Disease modifying therapy - generalThursday, September 10, 2009, 15:30 - 17:00
Endovascular treatment for chronic cerebrospinal venous insufficiency in multiple sclerosis. A longitudinal pilot studyP. Zamboni, R. Galeotti, B. Weinstock-Guttman, G. Cutter, E. Menegatti, A. Malagoni, D. Hojnacki, J. Cox, C. Kennedy, I. Bartolomei, F. Salvi, R. Zivadinov (Ferrara, IT; Buffalo, Birmingham, US; Bologna, IT)
Objective: To evaluate safety of minimally invasive endovascular treatment (EVT) for chronic cerebrospinal venous insufficiency (CCSVI) associated to multiple sclerosis (MS) using MRI, clinical and haemodynamic outcome measures.
Background: CCSVI is a vascular picture characterized by multiple strictures at the level of the main extracranial cerebrospinal venous outflow routes including the internal jugular and the azygous venous systems. It is strongly associated to MS (JNNP 2009 Apr;80(4):392-9).
Design/Methods: We designed an open-label, MRI-blinded, two-center, randomized, EVT intervention parallel-group, 12 month study (EVTMS) following an initial cross-sectional (CVIMS) study. Sixteen relapsing-remitting (RR) MS patients, 8 from Bologna, Italy and 8 from Buffalo, NY were enrolled in CVIMS. All 16 patients who completed the CVIMS study and presented severe hemodynamic venous anomalies accepted participation in the EVT intervention prospective study (EVTMS). Half of the cohort (early intervention group, 4 from Buffalo and 4 from Italy) were randomly selected to have the EVT procedure (in Italy) at 3 months and half (delayed control intervention group, late group) at 6 months. The EVT procedure consists of selective venography complemented by balloon dilatation when significant stenosies are detected. All patients will be prospectively evaluated at 3, 6, 9 and 12 months with sonography, MRI, and clinical examinations, or in case of MS relapse only with sonography and clinical examinations.
Outcome measures: Safety, and preliminary efficacy will be monitored using MRI (T2 and Gd lesions measures), Doppler haemodynamic parameters of CCSVI and clinical measures (relapse rate, EDSS, MS functional composite). In addition, a variety of vascular and other MRI measures (including susceptibility-weighted imaging and CSF flow) assessments will be performed and compared to the 1-year outcome in all cohort as well as in between the 2 groups (early and delayed EVT intervention).
Preliminary Results: Mean age at baseline was 36.1±7.3 yrs, mean disease duration 7.5 ±1.9 yrs and median EDSS 2.5. Mean number of gadolinium (Gd) active lesions at baseline was 0.38±1.5 and mean number of T2 lesions 27.1±10.5. Median of Doppler parameters of CCSVI was 4 (2-5). Mean follow up at the time of abstract presentation will be 11 months.
Conclusion/Relevance: This study should provide valuable data on safety, tolerability and preliminary efficacy of EVT for CCSVI associated to MS.