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Dear Doc,

Yesterday there was a Live feed online with a statement form the MS society Canada. They profoundly advised against treatment, using teh following arguments:

'We are not recommending experimental endovascular surgery as a treatment for CCSVI at this time because the potential risks associated with endovascular surgery are significant, and there is as yet insufficient evidence of its potential benefit. For anyone considering endovascular surgery, here are some of the possible adverse events that need to be considered: complications and even death can occur; there is a risk of infection at the puncture site; there is a risk for damage to the blood vessel which could lead to the formation of clots; there is a risk of internal or external bleeding if anti-coagulants are used; and if a stent is inserted in an attempt to keep the vein from narrowing once more, there is a risk that the stent may become dislodged and go to the heart, which could cause death or the need for emergency heart surgery.'

Simple question: what do you think?
Especially the part of "there is a risk for damage to the blood vessel which could lead to the formation of clots"

Would really like to hear your opinion.

Regards,
Inge

I agree with GApeach - in fact, every word!! I've developed a crush on Dr. Sclafani (don't worry, doc - I'm happily married) - BUT lack of libido is very true for me and that might be another component to measure before & after liberation...

Inge67 wrote:Dear Doc,

Yesterday there was a Live feed online with a statement form the MS society Canada. They profoundly advised against treatment, using teh following arguments:

'We are not recommending experimental endovascular surgery as a treatment for CCSVI at this time because the potential risks associated with endovascular surgery are significant, and there is as yet insufficient evidence of its potential benefit. For anyone considering endovascular surgery, here are some of the possible adverse events that need to be considered: complications and even death can occur; there is a risk of infection at the puncture site; there is a risk for damage to the blood vessel which could lead to the formation of clots; there is a risk of internal or external bleeding if anti-coagulants are used; and if a stent is inserted in an attempt to keep the vein from narrowing once more, there is a risk that the stent may become dislodged and go to the heart, which could cause death or the need for emergency heart surgery.'

Simple question: what do you think?
Especially the part of "there is a risk for damage to the blood vessel which could lead to the formation of clots"

Would really like to hear your opinion.

Regards,
Inge

As someone who actually underwent the procedure, this statement sounds like someone wanted to discredit it using every known problem or possible complication. At the same time this statement was ignoring the vast majority of successful and safe outcomes. Just take the

"...there is a risk of infection at the puncture site;..."

as an example. What they didn't tell you is that the incision is approximatively 1/4 of an inch wide, and the area is carefully prepped with an iodine antiseptic. This is a standard operating procedure, and the instances of infection are very, very low.

While it is true that these problems are POSSIBLE, that doesn't mean that they are PROBABLE. Every day people undergo interventional procedures because the benefits grossly outweigh the risks.

Donnchadh

Totally agree. It would be nice though that we can counter their fear srategy with answers from professionals such as the Doc.

Dear Dr. Sclafani,


Just a quick note The Health ministry of Kuwait !!!!!! decided to treat all
its 6000 MS patients with CCSVI angioplasty . The operations would be conducted after a written approval by the patients and informing them
on possible side effects of the operation. ( Source Kuwait News Agency 08/04/2010 ) Hope to see you soon
Thank you for your dedication
Light exists while darkeness is the absence of l

drsclafani wrote:

John and I are wondering why he could not have this procedure done as elective? He paid the cash upfront for it and it should be his choice to do this. It is not like he submitted to insurance and they are denying payment.
I do understand on your end that the hospital is saying NO you can't do this right now. I just wondered from someone paying cash and electing to do this perspective.

You probably could find someone to do it....I am sure that many private physicians will treat you. If that is the way this unfolds, who will write the guidelines, the standard,s. Who will assure quality. These physicians They may or may not practice state of the art or have appropriate qualifications, etc

I would predict however that if this treatment proves to be correct, YOU will clamor for quality of care, proper credentials, published outcomes, etc.

Look, we have a handful of groups treating patients who any serious numbers. Each has his own way of doing this. Don't you want to know which is best? How are we going to learn that if it isnt published. and it shouldnt be published if you, the patient, have not been informed and protected

We CERTAINLY do want this procedure done by someone who knows what they are doing (YOU)!! I just wonder why we could not CHOSE to have you do it being well informed and knowing the risks as elective??? We are so waiting for you to do John's procedure......we will wait as long as it takes. Although, tomorrow would be NICE

Dr. Sclafani:

In case you missed this earlier question:

drsclafani wrote:Almost all of these narrowings occur near the confluens of the jugular vein with the subcclavian where valves are seen normally in about 85 per cent of patients. Problem is these valves are highly dysfunctionally developed in patients with MS. I think the IVUS really shows this really well.The venogram shows narrowing but the IVUS shows that the narrowing is valvular.

These narrowings are not inflammatory strictures and they are not "buildup of tissue on the wall of the vein (sort of like plaqeu).

How do you determine that the narrowings are not caused inflammation?

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.

Have you approached any neurologists about partnering on such a study, i.e. where you would perform the procedure, and they would do the follow-up evaluation using standard MS clinical tests, like EDSS, MSFC, QOL surveys, etc? If so, have you gotten any encouraging responses?

Thank you again for staying around to continue answering questions here.

Referring to the statement from the Canadian MS Society about the dangers of a venogram/CCSVI treatment -- I don't want to clog up this thread, but I want to express that what gets to me (and many people) is the lack of balance when a powerful and visible entity like a national MS society goes to such trouble to warn people about the "serious" risks from procedure like this yet gives positive publicity to the many other MS treatments and procedures -- many of which are associated with far more serious and even fatal problems. Have they ever issued such a public warning about, for instance, the portacaths people often get to make frequent infusions possible?

Don't forget about the symptoms no one likes to talk about...

NEURO-PSYCH symptoms... my worst MS symptoms: depression with suicide ideation, bi-polar disorder, personality disorder, paranoia, and cognitive troubles.

CCSVI treatment CAN help these symptoms... this is a must-read thread: http://www.thisisms.com/ftopic-8903-day ... asc-0.html

Even though I cannot be helped now (intracranial malformations), I still have hope for the future and find that no matter how hard I try, I cannot pull myself away from TIMS -- I'm addicted.

Dr. Sclafani, you are the most caring, understanding and compassionate person and a brilliant, forward-thinking doctor.

I hope you feel wonderful being a HERO in the MS community.

~HP

Quote:
IT was the amount of patients who could undergo neurological exams that limited our procedures.


Hi Dr. Sclafani,

Can you clarify and expand on your above quote, if that information is not inappropriate.

When I started, i never expected such a rapid growth. I guess speaking directly to patients, struck a cord and the response was overwhelming. Thanks for the trust, by the way.

My plan has always partnered with our local neurologists. I did not want to treat so many patients with MS without a neurologist to assess, confirm the diagnosis and record their neuro status prior to any intervention so that progress could be competently and objectively assessed. The increase in volume exceeded the capacity for my neurologist partners. Thus, while I could treat more patients, we could not get them examined fast enough.

So I am in the process of increasing neurologist participation, educating additional interventionalists and expanding the program

so the speedbump might actually allow me to increase treatment

Simple question: what do you think?
Especially the part of "there is a risk for damage to the blood vessel which could lead to the formation of clots"

Would really like to hear your opinion.

yes, i saw this too. i am in the process of doing an evidence based comparison of the complications of venography, venous angioplasty and anticoagulation, tysabri, copaxone and one or two other safe therapies.

will get back when i have all the information

I agree with GApeach - in fact, every word!! I've developed a crush on Dr. Sclafani (don't ...., doc - I'm ...married) - ...lack of libido ... that might be another component to measure before & after liberation...

i took a few words out.....but calm down anyway

drsclafani wrote:

yes, i saw this too. i am in the process of doing an evidence based comparison of the complications of venography, venous angioplasty and anticoagulation, tysabri, copaxone and one or two other safe therapies.

will get back when i have all the information

Interesting to see you write Tysabri in there as a safe therapy. That is debatable. lol Would be very interested to see you include Low Dose Naltrexone in the safe therapies. Much safer than Tysabri, probably even the other CRABs but sadly as a generic will likely never be FDA classified as an MS therapy. But if you have seen any of the posts about it, there is one from Joan somewhere in regards to why LDN may work so well for MS especially considering CCSVI. www.ldnscience.org, www.ldnaware.org

Maybe we should move to Kuwait????????????
Would the IRB agree to such a solution?

We do not know what the ethic standards are in Kuwait, although I am not suggesting that they are anything but ethical.

My IRB would have no standing in kuwait and i would not be obligated to work under my university's IRB. It would work under the Kuwaiti standard. But no one has invited me to kuwait yet

drsclafani wrote:yes, i saw this too. i am in the process of doing an evidence based comparison of the complications of venography, venous angioplasty and anticoagulation, tysabri, copaxone and one or two other safe therapies.

Hmmm... what could those "safe" therapies be? In all of these years, big pharma has so kindly provided us with Tysabri (around 1 in 1000 chance of developing PML which increases the longer you're on it), Interferons (which have risk of liver failure and depression), copaxone (which can cause IPIR's and lipoatrophy) or novantrone (which can cause leukemia or heart toxicity).

Oh, the wonderful choices we've had to choose from...