Chronic cerebro-spinal venous insufficiency (CCVI)Thursday, October 03, 2013, 15:45 - 17:00
British Columbia chronic cerebrospinal venous insufficiency (CCSVI) registry: early self-reported benefits are not sustained at follow-up interviewL. Kipp, I. Yee, A. D. Sadovnick, T. Greenwood, M. de Lemos, G. Keyes, L. Machan, A. Traboulsee (Vancouver, CA)
Background: Venoplasty with or without intravascular stents (the liberation treatment) has been proposed as a treatment for multiple sclerosis (MS) patients with radiologic findings suggestive of Chronic Cerebrospinal Venous Insufficiency (CCSVI). The purpose of the British Columbia (BC) CCSVI Registry is to gather information on safety and efficacy from MS patients in BC, Canada who have received the liberation treatment abroad.
Methods: A standardized telephone survey is used to interview volunteer MS patients up to 4 times - initial, 6-month, 12-month and 24-month follow-up. Participants are asked to rate their general health (GH), fatigue level (FL), mobility (M), exercise level (EL) and procedure rating (PR) on a scale of 5 (1= much better, 2= somewhat better, 3= same, 4= somewhat worse and 5= much worse). Results: As of April 23, 2013, 76 patients completed the first 2 interviews. Patient-reported outcomes at initial interview (average 15.5 months post-treatment) and 6-month follow-up (average 21.5 months post-treatment) are:
o initial interview - 50% 1+2; 29% 3; 21% 4+5
o 6-month follow-up - 16% 1+2; 57% 3; 26% 4+5
o initial interview 66% 1+2; 57% 3; 8% 4+5
o 6-month follow-up - 16% 1+2; 26% 3; 26% 4+5
o initial interview - 40% 1+2; 45% 3; 16% 4+5
o 6-month follow-up - 13% 1+2; 53% 3; 34% 4+5
o initial interview - 53% 1+2; 30% 3; 17% 4+5
o 6-month follow-up - 36% 1+2; 45% 3; 20% 4+5
o initial interview - 50% 1+2; 20% 3; 30% 4+5
o 6-month follow-up - 46% 1+2; 18% 3; 36% 4+5
Conclusions: The majority of participants self-reported benefits in general health, fatigue level, mobility and exercise level following CCSVI liberation treatment are short term and decline the longer the time period from treatment. Interestingly, while this self perception of impact of the therapy declines over time, this perception is less true when patients are asked to rate the overall procedure (PR). This may reflect psychosocial and interpersonal issues rather than be a true measure of treatment outcome.
Data collection is ongoing.
L. Kipp, I.M. Yee, T. Greenwood, M. deLemos, L. Machan, G. Keyes nothing to disclose
A.D. Sadovnick - Grant support from MS Society of Canada Scientific Research Foundation, CIHR, Alzheimer Society of Canada. Travel support and honoraria from BiogenIdec, Teva Neuroscience, Merck-Serono, consultant for Novartis
T. Traboulsee- received grant funding from the MS Society of Canada, Canadian Institute for Health Research, Lotte and John Hecht Foundation, Vancouver Hospital Foundation, Bayer, Roche, Biogen. He has served on data safety monitoring board for Merck Serono and clinical trial steering committee for Roche. He received honoraria or travel grants from Biogen, Teva Canada Innovation, Roche, Merck/EMD Serono, Chugai Pharmaceuticals.