what is this? here are details for our colleques who are not aware of it--- the comments given are ???
Chronic cerebro-spinal venous insufficiency (CCSVI) is a term developed by Italian researcher Paolo Zamboni in 2008 to describe compromised flow ofblood in the veins draining the central nervous system.[1][2] Zamboni hypothesized that it played a role in the cause of multiple sclerosis (MS),[3][4] and devised a procedure based on it that generated optimism among people with MS.[5][6]
Within the medical community, both the procedure and CCSVI itself have been met with skepticism. Zamboni's research was neither blinded nor did it have a comparison group.[5] Research on CCSVI has been fast tracked but have been unable to confirm whether CCSVI has a role in causing MS.[7][8][9][10][11]The "liberation procedure" has been criticized for possibly resulting in serious complications and deaths while its benefits have not been proven.[5][6] This has raised serious objections to the hypothesis of CCSVI originating multiple sclerosis.[12] Additional research efforts investigating the CCSVI hypothesis are underway.
CCSVI was first found using specialized extracranial and transcranial doppler sonography.[1][16] Five ultrasound criteria of venous drainage have been proposed to be characteristic of the syndrome, although having two of them is enough for diagnosis of CCSVI:[1][16][28]
It is still not clear whether magnetic resonance venography, venous angiography, or Doppler sonography should be considered as the gold standard for the diagnosis of CCSVI.[18] Use of magnetic resonance venography for the diagnosis of CCSVI in MS patients has been proposed by some to have limited value, and to be used only in combination with other techniques.[29] Others have stated that magnetic resonance venography has advantages over doppler since results are more operator-independent.[10]
Balloon angioplasty and stenting have been proposed as a treatment option for CCSVI in MS. As a form of treatment, outside the trial setting, these procedures are not currently recommended.[3] The proposed treatment has been termed "liberation procedure" though the name has been criticized for suggesting unrealistic results.[12] As of 2011, angioplasty treatment for CCSVI is in phase III trials.[30]
Angioplasty in a preliminary study by Zamboni improved symptoms in MS.[31] High re-stenosing rates led authors of Zamboni's pilot study to propose that the use of stents might be a better treatment than balloons angioplasty,[16] while later they stated that stents should not be used.[32]
Further trials however are required to determine if the benefits, if any, of the procedure outweigh its risks.[16] The neurological community and many MS organizations such as the National Multiple Sclerosis Society of the USA recommend not to use the proposed treatment until its effectiveness is confirmed by controlled studies,[5][6][16][33] The Society of Interventional Radiology in USA and Canada considers that published literature on the effectiveness of CCSVI intervention is inconclusive and support decisions made by patients, families and physicians to perform angioplasty in such cases.[34] The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) position is that procedures for CCSVI should not be offered outside well designed clinical trials as harm could be caused.[35]
Kuwait has become the first country in the world where it is explicitly allowed by the medical authorities and paid by the state health system.[36] The procedure is being performed privately in 40 countries.[37] It is not available in Canada as of September 2010.[37]
Zamboni and colleagues claimed that in MS patients diagnosed with CCSVI, the azygos and IJV veins are stenotic in around 90% of the cases. Zamboni theorized that malformed blood vessels cause increased deposition of iron in the brain, which in turn triggers autoimmunity and degeneration of the nerve's myelin sheath.[14][16] While the initial article on CCSVI claimed that abnormal venous function parameters were not seen on healthy people others have noted that this is not the case.[16] In the report by Zamboni none of the healthy participants met criteria for a diagnosis of CCSVI while all patients did.[1][16] Such outstanding results have raised suspicions on a possible spectrum bias, which originates on a diagnostic test not being used under clinically significant conditions.[16]
In 2010 and 2011 further studies of the relationship between CCSVI and MS have had variable results.[8][9][10] As of September 2010 there were a growing number of papers that raise serious questions about its (CCSVI) validity",[12] although evidence had been "both for and against the controversial hypothesis".[17] It has been agreed that it is urgent to perform appropriate epidemiological studies to define the possible relationship between CCSVI and MS, while existing data does not support CCSVI as the cause of MS.[18] A randomised controlled study of 499 patients confirmed twice as big prevalence of CCSVI in MS patients in comparison with healthy controls, but this prevalence was also increased, to a lesser extent, in patients with other neurological diseases.[19] If there is a relationship between CCSVI and MS it is expected to be a complex one.[17]
Most of the venous problems in MS patients have been reported to be truncular venous malformations, including azygous stenosis, defective jugular valves and jugular vein aneurysms. The innominate vein and superior vena cava have also been reported to contribute to CCSVI.[20] A vascular component in MS had been cited previously.[21][22]
Several characteristics of venous diseases make it difficult to include MS in such group.[12] In its current form, CCSVI cannot explain some of the epidemiological findings in MS. These include risk factors such as epstein-barr infection, parental ancestry, the day of birth and geographic location.[12][23] MS is also more common in women, while venous diseases are more common in men. Venous pathology is commonly associated to hypertension, infarcts, edema and transient ischemia, and occur more often with age, however they are hardly ever seen in MS and the disease is rare to appear after age 50. Finally, an organ-specific immune response is not seen in any other kind of venous disease.[12]
Iron deposition as a cause of MS received support when a relation between venous pressure and iron depositions in MS patients was found in a neuroimaging study and criticism as other researchers found normal ferritin levels in the cerebrospinal fluid of MS patients.[18][24] Additionally iron deposition occurs in different neurological diseases such as Alzheimer's disease or Parkinson's disease that are not associated with CCSVI.[1][16] Evidence linking CCSVI and iron deposition is lacking, and dysregulation of iron metabolism in MS is more complex than simply iron accumulation in the brain tissue.[25]
Published date: 25 Aug 2011 at 10:14AM
NICE (National Institute for Healthcare and Clinical Excellence) have issueddraft guidance on chronic cerebrospinal venous insufficiency (CCSVI).
The guidance, published today and now open for public comment, states that more research into CCSVI is needed.
The guidance also recommends that treatment for CCSVI should not take place outside of a properly controlled clinical trial.
Professor Bruce Campbell, Chair of the independent committee that develops NICE’s Interventional Procedures guidance said:
"….it is really important to find out whether percutaneous venoplasty is clinically effective and safe for use in the NHS. Based on the existing evidence, we believe that clinicians should only consider offering percutaneous venoplasty as a treatment option for people with MS who fit thediagnostic criteria for CCSVI, as part of structured clinical trials.
"In particular, we would welcome controlled research comparing percutaneous venoplasty against “sham venoplasty”, in the same way that drug treatments are compared to a placebo. This is so that we can learn more about whether venoplasty works and for how long. Further research could also improve the understanding of the relationship between MS and CCSVI, as this is very unclear at present”.
A consultation will now open until 21 September and people with MS have been invited by NICE to offer feedback.
Dr Doug Brown, Head of Biomedical Research at the MS Society, said: “We welcome the call for further research into the link between MS and CCSVI. The MS Society is part of an international effort to speed up research into this area and there are currently a number of studies and clinical trials ongoing world-wide – the outcomes of which will be pivotal in determining what direction future research should take.”
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