DR GILHOOLY'S DISCUSSION ON VALVES

[dania]

Dr Gilhooly's discussion on valves
by Arlene Pellar Hubbard on Wednesday, September 7, 2011 at 11:59am

Dealing with Valves in CCSVI



Treatment of CCSVI has developed rapidly in the past 2 years with over 75 centres worldwide now offering differing forms of angioplasty procedures. Some centres are very research orientated with a steady flow of good quality research adding to the body of evidence supporting CCSVI as a real entity worthy of intervention.



The draft NICE guidelines in the UK has endorsed this approach and has encouraged further investigation of CCSVI in MS in the UK. We are pleased to have contributed to this process by direct conversations with the NICE committee and providing patient evidence of the effectiveness of this treatment.The excellent safety data from our clinic in Edinburgh is quoted in the draft guidance as well as the studies from Bulgaria and Poland.



It has become clear that one of the main issues with CCSVI is venous hypertension; raised pressure within the venous system of the brain. This increased pressure is transmitted to the deep veins in the white matter of the brain and in time affects the integrity of the tight junctions of the blood brain barrier.

Venous hypertension develops principally because of intraluminal abnormalities such as abnormal membranes, webs and most commonly abnormal jugular valves. A secondary effect of the decreased flow caused by an intraluminal abnormality is the development of collateral veins where the smaller veins enlarge due to increased blood flow. This in turn reduces further the flow in the jugular veins and can lead to stenosis or narrowing of the jugular veins. The presence of stenosis is usually an indicator of intraluminal abnormalities but venous hypertension can still exist in the absence of stenosis.



Treating the valves and other intraluminal abnormalities is therefore a central issue in the treatment of CCSVI and one that all the treatment centres in the world are dealing with. A balance has to be struck however, between aggressively treating the valves with high pressure balloons to reduce venous hypertension, and the possibility of vein damage. Excessive pressure could cause scarring and possibly further venous problems.



We recently discussed this issue with some of the world's leading experts on CCSVI.



Dr Salvatore Sclafani from New York pointed out that the veins are totally dependent on the venous blood for their nutrients and therefore this flow should not be disrupted for any significant period of time. Overenthusiastic and aggressive use of balloon catheters to disrupt valves could be damaging to the veins in the long term if the oxygen supply is reduced by the very procedure which is aimed at restoring normal flow. Current practice in the UK is similar to other centres where the valves and other intraluminal obstructions are treated with a combination of balloons, cutting wires, cutting balloons and particularly double balloons.



Dr Ivo Petrov in Bulgaria has performed over 1300 CCSVI procedures and was closely associated with the development of CCSVI in the UK. His practice is similar to that in the UK when dealing with valves but feels that although current treatment options are bringing good results, that further technical advancements will continue to improve the procedure.



The use of stents in the neck veins has been one solution to this problem but it has become clear that this approach is associated with increased complications. Professor Simka in Katowice has reported that the use of stents in his unit has dropped from 50% of patients to only 5%.



Professor Paulo Zamboni has obviously given this area much thought and has filed a patent for a device called a valvulotome. He feels this will be the most effective way of dealing with abnormal valves without damaging the vessel wall but on further questioning it became clear that there is no suitable valvulotomes available at present which are the right size for use in the jugular veins. This type of device is designed to permanently damage the valves without damaging the surrounding veins. It has been used in cardiology to remove the valves of the saphenous veins used in cardiac grafting.



There has been much discussion about the use of valvulotomes between some of the world's leading endovascular CCSVI surgeons including Professor Paulo Zamboni, Mr Donald Reid and Mr Ted Diethrich of Arizona. The current devices are designed to damage normal valves where the cusps are in the expected positions. In CCSVI we face the problem of abnormal valve cusps which will require a different design. Another consideration is the use of these devices in the neck veins could increase the risks in what is a very safe intervention. The anatomy of the jugular veins is such that the left jugular has a marked twist immediately after the valve, which could increase the risk of vein damage with the use of a valvulotome. The right jugular is usually straight which would make this form of treatment potentially less hazardous. Given the nature of the venous system where the drainage is shared bilaterally in the venous sinuses, it begged the question, would treatment of only the right jugular produce a reduction in venous hypertension? We sought the opinion of a Professor of flow mechanics who did extensive calculations on flow and pressure before concluding that he thought that it would improve venous hypertension.

The valves in the jugular veins are not essential with over 20% of the population having no valves in these veins. It is thought that permanent disruption of the valves using balloons alone is not possible at present and that over aggressive high pressure ballooning may risk venous damage.



The future of CCSVI treatment may well involve the development of a new device such as a valvulotome which can safely disrupt the jugular valves and so reduce venous hypertension over a long period of time. We are working with our International colleagues over the development of this.



In the meantime, the encouragement of new research by NICE brings the prospect of angioplasty treatment on the NHS closer to reality. We would encourage all our patients to comment on the current draft guidance from NICE before the end of the public consultation period on 21st September 2011. You can see these on http://guidance.nice.org.uk/IP/891/DraftGuidance

[esta]

well, i met him in poland before they set up their edinborough clinic not sure he has as much experience as dr. arata re valves. i do appreciate this, tx dania, as i'm still trying to decide by february to go to dr arata or wait for this valvutome device, yet knowing, i'm not ready to wait... feb is too long.

[dania]

What is this valvutome device?

[esta]

valvulotome ,sorry the device dr zamboni is patenting

[Cece]

Professor Paulo Zamboni has obviously given this area much thought and has filed a patent for a device called a valvulotome. He feels this will be the most effective way of dealing with abnormal valves without damaging the vessel wall but on further questioning it became clear that there is no suitable valvulotomes available at present which are the right size for use in the jugular veins. This type of device is designed to permanently damage the valves without damaging the surrounding veins. It has been used in cardiology to remove the valves of the saphenous veins used in cardiac grafting.

Valvulotomes are used in cardiology to remove valves in the saphenous vein? I wonder how effective this is or if there is damage done to the vein. A difference would be that, in such a graft, it is being placed as an artery with high pressure blood flow. In a jugular, if a valvulotome is used, it is in a low pressure flow environment with positional changes in flow which might increase the odds of the vein sticking together at the place where the valve was cut off or increased odds of clotting. But if it works!

It is thought that permanent disruption of the valves using balloons alone is not possible at present and that over aggressive high pressure ballooning may risk venous damage.

As always, durability is the issue. I don't know if it is right to say that permanent disruption of the valves with balloons alone is not possible. Dr. Zamboni's original work showed that 50% did not restenose after 18 months.

The use of stents in the neck veins has been one solution to this problem but it has become clear that this approach is associated with increased complications. Professor Simka in Katowice has reported that the use of stents in his unit has dropped from 50% of patients to only 5%.

This is a marked decrease in usage.
With stents, there does seem to be increased complications which is only exacerabated by the travelling patients who do not get timely or consistent follow-up care.

Dr Ivo Petrov in Bulgaria has performed over 1300 CCSVI procedures

Now there's a high number!

Dr Salvatore Sclafani from New York pointed out that the veins are totally dependent on the venous blood for their nutrients and therefore this flow should not be disrupted for any significant period of time. Overenthusiastic and aggressive use of balloon catheters to disrupt valves could be damaging to the veins in the long term if the oxygen supply is reduced by the very procedure which is aimed at restoring normal flow. Current practice in the UK is similar to other centres where the valves and other intraluminal obstructions are treated with a combination of balloons, cutting wires, cutting balloons and particularly double balloons.

That is interesting. Back in February or so, Dr. Sclafani reduced the duration of ballooning. I assumed it was to spare the brain that temporary reduction in outflow or to reduce the damage to the vein walls in some way but I wasn't thinking about reduction in nutrient supply to the veins.

EHC in particular uses double balloons (aka "kissing balloons")? These are a substitute for high pressure balloons, by putting two regular balloons side-to-side so that they both expand and push on the stenosis and each other simultaneously. The main difference between this and a high pressure balloon is that double balloons require a larger entry insertion.

[BadCopy]

Is it easy for a IR or other doctor to see if your valves are an issue? What is the process to make that determination?

I am interested in the idea that the valves may be causing, or at least significantly contributing to, CCSVI. My question is, what determines if the valve is causing a problem. I am not sure I want to jump forward to the point of just removing them before being sure they ate a part of the problem. I have seen what appears to be a large correlation between people that had agressive ballooning at the valves and a longer amount of time their symptoms were reduced.

I guess what I am saying is that the valve issue makes sense and would definately explain the experience I have had with CCSVI. But how do docs determine what a good or bad valve is and if it needs to be dealt with? Or is it a process of elimination?

By the way I have not been following for a while, so if some of this is old news please let me know. I am very interested in the valve issue because I have suspected that it is a player in my situation for some time.

[DrCumming]

Is it easy for a IR or other doctor to see if your valves are an issue? What is the process to make that determination?

I am interested in the idea that the valves may be causing, or at least significantly contributing to, CCSVI. My question is, what determines if the valve is causing a problem. I am not sure I want to jump forward to the point of just removing them before being sure they ate a part of the problem. I have seen what appears to be a large correlation between people that had agressive ballooning at the valves and a longer amount of time their symptoms were reduced.

I guess what I am saying is that the valve issue makes sense and would definately explain the experience I have had with CCSVI. But how do docs determine what a good or bad valve is and if it needs to be dealt with? Or is it a process of elimination?

By the way I have not been following for a while, so if some of this is old news please let me know. I am very interested in the valve issue because I have suspected that it is a player in my situation for some time.

In the majority of patients with CCSVI, the narrowing/obstruction is related to valve leaflets which do not open completely. Often these can be seen on conventional US but not always. IVUS is the best tool for evaluating the cause of obstruction and for seeing the effects of ballooning and determining when the procedure is complete.

[CindyCB]

I found this very interesting - I felt that my problems must be down to valve malformations as I do not have MS but have CCSVI and (what I believe to be) problems from that.

My valves are not the same as those seen in MS patients though - I wonder if this is the difference and what has kept me from developing lesions on the brain.

My valves are not stuck shut but they are assymetric with a small amount of reflux but the main problems are stenotic lesions in the IJVs and reduction in flow velocity.

I have chosen not to have treatment yet until things develop more with regards to treating the valves. I figured if I got venoplasty and the valves are the same then surely the problem would reoccur.

I also felt that if a certain percentage of people do not have valves anyway then getting rid of them must be the way forward... that is of course providing the previous medical research on IJV valves is correct as it doesn't seem IJVs have received much attention in the past.

I think in many ways I would make an interesting case study given I have no diagnosis concerning my neurological symptoms but confirmed CCSVI.

[dania]

Wise decision.

[CindyCB]

Thank Dania,

I have been reading this forum with much interest throughout this - I am sorry to say your story is one of the ones that made me take a step back and wait to see how things develop. I'm really sorry to hear of the problems you have developed.

I am pleased that the 'common thinking' on the valves etc seems to be coming around to my gut feelings on the subject. I am sure it will take a lot more time, money and research before it moves onto the next step but at least the wheels are turning.

[dania]

I am glad my story helped you arrive at a decision. When I posted my negative experience I was told I was scaring people. All I wanted to do was warn them of the possibility that this can happen. Now more people have had a similar experience to mine, unfortunately.
Have you been in touch with Dr Arata. He is convinced this is a valve problem? He may be able to help.

[CindyCB]

It's always worth seeing both sides of the coin - if something seems to good to be true, then it probably is.

I was booked in for treatment and decided in the week before to only have the tests done - I am glad I did because I was told by that clinic that they would treat me but that the results might only last 3-4 months anyway so I decided I wouldn't take any chances just yet.

I was in touch with Dr Sclafani who kindly said he would see me based on my first set of test results (I've had two) but as I am in the UK I decided to see a clinic in Europe because I didn't want to fly longhaul - my symptoms got very bad after a flight from LA to the UK in 2008, probably coincidence but who knows.

I do not know a lot about Dr Arata - where would I find more details?

[Cece]

Dr. Arata is no different than the other doctors in thinking that CCSVI is primarily a disorder of the valves. Dr. Gilhooly in the UK published this letter last week saying this as well. Dr. Arata is different in his approach to treating the valves, but he is more aggressive (breaking the annulus, not just ballooning the leaflets). There is no research to support that this is correct and there is clinical experience from some of the other doctors to indicate that it leads to greater complications, not fewer.

Here is the relevant quote from the letter posted above:

Treating the valves and other intraluminal abnormalities is therefore a central issue in the treatment of CCSVI and one that all the treatment centres in the world are dealing with. A balance has to be struck however, between aggressively treating the valves with high pressure balloons to reduce venous hypertension, and the possibility of vein damage. Excessive pressure could cause scarring and possibly further venous problems.

I also have had relapses associated with long flights. One 8 hour flight to Hawaii from Atlanta and one to NY from Spain. It's particularly noticeable since I have had only a few relapses in my MS journey.

CindyCB, it sounds like you are making the choice that is right for you and that CCSVI treatment is always available if you change your mind. It's interesting that thyroid disease is part of your clinical history because one of the collaterals with CCSVI are the thyroid veins, which may then mess up the thyroid.

BadCopy, I agree with Dr. Cumming that IVUS is the best tool for determining what is causing the stenosis. On flouroscopy as part of the procedure, the IR might see the narrowing, but on IVUS they might see the exact cause of it when it is abnormal valve leaflets, which is most commonly is. With IVUS they can check the valves and, if they are bad (they look like little white roadblocks stuck out from the vein wall, with the flow diminished at that site), they can use IVUS to measure the vein size and balloon precisely so that the valve is ballooned but the healthy vein it is attached to is not overly stretched. It is of interest that our two MN docs, Dr. Cumming and Dr. Snyder, are both using IVUS. Dr. Cumming has been using it for quite some time and Dr. Snyder made the comment after Dr. Sclafani's symposium that he will be using it. My own CCSVI issues were caused by abnormal valves with fixed leaflets. My left jugular had the more aggressive ballooning based on the size it is and it is the one that closed up afterwards (although not as bad as it had been initially) and needed reballooning in July. Outcome has been excellent, so far....

You say you suspect the valve issue is a player in your situation, I would agree based solely on odds! Dr. Sclafani has said that 75% of the cases he's treated have been abnormal valves, which leaves 25% to be hypoplasias, membranes, webs, and assorted oddities.

[dania]

Cindy B, you have nothing to lose by contacting Dr Arata. I am sure he will look at your images, therefore not having to cross the Atlantic. You case is special, and maybe he may have a unique solution for you. Worth a try. Nothing ventured nothing gained. Good luck.

[1eye]

What about a plastic device that is designed to expand by itself after placement, possibly molded to the shape of the middle of the valve? The valve itself could hold it in place.