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While some physicians only use angioplasty to treat CCSVI, others may offer a combination of angioplasty and stents. Therefore, it is important to discuss with your physician what type of procedure he or she may perform, and to understand the various risks associated with each option.
Once the skin and groin tissue are anesthetized, the femoral vein is punctured with a small needle. A guidewire is advanced through the needle into the vein. The needle is removed and a catheter, which is a small hollow tube, is introduced over the wire. The catheter, which is extremely narrow, is inserted into the vein (which is much wider), and threaded upwards into the right ventricle of the heart, out of the right atrium of the heart, and into the superior vena cava. From the superior vena cava, the physician can access the veins that drain the central nervous system, including the internal jugular veins (IJVs), the azygos vein, vertebral veins, and others. Is CCSVI Treatment a form of surgery? Because the patient is awake and aware during the procedure, many physicians will interact with the patient while performing diagnosis and treatment. For example, the physician may ask the patient to "hold your breath now," or "exhale now," in order to help measure blood flow rate or to assess the effects of the treatment. Further, the operating room may have closed-circuit computer or television screens that can show any images the physician has taken from within the vein; patients can sometimes watch the inside of their veins during the procedure.
Patency Rates by Stenosis Location Table 1: Patency by Stenosis Location (Data from Zamboni, 2009)
Table 1 indicates that for the most common type of venous obstruction – stenoses in the internal jugular vein(s) – angioplasty is effective about half of the time. In 47% of the cases, re-narrowing or reblockage occurred at the point where treatment was performed (peak restenosis rates occurred between 7 and 9 months post procedure; the majority of restenosis concluded by the 12th month). Hence, restenosis in the jugular veins after angioplasty is a significant problem, and clearly limits the efficacy of using a single balloon angioplasty procedure as the lone approach to CCSVI treatment for many patients.
In summary, efficacy of CCSVI treatment varies considerably depending on the location of the venous obstruction being cleared. While obstructions in the azygos vein respond well to balloon angioplasty, obstructions in the IJVs may require repeated attempts, and ultimately may not respond to balloon angioplasty. As a result, patients may need to consider whether to attempt repeated procedures with balloon angioplasty, or look to alternatives if they experience restenosis. While over-dilating the vein or using super-rigid balloons have been proposed to minimize restenosis rates, these procedures remain largely untested.
Per Table 2, the most significant outcome for RR patients (together with improved MSFC scores), is the notable reduction in the number of relapses. Perhaps equally important, it was reported that only patients who restenosed had relapses – no patient whose treatment remained patent had a single relapse in the 18 month measured time-period after treatment. This finding suggests that neither the presence of Disease Modifying Drugs (DMDs) nor the placebo effect is entirely accounting for the decrease in relapses for RRMS patients: if the placebo effect and DMDs were responsible for decreases in relapse numbers, then there would be no difference in relapse numbers between patients who did and did not restenose.
Results for PPMS Patients
Lastly, we urge caution in interpreting all results. As Dr. Zamboni writes in the conclusion of the study: “The major shortcoming of our study is that is [sic] not a blinded study. There is a great possibility that bias could be playing an important role in trying to find hope for the treatment of this chronic disease. However, these data will be fundamental in planning a multicenter randomized controlled trial...”
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