DrSclafani answers some questions

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Re: DrSclafani answers some questions

Postby NZer1 » Mon Jan 15, 2018 4:47 pm

Hi Sharon,
would be a positive if the responses 'appeared' else where, imo!

I am ... and well! :)
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Re: An easy question

Postby drsclafani » Tue Mar 27, 2018 3:33 pm

costumenastional wrote:
drsclafani wrote:yes ccsvi could be the cause of the tinnitus, so could it be a symptom of MS
tinnitus is often heard when the dye is injected into the catheter. it is related to turbulent flow near the middle ear.



No way! My dear neuro told me that i have tinnitus because i listen to loud music :) I guess trance lovers are all experiencing this stupid thing.
The fact that it started after my first relapse and 5 days of solymedrol had nothing to do with it of course. Another just told me "yes, you may well become deaf from MS".
Same goes for the black spots i ve been seing in both my eyes after my optic neuritis. No MS related. We all see black spots occasionaly was their expanation...Again, the fact that it started right after my left eye went blind is just another coincidence.

Dear Doctor Sclafani, it is so obvious what we are dealing with here...
And it is ridiculous that having a real doctor to explain stuff everyone should know, comes as such a surprise. But i ll take what i can get and hope you ll stick around cause for most of us, having the chance to really learn is phenomenal and beyond our expectations.

Thank you.


Probably not many people still here. I was looking for something and read this discussion about tinnitus.
Evidence is pretty clear that tinnitus by itself, even without MS, is associated with CCSVI and that angioplasty has high efficacy in treating Meniere's disease that has failed all other therapies. Meniere's is tinnitus, vertigo, ear fullness and pain, hyper accusus and hearing loss.

Tell your neuro

DrS
Salvatore JA Sclafani MD
Patient contact: ccsviliberation@gmail.com
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be heard

Postby drsclafani » Tue Mar 27, 2018 3:48 pm

DizzyLiz wrote:Ahmen Dr Sal. What can we do to help?
DL


As I said back in 2010 and 2011, doing a randomized trial without safety trials and without determining best technical practice would not get the proper data.
Now we see an underpowered study in Brave Dreams where large high pressure balloons and IVUS were not used.
benchmarks and biomarkers without good dissection of various symptoms is a real limitation..
Brave Dreams was a disappointment to me for many reasons but technical discussion was absent so it is impossible to critically analyze the results, as underpowered as they are.

Hector Ferral and I think it would be a good idea to analyze long term outcomes to see whether angioplasty by our techniques (fairly similar: use of IVUS, high pressure balloons, routine anticoagulation, etc. We are confident that short term clinical relief is obtained in a fair amount of patients but longo term relieff is not so clear. l

We think it is time too re-evaluate are early patients, 2011 and especially 2012. If there are any patients who are willing to help as DIzzyLiz says above, We do need help.
Please spread the word that Dr. Sclafani and Ferral seek followup from our patients to clarify long term effects like reduction in attacks, stabilization of symptoms, etc.

To any of my patients from the past, please email me at ccsviliberation@gmail.com and those of Dr Ferral, email him.

DrS
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Patient contact: ccsviliberation@gmail.com
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Re: DrSclafani answers some questions

Postby NZer1 » Fri Apr 06, 2018 10:19 am

Hi Dr S :)
Do you think that many of the published papers on CCSVI trials are presenting impressions that are not the true effects of a change in the vascular flow?

Better said that the study results are not honestly or clearly able to report the process because of the methods for recording change are too black and white and the peer process is by knockers and not thinkers who have questions?

It appears that the way the change is reported is failing Science. For instance, the reports don't state that a person had xyz flow found by Doppler and or IVUS then had PTA which changed the flow to abc percentage at the time of treatment and the change was checked again at 6 months, 1 year and three years and the flow was nmo at three years.
Also needed is the report of change in symptoms reported at each time frame.

If PTA can be seen this way whereby for instance an improvement of 75% happened during treatment lasted 6 months but was lost by 1 year and the patient had a minimal change such as bladder and headache improvement but was lost in the same time increments. Another patient may have had 90% improvement during treatment which lasted for 6 months, 1 year and 3 years and the symptom improvement was dramatic and increased during the time (3 years). In essence, an 'under and over' statement showing the breakpoint of what works and what won't work, eg less than 75% and over 85%?

If the above situation was reported it would show what is happening, aka that undertreating doesn't work, that some improvement by PTA can work and that follow up is the only way to show what is occurring by treating. Reporting on 75% change at PTA treatment time as being an indication for PTA overall is simply a lie! Many personal reports have shown that there appears to be a break point for flow change where under eg 75-80% will not improve symptoms and over that % will BUT the literature is so poorly written that this isn't heard.

It's as though all the drama that is occurring to debunk CCSVI is caused by poor quality reporting and concluding! As well as the biases by $$$ and Egos.

So the issue is quality reports and quality thinking. Way too many knockers and Science is shooting itself in the foot and not acknowledging its failings.

;)
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Re: DrSclafani answers some questions

Postby NZer1 » Fri Apr 06, 2018 11:24 am

More as I get my words in order ... ;)

Very frustrating seeing the peer review process is being corrupted by $$$ and Pharma is often the fuel.
Egos and job security issues are driving Science in the wrong direction far too often.
The example of CCSVI treatment having a positive effect on some of the PwMS population is a classic example of how language skills plus twisting the reports of findings are used to either not document honestly or not document fully the things that did happen and the things that might happen if the trial quality was improved rather than the technique.
The technique is in an embryo stage, same with the learning curve but some of the debunking 'team' has far too many issues that are not about learning or open-minded thinking instead about Egos, $$$ and individual job statuses.
Another example is to report that PTA doesn't work when the PTA didn't actually reach a % of flow increase that is either consistent, eg all px with 85% or greater improvement after PTA, or a % of treatment by PTA that is known to make a difference in symptoms such as greater than 80-85% sustained for more than 1 year.
VERY poor quality reporting and it can only be for corruption of the Science that it is driven by, imo.

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Re: DrSclafani answers some questions

Postby NZer1 » Sat May 05, 2018 8:22 am

Hi Sal,
Have you considered presenting a paper for publishing that shows the incidence of vascular issues and that same paper doesn't say that treatment was used?
I am guessing that you have had lots of px and also that you have seen all sorts of problems that show there is a problem.
If the FDA are shown that there is a common problem then that detail is the focus rather than whether it is treatable by PTA etc.
The FDA saying that treatment doesn't work is not correct to some cases and should not be the focus, the focus needs to be simply incidence, imo
The use of IVIS to identify and show that there is a need for treatment development creates a vacuum again where the FDA has to ask themselves why they are stopping IR's from treating.
The reason for stopping IR's appears to be for covert, eg Pharma or Neuro, reasons of ignorance and bruised Egos or reasons for protecting against loss of revenue to Pharma.
It would seem that the thinking time has come in the treatment arm/IR's to also show that the treatment must have a regular improvement in each px to warrant the PTA option. That the treatment must achieve a flow improvement of xyz % before the px gains improvements, therefore, the responsibility for an IR to use IVIS and to follow px for eg at least two years gives a new level of responsibility to the IR.
There have been too many examples of not achieving better than 75% flow improvement and therefore the px doesn't have improvement but does have huge costs. That finding of less than 75% and the costs seem to be the FDA and Neuros tool for stopping the whole process of helping PwMS and returning to the auto-immune concept and the take this drug game.
So again the FDA stopping the method and IR's has to be clarified WHY and then re-approached with new considerations as to the method by IR's. Like saying yes the problem exists first and it is indisputable before even saying that it is a cause of disability. And also that previous PTA has been a learning curve that improvements have to be present, sustainable and greater than eg 75% before moving to doing the treatment by PTA and IVIS.

The information you have is useable to show incidence, and that is the most important detail that gets swept under the matt by Neuro's and Pharms!

Please use what you have in records to show incidence and with a clear picture of incidence, rather than the issue that FDA requires an expensive trial process which with its reductionism and study methods gets manipulated to mean things that aren't correct or honest assessments.

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Re: DrSclafani answers some questions

Postby NZer1 » Sat May 05, 2018 8:40 am

An example of putting pressure back on the FDA without talking about the PTA directly.

Understanding jugular venous outflow disturbance.
https://www.ncbi.nlm.nih.gov/pubmed/29687619
Abstract
Extracranial venous abnormalities, especially jugular venous outflow disturbance, were originally viewed as nonpathological phenomena due to a lack of realization and exploration of their feature and clinical significance. The etiology and pathogenesis are still unclear, whereas a couple of causal factors have been conjectured. The clinical presentation of this condition is highly variable, ranging from insidious to symptomatic, such as headaches, dizziness, pulsatile tinnitus, visual impairment, sleep disturbance, and neck discomfort or pain. Standard diagnostic criteria are not available, and current diagnosis largely depends on a combinatory use of imaging modalities. Although few researches have been conducted to gain evidence-based therapeutic approach, several recent advances indicate that intravenous angioplasty in combination with stenting implantation may be a safe and efficient way to restore normal blood circulation, alleviate the discomfort symptoms, and enhance patients' quality of life. In addition, surgical removal of structures that constrain the internal jugular vein may serve as an alternative or adjunctive management when endovascular intervention is not feasible. Notably, discussion on every aspect of this newly recognized disease entity is in the infant stage and efforts with more rigorous designed, randomized controlled studies in attempt to identify the pathophysiology, diagnostic criteria, and effective approaches to its treatment will provide a profound insight into this issue.
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Re: DrSclafani answers some questions

Postby NZer1 » Sat May 05, 2018 9:23 am

If every IR who has treated PwMS presented papers that show incidence and that did not say 'MS' treatment occurred then one hurdle at a time would be achieved.
'We' don't appear to have gone beyond that hurdle with Neuro's and Pharma via the FDA process 'yet', INCIDENCE has to be unrefutably proven first!!
Last edited by NZer1 on Sun May 13, 2018 12:25 am, edited 1 time in total.
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Re: be heard

Postby Cece » Sat May 12, 2018 6:41 pm

drsclafani wrote:We think it is time too re-evaluate are early patients, 2011 and especially 2012. If there are any patients who are willing to help as DIzzyLiz says above, We do need help.
Please spread the word that Dr. Sclafani and Ferral seek followup from our patients to clarify long term effects like reduction in attacks, stabilization of symptoms, etc.

To any of my patients from the past, please email me at ccsviliberation@gmail.com and those of Dr Ferral, email him.

DrS

Have you heard from many patients? Do you have other means of contacting them? The patients who remain involved in the CCSVI forums may not be a very representative sample of patients for one reason or another. But if you put together a "surveymonkey" type survey, that would be an easy link to share that might reach more former patients. You would have to include a request in the survey for some identifying information to eliminate anyone taking the survey who was not actually a former patient but that would be easy enough. Just a thought!

https://www.surveymonkey.com/
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Re: DrSclafani answers some questions

Postby Cece » Sat May 12, 2018 6:48 pm

NZer1 wrote:An example of putting pressure back on the FDA without talking about the PTA directly.

Understanding jugular venous outflow disturbance.
https://www.ncbi.nlm.nih.gov/pubmed/29687619
Abstract
Extracranial venous abnormalities, especially jugular venous outflow disturbance, were originally viewed as nonpathological phenomena due to a lack of realization and exploration of their feature and clinical significance. The etiology and pathogenesis are still unclear, whereas a couple of causal factors have been conjectured. The clinical presentation of this condition is highly variable, ranging from insidious to symptomatic, such as headaches, dizziness, pulsatile tinnitus, visual impairment, sleep disturbance, and neck discomfort or pain. Standard diagnostic criteria are not available, and current diagnosis largely depends on a combinatory use of imaging modalities. Although few researches have been conducted to gain evidence-based therapeutic approach, several recent advances indicate that intravenous angioplasty in combination with stenting implantation may be a safe and efficient way to restore normal blood circulation, alleviate the discomfort symptoms, and enhance patients' quality of life. In addition, surgical removal of structures that constrain the internal jugular vein may serve as an alternative or adjunctive management when endovascular intervention is not feasible. Notably, discussion on every aspect of this newly recognized disease entity is in the infant stage and efforts with more rigorous designed, randomized controlled studies in attempt to identify the pathophysiology, diagnostic criteria, and effective approaches to its treatment will provide a profound insight into this issue.

This was from the Chinese researchers. Even though we have much more research to pore through than we did in 2009, it still seems as if CCSVI research is in its infancy as they say. I wish it were further along.
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Re: be heard

Postby CureOrBust » Mon May 28, 2018 1:45 am

drsclafani wrote:Hector Ferral and I think it would be a good idea to analyze long term outcomes to see whether angioplasty by our techniques (fairly similar: use of IVUS, high pressure balloons, routine anticoagulation, etc. We are confident that short term clinical relief is obtained in a fair amount of patients but longo term relieff is not so clear.
email sent.

Cece wrote:Have you heard from many patients? Do you have other means of contacting them? The patients who remain involved in the CCSVI forums may not be a very representative sample of patients for one reason or another. But if you put together a "surveymonkey" type survey, that would be an easy link to share that might reach more former patients. You would have to include a request in the survey for some identifying information to eliminate anyone taking the survey who was not actually a former patient but that would be easy enough. Just a thought!

https://www.surveymonkey.com/
I don't remember any validation of people responding on surveymonkey, so that you would know they are really previously treated patients, or simply trolls. However, I guess if you only gave the link to validated participants, you could at least have a standard and formalized questionnaire among all responses.
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