NATIONAL HARBOR, MD. -- Percutaneous balloon angioplasty improved flow dynamics in multiple sclerosis patients with chronic cerebrospinal venous insufficiency in a pilot study.
An association has been made recently between multiple sclerosis and chronic cerebrospinal venous insufficiency (CCSVI) that is characterized by stenosis and reflux of the principal extracranial venous drainage, including the internal jugular veins and the azygous veins. But there has been considerable debate about the validity of percutaneous balloon angioplasty in the treatment of this stenosis.
Dr. Manish Mehta of Albany (N.Y.) Medical College and his colleagues conducted the first angiographic study to quantitatively analyze the impact of percutaneous balloon angioplasty on flow dynamics across these lesions. Dr. Mehta shared their results at the Vascular Annual Meeting.
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Image shows stenosis of right internal jugular vein (left); it was treated using angioplasty (middle), giving improved flow (right).
The researchers assessed 50 internal jugular veins (IJVs) from MS patients with CCSVI, as well as 12 IJVs from healthy volunteers, all of whom underwent detailed angiographic evaluation. The technical components of all venograms were standardized.
Quantitative analysis included the contrast time of flight from the mid-IJV to the superior vena cava, and the primary venous emptying time (PVET), quantified as greater than 50% of venous emptying from the IJV. The time of flight and PVET were recorded in patients with CCSVI prior to and subsequent to balloon angioplasty. The same data were recorded in the healthy controls. All data were collected prospectively, and statistical analysis was performed using two-tailed Student's test.
Of the 50 CCSVI-MS patients who had IJV stenosis greater than 70% and reflux and who underwent balloon angioplasty, technical success (defined as less than 20% residual IJV stenosis) was achieved in 44 (78%). CCSVI patients were observed to have a significant improvement in both the time of flight and PVET following balloon angioplasty that paralleled those of healthy subjects without MS.
"The results of this prospective pilot study suggest an association between MS and CCSVI, which results in abnormally elevated time of flight and PVET through the IJV," Dr. Mehta said. "Furthermore, balloon angioplasty of these lesions improves the hemodynamic parameters so that they are comparable to those of healthy non-MS patients."
Dr. Mehta stressed the need for randomized studies to further investigate this issue and said that this patient population is at high risk for a placebo effect with regard to their reported symptoms. He also stated that this treatment is being provided to many patients around the world and that the U.S. Food and Drug Administration has cautioned against its use outside of well-regulated trials due to lack of safety and efficacy data.
Dr. Mehta reported that he had nothing to disclose.