Download 26. Polish Experience In CCSVI Treatment

POLISH EXPERIENCE
IN CCSVI TREATMENT
Marian Simka
EuroMedic Department of Vascular &
Endovascular Surgery
Katowice Poland
Multiple sclerosis is a chronic and debilitating
neurologic disease of as yet unknown etiology.
Although it is commonly regarded as an autoimmune
disorder, many findings are difficult to explain on the basis
of autoimmunity.
An efficient therapy that can protect a patient from
progression of the disease does not currently exist.
The discovery of occlusions in the extracranial
veins that drain the central nervous system, so
called chronic cerebrospinal venous
insufficiency (CCSVI) sheds a new light on
this problem
How could we define CCSVI ?
CCSVI is a functional and/or structural
abnormality of the veins draining the
central nervous system
CCSVI comprises clinically significant stenoses
or occlusions in the main venous pathways
draining the brain and spinal cord
internal jugular veins
azygous vein
brachiocephalic vein
Perhaps, lesions in
the intracranial veins
also play a role
CCSVI
Prevalence of CCSVI in MS patients:
- most of research based on Doppler sonography
(highly operator-dependent)
- prevalence according to catheter venography
assessment: 96% of MS patients
(Simka M. Funct. Neurol . 2011)
Prevalence of CCSVI in healthy controls:
- according to Doppler sonography findings: 0-30%
- according to catheter venography – not known
Is CCSVI related to multiple sclerosis ?
- Higher prevalence of retinal pathology in MS
patients with unilateral stenosis of internal
jugular
veins
(phenomenon
poorly
understandable within autoimmune paradigm of
MS)
Optical coherence tomography of the eye – average
ganglion cell complex thickeness
normal OCT values
borderline OCT values
abnormal OCT values
100
90
**
80
70
*
60
50
40
30
20
10
0
no CCSVI
detected
bilateral IJV
stenosis
unilateral IJV
unilateral IJV
stenosis stenosis ipsilateral eye contralateral eye
azygous vein
stenosis
Is the treatment for CCSVI safe ?
 Zamboni ; J Vasc Surg. 2009 - 65 patients
Ludyga ; Phlebology 2010 – 344 patients
Petrov ; J Endovasc Ther. 2011 - 461 patients
Kostecki ; Neuroendocrinol Lett. 2011 – 36 pts
Mandato ; J Vasc Interv Radiol.2011 – 257patients
TOTAL: 1163 pts
No major complications, except for early
thrombotic occlusions of treated veins (1-2%)
Does the treatment for CCSVI result in
improvement of MS ?
 Zamboni ; J Vasc Surg. 2009 - 65 patients
Ludyga ; Przeg Flebol. - 94 patients
Kostecki ; Neuroendocrinol Lett. 2011 – 36 pts
TOTAL: 195 patients
- Improvement in some domains, especially
regarding quality of life
- No significant improvement in terms of EDSS
MSIS-29 ― 6 months after endovascular
treatment
improvement
worsening
-60
-50
-40
-30
-20
-10
0
10
20
MSIS-29 total scores
30
40
50
60
Change of fatigue severity 6 months after endovascular
treatment depending on pre-procedural FSS scores
CCSVI can be diagnosed by means of:
color doppler sonography
100
90
80
70
60
50
40
30
20
10
0
Diagnostic accuracy of Doppler sonography (catheter
venography as the reference test)
sensitivity
specificity
positive predictive
value
at least one positive Zamboni’s criterion
at least 2 positive Zamboni’s criteria
at least one positive ISNVD criterion
at least 2 positive ISNVD criteria
negative predictive
value
Still, current knowledge about CCSVI is very limited
MRI efficacy of endovascular
treatment for CCSVI
• Zamboni ; Eur J Vasc Endovasc Surg 2011 –
15pts, a crossover study, statistically
significant improvement in terms of plaque
load during 6 months follow-up
What we do not know:
• Is CCSVI the causal factor for MS, a co-factor or an
epiphenomenon
• By which mechanism does CCSVI drive MS:
- initiation of autoimmune reaction ?
- toxic role for iron ?
- chronic ischemia and hypoperfusion of nervous
tissue ?
- pathologic interplay between neurons and glia ?
What we do not know:
• How high is prevalence of CCSVI in “healthy”
population ?
• How high is such a prevalence in the patients
with other neurologic diseases ?
What we do not know:
• Is CCSVI is a congenital pathology ?
• Congenital only in some MS patients?
What we do not know:
• How to diagnose CCSVI ?
- which is the best method? - Doppler
sonography, MR venography, catheter
venography ? a combination of the tests?
• What should be regarded as a pathology –
and what as an anatomic variant ?
What we do not know:
• Are treatments for CCSVI efficient in a longterm perspective ?
• Which subgroups of the patients can benefit
and which cannot ?
• Are we under-treating or over-treating the
patients ?
What we do not know:
• Should endovascular or surgical treatment
for CCSVI be accompanied by
pharmacological treatment ?
• If yes, which drugs should be used ?
What we do not know:
 which lesions should not be treated?
 which patients should not be treated?
DO NOT KNOW
more research is needed
Clinical efficacy of endovascular
treatment for CCSVI
Two Randomized Control Trials with sham
surgery arm are being done
• USA
• Italy
The results should be known the next year
(American study) and in 2013 (Italian study)