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XII CONGRESSO NAZIONALE SICVE Bari , 6-8 Ottobre , 2013 Attualità in tema di CCSVI Chronic Cerebrospinal Venous Insufficiency. Prof. Luca di Marzo. Dipartimento di Chirurgia “Pietro Valdoni ”.
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XII CONGRESSO NAZIONALE SICVEBari, 6-8 Ottobre, 2013Attualità in tema di CCSVIChronicCerebrospinalVenousInsufficiency Prof. Luca di Marzo Dipartimento di Chirurgia “Pietro Valdoni”
SCLEROSI MULTIPLALa sclerosi multipla è una malattia demielinizzante del sistema nervoso centrale a decorso clinico e sintomi multipli e variabiliPuò 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 (ChronicCerebrospinalVenousInsufficiency) E’ stata postulata l’ipotesi di una eziologia della SM su base vascolare
TCCS-ECD criteriaof highlysuspectedanomalousvenousoutflow
58/149 studi clinici FAVOREVOLI 6 (603 pz) CONTRARI 32 (3558 pz) INCERTI 20 (2397 pz)
FAVOREVOLI (603 PAZIENTI)
SafetyProfile of Endovascular Treatment for ChronicCerebrospinalVenousInsufficiency in Patients With Multiple Sclerosis Ivo Petrov,et al. CardiologyDepartment, Tokuda Hospital Sofia, Bulgaria (461 pazienti)
CONCLUSION: “The reestablishment of cerebralvenousreturndramaticallyreduced CF perception in a group of MS patients with associated CCSVI, suggestingthat CF islikely the symptom of CCSVI”. (31 PAZIENTI)
“Ourfindings are consistent with a role of venoushypertension in the complexpathogenesis of MS” “The mainfinding of ourstudyisthatendovascular treatment of CCSVI by means of simple PTA isfeasible and safe. The procedure iswelltolerated 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 relapsesweredetected
INCERTI (2397 PAZIENTI)
CONCLUSIONS: “Abnormalflow pattern in IJVsis more common on the left side. Lessoftenit can be found in azygousvein and in brachiocephalicveins. Furtherresearchisneeded to investigate the significance of CCSVI in MS patients. The protocolwedescribed can be used for most of modernmagneticresonanceunits.” (830 pazienti)
CONCLUSIONS: “The methods for diagnosing CCSVI need to be refined, as the between-centre differences, particularly in single criteria, wereexcessively high. Despitethesediscrepancies, the strong associationsbetween CCSVI and MS phenotypesuggestthat the presence of CCSVI mayfavour a laterdevelopment of MS in patients with a lowersusceptibility to autoimmune diseases and mayincreaseitsseverity.” (710 pazienti)
CONTRARI (3558 PAZIENTI)
CONCUSION: “ CCSVI isnotassociated with MS” (1165 PAZIENTI)
REVIEW “A number of recentvascularstudies do notsupport the CCSVI theory, but some elements of CCSVI might be explained by slowercerebralvenousblood flow secondary to the reducedcerebralperfusion in patients with MS compared with healthyindividuals.” Lancet Neurol. 2011
CONCLUSION: “Finally, no proventherapeuticeffect of the ‘‘liberation’’ procedure (unblocking the extracranialvenousobstructionusingangioplasty) hasbeenshownup”
Placebo effecthasnotbeenexcluded in currentlyavailablepublications.” • …, thistheorydoesnotfitinto the existing bulk of scientific data concerning the pathophysiology of MS.(…) • …. thisisnot a sound basis on which to offer a new treatment, whichcouldhavepossible procedure-relatedcomplications, to an oftendesperatepatientpopulation.”
Headacheafter the procedure in 8.2% of patients; • Headachepersisted > 30 days in 1 patient. • Neckpain in 15.6% • Venousthrombosis (0,2%) (1200 PAZIENTI) J VascSurg2013
“Riskof stentmigrationsignificantlyincreases in the veinswhencompared to the arteries, due to the low volume and high compliance of the venoussystem. Furthermore, because the internaljugularveinsusuallydilatewhileapproaching the heart, thereexists the risk of stentmigrationtowards, or eveninto, the heart or pulmonarycirculation.” Curr Treat Options CardiovascMed 2012
Sustainedintraproceduralarrhythmiaswereobserved in threepatients, and tworequired 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 CerebralHemodynamics(ESNCH) has, therefore, considerableconcernsregarding the accuracy of the proposedcriteriafor CCSVI in MS. • Weunanimouslybelievethatanypotentiallyharmfulinterventional treatment suchastransluminalangioplastyand/or stentingshould be stronglydiscouraged. Thisis due, notonly to the lack of anyevidence, butalso to the risk of seriouscomplications for the patients.
Patients and their relatives do not need to have beliefs, Patients and their relatives need facts! 3/5
Weneed a well-done RCT • Prospective • Randomized • Controlled • Blinded (masked) outcome(s) assessment • Representativepopulation • Clear primaryoutcome • Clear inclusion/exclusioncriteria • Adequateaccounting for dropouts, crossovers • Treatment groups are balanced/equivalent 19/25