XII CONGRESSO NAZIONALE SICVE Bari, 6-8 Ottobre, 2013 Attualità in tema di CCSVI Chronic...

XII CONGRESSO NAZIONALE SICVEBari, 6-8 Ottobre, 2013

Attualità in tema di CCSVI Chronic Cerebrospinal Venous Insufficiency

Dipartimento di Chirurgia “Pietro Valdoni”

Prof. Luca di Marzo

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.

EZIOLOGIA SCONOSCIUTA

Genetica (HLA-DR15;HLA-DQ6)

Infezione (virus Epstein-Barr)

Ambientali (solventi, tossine,territorio)

Deficit vitaminici (vit D)

Vascolare (?)

AUTOIMMUNITA’

CCSVI(Chronic Cerebrospinal Venous Insufficiency)

E’ stata postulata l’ipotesi di una eziologia della SM su base vascolare

TCCS-ECD criteria of highly suspected anomalous venous outflow

58/149 studi clinici

FAVOREVOLI 6 (603 pz)

CONTRARI 32 (3558 pz)

INCERTI 20 (2397 pz)

FAVOREVOLI

(603 PAZIENTI)

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)

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)

“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

• Improvement of the MSFC

(MS Functional Composite)

• Improvement in QOL

(quality of life)

• No relapses were detected

INCERTI

(2397 PAZIENTI)

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)

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)

CONTRARI

(3558 PAZIENTI)

(100 PAZIENTI)

(1165 PAZIENTI)

CONCUSION:“ CCSVI is not associated with MS”

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

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

• 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.”

COMPLICANZE

• 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

“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

• 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)

• 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.

CONCLUSIONI

Patients and their relatives do not need to have beliefs, Patients and their relatives

need facts!

3/5

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

Grazie!