Injection Treatment of the

Greater Saphenous Vein

by Ken Biegeleisen, M.D.

NOTE: Some of the the following sections are complex, and involve information which many doctors do not know! You do not have to read it all!

All patients, however, must read the three sections numbered XIV-XVI. They discuss the question of "saving" varicose veins for use in bypass surgery.

 

 

TABLE OF CONTENTS

I. 

What's a varicose vein? 

II.

Physiology and pathology of veins

III.

"Doctor, don't I need that vein?"

IV.

Effect of diet and exercise

V.

What causes varicose veins?

 

  1. Wall weakness
  2. Abnormal hook-ups between vessels
  3. Disease of the deep veins

 VI.

How should varicose veins be treated?

 

Reasons for treating them:

 

  1. Should they be treated at all?
  2. Cosmetic
  3. Leg pain
  4. Bleeding, phlebitis and ulceration

 VII.

Which treatment?

 

  1. Stockings
  2. Surgery
  3. Injections
  4. Laser & RadioFrequency (RF) ablation

VIII.

What happens to the vein after injection? 

IX.

The medicines used to inject veins

X.

Other non-surgical methods

XI.

Long term outcome of injection treatmentt

XII.

What is meant by "better long-term outcome"?

XIII.

Combined approach (i.e., injections & surgery)

 

 

 

ALL PATIENTS ARE REQUIRED TO READ THESE SECTIONS:

 

 

XIV.

Should the Saphenous Vein be treated at all?

XV.

Arguments in favor of "saving" the Saphenous Vein

XVI.

Arguments against "saving" the Saphenous Vein

 

 

 

THE FOLLOWING IS OPTIONAL!
IT CONTAINS GRAPHIC DESCRIPTIONS & ILLUSTRATIONS:

 

 

XVII.

Side Effects of Vein Injections

 

 

 

Injection Treatment of the

Greater Saphenous Vein

by Ken Biegeleisen, M.D.

 

I. What's a varicose vein?

Most people think that any vein which is big and ugly is a varicose vein. This is not a very scientific definition, but the truth of the matter is that it's really not that long ago that the doctors themselves thought this way! But with the advent of ultrasound and other fairly sophisticated medical instruments, this "definition" of varicosity has become woefully inadequate.

If we add, to "big and ugly", the requirement that the vein be tortuous, then we are a little closer to a scientific definition of varicose vein. "Tortuous" means that the vein twists back and forth, so that it's a little like a snake sitting on your leg:

 

This distinguishes varicosity from the enlargement caused by exercise, where the vein enlarges in width only. The length of a normal vein does not change with exercise, and therefore, the vein remains straight as it widens. But a varicose vein is enlarged in all dimensions -- both length and width. When it gets longer than the leg, it starts to coil back and forth, like a snake.

Although most tortuous veins are, in fact, varicose veins, it is possible that on occasion a large, ugly, tortuous vein will be biologically normal in function. Therefore, the best definition of the word "varicose" is a definition which is based on loss of normal function in a vein. And just what is the function of normal leg veins?

 

II. Physiology and pathology of veins

Normally, veins have only one function: to move old blood up, and out of the leg. Here's how it works (see the picture below):

 

 

Thick-walled vessels called arteries (the red ones, labeled "A") carry blood into the leg. Once there, the blood moves into a vast network of tiny, tiny capillaries ("C"), from which oxygen, passing right through the ultra-thin vessel walls, is delivered to the surrounding tissues. Then, when all the oxygen has been removed , the blood collects into ever-larger veins (the blue ones, labeled "V"), to leave the leg and return to the heart and lungs for more oxygen. Physiologists refer to the movement of blood out of the leg as venous return.

If you think about it, you'll immediately realize that it's a lot harder to get blood out of the leg than in. The trip down, from the heart to the leg, is downhill, and therefore gravity-assisted. But the trip back is uphill. To make matters worse, the driving blood pressure is much higher in the arteries than in the veins. In actual fact, the blood pressure in veins is NOT ENOUGH to move blood uphill, against gravity! So how, then, does the blood get out of the leg?

Believe it or not, medical science cannot give an entirely satisfactory answer to this question! But there's quite a bit that is known about it. To make a long story short, the muscles of the leg provide much of the driving force for venous return. When you're lying down, your leg doesn't need to overcome the pull of gravity - it's only when you're standing up that there's a problem. But when human beings stand for any length of time, it's usually because they're going somewhere; i.e., walking. The contractions of the leg muscles during normal walking provide much of the driving force for venous return.

Do you recall how tired your legs feel when you have to stand still for long periods of time, e.g. while waiting on a long line to get into a movie? Have you ever wondered why? After all, when you're standing still on a line, you're not really working. So why should you feel tired?

The answer is that your leg muscles are not contracting much, and the venous blood therefore collects in the feet and ankles, stagnating. As long as you stand still, a normal body waste product called lactic acid builds up faster than your venous circulation can clear it away, and it's the lactic acid that makes your legs feel tired. If you stand for even longer, then the lactic acid level can exceed a certain critical limit, above which you can even get a painful leg cramp.

That's why all the health magazines and TV shows recommend walking and other leg exercises for varicose vein sufferers.

But there's another critical factor in venous circulation - valves. It's not enough for the leg muscles to pump, because walking is an intermittent process, and when you step from one leg to the other, the muscles of the first leg relax. Then, all the blood which the first leg worked so hard to pump up, will start to fall back down -- unless, that is, something prevents this from happening. The things which prevent this are the valves. Here's what they look like:

 

This drawing shows a schematic representation of venous valves. They are purely mechanical, and require no energy to work. The drawing has three parts. On the left is a cross-section of a vein, containing one valve. The valve has two parts, called cusps. As the middle drawing hopefully shows, when blood tries to move up (i.e., the normal direction), the valves automatically open. But if the blood tries to go back down (right-hand drawing), the valves snap shut.

In a varicose vein, the diameter of the vein gets steadily larger through the years, until a point is reached where the valves fail. It looks something like this: 

 

 

The first drawing, on the left, is the normal situation. Here, when blood tries to flow backward (i.e., downward, toward the foot), the valve cusps snap shut. In the middle drawing, however, the vein has enlarged, and the valve cusps are having trouble holding back the column of blood against the pull of gravity. Some blood leaks through.

In the right-hand drawing, the vein is grossly enlarged, and the valve cusps are now merely useless appendages taking up space on the vein wall. They are not large enough, relative to the size of the vein, to have any effect at all on the direction of blood flow. When the patient stands up, gravity will pull all the blood downwards, toward the feet. This is backwards relative to the normal direction of blood flow in veins. This is now a full-fledged varicose vein.

This is the hallmark of a varicose vein, and the best definition of one: In a varicose vein the blood flow is REVERSED. Instead of serving the normal purpose, which is to move blood up, and out of the leg, a varicose vein takes in blood from surrounding veins and moves it BACK DOWN into the foot, whenever the patient assumes the upright posture.

Whether or not the vein is ugly is therefore entirely irrelevant. If the vein looks good, but carries blood backwards, then it's a varicose vein no matter how pretty it looks. 

III. "Doctor, don't I need that vein?"

Many patients express concern that removal of varicose veins will have some sort of adverse effect on their health.

This is an understandable fear. After all, varicose veins are often very large, dramatic-looking vessels. They must be doing something, no?

No! If you have understood the previous discussion, then you now know that varicose veins carry blood backwards. This does your body no good whatsoever!

Think of the work your body must do to pump blood up, in the normal direction, from the leg back to the heart and lungs. This is work done against the pull of gravity. It's hard work!

Now consider this:  Every drop of blood which enters a varicose vein enters from the top, and runs back down to the foot. This is backwards! It's entirely contrary to the normal flow of blood, and it does no good whatsoever!

In fact, varicose veins are a significant impediment to normal circulation. In severe cases, the disturbance to normal blood flow can be so severe that the leg will ulcerate. Such ulcers, if not properly treated, can become chronic. I've seen patients who walked about with open sores on their legs for over 5 years, before they found a doctor who knew how to treat them. And it was all from varicose veins.

That's why we say that there is no harm in removing a varicose vein: In most cases the patient will look and feel better, and tests of the quality of venous circulation will show a substantial improvement!

But now you may be wondering whether perhaps doctors should be attempting to repair the vein, instead of simply removing it.

This has been tried by pioneering vascular surgeons. The most recent effort involved placement of synthetic bands around the vein at the sites of the valves. This pressed the valve cusps together, restoring the competence of the vein (see the drawings above if you forgot what a valve cusp is). Unfortunately, within 1-2 years, the veins failed again! Considering all the effort, expense, and suffering involved in such surgery, this outcome was extremely disappointing. Consequently, this operation is rarely performed.

Therefore, if the vein is seriously diseased, it's best to simply remove it (by injections or surgery).

Besides, the veins which typically go "bad" in people with varicose veins are unimportant veins, even in health. The human body is built in such a way that all vital vessels are deep. Varicose veins, on the contrary, are surface vessels, and all surface vessels are EXPENDABLE. Normally, the total contribution of all the surface veins of the leg is no more than 5-10% of the venous circulation, and, if necessary, every bit of that can be re-routed to the deep veins, which have tremendous reserve capacity.

It is entirely possible to remove every visible vessel from the surface of the human body, without serious circulatory disturbances resulting. This, again, is because all the vital vessels are deep. There are no essential blood vessels visible on the surface of the human body!

Therefore, at the present time, the only reason to refrain from operating upon (or injecting) a serious varicose vein problem is the theory of saving veins for arterial bypass surgery later in life. This is dealt with in a later section.

 

IV. Effect of diet and exercise on varicose veins

The question of exactly why a vein enlarges and becomes varicose is an exceedingly complex question; one which has been the subject of many whole books.

We are not going to attempt to answer the question fully, but only to review the broad outlines of what is and isn't known.

First, we'll start with what DOESN'T cause varicose veins. Varicose veins are NOT caused by any of the following:

  1. Too much exercise
  2. Too little exercise
  3. Lack of fiber in the diet
  4. Vitamin deficiency

Each of these theories has been promoted in the press, particularly in the "women's press", as a cause of varicose veins. In each case, there is a reason for the theory. Please do not think that the theories are illogical, because they're not. They're logical; but they're still wrong.

Consider exercise. We have already seen that the vigorous contractions of leg muscles are necessary for normal circulation. But it turns out that exercise also increases circulation in varicose veins; not just healthy ones. And, increasing the blood flow to varicose veins is not necessarily good (remember, they carry blood backwards). As far as we know, right now, causing the blood flow in varicose veins to increase is neither good nor bad -- i.e., it doesn't seem to hurt, but nor is there any evidence that it helps.

The same can be said for the various diets and vitamin supplements which have been pushed. To make a long story short, thousands and thousands of people have tried all sorts of dietary measures to remove varicose veins. None of them worked. In particular, the high-fiber diet was followed by innumerable people the world over, including many of our own patients -- some of them for years on end. No one got better.

Vitamin E does not work. Bioflavinoids do not work. None of the dietary supplements for varicose veins work.

 

 

V. What causes varicose veins?

 

1. Wall weakness

There are three things which are known, which bear on the causation of varicose veins. None of the three will respond to therapy by diet or exercise.

In the first place, it has been known for 30 years that varicose veins have abnormalities of their wall chemistry. The original observation was that varicose vein walls were deficient in collagen. Now, since collagen is the structural protein which gives many organs strength (including skin and bone), it would be expected that a vein deficient in collagen might be prone to stretch, and to thereby turn into a varicose vein.

Subsequently, other scientists made other studies on the walls of varicose veins. Their findings did not always agree with each other. In fact, some observers found more collagen in varicose veins! (But the extra collagen, if any, may prove to be defective).

Thus, most observers seem to agree that varicose veins have abnormalities of the wall chemistry, although they don't necessarily agree on what the changes are.

But there's still a problem. Some scientists say that the chemical changes in varicose veins are "secondary", not "primary". This means that the vein became varicose first, and only then did the chemistry change. Thus, these scientists do not doubt the validity of the chemical changes - they simply say that the changes are the result of the disease, not its cause. 

 

2. Abnormal hook-ups between blood vessels

Varicose veins may be caused by things called arteriovenous communications, which means places in the circulation where arteries and veins are hooked up without any capillaries in between.

If necessary, please refer back to the drawing and discussion in Section II ("Physiology and pathology of veins"), where it was pointed out that the pressure in arteries is higher than the pressure in veins. This is because the heart does a lot of WORK pumping blood down to the body's billions of capillaries, and when the blood collects in veins for the trip back, the pressure is mostly "used up" already.

What would happen if an artery and vein were connected directly together, without capillaries in between? Theoretically, the pressure in the vein would rise.

In fact, that's exactly what happens. There's a man-made situation where this may be directly observed. For patients whose kidneys have failed, modern medicine now offers "dialysis". This is a large machine through which blood is pumped. Exactly what happens within the machine is unimportant to our present discussion. The important thing is that patients without kidneys need to have their blood "cleaned up" several times per week, and in order to accomplish that, all of their blood must be pumped through a dialysis machine.

In order to filter a person's entire blood volume, you need access to a large blood vessel, at least twice a week. Which vessel will you use? The veins on the arms, legs, and hands are much to small for this purpose! So what will the doctors do? Cut you open every three or four days, to find a large vessel?

Of course not. But they do employ surgery -- once! They open up the wrist, and find a small artery inside. Remember, an artery is a high-pressure vessel. Then they connect it to a small surface vein on the arm. Now all the arterial pressure is transferred to the surface vein. Voila! Within a matter of days, the surface vein blows up like a balloon!

Now the patient has a huge vein, right there on the surface. When this vein is connected to a dialysis machine, it is large enough to allow rapid passage of all the blood in the patient's body to enter the dialysis machine, get "cleaned up", and return back to the patient, within a reasonable period of time.

So it's true that connecting an artery to a vein makes the vein blow up, sometimes literally "like a balloon". But does this have anything to do with varicose veins?

Throughout the 20th century, certain doctors have claimed that varicose veins are caused by arteriovenous communications. In fact, it's now known that they exist in the legs, but only in the legs of varicose veins patients. A well-known vascular surgeon, Lars Schalin of Sweden, has identified them by operative microscopy. They're there, and there are lots of them.

In our own office, we have identified arteriovenous communications by angioscopy, a procedure which looks directly into a vein.

So the arteriovenous communications do exist. And it's a fact that connecting an artery to a vein raises the pressure in the vein. So here's an entirely plausible explanation for varicose veins.

Unfortunately, although the arteriovenous communications are there, they are small. Some say that they are too small to cause disease, the very largest of them being no more than 1/2 millimeter in diameter (about one-fiftieth of an inch).

The skeptics are therefore willing to admit that the arteriovenous communications are there, but they say that they are secondary. Hmmm ... there's that word again. It means that maybe the varicose veins appeared first, and then the arteriovenous communications came later.

So it's just like the situation with the altered wall chemistry. It's there, but was it the cause of the disease, or was it caused by the disease? "What came first, the chicken or the egg?" No one knows! 

  

3. Disease of the deep veins

Seshadri Raju, a prominent vascular surgeon, proved years ago that every patient with varicose veins has disease of the deep veins. When we say "varicose vein", we're always talking about a vein which is either visible on the surface of the leg, or just under the skin. So what Raju is telling us is that in patients with surface varicosity, the deep veins, which we cannot see or feel, are also diseased, even if it does not seem so from simple observation and physical examination.

Raju proved this using a sensitive technique called "descending venography", which detects very subtle dysfunction in the deep veins.

After making this discovery, Raju proposed that all varicose veins are secondary to (i.e., caused by) disease in the deep veins, the latter being a condition which doctors often refer to as chronic venous insufficiency. Chronic venous insufficiency is very similar to varicose veins, in that the main manifestation of the disease is valve dysfunction (if necessary, see the drawings in Section II, "Physiology and pathology of veins"). Only here, it's in the large, vital veins deep in the leg; not merely in unsightly surface veins.

Unfortunately, even if it proves true that the real cause of varicose veins is disease in the deeper veins, this leaves many questions unanswered. Why did the deep veins "go bad"? Thus, all the same questions come up again! Do the deep veins have abnormal wall chemistry? (Yes -- they probably do). Are there arteriovenous communications in the deep veins? (Yes, there are. But no one knows whether they are primary or secondary!).

I hope you can see that the question "What causes varicose veins?" is far from simple. Although we know a lot about it, our knowledge is not enough to provide a simple answer, or a simple cure.

In summary, there are at least three things which can cause varicose veins. Whether any one of them is more important than the other two is not known. It may even turn out that varicose veins is more than one disease, with different cases resulting from different causes.

So, you see, we really don't know what causes varicose veins. But we treat them anyway! 

 

VI. How should varicose veins be treated?

Reasons for treating them.

1. Should they be treated at all?

The first question which must always be asked is this: "Is any treatment at all required?" And, in this office, that question is asked first.

The mere fact that a vein is big and ugly does not necessitate that it be treated. Even the reversal of the normal direction of blood flow does not, automatically, necessitate that any action be taken.

Doctors used to think that varicose veins got worse and worse, relentlessly, until the patient developed either ulceration or phlebitis. I have no idea why they thought this, because scientific studies have ridiculed this idea. We now know that most varicose vein sufferers will never get either phlebitis or ulceration.

Conversely, those who do get complications such as ulcers or phlebitis often get them early, and not at the end of a long road. Therefore, the idea that varicose veins always get worse and worse and worse, until they ulcerate or become phlebitic, is a false idea. That's why "prophylactic" or preventive treatment is discouraged in this office.

The only patients in whom we recommend preventive treatment are those in whom serious complications can be clearly foreseen. And that is NOT the majority of patients -- it's a small minority.

Therefore, if you don't have a serious problem now, and you seek treatment because "your mother had terrible legs and you don't want to end up like she did", we will probably send you home with instructions to come back when, and IF, your legs actually "go bad". We do not encourage preventive treatment! 

 

Reasons for treating varicose veins

2. Cosmetic

The most common reason for people seeking vein treatment is cosmetic: the patient wants his/her legs to look better! There's nothing wrong with that -- as long as you're being honest with yourself and with us. If that's what you want, just say so! Do not, however, count on any help from your insurance -- these days, they try to wiggle out of paying for vein injections even if you are dreadfully ill, crippled, or dying. They're not interested in your health or welfare. All they want is your money.

So don't think that telling us that your legs hurt is going to improve your chances of insurance coverage, because it probably won't. 

 

Reasons for treating varicose veins

3. Leg pain

Having said all that, let me now say that many patients with varicose veins do have discomfort. It's almost never a sharp, stabbing pain, but rather a dull ache, or an unpleasant feeling of heaviness in the legs. It only occurs in the upright position, and it is relieved by lying down and elevating the legs (although it can take a few hours to go away in bad cases).

If you have severe, unbearable pain in your legs, you probably have something other than varicose veins. The pain of varicosity is usually not severe; but rather a dull ache, or an unpleasant sensation of heaviness.

But the fact that varicose vein pain is not severe doesn't mean that you "just have to live with it". Nothing of the sort! Relief of pain is a perfectly good reason to seek treatment for varicose veins, if you feel that the inconvenience and expense of treatment is justified by the pain you feel.

Technically, health insurance is absolutely obligated to relieve your pain, but I'm warning you -- they'll try to get out of paying! They don't care how you feel.

Leg pain is the second most common reason for patients coming to this office. 

 

Reasons for treating varicose veins

4. Bleeding, phlebitis and ulceration

If you have the serious complications of varicose veins, you'll need to be treated. Again I'll remind you that these complications affect only a minority of patients.

Ordinarily, if you don't have these things already, or at least clear signs of them developing, then the odds are you'll never get them. 

VII. Which treatment?

Once it's determined that you need treatment (or you simply want treatment), the obvious next question is "which one?". This question has been batted around by doctors for well over 100 years, and the definitive answer is not in yet! Nor do I expect it to be in our lifetimes!

The first possibility is "no treatment". If there's no serious problem right now, then you might as well go home! As explained above, we rarely do prophylactic treatment.

But if you're determined to have a good-looking leg, or if your leg aches, or if you have any of the serious complications of varicose veins (bleeding, ulceration, or phlebitis), then you'll need to be treated. But which treatment? 

1. Stockings

The least invasive treatment for varicose veins is simply to wear a special stocking. These go by various names, such as "surgical stocking", "compression stocking", "gradient pressure stocking" or "venous stocking".

They are rated by pressure, and the pressure scale is the same one your doctor uses when he tells you your blood pressure. Blood pressure is given in "mm of mercury", or just "mm" (i.e., "millimeters"). (In older blood pressure cuffs you can actually see a column of mercury moving up and down with the heartbeat).

The average venous pressure in the human leg, measured at the ankle in the upright position, is around 40 mm. It turns out that the best stocking for patients with varicose veins is one which squeezes the ankle with the same pressure, about 40 mm, which pushes on the blood, helping to move it upward.

A 40 mm stocking is very tight. It presses hard enough to cut off the circulation in old people or in diabetics, and therefore it cannot be dispensed without a doctor's prescription, which also makes it very expensive. Nowadays, however, patients can purchase compression stockings without a prescription, which has greatly lowered the cost. The ankle pressure of the non-presecription stocking is not, however, a full 40 mm, but usually described as a range of 20-30 mm. We have found that these are adequate for most of our patients, and we recommend them frequently.

Whether or not you come to our office, or any other vein office, you can march down to your local surgical supply store and purchase these stockings yourself. These days they are also sold at large chain pharmacies, such as Duane-Reade or CVS. What you will need, when you go for these stockings, are your calf and ankle measurements. You'll need a tape measure for this. Measure the widest part of your calf, and the narrowest part of the ankle (which is almost invariably just above the ankle bones), as per the following picture:

 

 

If you don't have a tape measure, they'll probably have one in the store.

When you locate the stocking section, pick up a box of stockings and, look around it for the pressure rating. If it says "5-10 mm", or "10-15 mm", or anything except "20-30 mm", put it back! Only the highest pressure, i.e., 20-30 mm, is acceptable.

Next, locate the size chart which is (almost) always on the box. It will look something like this:

Refer to your ankle and calf sizes, which you should have brought with you. Use them to select "small, medium or large". That's all there is to it!

We will not go into the mechanism of action of these stockings. Suffice it to say that in certain people, they make the legs feel better. These people are often willing to wear compression stockings forever. But most of our patients aren't.

The stockings do not cure the disease, or even change it. They simply make the legs feel better. At night, when they come off, the leg is exactly the same as it was when the day began. Thus, treatment of varicose veins by stockings is life-long.

In recent years, the stocking companies have made surgical hose look better and better, and these days they are far more likely to be acceptable to the appearance-conscious patient. 

 

2. Surgery

Around 1900 the "stripping" operation was introduced for varicose veins. Its popularity has waxed and waned throughout the 20th century.

When the operation was first performed, it was hoped that it would provide a permanent cure for varicose veins. That hope proved to be premature. By 1920, there were so many surgical cases whose veins had grown back that the method was scrapped almost completely.

From about 1920 to 1940, nearly every case of varicose veins in the United States was treated by injection! This may come as a surprise to people who think that injection treatment of varicose veins (sclerotherapy) is a "new miracle treatment from Europe". It's not new at all !

But by 1940, after 20 years of vein injections in America, there was a multitude of patients whose veins had grown back. So the surgeons went back to surgery. They changed the operation a bit, and the new, improved stripping operation worked somewhat better than the old one.

But then a veritable war began, between injectionists and surgeons. The subject of the war was this question: "Which treatment (i.e., injections vs. surgery) is the one which really cures varicose veins?"

This question was not answered until 1956, when H.I. Biegeleisen (the author's father) published a statistical study proving that varicose veins are never cured! All patients, whether they are operated on or injected, eventually grow new veins.

But the war continued. The new question was this: "OK; we can't permanently cure varicose veins. But whose treatment (i.e., injections vs. surgery) keeps bad veins away longest?". The medical term here is "remission", i.e., "Whose treatment gives the longest remission?".

This question was batted around for around 25-30 years, when it ran head-on into the era of bypass surgery. With ever-increasing frequency, Americans with the heart disease called angina were getting their coronary arteries bypassed (this is described in more detail presently). In angina, the coronary arteries (which carry the blood supply to the heart muscle) become blocked. In the bypass operation, a leg vein is spliced into the coronary circulation, to bring in more blood.

The leg vein they usually use is the greater saphenous vein. This is the same vein which is usually diseased in varicose veins! All of a sudden, vascular surgeons started to ask a new question: "Should we save the saphenous vein, just in case the patient needs a bypass operation later?".

We shall return to this question shortly. But first, we must consider injections. 

3. Injections

Injections for varicose veins go back to at least 1840. They did not become popular until this century, but around 1900 surgery also became popular. Most of the surgeons stopped injecting, and began operating. Injections almost disappeared from the practice of venous medicine.

Around 1920, however, the tables turned. As I explained earlier, it had become apparent that surgery (at least as it was done back then) had a poor long-term outcome. Consequently, injections gradually replaced surgery as the treatment of choice for varicose veins. In vascular clinics from coast-to-coast, all the surgeons were injecting veins.

Injections became so popular that the medical literature published insulting commentaries on surgery, going so far as to call any surgeon who ever operated on varicose veins a "barbarian"!

Injections reigned supreme for about 20 years, but by the time World War II was over, vein surgery was back. At that point people had finally realized that the problem of re-growth of varicose veins had not been solved by injections. In fact, many surgeons claimed that veins grew in even faster after injections than they had after the old surgery.

So, as pointed out earlier, new forms of stripping surgery were developed, and these became widely used, once again, for the treatment of varicose veins.

Injections, for the second time in the 20th century, became scarce.

Starting in the 1970's, new forms of injection therapy were devised in Europe, and they were very gradually introduced to the United States. But it was not until about 1990 that injections had grown sufficiently in popularity that they were once again well-known in this country.

Nowadays, injection treatment (sclerotherapy) of varicose veins is widely practiced in America, and its popularity is again peaking. But, as has happened so many times in the past, new developments have occurred which make the task of selecting a method of treatment difficult. One of the most important of these developments came from this very office, and we shall describe it shortly. 

3. Laser and RadioFrequency (RF) ablation

It is not seriously controverted that I am the inventor of laser and RF ablation of large varicose veins, although, oddly enough, I do not practice these methods at this time. The history of these technologies is reviewed in several other places on this web site.

Both techniques - laser and RF - involve insertion of an intravenous catheter into the trunk of the saphenous vein. This requires a small incision in the inside of the thigh, and the use of a method called the "Seldinger" technique, which involves use of a large-bore plastic cannula and a metal guide wire. Once in the vein, the catheter is advanced in the direction of the groin, but not all the way up (because there are too many vital structures at the top, and these could be accidentally injured).

When the catheter has reached the highest safe point, a switch is thrown, and the vein is heated (i.e., "cauterized"). In the laser procedure, the heat is introduced by laser light, which is conducted to the inside of the vein by fiberoptic pathways. Once the laser light has reached the inside of the vein, there it rather indiscriminately heats the blood and scalds the wall of the vein.

In the RF procedure (i.e., "Venous Closure"), the heat is introduced by the passage of electrical current through a heating element in the catheter.

Both procedures (i.e., laser and RF) involve great heat, and therefore must be done very carefully, lest vital surrounding structures be accidentally burned also.

The procedures are completed by withdrawing the catheter slowly - with the heat still on - until it has been entirely removed from the vein. The leg is then bandaged.

The laser and RF ablations, in the form in which they are currently done, are bizarre misapplications of the technology as I originally described it - a technology no company, to this day, has had the good sense to manufacture and market. These catheters, according to my original design, were intended to "see" into the vein, so as to locate the key points in the vein which must be cauterized. It is not necessary to scald the whole vein, but when the catheter is "blind", as all of the current models are, there is no choice! If you can't see into the vein, then you can't aim for specific targets, but rather must scald the whole thing!

When the laser and RF catheters were first introduced, people had terrible painful reactions from the extensive heat injury. In current models, the heat treatment is better-controlled, and the painful reactions are less common now. But you must understand that these treatments are not the "equivalent of surgery", and will not bring about the same long-term remission, regardless of what marketing lies are told by the catheter manufacturers.

About the best thing which can be said about laser (or RF) ablation is that it is covered by insurance, so that, from the patient's perspective, it's a "free treatment". For this reason, and for this reason only, I do not try to compete with the promoters of the new laser therapy. Unless a patient can afford to pay for injections (which, currently, are outrageously rejected by health insurers), I reluctantly refer them for laser where necessary.

The history of the expropriation of my Venoscope technology is described elsewhere in this web site.

At the present time, laser/RF ablation is not performed in our office. Let us therefore return to our discussion of injection sclerotherapy.

 

VIII. What happens to the vein after injection?

After injections, the varicose vein shrinks. If the leg was ugly because of the vein, then it will look better! If it ached, it will feel better also.

If the vein was interfering with the normal flow of blood, as indicated by instrumental tests, then the blood flow will be corrected, and the tests will revert to normal.

How do the injections work? The medicines don't actually make the veins shrink themselves. Your body makes the veins shrink. The medicine is merely a catalyst -- a thing which starts a process going, but does not actually do the work itself.

The essence of how the treatment works is this: The medicine irritates the sensitive inner lining of the vein. Once your body "sees" that the vein has been injured, a process called "resorption" takes place. This simply means that the body itself begins to dissolve and remove the vein. It's a gradual process, which often takes months to complete. The medicine is the "trigger" which starts the process off, but it's your own body which actually removes the vein.

If you understand this, then you will understand that the goal of treating varicose veins by injection is to selectively irritate the inner lining of the varicose vein, without doing any harm to nearby veins that are normal. This goal is not at all difficult to achieve. Substances as harmless as ordinary salt (called saline when in solution) will suffice.

Now, there's nothing toxic or irritating about ordinary salt -- at low concentrations, that is. Your own blood stream happens to contain about 1% salt, from the minute you're born to the moment of your death. So you can't irritate a blood vessel by injecting 1% salt into it -- that much is in it all the time! But, if you inject 20 times that much (i.e., 20% saline) into a blood vessel, you will most definitely irritate it. Recall the expression "rub salt in a wound" -- at high concentration, ordinary salt is very irritating to living tissue. So, at a concentration of 20%, salt becomes what doctors call a sclerosant -- a medicine capable of irritating the sensitive inner lining of a vein, and consequently triggering its shrinkage and resorption.

But as soon as the 20% saline is injected, it mixes with blood. Before it has moved even a few inches, its concentration has dropped greatly, so that it's no longer capable of triggering sclerosis. Therefore, the saline only works at the exact site of the injection. In order to treat veins safely with saline, you need to give a series of small doses, up and down the vein. Each dose affects only the local portion of the vein immediately adjacent to the injection site.

No single injection is strong enough to knock out the whole varicose vein, and, except in very unusual circumstances, not enough concentrated saline will ever reach a neighboring vessel to initiate unwanted sclerosis of healthy vessels. 

IX. The medicines used to inject veins

In the discussion so far, we have referred exclusively to saline, or concentrated salt solution. That means sodium chloride, the same chemical used for ordinary table salt.

In case you're wondering, kitchen-grade salt is not acceptable for this treatment. To be suitable for medical use, the salt must be highly purified, and approved for intravenous injection in human beings. That means that it's a lot more expensive than table salt.

There are many other medicines used besides salt. In fact, salt, by itself, is rarely relied upon exclusively in treatment of large varicose veins (although it has recently been successfully combined with other drugs).

Most of the many medicines used for vein injections fall into one of two different categories:

  1. Salts other than sodium chloride
  2. Fatty acids

In the early 20th century, salts were the mainstay of vein therapy. That is no longer the case, but several of them remain popular today. On a world-wide basis, the salt (other than sodium chloride) which has been most frequently used has been sodium iodide (which is usually combined with pure iodine to give a dark brown solution). The use of this product is generally associated with the name of the famous Swiss Phlebologist, Karl Sigg. The Swiss product, called Variglobin, was, in its day, the most powerful sclerosant in the world. Unfortunately, is it no longer manufactured, and current iodine sclerosants are less concentrated. These less-powerful iodine solutions are not used in this office.

There are numerous other salts which have been used, or proposed. Next to Variglobin, the most popular of them is sodium salicylate (a close relative of aspirin). It is not approved for vein injection in America. In fact, none of the non-sodium-chloride salts are approved for the treatment of veins in this country.

The second large class of sclerosants is the fatty acids, which, on a world-wide basis, are considerably more popular than salts. In the course of the 20th century, fatty acids have become the mainstay of injections everywhere.

The first drug of this sort was sodium morrhuate, an extract of cod liver oil. Its efficacy in varicose veins was discovered in 1930, quite by accident, in tuberculosis patients. Back then, tuberculosis therapy included injections of cod liver oil. A pair of observant British physicians, named Higgins and Kittel, noticed that the veins into which cod liver oil was injected often shrunk and withered away. They proposed, in the British journal Lancet (the approximate equivalent of our Journal of the American Medical Association), that an extract of cod liver oil be prepared for the treatment of varicose veins.

The active ingredient in cod liver oil was then extracted by a pharmaceutical company. It proved to be not the vitamin A (which was the reason for cod liver oil injections in the first place), but rather the fatty acids. Cod liver oil, which, incidentally, is very similar to human liver oil, is a mixture of hundreds of fatty acids, many of which are well-known and well-studied, but others of which have never even been fully characterized by chemists.

What's a "fatty acid"? The closest thing to fatty acids in everyday life is soap. In fact, it would be possible to sclerose a vein with soap, but household soap is a very crude, impure mixture which would cause devastating reactions if injected. You could think of morrhuate as being a very, very highly purified soap. But it would cost a fortune to wash with it!

The first large-scale clinical trial of the new drug, sodium morrhuate, was done by my father, Dr. H.I. Biegeleisen, in 1933. It established sodium morrhuate as the drug of choice in varicose veins, a distinction which the drug maintained until 1946. The publication of his study, in the journal Surgery, Gynecology & Obstetrics, also launched his own career as a vein specialist.

Between 1930 and 1946, a fairly large number of other plant and animal extracts were marketed by the pharmaceutical industry. Most of them were fatty acid in nature (there were also a few salts). There were so many of them that the competition for sales drove most of these companies into bankruptcy.

Furthermore, all plant and animal extracts shared a common disadvantage: They all caused allergic reactions in some patients. On occasion, these allergic reactions were life-threatening.

It is now known that the allergies were due to protein impurities, and not to the fatty acids themselves. Therefore, in order to avoid allergies, it was necessary to aggressively purify the product. That has since been done with morrhuate, but the modern, non-allergenic morrhuate is considerably weaker than the old-fashioned "dirty" morrhuate used to be. That's apparently been the "price" of purity.

But there was another approach to avoidance of allergies: creation of a synthetic fatty acid. The composition of such a man-made medicine could be rigorously controlled, and a product nearly 100% protein-free could easily be made. This proved to be the method of choice for creation of an "ideal" fatty acid sclerosant. In 1946, the pharmaceutical industry released a new synthetic, "sodium tetradecyl sulfate", under the trade name Sotradecol, for the injection treatment of varicose veins.

Sotradecol, a man-made medicine, was the second-strongest sclerosant in the world at the time of its discovery (Variglobin was stronger). It had significant advantages over existing products. Unlike Variglobin, it was painless on injection. Unlike morrhuate, it rarely produced allergic reactions.

Sotradecol has been the most widely-used sclerosant in the world since 1946, although it is currently getting slowly "edged out" by newer drugs from Europe. Nevertheless, for reasons which you will understand shortly, Sotradecol remains the main medicine used in this office.

Ascera
"New miracle drug from Europe"
(???)

If you read women's magazines, you will surely have read about the so-called "miracle wonder drug from Europe", Asclera. Don't fall for it!

Asclera is a trade name for a German drug whose generic name is Polidocanol. It was originally created, probably as early as the 1950s, as a local anesthetic, but it was found to be capable of sclerosing varicose veins. Therefore it was marketed as a sclerosant (i.e., a medicine for varicose veins), under the trade name Aethoxysklerol.

Aethoxysklerol became very popular in Germany. When my father went to the European vascular meetings in the 1960s, he brought back samples of Aethoxysklerol, and tested them on his patients. His conclusion: Aethoxysklerol is a safe and effective medicine, but has no advantages over our domestic Sotradecol. Furthermore, it was not FDA-approved, and the market for it in America was so small, no American pharmaceutical company was willing to spend the $100 million dollars necessary to push it through the F.D.A.

In the 1980s, when I first went into practice, I too brought back samples of Aethoxysklerol from Europe, and, like my father before me, I tested them. Also like my father before me, I concluded that Aethoxysklerol was a perfectly good drug, but had no special advantages over domestic drugs. It was useful to have around, however, because there are always occasional patients who have allergies to domestic drugs, and they can be treated with Aethoxysklerol.

In the 1990s, decades after my father first tested Aethoxysklerol, American dermatologists suddenly became interested in spider vein injections, and began to bootleg Aethoxysklerol from Europe. Why? That is, why would they bootleg in a non-approved drug when we have, right here in America, approved drugs that are just as good?

Here's why. Aethoxysklerol was sold at a strength of 0.5%, which is appropriate for spider veins, whereas American Sotradecol was sold at a strength of 1%, which is too strong for such tiny vessels. Knowledgeable American practitioners of spider vein injections understood that Sotradecol had to be watered down to make it safe for spider vein injection, but the new dermatologists of the 1990s didn't know this. So they used it straight out of the bottle! All their patients got chemical burns!

Thus the myth arose that Aethoxysklerol was "safer and more effective" than Sotradecol, and American dermatologists in great numbers began to bootleg it and use it in their offices. At first the F.D.A. protested, but in the process of time, legal cases persuaded the courts that, in the interest of "patient safety", the F.D.A. should "look the other way", and allow dermatologists to continue importing Aethoxysklerol.

What followed was a never-ending series of ridiculous press releases and television interviews by ignorant, publicity-hungry dermatologists, each proclaiming that he was offering a "new treatment for spider veins" employing a "miracle wonder-drug from Europe: Aethoxysklerol!"

"Miracle wonder drug?" Remember, we're talking about a drug which my father had tested and rejected 30 years earlier!

This ridiculous situation persisted for 20 more years until 2010, when, after over a half-century of being an "underground" medicine, Polidocanol i.e., Aethoxysklerol, suddenly and miraculously passed the F.D.A., and became an "approved" drug! How it finally got past the F.D.A. is anyone's guess. My guess is that money was involved, because the public can always be fooled by calling something a "new miracle wonder-drug from Europe", and where there's money, even massive barriers have a way of "magically" melting away.

The new American Polidocanol, however, was not called "Aethoxysklerol". It was marketed here under a brand-new trade name: Asclera.

But guess what. "Asclera" is made by the very same German company, Kreussler, as Aethoxysklerol. In fact, it is Aethoxysklerol, simply shipped to America in bulk and re-packaged with a different name!

I was just as interested in Asclera as the other American Phlebologists, but when I found out what they were planning to charge for this stuff, I balked. Get this: The cost of American Asclera is eighty times more expensive than domestic sodium tetradecyl sulfate. That's "80" times more expensive, not "8"!

I, for one, will not spend 80 times more than a medicine is worth, without good cause.

Therefore, if you come to my office, and insist on "The new miracle wonder-drug from Europe, Asclera", I'll cheerfully administer it, but I'll have to charge you over twice what I charge my regular patients, to cover the cost of this ridiculously over-priced old medicine from mid-20th century Germany.

Conclusions

To summarize, saline (i.e., sodium chloride), Morrhuate and Sotradecol (i.e., sodium tetradecyl sulfate) are the drugs we use to inject varicose veins. All three are approved for use in America. None of them have any known chemical side effects. The only thing which can go wrong with them is that they can be injected in the wrong place. But the problems which arise from that are not the medicine's fault! Those are physician errors!

All three medicines have been around longer than penicillin. Therefore, if you've ever been afraid of getting your veins injected because you had concerns about medicine toxicity, forget it. Provided that you are not allergic, these medicines have no known chemical toxicity. Like the prototype, ordinary salt, they act by a mechanism which is completely dependent upon high concentration, not upon chemical toxicity.

And, like salt, they only work at the exact injection site. As soon as they mix with blood, they get diluted and neutralized. So it is extremely unlikely that they will ever cause damage to any vein other than the one into which they are injected.

As my final comment, let me say that, contrary to the claims of the "miracle European drug" people, we are of the firm belief that differences in the outcomes of sclerotherapy treatments are determined entirely by differences in operator skill, not in the drug used. 

 

X. Other non-surgical methods

There are other ways to bring about sclerosis in varicose veins.

In France, cryotherapy with liquid nitrogen was attempted. A cold probe, with liquid nitrogen flowing through the inside, was inserted into the vein, to freeze it. When the procedure was completed uneventfully, the result was good. Unfortunately, sometimes the cold probe got stuck, causing frostbite to the surrounding tissue. Therefore, this approach has remained experimental.

In England, veins were sclerosed by applying electric shock through intravenous wires. This also worked well, but the electrocautery machine used was originally designed to burn out bladder tumors; a procedure which required high voltages and currents. Such an instrument was too powerful for routine use in veins. It worked, but it was unnecessarily painful. If a better instrument could be designed, it would have promise for the future.

In Russia, an investigator sclerosed a vein by inserting a cat gut suture, and simply leaving it there. It produced a continuous irritation within the vein, which ultimately triggered the body's intrinsic vein-shrinking process (cat gut sutures needn't be removed; they dissolve by themselves after a few weeks). 

XI. Long-term outcome of injection treatment

Throughout the 20th century, surgeons and vein injectionists have been at each other's throats. The surgeons used to say that the only way to permanently eliminate varicose veins was by surgery, and that any failed operation was due to faulty surgical technique. If you listened to any one of them, he would tell you that his operations never failed! It was always the other surgeons, who were "less skilled", whose poor surgical technique was the cause of all the treatment failures.

As for injections, the surgeons were unanimous in claiming that they always failed!

The injectionists, on the other hand, claimed that their method was just as good as vein stripping, and that all vein surgery was therefore unnecessary and greed-motivated. In chorus with their surgical rivals, however, the injectionists all proclaimed that treatment failures were the result of faulty technique.

The beginning of making sense out of this occurred in 1953, when my father, H.I. Biegeleisen, published a 20-year study showing that no one was ever cured of varicose veins! Whether they were injected or operated upon, the inevitable result was the same: recurrence. The extent of the surgery, or the number or type of injections, were all irrelevant. If you followed the patient long enough, sooner or later, new veins always appeared. No one was permanently cured!

My father's study was not well-controlled from a rigorous statistical standpoint, but his conclusions were correct, and subsequently came to be universally accepted by the medical profession. Nowadays, no one claims to be able to permanently "cure" varicose veins. You treat the ones which are there, and you inform the patient that eventually new ones will grow in.

The next breakthrough came in 1973, with the landmark study of the British surgeon John Hobbs. Mr. Hobbs (in Britain, surgeons are called "Mr.", not "Doctor") personally injected and operated on hundreds of patients, and did his own 6-year follow up. It was a monumental task, and it stands as the only reliable statistical comparison between injections and surgery which has ever been done, since it's the only one in which the injections and surgery were all done by the same doctor.

It will perhaps come as no surprise that the study proved that both methods work on most cases! But the long-term outcome was not the same for both methods. In some types of varicosity, surgery gave a better long-term outcome, and in other types of cases, injections gave a better long-term outcome.

Therefore, the question "What's the best treatment, injections or surgery?", no longer has any meaning. Neither one is "best". The preferred method depends entirely on the particulars of the individual case. 

XII. What is meant by "better long-term" outcome?

The quality of the outcome of vein injections is measured according to three criteria:

  1. Cosmetic improvement
  2. Relief of pain
  3. Length of remission time

1. Cosmetic: If the patient is worried about how the leg looks, then the major determining factor in "rating" the outcome is the appearance of the leg. In general, injections work better than surgery! Although there are some exceptions, this is the usual case.

For one thing, surgery does not always work. Relative to a standard operation such as a gall bladder removal, or an appendectomy, vein surgery has a high failure rate. For example, if a person has the appendix out, it's out! Have you ever heard of a person getting their appendix out, and then having it grow back?

But in 10-20% (depending on whom you ask) of vein surgery cases, a new vein will grow in, sometimes almost immediately. The reason is that this is difficult surgery, and most surgeons won't take the time to do it right. Furthermore, this 10-20% failure rate is in the hands of good surgeons! In the hands of average general surgeons, the failure rate has been said to be as high as 50%!

(This last figure cannot be proven, because surgeons with a 50% failure rate neither keep statistics, nor publish papers. You may, therefore, wish to consider it to be "hearsay". But among academic vascular surgeons, such hearsay is both heard, and said!).

2. Relief of pain: If a patient's primary reason for seeking treatment is relief of pain, then it hardly matters which method of treatment is chosen, because they are all highly effective at relieving pain.

3. Length of remission: In length of remission, however, there are significant differences between injections and surgery. Remember that surgery has a relatively high failure rate. But for those patients whose surgery does not fail, there is a relatively long remission.

How long? This cannot be answered for an individual. Only group statistics exist. According to Mr. Hobbs, the British surgeon mentioned above, by the end of a six-year period, 85% of surgical patients will have required further treatment. But in the injection group, that figure is 95%!

While these may not seem to be encouraging statistics, the fact remains that 15% of surgical patients will experience a long-term remission (more than six years) after surgery. This is not a large percentage, but injection patients have essentially no chance of going more than six years without further treatment.

Furthermore, among the patients who do go on to require further treatment, the amount of treatment needed will be greater in the injection group than in the surgical group.

If the differences between injections and surgery had to be summed up in a single sentence, it would be this sentence:

"The cosmetic outcome of injections is usually better,
but surgery usually lasts longer".

Note the word usually, emphasized by italics in the above sentence. These are generalizations. In individual cases, things may go differently. 

 

XIII. The combined approach

Since the early 20th century, a combined approach, with some surgery and some injections, has been used. In principle, the long-term remission of surgery and the cosmetic advantages of injections could both be had.

In the greater New York area, I know of no surgeons who have first-rate skills at injection treatment, and I know of no first-rate vein injectionists who also operate. Therefore, in New York, the combined approach requires two different doctors.

In our practice, we occasionally refer patients to one or another of a very select group of highly-specialized surgeons who have chosen to devote their lives to vein surgery. For patients in whom surgery is indicated, we will refer them to one of these surgeons for an operation.

It is almost never medically necessary to operate, because veins can almost always be injected. But in the interests of a longer remission time, we will refer patients out, if it is indicated, and if they are agreeable to surgery.

I should point out that most "vascular surgeons" nowadays do NOT specialize in vein surgery! The public believes that vein surgery is part and parcel of vascular surgery, and that simply isn't true! The specialty of "Vascular Surgery" did not even exist until after the Vietnam War, and it was created to serve the needs of surgeons who specialize in "arterial bypass" surgery. Diseases of the arteries and disease of the veins are NOT the same, and patients with one of these forms of disease usually do NOT have the other.

Therefore, for the first 20 years, Vascular Surgeons operated almost exclusively on arteries. During this period, most of them looked down on vein surgery as being "beneath their dignity", since it had always been considered part of "General Surgery" -- not something which ought to be done by a specialist.

As for training, it was not long ago that Vascular Surgeons had no training at all in veins. Fortunately, things have begun to change, but, on the whole, Vascular Surgery is still heavily concentrated on arterial disease, and remains light on the venous side.

Therefore, if we believe that occasional patients really would benefit from vein surgery, we have to be very careful whom we send them to. In my opinion, there are only 2 or 3 really good vein surgeons in the entire greater New York area. 

XIV. Should the saphenous vein
be treated at all?

Having said all this about the saphenous vein, I must now report to you that some surgeons are saying it should NEVER be treated; not even when it's varicose! Not by surgery -- not by injections. Not at all!

Why? Because this is the era of bypass surgery, and veins are used as grafts in these procedures.

Bypass surgery is the current favored treatment for blocked arteries. How does this blockage come about? As we age, our arteries gradually get clogged by calcium and cholesterol. Although this happens to everyone, some people clog off faster than others. When it gets really bad, it's considered a disease, called atherosclerosis (or arteriosclerosis, or simply "hardening of the arteries").

As atherosclerosis gets worse and worse, the blood supply to the internal organs can become critically diminished. Although it's a generalized disease, affecting the entire body, all organs do not necessarily deteriorate at the same speed. For example, if the kidneys are the first organs to go, then the patient will require dialysis to stay alive. On the other hand, if the eyes are affected first, the result can be blindness.

The most-discussed of the serious complications of atherosclerosis is the "heart attack", the leading cause of death in America. Most patients destined to get a heart attack will develop warning signs and symptoms years earlier. These begin when the heart's blood supply becomes inadequate to sustain a fast heartbeat. Then, when the patient tries to run or climb stairs, the heart muscle cramps. It's a very painful sensation, and it has a name: angina.

Angina is a sign of severe coronary artery occlusion, and it often progresses to a complete, or near-complete blockage, at which point part of the heart muscle can physically die! This is called a "coronary infarction", which means "heart attack".

In order to prevent this, surgeons invented the coronary artery bypass, where a vein is spliced into the arterial circulation to bring blood around the blockage. Below is a drawing illustrating the operation. Please refer to this drawing as you read the following discussion. 

In the drawing above, the normal direction of blood flow is indicated as:

A àBàCàD,

but the segment "BC" has become completely blocked by atherosclerosis. So the surgeons splice a vein graft (labeled "G") into the coronary circulation to bring blood around the blockage. It's possible (although not necessarily the method of choice) to use a varicose vein for this purpose.

So, even though varicose veins are not considered a good choice for graft "G" in the above illustration, they are used on occasion. This raises an entirely new question in every interaction between vein doctors and their patients:   Should you ever get your varicose veins treated? Or should you save them in case you need them later, for a coronary artery bypass?

Here are the "pros" and "cons": 

XV. Arguments in favor of "saving" the Saphenous Vein

1. If you have blockage of the so-called Left Main Coronary Artery, your chances of dying of a fatal heart attack can be significantly reduced by coronary artery bypass (but see item 1 below). The operation could be difficult or impossible without a saphenous vein to use as a graft.

2. If you have severe heart failure, in addition to coronary artery blockages, your chances of dying of a fatal heart attack can be significantly reduced by coronary artery bypass (but see item 2 below). The operation could be difficult or impossible without a saphenous vein to use as a graft. 

XVI. Arguments AGAINST "saving" the Saphenous Vein

1. "Left Main Coronary Artery" blockages are relatively rare. In my personal experience as a medical resident, during which time I admitted dozens of patients to the hospital for coronary angiography/bypass, not one had an occlusion of the "Left Main Coronary Artery".

2. Patients with both severe heart failure and significant coronary artery blockages are only a small minority among those who receive coronary artery bypass in the United States. In my personal experience as a medical resident, during which time I admitted dozens of patients to the hospital for coronary angiography/bypass, very few had both severe heart failure as well as significant coronary artery occlusions.

3. The great majority of patients who will undergo coronary artery bypass will NOT derive the main benefit which they think they're going to get: prolongation of life, and prevention of heart attacks. That's right, folks. The operation generally does not work, if the definition of "work" is "prevention of heart attacks". Most of the time, the operation does NOT prevent heart attacks.

When coronary artery bypass was invented, it was hoped and believed that it would prolong life in cardiac patients. But it didn't. Since its origin, the operation has been the most intensely studied medical procedure in history. The statistics which have been compiled are voluminous. It became quickly obvious, at the outset, that the operation did not prevent heart attacks, and that's what I was taught in medical school.

Now, over 30 years later, the statistics are even more voluminous, but they still show the same thing: the operation doesn't work!

4. In spite of this, every day in America, angina patients are told that if they don't get this operation, they will die. In the great majority of cases, this is a bold-faced lie.

5. In America, where coronary surgeons can easily make $50,000 per day (that's "per day", not "per year"), massive numbers of coronary bypasses are performed every year. The number is surely in the hundreds of thousands, and possibly as many as a million. In Europe, where many surgeons can earn only a few hundred dollars for doing the same operation, the number of coronary bypasses done is only a small fraction of the number done here in America. Do you think money has anything to do with this?

6. If the operation doesn't save lives, then why is it done? Because it relieves chest pain. The angina, or chest pain of coronary artery disease, is regularly relieved by surgery. But there's an unanswered question: "Why is the pain relieved?". This question arises from the well-established fact that the grafts of one-out-of-seven patients are found to have failed after a year. This means that the bypass in the drawing above (the segment marked "G") has closed off. The coronary circulation, at that point, should have either reverted to its original sick pattern, or maybe even become worse. And yet the majority of these patients still feel fine! Why?

7. It has been proposed that the explanation for the relief of chest pain by the operation may have nothing at all to do with circulation! You see, in order to get to the heart, the surgeon has to cut through the "pericardium", the sheath that surrounds the heart. And that's where all the nerves are. So the theory has arisen that maybe the operation relieves chest pain because the nerves are all cut.

8. It wouldn't be a bad thing to relieve a patient's chest pain by cutting the nerves to the heart, but that doesn't require a prolonged hospital stay -- it could probably be done on an outpatient basis! Moreover, it surely does NOT require "saving" veins!!

9. There is considerable evidence that patients with varicose veins have less chance of needing a coronary bypass than the average American. The statistics supporting this are from this very office. We proved unequivocally that people with varicose veins have lower blood pressure, a disease which is strongly linked statistically with cardiovascular death. We published this in the peer-reviewed medical journal Phlebology (volume 4, pp.191-196, 1989).

In the same study, we showed also that people with varicose veins were much less likely to have angina than age-matched people from the general population. It was not possible for us to prove this as a hard statistic. Nevertheless, the evidence was suggestive of a significant negative correlation between varicose veins and coronary artery disease.

10. The conduit (i.e., "tube") usually used in coronary artery bypass is the saphenous vein. For years, certain observers have been asking "Why?" After all, it's not a good graft!

The best graft is the "internal mammary artery", a small artery which runs down the inside of the rib cage. The internal mammary artery is, or course, an artery, not a vein. And the life-span of arteries, when used as grafts in the arterial system, is much longer than the life-span of vein grafts in the arterial system. The life-span of a vein, when used as a conduit in coronary artery bypass, is in the 5-10 year range. But an artery can last the lifetime of the individual in some cases.

Why, then, are saphenous veins used so much in coronary artery bypass? Because they are easier to get at. It's a matter of convenience! Dissecting free the internal mammary artery from the inside of the rib cage takes longer. And when a surgeon is trying to make $50,000 a day, time is of the essence.

If a patient really needed a coronary artery bypass, and if the saphenous vein was not available, then the surgeon might be forced to use the internal mammary artery. Thus, the patient might actually be better off, not worse!

11. It's a known fact that, compared to healthy veins, varicose veins make poor grafts. They're too big, they're too irregular in shape, and their inner linings are often scarred by phlebitis. There's no doubt that they fail as grafts faster than normal veins do.

Therefore, many vascular surgeons make little or no effort to save varicose veins, when the veins are causing health problems. But others disagree, noting that although they make poor grafts, they can still be used in desperate situations. Are you going to be in a desperate situation?

12. It's a well-established fact that varicose veins invariably recur. That is, new ones always grow in after the old ones are treated. The phenomenon of recurrence has been studied in depth by the British surgeon John Hobbs, mentioned earlier in this report, whose publication on the subject has remained, for 20 years, the standard of knowledge in the field.

Within six years after treatment for varicose veins, most patients have required further treatment. The figure for surgical patients is around 85%. For injection patients, it's at least 95%. That means that unless a patient is going to need coronary bypass within the next 6 years, there's almost no chance of there not being another varicose vein to use as a graft.

Therefore, the only patients in whom "saving" the saphenous vein is an urgent consideration are patients in whom the significant possibility of a sudden need for coronary bypass can be foreseen within the next 6 years. On the other hand, if you are a young, healthy person with a normal cholesterol level, no chest pain, a normal electrocardiogram ("EKG"), and no family history of early cardiac death, then saving your varicose veins for use as bypass grafts is probably pointless.

13. Recent studies from our own office have shown that large varicose saphenous veins never completely disappear after treatment. They shrink to a size so small that they can be neither seen nor felt. After they have shrunk thusly, they no longer have any measurable harmful effect on the circulation. And yet, within a year or two, sensitive ultrasound studies invariably show signs suggesting that the shrunken saphenous veins are once again carrying blood. It's a tiny trickle at first. The patient, at this early stage, rarely has any awareness of the recurrence. But by 5-6 years, the vein has grown back, and can again be used as a bypass graft, if the surgeon is inclined to use varicose veins at all.

This would have been regarded as a very negative aspect of injections only a few years ago, but now, in the era of bypass surgery, it has turned out to be a potential advantage! You can get your veins treated now, and years down the line, when they grow back, you can get your coronary artery bypass!

Some surgeons would object, saying that a recurrent saphenous vein will make a poor bypass graft. They're right. But the original one would have made a poor graft also.

14. Worst case scenario: You need a bypass; the saphenous veins have been injected, and, for some reason, they either haven't grown back, or they just can't be used. What do you do?

  1. First of all, there's that internal mammary artery, mentioned above.
  2. Then, there are other veins. Arm veins are usually too small, but in some patients, they're large enough. There are other leg veins which can be used, principally the "short" saphenous veins behind the knees.
  3. There are synthetic grafts which can be used. They work fine, but they don't last as long. It's not the best way to go, but it's something which can be done when no real vessels are available.
  4. There's a treatment called "endarterectomy", in which the clogged artery is simply opened up and "cleaned out". No graft is put in. My own mother, who (without consulting with me) got a coronary artery bypass operation, needed 5 grafts, and they only could find 4 vessels. So they did an endarterectomy on the fifth.
  5. There's balloon angioplasty, which becomes more popular all the time. In this procedure, a balloon is blown up in the clogged vessels, which forces them open. It's a relatively simple procedure, requiring no surgery. The balloon is at the end of an intravenous catheter, which is threaded in through an arm vein.
  6. Balloon angioplasty doesn't hold up as long as surgery, but it's relatively non-invasive, and can easily be repeated a few years later, if necessary.

  7. Finally, there's laser angioplasty, in which the clogs are burned out with a laser. It's otherwise just like the balloon procedure. The laser light is sent through a catheter which is threaded in through an arm vein.
  8. Critics of laser angioplasty say it doesn't hold up as long as surgery, which is true. But, like its cousin, balloon angioplasty, it can readily be repeated in a few years, if necessary. Laser angioplasty is not done in most medical centers. I'm not sure why. In those centers where it is done, its advocates praise its merits highly.

In short, there are a fairly large number of alternatives to the use of saphenous veins in bypass surgery. One of them, the internal mammary artery, is actually better. The others are not as good, but they'll do in an emergency.

But will an emergency arise? In all the years I've been injecting veins, I've heard of no case in which a patient needed a coronary artery bypass (or a leg bypass), and got into any trouble at all because of previous vein injections!

Does this mean that it's never happened? No. It's possible that there have been cases, which have not been publicized. But since such a thing would, in all probability, lead to a lawsuit, it seems likely that there would be some talk of it. And there isn't.

Therefore, it is my belief that the entire issue of "save the saphenous" is a man-made issue which has been blown way out of proportion. It's my opinion that unless a patient has a relatively clear-cut cardiac risk, saving the saphenous vein for bypass surgery is usually pointless.

Obviously, it would not be hard, in a city the size of New York, to find any number of other doctors who either agree or disagree with me.

 

 

Ken Biegeleisen, M.D.
19 East 80th Street
New York, N.Y. 10075

212-717-4422

 

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