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Posted: **Tue Jun 15, 2010 12:14 pm**

These results are not very impressive.

http://www.ctv.ca/CTVNews/Health/201006 ... vi-100614/

Posted: **Tue Jun 15, 2010 2:22 pm**

oooooooooo one for the neuros. how is the vasco camp taking this one i wonder? ;)

Posted: **Wed Jun 16, 2010 5:47 am**

scorpion wrote:These results are not very impressive.

http://www.ctv.ca/CTVNews/Health/201006 ... vi-100614/

Makes you wonder when several other studies have shown a high percentage of venous blockage and this one quite different.

Then again, when the CRAB drugs were being developed, Copaxone's initial trials showed no statistical benefit over placebo. So they went back and "dredged" the numbers and made it look better second time around to get the FDA approval. Ah, money talks!

Harry

Posted: **Wed Jun 16, 2010 5:54 am**

it's published in annals of neurology by neuros. not the journal of vascular research or journal of vascular surgery or something similar. so personally i do not find the conclusions surprising. i would think a closer look at the methodology and analysis would be worthwhile. as you note, harry, it's easy to play with numbers.

Posted: **Wed Jun 16, 2010 7:53 am**

Hey guys---got the paper in front of me. They were vascular docs. Here's what I've been writing down in CCSVI land....the conversation began to devolve into neuros vs. vascular, so I'll copy it up here--

cheerleader wrote:

These were vascular specialists performing the ultrasounds. Ursula was tested at Charite, and she posted on here and said they were vascular docs.

I really wanted to keep this discussion away from attacking the doctors, and simply looking at what might have been different in their protocol. What I found was that they employed valsalva manuever and looked at internal jugular vein valve insufficiency as a measure of venous reflux and Dr. Zamboni utilized normal breathing. They also measured 2 points, and Dr. Zamboni's protocol looks at the entire jugular. Their TCD machine was different, and they admitted that interpretations of TCD scans are variable. That's all I could find in the German paper...but I'm sure that Dr. Zamboni's team will answer the study, if he is given the opportunity to reply in the Annals of Neurology.
cheer

One more time...the conversation needs to be about the methodology, not people. The doctors claim to utilize Dr. Zamboni's CCSVI doppler protocol. They look for the 5 Zamboni quantifications, but they used different tests to find these In the paper, they state repeatedly, valsalva is an adequate means to test for venous reflux. But it is not. Dr. Zamboni found reflux in absence of valsalva maneuvers. They claim that 2 locations of measurement (one for jugular and one for vertebral veins) are enough. But it is not. Dr. Zamboni's team measured the entire jugular. They claim that there is no real protocol for TCD testing, and so they dismiss it out of hand. Dr. Zamboni has a TCD protocol, and it was not followed.

It was good for me to read the entire paper, because the discrepancies were obvious. For anyone truly concerned, buy the paper online. It will put your mind at ease. I would assume the the Annals of Neurology will publish Dr. Zamboni's reply.

Again, I ask that we stay away from shooting the messenger, and simply look at the science. Thanks-
cheer

Posted: **Wed Jun 16, 2010 11:18 am**

cheerleader wrote:Hey guys---got the paper in front of me. They were vascular docs. Here's what I've been writing down in CCSVI land....the conversation began to devolve into neuros vs. vascular, so I'll copy it up here--

cheerleader wrote:

These were vascular specialists performing the ultrasounds. Ursula was tested at Charite, and she posted on here and said they were vascular docs.

I really wanted to keep this discussion away from attacking the doctors, and simply looking at what might have been different in their protocol. What I found was that they employed valsalva manuever and looked at internal jugular vein valve insufficiency as a measure of venous reflux and Dr. Zamboni utilized normal breathing. They also measured 2 points, and Dr. Zamboni's protocol looks at the entire jugular. Their TCD machine was different, and they admitted that interpretations of TCD scans are variable. That's all I could find in the German paper...but I'm sure that Dr. Zamboni's team will answer the study, if he is given the opportunity to reply in the Annals of Neurology.
cheer

One more time...the conversation needs to be about the methodology, not people. The doctors claim to utilize Dr. Zamboni's CCSVI doppler protocol. They look for the 5 Zamboni quantifications, but they used different tests to find these In the paper, they state repeatedly, valsalva is an adequate means to test for venous reflux. But it is not. Dr. Zamboni found reflux in absence of valsalva maneuvers. They claim that 2 locations of measurement (one for jugular and one for vertebral veins) are enough. But it is not. Dr. Zamboni's team measured the entire jugular. They claim that there is no real protocol for TCD testing, and so they dismiss it out of hand. Dr. Zamboni has a TCD protocol, and it was not followed.

It was good for me to read the entire paper, because the discrepancies were obvious. For anyone truly concerned, buy the paper online. It will put your mind at ease. I would assume the the Annals of Neurology will publish Dr. Zamboni's reply.

Again, I ask that we stay away from shooting the messenger, and simply look at the science. Thanks-
cheer

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I looked through numerous sources on the web and almost all of them stated valsava is an adequate test for venuos reflux. In fact one vascular doctor refererred to it as "time honored in examinations for venous reflux." I am not sure why Zamboni is dismissing the technique. So if almost all the "plumbers" believe that the valsava is an appropriate way to test for relux, we are to believe the one lone "plumber"?

Huh?."They claim that there is no real protocol for TCD testing, and so they dismiss it out of hand. Dr. Zamboni has a TCD protocol, and it was not followed.".

"Negative results count more against a claim than positive results count for it. This is especially true if negative results continue over time as the alleged phenomenon is studied, even if they are few in number compared to the positive results. The reason is simple.If the phenomenon is real, those studying it should eventually reach the point where they can reliably demonstrate it and where they can teach others how to reliably demonstrate it. AS experimental and theoretical work progresses, more evidence and more sound evidence for the related phenomena should appear. If the phenomena predicted by a theory remain plagued by evidential flaws as research progresses, then the theory itself becomes very suspect."

Posted: **Wed Jun 16, 2010 11:42 am**

good to know they were vascular researchers, interesting. good to have clarification on the methodological variations.

lots of things that are time tested end up obsolete eventually. maybe this is valsalva's time, or circumstance, or whatever. i don't know. i just keep taking my vitamins LOL

Posted: **Wed Jun 16, 2010 11:47 am**

Scorp-
You know I am no sonographer...but this is what Dr. Zamboni has explained. Valsalva maneuver (putting pressure on the vein) will test to see if the internal jugular vein valve is incompetent. This extra pressure will exert reflux in IJVVI. Valsalva is very important when testing for jugular vein valve insufficiency. But what Zamboni found in CCSVI was unique. He found reflux with just regular breathing, by measuring the entire vein (not at just one apex point) Not sure if you've seen Dr. Sclafani's description of watching Dr. Erica Menegatti (Dr. Zamboni's colleague) doing the doppler scan, but it's very different than the protocol used by the German docs. This is probably why CCSVI is a new find.

Dr. Zamboni is teaching this process. Dr. Menegatti has worked with the doctors at BNAC, she's worked with Dr. McDonald and Dr. Sclafani's tech, as well. The procedure is being taught to others. It is very different than what I read in the German paper. I guess I don't know how to say it any other way. But the German researchers did not use the same techniques...they tested for the 5 parameters, but not the same way.
cheer

Posted: **Wed Jun 16, 2010 12:59 pm**

Cheer,

I read this paper, and while I admit most of it went over my head, I'm not sure why you say the tests done by the authors are so different from the ones done by Zamboni. It looks like they tested for other parameters they thought were useful (cerebral blood flow, jugular valve incompetence) in addition to Dr. Zamboni's criteria. The authors state as much:

The aim of this study was to (i) evaluate the ultrasound findings reported by Zamboni and co-workers suggesting a role of ‘CCSVI’ in the pathogenesis of MS, and (ii) to extend the studies they performed through acquisition of additional ultrasound indices such as blood volume flow (BVF) and internal jugular venous valve competence (Valsalva maneuvre) to more comprehensively evaluate the haemodynamic effects of any suspected cerebro-cervical venous congestion.

But they were familiar with Zamboni's 5 criteria:

Assessment of ‘CCSVI’ criteria. A specific effort was undertaken to search for the
presence of one or more of the following criteria by which ‘CCSVI’ has been defined (table 6): (i) a reflux >0.88 sec in the IJV and/or the VV, (ii) reflux in the deep cerebral veins (DCV), (iii) B-mode evidence of proximal IJV stenosis, defined as local reduction of CSA ≥ 50% in a recumbent position (0°), (iv) flow not Doppler detectable in both IJVs and/or both VVs (v) a missing IJV diameter decrease in the sitting position, so called “reverted postural control” of the main cerebral venous outflow pathways.

It looks like they used the Valsalva maneuver only to test for valve incompetence. They found 38% of the patients and 30% of the controls that had reflux during the Valsalva maneuver. Yet, in their comparison to Zamboni's criteria (in the article text and in the table at the end of the article) they list 0 as the number of patients/controls who showed >.88 sec. of reflux. So, apparently they are not counting those who showed reflux during the valsalva.

In a single patient with RRMS we detected a constant bi-directional flow in the left IJV in a supine position. This flow pattern turned into an orthograde flow when sitting up. In contrast to our findings Zamboni, et al. reported a reflux >0.88 sec in the IJVs and/or VVs in any body position in 70% of the patients with MS.11,12 The Doppler-sonographic observation of bi-directional flow in parts of the IJVs may be caused by a pulsation artifact from the nearby carotid artery and hence be misinterpreted as a venous reflux, particularly if blood flow measurements were not assessed along the entire IJV. VM testing seems a adequate method by which to detect venous reflux. In our study we detected IJVVI in 38% of MS patients, hence slightly more often than in our reference cohort as well as compared to values reported earlier.28 As Zamboni and
co-workers did not report analysis of IJV valve competence using VM it cannot be excluded that what they detected as reflux was rather caused by IJVVI then by stenosis.

The authors checked only one spot in the jugular and vertebral veins for the purposes of determining blood flow volume, an additional measurement they added. But for the purpose of testing criteria 3, B-mode evidence of proximal IJV stenosis, they did check the entire vein:

Regional narrowing of the IJV and VV was assessed by insonating their entire accessible length using the sagittal plane of the B-mode imaging. For assessment of the IJV additional measurements were obtained in the horizontal plane.

I can't say I really understand all of the possible reasons the authors give for their differences with Dr. Zamboni's results. It would be nice if they and Dr. Zamboni could discuss the discrepancies, but realistically this probably won't happen.

Posted: **Wed Jun 16, 2010 1:45 pm**

Glad you got the paper patient...check this out,

Where the IJV was completely flat no CSA and therefore no BVF measurements could be obtained. In case of marked
respiratory variation of CSA and flow velocity measurements within subjects they were asked to briefly hold their breath after a normal exhalation, and measurements were obtained during these episodes of apnoe.Page 7 of 39

This seemed really odd to me...why would the IJV be completely flat, and no BVF measurements could be obtained? And then why did they ask the subjects to hold their breath and take blood flow during breath holding? This is where the protocol differs from Dr. Zamboni's. Dr. Z specifices that there should be no breath holding, which I assume affects the blood flow. But I do not know how, nor am I going to get a sonographer's
degree anytime soon.

But this paper talks about how breath holding changes jugular venous pressure:

To determine the mean jugular venous pressure, the examiner should observe the nadir of the venous column on inspiration and then the crest of this column on expiration. Next, the midpoint of the excursion of the venous pulse during normal respiratory cycles is estimated visually. Exaggerated breathing or breath holding distorts the normal mean venous pressure and should be avoided.

http://www.ncbi.nlm.nih.gov/bookshelf/b ... &part=A622

Anyhoo...all I know is Zamboni made a big deal in Bologna about no breath holding, no valsalva, his method was different. I really hope his reply is published, because it's vitally important that if his technique is so revolutionary, he needs to make sure techs understand that before publishing papers saying they have "followed his criteria."

cheer

Posted: **Wed Jun 16, 2010 11:48 pm**

cheerleader wrote: ...
Anyhoo...all I know is Zamboni made a big deal in Bologna about no breath holding, no valsalva, his method was different.
...

Yes, "...his method was different".
But, in the same time, that doesn't mean that his method is correct, or the others methods are incorrect or he is right and the others are wrong.

M.

Posted: **Thu Jun 17, 2010 4:09 am**

post deleted - I know little about the subject, so I'll leave it for the experts to sort out.

Posted: **Thu Jun 17, 2010 5:43 am**

I haven’t seen the actual paper. But from reading what everyone here has said the researchers did not in fact try to replicate Zamboni’s results but merely tried to generate data to contradict them.

I did not know about them defining reflux as having a duration of greater than 0.88 sec. The figure I remember Zamboni quoting was 0.5 sec. I really don’t think they had a lot of results in the 0.5 to 0.8 range but I do wonder where the 0.88 sec comes from.

It could be said that 0.38 secs is not very long so not significant. But equally it could be said that it is an increase of 70% on Zamboni’s criteria. Which is the right way to look at this?

As I think Dr S has already said unless there is an agreed standard for how these tests are done they are just going to generate more argument.

I don’t mind admitting that I would like more research which confirms Zamboni. But second best would definitely be results that clearly refuted them. I don’t think results like these help anyone who really cares about getting at the truth.

Posted: **Thu Jun 17, 2010 6:06 am**

Time to disclose some information.

I have been tested in my country as part of a small "open label" pilot study (which is being conducted with the utmost discretion).

The Doctor/Technician is a very experienced one with more than 15 years of expertise doing vascular echo doppler imaging. In fact he worked at the same institution founded by one of guys who invented/perfected the coronary by-pass technique.

He has been perfecting his technique regarding CCSVI during months. It is NOT easy to master even for very skilled professionals. At first, with normal equipment he tended to not find anything or some minor clues. With the pass of time and better equipment he started to find the patterns we all know about.

The only thing that they told me after almost an hour of testing was "you have some patterns that we have not observed in healthy controls".

My advice, go local as Cheer says, and find someone interested in learning and at the same time wants to help you.

Reading is excellent. Get informed but get tested, too.

Posted: **Thu Jun 17, 2010 6:12 am**

AMcG wrote:...I did not know about them defining reflux as having a duration of greater than 0.88 sec. The figure I remember Zamboni quoting was 0.5 sec. I really don’t think they had a lot of results in the 0.5 to 0.8 range but I do wonder where the 0.88 sec comes from.
...

"The value of cerebral Doppler venous haemodynamics in the assessment of multiple sclerosis"
(Paolo Zamboni, Erica Menegatti, ....)

....
1.2.1. Physiologic flow direction in the IJVs and\or VVs with the head in
any position
The physiologic direction of venous flowwas assessed during a short
period of apnea following a normal exhalation, as previously reported,
with the head positioned at 0°, +15°, +30°, +45°, +90° in the four
extracranial venous drainage pathways [11]. We assess the eventual
presence of reflux in the IJVs and VVs in the same experimental
condition and never in a forced condition as Valsalvamanouevre [15,16].
According to a recent study on reflux time cut-off values,we considered
reflux a flow directed toward the brain for a duration >0.88 s
.....

M.

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