DrSclafani answers some questions

[drsclafani]

Dear Dr. Sclafani,

I have PPMS for about 4 yers ago; however, I can still walk a few hundred meters at a normal pace at one time and can be in a motion for the whole day. I already had a CCSVI procedure about a month ago. They found a long, medial stenosis in the right IJV that was dilated. The left IJV and the azygos was fine. Unfortunatelly, I just found out a month after the operation that my right IJV got restenosed in a 1 cm long section. As my condition continued deteriorating I am just wondering if the deterioration could be due to restenosis or some veins other than IJV and azygos are also stenosed. Why do no one check other veins for these patients at most of the hospitals? Dr. Salvi, a neurologist working with dr. Zamboni, said clearly that they found a sort of ABSENCE of VENOUS OUTFLOW from the SPINAL CORD in case of PPMS patients and in most cases there was NO problem with IJVs. PPMS patients have laesios in the SPINAL CORD not only in the brain. Are interventional radiologists considering these facts when doing the CCSVI procedures? Is there a relation between the location of the laesios (e.g. brain, thoracic, lumbar or cerical part of the spinal cord) and the veins stenosed? What is your view on the veins that could potentially play a role causing laesios in the different part of the spinal cord and therefore at PPMS patients?

Look forward to hearing from you.

My proceedure begins with an injection of the left ascending lumbar vein which attempts to visualize the veins of lower spine, called the lumbar veins which also connect to the inferior vena cava and the renal vein. before proceeding to connect with the hemiazygous vein.

among the malformations that occur are poor development of the lumbar veins, leading to agenisis, which is absence, or hypoplasia which is underdevelopment. Many physicians do not perform these venograms because there is really no possible treatments for these maldeveloped veins. they take time. They are often not reimbursed by insurers.

i think that they are necessary to unravel more of the story and help patients understand the ccsvi picture better.

[drsclafani]

Hi Dr. Sclafani,

CONGRATULATIONS on your busy morning today at ISET.
Hopefully, we won't have long to wait for you to tell us all about it!

Thursday Jan 20 2011
Session XII: Symposium on Practical Issues Associated with CCSVI

Moderators: James Benenati, M.D., Barry Katzen, M.D.

9:00 AM Clinical Evaluation of MS Patients
Speaker: Salvatore J.A. Sclafani, M.D.

9:10 AM Imaging Evaluation of the MS Patient for CCSVI
Speaker: Michael Dake, M.D.

9:20 AM Venographic Evaluation of CCSVI
Speaker: Ziv J. Haskal, M.D.

9:30 AM Patient Selection for Treatment of CCSVI
Speaker: Michael Dake, M.D.

9:40 AM Patients I Chose Not to Treat
Speaker: Lindsay Machan, M.D.

9:50 AM Patient Techniques and Challenges in Treating CCSVI Patients
Speaker: Paolo Zamboni, M.D.

10:00 AM Post-procedural Care and Follow-up
Speaker: Ziv J. Haskal, M.D.

10:10 AM Panel Discussion: Should Interventionalists Become Engaged in Treating MS Patients? Panelists: Michael Dake, M.D., Ziv J. Haskal, M.D., Lindsay Machan, M.D., Salvatore J.A. Sclafani, M.D.

thanks. it was very thrilling for me. I have never been invited to speak at this meeting before. I must say that this lecture was quite challenging. Afterall, i do not treat MS, i treat ccsvi. But you have all taught me a great deal about MS over the year and I was quite comfortable discussing the clinical presentations of the disease and giving my colleagues a structured way to approach such patients.

Several in the audience asked why this was important: that is a neurologist's role. I told them that you shouldnt treat a disease if you couldnt recognize it

[drsclafani]

• Hi Dr. Sclafani,

hi searchy, pleasure to meet you.

I would like to know your opinion about the following questions, what makes me a little bit confused after reading about the technique, what is used by Dr. Sinan, and Dr Arata. ( Larger balloons, and destroying the valves)

I am using the same technique.

Dr Sinan was first to describe using larger balloons at my symposium last June. I was surprised but pleased to see that he stated that patients tolerated distension of the vein to such diameters. I was fearful that excessive distension would be problematic and lead to thrombosis.

In my knowledge the jugular vein valve is the only valve between the heart and the brain, which has a significant role in the prevention of venous reflux and plays an important role in preventing retrograde blood flow to the brain.

I wonder how important these valves are. 15% of humans do not have them.

Are they really “destroying” the valves or restoring the original normal function?

it depends upon how far the distension of the balloon. The valve is composed of two major parts, the ANNULUS which is the scaffolding for the attachment of the mobile VALVE LEAFLETS.

The annulus is very resistant to stretch, makes sense: it holds the valve leaflets at the proper distance from each other. resistance so great that it takes up to 25 atmospheres of pressure to stretch them. In the process of that stretch of inelastic tissue, a disruption of the tissue occurs.

If these velves are permanently destroyed then it does not affect the intracranial pressure?

Excellent questions you ask!
Increased central venous pressure could be transmitted along the axis of the jugular veins in situations where there are incompetent valves or absence of valves. As i said 15% of humans do not have valves. without obvious sequellae. I wonder how important these valves are in upright mammals. i can see their value in quadripeds and those animals that spend time upside down like bats.

That is not to say that reflux cannot occur. generally this pressure would be dissipated along the dural sinus and cervical collaterals. Occasionally is it reported to be associated with transient global amnesia.

However one must put that potential in perspective. If your normal jugular vein can distend to 16-18 millimeters but your annulus is fixed at 6 millimeters. You might just as well have a complete diminutive jugular vein. The vein swells to accomodate the flow just as the banks of a river swell to accomodate the spring rain. A beaver's dam restricts flow and leads to flooding upstream.

If they are destroyed what is the long-time effect of that? Does it increase the chances of transient global amnesia?

it is possible that this might occur, but that is often associated with high central venous pressure.

What happens with the remaining pieces of the valve?

i believe it remains attached to the wall. I have seen this with ivus but i am waiting more experience with ivus before really studying this.

Could transient blood reflux up into the brain cause MS lesions and damage, if valves are not there any more?

as long as there is unrestricted flow in the jugular veins, there shoujld not

but remember, we are early in this process.

[drsclafani]

Not sure if we'll hear from you tonight or not! Did anything from the other doctors' presentations change the way you think on any aspect of CCSVI?

i think mike dake made me think that some of the J2 and J3 narrowings might actually be stenoses more frequently that dr z and i think they are. But still not sure that mike is correct.
ziv haskal showed some cases where stenoses were apparent in one view but with the head turned in another direction it looked normal. That turned my head!

[Liberation]

........

[spiff1970]

Not sure if we'll hear from you tonight or not! Did anything from the other doctors' presentations change the way you think on any aspect of CCSVI?

i think mike dake made me think that some of the J2 and J3 narrowings might actually be stenoses more frequently that dr z and i think they are. But still not sure that mike is correct.
ziv haskal showed some cases where stenoses were apparent in one view but with the head turned in another direction it looked normal. That turned my head!

that's an interesting point. I had the procedure done in July. I had a stent placed in my LIJ and angio was performed in the RIJ. I experienced a small improvement in the first days but then it went back to "normal" with the usual fluctuations in MS symptoms and a small flare in September. One thing I've noticed since the intervention is that when I lie in certain positions (i.e. on my side but with the head tilted or twisted up) I feel the blood flushing in my RIJ which I suspect might mean reflux in the vein. I don't have this feeling when I lie on my back or belly. Do you have any clues of what this flush may mean?

Spiff

[suzq77]

Dr. S,

I noticed in an earlier response on this thread you said, "I hate stents."

Do you mind me asking why? After 2 venograms (1st to treat stenoses, 2nd to treat valves with larger balloons opened for longer) I restenosed - worse than ever - and all improvements regressed with a vengeance. In fact, my left IJV is completely occluded with a clot and my azygous is almost completely occluded as well.

During 3rd venogram in the 2nd week of January, doctor was unable to get to either occlusion - neither via femoral/lower approach nor via neck/higher approach with left IJV. Currently my right IJV is "big enough to drive a truck through" to quote the ultrasound tech, accommodating 75% of the blood flow. There's even a collateral on the right side (almost as big as right IJV( that needed ballooning, along with the right IJV). Both responded well.

I am scheduled for a 4th venogram with planned stent placement in a little less than 2 weeks. He doesn't like to use stents in someone my age (33) but it appears there are no other options.

Your thoughts and feedback are, as always, very much appreciated.

Thanks!

[drsclafani]

Not sure if we'll hear from you tonight or not! Did anything from the other doctors' presentations change the way you think on any aspect of CCSVI?

i think mike dake made me think that some of the J2 and J3 narrowings might actually be stenoses more frequently that dr z and i think they are. But still not sure that mike is correct.
ziv haskal showed some cases where stenoses were apparent in one view but with the head turned in another direction it looked normal. That turned my head!

that's an interesting point. I had the procedure done in July. I had a stent placed in my LIJ and angio was performed in the RIJ. I experienced a small improvement in the first days but then it went back to "normal" with the usual fluctuations in MS symptoms and a small flare in September. One thing I've noticed since the intervention is that when I lie in certain positions (i.e. on my side but with the head tilted or twisted up) I feel the blood flushing in my RIJ which I suspect might mean reflux in the vein. I don't have this feeling when I lie on my back or belly. Do you have any clues of what this flush may mean?

Spiff

spiff
it likely means that when you turn your neck, there is turbulence leading to vibrations which are giving you a sensation of flushing. i do not think that it is likely occluded since it sounds like there is flow.

[drsclafani]

Dr. S,

I noticed in an earlier response on this thread you said, "I hate stents."

Do you mind me asking why? After 2 venograms (1st to treat stenoses, 2nd to treat valves with larger balloons opened for longer) I restenosed - worse than ever - and all improvements regressed with a vengeance. In fact, my left IJV is completely occluded with a clot and my azygous is almost completely occluded as well.

During 3rd venogram in the 2nd week of January, doctor was unable to get to either occlusion - neither via femoral/lower approach nor via neck/higher approach with left IJV. Currently my right IJV is "big enough to drive a truck through" to quote the ultrasound tech, accommodating 75% of the blood flow. There's even a collateral on the right side (almost as big as right IJV( that needed ballooning, along with the right IJV). Both responded well.

I am scheduled for a 4th venogram with planned stent placement in a little less than 2 weeks. He doesn't like to use stents in someone my age (33) but it appears there are no other options.

Your thoughts and feedback are, as always, very much appreciated.

Thanks!

i hate them for many reasons
1. they are not designed for repeated rotations
2. they are not designed for the jugular vein
3. thombosis
4. intimal hyperplasia
5. they are used for failures of angioplasty

[Cece]

This was discussed at ISET: who should be treated. I was a lone voice for treating high EDSS patients on humanitarian grounds. I think they got the point.

Really? Thank goodness you were there. I do not like the thought of this being denied to the people who need it most. There is a 10 on the EDSS scale for a reason.

It must be the thought that CCSVI treatment is experimental and you do not experiment on people who are that ill. But CCSVI treatment is simply venoplasty and venoplasty is not experimental.

[suzq77]

Dr. S,

I noticed in an earlier response on this thread you said, "I hate stents."

Do you mind me asking why? After 2 venograms (1st to treat stenoses, 2nd to treat valves with larger balloons opened for longer) I restenosed - worse than ever - and all improvements regressed with a vengeance. In fact, my left IJV is completely occluded with a clot and my azygous is almost completely occluded as well.

During 3rd venogram in the 2nd week of January, doctor was unable to get to either occlusion - neither via femoral/lower approach nor via neck/higher approach with left IJV. Currently my right IJV is "big enough to drive a truck through" to quote the ultrasound tech, accommodating 75% of the blood flow. There's even a collateral on the right side (almost as big as right IJV( that needed ballooning, along with the right IJV). Both responded well.

I am scheduled for a 4th venogram with planned stent placement in a little less than 2 weeks. He doesn't like to use stents in someone my age (33) but it appears there are no other options.

Your thoughts and feedback are, as always, very much appreciated.

Thanks!

i hate them for many reasons
1. they are not designed for repeated rotations
2. they are not designed for the jugular vein
3. thombosis
4. intimal hyperplasia
5. they are used for failures of angioplasty

#1: do you mean movement in the neck?
#5: would you consider my situation a failure of angioplasty? It seems like a last resort treatment.

Thanks!

[eric593]

Wouldn't it also be considered experimenting on humans to destroy people's valves when, as you say, you don't know what the outcome is, only that 'some' people are born without jugular valves without apparent problems? Shouldn't more be known about outcomes before valves are routinely destroyed? Especially when people are paying for procedures like destroying valves where no data on safety much less efficacy exists? Could you possibly speak about the ethics of this kind of treatment that seems to go much further than performing an established procedure (angioplasty) for a different medical situation (symptoms of fatigue, cogfog, etc)?

Suzq77 - was that risky to balloon not only your RIJV but the collateral as well given that the other side and your azygous were blocked too? Did the doctor think it was risky to interfere with the only blood drainage route and its collateral since treating the other side and your azygous had resulted in.even worse blockages?

Dr. Sclafani - so many people seem to be going for repeat procedures, more than two, sometimes 3, 4, 5, over such short periods of time. Could you comment on whether there are increased risks with this or whether there should be more time between procedures, or limited procedures if the body appears to respond negatively to dilitation? There seems to be a shift to untested and/or repeated treatments. This worries me, given that MSer's already deal with a lot.

With the increase in # of people we hear about with poor or worse outcomes and/or the use of untested treatment methods outside of clinical trials, I'm wondering if it hasn't crossed into experimentation for profit on a vulnerable group? Is this something you can comment on?

For example, shouldn't the consequences already be known of destroying valves (or even whether this valve problem is restricted to the MS population at least) before such an irreversible procedure is undertaken?

I've also heard mentioned by a treating IR that he's seen the damage done to veins where cutting balloons have been used in earlier procedures. With their use, is there a risk of damaging the vein wall and creating even greater problems with their use? Are you seeing vein wall scarring/damage from cutting balloons using IVUS?

[drbart]

Hi Dr S,

Is it feasible to replace a long, thin IJV that has a long, thin (8x80!!) stent?

I see articles on bovine replacements.. has this work progressed to be useful to humans?

[suzq77]

Suzq77 - was that risky to balloon not only your RIJV but the collateral as well given that the other side and your azygous were blocked too? Did the doctor think it was risky to interfere with the only blood drainage route and its collateral since treating the other side and your azygous had resulted in.even worse blockages?

What's not risky? Walking out my front door is a risk. Taking four years of Novantrone, increasing my chances of heart damage and leukemia, was a risk. But I did it. I'm dealing with a lot of unknowns, that's just the nature of the cards I've been dealt. I think we're all just trying to do what we can to fight a disease that successfully dodges almost every bullet aimed in its direction.

I'm not being flippant or making rash decisions. I'm trying to do the best I can with the information I have. I trust my doctor. I just had a few questions regarding Dr. Sclafani's opposition to stents. I want what everyone else wants: to get better.

And the right side has always been the least troublesome. As of my 2 week follow up ultrasound (which my IR orders for the day after and 1, 2, 3, 4 etc weeks post) it looked great.

No offense to the good doctor, as he has selflessly devoted countless hours of time and energy to this cause for no personal gain of his own, but his is just one opinion. Certainly not the final one. The one that matters the most to me? Mine. It's my body and I decide what I'm going to do with it. I only get one; might as well make the most of it.

[Cece]

For example, shouldn't the consequences already be known of destroying valves (or even whether this valve problem is restricted to the MS population at least) before such an irreversible procedure is undertaken?

Eric, you are not thinking of these as functioning valves that are being destroyed, are you? These are nonfunctioning valves.