Article

The perfect crime? CCSVI not leaving a trace in MS

Department of Neurology, Goethe-University Frankfurt, Schleusenweg 2-16, 60528 Frankfurt am Main, Germany.
Journal of neurology, neurosurgery, and psychiatry (Impact Factor: 5.58). 02/2011; 82(4):436-40. DOI: 10.1136/jnnp.2010.231613
Source: PubMed

ABSTRACT Multiple sclerosis (MS) is a chronic, inflammatory demyelinating disease of the central nervous system, believed to be triggered by an autoimmune reaction to myelin. Recently, a fundamentally different pathomechanism termed 'chronic cerebrospinal venous insufficiency' (CCSVI) was proposed, provoking significant attention in the media and scientific community.
Twenty MS patients (mean age 42.2 ± 13.3 years; median Extended Disability Status Scale 3.0, range 0-6.5) were compared with 20 healthy controls. Extra- and intracranial venous flow direction was assessed by colour-coded duplex sonography, and extracranial venous cross-sectional area (VCSA) of the internal jugular and vertebral veins (IJV/VV) was measured in B-mode to assess the five previously proposed CCSVI criteria. IJV-VCSA ≤ 0.3 cm(2) indicated 'stenosis,' and IJV-VCSA decrease from supine to upright position 'reverted postural control.' The sonographer, data analyser and statistician were blinded to the patient/control status of the participants.
No participant showed retrograde flow of cervical or intracranial veins. IJV-VCSA ≤ 0.3 cm(2) was found in 13 MS patients versus 16 controls (p=0.48). A decrease in IJV-VCSA from supine to upright position was observed in all participants, but this denotes a physiological finding. No MS patient and one control had undetectable IJV flow despite deep inspiration (p=0.49). Only one healthy control and no MS patients fulfilled at least two criteria for CCSVI.
This triple-blinded extra- and transcranial duplex sonographic assessment of cervical and cerebral veins does not provide supportive evidence for the presence of CCSVI in MS patients. The findings cast serious doubt on the concept of CCSVI in MS.

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Available from: Waltraud Pfeilschifter, Aug 25, 2015
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    • "In contrast to the previous observations, an Italian study, investigating only MS patients with clinically isolated syndrome, reported a normal ultrasound investigation in 84% of study population (Baracchini et al. 2011). Moreover, CCSVI could not be detected in additional series of MS patients investigated in Greece (Tsivgoulis et al. 2011) and Germany (Frankfurt/Giessen) (Mayer et al. 2011). In addition, the largest to date, methodologically robust (using both local and central blinded readers) ultrasound case–control study involving 1874 subjects from 35 Italian centers reported a similar (very low) prevalence of CCSVI in MS (3%) and HC (2%) (Comi 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.
    Brain and Behavior 11/2014; 5(1). DOI:10.1002/brb3.297
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    • "The most viewed CCSVI videos on YouTube were overwhelmingly positive towards the theory and the 'liberation' procedure. This contrasts with the skeptical perspective of many in the medical community, a number of research findings and many national MS societies [36] [37] [38]. Zamboni and other researchers have, however, continued to publish positive findings [12] [39] [40] [41]. "
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    ABSTRACT: Venoplasty has been proposed, alongside the theory of chronic cerebrospinal venous insufficiency (CCSVI), as a treatment for multiple sclerosis (MS). Despite concerns about its efficacy and safety, thousands of patients have undergone the procedure. This paper analyses YouTube videos where patients have shared their treatment experiences. Content analysis on the 100 most viewed videos from over 4000 identified in a search for 'CCSVI', and qualitative thematic analysis on popular 'channels' demonstrating patients' experiences. Videos adopt an overwhelmingly positive stance towards CCSVI; many were uploaded by patients and present pre- and/or post-treatment experiences. Patients demonstrate rather than merely describe their symptoms, performing tests on themselves before and after treatment to quantify improvement. Videos combine medical terminology and tests with personal experiences of living with MS. Social media technologies provide patients with novel opportunities for advocating for particular treatments; generating alternative forms of 'evidence' built on a hybrid of personal experience and medical knowledge. Healthcare practitioners need to engage with new digital forms of content, including online social media. Instead of disregarding sources not considered 'evidence-based', practitioners should enhance their understanding of what 'experiential-evidence' is deemed significant to patients, particularly in contested areas of healthcare.
    Patient Education and Counseling 07/2013; 93(3). DOI:10.1016/j.pec.2013.06.006 · 2.60 Impact Factor
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    • "Our results are in agreement with some other small studies using extra-and transcranial color-coded sonography which also examined the proposed link between CCSVI and MS. In a recent study [10], twenty MS patients were compared with 20 healthy controls. Extraand intracranial venous flow direction was assessed by color-coded duplex sonography, and extracranial venous cross-sectional area of the internal jugular and vertebral veins was measured in B-mode to assess the five previously proposed CCSVI criteria. "
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    ABSTRACT: Recently, a chronic state of impaired venous drainage from the central nervous system, termed chronic cerebrospinal venous insufficiency (CCSVI) was claimed to be a pathologic condition exclusively seen in patients with multiple sclerosis (MS), suggesting that cerebral venous congestion plays a significant role in the pathogenesis of MS. This hypothesis has gained enormous attention among patients and physicians but has been questioned since. Twenty seven patients with MS and 32 healthy controls underwent color extra cranial Doppler exam aimed to detect four parameters of abnormal venous flow: no Doppler-detected flow in the IJV or vertebral veins (VV), reflux in the internal jugular veins (IJVs), venous flow stenosis in the IJVz (cross sectional area <0.3 cm) or reverted postural control in the IJV. Except for one healthy patient, blood flow direction in the IJVs was normal in all subjects. When aiming to detect at least one parameter of abnormal venous flow per subject, two parameters or three parameters no significant difference was found between subjects and controls (p = 0.707, 0.62, 0.849 respectively). We found no evidence to suggest that MS patients have excess of CCSVI. In addition we failed to observe a typical venous flow pattern in MS patients. Until carefully designed controlled studies to investigate CCVSI have been completed, invasive and potentially dangerous endovascular procedures as therapy for MS should be discouraged.
    Journal of the neurological sciences 08/2011; 309(1-2):102-4. DOI:10.1016/j.jns.2011.07.005 · 2.26 Impact Factor
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