ISET January 2011

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

Postby Cece » Mon Jan 17, 2011 1:21 pm

ISET 2011 will feature the following presentations as press releases, embargoed until time of presentation:

Controversial MS Treatment Lessens Fatigue, Research Shows — Teleconference available Monday, Jan. 17
Stents Help Stroke Victims When Other Treatments Don’t, Research Shows
Tiny Ultrasound Device May Help Patients With Deadly Lung Clots
Two-Year Zilver Ptx Trial Results Show Drug-Coated Stents Keep Leg Arteries Open
Saturating Cancerous Livers With Chemotherapy Beneficial, Limits Toxic Side Effects

What pair0dime posted is one of only five press releases that will be coming out of ISET. (The other four not being CCSVI-related.)
http://www.isetnews.org/index.php?sid=S ... 1847G6WNQV
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Postby pairOdime » Mon Jan 17, 2011 5:15 pm

Medpage Today (link to full ISET story below)
http://www.medpagetoday.com/MeetingCove ... ings/24389

MIAMI BEACH -- Neurologists and endovascular interventionalists may be edging closer to agreement on how to evaluate the controversial vascular theory of multiple sclerosis, but important gaps still appear to divide the two groups.

That was the upshot of a panel discussion held here Monday at the International Symposium on Endovascular Therapy (ISET), featuring the National Multiple Sclerosis Society's (NMSS) chief medical officer -- a neurologist -- along with several representatives of the interventional community and a patient advocate for more aggressive study of the theory.

Like North and South Korea glaring at each other across the demilitarized zone, relations between neurologists and endovascular interventionalists have become tense over the theory that obstructions in the jugular vein disrupt blood outflow in the brain, leading to the nervous-system inflammation characteristic of MS.
-------------------------------------------------------------------------------------------
A third panelist took an even dimmer view of IRB review, saying he quit his university job rather than accept what the school's IRB was was going to require.

Salvatore Sclafani, MD, was chairman of radiology at SUNY Downstate Medical Center in Brooklyn, and wanted to perform CCSVI testing in patients there, with treatment for those testing positive. He told ISET attendees that the IRB rejected his application, telling him instead to conduct a double-blind, sham-controlled trial.

Sclafani said such a trial would be premature at this stage, with too many unknowns about techniques, patient selection, and follow-up treatment.
Rather than give up the research entirely, he left his post at SUNY Downstate and moved to an ambulatory center where, he said, he could evaluate "a thousand patients a year."

"This awful disease needed me to leave my practice," he said.

Benenati also pointed out interventionalists have been derided as "cowboys" before for procedures that eventually became standards of care. "We were cowboys when we did iliac angioplasties, we were cowboys when we did TIPS [transjugular intrahepatic portosystemic shunt], we were cowboys when we started stroke therapy," he reminded attendees.
It's a paradigm shift
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Postby cheerleader » Mon Jan 17, 2011 5:15 pm

First big press release today after Sharon Richardson and Dr. Dake's presentations: It's official, the Stanford trial is beginning!


Stanford and the Baptist Cardiac & Vascular Institute in Miami, plan to begin a trial in 2011 to assess the condition and treatment with angioplasty. “If a person has MS and has a blood vessel obstruction, and if it’s removed, we will look at whether we can we demonstrate objectively that there is improvement in blood flow,” Dr. Dake said.



link
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Postby HappyPoet » Mon Jan 17, 2011 5:29 pm

Rather than give up the research entirely, [Salvatore Sclafani, MD] left his post at SUNY Downstate and moved to an ambulatory center where, he said, he could evaluate "a thousand patients a year."

YESSSSSSS!
:) :D :) :D
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Postby Cece » Mon Jan 17, 2011 5:48 pm

HappyPoet wrote:
Rather than give up the research entirely, [Salvatore Sclafani, MD] left his post at SUNY Downstate and moved to an ambulatory center where, he said, he could evaluate "a thousand patients a year."

YESSSSSSS!
:) :D :) :D

you think, in a thousand patients, he'll be fitting in just ONE cece anytime soon? :)

pairOdime, you have rocked it in this thread, another great link with so much information in it!

Great results and news from Dr. Dake as well.
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Postby hopeful2 » Mon Jan 17, 2011 6:04 pm

I believe Jack Burks, MD who participated in Monday's CCSVI panel representing the neurologist's point-of-view is:

Chief Medical Officer (CMO), Multiple Sclerosis Association of America (Cherry Hill, NJ).

In their press release Medpage posted his affiliation (erroneously I believe) with National Multiple Sclerosis Society (NMSS).

I'm not sure why I felt the need to post this---I don't agree with some his views---but irregardless he should be identified correctly.
Last edited by hopeful2 on Mon Jan 17, 2011 7:25 pm, edited 1 time in total.
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Postby marcstck » Mon Jan 17, 2011 6:08 pm

Great summary in Medpage. One minor correction, though. Dr. Jack Burks is the chief medical officer of the MSAA, not the NMSS. He is on the medical advisory board of the New York chapter of the NMSS, though…

If the chief medical officer of the NMSS was as open to CCSVI as Dr. Burks is, that would be really BIG news…

Perhaps in time…
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Postby Cece » Mon Jan 17, 2011 9:13 pm

Even before dealing with these points, Burks said, radiologists and interventionalists will need guidance in confirming that patients who come to them for CCSVI testing and correction genuinely have MS.

"Let me tell you something you're going to be experiencing if you haven't experienced it already," he told attendees. "If this thing is accepted as the major treatment for multiple sclerosis, [patients will say] if this helps in multiple sclerosis, it will surely help in Parkinson's and Alzheimer's and every other disease known to man."

Burks continued, "The patients will know how to get the procedure -- tell people they have multiple sclerosis, because that is the key to getting tested [for CCSVI]. So we have to have criteria for the diagnosis of MS, so that unsuspecting interventionalists aren't confronted with people who say they have MS but may not."

This seems...a wee bit paranoid, doesn't it? The Hubbard registry (for example) is not requiring an MS diagnosis, only a CCSVI diagnosis.

Plus it is pretty forward-looking to be worrying about the problems that will arise after this is accepted as the major treatment for MS patients with CCSVI. Plenty of ground between here and that point to deal with first.
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Postby pairOdime » Tue Jan 18, 2011 9:33 am

Another release today from ISET....
Tuesday, January 18, 2011

CCSVI: The Big Picture
http://www.iset.org/files/content/docs/issue_3_LR.pdf

Nearly 700 people attended the ISET Town Hall on CCSVI.
The story leads with Sharon and her CCSVI treatment.
It's a paradigm shift
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Postby Cece » Tue Jan 18, 2011 10:05 am

Did you see the poll further into the ISET document, that asked, "Do you believe there is a role for endovascular therapy in CCSVI?" with 63% saying yes, 35% saying don't know, and 2% saying no. :)

On a different note:
In the panel discussion that followed
the Town Hall presentations,
Martin Leon, M.D., noted that “it’s
striking to see how far this has gone,
but I have to say we’ve encountered
many of these things before, most
recently with transcatheter valve
therapy. I agree we need an immediate
multidisciplinary commitment


I googled transcatheter valve therapy, there are similarities, here is Dr. Leon discussing transcatheter valve therapy at some other conference in 2009:
Leon concluded that the “explosive growth in transcatheter aortic valve implantation (TAVI) procedures is due to clear and compelling clinical needs, which have placed immediate burdens on the evidence-based medicine clinical trial process. The absence of both standardized definitions and rigorous clinical trial methodologies have made inter-study comparison difficult, and accurate clinical assessments of therapies problematic. As a result, an international, academic, multi-society effort like VARC, or others, which strive to achieve reasonable consensus on clinical research issues, is clearly required.”

I would say that in CCSVI there are clear and compelling clinical needs which have placed immediate burdens on the evidence-based medicine clinical trial process.
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Postby pairOdime » Thu Jan 20, 2011 4:44 am

Coming up at ISET this morning...
Thursday Jan 20 2011
Session XII: Symposium on Practical Issues Associated with CCSVI

Moderators: James Benenati, M.D., Barry Katzen, M.D.

9:00 AM Clinical Evaluation of MS Patients
Speaker: Salvatore J.A. Sclafani, M.D.

9:10 AM Imaging Evaluation of the MS Patient for CCSVI
Speaker: Michael Dake, M.D.

9:20 AM Venographic Evaluation of CCSVI
Speaker: Ziv J. Haskal, M.D.

9:30 AM Patient Selection for Treatment of CCSVI
Speaker: Michael Dake, M.D.

9:40 AM Patients I Chose Not to Treat
Speaker: Lindsay Machan, M.D.

9:50 AM Patient Techniques and Challenges in Treating CCSVI Patients
Speaker: Paolo Zamboni, M.D.

10:00 AM Post-procedural Care and Follow-up
Speaker: Ziv J. Haskal, M.D.

10:10 AM Panel Discussion: Should Interventionalists Become Engaged in Treating MS Patients?
Panelists: Michael Dake, M.D., Ziv J. Haskal, M.D., Lindsay Machan, M.D., Salvatore J.A. Sclafani, M.D.
It's a paradigm shift
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Postby Cece » Thu Jan 20, 2011 11:53 am

pairOdime wrote:Coming up at ISET this morning...
Thursday Jan 20 2011
Session XII: Symposium on Practical Issues Associated with CCSVI

Moderators: James Benenati, M.D., Barry Katzen, M.D.

9:00 AM Clinical Evaluation of MS Patients
Speaker: Salvatore J.A. Sclafani, M.D.

9:10 AM Imaging Evaluation of the MS Patient for CCSVI
Speaker: Michael Dake, M.D.

9:20 AM Venographic Evaluation of CCSVI
Speaker: Ziv J. Haskal, M.D.

9:30 AM Patient Selection for Treatment of CCSVI
Speaker: Michael Dake, M.D.

9:40 AM Patients I Chose Not to Treat
Speaker: Lindsay Machan, M.D.

9:50 AM Patient Techniques and Challenges in Treating CCSVI Patients
Speaker: Paolo Zamboni, M.D.

10:00 AM Post-procedural Care and Follow-up
Speaker: Ziv J. Haskal, M.D.

10:10 AM Panel Discussion: Should Interventionalists Become Engaged in Treating MS Patients?
Panelists: Michael Dake, M.D., Ziv J. Haskal, M.D., Lindsay Machan, M.D., Salvatore J.A. Sclafani, M.D.

This was the more practical side, whjch is the nuts-and-bolts that I find more interesting these days, as opposed to the bigger-picture theory and controversy as covered on Monday's symposium.

By "Venographic evaluation," by Dr. Haskal, that must be the catheter venogram, since MRV would fall into the imaging evaluation as covered by Dr. Dake.

I am still concerned about just which patients Dr. Machan would choose not to treat! I suggested a few possibilities before (heart palpitations), I could also see being reluctant to treat a patient with unrealistic or unhealthy expectations of what the procedure could accomplish? There is also be the ongoing question of just how much stenosis is necessary; do you choose not to treat a patient with a 30% stenosis? A 20% stenosis?

I'm glad that Dr. Haskal covered post-procedural care and follow-up, but there should almost have been another talk after that, such as "Back for more: the repeat venoplasty in CCSVI patients" to address special concerns in patients who've been treated previously.

And should Interventionalists become engaged in treating MS patients? Of course, yes. :D
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Postby cheerleader » Thu Jan 20, 2011 1:30 pm

Here is Sharon Richardson's, CCSVI Alliance president, interview with an ISET reporter. It was featured in the newspaper received by all attendees, and is reprinted with permission:

The controversial theory that connects chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis will be thoroughly examined during the ISET Town Hall this morning. The idea that comprised blood flow in the veins that drain the central nervous system could cause MS in some patients was first advanced by Paolo Zamboni, M.D., one of today’s featured speakers. Dr. Zamboni’s intriguing and prom- ising work on the subject has prompted the establishment of a patient-advocacy organization know as the CCSVI Alliance, which supports continued research on the subject, as well as patient and physician education.

Sharon Richardson, president of the CCSVI Alliance, will speak today during the Town Hall to chronicle the journey of MS sufferers and what a potential breakthrough could mean to the as many as 350,000 indi- viduals in the United States stricken with the disease. She answered questions about the Alliance, which has additional information available for ISET attendees at a table exhibit in the foyer outside the Exhibit Hall.

ISET Today: What is the mission of the CCSVI Alliance? What are your goals for the current year?
Ms. Richardson: CCSVI Alliance promotes education and research about CCSVI and its relationship to multiple sclerosis (MS) by providing objective information to the MS community, supporting medical inves- tigations of CCSVI and fostering collaboration among patients, advocates and professionals.

What was the catalyst for the creation of the Alliance? How did it evolve?

A few members from an Internet forum for MS sufferers decided they would like to start a nonprofit to pro- mote education and research in this exciting new area. A small group of patients in the New England and Joan Beal, who was instrumental in introducing Dr. Paolo Zamboni’s research to doctors at Stanford, rec- ognized the need for a professional organization to try to tie together the patient and professional interests, and provide an objective presentation of the relationship between MS and CCSVI.

Tell us about those involved with the Alliance. What kinds of boards have you established, and what type of individuals serve on them?

We currently have two boards: the board of directors and the patient advisory board. There is significant diversity on the board of directors. All are MS patients who have been treated for CCSVI except for one member who is the spouse of an MS patient. We have a retired chief financial officer, a marketing consulting, a Ph.D., an engineer, an MBA, a musician and a sales executive. We have members on the West Coast, the East Coast and in the heartland. We are not an international organization at this point. We are concentrating on the CCSVI situation in the United States.

The patient advisory board currently consists of seven members, each of whom has MS, and each of whom has undergone CCSVI treatment. Members of this board have different areas of expertise that the organization calls upon for various projects.

We’ve also conceptualized a medical advisory board, which will consist of doctors and scientists interested in studying the relationship between CCSVI and MS. Although we have not formally established this board yet, several doctors and scientists have contributed to the organization by reviewing our content prior to publishing at www.ccsvi.org

What has been the reaction from MS sufferers to the Alliance? What are you hearing from them? How is the Alliance addressing their concerns, and what services or support do you offer?

We have received a very positive response from the MS community of patients, caregivers and medical professionals. Our website helps to educate those wanting to learn more about CCSVI. The medical content was reviewed by a world- class team of medical professionals, some of who are at ISET. The website includes an original analysis of CCSVI published research, tools and strategies for discussing CCSVI with doctors, including how to assemble an effective medical team, presentation of safety and risk, a database of all IRB- and NIH-approved CCSVI clinical trials and written perspectives by patients who have been treated for CCSVI. The exclusive, recorded interviews with medical and scientific professionals who are the leaders in the research and study of CCSVI have become a highlight of the website.

How is the Alliance reaching out to physicians and others in the medical community? What are you hearing from these folks?

Our outreach efforts to the medical community include the Endovascular.org forum where we host a CCSVI group. We have also established a relationship with the National Multiple Sclerosis Society and the Multiple Sclerosis Association of America. The NMSS just recently recognized our website as a valuable, balanced and accurate resource for people affected by MS seeking information on CCSVI and related treatment. The NMSS now links to our website. Last week the Alliance hosted its inaugural educational event in Boston. The audience included not only patients and caregivers, but a number of medical professionals from Boston Medical Center and national and local representatives from three multiple sclerosis societies.

What type of funding supports the work of the Alliance?

To date our fundraising support has primarily come from individual donors making contributions and events, such as our upcoming “Opening Minds for CCSVI Walk- n-Roll” in March. The first week in March, we hold a two-day educational and fundraising event in Tampa, Florida. Our strategic plan, which is near com- pletion, will include soliciting grants from private and corporate foundations.

What initiatives is the Alliance currently supporting? How are you working with the medical com- munity to advance research and knowledge about CCVSI?

The Alliance has spent its first year building the infrastructure for a professional organization. In 2011 our efforts will focus on fund- raising so that we may offer educational programs to patients and move forward to help establish a multidisciplinary collaboration of medical professionals. MS is a multi-factorial disease, and we need everyone working together to find the answers to the relationship of CCSVI and MS. It is crucial that a patient database or registry be created to begin tracking not only the short-term, but the long-term effects of CCSVI treatment.

How did you become involved in the Alliance? What is your background and how did you, personally, decide to channel your energies into this area?

While in New York to hear Dr. Zamboni speak at NYU, I met with one of the Alliance founders. She asked me to volunteer by creating a database for the Alliance. A month later, I became president. At that time, early 2010, there were not many people who had been treated in the U.S. for CCSVI. We recognized the need for an accurate source of information on CCSVI because, in many instances, patients were being misled on the Internet. I had recently retired as president and CFO of a manufacturing company. I had the extra time and, selfishly, I wanted the research to move forward. I have a brother with MS and a grown daughter with MS. I do not want any of my four grandchildren to be affected by this disabling disease.
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Postby Cece » Thu Jan 20, 2011 4:42 pm

If you read it in the newsletter itself, you also get a picture and the joy of knowing CCSVI made the front page of the ISET newsletter two days in a row:
http://www.iset.org/files/content/docs/issue_2_LR.pdf

In the same link, there's Dr. Katzen's article on patient advocacy, talking specifically about CCSVI.
Let’s not forget, however, patient
advocacy can be an extremely important
contributor to the advancement
of medicine. An excellent example is
that of uterine fibroid embolization
(UFE), a proven therapy that was
entirely patient advocacy driven.
In the case of CCSVI, there is no
doubt that research would not be
moving forward without the push
from patients. Whether it bears out
remains to be seen.

It's interesting that in Dr. Katzen's article he used the word naive ("It’s easy to dismiss patient advocates as naïve") and in the CCSVI article in the ISET newsletter from Tuesday Dr. Burks used the word naive ("Very naïve interventionalists, who we refer to as cowboys, are overstating the possible value of CCSVI. Neurologists think we need to shut down these interventionalists.”)

That could be a thread of its own: why would there be a perception of naivety, does the charge of naivety have any validity, what will it take to show that this is not naive and that this is real?
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Postby hopeful2 » Fri Jan 21, 2011 11:06 am

Cece, thanks for your post (on a different thread) about fusion imaging at the European Congress of Radiology. While scrolling thru the Esaote pages I saw this advertisement on page 7:

A dedicated area to MyLabTMVinco, the unique Product designed for CCSVI diagnosis, is located just after the main entrance area: Esaote is proud to present this innovative product and its new concept to the Radiological world!

I didn't know about a product marketed specifically for CCSVI diagnosis. I'm curious to know how much sharing of information on new technologies, products (and of course IR procedures) happens across the globe? I know there have been symposia and conferences dedicated to CCSVI that were attended by folks from a variety of continents---but do individuals from ECR communicate regularly with ISET faculty and attendees?

I realize Dr.s Zamboni, Sinan, Simka and others (my apologies for names I'm leaving out) speak often with doctors who were at ISET (I know Zamboni was at ISET so he covered both events) but I'm curious to hear how much of that actually happens.

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