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

Abstract

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.

Prospective randomized trial of venous angioplasty in MS (PREMiSe)

“…In line with our findings, 2 recent retrospective studies show an increase in disease activity irrespective of adherence to disease-modifying therapy in patients with MS presenting with CCSVI who underwent venous angioplasty. 9,10 No differences in cognitive or QoL outcomes were observed between the 2 treatment arms in shamcontrolled phase 2. However, various outcome measures showed within-group improvements over 6 months in both phases and need further analysis.…”

“…1 There is controversy as to the nature of these structural and functional extracranial venous anomalies and whether they even represent pathologic findings, and certainly no agreement exists as to whether there is any etiologic relationship with MS. Several recent prevalence studies that used different imaging techniques have reported large discrepancies in the prevalence of extracranial venous anomalies characterized as CCSVI findings in patients with MS. [2][3][4][5][6][7] Endovascular treatment for these venous anomalies was introduced in an open-label study that included 65 patients with MS with postprocedure follow-up of .18 months. 8 Several subsequent prospective open-label, nonrandomized studies investigated safety and efficacy of venous angioplasty in MS. [9][10][11][12][13][14][15][16][17][18] Findings from some of these studies have generated considerable controversy over potential treatment benefit, which remains unproven, whereas others showed a potential increase in disease activity. 9,10, 19 We investigated safety and efficacy of venous angioplasty in patients with MS exhibiting findings of extracranial venous outflow restrictive anomalies described as hallmarks of CCSVI in the setting of a prospective, double-blind, sham-controlled, randomized pilot trial.…”

Cerebrospinal Venous Outflow in Multiple Sclerosis Patients versus Fatigue and/or Depression

“…Our outcomes do not support the hypothesis that endovascular treatment of venous outflow anomalies would improve the quality of life in MS patients. Such significant effect was indeed not found in a number of other studies [4,5,6]. …”

“…Overall, according to the results of several studies available today, a significant effect of endovascular treatment of CCSVI on the objective neurological status has not been proven. On the other hand, a significant improvement of patients' (subjective) quality of life has been suggested in several studies [4,5,6]. The effect on the quality of life has been measured using various different instruments like the Multiple Sclerosis Quality of Life-54 instrument (MSQoL-54), the Multiple Sclerosis Impact Scale-29 (MSIS-29) and non-standardised questionnaires.…”

Is there any relation between chronic cerebrospinal venous insufficiency and multiple sclerosis? – a critical review

“…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.…”