Endovascular treatment of CCSVI in patients with multiple sclerosis: Clinical outcome of 462 cases

Centro Studi Sclerosi Multipla, Ospedale di Gallarate, Gallarate, Italy, .
Neurological Sciences (Impact Factor: 1.45). 01/2013; 34(9). DOI: 10.1007/s10072-013-1300-5
Source: PubMed


Although it is still debated whether chronic cerebro-spinal venous insufficiency (CCSVI) plays a role in multiple sclerosis (MS) development, many patients underwent endovascular treatment (ET) of CCSVI. The objective of the study is to evaluate the outcome and safety of ET in Italian MS patients. Italian MS centers that are part of the Italian MS Study Group were all invited to participate to this retrospective study. A structured questionnaire was used to collect detailed clinical data before and after the ET. Data from 462 patients were collected in 33 centers. ET consisted of balloon dilatation (93 % of cases) or stent application. The mean follow-up duration after ET was 31 weeks. Mean EDSS remained unchanged after ET (5.2 vs. 4.9), 144 relapses occurred in 98/462 cases (21 %), mainly in RR-MS patients. Fifteen severe adverse events were recorded in 3.2 % of cases. Given the risk of severe adverse events and the lack of objective beneficial effects, our findings confirm that at present ET should not be recommended to patients with MS.

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    • "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). However, numerous independent investigators failed to detect any association between CCSVI neurosonology criteria and MS in numerous case–control studies, while " Liberation treatment " has been complicated with serious adverse events (SAEs) leading to substantial criticism of " venous hypothesis " of MS pathogenesis (Barkhof and Wattjes 2013; Valdueza et al. 2013). "
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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.
    Full-text · Article · Nov 2014 · Brain and Behavior
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    • "It consists of angioplasty of internal jugular veins and, less commonly, azygos veins, as well as implantation of stents within internal jugular veins at some sites. Following first reports on the efficacy of this method, particularly with respect to the relapsing-remitting disease [25], other reports were published suggesting lack of positive effects of angioplasty procedures [26,27] and discrepancies between treatment results as measured by the assessment of clinical status (Expanded Disability Status Scale, EDSS) and the extent of MRI lesions and the results of subjective quality of life assessment (MSQoL) [28]. Single reports of complications related to angioplasty procedures [29] and stent implantation [30] were also published. "
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    ABSTRACT: Though the etiology of multiple sclerosis remains unknown, the widely accepted explanation is that it has an autoimmune inflammatory background. In 2006 Paolo Zamboni renewed the somewhat forgotten vascular theory of the pathogenesis of multiple sclerosis, proposing the new entity of ‘chronic cerebrospinal venous insufficiency’. As a result of this hypothesis, Zamboni suggested an endovascular treatment for multiple sclerosis involving venoplasty of the internal jugular vein and the azygos vein. Unfortunately, several teams have tried to replicate Zamboni’s results without success. In this review, we present a chronological description of the results of the studies conducted by Zamboni and the later attempts to replicate his work. The main conclusion is that, taking into account results that are currently available, we should remain cautious and routine use of this treatment in patients should not be advisable.
    Preview · Article · Jun 2014 · Polski przegla̜d radiologii i medycyny nuklearnej

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