Considering CCSVI-Related Procedures

We respect and honour your right to make decisions for the benefit of your own health. This section of the website is dedicated to some of the practical issues for those who are considering a CCSVI procedure.

The MS Society of Canada awaits more detailed information on the currently undetermined nature of the link between CCSVI and MS. We cannot advocate for a procedure that is not yet backed by rigorous scientific evidence. We believe this would be fundamentally irresponsible of us as an organization with people affected by MS as our first priority.

For those seeking information specific to CCSVI procedures, we hope this section will provide you with trustworthy and meaningful information, whether you:

• are awaiting more information
• are trying to make up your mind about the procedure
• have decided to go for the CCSVI procedure
• have already gone for the CCSVI procedure.

If you are new to issues about MS, please visit the MS Society of Canada website for information on approved treatments for 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. Your physician may be wary of any CCSVI-related procedures. Many physicians are trying to keep an open mind until science points to the answers, but as practitioners they must be guided by the principles of evidence-based medicine.

If after a discussion, you decide to go for a CCSVI procedure, keep your doctor(s) informed of this decision. In general, it is important to keep the communication channels open between you and all of your health care professionals. This is especially the case when anything has changed for you medically, or when you've had a procedure that can be considered invasive in nature. It will be important to keep them updated when you return, so that they ensure appropriate aftercare. For instance, if you were to decide upon a stent, your doctors would need to know about this to ensure an appropriate MRI machine is used in the future.

Possible Benefits

Anecdotally, 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.

People have observed increased warmth and sensation in their hands and feet, a decrease in fatigue, improved heat-intolerance, better balance and mobility, and a decrease in pain among other reported improvements.

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.

Angioplasty in Veins versus Arteries

The venous drainage of the brain is a highly flexible system naturally designed to have many alternate routes. This way, if one vein is damaged, other veins draining the brain and spinal cord can easily handle the blood flow out of these organs. Further, different veins are in use depending on whether a person is standing up or lying down. A proportion of the brain's venous drainage runs through the internal jugular veins when standing, however when lying down, that proportion of the venous return tends to flow through alternate venous routes.

The arterial system does not have the same flexibility - which is why we needed to develop arterial angioplasty, a well-recognized life-saving procedure for those who have coronary blockages.

Arterial angioplasty and the insertion of stents into certain arteries are established medical procedures. However, it is very important to emphasize that the walls of arteries differ greatly from veins. Arteries are muscular, thick-walled vessels that carry oxygenated blood under high pressure from the heart to the tissues. Think of them like thick, hard PVC plastic. Veins on the other hand, are thin-walled - think of saran wrap -- and collapse naturally when not filled with blood. If blocked either by a malformation or by external pressure from a muscle or bone, narrowed veins will return to their pre-surgical shape (i.e., re-stenose) after being artificially expanded by insertion of an inflatable balloon.

Venous angioplasty is rarely used in the medical world because the incidence of re-stenosis is so high.

CCSVI Testing

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:

1. 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
2. Abnormal venous blood flow (for example, reflux, or flow time)

There are many high resolution imaging technologies that exist, however most of the technology available has been used in the context of arteries and the arterial system, so many imaging technicians have limited or no experience imaging the venous system. For this reason, a variety of imaging technologies are currently being used in CCSVI testing, including duplex ultrasonography (Doppler), magnetic resonance venography (MRV) and catheter venography (invasive).

Each imaging technology has particular advantages and disadvantages. Some believe that the most accurate imaging is through multiple approaches (e.g. MRV, MRI/SWI together with duplex ultrasonography for non-invasive diagnosis, with confirmation via catheter venography).

Depending on the imaging technology being used, you will either be asked to be in a sitting, reclined position or be lying down, and it usually takes under an hour.

To sum up, imaging for CCSVI is not standardized at this time, making it difficult to accurately diagnosis it. One goal of current research efforts is to determine a standard diagnostic protocol for CCSVI imaging.

When speaking to staff at a potential diagnostic centre or to an interventional radiologist, here are some of the questions you may want to ask:

• How is the testing done? Which imaging technology will be used?
• Will the testing be invasive or not, and if so, what are the risks?
• How much will the testing cost?
• Is a combination of testing tools recommended and if so, can you explain why?
• If a combination of testing tools is not recommended, what are the advantages and disadvantages of the tool being used?
• What would I learn by having this testing done?
• Do technicians need special skills to evaluate the test results?
• How accurate and reliable are the test results?
• How long will the procedure take and what position will I be in (sitting and fully reclined or lying down)?
• Does the position I'm in affect the findings of the test?
• If the test indicates that I have signs of CCSVI, does that mean I should have vascular surgery?
• What if the test indicates that I do not have CCSVI?
• Can I get copies of the test results? Will you discuss them with a surgeon if necessary?
• What explains the fact that some individuals report obtaining different results at different clinics?

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 have been diagnosed and are thinking about having the procedure done, or have decided to have it done, keep the following in mind to ensure that your procedure will be as safe as possible.

• It is important to acknowledge that there is a large financial incentive for centres in other countries to offer the procedure. While the intentions of the physicians offering the procedure may be good, they also serve to benefit from the medical tourism they are offering. Accreditation and other measures of quality may vary. Try to communicate with other people who have had the procedure done at the centre(s) you're considering so that you can hear about the research they did in choosing that centre as well as their experience;
• 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

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.

What to Expect: The procedure itself

The procedure generally takes a couple of hours. You will be asked to remain still. If you think you may need to use the washroom during the procedure a catheter can be arranged. Should you experience pain or discomfort this should be relayed to the surgeon. Anecdotally, people have reported mild discomfort to pain and a feeling of pressure during the procedure.

The procedure:

• 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.

Stents

Some people have stents inserted into their veins.

While CCSVI-related procedures are controversial, the use of stents is of particular concern in the debate. 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.

Re-stenosis

Re-stenosis (re-blocking of the veins) occurred in Dr. Zamboni's study with internal jugular endovascular treatment in 47% of individuals within 18 months of initial treatment. This is an important factor to consider when deciding whether or not to get the procedure because if you do experience benefit from the opening of veins, it may be temporary.

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.

Dr. Zamboni himself strongly recommends that those with relapsing forms of MS remain on their disease-modifying therapies. 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. Given that restenosis occurred in Dr. Zamboni's study with internal jugular endovascular treatment in 47% of individuals within 18 months of initial treatment and has been reported anecdotally by many, this may be more than a one-time cost.

You may also need to consider the cost associated with travel, accommodation, need for vaccinations etc.

As with any chronic disease, there are many costs associated with MS. Ask yourself if you are okay with spending a significant amount of money on a treatment for a condition that is not yet proven to be correlated to MS.

You may be able to help subsidize any CCSVI procedures through a tax credit offered through the federal government. People with MS who have travelled outside of Canada for procedures and services such as the CCSVI procedure or stem cell procedure may be eligible to claim, as a medical expense, the cost of the procedure as well as travel costs to and from the medical practitioner or medical facility.

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

Stents

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.

After-care

The MS Society of Canada continues to encourage governments to ensure that no Canadian, who undergoes treatment for CCSVI outside of Canada, is denied necessary post-treatment and follow-up medical care they require when they return home. This is primarily the responsibility of provincial and territorial governments.

The provinces of Nova Scotia, PEI and New Brunswick have committed physicians in those provinces to provide appropriate post-treatment care.

The government of Ontario has developed guidelines that are designed to educate people on the follow-up care that patients with MS who have undergone an endoluminal vein dilation procedure can expect from their health care practitioner in Ontario. These guidelines are based on the guidelines developed by The Ontario Multiple Sclerosis Expert Advisory Group for health care practitioners in Ontario.

Ontario

Some of the provincial College of Physicians and Surgeons have published information related to aftercare. While not official College Standards of Practice on this topic, these documents regarding the follow-up testing or treatment for any patient who has received medical care outside of the country may be helpful to you or your treating physician.

Alberta (in English only)

Quebec

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 clotsoften 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.

Testing that can be done for venous blood clots include physical examination, ultrasound, venography, and occasionally, blood tests. If there is a suspicion of a pulmonary embolus, a computerized tomography (CT) scan is generally done.