M Arata1, F DeBarge-Igoe2, P Grewal3, S Cen4
1Synergy Health Concepts, Newport Beach, CA, 2Synergy Health, Newport Beach, CA, 3Pacific Interventionalists, Newport Beach, CA, 4Division of Biokinesiology and Physical Therapy University of Southern California, Los Angeles, CA
Enter Objectives / Purpose Statement:
Autonomic dysfunction has been identified as a co-morbid syndrome in patients with neurodegenerative disorders. Chronic Cerebrospinal Venous Insufficiency (CCSVI) is a pathophysiologic state whereby there is functional or anatomic obstruction of the internal jugular veins. We have previously ascribed the symptoms of CCSVI to autonomic dysfunction. Further, it has been reported that patients identified with CCSVI report improved QOL parameters after treatment with jugular ballooning. Our purpose was to evaluate the change in quality of life (QOL) after balloon dilation of the jugular veins in patients with symptomatic autonomic dysfunction.
384 patients treated with jugular ballooning for autonomic dysfunction completed a modified, validated, and standardized MS Quality of Life Inventory Questionnaire prior to procedure (N=384), 1-2month post procedure (N=384), 2-3 month post procedure (N=199), 3-6 months post procedure (N=149), and 6-9 months post procedure (N=2). This questionnaire included Health Status Questionnaire (SF-36), Modified Fatigue Impact Scale (MFIS), MOS Pain Effects Scale (PES), Bladder Control Scale (BLCS), Bowel Control Scale (BWCS), Impact of Visual Impairment Scale (IVIS), Perceived Deficits Questionnaire (PDQ), and Mental Health Inventory (MHI). The SF-36 is composed of two components, the PCS and MCS, each score ranges from 0-100, a higher score indicates improvement. The MFIS score ranges from 0-84, higher score indicates a greater impact of fatigue on daily life. The MOS-PES score ranges from 6-30; a higher score indicates greater impact of pain on daily life. The BLCS score ranges from 0-22, a higher score indicates greater problem with bladder control. BWCS score ranges from 0-26, a higher score indicates greater problem with bowel control. The IVIS score ranges from 0-15, a higher score indicates greater visual impairment on daily activity. The PDQ score ranges from 0-80, a higher score indicates greater perceived cognitive impairment. The MHI score ranges from 0-100, a higher score indicates better mental health. Mixed model (SAS ® 9.2 proc mixed) was used to estimate the trajectory slope (day as unit) of each of the scales.
There were statistically significant (p=<0.01) improvements in all scales except for Impact of Visual Impairment Scale (p=0.1). The estimated improvements per 100 days for SF-36 (PCS, MCS), MFIS, MOS-PES, BLCS, BWCS, IVIS, PDQ, and MHI are 1.21 (0.24, 2.19), 2.4 (1.43, 3.38), -7.86 (-9.91, -5.8), -1.85 (-2.48, -1.22), -1.33 (-1.88, -0.77), -0.64 (-1.14, -0.14), -0.2 (-0.45, 0.04), -3.59 (-5.12, -2.06), and 3.4 (1.76, 5.05) respectively.
The quality-of-life of patients with autonomic dysfunction continuously and dramatically improves in 1 to 9 month after jugular ballooning as shown by improved MS QOL questionnaire responses administered pre-procedure and compared to time points post-procedure. Statistical significance was reached in all measured parameters except for IVIS which is borderline significance. Our data suggest that jugular ballooning can be a very effective treatment for patients with autonomic dysfunction.