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High-pressure balloons for CCSVI – a necessity for proper treatment

az-sint-jan

In CCSVI treatment, veins in the thorax and neck area are dilated with balloons. The intention of course is to facilitate the drainage of blood.

This blood drainage is hindered by narrowing in the vessels (= veins) and by valves that do not open sufficiently. This causes restriction in the drainage of blood, which seeks a route via collaterals; these are side branches and connections to veins that already exist, which become wider and larger to gain more capacity to transport the blood away. The actual vein itself may finally collapse because it is transporting away little or no blood. It seldom or never happens that this vein blocks up completely, so that nothing can flow through it any more.

In the treatment of CCSVI, we track down the veins with a guide wire and catheter, in order then to be able to inject contrast agent, which allows us to obtain an image of the veins and any collaterals. The contrast agent behaves just like blood, so we can see the speed with which it flows away, and the route it takes on its way. We thus obtain a realtime functional image of the blood drainage. The next thing is to analyse the images to determine the reason why the contrast agent chooses another route, or does not flow away quickly enough, or even remains behind in the vein.

Frequently there are constrictions or poorly-functioning valves low down in the neck. The constriction is often very short and ring-shaped at the place where the valves are attached to the vein wall. Poorly-operating valves are usually ones that open insufficiently, perhaps due to deformation or scarring.

We know that restrictions in veins are hard to stretch open. It is essential to use a balloon that is large enough compared to the patient’s veins. Also, the balloon has to be inflated for long enough to give the tissue enough time to stretch open. Moreover, you must be able to apply enough pressure to the balloon to allow sufficient force to be developed to break the fibres that are causing the narrowing or deformation.

The average diameter of the jugular vein is 12 to 14 mm. The pressure needed to force open a restriction in a vessel can easily reach 10 to 14 atmospheres. These are very high pressures, for which it is essential to have a balloon that retains its own diameter and does not burst at these pressures.

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  1. Contrast injected into the vessel flows away via collaterals; limited narrowing but probably the valve system is not opening completely
  2. Balloon with a dent where the restriction is
  3. Balloon completely opened out; here this was at 14 atmospheres
  4. Follow-up image after use of the balloon: good drainage of contrast back to the heart; vessel is wide open.

In practice, during the inflation of a well-chosen balloon, you see that it inflates first in front of and behind the deficit. By well-chosen, I mean its diameter compared to the vessel. A dent remains in the balloon at the position of the narrowing or stenosis. Then the pressure in the balloon is increased until this dent disappears (usually 12 to 14 atmospheres, and sometimes more). Next you look at the pressure meter you used to inflate the balloon, and you usually see some pressure drop happening as a few more fibres part. Then you apply a little more pressure back to that where the balloon became fully open. Finally you maintain this for a minute or two until the situation is stable without pressure drop.

In my opinion this is the best way of working, in which you of course must have balloons that are large enough and can withstand such pressures. These are known in the profession as high-pressure balloons.

Many centres make use of smaller balloons as an alternative, and use two of them next to each other. An extra guide wire may also be inserted alongside the balloons to create extra force to break the fibres that are causing the restriction: the extra wire has a kind of cutting effect. These are both recognised and practical alternatives, but they remain alternatives that you should use if the first logical step does not work, this being a balloon that is large and powerful enough.

The disadvantage of the high-pressure balloon is that it is much stiffer and more awkward than the others, particularly in these large diameter sizes. There is simply more material needed to create a large, strong balloon. The vessels, however, are large flexible routes into which such balloons can be inserted without difficulty.

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