Sclerotherapy

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The sclerotherapy ( ancient Greek σκληρός skleros , German , hard ' and ancient Greek θεραπεία therapeia , German , Heal ), even obliteration called, provides a minimally invasive and outpatient by guided therapies for the treatment of varicose veins of the leg veins and the hemorrhoids and varicose veins represent the esophagus. In the planned elimination of spider veins and varicose veins through sclerotherapy, the diseased veins are closed by injecting a sclerosant and, in the long term, converted by the body into a connective tissue cord, which is ideally broken down by the body. In the case of hemorrhoids, sclerotherapy leads to a deliberate inflammatory reaction in the tissue, through which the enlarged hemorrhoids are fixed or stabilized again. A sclerosis itself may also (patho) physiological conditions by itself take place in the organism, such processes. B. in the kidney (glomerulosclerosis).

application areas

According to the Bonn vein study, over 90% of the German population suffer from varicose veins or spider veins. 60% of the population are affected by spider veins and reticular varicose veins. Therefore, one can speak of a common disease in this disease. With sclerotherapy, all forms of varicose veins can be successfully treated and possible complications can be counteracted. Other goals of treatment are to eliminate symptoms and improve aesthetic appearance and quality of life. In addition to spider veins and reticular varicose veins, areas of application are also varicose veins of the perforating veins, side branches and trunk veins. If varicose veins reappear after surgical treatment (so-called recurrences ), these can also be treated with sclerotherapy. Other indications are hemorrhoidal disease and acutely bleeding varicose veins of the esophagus (esophageal varices).

Other areas of application such as varicoceles (varicose veins in the scrotum), lymph cysts or Baker cysts are not officially approved. Cysts such as B. in the thyroid can also be treated with sclerotherapy.

Sclerotherapy converts unwanted or pathologically altered veins into connective tissue or a strand of connective tissue. This process is also known as sclerosis and the treatment with sclerotherapy is therefore often referred to as sclerosis. The treated vein is then tightly closed and the resulting cord of connective tissue corresponds in its functional result to the removal of a varicose vein using surgical or endovenous thermal methods. As a rule, the body breaks down the connective tissue cord on its own. The treated vein is not required to transport the blood back to the heart, because the blood looks for a new route via other veins.

In order to increase the effectiveness of the sclerosant by staying longer at the target site (the vein wall of the vessel to be closed), air was injected in advance in the past in order to achieve a short-term blood-free vein. This is achieved today with a foamed sclerosant.

Contraindications (contraindications)

Sclerotherapy must not be used if there is a known allergy to the sclerosant, in patients with a deep vein blocked by a blood clot (acute thrombosis ), and in patients with local infections in the treatment area and severe acute general infections. Sclerosing foam should also not be used if the disease is caused by a known hole in the atrial septum of the heart (known and symptomatic open foramen ovale). Particular caution is required in patients at high risk of thrombosis, e.g. B. in patients with a congenital tendency to blood clots or patients who have ever had a thrombosis. Being bedridden or unable to walk, severe arterial circulatory disorders (grade III and IV according to Fontaine), a poor general condition and migraines after previous foam sclerotherapy are relative contraindications Breastfeeding can be interrupted for 2 to 3 days.

Small varicose veins: spider veins and reticular varices

Varicose veins are pathologically enlarged, superficial veins that are often meandering and protruding in knots on the legs and are known in technical terms as varices. Spider veins are the smallest varicose veins with a diameter of up to 1 mm and lie in the upper layer of the skin (dermis). Therefore, they are also clearly visible. They are often heavily branched and can be blue to reddish. These smallest varicose veins are often associated with the so-called reticular varices, which are still clearly visible, but already a little deeper than the spider veins in the skin. Reticular varices have a diameter of 1-3 mm and often represent nutrient veins of spider veins. These nutrient veins supply the spider veins with blood and should therefore be treated to remove the spider veins. As with large veins, the cause of the appearance of spider veins and reticular varices is a pathological backflow of blood due to defective venous valves. Spider veins and reticular varices are mostly viewed as aesthetic treatment indications, although some patients complain of pain, cramps, burning, itching, or heavy and / or tired legs.

Spider veins and reticular varices can also be the first signs of the presence of larger varicose veins or deeper problems. It is therefore advisable to examine the veins with the help of an ultrasound, even with smaller varicose veins. The sclerotherapy of spider veins and reticular varices is also called micro-sclerotherapy or fine sclerotherapy and is thus differentiated from the sclerotherapy of larger varicose veins. The term “micro” refers to the treatment of very small veins with particularly fine needles. Depending on the severity of the spider veins, one or more sessions are required. Sclerotherapy is carried out on an outpatient basis, is painless and does not require incisions. Anesthesia or local anesthesia is not necessary.

Larger varicose veins

In contrast to spider veins, larger varicose veins require treatment from a medical point of view, since if left untreated, they can cause serious secondary diseases including thrombosis or open legs (leg ulcers). Complaints with varicose veins can include, in addition to the impaired aesthetic sensation, heavy and tired legs, feelings of tension, tingling, pain when resting, cramps, itching, but also water retention (edema) in the ankle area and skin inflammation.

Larger varicose veins are mainly caused by non-functional perforating veins, side branches or trunk veins. The varicose veins are caused by the local reflux and the sinking of blood in the leg veins according to the force of gravity. The causes of the blood reflux are no longer properly closing venous valves and the enlarged diameter of the veins enlarged by the congestion of blood. For larger varicose veins, sclerotherapy can be used as an alternative or in addition to varicose vein surgery or thermal procedures. Sclerotherapy works without incisions, anesthesia or anesthesia. In contrast to the thermal methods, no tumescent anesthesia is necessary. After the treatment, you will be able to work again immediately and be able to bear normal stress.

So far, no therapeutic method can cure varicose vein disease forever. Therefore, despite successful therapy, varicose veins can form again and make further treatments necessary. The advantage of sclerotherapy is that it can be repeated as often as required without any problems. In the case of larger varicose veins, the sclerosing agent is often used as a foam, which is always prepared from liquid sclerosing agent and a syringe system immediately before therapy (see foam sclerotherapy ).

Hemorrhoid disease

Everyone has hemorrhoids. Hemorrhoids represent a cavernous body system in the rectum that is primarily responsible for the fine sealing of the rectum. They are located like a cushion in a ring around the anus. If the erectile tissue is enlarged and causes discomfort, it is called a hemorrhoidal disease. It is estimated that around 70% of adults will have hemorrhoid disease at one point in their life. The most common symptom is bright red bleeding from the anus that occurs during or immediately after defecating. If the hemorrhoids are pushed out of the rectum during pressing or even remain outside the rectum, this so-called prolapse can affect the fine sealing. This can lead to oozing and stool smear, which in turn can lead to skin irritations such as itching and burning. Four stages are distinguished based on the size of the hemorrhoidal cushions and the extent of the prolapse. Hemorrhoidal disorders in stages I to II (or also referred to as grade 1 to 2) can be treated on an outpatient basis with sclerotherapy, in which the sclerosant is injected into the pathologically enlarged hemorrhoids with the help of a proctoscope (anus mirror). Surgical intervention may be necessary as the disease progresses.

Sclerosants

The most widely used active ingredient in sclerotherapy treatment today is polidocanol . The sclerosant was approved under the name Aethoxysklerol as early as 1966 and is the only approved drug in Germany for the sclerotherapy of varicose veins and hemorrhoids. So that both large and very small varicose veins can be optimally treated, the drug is offered in Germany in five different concentrations (0.25%, 0.5%, 1%, 2% and 3%). 3% Aethoxysklerol is approved for the treatment of hemorrhoids .

Polidocanol has many different names. In the European Pharmacopoeia polidocanol under the name lauromacrogol 400 ( International Nonproprietary Name to find). Other common names are macrogol-9-lauryl ether and polyethylene glycol dodecyl ether. Although Polidocanol contains an alcohol group in its chemical structural formula, it has nothing to do with alcohol ( ethanol ) in common parlance.

As a modern sclerosant, the active ingredient polidocanol belongs to the class of detergents . Detergents are surface-active substances that, due to their chemical structure, reduce the surface tension of the water. In the sclerotherapy of varicose veins, the polidocanol molecules primarily interact with the cell membrane of so-called endothelial cells that line the inner wall of the veins. The detergent effect creates “holes” in the cell membrane, which damages the inner wall of the varicose veins, closes the varicose vein and, in the long term, is converted into a connective tissue cord by the body's own restructuring processes and ideally broken down. A great advantage of detergents is that these sclerosing agents can be used to produce a stable microfoam. This foam is displaced more slowly by the blood in the varicose veins and acts more strongly than the liquid sclerosant due to the prolonged contact with the vein wall. The use of foam therefore makes sclerotherapy more effective for larger varices.

Although it does not have the typical structure of a local anesthetic at first glance, Polidocanol also has a local anesthetic and is therefore often used in skin preparations.

Polidcaonol is approved outside of the German-speaking countries Germany, Austria and Switzerland in many European countries and also outside of Europe e.g. B. in the USA, Australia, Japan and China. In addition to Polidocanol, there is another sclerosant approved in several countries, the so-called sodium tetradecyl sulfate (STS, Fibrovein , Sotradecol , Trombovar ).

execution

Leg varices

The treatment of varicose veins should be carried out by a doctor or phlebologist who specializes in venous and / or vascular diseases and is often carried out by specialists in dermatology, general surgery, vascular surgery, angiology or internal medicine. In the course of 1.5 years of further training after the specialist training, the additional qualification as a doctor for venous diseases ("phlebologist") can be acquired. Here, in addition to specialist expertise, training is provided specifically for the prevention, detection and treatment of diseases of the leg vein system.

Many people still see varicose veins as a cosmetic problem rather than a disease. However, early treatment should be given to avoid progression and complications. A doctor's visit is particularly necessary if there is swelling and pain in the legs or if the varicose veins change.

To make the diagnosis, the doctor will ask about the history of the disease ( anamnesis ), followed by a physical examination. According to the current guidelines of the German Society for Phlebology, an ultrasound examination of the leg veins should also be carried out. In the case of spider veins and reticular varices, an examination with a Doppler ultrasound instead of the duplex ultrasound examination may be sufficient.

After the diagnosis has been made, the attending physician will usually define a treatment plan that includes the following steps and the period in which the sclerotherapy is carried out. A single treatment session usually lasts no more than 15 to 20 minutes.

Doppler and duplex ultrasound examination of leg veins

Doppler sonography and imaging by means of duplex sonography are both ultrasound examinations that are important pillars in the diagnosis of venous diseases. With the help of ultrasound, the extent and course of the disease can be clarified. The treatment plan is also created individually on the basis of these examinations.

Veins and varicose veins that are not visible from the outside can be examined non-invasively with the ultrasound. With a Doppler sonography, the blood flow within the blood vessel is measured (blood flow measurement) and the doctor can assess changes in this way. The duplex ultrasound is a combination of the usual ultrasound imaging of the tissue and the Doppler ultrasound. With the duplex ultrasound, the course, diameter and texture of the vascular wall of superficial and deep veins and arteries can be displayed on the screen. In addition, it is possible to display the direction and speed of flow of the blood within the vessels. In this way, important information can be obtained about thromboses, disorders of the venous valves and any blood reflux.

When injecting into invisible varicose veins, the duplex ultrasound examination is also an important aid in avoiding punctures. With the help of imaging, neighboring arteries can be demarcated and the best possible puncture site for sclerotherapy of the diseased veins can be determined. During the injection, the ultrasound can also be used to track the spread of the sclerosing foam and thus the optimal amount of foam can be injected. The ultrasound examination thus contributes significantly to the safety and success of the therapy. An ultrasound scan is also often performed after sclerotherapy to document the success of the treatment.

Micro-sclerotherapy of spider veins and reticular varices

Depending on the diameter of the veins, the optimal concentration of the sclerosant is selected by the doctor. Polidocanol concentrations of 0.25%, 0.5% or 1% are usually used for small varicose veins. The effect of liquid polidocanol can be increased by foaming with air, but foam sclerotherapy is not officially approved for spider veins and reticular varices. Both liquid sclerosant and foam treatments are safe and effective methods of treating spider veins and reticular and subcutaneous varices.

The injection with fine cannulas is carried out with the patient lying down. One begins with the larger reticular varices and nutrient veins of spider veins, whereby the subordinate spider veins usually fade immediately upon injection. The discoloration of the treated vein ("blanching") due to the displacement of the blood by the sclerosant also confirms the correct position of the cannula in the vein. An untreated nutrient vein can cause spider veins to recur in the treated area. Vein locators make nutrient veins particularly visible and can thus increase the effectiveness of sclerotherapy.

Since Polidocanol also has numbing properties, sclerotherapy is painless. You may feel a slight burning sensation for a short time. Immediately after treatment, there may be a slight temporary reddening in the injection area, which is an indication that the sclerosant has reacted successfully with the vein wall and that the desired sclerotherapy reaction has started. After the treatment, a so-called local eccentric compression (e.g. cotton pad) is usually worn permanently on the sclerosed vein together with a compression stocking for the next 24 hours. The eccentric compression can then be removed. It is often recommended to wear the compression stocking during the day for the next 1-2 weeks, but sometimes only for a few days, depending on the extent of the spider veins. The compression can optimize the result of the sclerotherapy.

Depending on the extent of the disease and the desired treatment, several sessions are necessary for optimal therapy success. Micro-sclerotherapy is carried out on an outpatient basis and can remove small varicose veins without anesthesia and skin incisions. After the treatment, you can resume your normal daily activities immediately. Although there is no scientific evidence on the subject, many vein specialists recommend that sauna, solarium and extensive sunbathing should be avoided for 1-2 weeks after treatment.

Foam sclerotherapy for larger varicose veins

The effect of liquid Polidocanol can be increased by foaming with air in special syringe systems. The greater effect of the sclerosing foam is mainly due to the fact that the foam is less diluted by the blood after injection into the varicose vein. As a result, the dwell time of the sclerosant on the vein wall is longer, which means that the sclerosant can work better and the sclerotherapy of larger varicose veins becomes more effective.

To produce the sclerosing foam, the sclerosant is drawn up into a syringe and air into the other. The ratio is usually 1 part sclerosant plus 4-5 parts air. With the syringe systems, the two syringes are connected with the help of a three-way stopcock or a special connector. The liquid sclerosant is foamed by pumping back and forth between the two syringes until a fine-bubble and viscous microfoam is formed, which should be injected directly into the veins. No more than 10 ml of foam should be administered per day of treatment.

Before the injection, the safest and best places to inject are usually identified with the help of an ultrasound scan. The patient is standing and the course of the vein is marked on the skin with a pen. For the injection of the sclerosing foam, the patient is placed in the prone, back or side position. The sclerosing foam is then administered under ultrasound control so that the distribution of the foam in the vein can be precisely observed and controlled with the ultrasound. It is a great advantage of the foam that it is clearly visible in the ultrasound image.

Foam sclerotherapy can be done with a "simple" needle ( cannula ), but also with the help of an indwelling venous cannula - also known as a butterfly . An indwelling venous cannula is a needle with a small catheter and remains in the vein for intravenous administration of the sclerosant during treatment. Depending on the length of the vein, one or more injections are made. Care should be taken to ensure that the patient lies still for a few minutes immediately after the treatment and does not perform any Vasalva maneuvers (activation of the abdominal press). Following the sclerotherapy treatment, we recommend wearing a compression stocking for about 2 to 4 weeks. The treatment is usually carried out on an outpatient basis and without any anesthetic. Even after foam sclerotherapy, patients can immediately return to their normal everyday life. Just like after micro-sclerotherapy, sauna, solarium and extensive sunbathing should be avoided for 1-2 weeks after the treatment.

The diameter of the affected veins is an important decision criterion for the therapeutic approach with the saphenous veins. An observational study by the French Society for Phlebology has shown that the diameter of the great saphenous vein (great saphenous vein) is less than 6 mm in almost two thirds of patients who visit phlebological practices because of venous problems, making it a good indication for foam sclerotherapy consists. Stem vein diameters of more than 8 mm were found in only 8% of all patients.

Hemorrhoid disease

Hemorrhoids are usually treated by (colo) proctologists . In the additional training of at least one year, the doctor is trained to treat diseases in the rectum .

The history of the disease ( anamnesis ) is asked diagnostically . This is followed by an inspection, a digital (with the finger) palpation of the rectum, a proctoscopy (reflection of the anus) and / or rectoscopy (reflection of the rectum). The examinations are usually painless and can be carried out without any special preparation. This diagnosis is important to rule out other diseases, as the symptoms of hemorrhoid disease can also occur in other diseases of the intestine. Depending on the age and findings, a colonoscopy may be necessary.

The injection of the 3% polidocanol solution in cases of hemorrhoidal disease in stages I to II is carried out with the help of a proctoscope (anus). As the injection should be above the dentate line and there are no sensitive (pain) nerves here, the therapy is usually painless. In contrast to leg varices, the sclerosant is injected submucosally into the hemorrhoidal tissue and not into a vessel. Sclerotherapy leads to a deliberate, limited inflammatory response. In the long term, the enlarged hemorrhoids are fixed and stabilized again and an incident prevented.

The sclerosant is usually injected as a liquid, but it can also be injected in a foamed form.

Sclerotherapy is carried out on an outpatient basis and only takes a few minutes. You can easily go back to normal activities immediately after the treatment.

Depending on the severity of the hemorrhoidal disease, high success rates can be expected after 2-4 treatments at intervals of a few weeks. The success rates were e.g. B. 70% after one treatment session and 92% after the second sclerotherapy. The method can be repeated any number of times, so if a relapse occurs (recurrence of symptoms), sclerosis can be performed again without any problems.

Medical guidelines sclerotherapy

Leg varices

Since the first publication of a German guideline on sclerotherapy in 2001, which was drawn up on behalf of the German Society for Phlebology (DGP), it has been regularly revised and published. In May 2019, an S2K level guideline for "Sclerosing treatment of varicose veins" was published for the first time under the leadership of the DGP and with the participation of other specialist societies and the professional phlebological association of the Association of Scientific Medical Societies (AWMV).

The content of the guideline is also based on the results of the European guideline for sclerotherapy. According to the guideline, sclerotherapy aims to improve the aesthetic appearance of the legs and venous function, as well as to eliminate symptoms associated with varicose vein disease and prevent complications.

Sclerotherapy with liquid polidocanol is still rated as the method of choice for the treatment of spider veins and reticular varices , which allows an improvement of more than 90% at the end of treatment and has few side effects. For sclerotherapy of spider veins and reticular varices, concentrations of 0.25% to 1% polidocanol are recommended. Foam sclerotherapy is described as an additional treatment method for small varices.

For larger varicose veins such as lateral and trunk varices, foam sclerotherapy is significantly more effective than sclerotherapy with liquid sclerosant and is also a successful and cost-effective treatment option. Compared to other therapy options, it has few side effects, can be repeated as required and can be combined with other treatment options, e.g. B. only trunk veins can be treated, can be combined well. For the larger varicose veins, the concentrations of 1 to a maximum of 3% polidocanol are usually used. In routine cases, a maximum of 10 ml of foam should be injected per treatment appointment under ultrasound guidance, divided into several injections.

Endovenous mechano-chemical ablation (MOCA) of the stem varices was added to the guideline. The procedure combines the mechanical effect of a special catheter on the inner wall of the veins with the effect of a liquid sclerosant (in Germany polidocanol). At the beginning of MOCA, the attending physician inserts a catheter through a minimally invasive incision into the varicose vein. A rotating wire can be extended from this, which damages the vein wall in addition to the injected sclerosant due to the mechanical irritation. According to the guideline, this combination also leads to higher initial occlusion rates in stem veins with the liquid sclerosant.

Compression is recommended as part of the follow-up treatment of sclerotherapy, as studies on spider veins have shown that this can further improve the result. Long-term immobility should be avoided after sclerotherapy treatment. Any coagulum (blood clot) that may remain in the treated vein should be punctured and removed during the follow-up examination. In the case of spider veins and reticular varices, the success of the treatment can be monitored by assessing the clinical result; in the case of larger varicose veins, an ultrasound examination should be carried out.

Hemorrhoid disease

The guideline from 2019 replaced the S1 guideline from 2009 and was raised to an S3 level, i.e. H. A representative guideline group carried out systematic research on clinically relevant issues and assessed the scientific evidence (evidence). In addition to the lead German Society for Coloproctology (DGK) , other specialist groups were also involved in creating the guideline.

The diagnosis of haemorrhoid disease should include the basic proctological examination with anamnesis, inspection, palpation and proctoscopy (anusoscopy). To improve the symptoms and to accompany the therapy, patients with haemorrhoidal disease should be advised of the benefits of a diet rich in fiber and appropriate stool regulation. The experts also considered it important to avoid pressing during bowel movements and long sessions on the toilet.

In the guideline, polidocanol is named with a strong consensus as the sclerosant of choice due to its good effectiveness and its low side-effect potential. Sclerotherapy with 3% Polidocanol sclerotherapy is approved in Germany for the treatment of hemorrhoidal disease in stages I and II. In Germany, sclerotherapy is the therapy of choice and the most frequently used treatment method for first-degree hemorrhoidal disease. It can also be treated with anti-platelet therapy such as B. clopidogrel and anticoagulant therapy (blood thinners).

In the case of higher-grade hemorrhoidal diseases, rubber band ligation or surgical methods are usually preferred. Foam sclerotherapy could prove to be another option in the future for higher-grade stages as well. Local infiltration with local anesthetics (such as polidocanol) can be used to prevent pain after rubber band ligation.

Risks

Leg varices

When performed properly, sclerotherapy is an efficient form of therapy with few complications. Common side effects (frequency ≥ 1% and <10%) with sclerotherapy for varicose veins include a slight burning sensation during or shortly after the injection, when the sclerosant reacts with the inner vein wall as desired. As with other treatment methods, bruises or blood clots in the treated vein, small skin bleeding and temporary skin discoloration in the course of the treated veins can occur. With so-called matting, the finest new spider veins arise after treatment of a larger varicose vein or spider veins in the treatment area. The therapy may have been surgery, thermal methods, or sclerotherapy. Matting is therefore a cosmetic complication of varicose vein therapy . Temporary visual disturbances and migraines occur very rarely, with foam sclerotherapy occasionally (frequency ≥ 0.1% to <1%). Nerve injuries, small local tissue damage and superficial phlebitis can occur rarely to very rarely (frequency ≥ 0.01% to <0.1% or <0.01%). Deep vein thromboses occur rarely with sclerotherapy with liquid sclerosant (frequency ≥ 0.01% to <0.1%) and with foam sclerotherapy <1%.

Serious complications such as allergic shock have been reported in isolated cases .

In order to minimize risks, adequate diagnostics by a vein specialist or phlebologist as well as an optimal injection technique are essential. Larger varices should only be treated under ultrasound guidance. B. the risk of side effects can be significantly minimized by the ultrasound control.

Hemorrhoid disease

Sclerotherapy for hemorrhoids is also a method with few side effects and is usually not painful. However, transient burning sensations, pain, discomfort, or a feeling of pressure have been reported during and shortly after the injection. Occasionally, allergic reactions such as skin rash ( urticaria ) can occur. Small blood clots that are temporary and harmless may rarely form in the hemorrhoids being treated. Bleeding after the treatment is also rare, induration in the area of ​​the injection occasionally occurs, as well as inflammation in the area of ​​the rectum. Small tissue damage in the area of ​​the injection point (rarely with expansion into the surrounding tissue) rarely occurs with professional treatment.

literature

  • Klaus Huebner, Franz Xaver Breu: Practical sclerotherapy: Instructions for sclerotherapy treatment of varicose veins and other indications. Viavital, 2012. ISBN 9783934371491 .
  • Jochen Staubesand, Erwin Schöpf (Ed.): Newer aspects of sclerotherapy: varices, esophageal varices, varicoceles, organ cysts. Springer-Verlag, 2013. ISBN 9783642757563 .

Individual evidence

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  23. ↑ Schadeck M: Sclerotherapy of varices - A story with a future In: Phlebologie 46 ("), 2017, pp. 55–59.
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