Percutaneous Venous Angioplasty in Patients with Multiple Sclerosis and Chronic Cerebrospinal Venous Insufficiency: A Randomized Wait List Control Study

Purpose: To evaluate if jugular vein flow restoration in various venographic defects indicative of chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients can have positive effects on cerebral lesions identified using magnetic resonance imaging (MRI). Materials and Methods: The Brave Dreams trial ( ClinicalTrials.gov identifier NCT01371760) was a multicenter, randomized, parallel group, double-blind, sham-controlled trial to assess the efficacy of jugular venoplasty in MS patients with CCSVI. Between August 2012 and March 2016, 130 patients (mean age 39.9±10.6 years; 81 women) with relapsing/remitting (n=115) or secondary/progressive (n=15) MS were randomized 2:1 to venography plus angioplasty (n=86) or venography (sham; n=44). Patients and study personnel (except the interventionist) were masked to treatment assignment. MRI data acquired at 6 and 12 months after randomization were compared to the preoperative scan for new and/or >30% enlargement of T2 lesions plus new gadolinium enhancement of pre-existing lesions. The relative risks (RR) with 95% confidence interval (CI) were estimated and compared. In a post hoc assessment, venograms of patients who underwent venous angioplasty were graded as “favorable” (n=38) or “unfavorable” (n=30) for dilation according to the Giaquinta grading system by 4 investigators blinded to outcomes. These subgroups were also compared. Results: Of the 130 patients enrolled, 125 (96%) completed the 12-month MRI follow-up. Analysis showed that the likelihood of being free of new cerebral lesions at 1 year was significantly higher after venoplasty compared to the sham group (RR 1.42, 95% CI 1.00 to 2.01, p=0.032). Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66, 95% CI 1.16 to 2.37, p=0.005). Conclusion: Expanded analysis of the Brave Dreams data that included secondary/progressive MS patients in addition to the relapsing/remitting patients analyzed previously showed that venoplasty decreases new cerebral lesions at 1 year. Post hoc analysis confirmed the efficacy of the Giaquinta grading system in selecting patients appropriate for venoplasty who were more likely to be free from accumulation of new cerebral lesions at MRI.

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“…33 Finally, a recent RCT found significant improvement in several quality of life–related items in patients who underwent angioplasty. 34…”

Section: Discussionmentioning

confidence: 99%

Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial

Zamboni¹,

Galeotti

Salvi

et al. 2019

J Endovasc Ther

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“…Thus far, only 4 randomized controlled studies evaluating clinical efficacy of endovascular treatments for CCSVI in MS patients have been published [14][15][16][17]. All these studies were rather small and seem underpowered.…”

Section: Resultsmentioning

confidence: 99%

“…Taking into account this new analysis, it seems that we need more studies evaluating clinical efficacy of venous angioplasty in selected MS patients. Importantly, all aforementioned trials and also the open-label surveys have demonstrated that venous angioplasty in MS patients is a safe procedure and that serious adverse events associated with this treatment are rare [6,10,11,14,16,17,20,25,30,31]. Therefore, from ethical point of view, new trials performed in selected patients, considering low risk and possible clinical benefit, seem justifiable.…”

Section: Discussionmentioning

confidence: 99%

An overview of randomized controlled trials on endovascular treatment for chronic cerebrospinal venous insufficiency in multiple sclerosis patients

Simka

2020

Phlebologie

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About ten years ago it was hoped that venous angioplasty for abnormal veins, primarily the internal jugular veins, will be a much awaited treatment for multiple sclerosis. Yet, a majority of randomized clinical trials on endovascular treatment for chronic cerebrospinal venous insufficiency did not reveal clinical efficacy of these procedures in multiple sclerosis patients. Still, a detailed analysis of these trials suggests that they were poorly designed, underpowered and endovascular techniques used were often far from being optimal. Nonetheless, even considering weak points of these trials, it can be concluded that venous angioplasty should not be used as a routine treatment modality in multiple sclerosis patients. Still, a possibility that some patients may benefit from endovascular treatment cannot be ruled out. This may concern patients at early stage of the disease and presenting with lesions that can easily be managed with balloon angioplasty. Therefore, we need more studies evaluating clinical efficacy of venous angioplasty in selected subgroups of multiple sclerosis patients. Importantly, it has already been demonstrated that venous angioplasty in multiple sclerosis patients is a safe procedure. Thus, also from an ethical point of view, such trials seem justifiable.

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“…About ten years ago, it was hoped that venous angioplasty for abnormal IJVs would be a much-awaited treatment for multiple sclerosis. However, a majority of randomized clinical trials on endovascular treatment for chronic cerebrospinal venous insufficiency in these patients did not reveal the clinical efficacy of endovascular procedures [ 18 , 19 , 20 , 21 , 22 , 23 ]. However, these treatments focused on the pathological jugular valves and primarily comprised balloon angioplasty and/or stenting for such aberrant valves.…”

Section: Introductionmentioning

confidence: 99%

Results of Numerical Modeling of Blood Flow in the Internal Jugular Vein Exhibiting Different Types of Strictures

Rashid

Iqrar²,

Rashid³

et al. 2022

Diagnostics

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The clinical relevance of nozzle-like strictures in upper parts of the internal jugular veins remains unclear. This study was aimed at understanding flow disturbances caused by such stenoses. Computational fluid dynamics software, COMSOL Multiphysics, was used. Two-dimensional computational domain involved stenosis at the beginning of modeled veins, and a flexible valve downstream. The material of the venous valve was considered to be hyperelastic. In the vein models with symmetric 2-leaflets valve without upstream stenosis or with minor 30% stenosis, the flow was undisturbed. In the case of major 60% and 75% upstream stenosis, centerline velocity was positioned asymmetrically, and areas of reverse flow and flow separation developed. In the 2-leaflet models with major stenosis, vortices evoking flow asymmetry were present for the entire course of the model, while the valve leaflets were distorted by asymmetric flow. Our computational fluid dynamics modeling suggests that an impaired outflow from the brain through the internal jugular veins is likely to be primarily caused by pathological strictures in their upper parts. In addition, the jugular valve pathology can be exacerbated by strictures located in the upper segments of these veins.

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Percutaneous Venous Angioplasty in Patients with Multiple Sclerosis and Chronic Cerebrospinal Venous Insufficiency: A Randomized Wait List Control Study

Cited by 10 publications

References 35 publications

Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial

Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial

An overview of randomized controlled trials on endovascular treatment for chronic cerebrospinal venous insufficiency in multiple sclerosis patients

Results of Numerical Modeling of Blood Flow in the Internal Jugular Vein Exhibiting Different Types of Strictures

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