BNAC angioplasty trial corroborates Dr. Zamboni

cheerleader · Post by **cheerleader** » Thu Apr 07, 2011 2:03 pm

100% of pwMS had venous malformations and were treated by angioplasty. The normals did not have CCSVI.

Catheter venography was performed only in patients with MS after the Doppler sonography examination showed that all patients with MS fulfilled 2 venous hemodynamic criteria.1 It was performed via catheterization of the left iliac femoral vein and comprised visualization of the lumbar veins, left renal vein, azygous vein, and IJVs.3

Catheter venography of the right IJV showed the presence of an annulus in 4 patients, a septum in 3 patients, and no abnormalities in 3 patients. Catheter venography findings of the patients with MS in the left IJV were the following: annulus (5), septum (3), membrane (1), malformed valve (1), and normal examination findings (1).
All patients with MS underwent PTA at baseline.

Venous malformations are found in pwMS.

I suggest all people on this board read the paper through--
Dr. Zivadinov is corroborating Dr. Zamboni's findings of congenital jugular venous malformations in pwMS.

link to complete paper
cheer

marcstck · Post by **marcstck** » Thu Apr 07, 2011 3:36 pm

At baseline, as per inclusion criteria, all patients with MS
had to present 2 venous hemodynamic criteria and meet a
diagnosis of CCSVI to be enrolled in the EVTMS.

According to the paper, in order to qualify for the study, all MS patients had to test positive for CCSVI via Doppler sonography. The paper doesn't mention how many MS patients were tested in order to reach that population pool of 10 MS patients.

The paper shows that Doppler sonography is a very good predictor of anomalous findings in the veins of MS patients who test positive for CCSVI via sonography. Traditional MRV is not.

It doesn't show that all MS patients have CCSVI.

cheerleader · Post by **cheerleader** » Thu Apr 07, 2011 4:05 pm

Marc--
You read more into my post than what is there---all I stated was that 100% of the people w/MS in this study showed CCSVI and venous malformations, and the normals did not.

The specific venous malformations of annulus, webs, malformed valves, stenosis and septum found by Dr. Zamboni were the same defects noted by the BNAC team. The normals did not have these malformations.

That's all I'm saying, and that's in the paper---I recognize that it is referring to the inferiority of MRV for diagnosis and follow-up, but I feel it is important to note that BNAC is finding these venous malformations. Look at the pictures, the malformations are quite striking. The Annals of Neurology has not published a study noting these findings. This is a very important corroboration of Dr. Zamboni's findings.
cheer

marcstck · Post by **marcstck** » Thu Apr 07, 2011 4:26 pm

Sorry if I made an inference when none was intended.

I think Zamboni's initial observations of the types of malformations being found in the veins of MS patients have been confirmed in abundance in the course of all of the CCSVI treatments that have been done worldwide.

It is nice to see them quantified in a scientific paper, though.

Do we know that the Annals of Neurology has been presented with a paper showing this data? Was this paper submitted and rejected? This seems to be the first published paper including any data from a CCSVI catheter venography trial, other than Zamboni's original work. I think the BNAC treatment trial is the first to announce any results…

It will be interesting to see how Zivadinov's research is received next week at the AAN conference in Hawaii…

Cece · Post by **Cece** » Thu Apr 07, 2011 4:29 pm

Catheter venography was performed only in patients with MS after the Doppler sonography examination showed that all patients with MS fulfilled 2 venous hemodynamic criteria.

I read this as saying that all of the MS patients met the 2 criteria, not that there was a larger pool of patients some of whom did not meet the criteria and were excluded.

cheerleader · Post by **cheerleader** » Thu Apr 07, 2011 4:29 pm

Marc's right...in order to be included in the study, the patients had to have a prior dx of CCSVI--
I believe it is also important to note that these malformations were noted in those with a relatively new diagnosis of RRMS and lower EDSS scores. These patients were not the more progressed and older pwMS we've seen linked to CCSVI in other studies.
Here's the criteria---

The inclusion criteria were the following:
CCSVI as defined by presence of 2 venous hemodynamic criteria; diagnosis of relapsing-remitting MS ; Expanded Disability Status
Scale score range between 0 and 5.5; age of 18–65 years; disease
duration between 5 and 10 years; current treatment with US Food and
Drug Administration approved disease-modifying therapies; normal
renal function (creatinine clearance of 58 mL/min); and no
medical contraindications for PTA.

cheer

Cece · Post by **Cece** » Thu Apr 07, 2011 4:34 pm

ok, since I've already commented on the article, I am reading the article....

At follow-up, 50% of the patients with MS
presented with abnormalities on Doppler sonography but only 30% were diagnosed with restenosis.

It's a small study but that gives some sense of restenosis rates (30%). The discrepancy between that and the percentage of MS patients with doppler abnormalities brings to mind the patients who still have 2 or 3 Zamboni criteria on their day-after-the-procedure doppler.

marcstck · Post by **marcstck** » Thu Apr 07, 2011 4:43 pm

Cece wrote:ok, since I've already commented on the article, I am reading the article....
At follow-up, 50% of the patients with MS
presented with abnormalities on Doppler sonography but only 30% were diagnosed with restenosis.
It's a small study but that gives some sense of restenosis rates (30%). The discrepancy between that and the percentage of MS patients with doppler abnormalities brings to mind the patients who still have 2 or 3 Zamboni criteria on their day-after-the-procedure doppler.

Let's keep in mind that we are only talking about a population of 10 patients here. Exciting to be getting results from any treatment trial, but this was from a very small study…

More interesting will be to see what quantifiable benefits were achieved during the study.

1eye · Post by **1eye** » Thu Apr 07, 2011 5:27 pm

Oh, to be in England, now that April's here.

cheerleader · Post by **cheerleader** » Thu Apr 07, 2011 6:05 pm

Perhaps I am just dense...but the most interesting facet of this study, to me, is the verification of truncular venous malformations in pwMS. These are congenital venous abnormalities. Dr. Zamboni writes about these here, in a Phlebology Journal
http://phleb.rsmjournals.com/cgi/content/full/25/6/269

Patients fulfilling the Doppler screening criteria for CCSVI underwent selective venography of the lumbar veins, left renal vein, AZ and IJVs via catheterization of the left iliac femoral venous axis.7 As far as the morphology is concerned, we considered the following malformations:16

Annulus refers to significant circumferential stenosis of the whole venous wall;
Septum/valve malformation refers to anomalous valve apparatus causing significant flow obstacles at the level of the junction of the IJVs with the brachiocephalic/anonymous trunk;
Hypoplasia refers to under-developed long venous segments;
Twisting refers to severe stenosies in consequence of a twisted venous segment;
Membranous obstruction refers to a membrane almost occluding a vein;
Agenesis refers to the complete anatomical absence of a venous segment.

Annulus, septum, membranous obstruction, hypoplasia and agenesis are truncular malformations previously described in other venous segments (cava, iliac, deep veins of the lower limbs) .

These venous malformations were noted in Buffalo. This is the first published research showing these specific malformations in another patient population. These congenital malformations have been noted in Budd-Chiari, Vena Cava Syndrome, May-Thurner and the legs. This is only the second paper to show them in the jugular veins, specifically in people with an MS diagnosis.

Phlebology is not as sexy as neurology. Phlebologists don't go to Hawaii and have fabulous conventions paid for by corporate sponsors. (I just checked, their next convention is in LA at the Marriot, and they do have some sponsors....but still...) Phlebologists may have something to teach neurologists about disease....would that they pay attention.
cheer

jackiejay · Post by **jackiejay** » Thu Apr 07, 2011 6:42 pm

perhaps CTV (Avis Favaro) would be interested in this exciting news...put it back in the media spotlight...especially in this election season...

MrSuccess · Post by **MrSuccess** » Thu Apr 07, 2011 9:46 pm

just a reminder .... the BNAC and any subsequent CCSVI investigation .... is very expensive to undertake. To give as little as 10 pwMS the full range of tests and procedures will come at a great cost.

This is the problem .

The CCSVI treatment cost is prohibitive .... especially in light of the fact there is a 50 % chance ..... of needing multiple treatments .

This is why Medical insurance is slow to react.

Somehow , someway ..... the cost of the procedure needs to drop to about $ 5000 ....... and the success rate needs to climb to about 75-80 %.

Some effort has been made to ensure the problematic veins retain their ability to produce desired blood flow rates ...... by installing internal structural supports [ stents ].

This has produced mixed results ...... and great apprehension .

Did the 10 pwMS BNAC include any stent placements ?

And finally ..... the game of '' do they or don't they have MS or CCSVI '' is now a waste of time . Dr's Zamboni & Zivadov are correct in cutting to the chase.

When the bigger Trials are undertaken ....... they can afford to play that game..... as the Neurologists will demand this

For now : Great work Dr.Zivadov.

Mr. Success

marcstck · Post by **marcstck** » Thu Apr 07, 2011 10:19 pm

Zivadinov's trial is not using stents.

bretzke · Post by **bretzke** » Fri Apr 08, 2011 2:58 am

MrSuccess wrote:This is the problem .

The CCSVI treatment cost is prohibitive .... especially in light of the fact there is a 50 % chance ..... of needing multiple treatments .

This is why Medical insurance is slow to react.

Somehow , someway ..... the cost of the procedure needs to drop to about $ 5000 ....... and the success rate needs to climb to about 75-80 %.

I don't see cost as a problem. The latest and greatest ms drug has been introduced at a price of $48,000 per year. Manufacturers of other dmd's are increasing their prices, as well.

CCSVI diagnosis and treatment in some U.S. clinics is available at $7,500.

If CCSVI treatment becomes an alternative/replacement to current drug regimens, the savings to insurance companies and government funded health care could be huge!

Brian

1eye · Post by **1eye** » Fri Apr 08, 2011 5:09 am

Speaking of stents: one of the problems with them has been thrombosis which invades them and clogs the vein. My brother needed a replacement vein when he was born (I should ask Dr. Klieder who operated on him whether what he found was a malformation). That was in 1962 and he is still kicking. Eventually the left the device in even though nothing was draining anymore. He had needed it for spinal fluid as he had hydrocephalus. It was inserted into his jugular. It kept it patent all these years, though there was no blood anymore, so it could not have formed a clot.

It's made out of 50 year old plastic. If any of you hot shot doctors wants to place one or two into my jugulars, I volunteer. He has no valve and still has dizziness (as well as agoraphobia). I'm willing to accept that.