Question 1: What tests do you use to diagnose CCSVI?

Three different tests are used to diagnose patients with CCSVI:
Doppler ultrasound, MR venography (MRV), and catheter venography.

We offer all of these tests to patients at risk for CCSVI. Physicians have different opinions as to the best initial test, the best overall test, and the best test for follow-up after treatment. In our opinion, all three tests have a role in this patient population, but we consider catheter venography to be the gold standard for diagnosing CCSVI.

Question 2: Are you finding that the different tests are showing the same results?

No.

We are finding that the Doppler ultrasound and MRV results do not always correlate with findings seen on catheter venography.

Ultrasound is a fine art of imaging and variability can occur with different technologists performing the test with some differences in technique. Zamboni has established the criteria that should be used to diagnose CCSVI with Doppler ultrasound and the technique that should be used to make this diagnosis. Some variability may be due to the fact that not all centers follow his technique closely. This variability can lead to false positive (an abnormality is seen that does not truly exist) or false negative (an underestimation of a true abnormality) results. This is the case for both Doppler ultrasound and MRV. On MRV, artifacts can be seen due to non-vascular anatomy, such as the cervical spine compressing the vein, or technical factors, including poor opacification of veins, which could create the false impression that a significant blockage exists.

As described, our feeling is that catheter venography remains the gold standard for diagnosing CCSVI. The value of having a baseline Doppler ultrasound or MRV prior to venography is to help identify the sites where disease is suspected, to evaluate both normal and possibly variant anatomy that may add to the difficulty of performing a venogram, and to serve as a point of comparison for follow-up imaging performed after treatment.

Question 3: How are the venogram and angioplasty procedures performed?

A venogram is an invasive procedure used in MS patients to image the internal jugular, azygos, ascending lumbar, and pelvic veins.

Under sterile conditions, a small amount of local anesthesia (lidocaine) is administered to the skin and tissues overlying the left femoral vein, just over the left hip. Once that area is numb, a catheter, approximately the size of a piece of spaghetti, is introduced into the femoral vein. Contrast, or x-ray dye, is injected into the catheter to image the pelvic veins, including the left common iliac vein and the left ascending lumbar vein. This catheter is then advanced up through the abdomen and chest into the right or left internal jugular vein. When the catheter is placed near, then within, each internal jugular vein, contrast is injected to visualize the inside of the vein.

You will notice the camera over your head moving around you as images are obtained so we can see the vein from multiple views. At times, we may ask you to hold your breath and not move for a few seconds while the images are captured.

Dilute contrast is used to ensure subtle abnormalities of the vein are detected. If a stenosis (narrowing) is identified within the internal jugular vein, the diameter of the vein is measured and angioplasty is performed.

An angioplasty (also called venoplasty) is performed by placing a catheter with a balloon attached into the area of the vein that is narrowed, then inflating the balloon to treat the narrowed vein. A venogram is then performed to determine the response of the vein to angioplasty. Once the internal jugular veins are completely studied, the catheter is advanced into the azygos vein and images are obtained in multiple views. If narrowing is identified, angioplasty is performed again.

Question 4: What are the risks of a venogram?

In general, venography carries little risk.

An iodine-based x-ray dye is used during the procedure, and it is possible to have an allergic reaction to this dye. This can be treated should it occur.

This risk can be minimized by telling us in advance about any allergies you may have, especially those that may have occurred during any x-ray or CT scan procedures.

In order to place a catheter into the internal jugular and azygos veins, the catheter has to pass from the inferior vena cava, which is the main vein below the heart, into the superior vena cava, which is the main vein above the heart. As the catheter passes through the heart, it can cause changes in the heart rhythm, which is why patients are monitored throughout the procedure. This risk can be minimized by carefully observing the catheter as it passes through the heart.  Once the catheter is within the internal jugular or azygos vein, it is possible that blood clots can form, which, in turn, can block flow in the vein. This is rare, but can occur.

Question 5: What are the risks of an angioplasty?

In addition to the venogram risks, some risks for an angioplasty procedure exist.

During the actual angioplasty procedure, most patients experience some transient neck or chest discomfort. This typically goes away immediately after the angioplasty portion of the procedure is completed.

It is possible that an angioplasty procedure can disrupt the lining of the vein, which, in turn, can slow the flow of blood in that vein. If this is not addressed, with either additional angioplasty or stent placement, the vein can become completely blocked (see below).

Venous rupture is possible as well, but that risk should be minimized with careful sizing of the balloon used for angioplasty.

Some patients have reported a headache after angioplasty, but this typically goes away within hours or days after the procedure.

Question 6: Do you place stents?

Yes. However, we begin every procedure with the intention of only performing angioplasty. At this time, all available data indicates that angioplasty is an effective treatment for CCSVI. However, circumstances exist in which stent placement is appropriate.

Stents are flexible metal alloy cylinders which come in various diameters and lengths that match the size of the vein being treated. During the procedure, it is possible for the vein lining to be disrupted after angioplasty, which can ultimately lead to slowing of flow and complete blockage of the vein. In this situation, we believe that stent placement should be considered to optimize the possibility of re-establishing flow in the treated vein.

Additionally, a role for stent placement in treating patients with re-stenosis after angioplasty may exist. We are considering placing stents in patients who had a definite clinical benefit after angioplasty but had their symptoms return to baseline. This is discussed with patients on an individual basis.

Question 7: Is there any additional risk to stent placement?

In addition to the risks described above for a venogram and angioplasty, there are some risks to stent placement.

A clot can form within a stent, which can block the vein we are trying to keep open by having the stent there in the first place. Therefore, patients are put on medication to reduce the risk of clotting. This can include either Clopidogrel Bisulfate (Plavix) or Warfarin (Coumadin), based on individual patient circumstances. We recommend that patients stay on this medication for 6 months.

Additionally, a case in which a migrating stent, placed in a patient with CCSVI, was reported. The stent migrated into the heart and required an additional procedure to remove the stent. This risk is considered to be extremely rare.

Question 8: How long does the procedure take?

Most procedures typically take between 60-90 minutes, depending on how many veins require treatment with angioplasty.

Question 9: Do I need to stop any of my medications before this procedure?

At this time, we recommend that patients taking low-dose naltrexone should stop that medication two days prior to the procedure.

Patients taking a blood thinner such as Coumadin should stop taking that 5 days prior to the procedure.

Patients taking aspirin on a regular basis do not need to stop that prior to the procedure.

Patients taking Metformin for diabetes should not take it for 48 hours after the procedure.  Our nursing staff will review all medications with you during your pre-procedural assessment.

Do not stop any medications until you have confirmed with RIVI clinical staff, either physician, nurses, or P.A.

Question 10: What is the recovery associated with treatment?

The entire venogram and angioplasty procedure is performed through a small tube that enters the venous system near the left hip. The incision required to pass the tube through the skin and into the vein is minimal, no bigger than the size of the catheter itself. When the procedure is completed, no sutures are used to close the incision.

Patients leave with only a small band-aid.

Prior to discharge, we do require our patients to lie flat on their backs for 2 hours in order for the puncture site to heal.

Patients are asked to maintain a relatively low level of activity for the remainder of the day. The following day, light activity is recommended. Patients can then resume full activity the next day.

Some patients may experience some mild tenderness at the groin site.

Patients can shower on the day following the procedure.

Some patients may have some tenderness on the side of the neck that was treated with angioplasty. This can be relieved with an over-the-counter analgesic such as ibuprofen.

In rare cases, narcotic pain medication is required.

Some patients experience a headache after treatment. This goes away in each case, but may require medication as well.

Question 11: What changes in my medical condition can I expect after angioplasty of my internal jugular and/or azygos veins?

As all patients with MS know, there are a wide range of neurologic symptoms associated with this disease.

Available data shows that CCSVI is more common in patients with MS than in patients without MS. One of the questions surrounding this procedure is whether or not the abnormalities associated with CCSVI are responsible for or contribute to the symptoms experienced by patients with MS. As more of these procedures are performed, we find that most patients respond favorably, with significant improvement in at least one of their presenting symptoms.

Although the work done to date, in our patients and throughout the world, has been very encouraging, it is still not known which patients will respond well to intervention and which patients will not demonstrate much change. Durability and longevity of the results also remains unknown. Clinical research is working toward answering these questions.

Question 12: I am traveling to RI for my procedure. When should I arrive and when can I plan to go home?

We ask our patients to arrive in RI on the day prior to the procedure. Patients are given more specific instructions at the time they are booked for the procedure.

Most patients are able to travel home 24 hours after the procedure. We ask that you stay locally during that time so that if any issues arise, we are able to address them for you.

Question 13: How will I know if my veins are staying open after this procedure?

It is important that all patients are followed to ensure that symptom improvement is maintained and the veins remain open after treatment.

Doppler ultrasound tends to be the best way to follow these patients, and we recommend that patients are followed every 3 months after treatment for a period up to 1 year, then every 6-12 months after that.

Following symptoms is an important part of follow-up after this procedure. Since most patients see improvement in at least one of their presenting symptoms, worsening of these symptoms may indicate that the veins are narrowing again, a condition called re-stenosis.  Zamboni found a 50% restenosis rate in the blockages treated in the internal jugular vein, so this needs to be actively followed. Patients can be retreated should it occur.

Follow-up examinations can be performed by our practice, but if traveling is difficult, we can work with your local physicians to help you with this testing.

Question 14: What should I do if my symptoms return after treatment?

If you notice that the symptomatic improvement goes away in time, you should contact our office. Recommendations will be made on a patient-to-patient basis.

The degree of improvement following treatment, in addition to the severity of the original lesion(s) treated, plays a prominent role in the recommendations for each patient.

Question 15: What doctor will be performing my procedure?

A number of physicians within our practice are involved in every step of your care. They are board-certified interventional radiologists who have been practicing interventional radiology for many years and have extensive experience with venography and angioplasty procedures.  The doctor assigned to the clinic the day of your scheduled procedure will be doing your case.

Question 16: How does your scheduling system work?

Once a patient calls our office (401-421-1924 or scheduling line 401-432-2520x1173),  He or she is referred to the appointment scheduler who will take all the data and place them on our list and email them information.

Our list is compiled in order of the date that each patient makes initial contact with our office.  We do require a list of medications prior to scheduling any procedure.

Patients will not receive any additional formal communication from our office until a date is scheduled, at which point the patient receives a call from the physician who will perform the procedure. At the present time, we are not scheduling more than 4 months in advance

Question 17: Do you have a cancellation list?

No, we do not have a cancellation list.

Our master list is our cancellation list, which means if a patient assigned to a date cancels, we offer that spot to the next person on our list. We do not offer patients the opportunity to move up their appointment. Rescheduling is difficult for patients with travel arrangements. Additionally, it is logistically impossible to move everyone already scheduled in the event of a cancellation. This is why we are not scheduling more than 4 months in advance. By keeping the flexibility in our system, we are able to move patients up on our list faster.

Question 18: Are you treating children with MS?

No, we are not treating patients who are less than 18 years of age.

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