This Is MS Multiple Sclerosis Community: Knowledge & Support

https://docs.google.com/file/d/0B0L9MiV ... edit?pli=1

Recently published in Techniques in Vascular and Interventional Radiology by our favorite Canadian IR, Dr. Sandy MacDonald, these are the full Zamboni protocols for the diagnosis of CCSVI.

According to Joan over at the facebook page CCSVI in MS, none of the NMSS funded doppler studies have utilized the full protocol, which is dismaying.

I realise that research is published many months after the work is performed but CCSVI advocates need to say that external doppler ultrasound is a guide to CCSVI syndrome if used by skilled, trained people. Could someone update Dr MacDonald that invasive catheter venograms and intravascular ultrasound is the gold standard for CCSVI diagnosis?
MarkW

_________________
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

It's in his second paragraph. I agree with Dr. MacDonald that a noninvasive test is desirable, especially for people who lack a clear diagnosis of MS. But I do not think any person with MS should stop short of the venogram with ivus. There is an abstract from Dr. Siskin that concluded, "Findings on a Zamboni-protocol US are not associated with findings on contrast venography in light of the high false negative rate; 99% of the patients with a negative US had a significant stenosis and/or flow abnormality treated with angioplasty. A prospective study is needed to define the role of US and other modalities in the non-invasive diagnosis of CCSVI."
http://www.sirmeeting.org/index.cfm?do= ... s&abs=2088

Thanks for the detail Cece. I am at my in-laws so don't have access to a library to review the paper. I hoped that screening using the Neck Collar would be commonplace by now, so that we could say that doppler US was last decade's method. Must spend more time on the SIR meeting notes.
MarkW

_________________
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

Correct me if I'm wrong but I think Dr. MacDonald was trained in Ferrara and since he does the angioplasty as well, is well qualified to judge whether a person has CCSVI. I think (again, might be wrong) that he was not finding CCSVI until he had received training in Italy, and has sent people from his lab to get trained there.

Some rumours from neurologists were saying that testing in Barrie always resulted in a positive result, but I know better, as the first time I went there it was negative, the second time positive (after the procedure with Dr. Siskin, and nine months later).

I think it is not a good idea to disparage any doctor or facility that does not meet one's personal criteria for the procedure, especially if not even an M.D. One may have had input to NICE, without being an IR. He is one.

I would hope that those performing the procedure would set the standards, and that Dr. MacDonald is one in Canada who does. People in this forum are just that: mostly at least semi-anonymous "bloggers". Nobody who is not an MD should be giving medical advice if they want to avoid liability for it.

We are all in the same boat as regards the science and medicine. There is no national or international consensus, and even if NICE sets some kind of standards in the UK, many of the people here are not from there, and their local doctors are being jerked around by the FDA or other government committees, or medical governing bodies. I think one of our problems might be that many people have opinions and power, but are not qualified as IRs, or vascular experts of the caliber of Dr. MacDonald or Dr. Mehta. Many seem to be experts on the drug remedies, and some even work for drug companies, but do not necessarily do the procedure.

_________________
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'_MS' is over - if you want it
Patients sans/without patience

The person who wrote "MS-experts-in-Britain-have-to-open-their-minds" (article http://www.telegraph.co.uk/health/83598 ... minds.html) disagrees with you 1eye. The qualification of MD does not mean that the MD's view is always correct. You could view my challenges to Dr Arata on the use of IVUS. I challenged Prof Sclafani on the design of his proposed $5M trial but I trusted him to perform my second venoplasty. Dr MacDonald does not use venograms and IVUS on pwMS, so like me he is reviewing the work of others. My challenge to Dr MacDonald is that he wrote "some have advocated for magnetic resonance venography as a noninvasive modality to diagnose CCSVI, whereas others believe that catheter venography with or without the use of intravascular ultrasound may represent the gold standard for diagnosis" rather than saying invasive catheter venography with intravascular ultrasound is the gold standard for diagnosis of CCSVI syndrome in Spring 2012. The current literature and leading practice says that venograms and IVUS must be used in combination by a skilled practitioner to detect instances of CCSVI syndrome. NICE did not get this fact correct and very few clinics in the globe are using both tools. I will continue to challenge researches or reviewers (MDs or otherwise) so that pwMS have reliable information on CCSVI syndrome.
Kind regards,
MarkW

_________________
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

Gotta challenge you on this statement, dear Mark: you thought you were challenging him on the trial design of his proposed trial, but he had actually been answering a what-if question that had nothing to do with his own proposed trial. Dr. Sclafani has not released any plans or design for his actual trial.

I trusted Dr. Sclafani as well for both my procedures. No challenge there.

I also have a great deal of respect for Dr. MacDonald. There are small abstracts supporting the use of IVUS in CCSVI, but not yet a critical mass of such studies that we can say with scientific certainty that venogram plus ivus is the gold standard, although I too believe that it is.

Doppler ultrasound was critical to Dr. Zamboni's process of investigating CCSVI, back in the early 2000s when he had not yet taken it further to the point of actual endovascular treatment. We are seeing studies recreate some of the steps he took back then. He looked at autopsied jugular veins back in the early 2000s; the Cleveland Clinic looked at them in 2011. There are many studies that have attempted to recreate his doppler ultrasound findings, since those were what justified taking the exploration further into actual catheter venograms and treatment, so it is good to have a paper dealing with the protocols and techniques of the ultrasound methods. It will also be good when the plethysmography neck collars are further researched in CCSVI. I only know of a study by Dr. Simka that is underway, as well as one completed by Dr. Zamboni, when it comes to plethysmography, which I too see as a potentially more reliable and reproducible method. But that needs proving as well.

Hello Cece,
I am a pendant being less than precise, totally unforgivable. I should have said I challenged DrS's answer to the question:
"What formal steps should be made in order for the scientific community to acknowledge beyond doubt that CCSVI is real and has non-trivial consequences?"
I post the whole of my comment below for clarity.
A trial to prove to Neurologists that CCSVI is a symptom of MS, which should be treated, must include over 1000 subjects, otherwise the statistics are invalid. Neurologists are demanding 'double blind placebo controlled trials' which are just not feasible. IRs are trying to design and perform such studies and in my rarely humble opinion are falling into the trap set by the Neuros. CCSVI UK and I convinced NICE that sham trials were impossible, against the wishes of the neuros, a small win.
The more I study about MS the more I think that it is a multifactorial disease and the human race does not understand the etiology of MS. Let's simply treat symptoms of MS, including CCSVI and an over active immune system.
Best wishes,
MarkW

_________________
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

Hello, Mark. I completely agree with you that the fake interventions are a trap set by the neuro. Unfortunately, even the prof. Zamboni had to submit to this imposition, to be able to see accepted his Brave Dreams. I am Italian, and Brave Dreams' start is shifted from month to month, because additional checks are required every day.

A challenge to you, MarkW, is to stop being, as you yourself called it, pedantic, about MRI, Doppler, and wordings like 'with or without', 'may represent' or 'is'. You might discourage acceptance of some of the science. At its worst, advice by the unqualified about surgical procedures can result in destabilization or worse. I think IRs would agree with neurologists on that.

I am wary also about 'expert patients', or patients who believe having a disease gives them not only an interest, but a degree or specialization. There again, I would rather believe the initials, but track records give a doctor's degrees much more weight. They are my "Gold Standard". BTW, is gold a standard in the UK? The US was taken off it in the nineteen thirties, I think.

In engineering, bug-hunting after the problem is fixed is discouraged. So is fixing what isn't broken. I imagine there are cut-and-dried cases where IVUS, or some other tool, is not required. I will leave it to experts like Dr. MacDonald to write the papers, and to decide on tools and standards.

This in no way implies I have any illusions that a degree confers infallibility to doctors, who are as human as I am. I would be one of the last to believe that about an MD. Some specialists, surgeons, and even GPs I have met and read about, were actually dangerous. I have to admit, before I came to this site I had never heard of an IR, but the wrong person could get those initials, too.

Here, the doctors who usually decide what specialist to first send us to, when we require one, are GPs. That's why they are being targeted in magazines they usually have in their waiting rooms. BTW my new GP uses a computer for a lot of things, and doesn't have paper for sick people to share, in his waiting room. I think virulent diseases are also often spread by stethoscopes. Slowly, the guard is changing.

sorry, klutzy fingers used another alias.

_________________
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'_MS' is over - if you want it
Patients sans/without patience

I have to disagree. If you accept the idea that precise sizing is crucial in the treatment of CCSVI, because of the risk of undertreatment due to undersizing or vein injury due to oversizing, and you accept that IVUS is the only tool by which a doctor can be precise in his measurements because it gives you exact CSA of the vein, as opposed to the diameter of the vein as seen on venogram that would only be precise if the vein were a true circle and not an oval, then the conclusion is that IVUS is required in all cases, because IVUS is the only tool that can provide the precise sizing.

But it is not universally accepted that precise sizing is necessary.

My short answer Neigh/1eye is no.
I restate:
-MRV does not detect all instances of stenoses. It helps an IR see the venous anatomy to plan his/her investigation.
-Doppler ultrasound gives varying results with different operators and only detects stenoses not hidden by bones.
-MRI does not detect all instances of stenoses.
-Catheter venograms and intravascular ultrasound of a vein are required to detect stenoses in that vein. Fact.
These are facts reported by researchers or practitioners not my opinions. I simply analyse reasearch of leading practitioners and report them for pwMS to use or ignore as they see fit. I do not see many other undertaking this analysis. My aim is to assist pwMS to choose the best way of spending their money if they are considering a procedure for CCSVI syndrome.
Not sure what your aims are Neigh/1eye.
MarkW

_________________
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

Thanks for your comment Masci. Many of us in the UK informed NICE that a sham trial is impossible. I credit CCSVI UK with getting so many submissions to NICE, it was around 400 in total. I repeat my words on sham research to NICE below in case they help anyone preparing a dossier for their regulatory body.
Hope your wait in Italy is not too long, Masci.
Kind regards,
MarkW

 Trials comparing venoplasty against sham is a research dream. (Page 5).
NICE DRAFT:
1.2 NICE encourages further research on venoplasty for CCSVI in MS. Clinical trials should be controlled, ideally comparing venoplasty against sham. Technical success should be clearly defined and should include measurement of pressure gradients across treated vein segments before and after venoplasty. Outcomes should include clinical and quality of life measures.
MAW Comment;
(i) Trials comparing venoplasty against sham is a research dream. Real life patient experiences, including my own, report that balloon venoplasty (inflation of the balloon) is felt during treatment. In some cases pain is reported and local pain killers (eg Fentanyl via catheter) are used. Heavy sedation of patients in order to facilitate a sham trial would place trial subjects under increased risk, due to the sedative drug. I doubt that heavy sedation of patients would be accepted by any UK ethics committee and it is certainly not in the best interests of the trial subjects (people with Multiple Sclerosis).
(ii) Technical success for the treatment of CCSVI syndrome should be restricted to clearly defined observations of CCSVI syndrome, as described by Prof. Zamboni (ref 1). Observations and recording of the vein valves treated using Intravascular Ultrasound (IVUS) should be the initial success criteria of treating CCSVI syndrome. Ultrasound records before and after venoplasty must be the primary measure of success for treating CCSVI syndrome. Recently reported methodology (ref 3) measuring flow differences may be used in further research. However such studies are likely to be small-scale ones due to funding issues, as noted in NICE’s documentation.
(iii) Outcomes measuring clinical and quality of life measures are unusual for initial trials for the treatment of a syndrome. Such studies will be required once a generally agreed treatment procedure for CCSVI syndrome is in place. This is yet to happen, and could take several years.
==================================================================================================
NICE FINAL (IPG420):
1.2 NICE encourages further research on percutaneous venoplasty for CCSVI for MS, in the form of robust controlled clinical trials. Studies should clearly define selection criteria and patient characteristics. They should also clearly define technical success which may include measurement of pressure gradients across treated vein segments before and after venoplasty. Outcomes should include clinical and quality of life measures.
==================================================================================================

_________________
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

I agree with you Cece on IVUS for sizing. You also posted an Italian study which showed that stenoses (eg webs and spectums) are missed if IVUS is not used. So IVUS is also essential for complete diagnosis of that vein. I simply advise pwMS that catheter venography and intravascular should be on their 'essential tools check list" when selecting a clinic/doctor. Also an expert who investigates many veins is also essential before pwMS spend their own money.
Will we get the message across to pwMS eventually???
Best wishes,
MarkW

_________________
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html