Summary Of Evidence

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Analysis of Evidence

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Indications:

Multiple Sclerosis (MS)
MS is an autoimmune disease of the central nervous system. In MS, inflammation of nervous tissue causes the loss of myelin, a fatty material that acts as a protective insulation for the nerve fibers in the brain and spinal cord. This demyelination leaves multiple areas of hard scarred tissue (plaques) along the covering of the nerve cells. Another characteristic of MS is the destruction of axons, which are the long filaments that carry electric impulses away from a nerve cell. The demyelination and axon destruction disrupts the ability of the nerves to conduct electrical impulses to and from the brain, and produces the various symptoms.

Chronic cerebrospinal venous insufficiency (CCSVI)
Recent information suggests that obstruction to venous flow or inadequate venous valves in the great veins in the neck, thorax and abdomen may cause insufficient drainage and damaging backflow into the cerebral and spinal cord circulations.

Chronic cerebrospinal venous insufficiency (CCSVI) has been described as follows in multiple sclerosis (MS) patients. CCSVI is characterized by impaired brain venous drainage due to outflow obstruction in the extracranial venous system, mostly related to anomalies in the internal jugular and azygos veins. The current CCSVI diagnosis is based on Doppler sonography of extracranial and transcranial venous hemodynamics where there has been documentation of stenotic and occlusive lesions in the azygos and internal jugular veins in patients with MS. The literature is inconclusive on whether CCSVI is a clinically important factor in the development and/or progression of MS.

Treatment of CCSVI with balloon angioplasty and or stent placement
Venous angioplasty (with or without stent placement) is currently under investigation as a method to improve blood flow in chronic cerebrospinal venous insufficiency (CCSVI). The hypothesis is that symptoms of MS might improve with this treatment. Unfortunately, MS is associated with frequent spontaneous exacerbations of signs and symptoms. Thus it is very difficult to determine whether any change in medical condition is due to a treatment, or merely represents a normal fluctuation of the disease process. The literature currently is inconclusive on whether balloon angioplasty and/or stent placement are clinically effective in treating patients with MS.

Endovascular treatment for CCSVI is typically performed from common femoral vein access. Initially a venogram is performed so that images can be obtained. A small catheter is inserted and advanced into the right and left internal jugular veins as well as the azygos vein. If the venogram indicates a vein is stenosed then angioplasty is performed. Another venogram is done post angioplasty to confirm that the stenosis was successfully corrected. If the venous angioplasty results in no change or worsening of the stenosis, then stent placement is considered. Individuals who receive a stent typically are placed on anticoagulants for at least three months.

Limitations:

The evidence is inconclusive as to whether CCSVI impacts multiple sclerosis and therefore if treatment with angioplasty would impact the disease. Therefore, venous angioplasty (with or without stent placement) for any of the jugular veins, azygos veins, or other thoracic veins is considered investigational and not medically necessary for the treatment of multiple sclerosis and not covered by Medicare.