DrSclafani answers some questions

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

Re: DrSclafani answers some questions

Postby drsclafani » Wed May 09, 2012 7:39 pm

NZer1 wrote:Just had a look at the Hubbard video;
http://www.youtube.com/watch?v=bS1WYWssAkc
Very positive and very thought provoking.

**Following on from my previous question as I slowly (MS thing) get my head around the 'what seems like reality' questions, would it be a fair assumption that anyone looking at PTA should,
a. ask for IVUS treatment with a first PTA
b. be prepared for requiring more than one treatment
c. have no expectations for outcomes

**And a previous question that may have slipped through the net,
*My main point is actually regarding someone with 8 treatments. Is there risk that the point of no return has happened as the scaring for instance is still building up and issues are yet to develop?

Thank you,
Nigel


the answers to a,b and c are yes, yes, and yes.

i cannot imaging treating one of my patients eight times

if you had underdilation the valves seven times, you are going to have an eighth angioplasty.
f you have an injured wall that results in scarring, you are going to have some difficulties.

The veins are highly compliant, meaning that they can dilate greatly. In most cases we are trying to dilate a stenotic immobile valve. So i do not see a reason why the vein wall should scar. If you dilate excessively, that is when you are going to injure the vein wall. Patients feel pain as that vein wall is stretching excessively i think it is important not to excessively sedate patients. Their conscious assessment is an important focus of excessive stretch
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Re: DrSclafani answers some questions

Postby drsclafani » Wed May 09, 2012 7:49 pm

japentz wrote:Hello,
Brief history, I was treated at AAC in Towson. I was the very first patient treated there for CCSVI on January 10, 2011. AT the time 18mm balloons were used which i believe damaged the endothelium and thrombosis occurred in my left IJV. I have had 4 procedures (3.5 actually as once only one vein was treated).

The left IJV clots & a large collateral attempts to do its job. Then that failed, I felt terrible and met 3 of zamboni's criteria. Because of this, on the last procedure, I allowed a stent to be placed in the left IJV. It was open for a week, then, on double dose pradaxa, the stent filled completely with a clot. I felt good when it was open, then I felt bad again. Cog fog returned. The doctor won't do the procedure again as he feels it will just clot again.

Also, NO mention ever was made of any valve problems which is a concern and I am worried that my azygous came back "normal" each time. Especially since problems with it have been stated as very intricate to see.

I am one of a number of people that had "thrombosis" happen and the vein clot off. (another being Marie Rhodes, RN, who wrote "CCSVI as the Cause of Multiple Sclerosis".

QUESTION: A number of people are just like myself and Marie, vein thrombosed and with a stent. What developments are happening and what, if anything, can be done to clear or correct a clotting vein? Is there any hope for people like us? Are you working on solution to this problem that happens more than you all would like?

Thanks!
Judy


Judy,
this is a vexing challenge. Why you develop thrombus so quickly needs to be answered first. Have you been tested for hypercoagulable states?

yes, we are looking for solutions to how to re-open occluded veins, how to deal with intimal hyperplasia causing in-stent stenosis. The answers arent there yet.
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Re: DrSclafani answers some questions

Postby tiltawhirl » Thu May 10, 2012 12:17 am

drsclafani wrote:
NZer1 wrote:Dr.S
I have just read up on others that have been treated and it seems to me to still be a guessing game from my prospective. And that must go for many others.
Cece's comments have reminded me of the learning curve and the unknowns for each individual.
Long distance, high cost packages for someone with slow progression seems to be unrealistic on a tight Budget!

*Coming over now and getting you to do your magic is still at high 'risk' of needing to have a second treatment. And in saying that, it is likely to be the way in the future as well?

*Is that how you see it as well?

Regards,
Nigel


Nigel
there are two issues here. Firstly recognize that MS is a neurodegenerative disease with neuronal loss. That will result in disability. This disability is unlikely to heal itself; at least in the short term.
CCSVI, an associated condition, with outflow obstructions of the veins draining the cerebrospinal venous circulation, results in altered drainage that may affect cerebrospinal arterial inflow and arterial pulsatile flow, and decreased drainage of cerebrospinal fluid with resultant hydrocephalus. Relief of this obstruction affects some neurological symptoms such as chronic fatigue, temperature intolerance, memory and cognition disturbances and vision disturbance, often quickly. Sometimes other symptoms such as spasticity, ataxia, motor and sensory abnormalities also improve, usually not so quickly.

Opening a vein can be done with precision and safety but what result you get from venoplasty likely depends to a large degree on the degree of neurodegenerative neuronal death that is present.


I went into the treatment as an atheist and skeptic. My friends and family rallied around me to look into this procedure since there was nothing left in the treatment box that was relevent; which led me here. I was certainly not looking for the kind of outcome I got, but just the reduction of some of my symptoms in the very best outcome situation.

Dr S, how do you explain my damned near miraculous results(and others I have seen on the web) without attributing them to the flying spaghetti monster in the sky? What other processes are at work that we don't know about in regards to proper flow vs symptom changes?
As an aside, I will be very interested in seeing if there are any new lesions in my upcoming MRI in the fall.

Thx!
tilt


Edited to add that I am aware my results are not typical, but I am curious none-the-less
...and I for one, welcome our new Neurologist overlords!

My before and after CCSVI treatment video http://www.youtube.com/watch?v=RhosV4_DvWw
Visit my Lego Amusement Rides website http://www.brickshelf.com/cgi-bin/gallery.cgi?m=Bolliger
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Re: DrSclafani answers some questions

Postby japentz » Thu May 10, 2012 10:54 am

Thank you Dr. Sclafani! Yes, I was sent to a good hematologist. There were 4 points of inflammation found that would lead to hyper coagulation, however, after my 3rd procedure those went down to normal levels within about a month. That was the first time I had it tested, and I did so just for the reason of hypercoagulation. The hematologist was very impressed at the impact the venoplasty had on inflammation and also determined that hypercoagulation was not a standard thing for me.

My neurologist found that finding interesting as well. The decrease of inflammation in the blood after a procedure as inflammation is a big part of the MS disease process supposedly.

http://youtu.be/qNkqZnpEMv4

I'm really glad to hear this is being worked on as it affects a number of those I know that were treated.

*****

Cece, the problem is on going from the beginning. I've been treated like 4 times. I sure would like *not* to have thrombosis but this is a fact in my case. I would prefer it did not happen, but healthcare costs and inability to just go and get treated, prevent keeping up with this as should be done. I posted a link to a video I just did talking about this clotting problem.

here is the video. I hope there is hope. And an answer or progress being explored to resolve this. It is important people keep it real.

http://youtu.be/qNkqZnpEMv4
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Re: DrSclafani answers some questions

Postby NZer1 » Thu May 10, 2012 3:27 pm

Thanks Dr for the replies.
* I may seem overly persistent on this but it matters to my QOL if I act without full awareness of where I am heading, mostly financially, also as an advocate of CCSVI for people in NZ, and around the World.

I am reading daily the various research and study outcomes and from that I am well aware that this whole learning on CCSVI is in an infant stage. CSF, Arterial and Venous flows need to be fully understood and that is going to take time and commitment with a very large financial support.

** What my limited thinking comes to is that it is too early to know;

a. how many treatments an individual will require over time

b. what we understand to be 'best practice' today will change daily

c. human nature will attract ripoff merchants to this need

d. Neurologists are being shown up for their lack of understanding of Neurological disease cause and their clinical tests that are 'pertinent' to MS dx are not detailed enough for the task and therefore are unable to be of assistance in this learning curve

e. Costs are high for an individual to fund CCSVI treatments when this is still an evolving understanding

f. At this point in time 2 treatments over 18 months is a minimum and this should be budgeted for and there may be need for more treatments as studies are not complete to understand the success or future approach/s to treatment

The most common expectation at the moment is that people are just now hearing of the CCSVI scenario and are not understanding that this is not a one treatment fix nor is it understood well enough to connect CCSVI being a cause to any degenerative disease. I hear daily of people down my way that had treatment early, some with Insurance some without and they are between a rock and a hard place because they have jumped without full consideration of the future unknowns and without awareness of the financial total costs

I personally am advocating that people become well educated and have discussions with the IR's who make themselves available for discussion. To consider that there will be more than one treatment required and there may be need for ongoing treatments over time. That Insurance cover may not be available to everyone and therefore the cost needs to be thoroughly investigated. A decision based on cost does not give the same service and skills/experiences across the board. Ask as many questions as possible and get answers rather than be confused by the process of getting answers.
Don't Panic!
Talk!

Regards
Nigel
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Re: DrSclafani answers some questions

Postby magoo » Thu May 10, 2012 3:34 pm

Dr. Sclafani,
Are you aware of the FDA letter sent to Dr. Mehta? If so, does this have any bearing on you treating CCSVI? Do you see any additional challenges because of this, such as insurance or liability?
I ask because I'm concerned that treating physicians may back off. I'd love to know your opinion.
Thanks as always.
Rhonda
Rhonda~
Treated by Dake 10/19/09, McGuckin 4/25/11 and 3/9/12- blockages in both IJVs, azy, L-iliac, L-renal veins. CCSVI changed my life and disease.
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Re: DrSclafani answers some questions

Postby Cece » Thu May 10, 2012 5:18 pm

I'm also struggling to understand what effect the FDA communication will have on providers or patients. Can't wait for your opinion.

This might be minor but it's being requoted in the articles coming out on the FDA communication: http://www.fda.gov/MedicalDevices/Safet ... 303318.htm
Some researchers think that narrowing (stenosis) of specific veins in the neck and chest (internal jugular and azygos veins) may cause MS or may contribute to the progression of MS by impairing blood drainage from the brain and upper spinal cord.
Is this correct that it is only the upper spinal cord that could have cerebrospinal drainage impairment? I have always believed it to be the entire spinal cord.
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Re: DrSclafani answers some questions

Postby mo_en » Fri May 11, 2012 3:24 pm

Further on the comments by Magoo and Cece, aggressive anti-CCSVI literature has arisen, which openly questions the existence of CCSVI as a pathological entity (CCSVI and MS: no meaning, no fact, Claudio Baracchini - Matteo Atzori - Paolo Gallo):

"CCSVI appears to be a rather alien condition and its existence should be definitely questioned."

What formal steps should be made in order for the scientific community to acknowledge beyond doubt that CCSVI is real and has non-trivial consequences? After all the hard and pioneering work done by you and other physicians, i find it incomprehensible that objections on CCSVI are still "existential".
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Re: DrSclafani answers some questions

Postby drsclafani » Sat May 12, 2012 9:58 pm

tiltawhirl wrote:
drsclafani wrote:
NZer1 wrote:Dr.S
I have just read up on others that have been treated and it seems to me to still be a guessing game from my prospective. And that must go for many others.
Cece's comments have reminded me of the learning curve and the unknowns for each individual.
Long distance, high cost packages for someone with slow progression seems to be unrealistic on a tight Budget!

*Coming over now and getting you to do your magic is still at high 'risk' of needing to have a second treatment. And in saying that, it is likely to be the way in the future as well?

*Is that how you see it as well?

Regards,
Nigel


Nigel
there are two issues here. Firstly recognize that MS is a neurodegenerative disease with neuronal loss. That will result in disability. This disability is unlikely to heal itself; at least in the short term.
CCSVI, an associated condition, with outflow obstructions of the veins draining the cerebrospinal venous circulation, results in altered drainage that may affect cerebrospinal arterial inflow and arterial pulsatile flow, and decreased drainage of cerebrospinal fluid with resultant hydrocephalus. Relief of this obstruction affects some neurological symptoms such as chronic fatigue, temperature intolerance, memory and cognition disturbances and vision disturbance, often quickly. Sometimes other symptoms such as spasticity, ataxia, motor and sensory abnormalities also improve, usually not so quickly.

Opening a vein can be done with precision and safety but what result you get from venoplasty likely depends to a large degree on the degree of neurodegenerative neuronal death that is present.


I went into the treatment as an atheist and skeptic. My friends and family rallied around me to look into this procedure since there was nothing left in the treatment box that was relevent; which led me here. I was certainly not looking for the kind of outcome I got, but just the reduction of some of my symptoms in the very best outcome situation.

Dr S, how do you explain my damned near miraculous results(and others I have seen on the web) without attributing them to the flying spaghetti monster in the sky? What other processes are at work that we don't know about in regards to proper flow vs symptom changes?
As an aside, I will be very interested in seeing if there are any new lesions in my upcoming MRI in the fall.

Thx!
tilt


Edited to add that I am aware my results are not typical, but I am curious none-the-less


tilt,
what i am going to say is not science, it is logical or illogical, depending upon which answer suits your fancy.

it is startling to see the kind of result that you achieved after less than perfect angioplasty. The fact that this improvement in symptoms was achieved so quickly, suggests very strongly that venoplasty is not affecting your multiple sclerosis, a chronic demyelinating disease of the white matter of brain and spinal cord. I cannot comprehend how improving venous outflow of scarred and demyelinated neurons could return your balance, improve your cognition, alter your foot drop, and return sensory reception and integration of dead neurons in 24 hours. Can anyone?

Either you have had a phenomenal placebo effect and you really dont have neurological deficits or ccsvi has its own symptoms unrelated to MS or symptoms that are confused as MS, or symptoms that overlap with MS. It is the reason i assert that i do not treat multiple sclerosis and that by correcting venous outflow derangements i in some way reduce symptoms associated with ccsvi.

I am heartened by your outstanding improvement, especially in the current hostile and very discouraging environment. I want your result to continue beyond two weeks. I must temper your enthusiasm in that we must seek durability of those improvements and remain vigilant in maintaining the correction of venous obstructions that you had.

but for the moment, tilt, smell the roses.
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Re: DrSclafani answers some questions

Postby drsclafani » Sat May 12, 2012 10:17 pm

magoo wrote:Dr. Sclafani,
Are you aware of the FDA letter sent to Dr. Mehta? If so, does this have any bearing on you treating CCSVI? Do you see any additional challenges because of this, such as insurance or liability?
I ask because I'm concerned that treating physicians may back off. I'd love to know your opinion.
Thanks as always.
Rhonda


I thought that the letter was one sided and rather negative. as to the concept of CCSVI. However, the FDA was following the letter of the law in critiquing dr Mehta's study for lack of an IDE. It is well known that an IDE is expected when devices are investigated for new indications.

How difficult will the FDA be in approving IDEs? Will the FDA delay worthwhile studies? or inhhibit investigation? Will it object to investigatory studies because of divergence in results of ultrasound studies? Will the FDA efforts worsen the political atmosphere for scientific investigation? Or will it embrace the concept, and guide and aid development of good studies? because some studies using ultrasound did not confirm the Zamboni results? Will anyone ever study CCSVI as a separate entity that seems to happen with prevalence in MS rather than debate endlessly whether CCSVI causes MS or whether treatment of CCSVI has an effect on MS.

As I said from the beginning, i thought it was premature for trials last year. Given the experiences i have had in treating patients previously treated by others with underdiagnosis, under- and overtreatment, excessive usage of stents, etc, i am quite confident that i made a correct decision.

I am ready now. All i need is about $5M.

As far as treating patients, i could not in good conscience stop treating now after seeing first hand the positive effects in so many patients. I have thought about liability but there are good safety studies in print and there are good outcomes data that i cannot ignore. I will continue to treat patients. I will also definitely notify them of the FDA opinion on this. It is all part of good practice: an informed patient, making intelligent decisions.
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Re: DrSclafani answers some questions

Postby drsclafani » Sat May 12, 2012 10:19 pm

Cece wrote:I.

This might be minor but it's being requoted in the articles coming out on the FDA communication: http://www.fda.gov/MedicalDevices/Safet ... 303318.htm
Some researchers think that narrowing (stenosis) of specific veins in the neck and chest (internal jugular and azygos veins) may cause MS or may contribute to the progression of MS by impairing blood drainage from the brain and upper spinal cord.
Is this correct that it is only the upper spinal cord that could have cerebrospinal drainage impairment? I have always believed it to be the entire spinal cord.


Do did i
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Re: DrSclafani answers some questions

Postby drsclafani » Sat May 12, 2012 10:28 pm

mo_en wrote:Further on the comments by Magoo and Cece, aggressive anti-CCSVI literature has arisen, which openly questions the existence of CCSVI as a pathological entity (CCSVI and MS: no meaning, no fact, Claudio Baracchini - Matteo Atzori - Paolo Gallo):

"CCSVI appears to be a rather alien condition and its existence should be definitely questioned."

What formal steps should be made in order for the scientific community to acknowledge beyond doubt that CCSVI is real and has non-trivial consequences? After all the hard and pioneering work done by you and other physicians, i find it incomprehensible that objections on CCSVI are still "existential".


Take 1-2 hundred patients, half with MS and half healthy controls with no symptoms and compare their venography and IVUS blindly. if there is a difference we establish by gold standards once and for all that patients with MS have abnormal venous drainage. If there is no difference, then we go home.

take 1-2 hundred patients with MS, catalog all signs and symptoms, divide them into two groups: one group receives venoplasty, or valvuloplasty using venography and IVUS to confirm successful treatment, the other group receives a sham operation. Both groups blinded to whether they have had treatment or sham. Compare improvements in symptoms for a year.Determine whether there is a benefit in the treated patients. DO NOT focus on whether there MS improves or not. That is a study for later.

That is my opinion.
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Re: DrSclafani answers some questions

Postby tiltawhirl » Sat May 12, 2012 11:57 pm

drsclafani wrote:
tiltawhirl wrote:
drsclafani wrote:


I went into the treatment as an atheist and skeptic. My friends and family rallied around me to look into this procedure since there was nothing left in the treatment box that was relevent; which led me here. I was certainly not looking for the kind of outcome I got, but just the reduction of some of my symptoms in the very best outcome situation.

Dr S, how do you explain my damned near miraculous results(and others I have seen on the web) without attributing them to the flying spaghetti monster in the sky? What other processes are at work that we don't know about in regards to proper flow vs symptom changes?
As an aside, I will be very interested in seeing if there are any new lesions in my upcoming MRI in the fall.

Thx!
tilt


Edited to add that I am aware my results are not typical, but I am curious none-the-less


tilt,
what i am going to say is not science, it is logical or illogical, depending upon which answer suits your fancy.

it is startling to see the kind of result that you achieved after less than perfect angioplasty. The fact that this improvement in symptoms was achieved so quickly, suggests very strongly that venoplasty is not affecting your multiple sclerosis, a chronic demyelinating disease of the white matter of brain and spinal cord. I cannot comprehend how improving venous outflow of scarred and demyelinated neurons could return your balance, improve your cognition, alter your foot drop, and return sensory reception and integration of dead neurons in 24 hours. Can anyone?




I am heartened by your outstanding improvement, especially in the current hostile and very discouraging environment. I want your result to continue beyond two weeks. I must temper your enthusiasm in that we must seek durability of those improvements and remain vigilant in maintaining the correction of venous obstructions that you had.

but for the moment, tilt, smell the roses.


drsclafani wrote:Either you have had a phenomenal placebo effect and you really dont have neurological deficits or ccsvi has its own symptoms unrelated to MS or symptoms that are confused as MS, or symptoms that overlap with MS. It is the reason i assert that i do not treat multiple sclerosis and that by correcting venous outflow derangements i in some way reduce symptoms associated with ccsvi.



I would be willing to admit placebo effect or some sort of somatoform disorder very willingly, if:

1. I didn't meet the McDonald criteria for MS diagnosis clinically by having lesions demonstrated seperated by both time and space
2. I hadn't played the drums for 25 years and have an intimate knowledge of coordination; then watching that coordination slowly erode before my eyes
3. Both bowel and Bladder incontinence; Who craps their pants at the office for fun?
4. The ultimate optimist my entire life suddenly so depressed I was ready to check out permanently if something didn't change(no financial, marital, or family stresses to speak of or any reason to be depressed.)
5. I hadn't had 6 years of of using a cane and renting a wheelchair for longer distances.
6. I didn't have Bone-crushing fatigue
7. I didn't have incredible heat intolerance(My whole life I always said I should have been born in the Amazon basin as my favorite weather was always 95F and 80% humidity)

Otherwise, I look forward to more research being conducted by pioneers such as yourself to find out the answers to these questions to benefit others.

I am smelling the roses, and cautiously optimistic for the future.

Thanks Dr S.

tilt
...and I for one, welcome our new Neurologist overlords!

My before and after CCSVI treatment video http://www.youtube.com/watch?v=RhosV4_DvWw
Visit my Lego Amusement Rides website http://www.brickshelf.com/cgi-bin/gallery.cgi?m=Bolliger
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Re: DrSclafani answers some questions

Postby tiltawhirl » Sat May 12, 2012 11:59 pm

drsclafani wrote:
mo_en wrote:Further on the comments by Magoo and Cece, aggressive anti-CCSVI literature has arisen, which openly questions the existence of CCSVI as a pathological entity (CCSVI and MS: no meaning, no fact, Claudio Baracchini - Matteo Atzori - Paolo Gallo):

"CCSVI appears to be a rather alien condition and its existence should be definitely questioned."

What formal steps should be made in order for the scientific community to acknowledge beyond doubt that CCSVI is real and has non-trivial consequences? After all the hard and pioneering work done by you and other physicians, i find it incomprehensible that objections on CCSVI are still "existential".


Take 1-2 hundred patients, half with MS and half healthy controls with no symptoms and compare their venography and IVUS blindly. if there is a difference we establish by gold standards once and for all that patients with MS have abnormal venous drainage. If there is no difference, then we go home.

take 1-2 hundred patients with MS, catalog all signs and symptoms, divide them into two groups: one group receives venoplasty, or valvuloplasty using venography and IVUS to confirm successful treatment, the other group receives a sham operation. Both groups blinded to whether they have had treatment or sham. Compare improvements in symptoms for a year.Determine whether there is a benefit in the treated patients. DO NOT focus on whether there MS improves or not. That is a study for later.

That is my opinion.


This has been brought up before, but how do you envision performing a sham when there is most certainly discomfort and pain when the legit procedure is performed on fully awake patients?

tilt
...and I for one, welcome our new Neurologist overlords!

My before and after CCSVI treatment video http://www.youtube.com/watch?v=RhosV4_DvWw
Visit my Lego Amusement Rides website http://www.brickshelf.com/cgi-bin/gallery.cgi?m=Bolliger
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Re: DrSclafani answers some questions

Postby mo_en » Sun May 13, 2012 6:09 am

drsclafani wrote:I am ready now. All i need is about $5M.


That's $1000 from 5000 families (or 1 year of fingolimod for 104 MS patients). Seems like it's time for e-fundraising.
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