#43 Vascular Intervention for Multiple Sclerosis
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- Participants: Mean age 41, 46% male, minimal to moderate disability (not in wheelchair), taking MS disease-modifying agents.
- Vascular outcomes: No serious operative or immediate post-operative complications.
- Re-stenosis at 1-year ~50% for internal jugular.
- Neurological outcomes at 18 months, compared to baseline (no control/placebo group):
- No benefit seen in primary or secondary progressive MS subtypes.
- Significant improvements in relapsing-remitting MS subtype.
- Fewer patients relapsing over 1-year (50% versus 73%, p=0.0014).
- Fewer patients with MRI lesions (12% versus 50%, p<0.0001).
- Improved MS functional composite and quality of life scores.
- Concerns: Single study site, not randomized, no control group, and unblinded.
- Remission is a hallmark of relapsing-remitting MS: Untreated patients can have reductions (even prolonged) in clinical symptoms2,3 and/or MRI lesions.4 A control group and long-term follow-up essential.
- Hypothesis of CCSVI and MS: Chronic insufficient cerebral venous drainage à cerebral iron deposits à engender the immune response underlying MS. Angioplasty improves cerebral blood outflow à decreases cerebral iron deposits à improves MS symptoms.6
- Many patients are having this unproven procedure, and serious complications are being observed.7,8
- Subsequent studies question the relationship between CCSVI and MS.9-14
- Provider organizations and patient groups state there is no indication of a connection between CCSVI and MS and there are risks associated with angioplasty therapy.15,16