This Is MS Multiple Sclerosis Community: Knowledge & Support

Dr. Sclafani: IVUS needed to detect each valve. Dr. Arslan: Right equipment makes the difference; IVUS not needed

Dr. Sclafani on recurrence of symptoms: angioplasty may have benefits not related to MS symptoms ovr 20 yrs b/c of better flow

Dr. Sclafani: "Blinding patients is not possible."

Dr. Sclafani: no consensus on degree of stenosis in imaging, but consensus reached on how to measure stenosis

Dr. Sclafani: 3 months is too long to wait for follow up ultrasound to save the vein if a thrombus is present

Dr. Sclafani to Angela: cross sectional measurement with U/S w/b more useful to IRs than diameter to choose balloon size

Dr. Sclafani: changing criteria for U/S by deleting criteria #2 eliminates eligibility for some patients for venography

Dr. Sclafani: don't exclude symptomatic patients from having venography based on screening test

Dr. Sclafani: at least half a million people need to be screened (US data)

Anne Kingston@anne_kingston

Dr. Sal Sclafani: What's slowing CCSVI research "more than anything is lack of neurological collaboration." Zivadinov agrees

Sclafani says, "We are looking at a downstream cause for an upstream problem."

Is it impossible to blind patients? It's not technically impossible, with the use of anesthesia, and there are a few IRBs in place with blinding. It is ethically concerning. It is likely that any patient in such a trial would try to guess what group they're in. 'Wow' results would be unlikely to come from the sham group, unless there is some 'wow' placebo going on, which I suppose is the concern. Nonresults could come from the sham group or from nonresponders in the treatment group. There's expectations too. I've heard people say the treatment did not work, because they got cogfog and fatigue improvements but no mobility improvements. I prefer Dr. Dake's plan of 3 month sham trial vs Dr. Siskin's 2 year sham, but Dr. Siskin's is underway and Dr. Dake's is not, and I am very glad that there is a blinded trial underway. I would have to say that perfectly blinding patients is not possible, but good enough blinding is possible, because there is room to wonder which group you're actually in, and some of the benefit to the sham group is in the doctor's care outside of the procedure itself. So see? That almost sounds like I disagree with Dr. Sclafani.

Consequences of venous obstruction involving other vascular beds (Salvatore Sclafani, USA)


This presentation will focus upon venous obstructions caused by compressive forces outside the cerebrospinal venous circuit that may result in OUTFLOW obstruction or increased INFLOW into the cerebrospinal venous circuit. Venous thoracic outlet syndrome relates to obstruction of the axillary or subclavian vein as it exits the chest over the first rib. Also known as Paget Schroetter disease, it is a thrombosis caused by subclavian stenosis, often after vigour exercise. Patients present with a painful swollen and cyanotic upper extremity with weakness and paresthesia. Collateral veins are visible in the chest and shoulder. On occasion, it may cause OUTFLOW obstruction of the valvular area of the inferior jugular vein and may increase INFLOW into the cerebrospinal circuit by collaterals extending into the neck from the upper extremity. Renal vein stenosis caused by compression, most commonly by the aorta and superior mesenteric artery, is referred to as the Nutcracker phenomenon when asymptomatic and the Nutcracker syndrome when symptoms are present. Symptoms and signs include proteinuria, hypertension, unilateral hematuria, chronic back or pelvic pain, varicoeles and pelvic congestion syndrome, and, interestingly, chronic fatigue. MRI, CT and ultrasound are noninvasive screening tests; venography with hemodynamic measurements and intravascular ultrasound are confirmatory. In renal vein obstruction, hemiazygous and ascending lumbar collaterals may become cerebrospinal INFLOW veins of significance because renal venous blood flow is so great (500 ml/min). Endovascular stenting and reimplantation or transposition procedures are the treatment of choice. May- Thurner syndrome describes a clinical scenario associated with compression of the left iliac vein between the right common iliac vein and the lower lumbar spine. Originally thought to occur in young overweight teenaged and young adult women, it is found in about 37% of patients with history of DVT or reflux. Symptoms include progressive leg edema with no history of thrombotic problems, venous claudication, and mild complaints consistent with chronic venous insufficiency. Physical examination can demonstrate mild to severe edema, chronic leg skin changes, development of varicosities, significant venous collateral vessels, and ulceration. CT and MR may show compression, but venography with hemodynamic measurements and intravascular ultrasound are definitive. Venous collateral vessels include cross pelvic venous drainage and the left ascending lumbar vein that can act as a cerebrospinal INFLOW vein. Failure to treat the stenosis after iliac DVT is associated with persistent occlusive disease. Treatments include thrombectomy or thrombolysis and stenting.

I will be looking forward to a blog post from you, Marc, summarizing all of this! There is so much to dig through.

Yes, I remember that Parkinson's research. Surprising results.

For what it's worth, there has also been recent research showing little difference between placebo and untreated groups:
http://www.nejm.org/doi/full/10.1056/NE ... 5243442106
http://onlinelibrary.wiley.com/doi/10.1 ... E01.d02t04
I am not sure what to think. And a sham group comes at the cost to the patient, of not being treated, potentially for up to two years, and of undergoing the risks of angiography without the benefits.

Sclafani: Focus on issues with iliac & renal veins. Too bad there isn't more understanding of their importance in CCSVI.

Sclafani on Paget Schroetter Disease possibly impacting cervical collaterals

Sclafani giving important iliac and renal examples. Jugulars and azygous are just tip of CCSVI iceberg.

Yes! Sclafani "Treatment of the internal jugular and azygous veins may not be sufficient for flushing out all of the contributors to CCSVI."

What I meant was that many patients who have angioplasty have soreness in the chest and the neck after angioplasty. You can blind someone during the rpcoedure, but i find it difficult to imagine that someone with soreness in the chest or neck a few days later would not figure that out

Hello Cece,
Thanks for postings from Orlando, very helpful.
The TiMS forum drew the same conclusions last year as Dr S is saying at ISNVD 2012. I am disappointed that some ISNVD leaders are still calling for double blind trials. I expected Dr Hubbard to appreciate why patients can feel balloons being inflated (sometimes it hurts). Please convey patient experience to the meeting - what do we know we are only patients !!!
IRs could become like neuros (who know best for pwMS) if the are not careful.

Hello Marc,
The difference from your examples and for those undergoing de-stenosis is that we were awake. Using anethestic for no medical purpose is considered unethical in trials. Placebo is a well documented effect from drugs but a sham surgical procedure (which causes discomfort) on an awake patient is virtually impossible.

Kind regards,
MarkW