What does that mean for my veins?
Since the FDA approval of a commercially-prepared formulation of polidocanol foam (PEM – polidocanol endovenous microfoam), PEM has been commonly used to treat varicose veins of the legs. The doctors who authored this research publication studied their results with PEM treatment of varicose veins, after FDA approval, since “real world” results are sometimes different than the results reported from the original research trials. Also, the initial research results that resulted in FDA approval of PEM did not include some of the standard metrics that are commonly used to assess the results of varicose vein treatment, so these measures were included in this research study.
PEM is a combination of polidocanol liquid that is dispensed as a foamed mixture with carbon dioxide and oxygen gas. The PEM “dispenser” and its end product resemble shaving cream (although a lot more expensive!). The way the foam works is that the polidocanol chemical irritates the inside lining of the varicose veins, causing them to constrict and eventually close down. The polidocanol active ingredient is the “outside” of the foam bubbles. The foam mechanically pushes the blood out of the vein, so that the varicose vein is now filled with polidocanol foam which stays in contact for several minutes, thereby damaging and closing the varicose vein. The polidocanol is metabolized by the body and the gas is dissolved and does not cause gas bubbles in the blood. A significant advantage of PEM is that no, or very little, local anesthesia injections are necessary.
Before the availability of this commercially-prepared formulation of PEM, physicians often compounded (mixed) their own formulation of polidocanol foam using FDA-approved polidocanol liquid with various gases which might include either room air, or preferably, medical grade carbon dioxide gas. The use of room air as the mixing gas is thought to be less desirable, and perhaps less safe, since room air contains high concentrations of nitrogen gas which is not soluble in water or blood, and therefore can result in prolonged circulation of small nitrogen gas bubbles in the blood stream. (In our practice at Carolina Vein Care, when we must use physician-compounded polidocanol foam, such as when insurance does not cover the use of the commercially-prepared PEM, we always use carbon dioxide gas to prepare the foam, and not room air, for the above reasons).
The investigators found that the PEM was very effective in treating varicose veins. The treated patients not only had significant improvement in leg symptoms such as pain and swelling, but also showed over 90% success in keeping the treated veins closed when assessed by ultrasound of the veins at 3 and 6 months. Their published results support the continued use of PEM as a mainstay of varicose vein treatment.
At Carolina Vein Care & Aesthetics, Dr. Park and I have extensive experience with PEM and I agree that the results are excellent. Even though PEM is FDA-approved, most but not all insurance companies provide coverage for its use. In situations where insurance coverage is not available, we also have had excellent results using physician compounded polidocanol foam, and have found it to be very safe when prepared with carbon dioxide gas.
If polidocanol endovenous microfoam (PEM) sounds like a treatment option for your varicose veins, please contact us for an appointment!
Mark R. Jackson, M.D.
Board Certified Vascular Surgeon
* Original article “Results of polidocanol endogenous microfoam in clinical practice” published in January 2021 by authors Pamela S. Kim, MD, Steve Elias, MD, Nicos Labropoulos, PhD.
Original citation: Journal of Vascular Surgery: Venous and Lymphatic Disorders. Volume 9, Issue 1, January 2021, Pages 122-127