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
I was telling my husband last night about ISNVD, and he may have been humoring me by listening, because it would seem the depth of my interest in all things CCSVI is greater than the depth of his. But he pointed out that Dr. Sclafani and I were at one point in disagreement about the length of time to wait after ballooning to get a routine follow-up exam. When I was treated a year ago, Dr. Sclafani suggested three months for follow-up, and when my left vein kept hurting after the procedure, I was able to get in locally with Dr. Cumming for a one-month doppler check for thrombosis. It was good for peace of mind and because when it comes to clots, time is vein. Now with Dr. Sclafani saying that three months is too long for follow-up if thrombosis is present, we are in agreement. And ... let's see ... I side with Dr. Sclafani over Dr. Arslan about the necessity of IVUS for detecting each valve. I would be interested in what Dr. Arslan means about the right equipment being needed: are there IRs with better or worse angiography suites? Should that factor into our decision of where to go?Dr. Sclafani to Angela: cross sectional measurement with U/S w/b more useful to IRs than diameter to choose balloon size
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.