DrSclafani answers some questions

[Algis]

A quick question: why not to wear a neck brace (cervical collar?) in order to avoid the neck movements that could disturb the healing/incorporation of stent to the vein?

[drsclafani]

...
2. They wanted a double blinded study....i think that is premature, but probably needs to be done once we have figured out safety and best practice issues.

About six months ago I put you in contact with an Australian IR you previously knew or know of. He also applied for approval for a study here in Aus (and was rejected). Last time I saw him he explained the design of the study, and it sounded pretty interesting. Maybe you could email him again for clearer details.
The basics (from memory) were:
1. About 200 Patients (all MS)
2. Split into two groups (ie A & B each consisting of 100)
3. All patients would receive a venography, under a combination of 2 anaesthesia's. I don't remember the names of them, but one caused the patient to loose all track of time (so they had no idea how long they were in the operating theatre) and the second caused them to forget what happened during the procedure, with neither actually causing the patient to black-out, so they remained responsive to the person performing the procedure (ie hold your breath etc etc)
4. Half the patients would also receive treatment on this "first" venography, but no-one would be told if they did or didn't.
5. The raters were blinded to which patients were treated, and the dr's performing the venographies were to be kept away from the patient groups and raters.
6. Two months later, ALL patients would again undergo the venography, with the second group (not treated the first time) receiving treatment this second time. The patients that were treated in the first pass would be checked and treated for any restenosis.

The thing that sounded good regarding this study, was at worst, you would be treated in 2 months.

The dr's performing the venography / treatments are kept separate to the rest of the studies participants (ie patient, raters etc etc) so it attempts to approach the double blind criteria. They also had sneaky plans to push the placebo effect, but that would be hard to explain, clearly, not that the above does it all justice. I guess I simply liked the fact that worst case you would be treated in 2 months.

They also had plans to expect a % of people they didn't find CCSVI in, and the 200 (I think) number was based on achieving a certain confidence interval, assuming they didn't underestimate the number of people not found to have CCSVI.

that is very disappointing. I have thought of similar designed trials.
however jumping to a randomized trial is premature. It is like trying to fly intercontinental on the Kitty Hawk or driving transcontinental in a model T Ford. A dunk in the ocean would suggest that the idea of flying a plane across the ocean was not possible. Failure to drive the Model T from New York to San Francisco would suggest that cars could not successfully drive that far.

Randomized trials come after safety has been determined, after best practices have been determined and only then.

[drsclafani]

ok dr s. I know you are not hot to trot for stents but are the problems with them occluding caused by cell proliferation. Seems like ms folk have sticky veins(or sticky blood ) besides malformed veins. My humble opion a large dose of NAC (n-acetyl cysteine) taking continuously forever. this has been found to reduce excess cell proliferation even in cancer studies. It also is antiinflamatory and of course increases glutthione production. Hey my angioplasty from you didn't last to long I deffinately feel worse. But I also deffinately got intial improvements. So I will try again . Maybe larger ballons and web removal will be the trick. I stillthink dakes stent patiients have the highest incidents of long term improvements.But I understand your fear or worse damage. I think if you really keep an exact running chart of complaints of restenosis you are going to hear pains in neck , feeling of lack of oxygen, tiredness, cognitive fuzziness, and of course increased disability. don't ignore the aches in necks or on forehead where the veins are.these are signs. B

my biggest concern about stents is that when they fail, there is not much that can be done for them. When angioplasty fails, it can be repeated. Also it seems to me that putting a metallic foreign body in a blood vessel that has minimal blood flow in the erect position is asking for thombosis. And I think we are seeing that.

We havent really gotten any midterm followup on stents yet. Hopefully they are in the writing or reviewing stage.

AcetylCysteine does appear to be a relatively safe medication, used as an antioxidant in a variety of inflammatory diseases, as well as overdoses of medications and contrast media reactions. However it is not without risks and i would not recommend this as a method of reducing risk of stent restenosis at this point.

Recurrent symptoms really bothers me. The ideal strategies for effective angioplasty probably has not been fully worked out. Might several dilatations over a few months improve the remodeling of the abnormal collagen in the areas of obstruction? Might larger balloons do the trick to tear open fused valve leaflets? What is the optimal anticoagulation scheme? So many questions......

I am sorry that i have been hampered in retreating my patients who were managed six months ago. I never expected to be stopped like i was. It has been very frustrating and humiliating to be unable to continue treatments of patients i really care about. But perhaps it has allowed me to ask questions, seek answers and see the experiences of others without making them myself. I have to look for positives.

[drsclafani]

My humble opion a large dose of NAC (n-acetyl cysteine) taking continuously forever.

It could also good for people to take before a CT scan to help protect against potential negative effects caused by the contrast dye.. here is an article about it.

cetylcysteine works as a scavenger of free radicals that form when there is insufficient oxygen in the lower tubules of the kidney. The free radicals damage the tubules in some patients, especially diabetics with renal insufficiency.
i have found other strategies that have been more effective. A high volume infusion of fluid with sodium bicarbonate seems to be more effective in reducing the risk of the constrast media. Certain types of xray dyes have virtually eliminated this risk in most patients.

[drsclafani]

Thinking over what jak7ham9 said, one thing that stands out for me is that Dr. Dake was able to do a two-month check-up, at which many or most patients received an additional venoplasty or stent. His results may speak to the value of follow-up care, not the use of stents.

Jak7ham9, wishing the best for you.

I can only speculate on any of these results. We have to wait for outcome results in publications.

[drsclafani]

A quick question: why not to wear a neck brace (cervical collar?) in order to avoid the neck movements that could disturb the healing/incorporation of stent to the vein?

it is virtually impossible to prevent motion of the neck, even in a rigid collar.

Today, i reviewed a stent placed in the upper neck. The stent has clearly been damaged by compression against the transverse process of the second cervical vertebra

Other things are also compressed by the stenting process. Did I mention stretch or compression of the accessory nerve, also known as the 11th cranial nerve. It lies very close to the jugular vein in the upper neck and compression of this nerve leads to shoulder weakness, sometimes lasting a very long time.

[CureOrBust]

however jumping to a randomized trial is premature. It is like .... Randomized trials come after safety has been determined, after best practices have been determined and only then.

But we want to be treated now, and the ethics comities are blocking our treatment (such as yourself) until efficacy of treatment is proved. Damned if you do, and we are damned if you dont.

[drsclafani]

however jumping to a randomized trial is premature. It is like .... Randomized trials come after safety has been determined, after best practices have been determined and only then.

But we want to be treated now, and the ethics comities are blocking our treatment (such as yourself) until efficacy of treatment is proved. Damned if you do, and we are damned if you dont.

i understand your sense of urgency.

[magoo]

A quick question: why not to wear a neck brace (cervical collar?) in order to avoid the neck movements that could disturb the healing/incorporation of stent to the vein?

it is virtually impossible to prevent motion of the neck, even in a rigid collar.

Today, i reviewed a stent placed in the upper neck. The stent has clearly been damaged by compression against the transverse process of the second cervical vertebra

Other things are also compressed by the stenting process. Did I mention stretch or compression of the accessory nerve, also known as the 11th cranial nerve. It lies very close to the jugular vein in the upper neck and compression of this nerve leads to shoulder weakness, sometimes lasting a very long time.

I realize we have a long way to go before the standard is set for treating CCSVI. The various methods seem to be multiplying. As for the accessory nerve damage, it is very real. The upside is it does repair itself. Those of us who had this problem saw the problem resolve within 4-5 months. I did wear a soft cervical collar soon after treatment and I can't say if it helped my stents to integrate properly, but my results were good. The collar helped the headaches I was having which were brought on by aggrivating the nerve. My stents are very high, so not everyone with stents will have this problem.

Cece wrote:
Thinking over what jak7ham9 said, one thing that stands out for me is that Dr. Dake was able to do a two-month check-up, at which many or most patients received an additional venoplasty or stent. His results may speak to the value of follow-up care, not the use of stents.

Jak7ham9, wishing the best for you.


I can only speculate on any of these results. We have to wait for outcome results in publications.

I think Dake's follow up plan has been very beneficial. In addition, he is always available via email for any questions or concerns. He responds within minutes in most cases. I have been in constant contact with him over the past year. We also send progress emails to him. I am most excited to see the comparison in MRI from my treatment to now. The baseline was charted for us, so we will be able to measure the progress or regression.
I wish everyone had a follow up care plan. It is not a one shot deal at this point for most. Our results unfortunately will not be in medical publications because they were not in trial form. (I think )

[Cece]

I wish everyone had a follow up care plan. It is not a one shot deal at this point for most. Our results unfortunately will not be in medical publications because they were not in trial form. (I think )

It's the travelling and lack of local availability that interferes with the follow-up care. It may have taken me six months to understand why Joan was urging 'Go Local,' but what do people do when there is no local? I was also thinking of Dr. Dake finding a previously missed web and ballooning it on a patient at his one-year check-up.

But as for his results, at least short-term, they were accepted to be published! It didn't matter that it wasn't a trial.
First post (results accepted by a top medical journal):
http://www.thisisms.com/ftopicp-80051.html#80051
Second post (Stanford neuros interfere):
http://www.thisisms.com/ftopicp-95379.html#95379

[magoo]

I am 3000 miles away from Dake and the follow up plan has worked. I do however have a GP who talks with Dake when needed and has solicited help locally in case of emergency. Local is ideal, but not always available. There is no excuse for the lack of follow up care many are receiving.
As far as the paper by Dake, no one has seen it. That is CRIMINAL! He has had a lot of success and is one of the best out there. I hope one day to see it.

[1eye]

I already told this to someone, but:

Bill was a very sick baby. He had just come home. It was April 1964. I remember his head as 2 or 3 times its baby size. They took him away, and when he came home again a genius neurosurgeon named Kleider had operated on him and saved his life. I'm pretty sure the shunt was/is inside his IJV. Kleider had stopped blood flow in that vein and the shunt drained a swollen ventricle in Bill's head through a jugular path to his heart. I guess they figured it was OK to drain into venous blood as maybe with a check valve it was only taking whatever was in excess.

I'm pretty sure the IJV didn't carry any blood.

This was one of, if not the first surgery of its kind. Eventually the shunt was empty so they left it in.

My story and I'm sticking to it.

[1eye]

Certain types of xray dyes have virtually eliminated this risk in most patients.

I think I read somewhere they use India Ink. Guess that was only an early type of contrast.

To bring up Bill's jugulars: I don't see why a shunt could not be designed for this purpose. He eventually had no flow, and maybe it was always low-flow but if we can design a graphene, we should be able to handle blood. It's not corrosive, is it? Improve on nature, it may have taken eons, but it was pretty random. If natural selection had had a little design in it, maybe it would have been a lot better. As it was, it only counted till after breeding age.

[fogdweller]

my biggest concern about stents is that when they fail, there is not much that can be done for them. When angioplasty fails, it can be repeated.
...

Recurrent symptoms really bothers me. The ideal strategies for effective angioplasty probably has not been fully worked out. Might several dilatations over a few months improve the remodeling of the abnormal collagen in the areas of obstruction?

What do you think about using heated balloons? That was played with a bit years ago in coronary angioplasty, and it didn't work, but that is a different kind of restenosis. Maybe if remodeling the abnormal collagen is the goal, a heated balloon might work.

Just brainstorming.

[drsclafani]

A quick question: why not to wear a neck brace (cervical collar?) in order to avoid the neck movements that could disturb the healing/incorporation of stent to the vein?

it is virtually impossible to prevent motion of the neck, even in a rigid collar.

Today, i reviewed a stent placed in the upper neck. The stent has clearly been damaged by compression against the transverse process of the second cervical vertebra

Other things are also compressed by the stenting process. Did I mention stretch or compression of the accessory nerve, also known as the 11th cranial nerve. It lies very close to the jugular vein in the upper neck and compression of this nerve leads to shoulder weakness, sometimes lasting a very long time.

I realize we have a long way to go before the standard is set for treating CCSVI. The various methods seem to be multiplying. As for the accessory nerve damage, it is very real. The upside is it does repair itself. Those of us who had this problem saw the problem resolve within 4-5 months. I did wear a soft cervical collar soon after treatment and I can't say if it helped my stents to integrate properly, but my results were good. The collar helped the headaches I was having which were brought on by aggrivating the nerve. My stents are very high, so not everyone with stents will have this problem.

Cece wrote:
Thinking over what jak7ham9 said, one thing that stands out for me is that Dr. Dake was able to do a two-month check-up, at which many or most patients received an additional venoplasty or stent. His results may speak to the value of follow-up care, not the use of stents.

Jak7ham9, wishing the best for you.


I can only speculate on any of these results. We have to wait for outcome results in publications.

I think Dake's follow up plan has been very beneficial. In addition, he is always available via email for any questions or concerns. He responds within minutes in most cases. I have been in constant contact with him over the past year. We also send progress emails to him. I am most excited to see the comparison in MRI from my treatment to now. The baseline was charted for us, so we will be able to measure the progress or regression.
I wish everyone had a follow up care plan. It is not a one shot deal at this point for most. Our results unfortunately will not be in medical publications because they were not in trial form. (I think )

Long distance followup is difficult but not impossible. However in order for my followup to be logical i am having to find locations where Doppler screening can be done. I think i have canada taken care of but the US is more difficult. i have some ideas but cant get started unitil this followup is worked out.

With the hlp of TIMSers we have created a patient questionaire survey that patients will use before, one month, three months, six months and then every six months. the data can be tabulated and we can see any perceptible changes patients note.

now comes the really difficult part: finding neurologists who will work with me

so far i have found one, not too close but within 45 minutes of my shop. that is similar to salvi to zamboni, so it can work.

i think i am almost ready...but finding neurologists to partner with has been challenging.

s