Dr. Siddiqui at ISNVD

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Dr. Siddiqui at ISNVD

Postby Cece » Mon Feb 20, 2012 2:29 pm

https://twitter.com/#!/CCSVI_Society

One of my favorite topics!
Dr. Adrian Siddiqui presenting "IVUS consensus" No studies comparing IVUS with standard venography
Are there any studies underway?
Dr. Siddiqui: great resolution with IVUS to find stenosis. Less operator dependent. Only way to image azygos vein
Isn't ivus being the only way to image azygous vein rather significant? If the only other option is to balloon or not balloon rather blindly?

I love the National CCSVI Society. They also sponsored the global expo a few months back, which was excellent. They have earned Canadian charitable status. And they are live-tweeting ISNVD. @};- @};- @};-
Dr. Siddiqui just showed film of IVUS in healthy and diseased azygos veins while patient was breathing. Wow!
Dr. Siddiqui: IVUS showed more abnormalities in azygos veins than IJVs. Good for balloon sizing.
Dr. Siddiqui is from BNAC (Buffalo, like Dr. Zivadinov) and I believe their PREMise treatment study used IVUS?
Dr. Siddiqui: sad fact: 30,000 treated, but data only collected on ~300. Treatment w/out data collection unacceptable
But as patients, what are we to do, if the IRs are not collecting data? Choose one who is? Not get the treatment? Participate in a blinded study (which is not something I wanted to do)?
Dr. Siddiqui: difficult to correlate asymmetry because of lesion location. However Zamboni's original data attempted this
Not sure what is meant?
Cece
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Re: Dr. Siddiqui at ISNVD

Postby Cece » Tue Feb 21, 2012 10:44 am

from page 68 of ISNVD 2012 abstracts http://www.isnvd.org/files/ISNVD%20Abstract%20Book.pdf
Intravascular Ultrasound for detection of Azygous and Internal Jugular vein (IJV) abnormalities as part of the
PREMiSe (Prospective Randomized Endovascular therapy in Multiple Sclerosis) study

Y Karmon1,2, R Zivadinov3, B Weinstock-Guttman2, C Kennedy3, K Dolic3, K Marr3, V Valnarov3, A Siddiqui1

1Department of Neurosurgery, 2The Jacobs Neurological Institute, and the 3Buffalo Neuroimaging Analysis Center, State
University of New York, Buffalo, NY

BACKGROUND: Chronic cerebrospinal venous insufficiency (CCSVI) is a condition recently reported in patients with multiple
sclerosis (MS) [1]. A set of 5 extra- and trans-cranial venous Doppler Sonography (DS) criteria was proposed [1, 2] and reported
to be in accordance with catheter venography (CV) for the depiction of both Azygous and IJV stenosis [1, 3]. Despite being
the “gold standard” for assessing vascular problems, angiography only provides a luminography with little data on the vessel's
wall, or intraluminal structures. Our aim was to investigate for presence and type of mechanical impediments to the cranial/
spinal cord venous drainage and suspected deranged flow using CV based intravascular ultrasound (IVUS).

METHODS: PREMiSe is an endovascular angioplasty study enrolling patients with relapsing MS according to the revised
McDonald criteria[4,5], and who had Expanded Disability Status Scale [6] between 0-5.5 and fulfilled ≥2 CCSVI Doppler
sonography criteria at screening. The study was planned in two phases. The first phase was an open label and included 10
patients, whereas the second phase is placebo-controlled, blinded and randomized and will include total of 20 patients. The
current study is based on 10 patients participating in phase I and 16 in phase II. CV comprised visualization of AZY vein, right
IJV (RIJV) and left IJV (LIJV) in that order [3]. IVUS was performed using IVUS Eagle Eye Gold catheter (Volcano, CA), across
suspected stenotic segments (≥50% restriction) of the IJV's and azygous vein (AZY), in the phase I, and in all vessels in the phase
II. Abnormal predefined IVUS parameters included the presence of stenosis, presence or absence of respiratory pulsatility
and the presence of various intraluminal defects (septa, multiple channeled vein, intraluminal hyperechoic filling defect,
double/parallel lumen), and abnormally thickened wall.

RESULTS: The study included twenty six patients (mean age 45.7, SD=9.7; male=9, females=17; average disease duration
10.1 years) with clinical and MRI proven MS (20 Relapsing remitting MS, 6 secondary progressive MS) that have fulfilled ≥2
CCSVI Doppler sonography criteria at screening. Out of 18 Azygous veins that were investigated with IVUS, 16 (88%) demonstrated
various intraluminal defects
. Pulsatility was reduced in 7 (38.8%), and stenosis was demonstrated in 10 (55.5%). IVUS
of LIJV detected intraluminal defects in 7 out of 22 patients, reduced pulsatility in 14, and stenosis in 8. All patients who had
a stenosis by IVUS also demonstrated intraluminal defects. IVUS of the RIJV showed intraluminal anomalies in 4 patients
(20%), reduced pulsatility in 10 (50%), and stenosis in 5 (25%) patients out of 20 patients investigated.

CONCLUSIONS: Detailed IVUS imaging demonstrated a very high rate of intraluminal anomalies in the azygous vein during
the PREMiSe study. Similar anomalies were also found in the LIJV and RIJV in lower rates respectively. Stenosis demonstrated
by IVUS was demonstrated in a decreasing order in the azygous vein, left IJV and RIJV as well. IVUS provides
diagnostic advantages over "gold standard" CV in detecting intraluminal extra-cranial venous abnormalities indicative of
CCSVI
.

How does reduced pulsatility factor into CCSVI? It is unusual to have 16 out of 18 azygouses be abnormal, but this is looking at more than just stenosis and intraluminal abnormalities, and also including reduced pulsatility.

The conclusion is a familiar one: IVUS provides diagnostic advantages over catheter venography alone, because the intraluminal abnormalities of CCSVI can best be seen on IVUS.
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Re: Dr. Siddiqui at ISNVD

Postby Cece » Wed Feb 22, 2012 6:04 pm

from Arlene Hubbard's facebook report
https://www.facebook.com/pages/Hubbard- ... 9665829860
Yuval Karmon..given by Dr Siddiqui
Intravascular ultrasound for detection of azgos and IJV abnormalities and part of the PREMISE study
Angiography only provides a luminography with little data on the vessel wall
Angioplasty study double blind. 19 pt enrolled in the study
Catheter and IVUS performed
Looked at azygos was the lead in intravascular abnormalities 88%
LIJV the second most commonly affected vein
All with stenosis had intraluminal problems
Rijv only 20% intraluminal and stenosis
Ivus imaging demonstrated a very high rate of intraluminal anomalies in the azygous veing
Similar anomalies on the LIJV but less than the azygos
IVUS provides diagnostic advantages
When he says that angiography only provides luminography with little data on the vessel wall, that seems to be the justification for the importance of using intravascular ultrasound (ivus). How odd that the most stenoses were found in the azygous. 88% of patients having azygous stenosis is high, and could mean misdiagnosis in the azygous, or that the flow pulsatility abnormalities that Dr. Siddiqui and Dr. Karmon are including are a form of CCSVI that other IRs are not treating, or that the small sample size allowed for a randomly high number of people with azygous stenosis. It's interesting too that the left jugular was the second most commonly affected vein and that the right jugular only had issues in 20% of patients. Maybe we can't make much of this because of the small sample size. Did they do the full IVUS and angiography on the patients in the control group, who were getting a sham procedure? That gives them more data to work with.

But I like the line: IVUS provides diagnostic advantages.
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Re: Dr. Siddiqui at ISNVD

Postby Cece » Wed Feb 22, 2012 6:18 pm

https://www.facebook.com/pages/Hubbard- ... 9665829860
Dr Siddiqui
Premise study
Randomized placebo control
Multidisciplinary approach( several disciplines)
Ms is a chronic progressive disease
Dr Siddiqui discussed all the difficulties in designing the PREMISE study
Safety and effects of venoplasty
IRB approved with the entire team
How was it funded…you cannot get funded for sham procedures
Expensive study to conduct.
$25000 per pt no reimbursement for docs or patients…only for equipment.
They partnered with the hospital, and device companies
Phase 1
10 rrms with ccsvi
Phase 11 1 pt away from completing study
There's the rub. You cannot get funded for sham procedures. You can't ask a patient or an insurance company to pay for a sham procedure. It cost $25,000 per patient to conduct this study? It is amazing that this study happened at all. I would like to see NIH get involved with funding, now that CCSVI has more research to support it. We've been hearing that Dr. Dake's study has been fully funded for a very long time now, but the IRB is blocking it. Why would that IRB block when other IRBs allow? How are we supposed to get anywhere?
Cece
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Re: Dr. Siddiqui at ISNVD

Postby drsclafani » Sat Feb 25, 2012 12:01 am

Cece wrote:from page 68 of ISNVD 2012 abstracts http://www.isnvd.org/files/ISNVD%20Abstract%20Book.pdf
Intravascular Ultrasound for detection of Azygous and Internal Jugular vein (IJV) abnormalities as part of the
PREMiSe (Prospective Randomized Endovascular therapy in Multiple Sclerosis) study

Y Karmon1,2, R Zivadinov3, B Weinstock-Guttman2, C Kennedy3, K Dolic3, K Marr3, V Valnarov3, A Siddiqui1

1Department of Neurosurgery, 2The Jacobs Neurological Institute, and the 3Buffalo Neuroimaging Analysis Center, State
University of New York, Buffalo, NY

BACKGROUND: Chronic cerebrospinal venous insufficiency (CCSVI) is a condition recently reported in patients with multiple
sclerosis (MS) [1]. A set of 5 extra- and trans-cranial venous Doppler Sonography (DS) criteria was proposed [1, 2] and reported
to be in accordance with catheter venography (CV) for the depiction of both Azygous and IJV stenosis [1, 3]. Despite being
the “gold standard” for assessing vascular problems, angiography only provides a luminography with little data on the vessel's
wall, or intraluminal structures. Our aim was to investigate for presence and type of mechanical impediments to the cranial/
spinal cord venous drainage and suspected deranged flow using CV based intravascular ultrasound (IVUS).

METHODS: PREMiSe is an endovascular angioplasty study enrolling patients with relapsing MS according to the revised
McDonald criteria[4,5], and who had Expanded Disability Status Scale [6] between 0-5.5 and fulfilled ≥2 CCSVI Doppler
sonography criteria at screening. The study was planned in two phases. The first phase was an open label and included 10
patients, whereas the second phase is placebo-controlled, blinded and randomized and will include total of 20 patients. The
current study is based on 10 patients participating in phase I and 16 in phase II. CV comprised visualization of AZY vein, right
IJV (RIJV) and left IJV (LIJV) in that order [3]. IVUS was performed using IVUS Eagle Eye Gold catheter (Volcano, CA), across
suspected stenotic segments (≥50% restriction) of the IJV's and azygous vein (AZY), in the phase I, and in all vessels in the phase
II. Abnormal predefined IVUS parameters included the presence of stenosis, presence or absence of respiratory pulsatility
and the presence of various intraluminal defects (septa, multiple channeled vein, intraluminal hyperechoic filling defect,
double/parallel lumen), and abnormally thickened wall.

RESULTS: The study included twenty six patients (mean age 45.7, SD=9.7; male=9, females=17; average disease duration
10.1 years) with clinical and MRI proven MS (20 Relapsing remitting MS, 6 secondary progressive MS) that have fulfilled ≥2
CCSVI Doppler sonography criteria at screening. Out of 18 Azygous veins that were investigated with IVUS, 16 (88%) demonstrated
various intraluminal defects
. Pulsatility was reduced in 7 (38.8%), and stenosis was demonstrated in 10 (55.5%). IVUS
of LIJV detected intraluminal defects in 7 out of 22 patients, reduced pulsatility in 14, and stenosis in 8. All patients who had
a stenosis by IVUS also demonstrated intraluminal defects. IVUS of the RIJV showed intraluminal anomalies in 4 patients
(20%), reduced pulsatility in 10 (50%), and stenosis in 5 (25%) patients out of 20 patients investigated.

CONCLUSIONS: Detailed IVUS imaging demonstrated a very high rate of intraluminal anomalies in the azygous vein during
the PREMiSe study. Similar anomalies were also found in the LIJV and RIJV in lower rates respectively. Stenosis demonstrated
by IVUS was demonstrated in a decreasing order in the azygous vein, left IJV and RIJV as well. IVUS provides
diagnostic advantages over "gold standard" CV in detecting intraluminal extra-cranial venous abnormalities indicative of
CCSVI
.

How does reduced pulsatility factor into CCSVI? It is unusual to have 16 out of 18 azygouses be abnormal, but this is looking at more than just stenosis and intraluminal abnormalities, and also including reduced pulsatility.

The conclusion is a familiar one: IVUS provides diagnostic advantages over catheter venography alone, because the intraluminal abnormalities of CCSVI can best be seen on IVUS.

pulsatility is an interesting concept but i do not know how they measured that. if the wall of the vein is stiff, that would be significant
Salvatore JA Sclafani MD
Patient contact: ccsviliberation@gmail.com
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Re: Dr. Siddiqui at ISNVD

Postby Cece » Sat Feb 25, 2012 5:03 pm

Here's a definition of pulsatility taken from a different article (on pulmonary arterial wall distensibility):
pulmonary arterial pulsatility (the relative increase in vessel area during the cardiac cycle)
http://chestjournal.chestpubs.org/conte ... 9.abstract

So reduced pulsatility might mean that in pwMS the azygous vein was not increasing in size to the same extent that the vein was increasing in size in healthy patients, over the cardiac cycle? The vein would not increase as wide to accomodate flow.

We've heard about the collagen shift in jugulars from collagen I to collagen III, but has anyone looked at azygous veins to see if there is a collagen shift?
Cece
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