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Posted: Fri Apr 30, 2010 6:09 pm
by mmcc
drsclafani wrote:
Cece wrote:
mmcc wrote: I agree with you that the risk is probably less when done on veins, but the point I am trying to make is just that libneration surgery DOES have risks - ALL surgery does.
If I may quote Dr. Sclafani, from the very first page, regarding the word 'surgery':
drsclafani wrote:i cringe whenever i hear anyone refer to the surgeries. This is as much standard surgery as a tuna fish sandwich is sushi

Did you notice that I never used the word cutting, scalpel, general anesthesia, blood loss, retractors or cautery. Did anyone hear transplant, excision, or anastomosis?

This procedure is performed through a needle the size of a safety pin without any cutting. As the wheelchair kamikaze said to me tonite, he cannot find the spot through which i placed my instruments.

So, while it is true that the dictionary defines surgery as the treatment of disease by instrumentation or manipulation, treatment of ccsvi is as much a surgical procedure as lighting a firecracker is a space launch.
i think using the term surgery makes people think it is invasive and with all the risks associated with surgery.
I think it has fueled the concerns about safety beyond reality
You're right - it should be called a "procedure." Sorry.

And thank you Dr. S for all the very informative replies to questions. My daughter and I are scheduled for the procedure in a few weeks and the information you have provided has answered the questions we had.

Re: Winning the War

Posted: Fri Apr 30, 2010 6:53 pm
by drsclafani
Squeakycat wrote:
Cece wrote:
But venoplasty is invasive...
I have no expertise in this terminology.

I would say that venoplasty is MINIMALLY invasive, compared with sawing open your sternum and prying back your ribs, or other sorts of surgery so would MINIMALLY INVASIVE VENOPLASTY work?

Some other thoughts. It is a PERCUTANEOUS VASCULAR INTERVENTION, rather than surgery.

Or rather than surgery, what about just VASCULAR INTERVENTION?

I think words matter in this debate so it will be worth the effort to get this right and as the opposition is now doing with their consistent talking points about the dangers of CCSVI surgery, get into the habit of framing the debate in more favorable, and frankly accurate terms.

SIMPLY CALL IT
PERCUTANEOUS ANGIOPLASTY
PERCUTANEOUS VENOUS DILATATION
PERCUTANEOUS VENOPLASTY
PERCUTANEOOUS BALLOON DILATATION

WITH THE DESCRIPTOR: A MINIMALLY INVASIVE PROCEDURES PERFORMED UNDER LOCAL ANESTHESIA

JUST STOP USING THE TERM SURGERY

Re: Winning the War

Posted: Fri Apr 30, 2010 7:34 pm
by girlgeek33
drsclafani wrote:
SIMPLY CALL IT
PERCUTANEOUS ANGIOPLASTY
PERCUTANEOUS VENOUS DILATATION
PERCUTANEOUS VENOPLASTY
PERCUTANEOOUS BALLOON DILATATION

WITH THE DESCRIPTOR: A MINIMALLY INVASIVE PROCEDURES PERFORMED UNDER LOCAL ANESTHESIA

JUST STOP USING THE TERM SURGERY
So if I understand you correctly, you don't want to call it surgery? lol sorry, just trying to be funny... ;)

Posted: Fri Apr 30, 2010 7:37 pm
by Johnson
Cece wrote:Squeakycat, I agree, I just wish there were less unwieldy terms available.
Liberation is fairly unwieldy...

(That was deliberately facile, for humour.)

Conistent Description of CCSVI Treatment

Posted: Sat May 01, 2010 6:44 am
by Squeakycat
Dr. S,

Rather than a choice of descriptions, do you think this one covers it:

CCSVI treatment is:

PERCUTANEOUS VENOPLASTY,
A MINIMALLY INVASIVE PROCEDURE PERFORMED UNDER LOCAL ANESTHESIA



Again, I think words matter, but it is very important that we use the right ones to maintain accuracy as well as a favorable spin.

Posted: Sat May 01, 2010 8:31 am
by Squeakycat
drsclafani wrote:
I have been thinking about how to harness the energy and experience of patients on this site. I have fantasized about creating research measurement tools to learn about the subjective experiences after liberation. Imagine capturing the data and partnering on such a project.
At one level, what we want to capture is data which parallels that collected in drug trials. The standards seem to be things like
  • Number of relapses
    Change in the number of lesions on MRI
    Changes in EDSS and other subjective measures of MS disability
    Timed walking tests
    and so on.
These would answer the question of how CCSVI treatment stacks up against MS drugs, though not necessarily, the relationship between CCSVI and MS.

As an unfunded, voluntary, patient-driven registry, not everyone would have MRI results pre- and post- nor physician-assessed testing. Things like relapses might be tightly defined, again, both pre- and post- treatment, as relapses requiring hospitalization and/or medical treatment, not just self-assessed relapses though both could be reported, noting whether they are self-assessed or fit some other criteria.

Although it is controversial, patients can serve as their own controls in a sense by comparing their pre- and post- experience in things such as relapses and other relatively objective criteria such as timed walks.

Since we know at this stage that a lot of people with MS have CCSVI whether these conditions are related or not, perhaps it will be useful to simply identify and track the symptoms and signs of CCSVI that are likely improved by Percutaneous Venoplasty, a minimally invasive procedure done under local anesthesia. :D (Had to try that phrase on for size.)

So we would be looking at identifying and measuring a set of symptoms, pre- and post-procedure which are likely to specifically respond to CCSVI treatment and improved cranial-spinal blood flow such as:
  • cog fog
    memory
    fatigue
    sensation/tingling in various appendages
    feelings of coldness in various appendages
    changes in urinary control
    ambulatory changes
    choking
    sensitivity to warm temperatures
and these borrowed from the tracking sticky:
  • Number of relapses since first CCSVI intervention
    Impact on your MS symptoms in words (include date in brackets if there have been multiple updates)
    EDSS as of this update (self-assessed or physician-assessed?)
    FSS as of this update
    MSIS as of this update
As well as these from the Kuwait:
  • No complications
    All patients reported improvement ( 1 month) :
    Improvement or disappearance of Numbness
    Loss of Fatigue and increased energy
    Improvement of power (foot drop)
    Improvement visual acuity (No blurred vision)
    Reduced electrical sensation
    Memory improvement
    and so on.
This latter list would be useful now as a list of things that can be fixed when CCSVI is treated regardless of whether there is a relationship between CCSVI and MS and regardless of whether treating CCSVI "cures" MS. The issue is not MS. The issue is remedying the disabilities caused by impaired cerebrospinal blood flow as a result of cerebrospinal venous malformations. A list like this is something to take to the IR's and vascular surgeons as part of the case for treatment.

Putting this list together and tracking it takes neurology out of the discussion at this phase. The neurological questions can then be pursued at leisure with the paltry funding coming from the MS Societies, but we can get on with treating a debilitating vascular problem and assembling data needed to assess the value of treatment as well as other information such as the relationship between specific malformations and disability, if such exist.

What might be very useful would be to get all the current lists that are part of the IRB submissions and research proposals to compile a single master list and to obtain patient input on these lists, especially from those who have undergone Percutaneous Venoplasty, a minimally invasive procedure done under local anesthesia. That would include: Kings County, Stanford, Vancouver, Hamilton, Kuwait, Simka, Zamboni, et alia. That way we might build a master registry with this data with contributions from treatment centers that are not involved in research.

The quicker we can gather this data, the faster we should be able to get a number of centers up and running to treat the 2.5 million requiring treatment for their vascular problems.

Although perhaps not an ideal tool, Google Docs provides some basic tools for collecting the data and restricting access in a way that probably meets HIPPA requirements for protection of patient privacy and Google Sites provides a quick and dirty web presence for managing the data collection. Happy to volunteer to build both if this makes sense.

Re: External Deformity

Posted: Sat May 01, 2010 9:06 am
by drsclafani
Zeureka wrote:
drsclafani wrote:sometimes one notices bluish veins under the skin. they may represent other collateral veins that result from the jugular blockages.
i have not noticed or read of any clear association between ccsvi and other vascular malformations yet.
Hmm, I always noticed these quite strong bluish veins on my chest just underneath my neck...

And have a certainly very silly question, but have no clue about the standard venology exams for extremities (but know doppler exams of arms/legs also performed): what about strong bluish swollen veins on hands/wrists accompanied by sensation of stiffness/swelling (but hands not really swollen) with constant pins/needles? And same for bluish veins and sensations in feet?
could be due to venous obstruction too, but could also be caused by neurovasomotor problems

Posted: Sat May 01, 2010 9:11 am
by Cece
Squeakycat wrote:That way we might build a master registry with this data with contributions from treatment centers that are not involved in research.
Squeakycat, I think this is all brilliant, I'm curious to see what Dr. Sclafani thinks. My worry with this is how to keep the data clean, i.e., one entry from one person who has really had the percutaneous venoplasty procedure (a minimally invasive procedure done under local anesthesia), to the standards that it is convincing to anyone other than ourselves.

We could considered to be motivated and nonobjective and therefore at risk to compromise the data.

Posted: Sat May 01, 2010 9:12 am
by drsclafani
sofia wrote:Supressing the imune system and undergoing surgery, or venogram, ballooning/stenting, is that without problems? What about the risk of infection?
In my email from Bulgaria they told me to continue my dmd. I told my neuro that I was going abroad for operation, and cause of that I wanted to stop tysabri. His answer was that having invasive procedure done is no reason to stop my meds. (I've stopped them anyway because of side effects)

What about steroids, iv soulimidrol, shortly before liberation, is that problematic, or would that be any hindrance for having operation done? Again thinking about infection.

With every attack I have, I decide wether to take the steroids or just ride it out. I think I am having an attack now, and my op is scheduled in just over 2 weeks. I just do the 5 days of iv, not the follow up pills as they make me feel sick. It's vertigo so it is tempting with steroids, but I really do not want to miss out on treatment. But I'm not to keen on infections either.

Any guidlines on this?
The minimally invasive percutaenous venoplast should not result in infection, even in someone iwho is mmunosuppressed. There is a neglible needle sized puncture hole, that is the only entrance for infectious agents. it should close almost immediately after the procedure.

As long as, of course, proper sterile techniques are applied.

think about it, many MS meds are administered by patients and families, into the abdominal wall. That is actually more invasive since the medication increases the inflammation in the abdominal wall.

Moreover we often put in venous catheters to treat infections.

Posted: Sat May 01, 2010 9:14 am
by drsclafani
jr5646 wrote:Dr. S.,

You had mentioned venogram as the "gold standard" for ccsvi detection.. So, do think I should drop $4500 plus travel @ Buffalo - BNAC for testing, or wait and save it for a golf vacation after liberation?

Hopefully you'll get the IRB approval and get back in that saddle???

Thanks,
John

ozarkcanoer wrote:Newfie and everyone,

To my knowledge, this is what you will receive at BNAC :

To specify, you will receive:

MRV of the neck report and CD
MRI of the brain report and CD
Dopper report and CD
Clinical report only
No NP report
No genetic results

NP means neuropsychological exam. They will draw a small amount of blood for a genetic test but you will not get the results. Genetics is a very complicated thing but you are contributing to science !!

ozarkcanoer
Hard for me to comment on dr zivadinov's research project. It does seem high. perhaps some of that is going to further the research.

your call

Posted: Sat May 01, 2010 9:22 am
by Cece
Dr. S, you have a striking level of commitment...I am here because my foot drop and ON have been acting up this week and I have been resting them off...and resting...and resting...(conveniently with my laptop)...but I am pretty sure you could be off playing golf...if you are not yet tired of hearing thank you, here it is again: thank you

Posted: Sat May 01, 2010 9:33 am
by drsclafani
mmcc wrote:
girlgeek33 wrote:
mmcc wrote: I am a person willing to take a high level of risk to avoid further disability, but comparing PML to an insicion infection is hardly realistic. The risk of PML so far is estimated at 1 in 1,000, with not all cases fatal. The risk of death from angioplasty (in arteries - don't know for veins) is higher than that.

It is important to realize that neither Tysabri nor Liberation surgery, or any other medical treatment, including aspirin is risk free. The risks from libertation surgery cannot possibly be completely known at this point. I would remind you that a year into Tysabri as a monotherapy there were NO cases of PML. Liberation surgery has not been around long enough to know what the long term risks might be.

That said, I am waiting for my date to have it (and I took Tysabri, too).
I beg to differ. Angioplasty has been a well established, well practiced procedure for more than 3 decades. If this were a brand new, never performed procedure, then you would have a point. BUT, there has never been ANY reason to suggest that improved blood flow would ever have long term negative effects. The risks are early on for the most part. If something adverse were to happen, it would be earlier and not likely to be a year down the road.

This is not the invention of the wheel and it needs to be studied. This is a new use for the wheel, so understanding the benefits seems to be more the case. For that it seems to be overkill to have Drs halted doing this for us.
Angioplasty on arteries definitely has a risk. I agree with you that the risk is probably less when done on veins, but the point I am trying to make is just that libneration surgery DOES have risks - ALL surgery does. Right now there are too few surgeries done to know what that risk is.

For comparison, Tysabri (as a monotherapy) had no PML cases for almost two years after being given to thousands of people. Clearly we now know there is a risk. To me that risk - 1 in 1,000 - makes Tysabri with a very high success rate compared to the ABCRs acceptable.

I am having liberation surgery, but I think it is important to realize that the surgery is never wthout risks, and the level of that risk is not completely known yet.

I totally agree with permitting doctors to do the surgery, assuming they do whatever training is neccessary to be able to do it as safely as possible. But, we are all guinea pigs at the moment - undergoing a new MS treatment - and it is important to realize that.

I also agree that having blocked blood flow doesn't sound like a good thing.

Remember that stents were tried at Stanford and the use of that procedure was stopped because it was considered too risky considering their experience. I am sure they did not think it was as risky as it turned out to be when they started doing them.
i guess there really isnt a question here.

Posted: Sat May 01, 2010 9:41 am
by drsclafani
eric593 wrote:Dr. Sclafani,

I think it was Dr. Simka who recently responded to all the public fears now towards the use of stents and the risks involved. I believe that he commented that the risks associated with their use can be mitigated/eliminated with the proper choice of stent size and placement and that he has not had a problem with their use even though he's placed a significant number in patients.

Is this something that you have discussed with him or do you know if he is sharing his expertise in this area with stateside IR's so that they can also feel comfortable using stents in the event that angio is not successful? With somewhere around a 50% restenosis rate with angio, it would seem that the use of stents would really be optimal if we could avoid the serious risks of stent migration from happening. I'm wondering if North American IR's are learning from Simka's experience and will begin the use of stents again where appropriate.

Thanks.
I have not discussed this personally with dr simka. But we agree that stents are generally safe. If you oversize stents they should stick there. I would not hesitate to put a stent in if i have to but i have stated several times that my strategies are to validate the originator. For all i know, dr zamboni's recurrence rate might actually be better than mine or worse. Adding stents at this juncture seems premature to me. What if my recurrence rate is 5%? then i would have put stents in for no good reason. It would be another confounding variable.

My concern about stents is more related to in-stent restenosis. we will need more work to see what problems occur with this

Posted: Sat May 01, 2010 9:50 am
by drsclafani
Cece wrote:
drsclafani wrote: i think using the term surgery makes people think it is invasive and with all the risks associated with surgery.
I think it has fueled the concerns about safety beyond reality
But the IRB would know how minor of a surgical procedure it is, all things considered?
the IRB is composed of basic scientists, clinical physicians, often community representatives. Most or all do not practice in specialties that know very much about venography or venoplasty, certainly not the risks.

it is one of the functions of the principal investigator of a research project to explain all the risks of any procedures, tests, medications, etc that are part of the research components of the research. Each should be spelled out in detail, including the percentage incidence of complications of each one of them. These are scrutinized by the IRB for the sole purpose of protecting patients and their rights to safe care.

Posted: Sat May 01, 2010 9:54 am
by drsclafani
monik_77 wrote:Dear Dr. Scaflani,

Eveybody is seeing the yugular and the azygos veins in MS patients, but I have a question, in the studies developed until now, the rest of the veins of the body in MS patients were cheked and were corroborated that are normal or not???? because I think that should be necessary to see in MS patients that only these veins have the problems or determinate that is a vascular problem that also affect to more veins in the body.

Cheers,

Monica.
monica


i agree we should be paying attention to symptoms or signs that point to other venous problems.

but i th ink we should only testing for things that might be problematic to the patient. No need to search for things that are not a problem.
to study the entire body for vein problems might be very expensive and have no value.