Sunday, June 13, 2010

Some Thoughts on the Current State of CCSVI

Central nervous system

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Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.

-Sir Winston Churchill, November 1942

It's now been almost 13 months since I first posted information on CCSVI, in a piece titled "Is MS Actually a Vascular Disease?" (click here). At that time, CCSVI was hardly a blip on the MS radar screen, knowledge of it confined mostly to a few dozen patients fervently researching and discussing Dr. Zamboni's findings on the patient forums at ThisisMS.com. A small handful of MS patients had been treated by Dr. Michael Dake, at Stanford University, having stents placed in the narrowings (stenosis) found in the veins associated with their central nervous systems.

Well, what a difference a year has made. CCSVI has created a firestorm in the MS community, as desperate patients have embraced the theory as their best hope to beat back this horrifying beast we call Multiple Sclerosis. Canadian television has aired numerous news pieces detailing the theory and the "liberation procedure" used to treat it (click here), hundreds of patients have been treated for the condition at locations scattered around the world, and the Internet is full of seemingly miraculous before and after videos portraying patients whose MS symptoms have dramatically declined after undergoing endovascular procedures to address their vascular abnormalities (click here). Just this past Thursday, the US and Canadian MS societies announced $2.4 million in grants to fund seven trials designed to test the validity of the CCSVI theory (click here).

Still, there is widespread disgruntlement among the MS patient population, many of whom are dismayed at the almost complete lack of treatment options available locally in the US and Canada, feel that research is moving much too slowly, and in fact believe that a conspiratorial cabal of pharmaceutical companies, mainstream neurologists, and MS societies is intent on suppressing and killing the CCSVI theory in order to protect huge profits and rapaciously defended spheres of influence.

I understand the desperation and anger these patients feel, which speaks loudly not only of the promise of CCSVI, but also of the failure of mainstream neurology to come up with any options better than simply suppressing or modifying our immune systems, often with drugs that carry with them the possibility of terrifying side effects. We are told that our immune systems have somehow gone bonkers and decided to attack our own tissues, but we've never been told why, and with the tremendous profits being generated by drugs companies marketing drugs targeted at the immune system, that why has been left to dangle in the air, twisting in the breeze. CCSVI appears to answer that vital why, in a fairly elegant and easy to understand manner, and thus has been embraced by a patient population frantic for answers.

It's important, though, to take a step back and calmly assess the situation as it now stands. We must guard against hope eclipsing reason, which is difficult to do when, as MS patients are fond of saying, time equals brain. With the omnipresent escort of progressing disability haunting us, we all want solutions, and we want them as quickly as possible.

Still, it's important to discern the realities of where the state of CCSVI research now stands. Many patients insist that the theory has been proven, and that a simple and minimally invasive procedure can halt or reverse the ravages of their illness. It's quite possible that they are correct about the procedure, but the fact is, as has been stated by Dr. Zamboni (click here) and some of the other leading CCSVI researchers and physicians themselves (click here and here), that research is desperately needed to prove or disprove the association between MS and CCSVI, that the procedures used to treat the venous abnormalities that have come to be called CCSVI need to be refined and perfected, and that new medical devices (stents) must be developed specifically for use within the CNS venous system.

Thus far, the only positive peer-reviewed research that has been published regarding the association between CCSVI and MS comes from Dr. Zamboni, and from the research team at the Buffalo Neuroimaging Analysis Center (BNAC), whose initial trial results involving 500 patients were released in April. All other reports are strictly anecdotal, and as such have little credence in the eyes of science. It's vital for completely independent researchers to confirm the initial groundbreaking work done by Dr. Zamboni, to firmly establish that CCSVI is significantly more prevalent in MS patients than in the general population, and, once confirmed, that CCSVI is a cause rather than an effect of the disease. Despite many patients’ belief otherwise, neither of these two propositions has yet been established in any scientifically valid manner. Only once CCSVI is determined to be a causative factor of MS will the MS societies fund studies on treatment.

In the meantime, privately funded studies looking at treatment options have already been proposed, and some should be getting underway sometime this summer.

The studies recently funded by the US and Canadian MS societies are targeted at precisely the two primary goals of proving the CCSVI/MS connection and showing that CCSVI is a cause rather than an effect of the disease. Much has been made of the fact that $2.4 million is hardly an overwhelming amount of money to be spent on CCSVI research, especially when placed in the context of the tens of millions of dollars being spent researching other aspects of MS, but at least it's a start. Without the groundswell of patient activism and advocacy, there most assuredly would have been no funding given to CCSVI research whatsoever, and I urge patients to continue to agitate for more, and more timely, research to be done.

The genie of patient activism is out of the bottle, and wielded wisely, can exert great influence on the powers that be. We must be careful, though, to guard against hysteria and extremism, to keep the CCSVI movement from being branded the lunatic fringe of the MS patient community. Discretion is often the better part of valor, and the movement would do well to heed Teddy Roosevelt's advice to speak softly and carry a big stick. That big stick is money, as the MS societies rely heavily on donations from the population at large (contrary to popular belief, only 5% of their contributions come from the pharmaceutical companies). I would expect that a smart and well-organized campaign that impacted the societies’ bottom line would quickly get their attention. Efforts can be made, too, to get CCSVI sympathetic members placed on the boards of the societies, as was recently tried unsuccessfully in Canada (click here). There will soon be CCSVI specific nonprofit organizations moving to the forefront, and support for these organizations should rank high on the list of those patients seeking to further the cause of CCSVI.

Switching to the question of diagnosis and treatment, I'm getting more and more concerned about people flying all over the world to get treatment that is quite possibly temporary (angioplasty) or carries with it unknown but very possibly real and troublesome risks (stents). Again, I completely understand the desperation of those willing to spend tens of thousands of dollars, and travel thousands of miles, to get treatment. I myself was lucky enough to get treatment locally, although my liberation procedure was unsuccessful (click here). But as the pool of treated patients grows, some obvious trends are emerging.

Even when initially successful, patients treated with balloon angioplasty are too often experiencing restenosis within weeks or months of the initial procedure. This means that they must either spend more time and money traveling across continents to be treated once again, or swallow their losses. Patients treated with stents are also experiencing problems with restenosis and clotting, and the very use of the currently available stents (which were designed primarily for use in arteries located within the chest cavity, vessels that differ dramatically in their anatomy from the veins associated with the CNS venous system), presents a host of potentially dire unknowns.

Dr. Zamboni has repeatedly stated that he's very wary of stents being used in the jugular or azygos veins, and when the doctor who treated me first presented my difficult case to Dr. Zamboni, Zamboni recommended traditional open neck surgery (as in, slicing and dicing) rather than stenting. Many patients have been stented for CCSVI successfully, but once those stents go in, they're in there for life, and nobody knows what affect the stresses of bending, stretching, and torque that the stents will experience in the neck will have as time passes. Stents specifically designed for use in the veins associated with the CNS are a must if CCSVI does indeed prove to be fact rather than merely theory.

Patients considering the liberation procedure must also keep in mind that not all patients treated see benefit, and some have even reported getting worse after treatment. We've all seen the miracle videos on the Internet, but people on whom the treatment had no or negative impact generally don't make videos for YouTube or show up on the various patient forums. Therefore, what we see and read on the Internet is extremely skewed towards the positive. Between patients who have contacted me through this blog and others that I know personally, I'm aware of quite a few people who have received absolutely no benefit from the procedure. Of course, given the heterogeneous nature of MS (the disease is very different in different patients), this shouldn't come as a surprise, but patients need to be keenly aware that the liberation procedure in its current form is not always the panacea that its most fervent advocates often assert it to be.

Another important consideration for those patients who do decide to pursue CCSVI treatment is the experience of the doctor doing their procedure. Most Interventional Radiologists (the specialists who do endovascular procedures) have far more experience treating arteries than veins. In fact, the CNS venous anatomy has been so little studied that no definition of "normal" has been agreed upon, and this anatomy can and does vary widely from patient to patient.

Furthermore, CCSVI is not limited to only one type of abnormality; a multitude of abnormal findings have been discovered in the jugular and azygos veins of MS patients. These abnormalities include vein narrowing, abnormal and dysfunctional valves, anomalous membranes, and even septums that divide the blood vessel in two. Many doctors just starting to do liberation procedures will have little experience dealing with this variety of abnormality. The physician who did my procedure, Dr. Salvatore Sclafani, has publicly stated that, despite 30 years experience doing catheter procedures, it wasn't until he had done the procedure on about 20 patients that he started to feel comfortable with the "art" of liberation, and that he was learning copious amounts with each patient he treated.

Undoubtedly, as more and more patients undergo the procedure, the methods and equipment used will be altered and refined, and procedures done a year from now will likely be much more sophisticated than those that have been done to this point. Although the idea of waiting for treatment is abhorrent to many patients, it may actually be in their best interests to allow doctors to gain the experience necessary to perform the liberation procedure effectively, safely, and with long-lasting results. We are in an age of discovery, and the book on CCSVI and the best ways to treat it has only started to be written.

In short, what we don't know still vastly outweighs what we do know about CCSVI and its role in MS. I personally believe that CCSVI will prove to be a major piece of the MS puzzle. I don't believe that it will be THE answer for all MS sufferers. The promise of CCSVI is tremendous, and in conjunction with advances being made in stem cell therapies, a new age in the understanding and treatment of MS could very well be dawning. But as tedious and frustrating as it might be, we must let the course of science wind its way towards definitive answers. Those who feel they cannot wait and choose to be pioneers in the treatment of CCSVI, would do well to remember the experiences of the pioneers who settled the American West. Some made it to California, struck gold, and became rich beyond their wildest dreams. Others, like the Donner Party (click here), became hopelessly stranded en route, and suffered disastrous consequences.

Due to the nature and speed of my disease progression, I decided to follow the trail blazed by the first and bravest pioneers, and underwent the liberation procedure, although I made it clear that I would only agree to balloon angioplasty, and would not consider the use of stents (my doctor was in agreement). I may revisit that decision as my disease marches onward. Each patient must decide for themselves their tolerance for risk, but hopefully, as the saga of CCSVI continues to unfold, those risks will be considerably diminished. At the very least, the issue of CCSVI has pushed researchers to look beyond the autoimmune theory, and that alone is a very good thing.

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49 comments:

  1. As always, you speak openly and honestly which always has me coming back to hear your latest news. I have always agreed with you; we need to learn more before we jump into a quick decision. This is not guaranteed for any of us and we must make a choice for ourselves whether we want to go into this now or wait for more answers. I myself will watch and wait but others may not. As our MS disease differs for us, so do our choices. Thank you for your thoughts and I pray you find your answer. GOD bless....
    Kimmy :)

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  2. You're again a voice of reason and compassion.
    Judy

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  3. Very interesting, lots of insight. The one thing that bothers me about CCSVI is the lack of documented failure. By this I mean, that if people believe that something hasn't worked or they are the subject to a hoax they use the Internet to air their views. This is true of anything that costs money (Treatment for CCSVI is very expensive). Where are to these failiures? Where are the patients for whom the procedure did not work or made them worse? We need to hear about the failures as well as the successes. We need to know that this is a real treatment. Real treatments always have some failures!

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  4. Hi Marc,
    I've said it before .......... you have the author in you. And not only that, your thoughts correspond with my own, so you just have to be smart.
    I will send your thoughts to three leading neurologists here in Sweden. They never answer my mails, but I am sure they read what I send.
    I got into a discussion on medicinal cannabis with them and it resulted in quite a commotion. I was talking about quality of life and they answered that "we shouldn't believe that a little plant as cannabis would be the cure for ms." What an ignorant answer!
    Your thoughts cheered me up.
    Regards,
    Lennart

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  5. Thanks Marc for your usual reasoned and thoughtfull take...

    I think they are going to find CCSVI in a significant % of the non-MS population. Hopefully this won't be used to stop further research. Perhaps this is where the genetic makeup of the individual comes into play. Who knows how many conditions will be associated with CCSVI: migraines, Parkinson's, autism, etc. Hopefully this opens up a whole new branch of medicine with the possibility of a safe and minimally invasive treatment for many of us.

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  6. I think you need to visit CCSVI for MS in Toronto.....it will blow your mind!!

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  7. Sorry it is on Facebook

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  8. I am hopefully meeting with the Director of Radiology at a local teaching College soon to discuss CCSVI. My focus has changed with time from wanting to be Liberated to simply sparking a fire. That fire might someday Liberate me but for now I hope the flames help answer the many unknowns of this Venous mystery.

    Time is Myelin, David

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  9. Thoughtful & informative piece, as usual, Marc. But, as one of my friends, a bio-chemist recently told me, most results in medicine are anectotal since we need generations of study to determine validity.

    I still believe, that all people should have access to CCSVI testing & procedure if they wish. And if people choose to self-pay, doctors should not be stopped from performing the procedure.

    Each of us throws the dice in our own way.....

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  10. I think you are right on. The comments on TIMS and chat forums are nothing but unsubstantiated comments. Most of them didnt even have the damn procedure and yet they are praising any Dr feverishly that might answer one of their questions. I have had the procedure and keep getting worse. Rockstar, Savior, just a few of the acronyms.People be realistic. Have realistic expectations. I am just as desperate as the next guy believe me. Getting this pumped up is a set up for failure....We need to see realistic trials. Watching oneself deteriorate doesnt help I know. But there really is a mixed bag of results with this theory...

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  11. As the radiologist that did my doppler said to me: as the lesions of every MS patient are different, so are the stenoses. While I believe there is clearly a vascular component to MS, I don't believe it is all of it.
    Even Dr. Simka of the clinic in Poland says he believes MS is more than CCSVI and medications need to be further developed and research needs to continue.
    CCSVI doesn't explain the other commonalities found in MS. It's fabulous to have discovered a large piece of the puzzle, and we should be allowed to pursue treatment that is low risk, but we have to be cognizant that the journey doesn't end on the Liberation table.

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  12. Even though it's not normally "the way I roll" I feel like kissing you on the mouth.

    I hope you don't get tarred and feathered but that was a great and realistic overview of the total CCSVI situation.

    Minor disagreement "Only once CCSVI is determined to be a causative factor of MS will the MS societies fund studies on treatment." and I think you'll agree that convincing evidence of benefit in most any way would open the funding floodgates.

    98 out of 100!

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  13. Great, great post Marc. It's as if 'you've seen enough' and had to corral everyone's flailings. You succeeded I do believe as you pay great attention to the reasons why people, like myself of course, did not choose to wait. But you 'make it okay' if someone is really struggling with it all, to feel OK about either decision they make. Because, as you say, this is all so very personal.

    Great job as always my friend.

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  14. Although the idea of waiting for treatment is abhorrent to many patients, it may actually be in their best interests to allow doctors to gain the experience necessary to perform the liberation procedure effectively, safely, and with long-lasting results. We are in an age of discovery, and the book on CCSVI and the best ways to treat it has only started to be written.
    How would doctors get experience? Did I miss something?
    Doctors sharing details of their experience is key and necessary.

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  15. Great objectivity here. Thanks for the clarity in your explanation.
    Peace,
    Muff

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  16. Marc,

    Good post as always, I am all for more scietific research on CCSVI before spending thousands to fly abroad for the procedure. I am also thankful for the early pioneers that launched this theory into practice. I am frustrated with our MS Society's response in funding the research that is needed to prove or disprove CCSVI and its relationship to MS. I agree that the MS Society will respond to lack of giving (I have made that known to them). I am willing to be a pioneer because my options are limited (PPMS), but don't have the option. I am willing to be a guinea pig (or lab rat) but don't have the option.

    Time is more than brain, time is the ability to do things with our families. Time is being able to participate rather than just be a spectator. I can't find fault with any of the TIMS group clamoring for more funding and access to IR's. Time is not on our side, we battle time every day and we are losing the battle. Even if CCSVI would cause a declared seize fire for a moment, wouldn't that be a win? You took a minor risk with Dr. Sclafani, why can't we take the risk as well? The more people that the IR's see the more this will be proven or not.

    If I remember correctly from your earlier post you did have some stenosis, but angioplasty would not keep your veins open. The fact that you had stenosis is all that the currently funded studies are trying to establish. Why is this so hard?

    Jim

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  17. Marc,

    Great post, and, for what it is worth, I agree with your commentary. That said, I am not smart enough to know if the projects that are about to be funded by the Society will adequately establish if CCSVI is a causative factor in MS. What I do know(and I suspect you might agree)is that 2 years is a long time for people with MS. It would seem that the preliminary, mechanical, work about to be funded could be done a little more quickly. A sense of urgency does seem to be lacking.

    KC

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  18. I understand the need for calm and patience, but it is easier said than done. Honestly, if you had amazing results from your procedure would your take on all of this be different? The anecdotal reports have gotten us this far and are very important, the good and bad. I feel like the youtube posters should be commended for putting themselves out there, not categorized as posting "miracle videos". I don't think anyone is doing anything but giving their personal story.
    I'm glad you are concerned for those getting treatment now, but I'm sure they have weighed the risks and benefits for themselves. It is unfortunate when reality does not meet expectations, but really who could go into this without hoping for huge changes?
    Time will prove the relationship between CCSVI and MS, but people are experiencing changes which need to be shared to keep this going in my opinion.

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  19. Great essay Marc. When my wife got tested recently at BNAC (two of the Zamboni criteria were found) we had a chance for a brief conversation with Dr. Zivadinov. One thing I liked was that he was very definite in saying that they were pursuing the CCSVI testing as research to determine what if any connection exists between CCSVI and MS. Not with a mindset of what the answers will be going into the investigation. I'm glad the NMSS is funding additional validation studies, but wish they were also doing treatment trials too; so we'll have to wait for the ones that seem likely to occur based on what's floating around. The patient activism is something new on the scale being seen with CCSVI as the internet make it possible to build a mass of people into a movement that can accomplish something that might not have occurred without them. But like the Tea Parties, there's also elements of nothing but enthusiasm, and anger, villains, and impatience without a counterbalancing understanding as you have described of the complexity of most disease and treatments. There's no going back now. "The anatomy of CCSVI and it's Treatment" - the story to be written in, hopefully just a few years, will be a fascinating book.

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  20. Thank you, Marc, as always, for a cogent, well- written and documented post.

    I agree that the prudent course of action would be to wait on having a liberation procedure until the interventional radiologists willing to give it a go have more experience; however, they need to learn on several someones, so I too will be a pioneer on 6/24. I have struggled with SPMS for many years and have had M.S. for more than 30 years. So, I will volunteer to be the guinea pig this time in the hopes that my younger and often even-more- seriously-afflicted friends with M.S. may find some real answers. We all have been waiting long enough.

    Should the "liberation process" prove to be the key to a solution or even a piece of the answer, I will be heartened to know that young friends can play with their children and will walk down the aisle unassisted at their weddings.
    Roberta

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  21. Good post! My only concern would be...that the blockage of circulating blood to any organ (for any reason) and for any period of time cannot logically be seen as a good or even acceptable thing? MS aside,I would prefer circulating blood in all my bodily organs. I may feel differently, too, after my veins are freed...

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  22. I DID have the treatment. It'll be two weeks on Weds. Am I doing back flips? no. But I can tell you that the illness is gone. I am left with quite a bit of nerve damage that I may or may not heal completely from, but the improvements are many. Better?...absolutely. Dangerous? please, a root canal is far worse. Maybe I was an easy fix...Both jugs blocked, 50% and 100%, ballooned no stents.

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  23. Kimmy-you're absolutely right, there are no guarantees, and everybody needs to make choices based on their own particular circumstances. If a patient makes a well-informed decision one way or the other, they should be supported and commended.

    Judy-thanks

    anonymous-I think that those who haven't responded well to treatment could very well be quieted by the din of hyperbole that surrounds most every conversation regarding CCSVI. Most are also very disappointed, and confused as to why they are "failures", while others seem to have experienced such dramatic improvements. The few that have spoken up (and that's a very few) have quickly been washed away in the sweeping tide of enthusiasm that engulfs the Internet CCSVI world.

    Lennert-yes, it can be very frustrating talking to successful doctors, as a necessary component of rising to the top of the medical field appears to be a rather large ego. Still, the best are scientists at heart, and do have the best interests of their patients in mind. Keep on trying to engage those neurologists, you never know when a ray of light will shine through...

    anonymous-I agree, it's likely that many discoveries will be made in the course of researching CCSVI that shed light on many different conditions. That's why I consider CCSVI to already be a success, it has researchers looking in places you never thought to look before...

    anonymous-I've visited the many Facebook CCSVI sites, and what really blows my mind is the lack of critical thinking prevalent on most of them. I'm all for enthusiasm, but on many of the sites enthusiasm crosses the line to hysteria, and anybody voicing any doubt at all is unfortunately quickly dispensed with. It's important that everyone keep an open mind, doubters and believers both.

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  24. David-time spent reaching out to physicians to talk to them about CCSVI is time well spent. The CCSVI movement would have never gotten off the ground patients hadn't taken it upon themselves to aggressively pursue open-minded physicians.

    Hilda-I agree that patients should have access to treatment, as long as the treatment will be safe and effective. The problem is that procedures currently using stents may not be all that safe, and in the hands of inexperienced physicians, the treatment will very likely not be extremely effective. There needs to be a concentrated effort to get everyone on the same page, and while I support the recent funding of CCSVI research projects, I do think an effort needs to be made to expedite such research on humanitarian grounds.

    Anonymous-the mix of emotions stirred up by CCSVI can be tremendously confusing. On the one hand, we all want to believe that this is the answer, on the other there is the need for proof of concept. MS is horrible, and, as I once told my neurologist, I would crawl up the ass of a fat man if there were evidence it would help my condition. It's very important, though, to not let desperation cloud your judgment. Much easier said than done, though...

    anonymous-well put. There are definitely aspects of MS that CCSVI does not address.

    Bob-I don't roll that way either, so how about just a virtual man hug? Good point about funding getting flowing if verifiable proof of benefit surfaces. Maybe the data coming out of Kuwait will be that proof...

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  25. Lew-thanks for the kind words. I definitely support anyone making a well reasoned decision either way.

    Anonymous-it's not as if treatment has been stopped all over the world. There is treatment happening in Poland, Bulgaria, Kuwait, Mexico, and India. Preparations for proper trials on treatment are underway here in the States. There will be plenty of data and experience for these doctors to pass on to their colleagues. Doctors doing the procedure "under the radar" won't be contributing to the knowledge base necessary to validate the CCSVI hypothesis.

    Muffy-thanks for the kind words.

    Jim-the problem is that most of the procedures that have been done thus far (mine included) were basically done in a relative vacuum, and aside from anecdotal evidence, have not contributed much to our understanding of the complexities of CCSVI. Yes, people should have access to testing, especially if they're willing to pay for it out of their own pocket. Unfortunately, the current noninvasive imaging technologies have proven extremely poor at discerning CCSVI related blockages. The only way to definitively assess a patient's situation is with a catheter venogram. Hopefully, research will provide us with better ways of detecting the signs of CCSVI, and the folks conducting the research up in Buffalo have already refined many of the techniques they use when testing their first round of patients.

    KC-I totally agree that two years is too long to wait. The studies are supposed to release preliminary findings in six months, though. There does need to be a fire lit under the asses of many of those in charge of funding and conducting the research.

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  26. Blah blah-honestly, if I'd seen better results, I think my position would be exactly the same. My procedure didn't prove or disprove the theory to me, and I'm just as hopeful about CCSVI as I was in the minutes before undergoing the procedure. As for categorizing the patient videos as miracle videos, that wasn't meant to be derogatory, but I believe it is an accurate description of what is being depicted. Many of the huge improvements seen in the videos defy scientific explanation. That's not to say that the people in them are lying, or trying to deceive in any way. But dead or damaged nerve cells don't regenerate in 24 hours, and even a strong anti-inflammatory effect would take longer to be evident. Even the doctors performing these procedures are at a loss to explain what physical mechanism lies behind some of the more dramatic improvements seen. It's important for people to realize that such improvements shouldn't be the expected outcome for all undergoing the procedure.

    Larry-I agree that the funding of treatment studies would be terrific, but to the scientific mind a hypothesis must be shown to have validity before action to address it can be taken. As I stated in one of my above answers, in effect there are treatment studies happening around the world, the biggest being in Kuwait, where every MS patient is going to have access to the procedure in their state-funded medical establishment. The data that comes out of Kuwait should be quite telling.

    Roberta-best of luck on your upcoming procedure. It's certainly true that those willing to be "guinea pigs" now will be laying the groundwork for a brighter future for generations to come.

    Anonymous-logic would dictate that any blockages in blood flow would be have a negative effect on a person, but I've been told by many doctors that many people live their entire lives with such blockages to no apparent ill effect. That said, now that I know that I have a blockage in my jugular vein, I definitely would like to see it resolved...

    anonymous-congratulations on your successful treatment, and I hope that you do indeed see continued improvements. As I think I made clear, balloon angioplasty does not carry with it the same risk as stents, but the trade-off is that a large percentage of patients who do the balloon procedure suffer restenosis at some point in the first year after liberation. I sincerely hope that you are not one of them, and if it's not too much to ask, I hope you'll keep me apprised of how you're doing. Again, a big congratulations and wishes for continued improvements to you...

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  27. WcK,

    I loved your post, and I don't want to quibble, but there is a slight flaw in your logic.

    You wrote
    "It's vital for completely independent researchers to ... to firmly establish that CCSVI is significantly more prevalent in MS patients than in the general population"

    I think we will find that there will be at the very least 3 times as many people with CCSVI than MS and perhaps many more with low grade venous abnormalities in the target veins. I say this because research already shows that if one of an identical twin has MS, the other only has a 1/3 chance. CCSVI is congenital, and we are likely to find that it is associated with the same genes associated with MS. Also, vegetarian (i.e. low iron) diets play an established role in reduced disease incidence. Finally, the disease takes a very long time - people are born with it, and it strikes primarily in 20s to 40s; and severity of onset is likely to be correlated with severity of congenital abnormalities/severity of additional triggering factors.

    I think the current view is that
    (normal) MS = CCSVI + [something else];
    (abnormal) MS = [something else];
    some people with false positive MS diagnosis in places where it is already top of mind.

    I truly hope you find some relief, and that the ongoing research perfects techniques which help you.

    I love your writing; and would love to hear your thoughts on why I think general abnormality incidence is a red herring.

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  28. Thanks for the great article... I still firmly believe that those who have progressive forms of MS should be able to access diagnosis and treatment. Also, this push to show a link between MS and CCSVI is (and according to MS Docs) the first step. I disagree. If I have venous malformations certainly, whether or not I have MS, I should have access to treatment - just as the rest of the population currently has access.

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  29. Who is to determine how safety is defined for a person who is suffering from a quickly progressing disease?? If I were diagnosed with CCSVI and they asked me to sign a paper saying my risk of dying is great if I undergo a procedure that has been shown to help SOME people relieve their symptoms, I would ask, "Where do I sign?" Dying under the knife isn't half as frightening as dying while looking in a mirror.

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  30. I'm sorry about the last post-----I'm just sick and tired of people wanting to do what's best for me when they haven't a clue as to what's best for me.

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  31. There are a great deal of moments when I think to myself that I would pay untold $$$ for just a day of feeling "normal" once more. The Liberation Procedure sounds very appealing even if the results were temporary. Do you know how long it will be before Kuwait begins to publish any findings and do you know if the Zamboni methods will be used? Aarcyn

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  32. Nick-I can see your point, but if a substantial percentage of the "normal" population exhibits CCSVI, it would call into question the relevance that CCSVI has in the MS disease process. It certainly wouldn't eliminate CCSVI as a candidate for being a major causative factor, but would certainly indicate, as you say, that CCSVI alone is not the cause of MS. If you'd like to continue this discussion further, please e-mail me at WheelchairKamikaze@Gmail.com...

    anonymous number one-I understand your frustrations at having a progressive form of the disease and no access to CCSVI diagnosis and treatment. But your assertion that you should have access "just like the rest of the population" only applies if indeed CCSVI is a causative factor of MS. There is still the possibility that CCSVI is a benign condition. I personally don't believe this is the case, but there are many doctors (including vascular doctors) who do believe that such vascular abnormalities cause no harm to the patient who has them. If their opinion prevails, then undergoing procedures to correct CCSVI would be a waste of finances and medical resources. In effect, it would be internal cosmetic surgery.

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  33. Anonymous number two-no apologies necessary. Everyone is free to express their opinions and emotions here, as long as we keep things polite. The situation you present is one that is wrestled with by medical ethicists each and every day. Terminal cancer patients are routinely denied access to experimental procedures which might extend their lives, but are deemed too risky to be done on humans. Doesn't make much logical sense, I agree.

    The thing to keep in mind, though, is while we believe that the case for CCSVI is compelling, the majority of the medical community still does not. If a physician honestly believes that CCSVI has no relation to MS, then allowing a patient to undergo an invasive procedure would violate the Hippocratic oath to "do no harm", because although the chances are slight, catheterization does involve some risk.

    Aarcyn-I hear you, one day of normalcy would be incredibly precious. I do believe that Zamboni's methods are being used in Kuwait, but I'm not sure when they intend on publishing results. I'm sure they will, though.

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  34. Marc,

    My SPMS bride of amost 24 years is a New Yorker, through and through, who has been compelled to exile in Southern California as a result of my employment. She'd be back in our former little 450 sq. ft. Greenwich Village apartment in a minute if she could be, and who knows, it could still happen.

    Thanks for an excellent post on the way things are. We have been pursuing local screening and treatment for CCSVI. A MR study was recently completed that shows narrowing of the proximal internal jugular veins bilaterally.

    We sent the study CDs to Dr. Haacke, becuase (1) we want her date included in his database, and (2) we were hoping that he would give us his interpretation of what is visible.

    Yesterday we met with my cardiologist, whom I introduced to the subject of CCSVI. He's read the papers I sent him and has pursued the internet links to presentations and various writings. He explained the obvious, that randomized, double-blinded studies are necesary in order to satisfy scientific standards for validation of the theory. At the same time, he stated that the anecdotal evidence is becoming more and more compelling, and he addressed the procedural risks in a general way, with the caveat that he does not do this particular procedure.

    He explained that he would gladly sit down with an interventional radiologist, one who we all agree is excellent, and discuss my wife's MR study. Afterward, he will set us up with a consultation with the IR. I gave him a copy of the '99 paper by Lee et al and asked him to provide that to the IR.

    Like you, I would like to see a more complete picture of the data of all patients who have undergone the treatment to date. I started creating a spreadsheet of those who have posted on thisisms.com, but it would be good to be able to include the data of those who gained nothing after undergoing the procedure.

    The decision to undergo the procedure will ultimately be solely my wife's to make. As our cardiologist said, he cannot become part of that decision-making process for her. He cannot even quantify the risks of the procedure the way he things an IR will be able to do so.

    We are trying to keep this local because of the availability of follow-up care, especially in the event of restenosis.

    As it is, as you said, "under the radar", we are walking on eggshells in trying to pursue this treatment while being very consious about the importance of sharing the information revealed with the international community.

    Thanks for a very intelligent, thought-provoking post.

    Steven

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  35. It's rare to see such a balanced response on this issue. Inspiring, actually. Dr. Zamboni's preliminary findings gives me hope, but I remain rooted in realism. I'm a Canadian MSer and it is disheartening to see the blame being thrown around on this issue in Canada. Even politicians have added CCSVI to their debates, and in spite of veiled comments that they are tackling this on behalf of MSers, there is a group of politicians using this issue to stack their votes for the next election. This isn't about politics! And this should not be about "us" and "them." Add to the mix that apparently everything is the MS Society of Canada's fault. The irrational calls to stop fundraising for them will only impact the support group I go to, the scholarships they're giving out to kids whose parents have MS, or the equipment funding that many MSers need. The Canadian MS Society's stance is much like yours, and with the focus of patient safety being a priority. Whether it was this or stem cell treatment, they have always prioritized evidence that demonstrates that if I were to undergo some type of MS treatment, that it would be safe. There isn't enough data on either side and that's what we need more of. I have a fellow MSer friend from Calgary who unfortunately paid $12,000 to have this diagnosis done, and they found that he did not have CCSVI. I have another MSer friend from Toronto who paid $3000 to have the scan, and again, they did not find CCSVI. And yet another fellow MSer who has just come back from Poland, and has not felt much of a difference after getting the procedure done. It concerns me that the negative data is out there, but no one is talking about it. So what I'm trying to say is will you do a tour of Canada and preach your worthy message? :)

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  36. Thanks Marc - bang on as always. And @Raine - exactly. We are working on this in Ottawa.
    A few things:
    1. venous stenosis hasn't been shown to be abnormal and could in fact be caused by the testing procedure - no studies as yet to see if the stenosis persists over time or with readjustment of the head or whatever.
    2. you're right - there is no safe stenting procedure available for this vein at present and repeated dilation runs the risk of vein damage - this is a not insignificant risk of perforation, etc. Veins are very thin walled (designed to be responsive) and therefore won't hold a stent the way the thicker-walled arteries will. There have been treatment failures and deaths. Some people end up trapped in foreign countries, out of money and very ill. The treatment (and particularly the stenting) is not benign! Any time you pass a foreign body through your body, the body reacts.
    3. the research studies that have recently been funded by the MS Societies will look all around the issue of CCSVI and, in a relatively short period of time, will be able to identify if CCSVI is indeed abnormal (and not just a testing artifact) and what its effects are (not causation of MS, that will take longer, but whether it needs to be treated).
    4. The only people interested in promoting treatment of this right away are those making a profit from it - even Dr. Zamboni is pleading for more research.
    5. Those who are going for treatment - those with progressive MS - are, unfortunately, those for whom the treatment has shown the least benefit. Somehow this message is not getting out there. Even the initial studies showed NO long term benefit (beyond a year) for progressive MS patients. It is frustrating to see all these poor folks spending all that money for nothing!
    Thanks for your clarity of vision, MArc. It's tough with all the noise out there.

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  37. Marc - I've come to truly appreciate your wisdom and perspectives. As many, I've done a lot of reading over the past 6 months on CCSVI and I'm optimistic that it will be meaningful to many with MS, including perhaps myself. Here's what I contend to be a fundamental disconnect that I haven't seen adequately answered by physicians or policymakers: if I have CCSVI (which repeated clinical studies have proven I'm at high risk for because of my MS), isn't that a condition that should be treated prima facie. I've talked with interventional radiologists, who all say the same thing - if a patient comes to them with narrowed veins reducing blood flow from their brains, that needs to be treated. There's no mention of MS in that statement, and one thing should have nothing to do with the other.

    Yes, further research is justified to clarify and validate the relationship between CCSVI and MS, but CCSVI is a potentially harmful condition on its own and should be treated regardless of one's MS status. To do otherwise is blatant discrimination.

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  38. Nice post, Marc. I think you've made some good arguments but I beg to quibble.

    I don't agree that the association between CCSVI and MS is a burning question anymore. There is a compelling argument that the association between CCSVI and MS has been reasonably demonstrated both via the ever more numerous scans as well as results from the procedure [note: worsening symptoms in the post-procedural outcome is a result and also demonstrates the association].

    I think what remains to be demonstrated are the mechanics of the association (which you've touched on), how the magnitude and/or locations of the stenosis impact blood flux and the progression of the disease. The only way to accomplish that is with clinical trials.

    Let's not kid ourselves. Elvis is dead, JFK was shot by a single kook acting alone, man landed on the moon and the trickle of funding from the MS Society (in Canada, $700,000 for 4 studies over 2 years) is pointless gesture.

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  39. Another great post full of thoughtful remarks.

    Natalie summed up my feelings exactly. CCSVI and MS have been reasonably demonstrated to be concurrent in many people. We need to move on to treating the CCSVI and determining whether that treatment does indeed minimize disease progression and for how many.

    As for people voicing reservation being shot down, I think it is because there is so much power already pushing back against CCSVI and a lot of us feel the need to keep it front and center or it will disappear. Without all the grief that the NMSS and the MSSC received, they would have never funded CCSVI research. It would have gone the way of LDN. Ignored into oblivion - doctors won't prescribe it because no research has been done, no research is done because there isn't enough noise being made to force the issue. We don't want to see that happen with CCSVI and that's exactly where it was headed a year ago. So I will keep being one of those people who cheerleads for CCSVI without hesitation - not because I think it's the only answer to all our MS problems, but because I want the research done and I want the people with MS/CCSVI to be treated for it if they so desire. With Biogen just announcing 5 new cases of PLM in Tysabri users, angioplasty looks like a cakewalk.

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  40. A few other things:

    1.

    Venous stenosis is known by most vascular people to be abnormal anywhere in the body, and is not likely to be a false positive, but is very likely to be fixed, temporarily, by the person testing, for example, by the incorrect usage of the Valsalva manoeuvre. Proper diagnosis not achievable by those who are unaware or unsure the disease exists. That is because it is much easier to wave hands and claim it is a hoax, than to actually do the required tests, which are non-trivial even for expert radiologists, which most of the neigh-sayers are not.

    2.

    You're right - there is no standard stent available for these veins at present, but similar procedures are done every day even on the same veins, around the world. If veins could not support the treatment, many people, instead of walking around, would have had veins perforated or damaged, and patients would have died. Out of at least 1000 procedures, that has never happened. In fact, Dr. Zamboni has conservatively recommended against stenting, just to avoid the hot-dogging exploits resulting from inexperience. But there are many Liberation programs, and the current best practice is to balloon twice before using stenting. Dr. Sclafani sometimes uses cutting balloons, which make restenosis less likely, without stenting, by pre-creasing the inner vein wall

    3.

    Many studies to date, and much of the MSSociety's $2.4M boondoggle, unnecessarily revisit *again* the causation/prevalence issue, because of the unfortunately widespread Not Invented Here disease many researchers are victims of. The people with 'MS' are not the only people interested in promoting treatment of this right away. Dr. Zamboni, and both the Liberal and Conservative Parties of Canada, are pleading for treatment, as well as more research. He, and other CCSVI pioneers, know there is no point in trying to make a buck off of trade secrets, when they are getting a lot more than money from this venture.

    4.

    Of those who are going for treatment, some have progressive MS, for which Liberation, in Zamboni's first pilot study, had the least short term benefit. You are not likely to keep healing beyond a year, but then there have been *complete* recoveries, after that time, for SPMS patients who have gotten effective Liberation. If at first you don't succeed...

    It seems there is a lot of *dis-*information about.

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  41. Asian person-sorry, your response was not translated into English, so I have no way of knowing what you've said.

    Scott-on the face of it, your assumptions make perfect sense. I've been told by several top vascular physicians (at the NIH) that blockages such as those seen in CCSVI can be found in "healthy" people who never suffer any consequences from these blockages. There are lots of conflicting opinions on this. Knowing that I have a severe blockage in my jugular, I definitely would like to get it taken care of. As I've repeatedly said, I am a definite supporter of the CCSVI hypothesis, as is evidenced by my going through the liberation procedure. Still, I understand that the correlation between venous blockages and MS has not been proven to the very critical greater scientific community.

    Natalie-I agree with everything you've said. I'd love to see treatment trials being funded. Unfortunately, because of the controversial nature of CCSVI, mainstream science is going to be very methodical about this. Meanwhile, there are lots of liberation procedures going on worldwide, which hopefully will give us some verifiable information regarding treatment effectiveness and longevity.

    Judi-there is actually a difference between
    LDN and CCSVI. Unfortunately, tragically even, LDN has been ignored because no one will make any money from it's being found effective. It's a drug that's long been off patent, and finding funding for it has been almost impossible. The fact that nobody has given it a serious look is scandalous. CCSVI, on the other hand, stands to make many people lots of money if proven to be a vital part of the MS puzzle. Interventional radiologists and medical device manufacturers will make scads of money treating CCSVI and marketing devices made specifically for that treatment. This is why we are witnessing turf war dustups over CCSVI.

    Anonymous-thanks for your well presented comment. As I've mentioned before, I've had several top vascular physicians tell me that the CNS venous system has been so little studied that there is no definition of "normal". They then tell me that blockages seen in CCSVI most likely cause no ill effect. How they can make that assumption after admitting that they know very little about these things is certainly something of a disconnect.

    I don't think I've inferred that there is any physical danger undergoing the catheter procedure, but there is risk with stenting, especially, as you say, in the hands of inexperienced practitioners. Contrary to your statement, the placement of stents into jugulars is far from commonplace. Dr. Sclafani is the Dr. who worked on me, and has used the cutting balloon on a handful of patients. He's publicly stated that he is optimistic about its use, but isn't sure that it's the ultimate answer. He, too, is wary of the use of stents, and will not be using them in his upcoming clinical trial.

    I too would have liked to have seen treatment trials funded. The trials that were funded are not going over previously proving ground, though, as the Zamboni studies were seriously flawed from a scientific perspective, as they were not blinded. Science is all about replicable results, and so far his findings haven't been replicated. I personally am confident that they will be, but so far, there's been no such confirmation.

    As with all other MS treatments, it does look like progressive patients will not benefit to the extent that patients suffering from the other flavors of MS will. Progressive disease is a terrible problem...

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  42. Steven-thanks for your comments, and I wish the best of luck to you and your wife. The actual liberation procedure is quite safe, I only question the use of currently available stents, as no one can say how they'll hold up after years of undergoing the stresses of being in a blood vessel that twists and bends hundreds of times a day.

    Raine-I think it's most unfortunate that people are paying thousands of dollars for imaging that is proving to be unreliable. There is a definite need for a reliable noninvasive imaging protocol to detect CCSVI. The Doppler protocol that Zamboni uses is quite complex, and very few operators are currently competent to do it. Despite these problems, and despite the politicization of this issue, CCSVI still looks wonderfully promising. It is important that people understand the whole picture, though. Many of the Internet chat rooms have become echo chambers, with participants very adverse to any conflicting opinions.

    Dabble-as the responses to this post show, emotions run high when discussing CCSVI, and so little has been quantified about the hypothesis that evidence for all sides of the argument can be cited. The problem is, much of it is cited as stone cold truth, when the reality is that very little about CCSVI is yet written in stone. Still, dialogs such as the comments to this post are very valuable, as an exchange of information, as a way to make informed decisions, and to help shape opinions. As I have said before, I welcome with open arms those who agree and those who disagree, as long as the discussion stay civil.

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  43. The Japanese posts are spam about over-18 topics.

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  44. I agree with you, Kamikaze, about nearly everything. I do not think the scare stories about other countries are true. Certainly snake-oil speaks many languages, but "ye will know them by their fruit", not by flags or skin colour.

    Dr. Sclafani wants to have some of his early patients back. Are you one of them? He said there is more spinal involvement, in the area of the lumbar veins but other than that, he has written about most of the procedures, not just venography, which is pretty standard. The only real difference to any other vein is gravity, and Dr. Simka has had NO stenting 'incidents'.

    With veins, all roads lead to the heart and lungs.

    I think LDN may (sometimes) be beneficial if you can't get Liberation, because it is an agonist of angiogenesis. If this is true, it will help stimulate corollary growth. That may eventually become a problem as they seem pretty disorganised in CCSVI.

    I really don't see how the same drug can be good for cancer, when the difference between cancer and pre-cancer is angiogenesis.

    But I don't think Zamboni's results will ever be replicated by people who have an obvious confounding belief or self-interest in its being found non-existent, a lie, a hoax, or a hallucination.

    Especially so. But almost as importantly, by those interested enough in the possibility of its being genuine and true, to use the current published best practises to reverify it. There are enough outright successes to be believed even by totally unsuperstitious practical doctors. It only needs to be verified to satisfy a vocal minority of biased people who do not possess enough expertise to perform the procedure, let alone diagnose the abnormalities. If even radiologists can't find it... Doppler is a fairly new technology. I think probably some of these instruments can not be used, but that is even more controversy. I think what is needed is less.

    When I used to do lab work it was never good enough if it didn't have, not just make and model, but serial number. Because even that influences results. Good techs know how to allow for equipment biases. But with a new discovery, all bets are off, because what if it's still true, but some idiosyncracy makes your box the only one that can detect something?

    More testing is needed. I hear the mantra a lot. To convince certain people, but also to get standard practice for these problems nailed down, so that every experimenter does not make up her or his own. Not to re-prove CCSVI/'MS'. How many hundreds of successes do you need to see?

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  45. From an MSer in Canada, I am cautiously optimistic about CCSVI research and results. Im very happy its getting recognition and gaining momentum. Your article/update is beautifully written & presented. You are absolutely right, we must walk softly and carry a big stick, by advancing CCSVI research forward with dignity & professionalism it deserves. Researchers todate do question if ccsvi is cause or effect of MS. But why should it be limited to be proven as just the 'cause'? Whether Cause or Effect, ccsvi research must be fine-tuned with the goal of beneficial surgery for MS patients for improved quality of life and ease of symptoms, to whatever degree of benefit each patient gains. Dont you think? thanks for posting my comments.

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  46. Although it will be a while before I will get any treatment (CCSVI), I think its a good think that I am waiting. The more time goes on, the more we find out the dos and don'ts of CCSVI treatment. Time is an advantage in this case.

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  47. I'm with you 100% on this --excellent post!
    Daphne

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