Complications associated with the treatment of CCSVI

Burton et al. Complications in MS Patients after CCSVI Procedures Abroad (Calgary, AB). Can J Neurol Sci. 2011 Sep;38(5):741-6.

Background: The “chronic cerebrospinal venous insufficiency” or “CCSVI” hypothesis, namely that MS is caused by abnormalities in the azygous and internal jugular veins with subsequent alterations in venous hemodynamics in the central nervous system, has been a dominant topic in MS care in Canada over the past year.

Although there is no methodologically rigorous evidence to support this hypothesis presently, a considerable number of MS patients have undergone endovascular CCSVI procedures. Such procedures include angioplasty or stent placement in jugular and azygous veins. The safety and efficacy of these procedures is unknown, but not without risk. 
Methods: Chart and patient review of five patients with confirmed MS followed in Calgary were undertaken after patients came to medical attention by referral or admission secondary to complications believed to be associated with CCSVI procedures. 
Results: Complications upon investigation and review included internal jugular vein stent thrombosis, cerebral sinovenous thrombosis, stent migration, cranial nerve injury and injury associated with venous catheterization. 
Conclusions: As the debate about CCSVI and its relationship to MS continues, the complications and risks associated with venous stenting and angioplasty in jugular and azygous veins are becoming clearer. As increasing numbers of MS patients are seeking such procedures, these five cases represent the beginning of a wave of complications for which standardized care guidelines do not exist. Our experience and that of our colleagues will be used to develop guidelines and strategies to monitor and manage these patients as their numbers increase.
“I suspect these 5 cases, the Charing Cross case reported on this blog and the two deaths that have been widely publicised are only the tip of the iceberg.” 

“Unless collected in a rigorous and prospective way complications and serous adverse events are always under reported.”

18 thoughts on “Complications associated with the treatment of CCSVI”

  1. This study doesn't seem to differentiate between patients who had stenting, and patients who receive Venoplasty. Venoplasty is likely to have much fewer complications. For a 'scientific' paper, not to acknowledge this is pretty unscientific.

  2. RE: "For a 'scientific' paper, not to acknowledge this is pretty unscientific."This is a descriptive study; it simply describing complications in 5 cases. This practice is quite common in the medical literature; it is imply a way of alerting the community to a potential problem. I am not sure if venoplasty is less risky than stenting. On the arterial side stenting is less likely to result in re-occlusion (early and late) compared to angioplasty; this is why arterial stenting is now the norm.

  3. What? You know, or should know, that stenting veins is very different than stenting arteries. There is a higher risk of migration for one, veins have a thinner wall, have a less rigid structure etc etc. Also stents for veins in the neck would need to withstand a lot more movement than stents for arteries in the chest.

  4. Re: "What?"Show us the data? What we do know is that there has been two unnecessary reported deaths; these have occurred outside of clinical trials as a result of an unproven therapy for a condition that may or may not exist. It is time to put a halt to all CCSVI treatments outside of ethically approved clinical trials. This is what happens when Pharma develops drugs; I am not sure why we should expect anything less for surgical and radiological procedures or medical devices.

  5. Re "what"I was just talking about the difference in stenting viens as opposed to arteries. I thought this would have been obvious. It is very difficult to have a discussion with someone who keeps changing the question…

  6. No change in question. If you say that venoplasty is safer than stenting or angioplasty you need to quote the data supporting this statement. Both angioplasty and venoplasty damage the endothelium or lining of the blood vessel wall, which exposes the blood to various factors that activate the blood clotting cascade. Because venous blood flow is much slower than arterial blood flow this is more likely to result in propagation of the clot and occlusion of the vessel. A similar argument can be used for stents; at least stents are designed to keep the vessel open and stop the vessel collapsing. In addition, the new generation stents are made out of materials that are designed to prevent clotting and occlusion.

  7. Amazing how some can be so arrogant about their lack of knowledge on a subject!re "What?" : Wikipedia will not enlighten you.Please avoid insulting real medical professionals on their own blog. If you can't listen, then don't have the discussion. Full stop.G: you should not waste your time and test your patience with aggressive comments. You may want to restrict this blog and/or remove the anonymous commenting possibility.I asked the mouse doctor to reveal himself few weeks ago (out of admiration). It is only fair that you as the same from us.

  8. I'm not saying venoplasy is safer than angiolasy. I'm saying stenting arteries is different to stenting viens. The 2 deaths that have sadly happened involved stents and stent migration. I've had no side effects what so ever from venoplasty. I've also had many symptom improvements very uncharacteristic of the course of my MS before treatment. This improvements have built from the day of treatment to today, 6 months later.

  9. Re: "This improvements have built from the day of treatment to today, 6 months later."You can't use an n=1 trial, in other words yourself, to assess the efficacy of an intervention in a disease like MS, which is so heterogeneous and variable. How do you know that the improvement is not due to the placebo effect? Power calculations using the EDSS as an outcome measure for progressive MS need ~600 MS'ers to be followed for 3 years, i.e. 300 subjects per arm. Similarly you can't use n=1 trials to assess safety; safety studies needs hundreds and preferably thousands of subjects to build confidence about the safety of the procedure.

  10. I know my experience does not constitute a trial, but it is my experience…As for placebo, I can't conclusively say it isn't just as you can't say it is. For the previous 18 months before treatment I couldn't lift my own weight on my tiptoe with my left leg, now I can. Previously I had to pull myself up the stairs one at a time using the banister; now I can do two steps at a time with no banister. These are all very measurable improvements. I could list more but I've got work to do…

  11. More Fear-Mongering from the University of Calgary Neurologists https://www.facebook.com/notes/direct-ms/more-fear-mongering-from-the-university-of-calgary-neurologists/263794790316694“Over the last two years, the U of C neurologists have fought hard to denigrate the concept of CCSVI and to discourage anyone with MS from having their veins checked for blockages. The last thing they want to see is venous angioplasty becoming a part of standardized MS treatment given that it may well displace the need for the nearly worthless drugs all the U of C neurologists strongly encourage their patients to use. Most, if not all, of the neurologists have enjoyed substantial direct and/or indirect benefits from the MS drug companies over the last 15 years and they certainly don’t want the good times to be slowed or halted by a non-drug, vascular procedure. Since news of CCSVI treatment first broke, one of the strategies of the U of C MS neurologists use to discourage patients from getting CCSVI treatment has been classic fear- mongering….…I am sure if a vascular doctor published five anecdotal reports of MS patients having substantial improvement following venous angioplasty, the U of Calgary neurologists and the entire neurological community would strongly protest that such anecdotal reports mean nothing. They would undoubtedly lambaste the journal for publishing such junk science. I would tend to agree with such an assessment and reaction and I hope Burton and colleagues can understand why their five, cherry-picked, anecdotal reports of complications following venous angioplasty are nothing more than fear-mongering, junk science….”

  12. Re: "…cherry-picked, anecdotal reports of complications following venous angioplasty are nothing more than fear-mongering, junk science…." This is not the issue. The core issue is an ethical one; no one should be having to pay for any CCSVI procedure at present. They all should be done as part of an ethically approved trial. Once we get the results, and they are confirmed, and the procedure is shown to effective and safe then MS'ers should be encouraged to go ahead and have the treatment. I doubt very much the Calgary neurologists are doing anything else than trying to protect their patients from the risks of an unproven therapy.

  13. Re ‘The core issue is an ethical one’ You are so very wrong on this one. The core issue is whether the treatment relieves symptoms in a large number of MS’ers. If the field of neurology hadn’t been doing all in its power to get in the way, we would have more answers by now and patients would have the chance to enrol on proper trials. Right from the word go your minds were made up: 18 months ago at the Research Day presentation, Dr Klaus Schmierer referred to CCSVI as ‘a distraction’, Alastair Compston made up his mind in 2009 after what must have been at least 5 minutes thought. Everyone involved in CCSVI treatment thinks these sorts of trials are the way to proceed, but for many people, myself included, the prospect of progress in this direction was far too slow, and with MS, doing nothing is not a risk free option. Now I can be counted in as another success story of venoplasty for CCSVI. My life and MS are in a much better place and neurologists had nothing to do with it, which is a sad state of affairs.Those seeking treatment for CCSVI know there are certain risks with any medical treatment. The crux here is that although the application of venoplasty for this purpose is new, venoplasty is not, and we can see for ourselves if the rate of complications is acceptable. The supporting data from NICE shows that the Edinburgh Clinic has now treated 230 patients without one serious complication.

  14. Re: "The supporting data from NICE shows that the Edinburgh Clinic has now treated 230 patients without one serious complication."Why are they charging for the procedure when we don't if it works? It is unethical to charge MS'ers to participate in research. If they are not doing research and are charging for an unproven or ineffective therapy they are charlatans (http://mw1.merriam-webster.com/dictionary/charlatans).

  15. There is no point in going round in circles trying to explain this to you. There is enough information out there for patients to make up their own minds. No one is forcing anybody to to anything. I am truly grateful that they are providing this service and it has helped me in a way medication never has. I'll leave you to chat about ethics with your pals while I get on with my new life.

  16. "Why are they charging for the procedure when we don't if it works? It is unethical to charge MS'ers to participate in research?"Interesting Prof G. You want us to be guinea pigs in trials for free so pharma can then charge ridiculous amounts of money to the NHS?

  17. I think people going ahead with CCSVI treatment now are doing us all a huge service. They are helping us establish safety and efficacy data, both of which look promising, at an accelerated rate. This is potentially for the benefit of all MSers. Partly due to the very unhelpful stance of neurologists the choice has come down to paying to be in a trial or no trial happening.

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