DrSclafani answers some questions

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Postby Nunzio » Mon Apr 25, 2011 2:25 am

Cece wrote:
drsclafani wrote:Cece
this is a case where the azygous venogram showed reflux but NOTHING in two views to sugest the cause. . However IVUS easily showed a grossly abnormal valve posterior to the arch.

Have a look:

Image

There is a frontal and 70 degree oblique view.The image of IVUS shows thickened valves, outlined with orange arrows . These valves during the movie do not move. the final image on the right shows the waist of the balloon at the valvular obstruction.

I am glad for the orange arrows, because even with them I am having trouble finding the valve. What's fascinating is that you are right, it is hard to see anything in the venogram to indicate it even now that we know it is there.

I have seen this happening too often; even Dr. Galeotti showed a video where the jugular vein looked normal on venogram but they knew there was a problem at the valve level from the previously performed Doppler US.
My proposal is to use a compliant low pressure balloon in the Jugular and Azygous veins even if they look normal; that would have evidentiated the problem in the above case as shown on the picture to the right.
A compliant balloon doesn't need any special equipment and only add a little time to the procedure.
I hope any IR that doesn't have an IVUS available will use this technique.
drsclafani wrote: This is a substantial expense and we must prove its value.
The most important test would be to determine whether patients have a better outcome when IVUS is used. That is a five year study of durability and clinical outcome.

A less valuable test could be to do an "intent to treat" study. have a treatment plan based upon venography. then reveal the IVUS to the IR being studied (i will bet you guys like that one) to see whether the treatment plan changes.

Of course, we can documenet what percentage of vessels have something uncovered by IVUs, not uncovered by venography. By the way, there are other cases where ivus does not show what venography does.

My 5 year study would than compare IVUS vs. Venography with compliant balloon. I cannot visualize any lesion that would be missed by the compliant balloon and picked up only by the IVUS. The real advantage of the IVUS is in understanding how the valve leaflets move and in helping with the use of a valvulotome instrument when it will be available and knowledge is power.
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IVUS

Postby Rosegirl » Mon Apr 25, 2011 4:28 am

For those who have had one or more venograms and not seen any improvement, should we hold out for someone who uses IVUS? It seems that many doctors aren't using IVUS, so is there a way short of each of us calling each doctor to find out who has access to one?
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Postby 1eye » Mon Apr 25, 2011 5:18 am

Glad to hear there is another less expensive way which may find as many of these problems. Now we're getting into what some might consider the noise. Others the fine-tuning, at least as far as that question goes. As far as standards of care I think a lot of that seems to be determined by the market, when the patients know as much as we do about what works... sure, a few years of trials if you want, as long as you stay open.

You might want to ask the docs you are considering if they have ever used the compliant low-pressure balloon method of investigating valves. If they don't know what you're talking about, you might be able to explain it to them.
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Postby drsclafani » Mon Apr 25, 2011 5:22 am

Nunzio wrote:
Cece wrote:
drsclafani wrote:Cece
this is a case where the azygous venogram showed reflux but NOTHING in two views to sugest the cause. . However IVUS easily showed a grossly abnormal valve posterior to the arch.

Have a look:

Image

There is a frontal and 70 degree oblique view.The image of IVUS shows thickened valves, outlined with orange arrows . These valves during the movie do not move. the final image on the right shows the waist of the balloon at the valvular obstruction.

I am glad for the orange arrows, because even with them I am having trouble finding the valve. What's fascinating is that you are right, it is hard to see anything in the venogram to indicate it even now that we know it is there.

I have seen this happening too often; even Dr. Galeotti showed a video where the jugular vein looked normal on venogram but they knew there was a problem at the valve level from the previously performed Doppler US.
My proposal is to use a compliant low pressure balloon in the Jugular and Azygous veins even if they look normal; that would have evidentiated the problem in the above case as shown on the picture to the right.
A compliant balloon doesn't need any special equipment and only add a little time to the procedure.
I hope any IR that doesn't have an IVUS available will use this technique.
drsclafani wrote: This is a substantial expense and we must prove its value.
The most important test would be to determine whether patients have a better outcome when IVUS is used. That is a five year study of durability and clinical outcome.

A less valuable test could be to do an "intent to treat" study. have a treatment plan based upon venography. then reveal the IVUS to the IR being studied (i will bet you guys like that one) to see whether the treatment plan changes.

Of course, we can documenet what percentage of vessels have something uncovered by IVUs, not uncovered by venography. By the way, there are other cases where ivus does not show what venography does.

My 5 year study would than compare IVUS vs. Venography with compliant balloon. I cannot visualize any lesion that would be missed by the compliant balloon and picked up only by the IVUS. The real advantage of the IVUS is in understanding how the valve leaflets move and in helping with the use of a valvulotome instrument when it will be available and knowledge is power.


nunzio
which compliant balloon are you speaking about. I havent found one of an appropriate length and diameter. There would need to be several.

The balloons called compliant that i have had are short. Would you propose that operators interrogate the entire length of all three veins. That would take longer than an IVUS.
not all of the enigmatic lesions are at the valve level.

But i agree that it would be an acceptable alternative if we can get that technology clarified.
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Re: IVUS

Postby drsclafani » Mon Apr 25, 2011 5:27 am

Rosegirl wrote:For those who have had one or more venograms and not seen any improvement, should we hold out for someone who uses IVUS? It seems that many doctors aren't using IVUS, so is there a way short of each of us calling each doctor to find out who has access to one?


This is not an acceptable wait because
1. not sufficient number of physicians with IVUS
2. no way of finding them all
3. no proof that this is necessary
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Postby 1eye » Mon Apr 25, 2011 6:19 am

#3 is indeed a tricky one. We get into the whole cognitive dissonance/sour grapes thing and "what if I had waited?" and "did I waste my money?"

There are no guarantees in life, but sometimes a few "photographs with circles and arrows and a paragraph on the back of each one explaining what each one was" do help. Even in cases of blind justice.
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'MS' is over - if you want it
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Postby NHE » Tue Apr 26, 2011 1:58 am

1eye wrote:#3 is indeed a tricky one. We get into the whole cognitive dissonance/sour grapes thing and "what if I had waited?" and "did I waste my money?"

There are no guarantees in life, but sometimes a few "photographs with circles and arrows and a paragraph on the back of each one explaining what each one was" do help. Even in cases of blind justice.


With MS, we might as well be on the Group W bench...

"Kid, what'd you get?" "MS" "...and they all backed away."

Where can I pay my $50 fine damn it :?: :!: :x

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Re: IVUS

Postby drsclafani » Tue Apr 26, 2011 5:18 am

Rosegirl wrote:For those who have had one or more venograms and not seen any improvement, should we hold out for someone who uses IVUS? It seems that many doctors aren't using IVUS, so is there a way short of each of us calling each doctor to find out who has access to one?


There is no evidence
there is opinion.

it is my opinion that

1. ivus has been my greatest teacher of what is going on inside
2. ivus helps me greatly to finesse the procedure
3. there are alternatives to ivus, but i do not know how they compare to ivus
4. others should explore this technology to give other viewpoints

I try to use it for every case.
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Postby Nunzio » Tue Apr 26, 2011 9:25 am

drsclafani wrote:
Nunzio wrote:
Cece wrote:
drsclafani wrote:Cece
this is a case where the azygous venogram showed reflux but NOTHING in two views to sugest the cause. . However IVUS easily showed a grossly abnormal valve posterior to the arch.

Have a look:

Image

There is a frontal and 70 degree oblique view.The image of IVUS shows thickened valves, outlined with orange arrows . These valves during the movie do not move. the final image on the right shows the waist of the balloon at the valvular obstruction.

I am glad for the orange arrows, because even with them I am having trouble finding the valve. What's fascinating is that you are right, it is hard to see anything in the venogram to indicate it even now that we know it is there.

I have seen this happening too often; even Dr. Galeotti showed a video where the jugular vein looked normal on venogram but they knew there was a problem at the valve level from the previously performed Doppler US.
My proposal is to use a compliant low pressure balloon in the Jugular and Azygous veins even if they look normal; that would have evidentiated the problem in the above case as shown on the picture to the right.
A compliant balloon doesn't need any special equipment and only add a little time to the procedure.
I hope any IR that doesn't have an IVUS available will use this technique.
drsclafani wrote: This is a substantial expense and we must prove its value.
The most important test would be to determine whether patients have a better outcome when IVUS is used. That is a five year study of durability and clinical outcome.

A less valuable test could be to do an "intent to treat" study. have a treatment plan based upon venography. then reveal the IVUS to the IR being studied (i will bet you guys like that one) to see whether the treatment plan changes.

Of course, we can documenet what percentage of vessels have something uncovered by IVUs, not uncovered by venography. By the way, there are other cases where ivus does not show what venography does.

My 5 year study would than compare IVUS vs. Venography with compliant balloon. I cannot visualize any lesion that would be missed by the compliant balloon and picked up only by the IVUS. The real advantage of the IVUS is in understanding how the valve leaflets move and in helping with the use of a valvulotome instrument when it will be available and knowledge is power.


nunzio
which compliant balloon are you speaking about. I havent found one of an appropriate length and diameter. There would need to be several.

The balloons called compliant that i have had are short. Would you propose that operators interrogate the entire length of all three veins. That would take longer than an IVUS.
not all of the enigmatic lesions are at the valve level.

But i agree that it would be an acceptable alternative if we can get that technology clarified.

I found a company named Advanced Polymers that will let you specify the parameters of the compliant balloon you like to use.
COMPLIANT BALLOONS

Low pressure, thin and thick-walled
Fabricated from Polyurethane, Nylon elastomers, and other thermoplastic elastomers
Used for occlusion and anchoring in a variety of medical procedures
Compliance range: 20-100% or more
Sizes range from .5 to 60 mm in diameter in virtually any working length.
Burst pressures typically range from 0-30 psi (0-2 atm)
Typically used to replace latex and silicone balloons in critical high-value medical devices.

Advanced Polymers will custom produce a balloon to your specifications on either a production or prototype basis. Use our blank balloon drawing to create your own balloon specification.

http://www.advpoly.com/Products/MedicalBalloons/Compliant.aspx
My idea would be to use a "universal" compliant balloon 14 or 16 mm in diameter and same length as the one in the picture above. Since it dilates on very low pressure it will not damage the vessel wall even if the vein is smaller as the Azygous might be and only requires moving it once for the entire length of the Azygous vein.
I am not suggesting this to replace the IVUS, just for IR that do not have the IVUS available.
If you can patent it, just remember me when you start receiving royalties. :lol:
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Postby Cece » Tue Apr 26, 2011 9:44 am

Nunzio wrote:I found a company named Advanced Polymers that will let you specify the parameters of the compliant balloon you like to use.

kudos, Nunzio, great find!
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Re: IVUS

Postby drsclafani » Wed Apr 27, 2011 7:47 pm

Rosegirl wrote:For those who have had one or more venograms and not seen any improvement, should we hold out for someone who uses IVUS? It seems that many doctors aren't using IVUS, so is there a way short of each of us calling each doctor to find out who has access to one?


THIS IS A DIFFICULT QUESTION.

it would be presumptuous on my part to think that my way was the right way without the rigorous data necessary to prove it.

However, i am faced with the fact that I am unable to find all abnormalities on venography and that the combination of the two procedures seems to identify more than either alone.

In my practice, i always insist that IVUS be used when a patient has already had a procedure and either has dissatisfying results or loses improvements, especially in the short term.

There is a financial reality of about $2-3,000 and this is not inconsequential

one could ask the question in reverse....would you pay the premium for the IVUS?
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IVUS

Postby Rosegirl » Wed Apr 27, 2011 10:13 pm

YES!!!!!!!! Paying a premium for IVUS is a small amount compared to the cost in terms of dollars and hope that are required when faced with the prospect of needing another venogram.
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Postby NZer1 » Wed Apr 27, 2011 10:43 pm

Nunzio wrote:
drsclafani wrote:
Nunzio wrote:
Cece wrote:
drsclafani wrote:Cece
this is a case where the azygous venogram showed reflux but NOTHING in two views to sugest the cause. . However IVUS easily showed a grossly abnormal valve posterior to the arch.

Have a look:

Image

There is a frontal and 70 degree oblique view.The image of IVUS shows thickened valves, outlined with orange arrows . These valves during the movie do not move. the final image on the right shows the waist of the balloon at the valvular obstruction.

I am glad for the orange arrows, because even with them I am having trouble finding the valve. What's fascinating is that you are right, it is hard to see anything in the venogram to indicate it even now that we know it is there.

I have seen this happening too often; even Dr. Galeotti showed a video where the jugular vein looked normal on venogram but they knew there was a problem at the valve level from the previously performed Doppler US.
My proposal is to use a compliant low pressure balloon in the Jugular and Azygous veins even if they look normal; that would have evidentiated the problem in the above case as shown on the picture to the right.
A compliant balloon doesn't need any special equipment and only add a little time to the procedure.
I hope any IR that doesn't have an IVUS available will use this technique.
drsclafani wrote: This is a substantial expense and we must prove its value.
The most important test would be to determine whether patients have a better outcome when IVUS is used. That is a five year study of durability and clinical outcome.

A less valuable test could be to do an "intent to treat" study. have a treatment plan based upon venography. then reveal the IVUS to the IR being studied (i will bet you guys like that one) to see whether the treatment plan changes.

Of course, we can documenet what percentage of vessels have something uncovered by IVUs, not uncovered by venography. By the way, there are other cases where ivus does not show what venography does.

My 5 year study would than compare IVUS vs. Venography with compliant balloon. I cannot visualize any lesion that would be missed by the compliant balloon and picked up only by the IVUS. The real advantage of the IVUS is in understanding how the valve leaflets move and in helping with the use of a valvulotome instrument when it will be available and knowledge is power.


nunzio
which compliant balloon are you speaking about. I havent found one of an appropriate length and diameter. There would need to be several.

The balloons called compliant that i have had are short. Would you propose that operators interrogate the entire length of all three veins. That would take longer than an IVUS.
not all of the enigmatic lesions are at the valve level.

But i agree that it would be an acceptable alternative if we can get that technology clarified.

I found a company named Advanced Polymers that will let you specify the parameters of the compliant balloon you like to use.
COMPLIANT BALLOONS

Low pressure, thin and thick-walled
Fabricated from Polyurethane, Nylon elastomers, and other thermoplastic elastomers
Used for occlusion and anchoring in a variety of medical procedures
Compliance range: 20-100% or more
Sizes range from .5 to 60 mm in diameter in virtually any working length.
Burst pressures typically range from 0-30 psi (0-2 atm)
Typically used to replace latex and silicone balloons in critical high-value medical devices.

Advanced Polymers will custom produce a balloon to your specifications on either a production or prototype basis. Use our blank balloon drawing to create your own balloon specification.

http://www.advpoly.com/Products/MedicalBalloons/Compliant.aspx
My idea would be to use a "universal" compliant balloon 14 or 16 mm in diameter and same length as the one in the picture above. Since it dilates on very low pressure it will not damage the vessel wall even if the vein is smaller as the Azygous might be and only requires moving it once for the entire length of the Azygous vein.
I am not suggesting this to replace the IVUS, just for IR that do not have the IVUS available.
If you can patent it, just remember me when you start receiving royalties. :lol:


I like the thinking here and if I remember rightly this was suggested way, way back. :D
Thanks Nunzio,
Regards Nigel
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Two weeks before Liberation Procedure with you

Postby WeWillBeatMS » Thu Apr 28, 2011 11:14 am

Dr Sclafani,

I'm two weeks out from flying up to Brooklyn for the testing and procedure with you and I'm getting a little concerned (to say the least) about restenosis. What are the restenosis rates that you are seeing for people now? Also, daily I take 2,000 IU D3 daily, 500 MG of DHA (fish oil) Nordic Natural pills, 81 mg aspirin twice a day, and I do pretty good eating healthy. Are there any things you would recommend I do in these last few weeks to help my chances of not restenosing?

thank you,

WeWillBeatMS
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Postby drsclafani » Thu Apr 28, 2011 11:39 am

Nunzio wrote:
drsclafani wrote:
Nunzio wrote:
Cece wrote:
drsclafani wrote:Cece
this is a case where the azygous venogram showed reflux but NOTHING in two views to sugest the cause. . However IVUS easily showed a grossly abnormal valve posterior to the arch.

Have a look:

Image

There is a frontal and 70 degree oblique view.The image of IVUS shows thickened valves, outlined with orange arrows . These valves during the movie do not move. the final image on the right shows the waist of the balloon at the valvular obstruction.

I am glad for the orange arrows, because even with them I am having trouble finding the valve. What's fascinating is that you are right, it is hard to see anything in the venogram to indicate it even now that we know it is there.

I have seen this happening too often; even Dr. Galeotti showed a video where the jugular vein looked normal on venogram but they knew there was a problem at the valve level from the previously performed Doppler US.
My proposal is to use a compliant low pressure balloon in the Jugular and Azygous veins even if they look normal; that would have evidentiated the problem in the above case as shown on the picture to the right.
A compliant balloon doesn't need any special equipment and only add a little time to the procedure.
I hope any IR that doesn't have an IVUS available will use this technique.
drsclafani wrote: This is a substantial expense and we must prove its value.
The most important test would be to determine whether patients have a better outcome when IVUS is used. That is a five year study of durability and clinical outcome.

A less valuable test could be to do an "intent to treat" study. have a treatment plan based upon venography. then reveal the IVUS to the IR being studied (i will bet you guys like that one) to see whether the treatment plan changes.

Of course, we can documenet what percentage of vessels have something uncovered by IVUs, not uncovered by venography. By the way, there are other cases where ivus does not show what venography does.

My 5 year study would than compare IVUS vs. Venography with compliant balloon. I cannot visualize any lesion that would be missed by the compliant balloon and picked up only by the IVUS. The real advantage of the IVUS is in understanding how the valve leaflets move and in helping with the use of a valvulotome instrument when it will be available and knowledge is power.


nunzio
which compliant balloon are you speaking about. I havent found one of an appropriate length and diameter. There would need to be several.

The balloons called compliant that i have had are short. Would you propose that operators interrogate the entire length of all three veins. That would take longer than an IVUS.
not all of the enigmatic lesions are at the valve level.

But i agree that it would be an acceptable alternative if we can get that technology clarified.

I found a company named Advanced Polymers that will let you specify the parameters of the compliant balloon you like to use.
COMPLIANT BALLOONS

Low pressure, thin and thick-walled
Fabricated from Polyurethane, Nylon elastomers, and other thermoplastic elastomers
Used for occlusion and anchoring in a variety of medical procedures
Compliance range: 20-100% or more
Sizes range from .5 to 60 mm in diameter in virtually any working length.
Burst pressures typically range from 0-30 psi (0-2 atm)
Typically used to replace latex and silicone balloons in critical high-value medical devices.

Advanced Polymers will custom produce a balloon to your specifications on either a production or prototype basis. Use our blank balloon drawing to create your own balloon specification.

http://www.advpoly.com/Products/MedicalBalloons/Compliant.aspx
My idea would be to use a "universal" compliant balloon 14 or 16 mm in diameter and same length as the one in the picture above. Since it dilates on very low pressure it will not damage the vessel wall even if the vein is smaller as the Azygous might be and only requires moving it once for the entire length of the Azygous vein.
I am not suggesting this to replace the IVUS, just for IR that do not have the IVUS available.
If you can patent it, just remember me when you start receiving royalties. :lol:
i would never patent anything except to prevent someone else from getting the patent and restricting its use.

I just thought of a problem nunio. Even with non-compliant balloons, there is often difficulty is completely expanding such devices on curves. So i would expect that a compliant balloon would have all sorts of things that would suggest problems that are not real in the posterior and anterior aspects of the arch of the azygous.
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