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XII CONGRESSO NAZIONALE SICVE Bari, 6-8 Ottobre, 2013 Attualità in tema di CCSVI Chronic Cerebrospinal Venous Insufficiency Dipartimento di Chirurgia Pietro.

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Presentation on theme: "XII CONGRESSO NAZIONALE SICVE Bari, 6-8 Ottobre, 2013 Attualità in tema di CCSVI Chronic Cerebrospinal Venous Insufficiency Dipartimento di Chirurgia Pietro."— Presentation transcript:

1 XII CONGRESSO NAZIONALE SICVE Bari, 6-8 Ottobre, 2013 Attualità in tema di CCSVI Chronic Cerebrospinal Venous Insufficiency Dipartimento di Chirurgia Pietro Valdoni Prof. Luca di Marzo

2 SCLEROSI MULTIPLA La sclerosi multipla è una malattia demielinizzante del sistema nervoso centrale a decorso clinico e sintomi multipli e variabili Può manifestarsi con una vastissima gamma di sintomi neurologici e progredire fino alla disabilità fisica e cognitiva. Può assumere varie forme, tra cui quelle recidivanti e quelle progressive.

3 EZIOLOGIA SCONOSCIUTA Genetica (HLA-DR15;HLA-DQ6) Infezione (virus Epstein-Barr) Ambientali (solventi, tossine,territorio) Deficit vitaminici (vit D) Vascolare (?) AUTOIMMUNITA

4 La patogenesi coninvolge cellule infiammatoria (linfociti T, linfociti- B, anticorpi, microglia). Il risultato è la distruzione degli oligodendrociti con conseguente perdita completa o assottigliamento della guaina mielinica. PATOGENESI 10/25

5 CCSVI (Chronic Cerebrospinal Venous Insufficiency) E stata postulata lipotesi di una eziologia della SM su base vascolare

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9 TCCS-ECD criteria of highly suspected anomalous venous outflow

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11 58/149 studi clinici FAVOREVOLI 6 (603 pz) CONTRARI 32 (3558 pz) INCERTI 20 (2397 pz)

12 FAVOREVOLI (603 PAZIENTI)

13 Safety Profile of Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis Ivo Petrov,et al. Cardiology Department, Tokuda Hospital Sofia, Bulgaria (461 pazienti)

14 CONCLUSION: The reestablishment of cerebral venous return dramatically reduced CF perception in a group of MS patients with associated CCSVI, suggesting that CF is likely the symptom of CCSVI. (31 PAZIENTI)

15 Our findings are consistent with a role of venous hypertension in the complex pathogenesis of MS The main finding of our study is that endovascular treatment of CCSVI by means of simple PTA is feasible and safe. The procedure is well tolerated and produces a negligible rate of minor complications. (65 PAZIENTI) JVS, 2009

16 Improvement of the MSFC (MS Functional Composite) Improvement in QOL (quality of life) No relapses were detected

17 INCERTI (2397 PAZIENTI)

18 CONCLUSIONS: Abnormal flow pattern in IJVs is more common on the left side. Less often it can be found in azygous vein and in brachiocephalic veins. Further research is needed to investigate the significance of CCSVI in MS patients. The protocol we described can be used for most of modern magnetic resonance units. (830 pazienti)

19 CONCLUSIONS: The methods for diagnosing CCSVI need to be refined, as the between-centre differences, particularly in single criteria, were excessively high. Despite these discrepancies, the strong associations between CCSVI and MS phenotype suggest that the presence of CCSVI may favour a later development of MS in patients with a lower susceptibility to autoimmune diseases and may increase its severity. (710 pazienti)

20 CONTRARI (3558 PAZIENTI)

21 (100 PAZIENTI)

22 (1165 PAZIENTI) CONCUSION: CCSVI is not associated with MS

23 REVIEW A number of recent vascular studies do not support the CCSVI theory, but some elements of CCSVI might be explained by slower cerebral venous blood flow secondary to the reduced cerebral perfusion in patients with MS compared with healthy individuals. Lancet Neurol. 2011

24 CONCLUSION: Finally, no proven therapeutic effect of the liberation procedure (unblocking the extracranial venous obstruction using angioplasty) has been shown up

25 Placebo effect has not been excluded in currently available publications. …, this theory does not fit into the existing bulk of scientific data concerning the pathophysiology of MS.(…) …. this is not a sound basis on which to offer a new treatment, which could have possible procedure-related complications, to an often desperate patient population.

26 COMPLICANZE

27 Headache after the procedure in 8.2% of patients; Headache persisted > 30 days in 1 patient. Neck pain in 15.6% Venous thrombosis (0,2%) (1200 PAZIENTI) J Vasc Surg 2013

28 Risk of stent migration significantly increases in the veins when compared to the arteries, due to the low volume and high compliance of the venous system. Furthermore, because the internal jugular veins usually dilate while approaching the heart, there exists the risk of stent migration towards, or even into, the heart or pulmonary circulation. Curr Treat Options Cardiovasc Med 2012

29 Sustained intraprocedural arrhythmias were observed in three patients, and two required hospital admission AZ rupture (0,1%) during balloon dilatation Severe bleeding in the groin (0,1%) requiring open surgery (4 PAZIENTI)

30 The European Society of Neurosonology and Cerebral Hemodynamics (ESNCH) has, therefore, considerable concerns regarding the accuracy of the proposed criteria for CCSVI in MS. We unanimously believe that any potentially harmful interventional treatment such as transluminal angioplasty and/or stenting should be strongly discouraged. This is due, not only to the lack of any evidence, but also to the risk of serious complications for the patients.

31 CONCLUSIONI

32 Patients and their relatives do not need to have beliefs, Patients and their relatives need facts! 3/5

33 We need a well-done RCT Prospective Randomized Controlled Blinded (masked) outcome(s) assessment Representative population Clear primary outcome Clear inclusion/exclusion criteria Adequate accounting for dropouts, crossovers Treatment groups are balanced/equivalent 19/25

34 Grazie!


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