VenaSeal Closure is one of the latest advancements for treating varicose veins. This device, which gained FDA approval in 2015, uses an advanced medical adhesive (cyanoacrylate) to close the greater or lesser saphenous vein. Essentially, the end result of this is exactly the same as radiofrequency ablation or laser ablation.
The main difference with the VenaSeal procedure is that it does not require the use of tumescent anesthesia in order to perform the procedure. In radiofrequency ablation and laser ablation, heat is generated, and therefore without anesthesia, these procedures would be painful. Therefore, during laser and radiofrequency ablation treatments, the physician has to inject a weak local anesthesia around the entire length of the treated vein. This part of the procedure involves several needle injections, and some pressure.
On the other hand, the VenaSeal procedure uses a medical adhesive to seal the vein shut. Unlike radiofrequency ablation or laser ablation, the injection of the adhesive does not hurt, and therefore does not require tumescent anesthesia for the treatment. This shortens the treatment time, and decreases the pain of the procedure.
VenaSeal is an excellent option for patients who are fearful of needles and injections. It is also important that the patient’s insurance carrier approves VenaSeal. So far, most insurance companies have accepted this as a valid alternative for vein closure, but some still are hesitant to pay the higher price tag for this newer technology.
Candidates for VenaSeal are no different than candidates who will receive any other form of a vein closure procedure. They need an ultrasound to determine that they indeed have venous insufficiency.
The recovery from the VenaSeal procedure is similar to radiofrequency ablation or laser ablation, with nearly all patients returning immediately to their normal activities, and to strenuous activities within several days.
Risks and Side Effects
VenaSeal can have the same risks as radiofrequency ablation or laser ablation. These include bleeding, bruising, DVT, vein injury, or rupture, hyperpigmentation, or failure of the vein to seal.
However, VenaSeal poses about a 5% risk of allergic reactions to cyanoacrylates, such as hives, asthma, hay fever and anaphylactic shock. These are typically treated with agents such as Benadryl or oral steroids, and are typically not severe. Patients with known allergies to cyanoacrylates should not have this procedure.
Furthermore, unlike with RFA or laser ablation, VenaSeal has the potential for embolization (a piece of the glue breaking off and migrating into the venous system), although this is extremely rare. The glue can also causes problems at the injection site, although this is also quite rare.
The VenaSeal procedure received FDA approval in February of 2015. Several studies have been done in order to validate its efficacy, and at this point most of the studies were designed to show non-inferiority (not necessarily superiority) compared to the traditional treatments. At this point, the data does show that this procedure is at least equivalent in terms of safety and efficacy, to the traditional treatments of RFA or laser ablation