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The impending discontinuation of Sotradecol (sodium tetradecyl sulfate solution) by the FDA will reduce the options available to patients suffering from weakened veins with faulty valves that have become abnormally enlarged, painful or cosmetically unsightly.
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Sodium tetradecyl sulfate solution is a sterile anionic surfactant solution that acts as a sclerosing agent to stimulate intimal inflammation and thrombus formation. While not a permanent solution for varicose veins it is effective at diminishing smaller varicose veins and most spider veins.
Varicose veins are essentially just bulging veins that have become incompetent. The way sclerotherapy works is by injecting a solution into the veins. The solution irritates the lining of the blood vessel and causes it to collapse.
Some patients express feeling some discomfort or stinging sensations when a hypertonic saline solution is used. Patients may also experience cramping during the process, and that cramping can be uncomfortable for patients.
Another drawback to the hypertonic saline solution is that it can cause some short-term or even lasting staining in the legs where the collapsed veins are. Obviously, for patients who are seeking treatment for varicose veins due to aesthetic issues, staining is an issue that causes concern for them.
Hypertonic saline use to be the the most widely used solution for spider veins. It is simply a saline (salt) concentrate solution which irritates the tiny veins and subsequently closes them. Hypertonic saline is used widely and is very effective. It is also very inexpensive which means that physicians who use it may be able to charge a little less for their services. Furthermore, allergic reactions do not occur with this solution.
However, there are disadvantages to hypertonic saline. The most important disadvantage is that it is very painful. In order to be effective, the physician must inject the hypertonic saline directly in the vein where it often causes an intense burning sensation. To help ease the pain, physicians sometimes mix lidocaine in the solution or give their patients valium or a pain reliever, but this rarely makes the burning go away entirely. Furthermore, there are risks. If the physician misses the vein, the saline can cause severe pain and even ulceration at the injection site.
The remaining two sclerotherapy solutions are sodium tetradecyl sulfate (trade name Sotradecol) and polidocanol (trade name Asclera or Aethoxysklerol). They are very similar to one another. Both are popular, but are expensive, so physicians using these solutions usually have to charge a bit more. But the additional cost provides a more comfortable experience.
Both Sotradecol and Asclera / Aethoxysklerol are detergent-like solutions that work by interfering with the cells of the inner lining of the vein. After injection of these solutions, the vein wall essentially seals shut and closes. The solutions can also work by causing clotting of the tiny spider veins leaving them to eventually disappear as blood reroutes to other healthy veins.
Sclerotherapy involves using a needle to put a solution into the vein. The sclerotherapy solution causes the vein to scar. The scarring forces blood through healthier veins. The collapsed vein then fades.
After sclerotherapy, treated veins tend to fade within a few weeks, although they might not disappear completely. It can take a month or more for full results. Some veins need more than one sclerotherapy treatment.
Deep vein thrombosis carries a risk of a blood clot traveling from the leg to the lungs and blocking a vital artery. This is known as a pulmonary embolism. It's a very rare complication of sclerotherapy that needs immediate medical care. The symptoms include trouble breathing, chest pain or dizziness, or coughing up blood.
Before sclerotherapy, a health care provider might ask for an ultrasound test of the legs. This is likely if the veins are causing symptoms. Ultrasound is a painless procedure that uses sound waves to create pictures of structures inside the body.
Some people feel minor stinging or cramping when the needle goes into the vein. Tell your provider if it hurts a lot. Pain might result from the solution leaking from the vein into the tissue around it.
After removing the needle, your provider applies pressure to the area and massages it to keep blood out of the vein and to spread the solution. The provider might tape a pad onto the injection site to keep pressure on the area before moving on to the next vein.
Results of sclerotherapy for small varicose veins or spider veins usually show in 3 to 6 weeks. Larger veins might take 3 to 4 months. However, you might need more than one treatment to get the results you want.
Your health care provider might ask you to return for a follow-up visit about a month after the procedure to see the results. You might need more sessions. Generally, you need to wait about six weeks before having another sclerotherapy session.
Injection sclerotherapy is a technique or group of techniques for destruction of abnormal veins by injection of a medication that in some manner destroys the vein endothelium, leading to occlusion and subsequent fibrosis of the target vessel. The first attempts at sclerotherapy were reported in the 1680s,1 before the invention of the modern piston syringe. Modern sclerotherapy began in the first part of the 20th century with the techniques of Linser, Sicard, and others.2,3 Sclerotherapy was introduced to the United States in 1939 by McCausland, who reported an astounding series of 10,000 patients.4
Since the invention of synthetic sclerosants and the development of postsclerotherapy compression therapies in the 1940s and 1950s, injection sclerotherapy has assumed a major role in the treatment of venous insufficiency, particularly in the treatment of smaller veins such as telangiectasias and spider veins.
Ultrasound-guided injection sclerotherapy. (A) Patient with refluxing short saphenous vein (SSV). Attempted radiofrequency ablation of the vein was unsuccessful because the vessel was too tortuous for catheterization. (B) Transverse ultrasound image of the SSV caudal to the saphenopopliteal junction before injection sclerotherapy. (C) Doppler tracing shows prolonged reflux after augmentation. (D) Longitudinal ultrasound image of the SSV shows a 20G Angiocath (*) inserted under real-time ultrasound guidance. Approximately 3 mL of microfoam created from 3% sodium tetradecyl sulfate 1:5 with room air was injected under real-time sonographic monitoring. When the column of microfoam approached the saphenopopliteal junction, this point of potential communication was compressed for 5 minutes to prevent the spilling of microfoam into the popliteal vein. (E) Transverse image of the SSV at about the same level as (B) showing echogenic microfoam filling the vessel lumen. (F) In a different patient, longitudinal image of residual great saphenous vein lumen after attempted endovenous ablation. Reflux was still present by color flow. (G) Note echogenic microfoam filling lumen after injection of microfoam prepared from 3% sodium tetradecyl sulfate.
Overspill of sclerosant into the deep system can cause DVT if the concentration of sclerosant is high enough to damage the endothelium of the deep veins. This is of particular concern when treating vessels in the knee and thigh, where the deep vessels in question (femoral and popliteal veins) are unpaired and thus without available collaterals. More central complications of nontarget sclerotherapy are rare. Nonetheless, there have been a few reports of patients experiencing transient scotomata15 after being treated with sclerosing foam. The etiology of this experience is unclear, but it may be due to small amounts of foam crossing a clinically silent atrial septal defect. The author has seen this occur in one patient, who had complete resolution of symptoms within a few minutes.
Hypertonic saline 23.4% concentration is approved by the US Food and Drug Administration (FDA), but its use in sclerotherapy is off label. The principal advantage of this agent is the fact that it is a naturally occurring bodily material with no molecular toxicity. It is not widely accepted as a sclerosing agent because it can cause pain, burning, and leg cramps upon injections; if extravasated, it likely causes significant tissue necrosis; it is highly likely to produce marked postsclerotherapy hemosiderin staining, which is cosmetically unacceptable; and it is difficult to achieve adequate sclerosis of large vessels without exceeding a tolerable salt load. Suggested hypertonic saline concentrations are 23.4% for reticular veins (2-4 mm) and venulectasias (1-2 mm) and 11.7% (half strength) for telangiectasias (
Sodium tetradecyl sulfate, a synthetic surfactant (soap), is an FDA-approved sclerosant. It is commercially available in 1% or 3% standard concentrations. This sclerosant is reliable, safe, and effective. The main clinical concerns stem out of its tendency to cause postsclerotherapy hyperpigmentation in up to 30% of patients, a high likelihood of tissue necrosis upon extravasation (especially when injected in high concentrations), and occasional cases of anaphylaxis. Suggested sclerosant concentrations are 0.25-0.4% for reticular veins (2-4 mm) and venulectasias (1-2 mm) and 0.1-0.2% for telangiectasias (
Although 72% chromated glycerin (Scleremo) is very popular in Europe, it has not yet been FDA-approved for sclerotherapy in the United States. Compared with other sclerosants, it is very weak and is essentially useful for the treatment of small vessels. The main advantages of glycerin are that it rarely causes posttreatment hyperpigmentation, telangiectatic matting, or tissue necrosis if extravasated. On the other hand, it is very viscous, causes pain upon injection (for that reason, it is often compounded with lidocaine to decrease pain), is highly allergenic, and could lead to ureteral colic and hematuria. For spider veins and reticular veins, glycerin seems to be more effective than polidocanol, with fewer adverse effects but more pain.  041b061a72