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Regarding "A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency" Reply

Vascular Diseases Center, University of Ferrara, Ferrara, Italy.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter (Impact Factor: 2.98). 12/2009; 50(6):1348-58.e1-3. DOI: 10.1016/j.jvs.2009.07.096
Source: PubMed

ABSTRACT Chronic cerebrospinal venous insufficiency (CCSVI) is characterized by combined stenoses of the principal pathways of extracranial venous drainage, including the internal jugular veins (IJVs) and the azygous (AZY) vein, with development of collateral circles and insufficient drainage shown by increased mean transit time in cerebral magnetic resonance (MR) perfusion studies. CCSVI is strongly associated with multiple sclerosis (MS). This study evaluated the safety of CCSVI endovascular treatment and its influence on the clinical outcome of the associated MS.
Sixty-five consecutive patients with CCSVI, subdivided by MS clinical course into 35 with relapsing remitting (RR), 20 with secondary progressive (SP), and 10 with primary progressive (PP) MS, underwent percutaneous transluminal angioplasty (PTA). Mean follow-up was 18 months. Vascular outcome measures were postoperative complications, venous pressure, and patency rate. Neurologic outcome measures were cognitive and motor function assessment, rate of MS relapse, rate of MR active positive-enhanced gadolinium MS lesions (Gad+), and quality of life (QOL) MS questionnaire.
Outpatient endovascular treatment of CCSVI was feasible, with a minor and negligible complication rate. Postoperative venous pressure was significantly lower in the IJVs and AZY (P < .001). The risk of restenosis was higher in the IJVs compared with the AZY (patency rate: IJV, 53%; AZY, 96%; odds ratio, 16; 95% confidence interval, 3.5-72.5; P < .0001). CCSVI endovascular treatment significantly improved MS clinical outcome measures, especially in the RR group: the rate of relapse-free patients changed from 27% to 50% postoperatively (P < .001) and of MR Gad+ lesions from 50% to 12% (P < .0001). The Multiple Sclerosis Functional Composite at 1 year improved significantly in RR patients (P < .008) but not in PP or SP. Physical QOL improved significantly in RR (P < .01) and in PP patients (P < .03), with a positive trend in SP (P < .08). Mental QOL showed significant improvement in RR (P < .003) and in PP (P < .01), but not in SP.
PTA of venous strictures in patients with CCSVI is safe, and especially in patients with RR, the clinical course positively influenced clinical and QOL parameters of the associated MS compared with the preoperative assessment. Restenosis rates are elevated in the IJVs but very promising in the AZY, suggesting the need to improve endovascular techniques in the former. The results of this pilot study warrant a subsequent randomized control study.

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Available from: Roberto Galeotti, Jul 30, 2015
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    • "This hypothesis was based on specifically developed ultrasound features which were stated to detect cervical or cerebral abnormalities of venous drainage leading to increased intracranial venous pressure, subsequently followed by blood–brain barrier breakdown causing iron deposition in brain parenchyma initiating the development of MS (Zamboni 2006). Moreover, percutaneous transluminal angioplasty of extracranial veins (termed " Liberation treatment " ) has been proposed (based on nonrandomized data) as an alternative therapy for MS by the same group of investigators introducing CCSVI hypothesis (Zamboni et al. 2009c). Despite the lack of higher class evidence " Liberation treatment " has gained a considerable amount of attention and emotional involvement by MS patients worldwide (Chafe et al. 2011) and has started to be offered as a potential therapeutic option in MS patients in nonrandomized and uncontrolled studies (Hubbard et al. 2012; Mandato et al. 2012; Ghezzi et al. 2013b). "
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    ABSTRACT: Background Chronic cerebrospinal venous insufficiency (CCSVI) has recently been introduced as a chronic state of impaired cerebral or cervical venous drainage that may be causally implicated in multiple sclerosis (MS) pathogenesis. Moreover, percutaneous transluminal angioplasty of extracranial veins termed “Liberation treatment” has been proposed (based on nonrandomized data) as an alternative therapy for MS.MethodsA comprehensive literature search was conducted to identify available published, peer-reviewed, clinical studies evaluating (1) the association of CCSVI with MS, (2) the reproducibility of proposed ultrasound criteria for CCSVI detection (3) the safety and efficacy of “Liberation treatment” in open-label and randomized-controlled trial (RCT) settings.ResultsThere is substantial heterogeneity between ultrasound case–control studies investigating the association of CCSVI and MS. The majority of independent investigators failed to reproduce the initially reported high prevalence rates of CCSVI in MS. The prevalence of extracranial venous stenoses evaluated by other neuroimaging modalities (contrast or MR venography) is similarly low in MS patients and healthy individuals. One small RCT failed to document any benefit in MS patients with CCSVI receiving “Liberation treatment”, while an exacerbation of disease activity was observed. “Liberation treatment” has been complicated by serious adverse events (SAEs) in open-label studies (e.g., stroke, internal jugular vein thrombosis, stent migration, hydrocephalus).ConclusionCCSVI appears to be a poorly reproducible and clinically irrelevant sonographic construct. “Liberation treatment” has no proven efficacy, may exacerbate underlying disease activity and has been complicated with SAEs. “Liberation treatment” should stop being offered to MS patients even in the settings of RCTs.
    Brain and Behavior 11/2014; 5(1). DOI:10.1002/brb3.297
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    • "It could be diagnosed by means of MRI digital Venography and, especially, Duplex examination of cerebral and cervical vein system. [2] [3] Abnormalities of cerebro-spinal venous flow have been described also in no-MS patients. For example Koerte et al. [4] performed a 2D time-of-flight MR-venography of the upper neck region to visualize the venous vasculature in patients with migraine. "
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    ABSTRACT: CCSVI is the acronym for Chronic Cerebrospinal Venous Insufficiency, initially described by P.Zamboni, as being strongly associated with multiple sclerosis (MS). It is a syndrome characterized by stenosis of the internal jugular veins (IJVs) and/or azygous vein (AZ) with opening of collaterals and insufficient drainage. Bavera PM carried out 823 Duplex exams on a control group of 60 patients without MS. As expected CCSVI was found only in few subjects of the control group, three, two females and one male, but all affected with Sudden Sensorineural Hearing Loss (SSHL). Successively, we reported a case of bilateral SSHL with vertigo, showing evidence of the CCSVI pattern at Duplex examination (not associated with MS). To the best of the authors’ knowledge, this kind of association has never been reported. We studied 52 patients affected with cochleo-vestibular disturbances subdivided into two groups of out-patients:Definite unilateral Meniere (Men): 12 subjects (8 males and 4.females, mean age 41,6.yy) according to international AOO-HNS 1995 diagnostic criteria - No-Meniere (No-Men): 14 subjects (6.males and 8 females, mean age 44,7.yy) affected with unilateral cocleo-vestibular impairment A third group of subjects have been considered, as a “normal” group, 13 patients (8 females and 5 males, mean age 45,5 yy) affected with Benign Paroxismal Positioning Vertigo (BPPV) with cochlear involvement Asymmetrical artherious flow in VA or CA was revealed in 2 Men 9 no-Men and 1 BPPV, respectively 12,5 - 60,7 - and 8,6 %. Differences between Men and No- Men and between each of this group with respect to BPPV were highly significant (p<0.001). Asymmetrical venous flow in IJV or VV was detected in 9 patients in MEN group and in 4 in no-MEN and 2 BPPV, respectively 79 - 28,5 and 13 %. Differences between Men and No-Men and between each of this group with respect to BBV were highly significant (p<0.001)
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    ABSTRACT: Chronic cerebrospinal venous insufficiency (CCSVI) is a term used to describe impaired venous drainage from the central nervous system (CNS) caused by abnormalities in anatomy and flow affecting the extracranial veins. Recently, it has been proposed that CCSVI may contribute to the pathogenesis of multiple sclerosis (MS). It is hypothesized that venous obstruction results in abnormal flow that promotes inflammation at the blood-brain barrier and that this triggers a process marked by a disturbance of homeostasis within the CNS that leads to demyelination and neurodegeneration. The venous abnormalities of CCSVI are often diagnosed by ultrasound or magnetic resonance venography, however the prevalence of CCSVI detailed in groups of MS patients and patients without MS varies widely in published reports. Increased standardization of diagnostic studies to evaluate both anatomical and physiological findings associated with CCSVI is needed. The purpose of this article is to provide a background to understand the development of the theory of CCSVI and to frame the relevant issues regarding its diagnosis and relationship to the pathogenesis of MS.
    Functional neurology 10/2011; 26(4):181-95. · 1.86 Impact Factor
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