This Is MS Multiple Sclerosis Knowledge & Support Community

fogdweller wrote:

Cece wrote:

fogdweller wrote:Angioplasty is a very safe procedure. New uses for an accepted and safe procedure should not be a big problem.

Couldn't agree more. "But oh there was a death"...which is beyond tragic, ........

Btw it is a little known fact that when Dr Freedman did a clinical trial
on 20 (+or minus) patients with immune reboot with patient's own stem cells there was one patient who died on that trial. If you ask me the number of ccsvi even with stents surpasses the risk of that 20 patients
trial.


Take care all

Norm

Donnchadh wrote:
First of all, as someone who actually underwent the balloon procedure, it would be very difficult to partially inflate a balloon just enough for a MSer to perceive it and at the same time not be enough to relieve the stenosis.
All this just to fool the patient they have been treated? So the study can be "blind"? This isn't a pharma pill being tested.

i agree. Frankly, i do not see how you can do this ethically and humanely. I think it is premature to have such studies anyway. Would someone prove that Zamboni is validated? An entire country is being treated based on the results of 35 patients in Italy! We might want it to be true, but we need to prove that it is true.

Right now, there is a lopsided ratio of Doctors actually being able to perform the liberation procedure and truly desperate MSer's who need this only opportunity to be saved from MS. We don't have 20 years to "prove" CCSVI.

We cant rush this either. If there is no research, then every single unfortunate complication will be an albatross since we cant define the risk.

All procedures require patients to sign INFORMED CONSENT. not just research. that is a different standard than medications, most of which do not require patients to give offical informed consent after FDA approval. Procedures are different. INFORMED CONSENT requires that the patient understand the procedure, is told the incidence and types of complications, and the alternatives to treatment AND the risks and beneifts of those alternatives.

Without more studies that show those risks, NO ONE will be giving an informed consent.

A different standard of proof is needed; recording the objective observations (pre- and post- operation) of physical disabilities and patient narratives. Inductive reasoning is needed here. Each successive liberation procedure supplies the data needed to determine what's doing on.

Donnchadh

I agree.

Cece wrote:

newlywed4ever wrote:MORE Importantly! I agree with you about a study using fake venoplasty by not inflating; I cringed when I read that post.

Yeah, I wouldn't want to be in that study, and I was the one who thought it was noteworthy enough to bring up here.

I'm in favor of randomized trials if that's what it takes to get this accepted but I'd rather it not be necessary. And I don't know that it is. As far as I can google, angioplasty has never been subjected to randomized trials yet it has been in use for thirty years.

It is a different world there now. Many of us did investigation in an informal way in the past but hospitals and medical groups and societies now insist on it. Journal do not publish material without statements that the studies were done under IRB oversite.

Thanksfully, there WILL be people who will want to be in randomized double blinded trials. Either because they like it, or they feel an ethical responsibility to participate in new treatment evaluations or because (fill in the blank)

There have been many trials of angioplasty, but not as rigorous as is expected in the current era. On the other hand a recoent publication compared unconvered stents versus covered stents for restenosis of dialysis grafts. The data was informative, trustworthy and thus advanced the treatment in a secure way.

The new health care reforms require that many ideas be tested to prove efficacies and advantages over other therapies. none of us want treatments that are not proven, do we?

NZer1 wrote:Thanks for the update Dr. and others.
I have received Squeakycats first questionnaire and I hope it will be of use. Something that can be flicked around the globe at nil cost would be of so much more benefit. Some kind of adjust for error could happen. The use of expensive (MRI) type testing would not be practical for this trial. The same goes for anything that is dependant on the skills of the questioner or if there was a need for a Neuro or anyone who may have a bias.
ALSO wondering how you will go D.r with Satellite clinics around the globe New Zealand is a fantastic destination or ideal as a new central base, with easy access to rejuvenating your body, mind and soul!
Enjoy and thanks

Yes, this has potential to bring together lots of patients who have undergone therapies, including at locations where institutional review is not being done. Any data we can collect will be helpful.

As soon as my protocol is approved by my IRB, I am going to submit another one that will oversee the collection of the data we will collect from the squeaky one's efforts. Amazing

girlgeek33 wrote:Reading all the postings about randomized trials and sham surgeries it occurred to me, can't we just do studies without needing to have such things? What is the highest percentage of any "placebo" effect? From the number of people I have communicated with that have had the liberation procedure, almost everyone has significant improvements. If safety studies and studies to measure lesions and measure degree of symptoms are all done, can't the significance of the results be enough. There are so many of us, we would be lining up for these studies, well we already are, most seem to get on every list possible. I guess what I'm asking is that if significant results show in these types of studies, isn't that enough for the scientific community? Especially if we are talking about quality of life. That's what all of us with MS really care about!

Yes that data will be very valuable. but attaining overwhelming evidence is not going to be easy. It might actually be more convincing via a RCT

But remember PRIMUM NON NOCERE...first do no harm. So lets assure safety first and use the experience to create reproducible trials.

girlgeek33 wrote:

Cece wrote: I also have to wonder, at what point does common sense factor into science? Anecdotal, placebo, whatever. In our great numbers showing such significant changes has to make an impact on those in science...

Science is not about common sense. it is about a standard way of evaluating a hypothesis. You might use common sense to do something, but you use science to prove it.

Cece wrote:

girlgeek33 wrote:If safety studies and studies to measure lesions and measure degree of symptoms are all done, can't the significance of the results be enough.

I think this is exactly what Dr.S concluded, many pages back: if the pilot studies come back with overwhelming results, then no need for the randomized trials.

I might think that, but you and i both know that there are many physicians who will want Class I evidence before they send their paitents for these treatments. Thus for the sake of the community we need to have convincing evidence.

we can metaanalyze all the safety studies and there could still be nagging questions

My job is to share the things I learn, that includes trials

costumenastional wrote: Just a notice: i dont get it. I mean the doppler results. It is obvious that most of my stenoses were not highly advanced after all. I just dont understand how the doppler measurements are so different before and after. And this happened to many patients while i was hospitalized.
Also, i have the impression that injecting the dye may help the surgeon recognize were the problem is, but watching its flow it is very difficult to imagine that such tight stenoses may exist. The docs assistant told me he could see perfect blood flow. Then Dr Petrov came and found 4 places with problems. All i want to say, and please, correct me if i am wrong, is that the gold standard wouldnt be so gold if some surgeons were not so cabable. I do not think that the dye indicates the real chronic problem of the blood flow and sadly it might take years until diagnosis methods are perfected. And for now, all they do is stopping scientists from taking this further...

Sorry for the size of the post dear dr Sclafani.

I think that you had very significant stenoses. the Collaterals confirm it.

There is no direct correlation between ultrasound and venography that I know of.

Of course experience counts, in all walks of life. One cannot expect a technologist to understand or recognize everything that your imaging physician does. They have different jobs

JOJOB wrote:Hello Dr Sclafani,

I have myself a question to ask you.

I had a doppler in Paris with DR...., He did not find anything specially wrong with my jugulars except for the valve not working properly in my left jug. He told me to sleep in the inclined position. He also told me to come back to him in the next few months to have my azygous veins checked as he thought that a problem could be there.

I am not sure what Dr ..... is planning to do in a few months that he could not do now

In the meantime I have contacted an interventionist radiologist who believes in CCSVI and he programmed an MRV without any dye for the week after next. Is there any particular thing I should ask when they do it ? I have an appointment later with the dr, but it seems unlikely to me that the problem will be detected if it is lower down the azygous veins. If my understanding is correct, the only real method of finding anything is to have a catheter venogram. I would really appreciate if you could give me any guidance.
Thank you in advance.

There is valuable information from all tests. Many interventionalists use this information to plan their catheter studies. I find them informative but I make my treatment plan based upon IVUS and cathetervenography

In general MRv is not yet good enough to see the azygous abnormalities. Therefore catheter venography is necessary.

I do not understand why one would perform an MRv without contrast media.

For info: MS diagnosed 2005, 15 lesions on the brain plus one particularly annoying lesion at the top of the spinal cord that has been the subject of the last 4 relapses.[/quote]

markus77 wrote:hey doc,

just a few questions. i had the procedure in poland a few weeks ago. i received a stent on one side and angioplasty on the other. when is it possible for me to start lifting weights again? i was told to take it easy for 3 weeks. also what is the best sleeping position? does sleeping on your side affect the blood flow?

thank you sir for your time

it would be unethical for me to advise another physician's patient about such details in their treatment. You need to ask you treating doctors.

Weight lifting will markedly increase the size of the internal jugular veins during that exercise. That could lead to migration of a stent. This is a very important question to ask your physician

Hi Dr S,

Can you please go back to the Montel link if/when you have time.

http://www.thisisms.com/ftopict-11767.html

Thank you!

~Pam

fogdweller wrote:

girlgeek33 wrote:Reading all the postings about randomized trials and sham surgeries it occurred to me, can't we just do studies without needing to have such things? What is the highest percentage of any "placebo" effect? From the number of people I have communicated with that have had the liberation procedure, almost everyone has significant improvements. If safety studies and studies to measure lesions and measure degree of symptoms are all done, can't the significance of the results be enough. There are so many of us, we would be lining up for these studies, well we already are, most seem to get on every list possible. I guess what I'm asking is that if significant results show in these types of studies, isn't that enough for the scientific community? Especially if we are talking about quality of life. That's what all of us with MS really care about!

I am confused too. I was involved in doing a study with an endovascular device. We did not do sham surgeries. We just randomized the patients. Of course, our results were totally objective ... amount of ischemic dead tissue in the heart per subsequent x-ray like device. Not subjective like symptoms of MS. However, for a safety study I don't see why you would even do radomization.

I really have trouble with sham surgery in any guise from an ethics standpoint.

i agree and I will not be randomizing patients who undergo treatment under IRB oversite for a safety trial. Once I have IRB approval I will go back and see whether I can use patients on the waiting list as the controls. It changes the study but i think it is worthwhile to pursue with my IRB

ThisIsMA wrote:My apologies if this question has already been asked.

My understanding is that balloon angioplasty is a technique that has been used for decades to expand arteries and veins in many other areas of the body.

In the past, as each new location within the body for using balloon angioplasty to treat a condition was begun, were clinical trials required? Was IRB approval required? Were doctors initially prevented from doing the procedure at a new anatomical location?

Or is this a unique process that is happening with CCSVI and MS?

The reason this is happening for CCSVI and MS is clear. MS is a small group (cohort) of patients with the same disease process. Treating a patient is not research, treating a cohort is.

I have treated patients with stenoses of the jugular veins caused by cancer, injury, etc. NO PROBLEM. However if i designed a study about treating 100 patients with tumor obstructions, I would need IRB oversite.

The problem is that you are all in a well recognized cohort and being treated by something that is not proven, only suggested withpromising limited data. MS is considered a vulnerable group. thus oversite is necessary

i do not make the rules

mooshell wrote:I had an mrv w/ contrast on friday of my head, neck, and upper chest. had gone to see an intervemtional radiologist at a large teaching hospital. i had already had an mrv w/o contrast when i went to see him and he said my jugulars looked a bit small to him. enough to make him want to see more and with contrast. His nurse gave me the results today. She said he did not see any narrowing. I broke down after her call. I am very disappointed. Is there any point in having a doppler?

I also had an MRI of my heart about a wk ago just to see what it would show. I work in radiology so i got to have it as a test pt. The radiologist i work with saw an area in my heart that was dark. He said this means there is turbulance there and that usually means there is a narrowing. Could this in someway be related to ccsvi?

Would love some advice. Thank you.

While I believe that her interpretation could be correct, I think that MRv is not the test of choice. duplex ultrasound of the neck by the zamboni protocol is useful.

however even it that were normal, I think a catheter venogram should not be withheld from anyone with MS

fogdweller wrote:

ThisIsMA wrote:My apologies if this question has already been asked.

My understanding is that balloon angioplasty is a technique that has been used for decades to expand arteries and veins in many other areas of the body.

In the past, as each new location within the body for using balloon angioplasty to treat a condition was begun, were clinical trials required? Was IRB approval required? Were doctors initially prevented from doing the procedure at a new anatomical location?

Or is this a unique process that is happening with CCSVI and MS?

I have been asking this same question, and have not gotten a good response yet. I supose the hospital administrator or whoever gives permission to do a particular procedure (Not all hospitals allow their doctors to do all procedures depending on abilities and equipment and the like). If the procedure had no known benefit, I supose the adminstrator could forbid doctors at that hospital from doing that procedure (I suspect this is what hapended at Stanford). Totally new procedures or experimantal procedures go through the IRB I think.

Angioplasty is a very safe procedure. New uses for an accepted and safe procedure should not be a big problem. Inadequate circulation in the brain is something that it seems to me should be releived if we know how.

Somehow because it has become associated with treating MS we are angsting over it.

We need to do studies to get information, but we should also offer the angioplasty to people with CCSVI if they are not participating in a study.

a doctor can treat someone with a standard technique for a new indication. HE CANNOT TREAT A GROUP without IRB.

BUt again I say that while this procedure is safe in the hands of competent people, the identification of stenoses, valve problems etc, is most difficult and requires practice, training or both.

I strongly believe that as Centers open under IRB oversite, they should be used for these treatments. More concentrated experience will provide better care to paients while teaching these techniques to the next generation of practicioners.

There are many trials that need to be done

1. how many veins need to be angioplastied
2. which signs and symptoms of MS and CCSVI will repsond to venoplasty
3. stents versus no stents
4. type of stent
5. RRMS versus SPMS versus PPMS. which does it work on?
6 Role of IVUS, Doppler, MRv, catheter venogram
7 how to reduce incidence of restenosis
8 how to reduce incidence of restenosis after stenting
9. Are MS drugs necessary after liberation
10. . what about treating stenoses in patients with no MS
11. many more,

geez, i just gave away my research career