinner (anti-coagulant), which is commonly prescribed when stents are inserted into blood vessels. In another instance, a Canadian man died from complications during follow-up surgery after having a stent inserted in Costa Rica.Short-Term and Long-Term Risks
When people look at the risks of the procedure, they often consider only the immediate or short-term risks. These include some relatively rare risks:
- Hemorrhage (including a fatal hemorrhage from the blood thinners),
- Dislodgement of blood clots along the path of the catheter or from the tip of the catheter, resulting in heart attack or stroke
- Nerve damage in the neck (resulting in chronic pain), complications at the puncture site (bleeding, bruising), and theoretical risks that can occur with endovascular procedures, such as vessel puncture by the catheter.
There are however, other risks that are not immediately apparent:
- Risk of bleeding complications related to the use of blood thinners for varying lengths of time following the procedure.
- High rate of re-stenosis (re-narrowing of the veins). In Dr. Zamboni's study, the re-stenosis risk with internal jugular endovascular treatment was 47% within 18 months.
- Accumulated damage to the vessel wall from the balloon in repeat procedures may result in an increased likelihood of permanent obstruction.
How Would I Know if I'm Having a Complication Associated with a CCSVI-related Procedure?
If you are concerned that you might have complications resulting from a CCSVI-related procedure, be sure to seek immediate medical help. The first step in making the diagnosis of a blood clot is obtaining a history. Be sure to share all information you have regarding your recent procedure. Venous blood clots often develop gradually, over hours, with swelling, pain, and discoloration of the affected area. An extremity (e.g, arm or leg) may swell and be red, warm and tender.
If the clot has dislodged and moved to the lungs (pulmonary embolism), the symptoms will involve shortness of breath and pain. This is very serious and potentially life-threatening. If there is concern about a blood clot in the lungs (pulmonary embolus), your physician may first listen to the lungs looking for abnormal sounds caused by an area of inflamed lung tissue.