Advanced Non-Thermal, Non-Tumescent (NTNT) Solutions
Varithena & VenaSeal™
Non-Thermal, Non-Tumescent (NTNT) Treatments
Non-thermal, non-tumescent (NTNT) modalities are newer procedures that do not require the use of tumescent anesthesia. Current NTNT techniques include chemical ablation (Varithena), mechanico-chemical ablation (ClariVein), and cyanoacrylate adhesives (VenaSeal).
Varithena & VenaSeal at a Glance
- Varithena: "The only FDA approved foam sclerosant," injected into the vein "causing it to collapse and seal itself shut." Approved by the FDA in 2013.
- VenaSeal: Uses cyanoacrylate, "a strong, fast-acting medical adhesive," to permanently treat varicose veins. The FDA approved the VenaSeal Closure System in February 2015.
- Compression: Because compression "is not required post-procedure" with VenaSeal, it "is an attractive option for patients who cannot tolerate compression stockings."
- Recovery: VenaSeal closures "produce minimal-to-no pain or bruising."
Varithena™
Chemical AblationVarithena is the only FDA approved foam sclerosant. It is a form of sclerotherapy, in which a medicine is injected into the vein causing it to collapse and seal itself shut. The body will then reabsorb the vein into local tissue, in effect making the problematic vein disappear, shunting the blood into the healthy collateral veins.
Foam sclerotherapy has been used widely in the Phlebology community in the past dozen years. The "Tessari method," the practice of adding a gas to a liquid to create bubbles, has been the most common technique for producing foam for use in sclerotherapy. This technique involves manually mixing a small volume of liquid sclerosant with a volume of room air or other gas using two syringes and a three-way tap, or stopcock. Preparations created this way are referred to as "physician-compounded foam," and they are illegal.
While physician-compounded, non-proprietary foam is inexpensive to make, medical experts caution that there are risks: there have been a number of published cases of air emboli (small bubbles of gas in the bloodstream) from so-called "homemade foam" leading to neurological events in patients, including migraines, vision changes, strokes, and death. No physician-compounded foam has been approved by the U.S. Food and Drug Administration.
The Varithena Difference
Varithena is a proprietary foam preparation that was approved by the FDA in 2013 after rigorous safety testing on thousands of people. It is a chemical foam solution indicated to close the Great Saphenous Vein (GSV) and related tributaries. It is a proprietary mixture of 1% polidocanol, 65% oxygen, 35% carbon dioxide, and less than .8% of nitrogen.
When a physician creates their own foam, they use room air, which can contain as much as 78% nitrogen. While oxygen and carbon dioxide are rapidly absorbed into the blood stream, nitrogen is very slowly absorbed and those bubbles can persist and possibly cause a gas embolism and obstruct an important blood vessel. Varithena, in comparison, has extremely low nitrogen.
Varithena's primary safety feature is the consistency of its bubbles: each one is between 100-500 microns, with uniform density and stability—a standardized compound that is much more predictable for vein doctors to use on their patients, compared with physician-compounded foam, which isn't subject to any manufacturing standards. There have been no strokes or air embolisms associated with Varithena treatment.
VenaSeal™ Closure System
Medical AdhesiveCyanoacrylate is a strong, fast-acting medical adhesive, which has been used in the treatment of blood vessel abnormalities for more than a decade. In February 2015, the FDA approved the VenaSeal Closure System, which uses a medical adhesive to permanently treat varicose veins in the legs.
The VenaSeal system is made up of an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips, and syringes.
During the procedure, the physician fills a syringe with the medical adhesive, and then inserts it into a dispensing gun attached to an application catheter. Using ultrasound imaging, the doctor inserts the catheter through the skin into the diseased vein to allow injection of the VenaSeal agent, a clear liquid that polymerizes into solid material.
The Procedure & Recovery
The catheter is placed in specific areas along the diseased vein and the physician conducts a series of trigger pulls to deliver the medical adhesive, thus sealing the incompetent venous valve and eliminating reflux. Compression is applied to the leg during the procedure, according to the indication for use by the FDA, but since it is not required post-procedure, VenaSeal is an attractive option for patients who cannot tolerate compression stockings. VenaSeal closures are performed in a minimally invasive outpatient procedure and produce minimal-to-no pain or bruising.
Learn About Your Options
If you are experiencing leg discomfort or ulcers, or if you are interested in stopping the progression of varicose veins, the Vein Healthcare Center provides services for patients in Maine, New England, and surrounding communities. Dr. Cindy Asbjornsen is a certified phlebologist who provides complete medical care for your symptoms using the very best of today's treatment options.
Visit the American College of Phlebology to understand more about venous disease, its symptoms, and its treatment.