Prospective randomized trial of venous angioplasty in MS (PREMiSe)

Siddiqui, Adnan H.; Zivadinov, Robert; Benedict, Ralph H. B.; Karmon, Yuval; Yu, Jihnhee; Hartney, Mary L.; Marr, Karen; Valnarov, Vesela; Kennedy, Cheryl; Ramanathan, Murali; Ramasamy, Deepa P.; Dolić, Krešimir; Hojnacki, David; Carl, Ellen; Levy, Elad I.; Hopkins, L. Nelson; Weinstock‐Guttman, Bianca

doi:10.1212/wnl.0000000000000638

Cited by 44 publications

(48 citation statements)

References 35 publications

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“…Finally, a recently published class I sham‐controlled, randomized, double‐blind study investigating the safety and efficacy of venous angioplasty in MS patients fulfilling ultrasound criteria of CCSVI showed that venous angioplasty did not improve hemodynamic parameters in terms of venous hemodynamic insufficiency severity score as well as clinical outcomes in terms of annualized relapse rate, Expanded Disability Severity Score, and MS Functional Composite (Siddiqui et al. ). Moreover, “Liberation treatment” exacerbated underlying disease activity in terms of new T2 and gadolinium‐enhancing T1 lesions (Siddiqui et al.…”

Section: Resultsmentioning

confidence: 99%

“…Moreover, “Liberation treatment” exacerbated underlying disease activity in terms of new T2 and gadolinium‐enhancing T1 lesions (Siddiqui et al. ). In line with these findings, two recent open‐label, retrospective studies also showed an increase in disease activity irrespective of adherence to disease‐modifying therapies in patients with MS with CCSVI who underwent venous angioplasty (Alroughani et al.…”

Section: Resultsmentioning

confidence: 99%

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“Liberation treatment” for chronic cerebrospinal venous insufficiency in multiple sclerosis: the truth will set you free

et al. 2014

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BackgroundChronic 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.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“Liberation treatment” for chronic cerebrospinal venous insufficiency in multiple sclerosis: the truth will set you free

et al. 2014

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“…Findings from some of these studies showed positive effect of the treatment while other studies not only showed no potential treatment benefit even increase in disease activity reported. In an RCT by Siddiqui et al [5] patients with MS and extra cranial venous abnormality proved by Doppler Sonography criteria underwent venoplasty. it is showed that clinical and imaging outcomes are no better or worse in patients with MS identified with venous outflow restriction who receive venous angioplasty compared to sham controls who do not receive angioplasty [5].…”

Section: Discussionmentioning

confidence: 99%

Internal Jugular Vein and Multiple Sclerosis Story

Azarhomayoun

2016

JNSK

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The cause of Multiple sclerosis (MS) is unknown. Multiple theories for pathogenesis of MS postulated. The most accepted is autoimmune inflammatory process. In recent years the role of internal jugular vein abnormality in MS pathogenesis has been considered as "Big Idea" that raised hopes for MS treatment. But although the earlier studies were promising, their results were not reproducible and recent finding disputed the theory.

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“…CCSVI was described as a state of chronic impaired venous drainage from the central nervous system (CNS) and Zamboni et al regarded it as a potential cause of MS when there is 2 out of 5 Echo colored Doppler (ECD) Zamboni criteria [5]. This was followed a small open-label studies conducted to evaluate the effect of endovascular angioplasty in MS patients with CCSVI, a procedure known as "Liberation surgery [11,12]. It has been hypothesized that CCSVI might lead to clinically overt Multiple sclerosis either due to activation an autoimmune reaction by cerebrovascular endothelium in the setting of refluxing blood flow [13], or due noxious activity of iron deposit which can be stored in brain parenchyma as a result of break down in blood brain barrier [14].…”

Section: Introductionmentioning

confidence: 99%

“…Although subsequent clinical research has failed to support this hypothesis [16][17][18], the debate currently continues over whether the relationship is real. Echo colored Doppler was widely used to assess CCSVI in MS [5][6][7][8][9][10][11][12][13][14][15][16][17][18]. Magnetic resonance venography (MRV) have been used with less sensitivity in detecting intraluminal jugular defects [19,20] while venography was used by Yamout et al [21].…”

Section: Introductionmentioning

confidence: 99%

Assessment of chronic cerebrospinal venous insufficiency among Iraqi multiple sclerosis patients by Echo color Doppler sonography

Allebban¹,

Hassoun²

2017

ajbm

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Multiple Sclerosis (MS) is a chronic inflammatory disease affecting central nervous system in dissemination fashion, time and place. Immune pathophysiology is considered as the main underlying cause of MS since its original description. Recently, scientists hypothesized that chronic cerebrospinal venous insufficiency (CCSVI) is a potential cause of MS sparked a controversial discussion in the scientific communities. The aim of this study is to test this hypothesis by high resolution Duplex color Doppler sonography among Iraqi MS patient. Randomized cross sectional blind controlled study conducted on 42 Iraqi participants (23 relapsing remitting MS patients and 19 healthy controls) whom fulfilled the inclusion and exclusion criteria. All study participants were examined blindly with color Doppler and pulse wave Doppler. Chronic cerebrospinal venous insufficiency is assessed blindly according to Zamboni sonography criteria by expert sonographist. The examination performed in supine and sitting position with 5 minutes rest to reach a steady state. General gray scale ultrasound with 6-10 MHz linear probe was used for both sides of the neck to assess the followings: internal jugular veins (IJV) obstruction, state of jugular valves, measurement of cross sectional area of proximal part of internal jugular veins, assessment of blood flow whether present or absent and measurement time of reverse flow in both internal jugular and vertebral veins (VVs) during Valsalva maneuver (VM). CCSVI is considered positive in the presence of 2 or more of the Zamboni sonography criteria. There was no significant differences in all parameters and criteria of CCSVI between healthy control and MS study groups. In conclusion; this study concluded that CCSVI has no significant contribution in the pathogenesis of MS.

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Prospective randomized trial of venous angioplasty in MS (PREMiSe)

Cited by 44 publications

References 35 publications

“Liberation treatment” for chronic cerebrospinal venous insufficiency in multiple sclerosis: the truth will set you free

“Liberation treatment” for chronic cerebrospinal venous insufficiency in multiple sclerosis: the truth will set you free

Internal Jugular Vein and Multiple Sclerosis Story

Assessment of chronic cerebrospinal venous insufficiency among Iraqi multiple sclerosis patients by Echo color Doppler sonography

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