DrSclafani answers some questions

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drsclafani
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Re: DrSclafani answers some questions

Post by drsclafani »

julu wrote:Hello Dr. Sclafani, you have been very helpful to me over the past few years as the thinking on CCSVI and its treatment has been evolving. Thank you for all the time you give to this forum.

My question involves the current thinking on MRV's usefulness in diagnosing CCSVI. I know that venogram with IVUS is the best, but I'm not ready to take that step yet. My neurologist has ordered an MRI for me since I recently had my first relapse in four years (she does not think CCSVI has a relationship to MS). My internal medicine doctor is intrigued by CCSVI and is willing to order an MRV as an add-on to the MRI if it might give important information.

Would the MRV be likely to give information that could help my internist see what is going on inside my head? (I have a constant pressure sensation, and dizziness with turning my head in any direction, as well as brain fog which is getting worse.) I would like to have him on board when I take the next big step.

Also, if we proceed with MRV, is it important to ask that the Haacke protocol be followed?

Thank you so much for your advice.
Personally, i would not rely upon MRV to make decisions. It is fraught with appearances that just do not correlate with venography and IVUS

I think that external doppler ultrasound provides enough screening information to make decisions at a much lower price.
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Re: DrSclafani answers some questions

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NZer1 wrote:Dr. Sclafani to present "The many reasons of failure to improve or hold on to improvements after CCSVI treatment"

Quote;
“The highlights of my career always involve acceptance by peers and patients of unconventional solutions to desperate situations. The future of medicine is never predictable. Breakthroughs happen when someone sees something hidden in plain sight. Innovation in medicine requires obsession to the goal; one must have the grandiosity to believe that you can solve the problem, the courage to see that skepticism and rejection are constructive aids to success and the humility to recognize that the innovator is merely a vehicle to a better world. “

Now there's a packed paragraph. Unconventional solutions, perceptiveness, obsession, grandiosity, courage, humility.

The conference is a month away in a Canadian place called Sherbrooke: http://www.nationalccsvisociety.org/sherbrooke2013
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Re: DrSclafani answers some questions

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http://www.jvir.org/article/S1051-0443( ... 8/abstract
Results
No venography-related or IVUS-related complications, including vessel rupture, thrombosis, or side effects of contrast media were recorded among the 30 study patients. IVUS-detected venous abnormalities, including chronic, organized, thrombus-like inclusions were observed in 85% of azygos, 50% of right IJ, and 83.3% of left IJ veins, whereas venography demonstrated stenosis of ≥ 50% in 50% of azygos, 55% of right IJ, and 72% of left IJ veins. Sensitivity of venography for detecting IVUS abnormalities was 52.9%, 73.3%, and 80% for the azygos, left IJ, and right IJ veins, respectively.
Hmm, just cant remember the name of the doc that's using ivus and told us about the usefullness of ivus :lol:
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Re: DrSclafani answers some questions

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Re: DrSclafani answers some questions

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Robnl wrote:http://www.jvir.org/article/S1051-0443( ... 8/abstract
Results
No venography-related or IVUS-related complications, including vessel rupture, thrombosis, or side effects of contrast media were recorded among the 30 study patients. IVUS-detected venous abnormalities, including chronic, organized, thrombus-like inclusions were observed in 85% of azygos, 50% of right IJ, and 83.3% of left IJ veins, whereas venography demonstrated stenosis of ≥ 50% in 50% of azygos, 55% of right IJ, and 72% of left IJ veins. Sensitivity of venography for detecting IVUS abnormalities was 52.9%, 73.3%, and 80% for the azygos, left IJ, and right IJ veins, respectively.
Hmm, just cant remember the name of the doc that's using ivus and told us about the usefullness of ivus :lol:

These results are impressive considering that this is the first thirty patients this group has studied with IVUS. It is difficult to understand, however, why only 55% of patients had stenosis found in the right IJV.
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Re: DrSclafani answers some questions

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Hopefully it results in more ivus 'evidence'...
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Re: DrSclafani answers some questions

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Hi Dr Sclafani,

What is your take on Dr. Moguel's report?
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Re: DrSclafani answers some questions

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tzootsi wrote:Hi Dr Sclafani,

What is your take on Dr. Moguel's report?
Is this the report that you mean, tzootsi? http://www.thisisms.com/forum/chronic-c ... 22987.html

Dr. Moguel for those who might not know is from Clinics of the Heart in Cozumel, Mexico, and he is posting directly over at CCSVI Locator.
http://ccsvi-ms.ning.com/profiles/blogs ... restenosis (free ccsvi locator registration required in order to follow the link)
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Re: DrSclafani answers some questions

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tzootsi wrote:Hi Dr Sclafani,

What is your take on Dr. Moguel's report?
I have some comments to make but let me think on it overnight

s
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Re: DrSclafani answers some questions

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tzootsi wrote:Hi Dr Sclafani,

What is your take on Dr. Moguel's report?
Dr Moguel wrote:The liberation treatment, consisting on balloon angioplasty of the three major veins draining the brain (both left jugulars and azygous), is frequently complicated by a new narrowing of the vein in the same segment that was previously dilated.
I don't agree that restenosis is frequent, although it certainly does occur. Re-stenosis of valvular stenosis does occur but restenoses are more likely of the vein itself, rather than the abnormal valve. There are some who say there are wandering stenoses, or recurrent stenoses in different locations. These likely represent venous injuries that most commonly can be avoided by selecting the correct size balloon, restricting dilatation to the area of the venous injury and limiting the time that the balloon is inflated to a few seconds.
Dr Moguel wrote:The restenosis is a usual common phenomenon after any kind of angioplasty on any kind of blood vessels; all vascular specialists are very familiar with it. This complication comes after the injury done in the vessel, followed by an exaggerated response from the body to heal it, creating a hard scar. It is very similar to the scarring that occurs after a surgery, where some patients can develop harder and prominent scars.
I agree that restenosis is common in arterial angioplasty but the key is that the intention of arterial angioplasty is to injure the artery. Most angioplasty is done on arteries and these REQUIRE an injury, tearing the intimal and media of the artery to accomplish widening of the artery at the leve of a plaque. Restenosis also occurs commonly in patients with end staged renal disease, which is the most common reason for venous angioplasty. Veins do not tolerate tears as well as arteries and that is why we see so many thromboses reported after venoplasty for dialysis vein stenoses . When there is adventitial injury or significant tearing of the vessel, thrombus forms and then neointima deposits. This results in fibrin scar and intimal hyperplasia. Once this occurs, we have developed a different type of stenosis than that usually seen in MS which is usually a valvular stenosis or a hypoplasia of the vein.

In my view, the key to reducing restenosis is to AVOID over-dilation of the vein at high pressures. Overdilation causes perforation of the thin walled vein, leading to external hemorrhage and scar formation. Dilating the valve to a reasonable size should not typically require overstretch of the vein to a point that results in perforation of the vein. THIS SHOULD BE AVOIDED.
Dr Moguel wrote:The angiographic restenosis is defined by, of course, an angiography that finally reveals that a new narrowing exists.

Restenosis requires that a stenosis be seen at the point of the prior stenosis. Stenosis at any other location is not restenosis, but an iatrogenic stenosis, typically caused by overstretch of the vein leading to tear.
Since the valve is the most common part of the vein that is injured, it is usually possible to dilated the valve stenosis without exceeding the normal compliance (dilation) of the vein wall itself. Sometimes the valve resists stretch, perhaps because the annulus of the valve is hyoplastic. I have learned the hard way that exceeding size and pressure tolerances in order to try to dilate a recalcitrant, resistant valve stenosis leads to wall tear, wall dissection, and subsequent thrombosis or "hard" stenosis of the adjacent vein wall. I think that a few less vigorous angioplasties spaced a few months apart will be safer and more effective. An alternative to consider is surgical venoplasty or valvulotomy
Dr Moguel wrote:Sometimes the angiography is not enough but a direct measurement can disclose the problem, such as direct pressure register or other image modality like ultrasound, magnetic resonance, computed tomography or optical coherence tomography.
Pressures are not particularly reliable. I would not rely upon MRV or CTV. ultrasound is a reasonable screen for stenosis. not sure what OCT shows in this case.
Dr Moguel wrote:At this time no one is able to know how frequent is the restenosis after a correction of a chronic cerebro-spinal venous insufficiency (CCSVI) because all patients are treated overseas with a lack of follow up by image tests, so there is only a rough estimate by the recurrence of the symptoms which has been called “clinical restenosis” in other well known vascular scenarios.
I agree with Dr Moguel. It is very frustrating to try to follow patients. However clinical symptoms are the most important reflection of restenosis. I think clinical outcome is more important than angiographic stenosis anyway. Symptom relief is the only thing that has convinced me to perform these treatments.
Dr Moguel wrote:Multiple sclerosis patients are looking for a repeated vein angioplasty (two, three or more times) but they face the following problems:
Possible hard tissue responsible for the restenosis. This causes a narrowing sometimes impossible to open even at the highest pressure that a balloon can get, leading sometimes to the balloon burst.
Restenosis on restenosis. The treatment of a restenosis has an even higher restenosis risk than the first treatment, creating a vicious circle.
I agree as long as we are talking about vein restenosis and not valvular restenosis. REstenosis resulting for venous tear, leads to scar formation and angioplasty of scar requires more tearing, more blood leakage and more scar AND MORE RESTENOSIS. . That is one of the major reason for recurrent stenoses seen in treating dialysis venous access. ANGIOPLASTY FOR VALVULAR STENOSIS IN MS IS NOT THE SAME as treatment of vein wall restenosis.
Dr Moguel wrote:The first problem requires many times the help of a special balloon that is armed with four surgical micro-blades attached to its longitudinal surface (Flextome, Boston Scientific). These micro-blades work while the balloon is fully inflated, as seen in the figure below. Through this endovascular microsurgery, this balloon is able to open the vessel with a minimal lesion and less pressure than is used with a conventional balloon.
The second problem (restenosis after restenosis) is a challenge because of its very high prevalence. It occurs as a result of an exaggerated response from the body, to the damage after the elongation of the tissues during balloon inflation. AT the present time the best tool to reduce this risk is based on the attachment of certain drugs in stents or balloons. These drugs are directed to reduce the cell replication that causes the restenosis.
i do not think that higher pressure increases risk of restenosis PROVIDED the balloon size necessary to expand the valves does not exceed the stretchability of the surrounding vein wall. Cutting balloons have been advocated by some. However cutting balloons lead to tear of the vein wall. My use of them stopped quickly after a couple of vein wall injuries that led to thrombosis. I am concerned that cutting balloons will ultimately be shown to be too damaging to the wall and necessarily lead to restenosis. Perhaps the use of drug eluding balloons will reduce this scar formation but I need to see some proof that they can reduce restenosis caused by cutting balloons before i use them. .
Dr Moguel wrote:The actual better way of reducing restenosis without the use of stents are the medicated, also called drug eluting or drug delivering balloons that are capable of deploying the drug in the inner surface of the blood vessel. The actual drug is Paclitaxel, which is part of the treatment of several cancers but the dose in the balloon is very small so it is enough to act locally without any collateral systemic effect. The balloons that we use are Paclitaxel added (Freeway, Eurocor) and it can be consulted on the link http://www.eurocor.de/products/freeway_ ... formation/.
An example taken from a patient with severe restenosis is shown below.
These balloons were made for restenosis of smaller arteries. How well they work in the jugular veins remains to be seen. I am looking forward to some reports that show efficacy. If I see that I would use them in patients with restenosis.
Dr Moguel wrote: Note in this figure how a severe restenosis is present in a left jugular vein, two years after a successful liberation treatment. The patient had important recovery but a year after she had recurrence of symptoms suggesting a clinical restenosis.

The new narrowing is pointed with the red arrow; a cutting 8x20mm (Flextome) balloon is inflated at low pressure, followed by a medicated 8x20mm balloon (Freeway) inflated at low pressure in the same site.

The vein is finally dilated with a 14x20mm non-compliant conventional balloon (Atlas, Bard products), showing a very good result.

The first attempt to dilate this vein using only the normal balloon was not successful even at a pressure of 20 atmospheres which is the highest that this balloon is capable to afford without bursting.
Unfortunately, I did not see the images. So I cannot comment on the nature of the restenosis or its cause. If there was extravasation on the post angioplasty images, I will expect recurrent stenosis. I can't predict the effectiveness if no perforation occured.
Dr Moguel wrote:This case exemplifies the complexity of the treatment for restenosis which is a challenge for every endovascular specialist and the hospital staff as well as the availability of different kinds of therapeutic tools that should include the cutting and the medicated balloons.
I agree with Dr Moguel that treatment of true restenosis of the vein wall will be very complicated. Repeat angioplasty for valvular stenosis is not a failure, but part of the natural history of some valvular stenosis. Non-valvular stenosis is often a complication of angioplasty and it will also require ongoing care to maintain benefits patients have. This is not failure. We replace the brake linings of our autos periodically, that does not make repairing brakes a failure.

We need to convince payors (I am convinced) that many patients derive symptomatic benefit from venoplasty and that these procedures are worthwhile. The stress of financial drains for repeated angioplasty should not be born by patients alone.
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Re: DrSclafani answers some questions

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I have been thinking sadly about the loss of the Albany trial. It was such a heroic effort by one man to create a study that would prove whether treatment of CCSVI provided a treatment for MS.

The issues have been distorted to such a great degree that neurologists have elected to negate the entire concept of CCSVI.
the first issue is whether CCSVI causes MS. This issue is irrelevant to me at this point in time. This issue will take years to assess, evaluate, research and conclude.

We have spent three years evaluating whether ultrasound proves an association. In reality what we have tested is whether the technique of ultrasound described by Zamboni is a practical one. The literature suggests that it is not. It requires clear understanding of the concept of interpretation, proper technique needed to validate that concept, and general acceptance of that interpretation. Unfortunately, the ultrasound, while the ultrasound works very well in my practice, is not well reviewed in a variety of peer reviewed papers. Poor correlations have been reported and reproducibility is certainly at question at this point.

The wide variability in results speaks loudly that this is not a good screening test. Most of the randomized studies using ultrasound have really been a test of whether standard jugular ultrasound, or ultrasound done by Zamboni protocol and/or MRI are effective tools of screening. It is clear from the existing literature that Ultrasound requires adherence to a special technique, quite unique and different from standard ultrasound. This makes it a poor screening test. The wide variation in interpretations of ultrasounds in patients with MS indicates that it is not adequate to address the question of whether CCSVI is associated with MS.

We have allowed a suboptimal screening test to take center stage while obvious venographic abnormalities are amply and routinely seen in the peer reviewed literature. These venographic findings, reported in an adequate number of studies, have been largely ignored. The limitations of venography, inherent in a luminal imaging study of an intraluminal disease, only emphasize the degree of significance of these abnormalities. When augmented by an endoluminal imaging study such as intravascular ultrasound, the prevalence of venous abnormalities in patients with MS cannot be rejected.

But proving this association is only of secondary importance. What is most important is that some patients with venous outflow obstructions have symptoms that improve after angioplasty, and at a higher rate than that described for placebos in trials of medications and other therapies. This is the most important thing that we have learned in three years.

It is with deep regret that the entire concept has been politicized, discredited, misunderstood, denigrated, slandered and rejected out of hand. The techniques of treatment, the reasons for recurrence, complications, and failure must be understood in order to discover the role of venous outflow obstruction in neurological conditions. . Why some patients get better must be discovered. Failure to do so, would insult the good memory of Charcot and many others.

The issue here is not about MS, it is about whether venous outflow obstructions can result in neurological symptoms. It is about whether opening venous outflow improves some clinical manifestations often seen in MS.

We need to put MS on the back burner and focus on the symptoms.

s
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Re: DrSclafani answers some questions

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No responses here but 28 shares, 41 likes, and 8 comments on Facebook (CCSVI in MS page).
Cheer wrote:Dr. Salvatore Sclafani has been at the forefront of CCSVI research, diagnostics and treatment. Here is a truly thought-provoking post he made on the This Is MS.com forum earlier today. Thanks, Dr. S. We appreciate your contnued effort. Dr. Sclafani will be the keynote speaker at the NCS CCSVI conference in Sherbrooke, Quebec later this month. I look forward to meeting him, and hearing his thoughts.
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Re: DrSclafani answers some questions

Post by dlynn »

Dr. Sclafani,
on another thread, "Albany Researchers Cancel MS Clinical Trial", you mention "There are patients who have delayed onset of some improvements up to one year after treatment" Can this be the case also in treatment of NCS and PCS?
Have any of your CCSVi or NCS (20 yrs. or more dx) patients regained strength in their legs post procedure?
What improvements do you typically see in patients with 20+yrs. since diagnosis?

thank you
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Re: DrSclafani answers some questions

Post by pelopidas »

drsclafani wrote: The issue here is not about MS, it is about whether venous outflow obstructions can result in neurological symptoms. It is about whether opening venous outflow improves some clinical manifestations often seen in MS.

We need to put MS on the back burner and focus on the symptoms.

s
I think that this is how a conference of the neurovascular diseases should start with.
I feel really sorry about all those past years we were constantly using veins for catheterisation, infusion, central venous pressure
We never deeply studied them

and maybe this is what we have to do, examine a great number of neurological patients with MS- like symptoms by ivus assisted venography

But then neurologists should help
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Re: DrSclafani answers some questions

Post by tzootsi »

Hi Dr Sclafani,

Your latest comments were sensibe and thoughtful.
Another one - what is your take on Dr. Sergio Gianesini's procedure to alleviate vein compression via surgery?

http://www.ccsvi-sm.org/?q=node%2F1867
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