DrSclafani answers some questions

[drsclafani]

I hadn't realized it had been that long!!
I found an image of jugulars that has me uncertain.
It's from a chapter on CCSVI by Dr. Siskin & Dr. Vachon in Endovascular Interventions. http://link.springer.com/chapter/10.100 ... -7312-1_78



The Fig. 78.1 caption says that these images demonstrate normal anatomy of the mid- and distal portions of the vein. But in b, I think I see a narrowed portion in the mid-vein where the contrast looks lighter with one small collateral vein around it.

Dear Cece
it has been some time. I hope you are all well. I havent received an notifications of any additions oins to this thread so havent stopped by in some time.

I am also a bit confused by this image. They talk about distal and middle of the jugular but I find those terms confusing, preferring to use J3 and J2 for the ijv closest to head and J2 for middle. The area you mentioned does look like there is an impingement by muscle or a twist, probably physiological in nature due to rotation. However in the J1 segment near the chest is located an obvious valvular stenosis.

CCSVI activity in my practice is practically nil at this time. I see from time to time a new patient and occasionally one of my own patients needing a re-evaluation. I havent noted any new nuances to report back on. Results remain the same, mostly good and happy outcomes with other patients getting small improvements and some not getting any. I still believe that ccsvi treatments help the majority of patients but it is expensive and the published data, as bad as it mostly is, is confusing to patients who are more and more reluctant to come for a visit.

I look forward to the bravedreams outcomes to see if that will renew interest and hopefully allow me to continue to care for patients with ccsvi on a more routine basis. It is frustrating to finally become really expert in the treatment and not having anyone come

[1eye]

CCSVI activity in my practice is practically nil at this time. I see from time to time a new patient and occasionally one of my own patients needing a re-evaluation. I havent noted any new nuances to report back on. Results remain the same, mostly good and happy outcomes with other patients getting small improvements and some not getting any. I still believe that ccsvi treatments help the majority of patients but it is expensive and the published data, as bad as it mostly is, is confusing to patients who are more and more reluctant to come for a visit.

I look forward to the bravedreams outcomes to see if that will renew interest and hopefully allow me to continue to care for patients with ccsvi on a more routine basis. It is frustrating to finally become really expert in the treatment and not having anyone come

I wish to tell you that I personally still have seen no evidence to which I would give any credence (much of it tainted, skewed, politically biased, etc.), against the Big Idea.

In fact, the neurology profession has convicted itself, in my mind. It would take some serious testimony for me to ever read or listen to a member of that body again. I was skeptical from the first, long before my diagnosis, when much of my supposed meeting with "my" neurologist was spent reading (into the record) the discussion from the previous appointment, which had already been transcribed from a dictaphone tape, and was sure to be re-transcribed from the current tape. Eventually I became convinced that many of these feedback-reverberation-tapes were being kept, and documented, during my subsequent appointments at "MS" clinics. Richard Nixon would have been envious.

In fact, an acquaintance helped install the electronics and microphones, so that any visit to a local hospital can be covertly recorded. I think this is a violation of everyone's human rights by both the hospital administration and the Ontario government. Maybe there should be a commission to investigate it.

This ass-covering behaviour and waste of speech and paper, I personally put down to the guilt felt by professionals, who are complicit in the robbery of an entire class of patient, by FUD and obfuscation, using their so-called "qualifications", to fool pw"MS" into believing that their "doctors", and their phony medications, for an unknown disease, were the patients' only chance to live and recover. The real motivation for all this is for them and their drug-pushing overlords to get rich, at the expense of those who can least afford it. I thought then and still think that these people are in danger of disappearing where the moon don't shine.*

I will if at all possible arrive in Brooklyn some time in the next few months to see if I can get a better and more experienced CCSVI treatment. I know that that is not enough to keep a doctor out of retirement so I hope you are still practicing when that time arrives.

*This expression came from Dick Cavett, in an interview with Norman Mailer, when he said "Why don't you fold it five ways and put it where the moon don't shine?" My guess is that he was trying to avoid censorship by invoking the moon instead of the usual sun.

[drsclafani]

CCSVI activity in my practice is practically nil at this time. I see from time to time a new patient and occasionally one of my own patients needing a re-evaluation. I havent noted any new nuances to report back on. Results remain the same, mostly good and happy outcomes with other patients getting small improvements and some not getting any. I still believe that ccsvi treatments help the majority of patients but it is expensive and the published data, as bad as it mostly is, is confusing to patients who are more and more reluctant to come for a visit.

I look forward to the bravedreams outcomes to see if that will renew interest and hopefully allow me to continue to care for patients with ccsvi on a more routine basis. It is frustrating to finally become really expert in the treatment and not having anyone come

I wish to tell you that I personally still have seen no evidence to which I would give any credence (much of it tainted, skewed, politically biased, etc.), against the Big Idea.

In fact, the neurology profession has convicted itself, in my mind. It would take some serious testimony for me to ever read or listen to a member of that body again. I was skeptical from the first, long before my diagnosis, when much of my supposed meeting with "my" neurologist was spent reading (into the record) the discussion from the previous appointment, which had already been transcribed from a dictaphone tape, and was sure to be re-transcribed from the current tape. Eventually I became convinced that many of these feedback-reverberation-tapes were being kept, and documented, during my subsequent appointments at "MS" clinics. Richard Nixon would have been envious.

In fact, an acquaintance helped install the electronics and microphones, so that any visit to a local hospital can be covertly recorded. I think this is a violation of everyone's human rights by both the hospital administration and the Ontario government. Maybe there should be a commission to investigate it.

This ass-covering behaviour and waste of speech and paper, I personally put down to the guilt felt by professionals, who are complicit in the robbery of an entire class of patient, by FUD and obfuscation, using their so-called "qualifications", to fool pw"MS" into believing that their "doctors", and their phony medications, for an unknown disease, were the patients' only chance to live and recover. The real motivation for all this is for them and their drug-pushing overlords to get rich, at the expense of those who can least afford it. I thought then and still think that these people are in danger of disappearing where the moon don't shine.*

I will if at all possible arrive in Brooklyn some time in the next few months to see if I can get a better and more experienced CCSVI treatment. I know that that is not enough to keep a doctor out of retirement so I hope you are still practicing when that time arrives.

*This expression came from Dick Cavett, in an interview with Norman Mailer, when he said "Why don't you fold it five ways and put it where the moon don't shine?" My guess is that he was trying to avoid censorship by invoking the moon instead of the usual sun.

I would not want to get into this type of discussion. We all have frustration but only data will really speak loudly against opinion

[Cece]

I look forward to the bravedreams outcomes to see if that will renew interest and hopefully allow me to continue to care for patients with ccsvi on a more routine basis. It is frustrating to finally become really expert in the treatment and not having anyone come

Becoming expert in the treatment is worthy as there was the joy in mastery of techniques (it was amazing to share in that as it unfolded) and the possibility not just of helping individuals but of publishing and disseminating and having an influence. I think you have shown a high propensity to be right in your ideas and it takes time for everyone else to catch up. A bet on Dr. Sclafani is a good bet.

[Thekla]

Is there a review of Arata's TVA paper? Is it possible that this could perhaps be an unintended result of some ccsvi treatments that could explain the disparate results, with some 'lucky' patients having these nerve fibers simulated and a dysautonomia corrected whilst others had blockages corrected without affecting the significant nerves?

[drsclafani]

I look forward to the bravedreams outcomes to see if that will renew interest and hopefully allow me to continue to care for patients with ccsvi on a more routine basis. It is frustrating to finally become really expert in the treatment and not having anyone come

Becoming expert in the treatment is worthy as there was the joy in mastery of techniques (it was amazing to share in that as it unfolded) and the possibility not just of helping individuals but of publishing and disseminating and having an influence. I think you have shown a high propensity to be right in your ideas and it takes time for everyone else to catch up. A bet on Dr. Sclafani is a good bet.

Thanks Cece

i would say that my exploration of ccsvi and the accompanying dialogue with patients has been a highlight of my career.

The frustration lies with the inability to use the experience I have developed during that past four years.

time will tell.

S

[drsclafani]

Is there a review of Arata's TVA paper? Is it possible that this could perhaps be an unintended result of some ccsvi treatments that could explain the disparate results, with some 'lucky' patients having these nerve fibers simulated and a dysautonomia corrected whilst others had blockages corrected without affecting the significant nerves?

Thekla
This is a complicated question and I thank you for the question. I do not want to perform a critical review of Dr Arata's paper. There is some merit to his ideas but I just do not accept the concept, design, and hypothesis of it.

Most patients with MS and most patients with CcSVI have derangement of the autonomic nervous system, eg, heat intolerance, lack of sweating, low blood pressure, poor vasomotor tone in the extremities, difficulty with swallowing, to name a few.

I find it difficult to accept that balloon angioplasty for a short time will effect the vagus nerve adjacent to the jugular vein in the long term. I find that almost all patients with MS have problems with the jugular veins so I cannot accept a concept that angioplasty of normal IJV makes a difference. I do not believe in totally normal jugular veins in MS any longer. I am confident that what I see on IVUS in most patients with MS is not normal.

However i do think that the clinical improvements that are seen after ccsvi treatment are often positive effects the autonomic nervous system functions and OTHER cranial nerve functions managed by the brain stem. I am putting my money (ie my educated guess) on beneficial effects on hydrodynamics and hemodynamic changes atfer relief of internal jugular vein outflow obstructions.

If one accepts that these venous obstructions result in deranged CSF drainage that may lead to a trend to normal pressure hydrocephalus, as well as resulting in poor cerebral blood flow, relieving this obstruction may improve CSF drainage and cerebral blood flow sufficiently to improve perfusion to the brain stem and thus improve function of brain stem functions like cranial nerve problems causing diplopia, difficulty with swallowing, poor temperature control, poor vasomotor tone, etc.

Just my opinion

DrS

[pukai]

Dear TIMS - followers, dear Dr. Sclafani,

my name is Marcus, I' m living in Germany, and I had the CCSVI treatment in Brooklyn including Nutcracker stenting in the beginning of this year.

I have been what is called a "lurker" in this forum for almost exactly five years now, and for a long time, reading your posts and discussions and following the studies mentioned and linked here has been a kind of daily "virtual home" for me.
Today, I want to say thank you to all those posters who spent a lot of time to tell about their experiences, which motivated me and gave me a lot of hope. Yes, Dr. Sclafani - "only data will really speak loudly against opinion" - that' s true. But it was the personal reports of many people here in this forum that initiated great interest and a momentum for the venous connection of MS and other nervous diseases, and it gave me and many other patients a lot of energy to go on searching ways to find an effective treatment. That' s why I would like to give something back to other - perhaps new - readers in this forum and give a report about my Nutcracker and CCSVI experiences, as someone with a disease coined "MS".

I have to apologize if my post will perhaps become a longer one - it is so difficult to set priorities, and I hope this post fits to the rules of the thread. For those who are interested, I will try to pack the most important medical elements of my CCSVI and Nutcracker experiences with pathologic symptoms and description of changements after treatment into another, seperated second post, whereas this one is meant to introduce myself in this forum.
In my memory, reading about concrete problems of other people with MS here in 2009 and 2010 with informations about treatments and outcomes made me feel less alone. And to hear about which impeding symptoms in my case are probably caused by Nutcracker syndrome can perhaps help to take a second look at your own anamnesis.

The information I found here - that's what I can say for sure today - has changed my life as someone being at first diagnosed with a "mild" form of RRMS in 1997, which started to suddenly deteriorate since 2009.
With "Cheerleader' s" first notes from the Bologna meeting, which I found during a midnight internet search after having lost eyesight on one side within four days, and her text "Just the facts Ma'm", a difficult journey started.
In early 2010, I participated in a small 3Tesla - MRV imaging study in Jena according to Haacke' s SWI-protocol, revealing serious flow disturbances in the internal jugular veins. Later in 2010, there was an incorrect attempt of a Zamboni-ultrasound examination in Frankfurt, followed by another ("normal") MRV of the jugular veins and a first ballooning intervention in the same location. It showed only little success concerning fatigue for a short time. Comparing the pictures of my treatment with case studies discussed here in Dr. Sclafani' s thread, I suspected this first treatment to be incomplete and imperfect.
When in the end of 2012 strength in my legs started to vanish, balance problems occured and the neurologist expected me to probably change into Secondary Progressive MS , I decided to ask Dr. Sclafani if he could have a look on my previous treatments and data and give me an assessment of the situation. Fortunately, he answered very quickly, in a friendly way, and very focussed on a comprehensive explanation.

In early 2013 in Brooklyn, during the first examination and ballooning of both jugular vein valves and an immobile, but open valve in the azygous vein, Dr. Scalafani already found the renal vein compression and proposed stenting. But I decided - a little bit overwhelmed by his severe findings - to wait and see the results of the ballooning procedures first.
During approximately 8 months, my symptoms like balance problems, foot drop and dizziness improved, whereas urgent bladder and bowel problems (constipation) further on worsened slightly. But at Christmas time 2013, for the first time in my MS career, my walking ability deteriorated so extremely and rapidly, that I was thinking about having to use a wheelchair. For the first time, chronic pain in my upper thighs and spasticity after trying to take a short walk had started.

Almost exactly one year after the first CCSVI treatment without Nutcracker stenting, Dr S repeated the whole procedure, this time including the renal vein stenting. Jugular veins at the level of the valves had restenosed again, but were wider than before, and the pressure needed to open them up was much less this time. The whole stenting procedure - a 16 x 60mm Wallstent was inserted after IVUS measurement and testing the left renal vein by balloon - was smooth, with only short and little moments of pain. Thanks to Dr. S' s team, too - I always felt safe and secure in a friendly environment. As part of the aftercare, Dr. S recommended "gentle walking" for the next time, and I had to take Pradaxa for 4 weeks, then 100mg ASS until today.

I have waited for almost 8 months now since I had this second CCSVI treatment in Brooklyn before I decided to write about results. The outcome of the combination with Nutcracker stenting for me is tremendous. Spasticity in my legs is gone, I can walk 2 hours non stop again. No more balance problems, foot drop slowly vanished, no more dizziness. Almost no more problems with urgent bladder, no more constipation. These last two improvements have been totally unexpected ones for me.
What is amazing and a "new" symptomatic improvement occuring for the first time now: When realizing that my walking ability was going to be better and better, I plugged up courage and started jogging, very slowly and only for a very short distance.
Last year, after the first treatment without Nutcracker stenting, approximately six months later, I immediately had this balloon-felling again in my stomach / abdomen area and my legs refused to go on. when trying to move faster. This was my very first and single symptom of a disability in 1996 (!) before I developed problems with my left eye and numbness in my right hand one year later in 1997, which led to the diagnosis of MS at last. In 1996, several doctors had tried to find the reason for this "strange" problem; a gastroscopy and colonoscopy were done, ct-imaging of my small intestine, an examination of the diaphragm - without a result which could explain my symptoms.
This abdomen-leg-symptom vanished again, but over all the years until today, it came back from time to time in the same reproducible manner, whereas other clinical symptoms only occured once... Fortunately, there always was a kind of remission of this disability, but during the last years, it was a constant companion.
Now, this symptom has vanished! OK, I had some problems with coordination of my legs and with trying to keep my left foot in a straight forward direction during my first jogging attempts, but there was no more balloon-feeling and paralysis symptom of my legs any more forcing me to stop this test. I was so happy, unbelievable!
There are more symptoms and unexpected improvements obviously connected to Nutcracker stenting I will describe - as mentioned before - in my second post. The very valuable help in Leipzig/Germany by Prof. Scholbach concerning his duplex colour ultrasound examination of NCS and his experiences as a paediatrician is an important part of it, too.

This is perhaps no cure and I will always have the feeling of Damokles' sword hanging over my head. 51 years of bloodflow out of the left renal vein being more or less intensively directed into my epidural plexus and spinal canal can be the cause of neurological damage that leads over time to an effect in the immune system reaction. Perhaps this triggers an "autoimmune" answer which then has damaging effects itself. The pathophysiological mechanisms have still to be investigated.
But today, I am convinced that the veins described in CCSVI, Nutcracker syndrome and probably May-Thurner syndrome belong together as central areas of the venous system with impact on several disabilities connected to the nervous system. They should be examined and treated, if necessary, alltogether. For each patient, time is of the essence.

Thank you again all you TIMS - posters, but especially thanks to Dr. Sclafani and Joan Beal for your uncomparable dedication.

-Marcus

[1eye]

Thank you, Marcus. You have succeeded as well as today's medicine can, and I hope you have very long-lasting results. The description of the problem with misdirected kidney drainage is very informative.

Keep up the jogging!

And thank you, too, Dr. Sclafani.

[drsclafani]

This is perhaps no cure and I will always have the feeling of Damokles' sword hanging over my head. 51 years of bloodflow out of the left renal vein being more or less intensively directed into my epidural plexus and spinal canal can be the cause of neurological damage that leads over time to an effect in the immune system reaction. Perhaps this triggers an "autoimmune" answer which then has damaging effects itself. The pathophysiological mechanisms have still to be investigated.
But today, I am convinced that the veins described in CCSVI, Nutcracker syndrome and probably May-Thurner syndrome belong together as central areas of the venous system with impact on several disabilities connected to the nervous system. They should be examined and treated, if necessary, alltogether. For each patient, time is of the essence.

Thank you again all you TIMS - posters, but especially thanks to Dr. Sclafani and Joan Beal for your uncomparable dedication.

-Marcus

Dear readers,
Marcus' story is unfinished and there some amazing parts that may or may not be divulged in the future. These undisclosed parts of this story are incredible and unbelievable, but await further work.

Marcus has been an amazing patient. Thoughtful, persistent and adventurous, together we have learned quite a bit.

I am happy for your improvements

S

[Rosegirl]

Dear Dr. Sclafani,

Dr. Zamboni and others cautioned patients to wait for proven protocols if their condition warranted it. No major trials have been completed yet, but, based on your experience, can you give an overview of what is most likely to improve?

For example, two years ago, it seemed that CCSVI treatment often worked well with symptoms like dizziness, fatigue, cognitive problems and other symptoms that were literally all in the head.

For those who have trouble walking, it seemed that the patient either got complete relief or no improvement at all.

And for those non-responders or patients who relapsed after treatment, is there a limit on how many times and how often one might have a CCSVI procedure?

Thanks,

[drsclafani]

Dear Dr. Sclafani,

Dr. Zamboni and others cautioned patients to wait for proven protocols if their condition warranted it. No major trials have been completed yet, but, based on your experience, can you give an overview of what is most likely to improve?

This is a wise and politically appropriate caution. However some patients choose to have a procedure done before completion of trials because there are difficulties in getting trials started and finished. Moreover, doing trials without first analyzing safety and best practice made no sense either. So as I have no funding to do a trial, I continue to treat patients based on compassionate grounds, my own assessment of the validity of treatment and my own sense of risk/benefit analysis. Had outcomes of treatment been worse or risks more profound, I likely would have stopped treating as risk/benefit trumps compassionate use in my ethics.

That said, I have now learned many things

1. I cannot predict who will get benefits
2. I cannot set the value of benefits to an individual
3. The risks are now very low
4. my protocol is set
5. I do not have clarity regarding compression narrowings of the J2 segment, nor a good IR treatment of J3 impingements. Need more data before stenting them.
6. I do not want to stent the internal jugular veins except for bale out of complications or possibly stenoses persistently resistent to angioplasty
7. The evaluation of the Nutcracker syndrome is absolutely essential in patients with MS.
8. IVUS is very important for diagnosis and treatment planning, and assessment of angioplasty outcomes
9. Large high pressure balloons are essential
10. Primary progressive MS is different. While some patients do get improvements, many do not
11. I have seen every disability improved in at least one patient
12. most common improvements seem to be brainstem functions, such as cranial nerve function (diplopia, visual disturbance, dysarthria and dysphonia, swallowing difficulties) sympathetic nervous function (sweating, bladder difficulties, etc), temperature regulation, fatigue, balance. Other common improvements include relief from cognitive impairment, memory, fatigue, depression
13. severe ataxia rarely resolves, but may improve
14.
15. Improvements can take up to a year to be manifest. (One patient with hypothalamic dysfunction manifested in spermatogenisis took over one year to return to normal.)
16. A poor start on research, a fascination with replicating Zamboni's work on ultrasound, and a general, out of proportion, negativity to the concepts regarding the role of ccsvi as a cause of MS rather than as a method of symptom relief have distracted from good research partnerships.

For those who have trouble walking, it seemed that the patient either got complete relief or no improvement at all.

walking disability is complicated because spastic paralysis and paresis, imbalance, and fixed foot drop, together with a generally unfit physique impair ability to improve walking in many patients. Improvements in ambulation often take a very long time but do occur. Unfortunately dead neurons cannot be resurrected. However dysfunctional neurons can be made to work better in my belief.

And for those non-responders or patients who relapsed after treatment, is there a limit on how many times and how often one might have a CCSVI procedure?

first, patients who have return of disability:
1. early relapse of definite improvements suggests thrombosis or restenosis of treated veins. Venography should be repeated.
2. If this were an insured treatment, I would recommend follow-up venography in three months routinely regardless of .
3. If I suspected thrombosis, I would urgently perform ultrasound and if thrombosis was confirmed I would rush to venography and restore flow asap
4. No restenosis or thrombosis is found on followup venography and the initial examination performed was detailed, included IVUS, and imaged the dural sinuses, both jugular veins and brachiocephalic veins, the azygos vein, the left renal vein, the left iliac vein, I would suspect a placebo effect that dissipated.

Similarly for 'nonresponders:
1.if the exam was detailed, included IVUS and all relevant veins, I would think that neuonal death has trumped CCSVI flow deficits and that the treatment will not work.
2. if the exam was not a complete one, I would have no hesitation to repeat it as some patients with incomplete treatments can get better by doing the full deal. Witness Marcus' (Pukai's) improvements that really got better only after treatment of the nutcracker syndrome's contribution to spinal cord venous congestion.

[dlynn]

Dr. Sclafani,
Is it safe to assume, since you placed stents and I have no more pain, that blood flow is normal and my LRV is patent
and without clot?
And also, if blood flow is normal through those stents, is that any indication that stents if placed in, say, IJVs or Azy
would fare as well?
In what situation would you use a self expanding balloon?

Thank you

[drsclafani]

Dr. Sclafani,
Is it safe to assume, since you placed stents and I have no more pain, that blood flow is normal and my LRV is patent
and without clot?

I do not worry about loss of patency like I do from stenting of the internal jugular veins. Thrombosis after stenting of the renal vein is pretty uncommon. It is much less than the risk of thrombosis of stents in the internal jugular veins. In stent stenosis due to intimal hyperplasia is also uncommon. symptoms of renal vein thrombosis include blood urine, hypertension, chemical evidence of renal insufficiency and pain.

And also, if blood flow is normal through those stents, is that any indication that stents if placed in, say, IJVs or Azy
would fare as well?

I have very little experience with stenting of the azygos vein. Not much indication in my view. I would not look at stenting of the internal jugular vein in quite the same light. There are many differences

1. IJV stenosis is mostly intraluminal disease that responds well to angioplasty, rarely need stents....renal vein stenosis is extraluminal disease due to compression that does not respond to angioplasty and requires stenting
2. IJV flow is intermittent depending upon position of neck, standing, etc. Renal venous flow is higher than IJV
3.intimal hyperplasia is quite common in ijv stenting, but not n early so in renal vein stenting.

In what situation would you use a self expanding balloon?

there is no self expanding balloon. Do you mean self expanding stent?

Thank you[/quote]

[dlynn]

Dr Sclafani,
Yes, I do mean stent.
"There is no self expanding balloon. Do you mean self expanding stent?"

And also if there is any pain in the same location as previous to stenting the LRV, does that mean there is
problems again with PCS or the LRV or both? I sometimes get pain, not chronic as in the past, but this
concerns me. What are your thoughts on this? It's been nearly two years since the procedures (12-12)
Thank you