This Is MS Multiple Sclerosis Knowledge & Support Community

Great to have you on the site Dr. Cumming. Your area of expertise is exactly what is needed. We need the Vascular Specialists to study this thoroughly. Thank you for your interest in this very promising area of treatment.

very nice to see!

newlywed4ever wrote:This is exciting, Dr Cumming! I am in Michigan's U.P. and will need follow-up care at 1,3,6,9 & 12 mos. I was initially treated by Dr Siskin in August, have an appt with Dr Sclafani the end of January (I believe I've restenosed) and have not been successful in finding follow-up care locally (meaning within a day's drive). Would you be willing to provide follow-up care?

Hi,

Yes we should be able to help.

Please send an email to stephanie@ccsvimn.com

Cece wrote:Welcome to the forum, Dr. Cumming, what a surprise!

It is great to hear that the eleven procedures so far have gone well. When I was tested by MRV, I was number four, and at that time every one of us had shown CCSVI. Have those odds held up, are you seeing CCSVI in every MS patient who comes in?

Last winter when I first looked into this, it was that alone that was very intriguing and convincing: with very few exceptions, how could every last one of us be showing up with the predicted jugular and azygous malformations....

Btw, if I say that you know me as "Jeff's wife," my identity is revealed?

Yes, your identity is revealed

We have seen about 16 patients - all have had positive US or MRV. We have treated 11 and all have had 2 or > stenosis. Hard to imagine this is just coincidence....

Hi all! I personally have talked with Dr. Cumming by phone and I'm in the Seattle area! He really seems to be a great guy and if I were going home to visit my parents in the midwest in the near future, I would go to him for the testing and procedure.

He took time out of his day, while driving his son to hockey practice to talk to me about my fears and questions surrounding CCSVI and put me at ease. I would highly recommend anyone in the midwest to go to him if you want a compassionate doc to take care of you!

I was highly impressed with him as well.

Dr. Cumming, if you're available to answer, what are your thoughts on some of what we've been hearing about tearing the annulus as opposed to just stretching it and having it recoil back in a month or two? Or on high pressure balloons or on IVUS or on any of the various techniques that the various doctors are using? Everything I know I learned in Dr. Sclafani's thread, he is very convincing....

Cece wrote:I was highly impressed with him as well.

Dr. Cumming, if you're available to answer, what are your thoughts on some of what we've been hearing about tearing the annulus as opposed to just stretching it and having it recoil back in a month or two? Or on high pressure balloons or on IVUS or on any of the various techniques that the various doctors are using? Everything I know I learned in Dr. Sclafani's thread, he is very convincing....

Its complicated And its all theory at this point (as you know).

First, we need to be clear about where in the jugular vein that we are talking about. Most lesions are proximal (near where the jugular joins the subclavian) so we'll deal with them. I really like the concept that these lesions are congenital (vs acquired) and that there are a variety of causes (see the paper the from George Washington).

One cause of these proximal lesions is an annulus of residual mesenchymal tissue. To treat this, you will need to disrupt (tear) the tissue. I believe that if you get a good venographic result, then you probably have been successful doing this. If the balloon was undersized, then you probably will see immediate recoil. So, this raises the question of balloon sizing and inflation pressures. The larger the balloon the greater the injury to the vein wall. While this may give a better immediate venographic improvement, long term it may cause a more aggressive healing response resulting in restenosis. So, my approach, at this point, is to start with a balloon similar in size to the more normal vein above and to only use a larger balloon (or cutting technique) if that does not give an good venographic result. At this time, I do not think that aggressively over dilating the vein will give a better long term result. Hopefully we will be able to learn more about balloon sizing from current studies.

Other proposed causes of narrowing include webs and stuck valve leaflets. These lesions (in my limited experience) tend to require less force to successful treat. And in these situations, I definitely do not think the balloon should be over sized (unless required). I think the goal should be to minimize the amount of intimal injury.

As for high pressure balloons, we use them, but only inflate them to the pressure require to get the balloon to completely open. These balloons are what we call non compliant versus compliant. I don't think there is much role for the use of compliant balloons in this situation.

We have IVUS but have not used it for these procedures. Some of the imaging I have seen from IVUS looks interesting and may turn out to be useful in making treatment decisions.

So, in summary, my approach to dilating, is big enough and aggressive enough to get the job done with the secondary goal of minimizing the amount of injury to the vein wall and to the surrounding normal veins.

Two of the most important questions that need to be answered are:

1. Does treating CCSVI improve the symtoms of MS.
2. Does treating CCSVI stop or slow disease progression.

Of course there is the more basic question of what is the relationship of CCSVI to patients with MS (and possibly other neurological disorders) and if the concept of CCSVI is even valid. I believe it is, but, of course, I might be wrong. The science is coming. Its going to be a turbulent and exciting journey.

Happy New Year!

You make your case quite well!

With the intimal hyperplasia, my understanding is that it starts to show up about 3 months post-procedure, so it'll be awhile before the currently treating doctors will discover it if it turns out to be significantly affected by the bigger balloons and higher pressures.

We need Dr. Tariq Sinan to publish, he is the one who has been using the larger balloons for the longest time. And we need the registries that are getting underway.

Thank you for the discussion. Much food for thought here.

mjc701 wrote: Its complicated And its all theory at this point (as you know).

First, we need to be clear about where in the jugular vein that we are talking about. Most lesions are proximal (near where the jugular joins the subclavian) so we'll deal with them. I really like the concept that these lesions are congenital (vs acquired) and that there are a variety of causes (see the paper the from George Washington).

One cause of these proximal lesions is an annulus of residual mesenchymal tissue. To treat this, you will need to disrupt (tear) the tissue. I believe that if you get a good venographic result, then you probably have been successful doing this. If the balloon was undersized, then you probably will see immediate recoil. So, this raises the question of balloon sizing and inflation pressures. The larger the balloon the greater the injury to the vein wall. While this may give a better immediate venographic improvement, long term it may cause a more aggressive healing response resulting in restenosis. So, my approach, at this point, is to start with a balloon similar in size to the more normal vein above and to only use a larger balloon (or cutting technique) if that does not give an good venographic result. At this time, I do not think that aggressively over dilating the vein will give a better long term result. Hopefully we will be able to learn more about balloon sizing from current studies.

Other proposed causes of narrowing include webs and stuck valve leaflets. These lesions (in my limited experience) tend to require less force to successful treat. And in these situations, I definitely do not think the balloon should be over sized (unless required). I think the goal should be to minimize the amount of intimal injury.

As for high pressure balloons, we use them, but only inflate them to the pressure require to get the balloon to completely open. These balloons are what we call non compliant versus compliant. I don't think there is much role for the use of compliant balloons in this situation.

We have IVUS but have not used it for these procedures. Some of the imaging I have seen from IVUS looks interesting and may turn out to be useful in making treatment decisions.

So, in summary, my approach to dilating, is big enough and aggressive enough to get the job done with the secondary goal of minimizing the amount of injury to the vein wall and to the surrounding normal veins.

Two of the most important questions that need to be answered are:

1. Does treating CCSVI improve the symtoms of MS.
2. Does treating CCSVI stop or slow disease progression.

Of course there is the more basic question of what is the relationship of CCSVI to patients with MS (and possibly other neurological disorders) and if the concept of CCSVI is even valid. I believe it is, but, of course, I might be wrong. The science is coming. Its going to be a turbulent and exciting journey.

Happy New Year!

Thank you, Dr. Cumming! Very helpful analysis. It's good to hear the different professional opinions.

Dr Cumming - apart from using smaller balloons, do you have any protocol for minimizing intimal injury; do blood thinners help? I'm not sure Cece is correct regarding the 3 month restenosis timeframe. Some patients are being retreated after only a couple of weeks.

Brainteaser wrote:I'm not sure Cece is correct regarding the 3 month restenosis timeframe. Some patients are being retreated after only a couple of weeks.

The other two types of restenosis can happen quickly (elastic recoil or thrombosis) but regrowth of the vein wall in response to injury is slower.

edited to add:
http://radiopaedia.org/articles/intimal-hyperplasia
some images there that are basic but helpful

And it says this:

Stenosis from intimal hyperplasia is often difficult to treat. Unlike soft atheromatous plaques, these stenoses are firm and require prolonged high inflation pressures to dilate with a balloon. The stenoses often recur; repeated dilatation causes repeated intimal injury and perpetuates the intimal healing response.

Cece, I'd like to hear what Dr Cumming has to say on this very serious issue. As you quote '....repeated dilatation causes repeated intimal injury and perpetuates the intimal healing response. ' If people are being retreated frequently, there is greater potential for intimal damage. Additionally, my reading of 'Re-stenosis occurring 3 to 12 months after angioplasty is typically due to intimal hyperplasia.' does not necessarily mean that there can't be intimal damage in less than 3 months.

Brainteaser, yes, now that you've restated it, I see that you weren't confused about the types of restenosis.

I agree that this is serious. Intimal hyperplasia is what the very first US patient, Cheer's husband, struggled with after the procedure. Dr. Dake is an excellent doctor and even he was not able to keep the stent from closing up permanently.

Dr. Sclafani is now doing one-month check-ups on some of the patients treated with the more aggressive pressures and sizes of balloons. So if intimal hyperplasia is a concern at the one-month time, he would already be seeing it and we can ask him this. What I meant was that he's not yet up to the 3 month or 6 month check-ups where this would be most likely start to show up. Dr. Arata, however, has been using high pressures and big balloons since July. This is at Pacific Interventionalists. They however are not collecting data to publish on, as far as I understand. I am glad that Dr. Cumming has chosen to go with a registry so that his procedures will be added to pool of knowledge.

I will go quiet now and also await Dr. Cumming's response.
There are other things too to discuss from his long post above, such as what the preliminary answers seem to be to those two questions he listed, as well as the interesting mention he made in another thread about repeat venoplasty being safe and well tolerated in his varicose veins patients.

Thank you for your research and thoughts Cece, which are always welcomed.

Yes, the success of the CCSVI treatment procedure might very well hinge on the ability to address intimal injury, especially when MS patients are receiving repeated treatments over a short timeframe.

That's interesting what you say regarding the follow up of Dr Dake's patients. I have thought that in some ways the halting of Dr Dake may have been a blessing in disguise. Surely more can be learned from concentrated aftercare and monitoring of a small group of patients than treating hundreds or thousands without a meaningful aftercare program.

I am lousy at going quiet, it is like holding my breath.

If others here are unaware, Dr. Cumming is from Canada originally, I have wondered what his perspective is on the Canadian situation.