Why We Do Not
Treat Varicose Veins
...by Laser!

by Ken Biegeleisen, M.D.

 

Until recently I have taught that laser is pretty close to being an out-and-out fraud.

This is no longer the case.  In the past, laser was promoted only for "spider veins".  It never worked!  Now, however, it is also being promoted for the treatment of large varicose veins. This discussion shall therefore be divided into two parts:

  1. Spider veins, where laser still doesn't work, and
  2. Large varicose veins, where laser works, although not well.

 

I.   Spider Veins

 

In general, and with few exceptions, laser treatment of spider veins of the legs doesn't work. It works on the nose, and on certain congenital (i.e., inborn) lesions such as "port wine stain", but, when advertised for leg veins, it borders on out-and-out fraud.

 

A.   If laser doesn't work, then why does everybody keep talking about it?

 

Laser is one of the great marketing gimmicks of medical history. Those of us who grew up watching Flash Gordon neutralize his adversaries with a "ray gun" have been lured into an enduring love affair with the laser. It can bounce beams off the moon, destroy enemy satellites in orbit around the earth, and burn through the hardest substances known to man.

Anything with that much power must be capable of curing any human disease, no?

No! Read on, and learn the real history of laser in spider veins.

B.   History of Laser

1. The CO2 Laser

I've been treating varicose veins since 1979. At that time, I worked in the office of my father, the late Dr. H.I. Biegeleisen -- the man who invented the injection treatment of spider veins. (A copy of the first publication on this subject, reprinted from the June 1934 issue of the Journal of the American Medical Association, is available on request).

Even in my first year of practice, 1979, there were already rumors of a new "miracle" treatment for spider veins: laser. "All you do is shine the light at the spiders, and they disappear!", I was told.

The laser in use at that time was called the CO2 laser, or carbon dioxide laser. It produced an intensely hot, white beam of light which could cut through human flesh. Because it cauterized as it cut, there was less bleeding than with a surgical knife. The term "bloodless surgery" came into use, referring to the cutting of human flesh with a CO2 laser.

Then someone got the bright idea to try this device on spider veins. The result: they burned big holes in the patient's legs.

At the world vascular conferences, there were a number of researchers who presented reports on the use of the CO2 laser in the treatment of spider veins. Every one of them reported dismal results.

In a very short time, discussion of the use of CO2 laser in the treatment of spider veins ceased to be heard.

 

2. The Argon Laser

 

No sooner had the halls of academic medicine ceased reverberating to the echoes of "CO2 laser treatment", then the "argon laser" popped up to replace it.

The argon laser had a colored beam. To be exact, it was blue-green.

According to the principles of physics, blue-green light should be strongly absorbed by tissue of the so-called "complementary" color, which happens to be red.

In other words, the theory behind the argon laser was that everything red would be burned to oblivion, and everything else would be spared.

The thinking went like this: "Spider veins are red, and skin is white" -- therefore the argon laser ought to burn out the spider veins without harming the skin. Right?

Wrong! Perhaps because spider veins are not really red (some are blue, some are purple, etc.), and skin is not really white; or perhaps for some other reason; the fact remains that the argon laser did not work.

Here's what happened when doctors treated spider veins with the argon laser: Some of the vessels were burned out, but new ones promptly appeared in their place. The areas were never clear of vessels, no matter how many times the treatment was repeated. The results simply did not look good! Furthermore, the skin was not spared -- severe burn injuries were common.

Once again, there were a number of presentations at the world vascular conferences on the use of the laser, this time the argon laser, in the treatment of spider veins. Once again, every one of them reported dismal results.

Before long, discussion of the use of argon laser in the treatment of spider veins ceased to be heard -- in academic circles, that is. In the lay press, however, it was different. In fact, in the lay press it was only the beginning.

 

3.   Laser - One of the Great Marketing Tools of Medical History

 

In the days of the argon laser (the early to mid-1980's), doctors made an "important" discovery. But it was not a medical discovery, it was a marketing discovery.

That discovery was that laser advertising draws patients. The argon laser proved to be a priceless marketing tool! Doctors who advertised "laser treatment of varicose/spider veins" found their offices packed with patients. How could the doctor resist the lure of an office packed with patients?

But what did the doctors do with these new patients? You already know that the argon laser was a "bust" -- it didn't work!

What most of them did was classic "bait and switch" -- when the patients arrived in the office for their laser treatments, the doctor told them that there was something "different" about their case, and that they needed injections.

As a general rule, such doctors, in addition to lacking the ability to actually deliver the advertised laser benefits, also lacked the necessary skill and experience to render effective treatment for spider veins by injection. How, then, could they survive in the competitive, cut-throat business environment of New York City? Easy -- they billed insurance for the shots. That way, the patients got free treatment. What greater incentive could there be?

Furthermore, these patients couldn't complain about poor results! Since they hadn't paid anything, what right did they have to make demands on the doctor?

Did you notice that I said these doctors billed insurance? But you know (or ought to know) that insurance doesn't cover spider veins! How could the doctor collect from the insurance company for a non-covered procedure? Easy again -- he lied.

Thus was born one of the most harmful practices of the modern vein injection "industry" -- the practice of fraudulently billing insurance companies for non-covered cosmetic injections. The repercussions of years and years, and billions upon billions of dollars of such claims, are still with us today. In particular, it's become difficult to obtain insurance coverage for any vein injections, even when patients are severely ill. Many insurers now reject all vein injection claims, assuming, as a first assumption, that any such claims are for frivolous cosmetic work.

 

4. The "Tunable-Dye" Laser, etc.

 

The next "generation" of lasers began with the so-called "tunable-dye" laser. The light beam from this device had an adjustable color. One of its operating frequencies was supposedly exactly right for blood vessels (in technical language, it emitted a light beam which had the complementary color of the blood protein hemoglobin). Thus, once again, we were asked to believe that a laser would do what no laser had been able to do before.

To make another long story short, it didn't work.

This was immediately followed by a whole new class of "miracle" devices. These were not, strictly speaking, "lasers", but rather "laser-like" devices. From the promotional standpoint, it makes no difference. To the consumer, "laser" and "laser-like" mean the same thing: They don't work!

But television reports, as usual, suggest that they are more effective, less painful, and less expensive than injections. Don't believe it! I've spoken to doctors who have used these devices. The truth is that they are less effective, more painful, and more expensive than injections! What you're really paying for is the $200,000+ price tag on the device.

Well, in the hallowed halls of academic dermatology, things have changed a little. Having been embarrassed and humiliated repeatedly by associating their good names with lasers that didn't work, dermatologists are now making a much more limited claim: that these devices are a valuable adjunct, or aid, to treatment; but only at the very end of therapy, when the doctor is dealing with tiny, red vessels, less than 0.1 mm in diameter.

Specifically, the following protocol is typical of what is currently recommended by the new breed of "laserologists":

  1. First, all large varicosities are to be be surgically removed (or lasered; see below).
  2. Secondly, all medium varicose veins (so-called "reticular" varicose veins) are to be injected by qualified physicians or surgeons.
  3. Thirdly, the spider veins are to be be injected -- not lasered! The injections are to continue until every vein which is injectable has been treated.
  4. After all this, and only after all this, comes the "laser" portion of the treatment:  If there remain any so-called "mats" (defined as dense accumulations of multiple tiny red vessels, each one less than 0.1 mm in diameter), it is now declared that such mats are "better" treated by laser than by further injection.

Hmmm... what do they mean when they say "better" treated by laser than by injection? And just who are the injectionists making these claims?

Consider this: I'm pretty good at injecting spider veins. Why shouldn't I be? After all, I've been in business over 30 years, and furthermore, I'm the son of the inventor of the treatment.

But I wasn't always so good.

In the beginning, it took me 5-6 years to develop a decent injection technique; one adequate to treat vessels 0.1 mm in diameter. In other words, for the first 4 years of my own medical practice, I myself couldn't reliably get the needle into those small vessels!

Now let's again consider the case of those dermatologists who say that laser, even when limited to the end of the treatment only, is "better" than injection. How skilled are they at giving injections? How many years have they spent developing their injection technique? A more appropriate question is "Have they spent any time at all developing their injection technique? Or have they just worked on their billing technique?"

The long and the short of it is that when a doctor has little or no experience injecting veins, then the statement that "laser works better than injections" has little or no meaning.

In fact, since there are no vessels too small for an experienced injection specialist to treat, I am profoundly skeptical that any laser, or "laser-like" device, has, or will ever have any real role in the treatment of spider veins.

 

Why doesn't laser work?

 

As of the last date I reviewed this article, there are two things I've never seen:

  1. In all the years that laser has been talked up, I have not seen a single patient whose spider veins have been satisfactorily treated by laser, and
  2. I have not had a single patient whom I failed to cure by injection, who subsequently went out and got the job done by laser. Not one!


Here's the problem:  The entire theory of laser is wrong!

Spider veins lie on the surface of the leg, which leads to the "natural" conclusion that it is a "surface" disease. But the "natural" conclusion is wrong! The disease actually arises below the surface, where it cannot be seen. The vessels you see on the surface are merely end-branches, arising from "trunks" which are invisible.

There are two theories about the cause of spider veins. One theory states that the "trunks" are underlying varicose veins of a low grade. In other words, the spider veins are being "fed" by deeper varicose veins which are too small (or too deep) to bulge through the skin, so that they themselves are not cosmetically unsightly. But they disturb the circulation enough to cause spider veins to grow in the skin above them.

The second theory states that the "trunks" of the spider veins are tiny arteries, which have somehow managed to connect themselves to the network of tiny veins which permeate the skin above them. Now, arteries are high-pressure vessels. Since the surface veins ordinarily have low pressures in them, the introduction of high-pressure arterial blood makes them swell and stretch, becoming visible and unsightly.

It is highly probable that both of the above-mentioned theories are partly correct. But whatever the truth proves to be, whether it be varicose veins, or arteries, or both, none of these causes is amenable to laser treatment!

You see, laser is strictly a surface treatment. That is, laser light is visible light, and any vessel that is invisible to the eye is also invisible to the laser. That is why I believe that laser is NOT the "treatment of the future" for spider veins, but rather a failed treatment of the past -- a treatment whose time has come ... and gone!

OK, we know what the experts
say to the press.

What do they say to each other?

The dermatology journal called "Dermatologic Surgery" has emerged as America's premier place for publication of new articles about treatment of spider veins and small varicose veins. It is "peer reviewed", meaning that nothing can be published until it has passed a team of editors and reviewers.

This journal, then, is the "last word" in this field. What does it say about laser?

In the April 1999 issue (Dermatol. Surg. 25,4:328-336) is an article entitled "The Role of Lasers and Light Sources in the Treatment of Leg Veins", by Jeffrey Dover, Neil Sadick, and Mitchel Goldman, three of the nation's leading authorities on use of laser in spider veins. Here's what they say:

"When a systematic approach is used where feeder vessels are first surgically removed and sclerotherapy proceeds from largest to smallest vessels, 80-90% of vessels respond to a single sclerotherapy treatment. Because of the relatively modest results demonstrated with lasers and light sources...we generally recommend using lasers and light sources only for vessels that remain after this treatment approach."

They add this:

"Lasers and light sources should be considered prior to sclerotherapy in patients who are fearful of needles, who do not tolerate sclerotherapy, who fail to respond to sclerotherapy, or who are prone to telangiectatic matting."

This is the word from the masters. What can we add?

 

II.   Large Varicose Veins

A.   "Make the injustice visible"

 

I know all about laser treatment for large varicose veins, because I invented it. (If you don't care who invented it, click here to go directly to section B, entitled "Do they work?").

Here's the laser story. The field of Phlebology was lagging about 50 years behind most other branches of medicine, and, being the son of the early 20th century's major American innovator in this field, I set out most deliberately to come up with a better method than either injections or surgery.

After a decade of research, I developed the "Venoscope" (U.S. Patent # 5,022,399, June 11, 1991). What follows is a brief discussion of the instrument. For a more comprehensive history (parts of which, unfortunately, may be too technical for some readers), click here.

The Venoscope was a catheter, to be inserted into a large varicose vein. The catheter was to be equipped with fiberoptic pathways whereby to see directly into the vein, as well as to conduct laser light for therapeutic laser ablation. It was also supposed to have at least one channel for injections, or for the passing of a radiofrequency ablation wire. Finally, it was to have piezoelectric crystals, i.e., doppler crystals, whereby to do blood flow studies and ultrasound imaging from inside the vein.

As of this date, a true Venoscope has not been produced. No company wanted it. When, in the future, it is finally produced, it will be capable of traveling through the circulatory system to almost any part of the body, including places not accessible even to surgeons. Once there, it will be able to perform ultra-sensitive in situ blood flow studies, as well as to display the anatomy either under direct vision (via the fiberoptic bundles) or ultrasound imaging (via the piezoelectric crystals). After the diagnosis is confirmed, the instrument will be capable of delivering either medicine injections, laser light, radiofrequency energy, or any other treatment modality deemed necessary.

At the 1989 tri-annual World Congress of Phlebology, the most comprehensive and prestigious of all venous symposia, I showed a video of a prototype treatment employing an angioscope to deliver super-precise sclerotherapy under direct vision (click here to see the video). This work was funded by Olympus and Shott, two of the world's largest manufacturers of fiberoptic medical devices. But the participants in the Congress, while showing great interest in the video, purchased no angioscopy systems, and neither Olympus nor Schott went forward with the Venoscope project.

Continuously, through the years, I have presented the Venoscope to biotech companies, one after another. Alas, not one of them saw fit to manufacture and market the device. Each one told me the same thing: "Our consultants tell us existing remedies are adequate". Really? If that was so, then how come surgery has almost died out, and how come every hospital is now using a stripped-down pirated version of my invention?

A company called Diomed took the Venoscope, simplified it by removing everything which made it a medical step forward, and introduced a medically-pointless catheter which, however, was cheap to produce, so they didn't have to invest much. It was also easy to market, because the public is gullible enough to buy anything called "laser". And it sold..."like hotcakes", as the saying goes.

This allegedly-new device did one and only one thing: burn the living daylights out of the vein using laser light. The Diomed catheter is "blind"; you can't see through it. It's "deaf"; it has no doppler crystals wherewith to do flow studies or ultrasound imaging. And it's "dumb"; not only can't you go places surgeons can't, this dumb catheter can't even go where surgeons can go. In fact, you can't even be sure where the tip is.

In spite of all its limitations, corporate-sponsored pseudo-"medical" literature immediately began to appear, claiming that the new laser device was "the equivalent of surgery", which is totally impossible. This false literature also claimed that the cures were "permanent", which is a lie that flies in the face of all 20th century research on veins. This research, laboriously performed over a period of a hundred years, proved over and over again that no treatment for varicose veins is ever "permanent".

The story of how my patent was subsequently infringed by no fewer than seven companies (and probably more, by the time you read this) is told in the detailed history mentioned earlier. The long and the short of it is that in the past, when the possibility of justice for all still existed, it was necessary to add something significant to an old invention before the Patent Office would recognize it as a "new invention". Nowadays however, in an ever-increasingly-amoral America in which "money talks and no money walks", the federal courts have declared that you can indeed turn an old invention into a new one by simply taking something out.

Nice! This means that large companies can wait for a fool like me to labor for years to create a new invention (15 years in my case), then simply remove something from it, and call it "their own". They thereby expropriate all of the benefits, even though they did none of the work and took none of the risks. Gee, thanks alot American "justice" system.

By the way, patent protection for inventors is not some vague concept to be toyed with by bribe-taking judges at their whim; it's explicitly provided by the Constitution of the United States (if you go there, select Article I, Section 8, Clause 8).

Gandhi said "make the injustice visible".  I'm doing my best.

 

B.   Do they work?

 

But do the current crop of stripped-down laser vein-burning catheters work? There are now at least eight companies making a cheap imitation of the Venoscope. I don't get a penny of royalties from any of them. Nevertheless, I must admit: YES, the instruments work. But they are not the "equivalent of surgery". The only advantage surgery ever had over injections was a longer remission time, and you won't get that longer remission time from laser.

In fact, laser is only the equivalent of good injection sclerotherapy. I would recommend injections over laser in its current form except for one thing:  The insurance companies, which still do not pay for injections, not only pay for laser, but pay MORE than for surgery! As of this writing, insurers are paying as much as $3000 per leg, which is more than twice as much as I charge for injections!

Since I already told you that laser is not, and cannot ever be the "equivalent of surgery", you might be wondering why insurers pay for it at all. You might be wondering further why they pay MORE for laser than for surgery.

The only possible answer is that they are somehow benefiting from it. It has nothing to do with health. It has to do with the receiving of bribes or the equivalent thereof, to pervert justice and good medical care. These two things, perversion of justice and perversion of good medical care, are the hallmarks of 21st century American "healthcare", where only money counts.

Therefore, dear patient, I must advise you to take laser treatment if you have large varicose veins. I'd love to treat you by ordinary injection (I don't even own a laser device), and I will do so if you ask, but you won't get insurance coverage in my office. Therefore, and reluctantly, I am obligated to suggest laser, where the doctor will bill insurance, so that whether his treatment succeeds or fails, it will cost you nothing.

I could do laser myself, but I don't. There are two reasons, a bad one and a good one. The bad one is that I won't give thieves the satisfaction of seeing me use their products. The good one is that laser, in its current dumbed-down form, is a real step backwards in medicine, and I do not intend to support it.

Moreover, I can't afford the equipment. My fortunes have progressively diminished since the world began using laser for large varicose veins, and the incredible fact is that my own invention is gradually putting me out of business.



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

212-717-4422


 

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