Injection Sclerotherapy

"Some remedies are worse than the disease"

Publilius Syrus

Injection Sclerotherapy for Varicose Veins

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Varicose vein, a disease of the superficial venous system, is characterized by a weakness of the vein wall causing vein distention/dilatation. Once distended /dilated, most valves, along the diseased vein, will become incompetent. This means: they will leak and the normal uphill - back to heart - blood flow, with the help of gravity, will reverse course and become a downhill flow, back to calf/ankle. This flow pattern is called reflux. That is the scenario only if the patient is upright on his/her feet. With patient recumbent, even better with elevated leg, the favorable gravitational forces, will automatically facilitate resumption of the normal uphill back-to-the-heart flow. (One can easily understand now the temporary, but beneficial effect of leg elevation.) To make all this and the following sentences easier to understand, let's imagine an overflowing faucet. Obviously the escaped water, aided by (the same) gravity, in a free fall fashion, will be flooding the floor. Once leaking faucet is fixed and overflow properly controlled, future flooding should be prevented.

Normal and pathological junctional flow. (click to enlarge)

Normal and pathological junctional flow.
(click to enlarge, Fig 1)

Truncal varicose veins (VV) present a very similar scenario. The "faucet"/escape point is, however, located either in the groin or behind the knee, places were leg’s superficial vein (called saphenous) will join deep veins (femoral in the groin; popliteal behind the knee), sites called junctions (SFJ respectively SPJ). These two junctions are normally protected by a major valve responsible not just for maintaining the normal back-to-the-heart, uphill flow but also to drain the blood from the superficial system into the deep. Therefore, as long as this valve is competent i.e. normal, in no circumstances blood, from the larger deep vein can spill into the superficial vein.  Never! However, in the presence of a leaky i.e. incompetent junctional valve, blood from the deep vein, helped by gravity, (like the water in the presence of an overflowing faucet mentioned above), will escape into the superficial vein and will start its journey in an reversed, downhill fashion, flow pattern called reflux. (Fig 1)

Obviously, blood will not be “flooding" floors, but disease affected and already distended, bulging branches/tributaries of the vein that caused patient’s cosmetic distress in the first place. If, with passage of time venous pressure rises too, the patient may become symptomatic complaining of discomfort, pain, ankle swelling and complications such as superficial phlebitis, chronic venous insufficiency, venous ulcers may occur.

Click to enlarge the drawing

Truncal Varicose Veins:
Principals of care.
(Click to enlarge) (Fig 2)

The main difference between the two scenarios is that water flooded the floor in a free fall fashion, while blood, in its downhill/reversed course, uses as a conduit, the existing axial superficial vein trunk extending from the groin junction to ankle (the long saphenous vein) or from behind the knee junction to the ankle (the short saphenous vein). This conduit, in normal physiologic conditions, collects uphill flowing blood through attached branches/tributaries existing along the entire leg. In varicose veins, as previously mentioned, flow is reversed i.e. downhill, from the axial vein into the branches/tributaries.  Positioned in slightly deeper structures of the thigh and calf, in most cases, this axial vein is not visible. (For more detailed information please read anatomy and physiology.) (Fig 2)

To achieve the best therapeutic result, any treatment modality available for varicose veins has to follow three major steps. (See drawing).

Step 1. The method has to completely close/obliterate/stop the leakage of blood originating at the level of the escape point/junction regardless its position : groin or behind the knee.

Step 2. The method has to also stop (remove or close) the downhill pattern of blood flow existing in one the saphenous vein trunks (either along the inner aspect of the thigh or along the hind side of the calf) being the conduit enabling the downhill/reversed pattern of flow ("reflux"), and permitting large volumes of blood to spill/”flood” the branches/tributaries of the axial vein causing them further to distend/bulge.

Step 3. The method lastly, should also take care of the distended and bulging tributaries either removing or closing them, and if just possible, in the same session.

Any unwanted or diseased vein, varicose veins included, is either removed by surgery or closed by either chemical injury (injection sclerotherapy) or by thermal (heat/cold) injury (endovenous thermal ablation). Once properly closed/obliterated, the vein should become invisible as blood is unable to flow through a closed vein.

Injections Sclerotherapy* is a very old therapeutic modality being in use shortly after the syringe was invented way back in the mid 1800 and much before any practical surgical approach. It was and remains an office procedure.

To understand its principle please note that while vein closure is the aim of this therapeutic modality, the injected sclerosing agent will not close the vein directly.  It is the vein’s (basically  body’s) response to the induced chemical injury, that should close the injected vein(s) and deliver the desired results. Indeed, the sclerosing agent will cause a chemical injury of the inner lining/layer of the diseased vein. As with any other type of possible body injuries (cut or stab/pierce, gunshot, thermal (heat or cold) etc. etc.) our body reacts i.e. responds by mounting an inflammatory response that will end in a scar tissue, that in the vein - at least theoretically - should close/obliterate  the lumen of the vein. (Lumen being the inside space of a tubular structure such as a straw, blood vessel, veins included).  This, basically a healing process, may take several weeks to accomplish. It is important to understand as when surgery  is the therapeutic modality, the results are entirely dependent on the performer, very little is left for the patient. In sclerotherapy the performer has to master the injection technique, has to choose the best solution in proper volume and proper concentration but he/she can't control/modulate the patient's response ( the healing process) responsible for the the sealing/closing of the vein, thus the results are dependent basically by patient's response to injury. Even with best of all intentions it is unfortunate but any injury to a vein, chemical or thermal, will automatically also trigger undesirable blood clotting. This is a physiologic defense mechanism meant to stop bleeding following injury to any blood vessel, veins included. Unfortunately, and also physiologically, not only any clot, with passage of time, will shrink, retract and even “melt” i.e. disappear but a  clot is also  a natural enemy of the much awaited scar formation, meant and expected to seal/close the injected vein. In simple translation in the presence of especially bigger blood clot, less scar tissue will be formed. If less scar tissue is produced, the closure of the injected vein, especially the bigger varicose veins, will not be complete and the above mentioned (Step 2) will fail even if the best form of solution delivery was used, namely   foam/froth. In overall,  sclerotherapy has the highest immediate as well as late failure rates when compared to any other existing therapeutic option. A reported failure rate was 17.1 % in the first year! It is easy to understand that the larger the vein, the larger the clot will be, and the failure rates will be proportionately higher as well. Practitioners of this modality, in order to  somehow tame/moderate/prevent clot formation, have to impose a mandatory, lengthy and inconvenient compression protocol. Easy to say,  very difficult to achieve! I will  venture saying that it is easier to fly to the moon then properly compress and close and injected vein to prevent any blood clot formation. Unfortunately, with an upright, ambulant patient it is impossible to properly compress and close a distended superficial vein trunk and its  existing branches along the leg but mostly in the thigh.

The high (immediate and late ) failure rates are also compounded by the fact that the mandated proper closure of the incompetent and refluxing proximal escape pints/junction, (above mentioned Step 1) is very difficult  to achieve as practitioners are afraid to inject that area since a clot in this location could easily extend into the deep vein system causing a deep vein clot/thrombosis (DVT) a dreaded complication that may require hospitalization and long term anticoagulation (blood thinning medication). Moreover, should this  clot get to be dislodged, it could travel via the deep veins to the heart and lungs causing pulmonary emboli (PE) condition that can be also...lethal. In my opinion such complications are not permissible for a cosmetic condition VV basically are. Indeed occasionally the doctors promoting potentially dangerous therapeutic modalities should be more feared than the disease.

 Ultrasound (US)  guided injections was the first among the innovations/additions of the last few decades.  It enabled visualization of the deeper situated axial vein trunks  making it easier  to insert the needle into them and deliver the sclerosing agent's injury more accurate into the targeted vein trunk. The combination of the high tech US guidance and injection made also the procedure financially more attractive to the practitioners, but not much better or safer for the patient.

Foam sclerotherapy was the next improvement. Up to its introduction, all  sclerosing agents were injected in a simple solution/liquid form, liquid that is quickly washed away into the circulation and also diluted by the large volume of circulating blood and by this the contact between agent and inner lining of the vein, crucial for a satisfactory injury and closure was short, and potentially just minimal. In order to prolong the contact between agent and vein two detergent type sclerosing agents  available, (Sotradecol and Asclera or (Ethoxysclerol) can be easily mixed with air creating basically a froth consisting of hundreds if not thousands of tiny air bubbles carrying on their surface the sclerosing agent. If  properly injected, this combination of air and agent will linger longer time in the vein causing a deeper vein injury that in turn should trigger a better/stronger inflammation , subsequent healing and a more efficient vein closure. Of course ultrasound guidance is used.

I do agree that the foam/froth delivery form will induce a better vein injury, possibly resulting in even a better outcome however, there is a major problem with this form of delivery with lots of minute air bubbles. Indeed, air  in the circulation can be dangerous, in fact in excessive volume it can kill a human being. Confusional states have been described as well as transient blindness and chest pains during such foam injections. Recently, I heard from a patient that she had a 20 minute total paralysis/motoric loss of her left arm during such a treatment session with a colleague of mine. One has to know that we all are born with a communication between the two upper chambers of the heart called Foramen Ovale. Normally,  in few days/weeks after birth it should close without any treatment.  However, in up to almost 20-25% of the population a minute form of this communication called patent foramen ovale or PFO, while totally asymptomatic and clinically irrelevant congenital defect, is still present permitting those tiny air bubbles to pass from the right to the left side of the heart. From here, they are ejected by the heart  and could “land” anywhere in the body. If it "lands" in the eye it causes transient blindness, if in the brain it can trigger transient paralysis of a limb, possible confusional states, if in the coronary artery, chest pain…To prevent all this, the volume of foam/froth is limited forcing multiple injection session to accomplish the task and  delays in the desired results. Lastly, distant blood clotting, i.e. far away from the injected site  is another dangerous side effect of the foam method. If this happens in a deep vein, it will be  causing a deep vein thrombosis (DVT) and the patient could end having the life threatening  pulmonary emboli (PE). In my humble opinion, this form of delivery while more advantageous that simple liquid injections when  level and depth of injury  is considered, but it is far more dangerous because its distant thromboembolic (DVT and PE ) possible complications enumerated above.

Foam & stocking compression

Fig. 3 Foam & stocking compression

In a 2009 multi-center European study out of a total 1025 patients treated with foam injections in 10% (102 patients!) the method was a total immediate failure meaning that the varicosities have not totally disappeared.  Would anyone want to submit to any medical treatment that fails in 10%? Not me! Moreover, 11 patients in the study indeed developed deep vein clots (DVT) and one patient had a pulmonary embolism PE as well!! Wow!! Please remember all these patients will have to be put, besides in long term compression stockings, on a long term blood thinning medication as well to prevent additional blood clot(s) formation and especially to prevent potentially lethal PE !. All these patients went for a simple office procedure for a relatively simple medical condition that landed some of them in a hospital needing treatment for potentially life threatening conditions! No thanks! Not in my office! I can do better, much better by simply ignoring the method all together.

I have used liquid sclerotherapy between 1984-86 and my recurrence rate was an inadmissible 60-80% in just the first two years, and this with a judicious six  weeks (!) uninterrupted foam pads and surgical stocking compression protocol.(Fig 3) Can anyone imagine full six weeks in a surgical stocking day and night? I do not know how my patient tolerated this practice, but they did! I have also injected the veins using butterfly needles and the leg was elevated during injections to prolong the contact between sclerosing agent and inner lining of the vein but still at no avail.(Fig 4)

Fig.2  Injections with leg elevation.

Fig. 4. Injection with leg
elevation.

Not even concomitant lay open surgical surgical ligation, (Fig 1) under local anesthesia, of the leaking junction (point where blood starts its journey downhill along the  varicosities) in combination with injection sclerotherapy of the branches and using the same six weeks lengthy compression protocol (between 1986-90) saved the procedure’s bad reputation. True, the recurrence rate came down but was still close to an inadmissible 40-50%! A famed medical authority in the field (Dr. J.J. Bergan) said it correctly in one of his writings that: “It is anticipated that pure sclerotherapy in treatment of varicosities will not gain acceptance in institutions where critical review of results is practiced”. In conclusion, any form of sclerotherapy for varicose veins will fail because of the inability of the method to properly control Step 1 and Step 2, (see Fig 2) )

From that point on, namely end of the eighties and beginning of the nineties I gave up on sclerotherapy for varicose veins. Being a surgeon, I reverted to surgery using Ambulatory Phlebectomy, the minimally invasive protocol described on this web site, method that gave my patients excellent results, was/is performed in an office setting as sclerotherapy and never, but never ever endangered a patient. I never looked back and never incorporated any of the later arriving  high tech therapeutic modality inclusive the  endovenous thermal ablation. As they say: "if aint broke, why fix it?!"

In my humble opinion, no potential severe complications should cloud  any cosmetic procedure , varicose veins included, not even when the reported incidence is a relatively low 1-3% as for the patient hit with such potentially dire complication, the incidence is a full 100%!

In my 3500 operated cases using the minimally invasive approach I have never recorded any of the above mentioned potentially severe thromboembolic complications.  I recognize that when facing a potentially serious medical conditions (cancer, etc.) physician and patient have to take chances, however, never, never for mainly cosmetic gains! Not permitted, not in my vocabulary. I know, sever complication could occurr form a simple Aspirin tablet, but that is different. Thrmboembolic complications such as (DVT) and the potentially lethal PE  are complications imbedded in both sclerotherapy as well as the high tech endovenous ablation.

In conclusion, I will use sclerotherapy for veins that can’t be removed by ambulatory phlebectomy. These will be spider veins with a diameter of 0.1-1mm and reticular/network veins seen on the leg, chest, temple, etc. with a diameter of 1-2 maximum 3 mm. Anything beyond, will be removed surgically using Ambulatory Phlebectomy.

Advantages are clear: also an office procedure,  one single session is needed, the results are almost immediate and constantly excellent, no residual pigmentation and no severe thromboembolic (DVT & PE) complication were ever encountered. Laastly, ambulatory phlebectomy  is totally  from A to Z practitioner depended. Thus, the better the practitioner, the better the results. One caveat: "It is astonishing with how little reading a doctor can practice medicine,( to make money) but it is not astohishing how badly he may do it" - William Osler. (The inser is mine) I rest my case!

* Sclerotherapy: “sclera’ in Greek is “hard” and as the scar tissue needed for vein obliteration is a hard tissue like any other scar,  thus sclerotherapy in free translation would be “hardening therapy” or “therapy by hardening”.

Sclerotherapy Complications