It is time now to reconsider my last blog post in which I favored the use of stents to treat CCSVI-MS and assumed that their lack led to the presumed « failure » of Professor Zamboni’s Brave Dreams trial. (See previous post, January 7, 2018)
Quoted below is Dr. Sclafani’s critique of the Brave Dreams trial taken from ThisisMS.com website ThisisMs.com www.thisisms.com/
Jan 5, 2018 under CCSVI thread « Dr Sclafani Answers Some Questions ». My emphasis in bold.
NHE wrote:
Hi Dr. Sclafani,
How have the results of the Brave Dreams trial affected your practice ofs treating CCSVI?
Not at all. Zamboni's premise that MS might be caused by venous obstruction is not answered by this study. The paper asserts that treatment of obstructions is not shown to improve the condition of patients in a statistical way. I would say that treatment by the authors techniques did not show benefit but their project did not reach their planned statisticl relevance, enrolling too few patients to make the statements they sought.
But, if you recall, I stated many years ago that randomized trials were premature because there was no standard accepted best practice of the procedure, a necessary consition in which to judge the treatment. As in his early papers, the treatment was inadequate. The high restenosis rate in those early papers indicated that technical modifications were necessary. In this new study, they used compliant low pressure balloons to start and then only went to they thought that was necessary. They did not use IVUS and thus were guessing on balloon size since venography is inaccurate in estimating balloon size. They rarely used high pressure balloons and, when they did, they used balloon sizes that I am quite confident did not expand the lesions to effect ively break the stenosis. Although Zamboni alluded to the effects of the surrounding venous structures such as the dural sinuses, the renal vein and the iliac vein, these were not studied and their role in venous congestion should not be overlooked. A group of us are evaluqting their statistical analysis as well.
So at the current time, I do not find a compelling reason to stop treatments or to revert to the techniques that my experience has shown do not work. On compassionate grounds, I continue to treat patients with venous obstructions, using IVUS, high pressure large balloon dilatation, and inclusion of Nutcracker and May Thurner treatments in the comprehensive relief of symptoms associated with venous obstructions in patients with MS.
_________________
Salvatore JA Sclafani MD
Patient contact: [email protected]
So, Dr. Sclafani apparently does not use stents. His technique including the use of IVUS Intravenous Ultrasound and high pressure balloons better assures that the treated veins (including renal and iliac) do not re-stenose.
Dr. Zamboni opposes in particular the use of stents in the Internal Jugular Veins. Early on (Oct Nov 2009) « radeck » reported on the thisisms website that a stent too narrow to hold in the vein slipped into his heart. Emergency open heart surgery followed. (See the « Oh, Radeck ? » thread for stent discussion.) Early on upper jugular stents caused some nerve damage, so the narrower stent was tried. Dr. Zamboni eventually hoped to create a dissolvable stent or a « lip » stent to prevent a « radeck » incident. But thus far caution counsels against stents in Jugular Veins.
A French woman reported on the ForSeps website (SEP- Scleroses en Plaque – French for MS) that her husband had been lucky to be treated by Dr Sclafani. The outcome led to a spectacular recovery which impressed the French Neurologist. Dr. Sclafani warned the MS patient not to carry heavy objects with his arms down. Sure enough, her husband forgot the advice, carried the heavy sacks and the weight collapsed and restenosed his veins.
Matt Embry
(See MSHope http://www.mshope.com which provides an excellent « Recipe » for MS healing – Diet, Supplements, CCSVI, Exercise)
Matt Embry also reported on undergoing a successful angioplasty in which the veins restonosed. Rather than repeat the procedure, he favored boosting blood circulation through brisk exercise. (Not everyone enjoys his vibrant good health and physical prowess. One does the best one can wherever one begins.)
See « Who are the BIG names in CCSVI ? » thread launched by ozarkcanoer Nov 16, 2009. Towards the end of the thread Zjac020 was upset that the well regarded Brain Flow team in Italy did not warn him before his procedure that they do not use stents. Apparently the Polish clinic uses stents (last entry Feb 13, 2016). He apparently wanted stents to be inserted to guarantee patency.
Reading all this one can conclude that there are 2 Important questions to ask before the angioplasty procedure. « Does the IR use IVUS ? Does she use stents and where ? »
Stents in the Jugular Veins pose the greatest risk. Eventually we can hope appropriate stents will be developed, though the main hurdle now is political rather than technical. That is to say overcoming the vested interest opposition of the MS Drug/Neurology lobby to the VERY IDEA OF MS AS A CCSVI PROBLEM.
I would now conclude that blood flow through the brain’s draining veins can generally remain unrestricted if the angioplasty procedure is performed correctly. There may exist still the risk of re-stenosis, but that risk is probably less critical than the risk associated with a dislodged stent.
FRODO has posted the following which implies researchers are moving away from the auto-immune theory of MS. See the following post from ThisisMS.com January 25, 2018.
"Hans Lassman is one of the leaders in MS research. He does not say the word "autoimmune" anymore, nor speaks too much about myelin.
Multiple Sclerosis Pathology.
https://www.ncbi.nlm.nihs.gov/pubmed/29358320
Abstract
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), which gives rise to focal lesions in the gray and white matter and to diffuse neurodegeneration in the entire brain. In this review, the spectrum of MS lesions and their relation to the inflammatory process is described.
Pathology suggests that inflammation drives tissue injury at all stages of the disease. Focal inflammatory infiltrates in the meninges and the perivascular spaces appear to produce soluble factors, which induce demyelination or neurodegeneration either directly or indirectly through microglia activation. The nature of these soluble factors, which are responsible for demyelinating activity in sera and cerebrospinal fluid of the patients, is currently undefined. Demyelination and neurodegeneration is finally accomplished by oxidative injury and mitochondrial damage leading to a state of "virtual hypoxia."
My comment :
"soluble factors" like in venous blood for example???
More Good News lending credence to CCSVI-MS theory.
January 26, 2018 on ThisisMS 1eye posted the following:
"study shows PTA helps head-ache long term in MS"
https://www.ctvnews.ca/health/ms-patients-experience-fewer-headaches-after-jugular-veins-opened-with-balloons-study-1.3772510#_gus&_gucid=&_gup=Facebook&_gsc=u9bTJaC
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0191534
improvements seen long-term from PTA in RRMS, SPMS, may work in PPMS as well, relieves venous pressure"
Tags : CCSVI-MS, Dr Zamboni, Dr Sclafani, ThisisMS.com, Hans Lassman, Matt Embry, Stents, PTA
Quoted below is Dr. Sclafani’s critique of the Brave Dreams trial taken from ThisisMS.com website ThisisMs.com www.thisisms.com/
Jan 5, 2018 under CCSVI thread « Dr Sclafani Answers Some Questions ». My emphasis in bold.
NHE wrote:
Hi Dr. Sclafani,
How have the results of the Brave Dreams trial affected your practice ofs treating CCSVI?
Not at all. Zamboni's premise that MS might be caused by venous obstruction is not answered by this study. The paper asserts that treatment of obstructions is not shown to improve the condition of patients in a statistical way. I would say that treatment by the authors techniques did not show benefit but their project did not reach their planned statisticl relevance, enrolling too few patients to make the statements they sought.
But, if you recall, I stated many years ago that randomized trials were premature because there was no standard accepted best practice of the procedure, a necessary consition in which to judge the treatment. As in his early papers, the treatment was inadequate. The high restenosis rate in those early papers indicated that technical modifications were necessary. In this new study, they used compliant low pressure balloons to start and then only went to they thought that was necessary. They did not use IVUS and thus were guessing on balloon size since venography is inaccurate in estimating balloon size. They rarely used high pressure balloons and, when they did, they used balloon sizes that I am quite confident did not expand the lesions to effect ively break the stenosis. Although Zamboni alluded to the effects of the surrounding venous structures such as the dural sinuses, the renal vein and the iliac vein, these were not studied and their role in venous congestion should not be overlooked. A group of us are evaluqting their statistical analysis as well.
So at the current time, I do not find a compelling reason to stop treatments or to revert to the techniques that my experience has shown do not work. On compassionate grounds, I continue to treat patients with venous obstructions, using IVUS, high pressure large balloon dilatation, and inclusion of Nutcracker and May Thurner treatments in the comprehensive relief of symptoms associated with venous obstructions in patients with MS.
_________________
Salvatore JA Sclafani MD
Patient contact: [email protected]
So, Dr. Sclafani apparently does not use stents. His technique including the use of IVUS Intravenous Ultrasound and high pressure balloons better assures that the treated veins (including renal and iliac) do not re-stenose.
Dr. Zamboni opposes in particular the use of stents in the Internal Jugular Veins. Early on (Oct Nov 2009) « radeck » reported on the thisisms website that a stent too narrow to hold in the vein slipped into his heart. Emergency open heart surgery followed. (See the « Oh, Radeck ? » thread for stent discussion.) Early on upper jugular stents caused some nerve damage, so the narrower stent was tried. Dr. Zamboni eventually hoped to create a dissolvable stent or a « lip » stent to prevent a « radeck » incident. But thus far caution counsels against stents in Jugular Veins.
A French woman reported on the ForSeps website (SEP- Scleroses en Plaque – French for MS) that her husband had been lucky to be treated by Dr Sclafani. The outcome led to a spectacular recovery which impressed the French Neurologist. Dr. Sclafani warned the MS patient not to carry heavy objects with his arms down. Sure enough, her husband forgot the advice, carried the heavy sacks and the weight collapsed and restenosed his veins.
Matt Embry
(See MSHope http://www.mshope.com which provides an excellent « Recipe » for MS healing – Diet, Supplements, CCSVI, Exercise)
Matt Embry also reported on undergoing a successful angioplasty in which the veins restonosed. Rather than repeat the procedure, he favored boosting blood circulation through brisk exercise. (Not everyone enjoys his vibrant good health and physical prowess. One does the best one can wherever one begins.)
See « Who are the BIG names in CCSVI ? » thread launched by ozarkcanoer Nov 16, 2009. Towards the end of the thread Zjac020 was upset that the well regarded Brain Flow team in Italy did not warn him before his procedure that they do not use stents. Apparently the Polish clinic uses stents (last entry Feb 13, 2016). He apparently wanted stents to be inserted to guarantee patency.
Reading all this one can conclude that there are 2 Important questions to ask before the angioplasty procedure. « Does the IR use IVUS ? Does she use stents and where ? »
Stents in the Jugular Veins pose the greatest risk. Eventually we can hope appropriate stents will be developed, though the main hurdle now is political rather than technical. That is to say overcoming the vested interest opposition of the MS Drug/Neurology lobby to the VERY IDEA OF MS AS A CCSVI PROBLEM.
I would now conclude that blood flow through the brain’s draining veins can generally remain unrestricted if the angioplasty procedure is performed correctly. There may exist still the risk of re-stenosis, but that risk is probably less critical than the risk associated with a dislodged stent.
FRODO has posted the following which implies researchers are moving away from the auto-immune theory of MS. See the following post from ThisisMS.com January 25, 2018.
"Hans Lassman is one of the leaders in MS research. He does not say the word "autoimmune" anymore, nor speaks too much about myelin.
Multiple Sclerosis Pathology.
https://www.ncbi.nlm.nihs.gov/pubmed/29358320
Abstract
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), which gives rise to focal lesions in the gray and white matter and to diffuse neurodegeneration in the entire brain. In this review, the spectrum of MS lesions and their relation to the inflammatory process is described.
Pathology suggests that inflammation drives tissue injury at all stages of the disease. Focal inflammatory infiltrates in the meninges and the perivascular spaces appear to produce soluble factors, which induce demyelination or neurodegeneration either directly or indirectly through microglia activation. The nature of these soluble factors, which are responsible for demyelinating activity in sera and cerebrospinal fluid of the patients, is currently undefined. Demyelination and neurodegeneration is finally accomplished by oxidative injury and mitochondrial damage leading to a state of "virtual hypoxia."
My comment :
"soluble factors" like in venous blood for example???
More Good News lending credence to CCSVI-MS theory.
January 26, 2018 on ThisisMS 1eye posted the following:
"study shows PTA helps head-ache long term in MS"
https://www.ctvnews.ca/health/ms-patients-experience-fewer-headaches-after-jugular-veins-opened-with-balloons-study-1.3772510#_gus&_gucid=&_gup=Facebook&_gsc=u9bTJaC
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0191534
improvements seen long-term from PTA in RRMS, SPMS, may work in PPMS as well, relieves venous pressure"
Tags : CCSVI-MS, Dr Zamboni, Dr Sclafani, ThisisMS.com, Hans Lassman, Matt Embry, Stents, PTA
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