Treating venous reflux with medical grade adhesives.
Venaseal Procedure with The VenaSeal System by Medtronic is an adhesive based treatment for chronic vein disease in the thighs and lower legs. Specifically, this minimally invasive surgical procedure is approved by the Food and Drug Administration (FDA) to permanently eliminate varicose veins and venous reflux. Since venous reflux is the direct cause of the physical symptoms associated with long-term vein disease resolving it successfully is especially important.
As mentioned, the VenaSeal procedure uses surgical adhesive to shut down veins that aren’t working properly. This adhesive is a cyanoacrylate, meaning that it’s in the same class as what is commonly known as “Super Glue.” It permanently bonds to the walls of the vein and can’t travel elsewhere in your circulatory system. It’s also completely inert and won’t trigger allergic reactions or any type of immune response. It’s entirely safe, and in fact is commonly used in some types of brain surgery.
Venaseal Procedure less invasive than EVLT
Venaseal is even less invasive than its minimally invasive counterparts, Radiofrequency (RF) ablation and Endovenous Laser Therapy (EVLT). While Venaseal is a newer technology it’s expected to eventually eclipse both of the above treatments.
The primary advantages of VenaSeal stem from its extremely noninvasive nature. Among others, these include very little pain or discomfort and very brief recovery times.
How the VenaSeal System works.
This procedure treats the symptoms of chronic vein disease, which is technically named Chronic Venous Insufficiency (CVI). In plain language it eliminates CVI by sealing shut veins which aren’t working properly. While this may sound ominous the blood is automatically rerouted to healthier veins. This treatment doesn’t interfere with blood flow in the least and almost always improves overall circulation.
VenaSeal works best on the larger veins of the thighs and lower leg. In the majority of cases this will be the Greater Saphenous Vein (GSV) or the Small Saphenous Vein (SSV). Since the saphenous veins connect to practically all other veins in the legs treating one or both can eliminate nearly all the symptoms of CVI.
Damaged Valves in Veins Symptoms
Every larger vein in the body has a series of one-way valves which ensure that blood flows in the right direction, towards the heart. When these valves become damaged, weakened, or stretched out this results in backflow. This is the ultimate cause of all Chronic Venous Insufficiency and thus the cause of all the symptoms associated with leg vein disease. These include but are not limited to:
- Pain and discomfort
- Tired and achy legs
- Excessive swelling
- Varicose veins
- Spider veins
- Skin changes such as discoloration or scaly patches
- Restless Leg Syndrome (RLS)
- Bleeding from surface veins
- ankle ulcers, which can occur in severe, untreated vein disease
The VenaSeal Closure System can entirely eliminate or greatly relieve these symptoms by effectively treating venous reflux. Note that this stops the progression of vein disease as well.
Undergoing the Venaseal Procedure
Almost all vein disease is diagnosed by an ultrasound exam. Doppler ultrasound can directly measure venous reflux, making it the ideal tool for the job. Unlike X-Rays there’s no radiation involved so the process is entirely safe. Your surgeon will then review the results of the exam to determine whether or not you’re a good candidate for the VenaSeal procedure.
You won’t need to take any medications to prepare for VenaSeal. Only very small amounts of local anesthetic, usually lidocaine, are needed for pain control. To begin the procedure several tiny incisions are made which allow access the vein. These incisions are about 1/8 of an inch long, small enough so that stitches aren’t necessary.
Completing the treatment is simple. The surgeon inserts a small catheter to deposit medical grade adhesive at strategic points in the vein, sealing it shut. The blood begins to flow through nearby healthy veins which instantly eliminates venous reflux.
The VenaSeal System Advantages
Two other closure techniques are currently in use today yet VenaSeal is by far the least invasive. Only a small amount of local anesthetic is needed at the incision sites. This means very few needle sticks are involved which increases comfort and reduces the risk of infection. Bruising is almost nonexistent.
Since VenaSeal doesn’t rely of heat there’s no risk of thermal injury (burns). There’s also virtually no chance of causing nerve damage, which can occur very rarely with comparable heat-based treatments.
In the majority of cases patients can return to their normal activities immediately, including exercise. It’s also not necessary to wear compression stocking. In contrast, older techniques typically limit activities for up to two weeks and compression garments are mandatory during this period.
The VenaSeal System is exceptionally safe and effective. Even the least invasive procedures, however, carry some small level or risk.
Minor allergic reactions to the surgical adhesive can occur in extremely rare cases. These are almost always minor and resolve quickly. Very minor surface bruising can also occur. Finally, any time the skin is broken there’s the potential for infection.
In even rarer cases blood clots can form in the veins being treated. Should they break loose from the vein wall they can travel through the circulatory system, occasionally becoming lodged in the lungs. This is known as a pulmonary embolism which can be life threatening in some cases.
Before undergoing any type of surgery the risks must be weighed against the benefits. This being said, VenaSeal has an almost 100% success rate and has very, very few risks associated with it.
The VenaSeal Procedure
The VenaSeal closure system is used to treat chronic venous insufficiency (CVI). Also called symptomatic venous reflux disease, CVI in the lower extremity superficial venous system is often the underlying cause of painful varicose veins. The VenaSeal procedure uses a cyanoacrylate adhesive (CA) to close the vein. CA eliminates the need for tumescent anesthesia and post treatment compression stockings. There is no risk of thermal injury and patients can return to normal activities more rapidly.
VenaSeal is less invasive which means less pain and shorter recovery times.
Unsightly varicose veins (VV) have been documented in patients as young as 18 years of age. Women are at a higher risk of developing VVs than men. In both genders, however, the total risk increases with age. Ultimately more than half of all American adults will experience VVs at some point in their lives.
Dr. Allen Hamdan, Chairman of Surgery at Beth Israel Deaconess Medical Center, has the following to say: “In healthy patients the heart pumps blood throughout the body via the arterial system. The blood is then returned to the heart via the venous system. Healthy veins have valves which only allow blood to flow in a single direction, back towards the heart. In individuals with venous reflux, these one-way valves aren’t working properly and blood flows back down the legs. This pooled blood causes a variety of physical symptoms such as pain, heaviness, fatigue, and visible varicose veins.”
Common symptoms associated with disease of the superficial leg veins include:
- Discomfort, ranging from a minor ache to moderately intense pain
- Heaviness, which increases when standing for long periods
- Restless Leg Syndrome (RLS)
- Changes in skin color
- In advanced cases venous stasis ulcers can form on the insides of the ankles.
Clinical Studies on VenaSeal System Results
The VenaSeal procedure was studied in 2011, 2012 and 2013. The results show VenaSeal to be safe and effective, with consistent results.
- A high rate of closure was found in the studies. Studies were conducted after the procedure at different intervals (from 2 days to 3 years). After six (6) months, the closure rate varied from 92.9% to 98.9%
- VenaSeal has an acceptable safety profile. Documented side effects are minor and infrequent.
- Using the VenaSeal system eliminates the need for post procedure compression stockings.
- Tumescent anesthesia is not required for the VenaSeal system.
- The VenaSeal system does away with the risk of thermal injury.
- Patients who undergo the The VenaSeal procedure are able to return to normal activities quickly.
- VenaSeal is the only non-thermal, non-sclerosant, non-tumescent system approved for the treatment of chronic venous insufficiency in the United States.
Chronic Venous Insufficiency (CVI) or Symptomatic Venous Reflux Disease can lead to painful and irritating symptoms. There are several drawbacks to the traditional treatment methods of stripping and thermal therapies which can be avoided when using the VenaSeal system.
Two other minimally invasive technologies are currently being used to treat Chronic Venous Insufficiency (CVI). Both are safe, effective, and yield results which are indistinguishable to those of VenaSeal. They are, however, slightly more invasive and cause more downtime. Also note that compression stockings must be worn for approximately 2 weeks following these procedures.
- Endovenous Laser Treatment (EVLT). This procedure uses highly focused laser energy to produce heat which damages the walls of the vein being treated. This permanently seals the vein..
- Endovenous Radiofrequency (RF) Ablation. This procedure is almost identical to EVLT. The only real difference is that Radiofrequency (RF) energy is used to produce the results.
Q: Are there any other any other requirements which must be met?
A: Yes, but there’s a good chance you’ve already met them. Most insurance companies will ask about conservative treatments, which include:
The use of over the counter (OTC) pain relievers such as Motrin (ibuprofen), Aleve (naproxen sodium), and aspirin.
- Elevating the legs. If you’ve sat in a recliner chair or propped your legs up in any way then you’ve met this requirement.
- Wearing compression stockings. The majority of patients who seek professional treatment have tried compression hose at some point. If you haven’t, simply wear stockings for a few months before scheduling your procedure.
- Modify your activities. Again, if you experience symptoms severe enough to seek treatment you’ve most likely had to curtail your physical activities somewhat. This can be as simple as having to take a 90 second rest after standing for long periods.
Q: What if my insurance claim is denied?
A: any time benefits are denied you’ll receive a written explanation known as an Explanation of Benefits (EOB). This will state the reason your claim was rejected. A good example is failing to try conservative treatments first, i.e. not wearing compression hose. The solution is usually simple. Wear prescription stockings for the required period of time, then schedule an appointment for re-evaluation.
Vascular surgery: full-length cyanoacrylate procedures vs. combined cyanoacrylate-sclerotherapy procedures in the treatment of venous reflux.
During the last 5 years there’s been a surge of interest in cyanoacrylate “vein glue” for incompetent leg veins. One of the main advantages of using vein glue is the almost complete lack of downtime. What’s more, patients aren’t required to wear compression stockings post-procedure. From a patient’s standpoint, this alone is often enough to justify a vein glue procedure such as VenaSeal.
Overall the cyanoacrylate procedure has proven itself to be highly effective and extremely safe. In fact, it can credibly be claimed that these procedures carry almost no risk whatsoever. Yet while this may be true the technique does have its limitations and isn’t appropriate in all cases.
It’s possible to employ vein glue in two distinct fashions. The first is full-length application. Much as it sounds, this involves applying cyanoacrylate to the entire length of the treated vein. When used correctly this method is virtually 100% effective. It does, however, require large amounts of the expensive adhesive. Alternately it’s possible to use a segmental approach. This entails applying vein glue to strategically selected points along the length of the vein. This is still effective in the majority of cases and is much less expensive.
Researchers at the American Society for Venous and Lymphatic Disorders have proposed a third approach. This combines the ease and minimally invasive nature of segmental vein glue procedures with segmental sclerotherapy. As detailed below, this gives results which are comparable with full-length cyanoacrylate application.
Venaseal Procedure Study Methods:
The study cohort consisted of 24 patients, 17 women and 7 men, who underwent the combined procedure described above. Said patients presented with Chronic Venous Insufficiency (CVI) of the Great Saphenous Vein (GSV). Vein diameters ranged from 8-24 mm with a mean of 9.4 mm. A double-access access catheter was used to apply both cyanoacrylate and an air-sclerant foam, in this case aethoxysklerol. Various branch veins and perforators were treated via application of cyanoacrylate at junctional areas. No manual compression therapy was delivered during the procedure. After the procedure sterile non-compressive dressings were applied at the access site. Additionally, no compression therapy (compression stockings) were used post-operatively.
Venaseal Procedure Study Results:
The treated vein was immediately occluded in all 24 patients resulting in the elimination of venous reflux. The amount of cyanoacrylate adhesive used per vein was 10.5-33.7 mg with a mean of 16.1 mg. When averaged, this amounts to approximately 2.9 mg / cm. In comparable full-length procedures the amount of cyanoacrylate used was 24.7-67.0 mg with a mean of 39.9 mg. When averaged, this amounts to approximately 6.0 mg / cm. This means that, on average, 3.1 mg / cm less cyanoacrylate was used in the combined approach.
Venaseal Procedure Conclusions:
While the study suffered from small sample size it can be seen that the segmental approach achieved complete vein occlusion in all patients. In both the full-length and segmental approach no anesthesia was required beyond that needed at the access site. No compression therapy was required at any point in the procedure. Most notably, 3.1 mg / cm less cyanoacrylate was needed to complete the segmental approach. This represents a greater than 50% reduction when compared to the full-length method.
The American Society for Venous and Lymphatic Disorders recognizes the need for larger cohort studies. It is further recommended that trials of the above combined approach using non-acrylate adhesive be undertaken.
Case study: The VenaSeal cyanoacrylate procedure performed on an incompetent Great Saphenous Vein (GSV) of diameter 28.4 mm.
As recently as 20 years ago the primary method used to treat incompetence of the GSV was high-ligation and stripping. Fortunately, the past 8 years have seen the rise of minimally invasive thermo-ablative techniques. Specifically, this refers to Radiofrequency (RF) ablation and Endovenous Laser Therapy (EVLT). Collectively these two approaches have proven effective in the treatment of large diameter veins (>20 mm).
In recent years the use of cyanoacrylate adhesives in the treatment of incompetent leg veins has become increasingly popular. While this approach is gaining widespread approval some vascular surgeons remain critical of the procedure. In particular, skepticism remains as to the use of cyanoacrylate in the treatment of large diameter veins.
Prior studies have demonstrated the usefulness of cyanoacrylate vein glue in the treatment of incompetent GSVs. None of these studies, however, have investigated the use of cyanoacrylate in veins greater than 20 mm in diameter. This case study presents the successful treatment of one such vein with a diameter of 28.4 mm. This is notable in that the average diameter of veins treated in studies examining any of the above methods is 10.1mm.
The VenaSeal™ closure system is minimally invasive and catheter-based. As such, it may involve the following risks. Your doctor can help you understand these risks.
•Allergic reaction to the VenaSeal™ adhesive
•Arteriovenous fistula (i.e., an abnormal connection between an artery and a vein)
•Bleeding from the access site
•Deep vein thrombosis (i.e., blood clot in the deep vein system)
•Edema (i.e., swelling) in the treated leg
•Hematoma (i.e., the collection of blood outside of a vessel)
•Hyperpigmentation (i.e., darkening of the skin)
•Infection at the access site
•Neurological deficits including stroke and death
•Non-specific mild inflammation of the cutaneous and subcutaneous tissue
•Paresthesia (i.e., a feeling of tingling, pricking, numbness or burning)
•Phlebitis (i.e., inflammation of a vein)
•Pulmonary embolism (i.e., blockage of an artery in the lungs)
•Urticaria (i.e., hives) or ulceration may occur at the site of injection
•Vascular rupture and perforation