BACKGROUND: Jugular venous angioplasty has been performed as a treatment for a condition described as CCSVI. The efficacy of this treatment been challenged as being attributed to a placebo effect or that objective data is lacking and reported responses to treatment thus far have been only subjective in nature. The FDA states, “there is no clear scientific evidence that the treatment of internal jugular or azygos venous stenosis is safe in MS patients, impacts the symptoms of MS, changes the overall course of MS or improves the quality of life for MS patients.” observation of patients’ presenting symptoms for CCSVI treatment has lead to the hypothesis that these symptoms are related to autonomic dysfunction rather than a new entity, CCSVI or MS. Normalization of blood pressure post jugular venous angioplasty has also been observed and supports to the hypothesis of autonomic dysfunction. Heart rate variability (HRV) testing was therefore incorporated for assessment of autonomic dysfunction in patients undergoing jugular vein angioplasty.

METHODS: Autonomic function was assessed 24 hours pre procedure and 24 hours after jugular ballooning. Hrv analysis was carried out using the ans2000, D.E. Hokanson, inc. Bellevue, WA. A total of 24 patients underwent successful testing both before and after jugular angioplasty. R-r interval variation with deep inspiration was analyzed with determination of the mean circular resultant (mcr).

RESULTS: Sixteen (66.7%) patients saw and improvement in mcr 24 hours after jugular balloon dilation. In four (16.7%) patients the improvement was such that their mcr was normalized.

CONCLUSION: HRV testing allows objective assessment of response to treatment following jugular venous angioplasty in patients with symptomatic autonomic dysfunction. Jugular venous angioplasty should be studied further as a potential treatment of autonomic dysfunction.

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PURPOSE: to evaluate the changes in blood pressure that occur following jugular vein balloon dilation in patients exhibiting symptomatic autonomic dysfunction.

MATERIALS AND METHODS: a retrospective chart review was performed on 212 patients treated for ccsvi over a one- year time period. Blood pressure readings were obtained prior to (baseline) and following jugular ballooning. The change of bp from baseline was examined separately by categories. There were 6 baseline categories for paired t-test or wilcoxon signed-rank test was performed depending on the normality of change in bp.

RESULTS: systolic bp were categorized as follows: <90 (n=2), 90 to 105 (n=36), 106 to 120 (n=67), 121 to 140 (n=73), 141 to 160 (n=23), >160 (n=9). Changes respectively were 36±28.28 (n/a), 4.38±12.08 (p=0.04), 0.7±12.44 (p=0.65), -2.58±12.14 (p=0.07), -17.39±15.29 (p=<0.01), and -23.33±36.7 (p=0.03). Diastolic pressures were similarly evaluated. Balloons were used off-label.
CONCLUSION: among patients with symptomatic autonomic dysfunction blood pressure deviation from normal was normalized following jugular balloon inflation. Further study is warranted to confirm normalization of bp as an objective indicator of response to jugular balloon dilation therapy for autonomic dysfunction.

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BACKGROUND: The FDA recently stated, “the criteria used to diagnose CCSVI have not been adequately established. Therefore, data to support CCSVI as a clinical entity on its own or its relationship with MS are inconclusive and at times, contradictory.” Patients seeking treatment for CCSVI present with a number of symptoms that vary from patient to patient. However, after extensive review of patients’ symptoms, an observation was made that there are symptoms reliably present which are consistent with autonomic dysfunction.

METHODS: Prior to consultation, patients were asked for the presence of seven symptoms associated with autonomic dysfunction. The symptoms were fatigue, interrupted sleep, thermal intolerance, bladder/bowel dysfunction, cognitive impairment, and headache upon awakening. A total of 489 patient questionnaires were evaluated. Relative prevalence of each symptom and exploratory factor analysis was carried out.

RESULTS: Among these symptoms, brain fog cognitive impairment is highly related to fatigue and headache, with the presence of cognitive impairment, the odds of having fatigue and headache are OR (95% CI) 4.88 (7.44, 3.2) and 2.98 (4.49, 1.97) time higher than those without cognitive impairment. When having headache, the chance of having fatigue, poor sleep, cold hand and/or feet are significantly higher than those not with OR of 1.88 (2.88, 1.23), 2.14 (3.14, 1.45), and 1.66 (2.54, 1.08) respectively. When having poor sleep, the chance of having fatigue, cognitive impairment and cold hand and/or feet are significantly higher than those not with OR of 1.76 (2.62, 1.18), 1.84 (2.67, 1.26) and 1.86 (2.79, 1.24) respectively. Bladder bowel disturbances is more likely a stand along symptom which is only related to poor sleep with OR of 1.66 (2.53, 1.08). The prevalence rate of symptomatic dysautonomia are the following: bladder bowel disturbances: 76.89%, brain fog cognitive impairment: 63.6%, fatigue: 72.19%, headache: 39.06%, poor sleep: 59.92%, cold hand and/or feet: 73.21%. Exploratory factor analysis suggests three latent factors based on dysautonomia symptoms. Factor 1 has heavy weight on presence of fatigue and cognitive impairment; factor 2 has heavy weight on presence of poor sleep, cold hand and/or feet and headache; factor 3 has heavy weight on bladder bowel disturbances and absence of headache. The result from factor analysis suggests that the symptom grouped within each latent factor may share common physiological/pathological mechanism.

CONCLUSIONS: Based on presenting symptoms, dysautonomia appears highly prevalent among patients undergoing CCSVI treatment. Further study of the condition and its treatment should include assessment of autonomic dysfunction.

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INTRODUCTION: Quantitative imaging of CCSVI using magnetic resonance imaging (MRI) provides an opportunity to study not just anatomical abnormalities1-8 but also the ability to quantify flow2,3,4,7,9. These two pieces of information may provide new biomarkers over and above those originally introduced by Zamboni8 et al using ultrasound. Specifically, recent MRI findings suggest that the total internal jugular vein (IJV) flow normalized to the total arterial inflow as measured from the carotids and vertebral arteries and the dominance of flow on one side of the neck may represent risk factors for developing MS2-4.

MATERIALS AND METHODS: A previous study of 323 MS subjects was compared with a new group of 145 MS subjects and 33 healthy controls. IJV structure was assessed for stenosis, atresia, and aplasia using a combination of 2D time of flight MR venography (TOF MRV) and 3D contrast enhanced MR angiography and venography (CE MRAV). The subjects were sub-grouped into stenotic (ST) and non-stenotic (NST) categories. Two dimensional phase contrast flow quantification (PC FQ) was used to quantify the flow through the vessels of the neck perpendicular to the IJV positioned between the sixth and seventh cervical vertebrae as well as the second and third cervical vertebrae. All data were processed using FlowQ (for flow quantification) and SPIN (signal processing in NMR, for anatomical assessment) software. IJV flow was normalized to the total arterial input. All data were collected on a Siemens 3T TRIO scanner.

RESULTS: For the 145 MS patients, 71 were categorized as NST and 74 as ST. IJV flow was normalized to arterial flow and plotted as C2 vs C6. A total of 22 (28.4%) of the ST MS, 1 (1.4%) of the NST MS, and 1 (3.0%) of the healthy controls fell below 50% at both levels. This agreed with our previous findings in which none of the 100 NST MS patients fell below 50% at both levels while 70 (31.4%) of the ST MS did.

Figure 1: Plots showing the total IJV flow (Fijv) normalized to the total arterial flow (Fta) at the C2 level vs. the C6 level for two separate samples. Legend: triangle=healthy control, open circle=NST MS, cross=ST MS. (A) Published data on 323 MS subjects, 223 ST and 100 NST 2. (B) A new group of 145 MS, 74 ST and 71 NST, and 33 healthy controls.

DISCUSSION AND CONCLUSION: Quantifying flow for studying CCSVI in MS is a critical part of evaluating what is abnormal in an MS patient. It is now clear that a significantly higher portion of the MS population shows low internal jugular vein flow compared to normal controls and that 2D PCFQ serves as a key biomarker for MS.

REFERENCES: 1) F. Doepp et al, Neur. 2011; 77: 1745. 2) W. Feng et al., Radiological Research, 34:8, 802-809, 2012. 3) W. Feng et al, Rev Recent Clin Trials 2012; 7: 117-126. 4) EM Haacke et al. JVIR 2012; 23: 60-68 e61-63. 5) D. Hojnacki et al, Int Angiol 2010; 29: 127-139. 6) P Sundstrom et al, Ann Neurol 2010; 68: 255-259. 7) D Utriainen et al, Tech Vasc Interv Radiol 2012; 15: 101-112. 8) P Zamboni et al, Eur J Vasc Endovasc Surg 2012; 43: 116-122. 9) T Ludyga et al. Phlebology 2010; 25: 286-295. 10) JH Simon JH et al, AJNR 2006; 27: 455-461.

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Read publication here: http://www.ncbi.nlm.nih.gov/pubmed/22971469

Download PDF: Characteristics of flow through the internal jugular veins at cervical C2/C3 and C5/C6 levels for multiple sclerosis patients using MR phase contrast imaging

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On May 10, the Food and Drug Administration issued a medical alert noting that individuals with multiple sclerosis should be aware of the risks of serious injuries and death associated with treatments for chronic cerebrospinal venous insufficiency and that benefits of those treatments and promotion as an MS treatment “may lead people with the disease to make treatment decisions without being aware of the serious risks involved.

As always, the Society of Interventional Radiology strongly urges close communications between doctor and patient. Those persons with MS are encouraged to talk to their interventional radiologists and their other doctors about any concerns or questions. SIR members interventional radiologists who specialize in minimally invasive targeted treatments and who pioneered venous angioplasty and stenting endovascular techniques that may be central to novel treatments for MS may note an increase in calls from concerned individuals who have or are seeking treatment for CCSVI.

About 500,000 people in the United States have MS, and SIR understands the public’s desire to advance treatment for MS, generally thought of as an autoimmune disease in which a person’s body attacks its own cells. Currently, medicines may slow the disease and help control symptoms. The role of CCSVI (a reported abnormality in blood drainage from the brain and spinal cord) in MS and its endovascular treatment (through a catheter placed in a vein to widen) by an interventional radiologist via balloon angioplasty and/or stents to open up veins could be transformative for patients and is being actively investigated.

The FDA communication is directed toward individuals with MS, health care providers (including interventional radiologists, neurosurgeons and vascular surgeons) and clinical investigators. Health care providers were advised to inform patients that (1) there is conflicting evidence about CCSVI as a clinical entity, (2) CCSVI’s relationship to MS is scientifically unproven and (3) consensus on the diagnostic criteria of CCSVI has not been reached. The FDA also indicated that it has not cleared or approved any angioplasty device or stents for CCSVI treatment and that the use of those devices in treating CCSVI is considered off label. While the FDA does not regulate the practice of medicine and health care practitioners may choose to use a legally marketed device, based on their clinical assessment, for purposes other than the cleared or approved use, the FDA believes the safety issues observed to date warrant a communication on the subject, stated the FDA announcement.

SIR supports and agrees with the FDA’s recommendations to encourage research on CCSVI and the current knowledge regarding the safety and effectiveness of treatment procedures. SIR also agrees that clinical research of CCSVI should be performed through well-designed clinical trials, which should require approval through the FDA investigational device exemption (IDE) program.
In 2010, the SIR published the position statement Interventional Endovascular Management of Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis: A Position Statement by the Society of Interventional Radiology, Endorsed by the Canadian Interventional Radiology Association, which specifically notes

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For a $10,500 procedure, the monthly cost will be $254.73. This is an open loan. Providers will receive notice of financing approval and receive payment by wire transfer within 24 hours of notification that the procedure has been completed.

Deposits for the procedure will still be collected upfront with the option to finance the balance. The financing will be processed through IHP in conjunction with the Canadian lending firm and credit decisions will be available in minutes. Proof of approval will be supplied to Synergy.

The option for financing provides many more patients with the opportunity to travel to Synergy’s facilities and receive state-of-the-art care.

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