But first, a little shameless self-promotion: I was recently interviewed for a radio piece on CCSVI that will be airing on National
Public Radio this coming Monday, November 1, between 6 AM and 9 AM,

during their Morning Edition program (click here to find the NPR station in your area).

I have no idea how much of my interview they'll use, and wouldn't at

all be surprised if only a few seconds of my voice is heard. Still, it

was very flattering to be asked to participate, and it's also very

encouraging that NPR is doing a segment on CCSVI, which has been largely

ignored by the US media. For everyone who misses the live broadcast,

the segment will be archived on the NPR website, and I'll post a link as

soon as it's available.

And now, on with the show. I haven't written about CCSVI in quite some time, so the below post is very long,
almost twice as long as any other piece I've ever posted. You might want

to grab a cup of coffee and a couple of toothpicks to hold your eyelids

open before attempting to plow your way through it…

The topic of the vascular theory of MS, which was initially hypothesized by Italian
vascular surgeon Dr. Paolo Zamboni, and has come to be called CCSVI

(Chronic Cerebrospinal Venous Insufficiency), continues to inflame the

MS community among both patients and physicians alike (if you're unfamiliar with CCSVI, please click here).

At times the debate over the validity of the CCSVI theory and the

efficacy of the procedure used to address it (known as "The Liberation

Procedure") has reached the level of hysteria on MS Internet forums,

countless CCSVI Facebook sites, and in the print media, with

outrageously hyperbolic statements pouring forth from both sides. The

most fervent CCSVI advocates claim with absolute certainty that CCSVI is

the cause of MS, and that the Liberation Procedure is a cure for the

disease, while the theory's staunchest critics label it a hoax, and

those physicians practicing the Liberation Procedure con artists selling

desperate patients snake oil.

At this stage of the game, when very few scientifically valid trials have been conducted, both extreme
viewpoints have absolutely no basis in fact, and these vehement

arguments only confuse the issue all the more, creating adversarial

tensions precisely when a spirit of open-mindedness and cooperation are

desperately needed. Furthermore, these loudly voiced conflicting

opinions can only work to the detriment of chronically ill patients

vainly searching for answers that simply do not yet exist, adding

clutter and confusion to an already complicated issue.

We are in an age of discovery in regards to CCSVI, and over the last several
months much has been learned about the condition and the treatment

protocols used to address it, though the picture remains far from clear.

Many patients, understandably clamoring for easy access to the

Liberation Procedure, argue that the procedure is nothing more than

angioplasty, which is performed quite commonly on cardiac patients in

hospitals around the world, and that they should be given access to the

treatment for the simple reason that blocked veins need to be unblocked,

regardless of whether or not a patient has MS. Both of these arguments

seem quite valid at first glance, but don't really hold up to greater

scrutiny.

Angioplasty is indeed a common procedure, and a very safe one at that. The Liberation Procedure, though, is not angioplasty,
which is performed on arteries, but venoplasty, performed on veins, a

procedure that is done much less commonly. This may seem like a minor

discrepancy, but in fact presents some significant challenges to both

the doctors performing the procedure and the technologies used during

it.

In terms of anatomy, veins and arteries are very different creatures. The major arteries are quite rigid, designed to withstand the
intense pressure of blood being pumped through them by the beating

heart. Thus, when they are ballooned or stented open during angioplasty,

they tend to stay open, given their natural rigidity. Veins, on the

other hand, are thin-walled and flexible (just play with the ones on the

back of your hand to see what I mean), presenting a very different

target for the balloons or stents used during the Liberation Procedure.

Virtually all of the equipment used during the Liberation Procedure was

originally designed for utilization in arteries, and this has led to

less than ideal efficacy when used in veins, as I will discuss in more

detail a bit later. From a safety standpoint, as long as the procedure

is confined to the use of balloons to open narrowed or blocked veins,

the Liberation Procedure is quite safe.

As for the assertion that blocked veins need to be unblocked regardless of the overall health of
the patient, this too is not as clear-cut as it first may seem. Since

arteries are the primary culprits in cardiac disease and strokes, human

venous anatomy has been very little studied by modern medicine.

Incredible, but true. I've been told by several radiologists and

vascular specialists (including those at the National Institutes of

Health) that there truly is no definition of "normal" that can be used

as a benchmark when assessing an individual patient’s venous system.

Indeed, initial studies have shown that up to 25% of healthy people appear to
have the vascular blockages known as CCSVI, to no apparent ill effect (click here for info).

Venous anatomy is redundant and adaptable, and it had been thought that

blockages in veins are largely compensated for by this adaptability.

Blood flow blocked in one vessel was assumed to be simply routed through

another, or through new vessels grown by the body to make up for the

blockage, called collaterals. Perhaps one fringe benefit of the

investigation into CCSVI will be closer attention paid to venous anatomy

on the whole.

It's important to keep in mind that Dr. Zamboni's theory involves not only blockages in veins, but more precisely, the
reflux of deoxygenated blood back into the central nervous system caused

by those blockages. Therefore, not all venous blockages meet the

requirements of CCSVI.

My own case is a perfect example. A catheter venogram revealed that I have a significant blockage in my
right internal jugular vein. Further testing indicated that this

blockage is quite unusual, as it is not caused by an abnormality

internal in the vein, as is the usual case, but rather by an external

muscle pinching the vein significantly closed. The Interventional

Radiologist who did my procedure reviewed my case with Dr. Zamboni, who

is of the opinion that although my vein is clearly blocked, this

blockage has not resulted in a turbulent backflow of blood, and

therefore should not be treated. Not really what I wanted to hear, but

facts is facts. I do plan on getting further testing to confirm Dr.

Zamboni's opinion.

Earlier this month, one of the major international MS conferences took place in Sweden. Known as ECTRIMS
(European Committee on Treatment and Research in Multiple Sclerosis),

this year's conference featured many presentations on CCSVI, which in

itself is something of a victory. During last year's conference nary a

word about CCSVI was mentioned.

Much of the evidence at ECTRIMS presented was mixed, on the whole seemingly confirming a correlation
between Multiple Sclerosis and the vascular abnormalities known as

CCSVI, but also casting some doubt as to whether or not CCSVI is a

cause, rather than an effect, of Multiple Sclerosis. Dr. Robert

Zivadinov, who leads the team of researchers vigorously investigating

CCSVI at the University of Buffalo, presented several very interesting

papers. One paper demonstrated that the severity of CCSVI increases with

the severity of Multiple Sclerosis symptoms experienced by patients,

and with a more advanced disease course (click here for abstract). These findings were backed up by papers presented by researchers from Beirut (click here for abstract) and Italy (click here for abstract).

If CCSVI were the cause of MS, the researchers would expect that a

constant level of vascular abnormalities would be seen across the entire

spectrum of disability levels and duration of disease among patients

studied, which is not what their studies demonstrated. Other research

presented at the conference contradicted these findings, such as a paper

presented by Dr. Marian Simka, an Interventional Radiologist in Poland

who has been done hundreds of Liberation Procedures, which found that

CCSVI plays a role in the cause and progression of MS, and that the

vascular abnormalities were most likely congenital (click here for abstract).

Another study presented by Dr. Zivadinov found that subjects who presented with
CCSVI had significantly more lesions and brain atrophy as measured by

MRI than those MS patients without vascular abnormalities (click here for abstract).

Yet another investigation presented by Dr. Zivadinov looked at the

correlation between a gene implicated with MS, and CCSVI, and found that

the data supported an association between MS disease progression and

CCSVI separate from the suspect gene. The implications of these findings

are that CCSVI could be a risk factor in developing the disease, or a

result of the progression of MS (click here for abstract).

Clearly, the data presented at ECTRIMS was a mixed bag, which some CCSVI
advocates found disappointing in that much of the evidence offered did

not point to CCSVI being a direct cause of MS. Still, the studies did

reveal a very strong correlation between vascular abnormalities and

Multiple Sclerosis, which in itself is a giant step forward in

convincing a dubious scientific community that these abnormalities do

play a significant role in the puzzle that is MS. Much more research is

needed to resolve the challenging questions posed by CCSVI, and such

research is ongoing at the present time in multiple locations worldwide.

Some staunch CCSVI advocates have tried to dismiss research with findings not to their liking by claiming that the methodology used was
faulty, or that the researchers themselves were tainted by their

associations with pharmaceutical companies. As for the methodology used,

it may be different than that originally used by Dr. Zamboni, and thus

might in fact be invalid, but it does occur to me that the physical

abnormalities found in CCSVI are not subtle in nature. We are talking

about rather severe blockages in blood vessels, significant enough to

cause blood to actually flow backwards through those vessels. It would

seem that abnormalities of this magnitude should be detectable by more

than one set of extremely specific methods of measurement. But, as I

stated previously, venous anatomy has been little studied in the past,

so perhaps the technological choices are indeed limited.

As for researchers whose integrity has been compromised by their ties to
pharmaceutical companies, if all such physicians were prohibited from

taking part in research studies, there would be practically no medical

research conducted at all. A tragic truth about our current medical

system is that almost every physician practicing in the United States

has some affiliation with a pharmaceutical or medical device company.

This phenomenon is not limited to neurologists, as some would make it

seem, but is epidemic throughout the medical community. A wide range of

doctors have affiliations with drug companies; orthopedic surgeons have

relationships with the makers of artificial joints (click here for a fascinating New York Times article on this),

cardiac surgeons are courted by the makers of replacement heart valves,

and Interventional Radiologists have associations with the makers of

the stents, catheters, and balloons with which they ply their trade.

I've said it before, and I'll say it again, capitalism is a wonderful

engine for driving an economy, but is absolutely corrosive when applied

to the practice of medicine. When patients are viewed first as consumers

of medical products and services, something is seriously wrong. I

previously expounded on this disturbing topic in a previous post, "The

Medical Industrial Complex: Sick People Required", which you can access

by clicking here.

One of the big problems involved in the study of CCSVI in that none of the
noninvasive imaging techniques used to try to detect venous

abnormalities in patients before having them undergo an invasive

catheter venogram are all that reliable. MRV imaging in particular has

proven to be almost worthless, as yet another study conducted by Dr.

Zivadinov and presented at ECTRIMS demonstrated (click here for abstract).

Doppler Sonography, while more accurate, is only useful in detecting

CCSVI when used according to very specific protocols, and conducted by a

highly skilled operator. Even when such conditions are met, Sonography

is somewhat subjective, as the Zamboni trained sonographer who did my

Doppler scan has said. Sonograms can be interpreted differently by

different physicians, and time after time both MRV and sonogram imaging

done on patients have proven to be unreliable once a catheter venogram

is performed. The blockages suggested by the noninvasive techniques

simply don't correspond to what is actually found in patients when the

catheter is inserted into their veins.

While the academic questions regarding CCSVI are all very interesting and fodder for great
controversy, the biggest question for those of us suffering from

Multiple Sclerosis is whether or not the Liberation Procedure can

relieve our symptoms. If it turns out that the procedure is a cure,

well, then MSers have hit the jackpot. If liberation "only" results in a

dramatic drop-off in the misery caused by the disease, it's still a

huge win, and will forever change the way MS is researched and treated.

More importantly, hundreds of thousands of MS patients around the world

will have a new and relatively straightforward conduit to relief.

Since no formal treatment studies have been conducted thus far (several are
currently underway), we can only rely on the anecdotal accounts of

patients who have undergone the Liberation Procedure when assessing its

effectiveness. It's been estimated that over 2000 procedures have been

performed in various locations around the world, but we've only heard

from, at most, perhaps 100-150 of these patients. When assessing these

accounts, which are usually quite encouraging, it's important to keep in

mind that the preponderance of mostly positive reports related on

Internet forums and YouTube videos are a product of the natural

phenomenon of people who have positive outcomes to be much more inclined

to make their results public than those with negative experiences. This

isn't an attempt at subterfuge on anybody's part, but merely human

nature. Reports from several clinicians doing the Liberation Procedure

indicate that the success rate is less robust than might be inferred

from Internet accounts. Still, some important trends can be identified

in the anecdotal reports available.

It does appear that the Liberation Procedure does positively impact MS symptoms for a
significant portion of the patients on whom it is performed. These

positive results range from dramatic to slight, but another significant

portion of patients, albeit a minority, report receiving no benefit from

the procedure at all, some even telling of a worsening of their

condition post procedure. We are also seeing the very troubling trend of

restenosis (veins closing back up) several weeks or months after

balloon venoplasty, and also an increasing amount of accounts of

problems with stents implanted in patients' jugular veins, primarily in

the form of stent thrombosis (clotting), and stented veins stenosing in

areas above or below the location of stent implantation.

Although the accounts of restenosis are discouraging for the patients who
experience it, their stories speak loudly to the validity of the CCSVI

hypothesis and the effectiveness of the Liberation Procedure. Patients

tell of experiencing marked improvements after having had the procedure,

but then a dramatic worsening when their veins once again collapse.

Upon a second attempt at liberation, most of these patients once again

experience benefit. Unfortunately, many of these patients restenose yet

again, accompanied by the return of their MS symptoms. This is a strong

indication that resolving vascular blockages at the very least results

in symptom improvement for a significant number of MS patients. However,

with the incidence of restenosis far too common, strategies must be

developed to address this vexing problem. Obviously, patients can't be

expected to undergo repeated invasive procedures (which include a not

insignificant dose of radiation) to address a continuing pattern of

restenosis.

Stents have been used to treat veins that were resistant to ballooning or were otherwise problematic. The use of stents
in the jugular veins has been somewhat controversial from the outset,

as all of the available stents were designed for use in arteries, which

generally carry a much more robust blood flow than veins, and which

narrow in the direction of blood flow. This means that the risk of

clotting in arterial stents is much less than in veins, and that any

stent getting loose in an artery would only get pushed further into that

artery, rather than have a clear path to the heart, which is the case

for stents implanted in the jugulars.

As accounts of problems with stents increase, several doctors and clinics that perform the
Liberation Procedure have shied away from using them. Since, once

implanted, stents generally cannot be removed, the long-term failure

rates of stents are also of considerable concern. The only other patient

population that regularly receives venous stents are late stage renal

patients, whose veins collapse as a result of kidney dialysis. Studies

of the patency rates of stents placed in these patients are less than

encouraging, finding failure rates as high as 50% after one year (click here for info).

While the two patient populations in question are extremely different,

the risk of stent failure in the long term is a legitimate concern,

especially since the currently available stents were designed for use

primarily in thoracic arteries, where they're not subject to the

constant bending, twisting, and torque they experienced when placed in

the very flexible human neck. Whether or not to allow the use of stents

is among the many very difficult decisions patients considering

liberation must make. I personally decided that I would not allow their

use.

Obviously, large-scale treatment studies are desperately needed to determine not only the efficacy of the Liberation Procedure,
but also the best methods and practices for performing it. Currently,

the techniques used vary widely from doctor to doctor, with no real

consensus among the treating physicians regarding the size of balloons

to use during venoplasty, the use and placement of stents, or even what

constitutes a treatable stenosis. Furthermore, many of the

Interventional Radiologists performing the procedure have commented on

the rather steep learning curve involved in getting it right.

Increasingly, it appears that the CCSVI picture is more complicated than originally
thought, with more blood vessels (including the lumbar, iliac, and

vertebral veins) likely involved. The Liberation Procedure is a work in

progress, and procedures done a year from now will probably differ

significantly from those done today. Physicians are still in the early

learning stages in regards to the treatment of CCSVI, and patients

should be wary of being a part of anybody's learning curve. The success

rate of Interventional Radiologists who have done numerous procedures

appears to be much greater than those with less experience. Again, the

decision of what physician to choose needs to be given very careful

consideration by patients considering liberation; not just any doctor

offering the procedure will be adept in its performance. There is

increasingly a "Wild West" environment developing out there, as the

prospect of huge financial gains made by offering the Liberation

Procedure becomes apparent to physicians worldwide, who might undertake

the procedure without the proper training and requisite experience. This

is a pitfall that patients need to be very aware of, and must be very

careful to guard against. Ask any potential treating physician serious

questions, request patient references, and do as much research as

possible. Until the myriad questions regarding CCSVI and its treatment

are fully resolved, there will be plenty of opportunities for hucksters

to take advantage of desperate patients.

A burgeoning medical tourism industry has sprung up around CCSVI, with clinics offering the
Liberation Procedure in such diverse locations as Poland, Bulgaria,

India, and Costa Rica, for prices generally ranging from

$10,000-$20,000. Because of the persistent problems with restenosis,

stent thrombosis, physician competency, the necessity for post procedure

medical care, and the constantly evolving knowledge base regarding the

best standards and practices of the Liberation Procedure, I strongly

urge patients to forgo traveling long distances for treatment.

In a best case scenario, in which a patient travels thousands of miles and
spends heaps of money to be treated with balloon venoplasty, and finds

themselves to be amongst those lucky enough to see significant benefit

from the procedure, there is still the large risk (some place it at 50%)

of restenosis some weeks or months post procedure. In such a case, the

patient would be back to square one, less the large amounts of money

they spent on travel and the procedure itself.

Furthermore, aftercare is very important, as patients are commonly placed on blood
thinning drugs post procedure. These drugs need to be carefully

monitored for months after treatment. If a stent is implanted, it may be

quite difficult for patients experiencing complications to find

appropriate treatment locally, with the possibility of dire

consequences. Keep in mind, too, that there is no guarantee that any

given patient will be among those who experience dramatic improvement.

One prominent Interventional Radiologist that has performed well over

100 Liberation Procedures estimates that one third of his patients see

no benefit from the procedure. Given those odds, combined with the high

risk of restenosis and the very small but real chance of medical

complications that might arise after liberation, traveling long

distances and spending tens of thousands of dollars to pursue treatment

cannot be recommended.

Of course, every patient must make decisions regarding CCSVI and the Liberation Procedure based on their
own unique circumstances. For the majority of patients, I would strongly

advise waiting 6 to 12 months before seeking liberation, as much more

information from both academic and treatment research studies will be

available, and some standardization and identification of best practices

will be achieved in the coming months by the Interventional

Radiologists performing the procedure.

It's very important, and very difficult, to make an unemotional and accurate assessment of your
own condition and rate of progression. Karen likes to chide me about the

fact that I've been saying that I'm six months away from being

bedridden for the last three years. Presently, my right side is almost

completely paralyzed, and my left side is weakening considerably. Not a

good combination. I understand the desperation that all MS patients

feel, regardless of the particulars of their state of disability. We all

want to just be rid of this disease. But unless your situation is

genuinely dire, it will absolutely be in your best interest to allow the

science of CCSVI and the techniques that go into the Liberation

Procedure to mature, as doctors gain experience and more hard facts

about the condition become available. Most MS patients experience a

relatively slow progression of disability. Waiting, especially in the

face of the hype surrounding CCSVI, is extremely difficult, but in this

case might save you considerable bodily wear and tear, significant sums

of money, and much heartache.

I firmly believe that CCSVI will prove to play a major part in the MS puzzle. Like all things related to
MS, its impact will vary from patient to patient. For some patients, it

may very well be THE answer to their problems, for others only a partial

solution, and for others still it may play no role at all. MS is a very

complex and frustrating disease, truly a scourge to those who suffer

from it. CCSVI offers a light at the end of the tunnel, but there is

still much work that needs to be done. Thankfully, dedicated researchers

and physicians are actively looking for answers, even in the face of

sometimes withering criticism, and their findings may very well result

in paradigm shattering changes that rock the world of MS. But it is

still very early in the game, and it's important to remember that

discretion is often the better part of valor, and that the race does not

always go to the swift.

http://www.wheelchairkamikaze.com/2010/10/comprehensive-roundup-of-ccsvi-info.html