Dr. Zamboni at the podium
The room was full - over 700 people on the last morning of the conference when traditionally people sleep in or duck out early. There is so much interest in CCSVI. I think we converted some of the skeptics this week.
Intro: Dr. Barry Katzen of Baptist Hospital and conference host spoke and introduced the panel: Dr. Paolo Zamboni, Dr. Lindsay Machan of Vancouver,Canada, Dr. Salvatore Sclafani, Dr. Ziv Haskal, and Dr. Benenini of Baptist Hospital and SIR President.
Dr. Sclafani's presentation was "Identifying the MS Patient". Since most of the audience were not currently treating pwms this topic was introductory for them. He reviewed the McDonald Diagnosis Criteria and discussed the difficulty of making a diagnosis of MS. Discussed other diseases that can present as MS but are non-demyelinating. He said there are 79 "red flag" criteria for MS and 36 symptoms that point to other diseases. He discussed the EDSS and other scales used for measuring levels of disability by neurologists. He also discussed patient self-assessments.
Dr. Zamboni's presentation was "Evaluating the Imaging". Dr. Z again stressed (and others agreed firmly) that using duplex color doppler imaging along with proper positioning and measurable flow rates is the best way, short of a venogram, to see if CCSVI is present. He went over 5 types of obstructions with slide examples. Dr. Z stressed also that MRV alone cannot show CCSVI as it is limited and also doesn't show intracranial defects. The most important point he made was the venogram is the gold standard. In reviewing cases that used both venogram with prior duplex color doppler, there was agreement of CCSVI of 99%. When comparing venograms with MRVs there was agreement in only 30% (i.e. non-agreement in 70%). The same percentages were present when measuring flow rates. This is why color duplex doppler imaging is what must be used.
Dr. Lindsay Machan moderated a discussion about the various techniques used for treatment of CCSVI. Doctors Sclafani, Haskal, Zamboni all described the types of balloons they used and their approaches.
The question was asked: Who are the best responders to treatment for CCSVI?
Dr. Zamboni - has followed patients for 3 years and found that early disease responds best to treatment.
Dr. Sclafani - said he struggles with this question because he feels compelled to help all pwms and while he knows that early disease responds better, he feels that sicker patients can also be helped or at least prolong the time they can remain out of bed before they are bedridden.
Dr. Haskal - said before you can even ask that question you need to define what is a meaningful outcome. Trials will provide one way and treatment with follow up will provide another.
Dr. Machan - pointed out that small improvements in any symptoms are huge for the MS patient who has not had any relief from the drugs they've been given. (I wanted to stand up and applaud!)
Dr. Machan made a presentation about Patient Screening, or "The Cases that Shouldn't Have Been Chosen".
He reviewed some cases using slides of the venograms and procedures, pointing out problems. He then discussed the problem specifically in Canada for treating post operative patients who went abroad for the procedure. A discussion of after-care followed with a debate about using blood thinners vs. anti-coagulants. This led to a discussion of stents and the after-care wen stenting was used. Dr. Machan was frustrated not being allowed to treat patients but he could at least provide follow up using imaging and prescribing blood thinners. He noted that drugs like Plavix have their own complications and patients need to be followed. Dr. Katzen concluded this section by saying that at this time we all have more questions than answers.
Dr. Zamboni then presented various slides showing different types of stenosis and the techniques he uses to treat them. He concluded by saying in any trials, patient quality of life needs to be included in the measurable outcomes.
Dr. Haskal's presentation was also about follow up care. He reviewed various drugs used and discussed why one would be used over another, depending on the case. The discussion was not only about blood thinners and anti coagulants but also pain meds and their actions on the patient with respect to lesion locations. Dr. Haskal wants to see short trials of 6 to 12 months which he feels is sufficient to evaluate the 'placebo effect'. He said many patients don't have the time to wait for longer trials. (Again, I wanted to give him a standing ovation!). He reminded the group that when IRs first started doing angioplasty the same issues were raised.
Trials - the emphasis that everyone agreed on was consistency in the tools and protocols used in any trial for there to be a meaningful outcome. Patient questionnaires should be an important component. Because MS is progressive, results can be skewed due to disease progression. This is known and taken into account in MS drug trials and needs to be acknowledged here as well. Various types of assessment scales were discussed. All agreed that uniformity of measurements, reproducibility, and self assessments all must be included and are relevant.
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Audience Q & A
1. Should procedures need IRB approval? All agreed that would be the ideal situation.
2. What do you tell patients about risks and outcomes? Dr. Sclafani said he discusses the standard risks related to angioplasty. He says there are no guaranteed outcomes and each patient responds differently. He does not discuss individual adverse incidents unless the patient asks about them. The rest of the panel pretty much agreed with this.
3. How has reimbursement been working? Some said Medicare will pay if the diagnosis is that of venous stenosis without mentioning MS. Same for some insurance companies. But Canadians are all self-payors, as are people with limited insurance or HMO's out of network.
4. Dr. Arslan had a statement and a question. He said he has been doing the procedure and found that he tries to avoid stenting at all costs. What did the panel think about stents? All agreed that they try to avoid stents and the use of anti-coagulants. But they also said some veins don't respond and stents are sometimes needed. Use of anticoagulants up the anti for safety and needs careful monitoring. Dr. Haskal said that the same criteria for retreatment can be used as for a dialysis patient - age is also a factor. Each case needs to be evaluated on it's own.
Dr. Katzen made the statement: "So we are talking about a disease we don't know much about, a treatment we don't know much about, and outcomes we don't know much about." (So true! There is so much to learn!)
5. How do we get clinical trials without industry input? Dr. Hubbard's trial was discussed. The Buffalo trials and NIH were discussed.
6. With the push toward clinical trials, what does the panel see as the desired outcome of these trials?
LM - Does the treatment alter the outcome of disease for the MS patient.
PZ - Measurable outcomes that are reproducible
SS - a) longevity of results over a 20 year period. b) ethics of treating before randomized trials c) registry requirement d) quality of life and extension of 'time to bed'.
ZH - disagrees with 20 yrs and time to bed. First, quality of life measurement through patient self assessment over 3 to 6 months as a Phase I. Then can move forward with technical issues and Phases II or III.
LM - Stressed again the importance of training in the use of doppler imaging as crucial. PZ agreed strongly.
Dr. Katzen concluded the program by again saying we all have more questions than answers and that the topic of CCSVI is here to stay. He thanked everyone for the participation and attention.
I've tried to be factual (with a few comments I couldn't resist). For a more personal account of my ISET experience you can read my blog post called "New beginnings" at http://andisue.blogspot.com/
http://www.facebook.com/notes/andrea-wulkan/iset-summary-of-thursdays-presentations/492360822325