Lessons Learned at the Venaseal Varicose Vein Training Program

Posted by on May 20, 2017

Varicose Vein Glue vs. Traditional Treatment for Varicose Veins

This article’s target audience is meant for both the vein doctor and the varicose vein patient audience.

I believe it will benefit both.

Medical jargon is explained simply so everyone can easily understand.

Recently, I attended the Advanced Chronic Venous Summit in Minneapolis sponsored by Medtronic, the manufacturer of the Venaseal Closure System.

This was a tremendous introduction to learn a new vein closing technique before treating patients. Included in the Medtronics program were didactic lectures by four acclaimed vascular surgeons who were well versed in the Venaseal system.

Thirty-three vein specialists from around the country shared a unique learning experience which included hands-on experience.

This VenaSeal physician training program also incorporated plastic model training of the system before the actual hands-on experience commenced.

My Take on Venaseal Closure Compared to Radiofrequency Closure and Laser Ablation

Although the Venaseal procedure is not difficult for a practicing vascular surgeon, it is also not intuitive.

It is not faster than the ablation procedures of the saphenous veins done with laser or radiofrequency.

The adhesive is drawn up into a syringe which is screwed into a gun-like device. The trigger needs to be squeezed repeatedly to prime the tubing.

The tubing is introduced into the saphenous vein.

The tip of the tubing is placed under ultrasound guidance five centimeters from the sapheno-femoral junction.

The back table must be set up. The wet side of the table must be separated from the dry side.

If the adhesive accidentally touches water, it will set, harden and become unusable.

The entire kit must be discarded.

If the plastic tubing is kinked, it also becomes unusable.

That’s a fifteen-hundred-dollar kit that must be discarded without being used!

The packet comes with 5 cc of adhesive or glue. The average vein requires about 1.2 cc of glue.

Therefore, one package set could close three saphenous veins or 100 cm total vein length.

Normally, that could close two great saphenous veins and one small saphenous vein – if necessary.

Wires must be advanced into the proper position under ultrasound guidance. Sterile blue towels would be helpful to prevent these long wires from springing out and result in them being contaminated.

Cost of Venaseal

At this time, there is no insurance code to bill for this procedure.

insurance for varicose veins in PittsburghMedtronics representatives told me that they expect an insurance code to be available early in 2018.

Medtronics charges the vein doctor $1500 in the U.S. for the entire disposable kit. The kit includes 5 ccs of cyanoacrylate adhesive or glue. It expires in two years.

Medtronics will only allow doctors to purchase a minimum of five kits for a total minimum investment cost of $7,500.

Physicians can’t just buy one kit to try it out.

In Australia, Medtronics charges doctors only $500 for the same kit.

It is recommended that doctors charge the same for the procedure as what is currently reimbursed by insurance companies for an equivalent procedure plus the $1500 cost of the Venaseal system.

That charge is at the doctor’s discretion since insurance companies do not reimburse for this FDA approved procedure at this time.

Current charges average between $3,000 to $3,500 per saphenous vein treated.

It’s not uncommon to require treatment for more than one saphenous vein.

How Is Glue for Varicose Veins Performed?

The glue is applied inside of the saphenous vein a drop at a time.  Every three centimeters along its length the adhesive is compressed with the doctor or their assistant’s hands and ultrasound probe.

The probe compression prevents accidental extrusion of the adhesive proximally into the deep venous system. Compression is initially held for three minutes. Thereafter, each drop is compressed for thirty seconds until the adhesive solidifies.

It hardens almost immediately.

Once set, it is permanent.

Therefore, Venaseal adhesive is an implantable device for all intents and purposes.

Infection of the adhesive is possible.

Removal of an infected or chronically inflamed vein (which is occluded) with adhesive would require either long skin incisions or an external stripping device.

Those external stripping devices are about fifteen inches long rods with a metallic ring at the end.  Good luck trying to remove an occluded saphenous vein with glue inside.

Experts with this technique recommend not using Venaseal on patients who are sensitive to adhesives, steri-strips or bandages. In about twenty per cent of patients, an inflammatory reaction can be seen on the surface of the skin.

It is reported that anti-inflammatory medication like Ibuprofen hastens the recovery in these cases.

Occasionally steroids like a Medrol dose pack are required.

Venaseal does not treat the cosmetic aspect of the visible veins.

That often leads to recurrence in time.

Doctors are currently learning this technique.

One of the primary investigators and most experienced teacher of this technique in the U.S. has only less than two hundred cases of experience using Venaseal glue.

It’s still early in the learning curve.

How Venaseal is Marketed

It’s being marketed as a fix for varicose veins.

Twenty minutes or less is the normal treatment time for a doctor familiar with the technique.

Only one anesthetic needle pinch is needed.

No stockings are required before or after the treatment.

Insurance companies require a three-month trial of conservative medical management including stockings.

Since insurance companies don’t get involved at this time, that ridiculous rule is no longer needed.

Doctors have proven that symptomatic varicose veins should be treated without an initial three-month trial of compression stockings.

Another big advantage is that you can go to the gym right away. Vigorous exercise can be resumed immediately.

As far as pain goes, the reported incidence of discomfort is about the same as with radiofrequency. Sometimes the glue sticks as the tube is pulled out through the skin at the end of the procedure.

It needs to be sharply snapped off to prevent this discomfort which the patient remembers since it is at the end of the case.

Occasionally, the glue gets stuck under the skin at the entry site and has to be removed.

Now for the rest of the story as Paul Harvey might say.

The Cosmetic Dilemma of Venaseal Treatment Alone

This glue or adhesive treatment is not a permanent solution in the sense that the visible veins don’t go away.

In 50-80% of patients, there will be an improvement in appearance but people want the “bumps” gone – not smaller.

In my experience, these remaining surface veins often will enlarge over time and cause recurrent problems.

We have learned that most patients will be unhappy if adjunctive procedures like phlebectomy (removal of the visible varicose veins) or sclerotherapy (injections) are not performed either at the same time or after the saphenous vein is closed.

The biggest problem with Venaseal is that it doesn’t take care of “the bumps”. The bumps are the visible bulging varicose veins that are seen on the surface of the skin.

Most people who spend thousands of dollars out of pocket want and expect superior cosmetic results.

They don’t want to hear that there is at least a fifty per cent chance (or greater) that they will require further procedures that do require heavy compression stockings and further degrees of discomfort.

Most people want their legs to look great as well as getting symptomatic relief.

It is recommended by the Venaseal consultants that you should come back in three months to see if you need further treatment of the remaining bumps. Remember, at least fifty percent of people or more will need to have a clean up the remaining surface veins.

Eventually those remaining veins will grow back since glue cannot get very far into the tortuous surface tributary branches which are the visible varicose veins. Medtronics consultants say that at this point (three months after the Venaseal procedure) that patients can use their insurance.

But what if you chose this approach because you had a high deductible?

???

At this point, you would have to do the obligatory 3-month trial of conservative medical management required by insurance companies. You also have to wear compression stockings after this follow up treatment or treatments to “clean up the bumps”.

Insurance will only cover painful varicose veins which are resistant to conservative medical management and it must interfere with activities of daily living.

If you choose glue, you don’t have to worry about these rules but the cosmetic surface vein branches will not be addressed.

Complications of Venaseal Glue

The Venaseal consultants report that there has not been a reported case of deep vein thrombosis or DVT.

DVT occurs in 1-2% in cases of radiofrequency closure and endovenous ablation of saphenous veins.

No numbness or skin burns is an advantage vs. a small per cent in laser and radiofrequency procedures that usually resolves with time.

However, I personally saw a patient treated in another office who reported told me that after their Venaseal procedure that they suffered a DVT and a pulmonary embolism (clot moved to their lungs).

Hyperpigmentation can occur if the treated vein is close to the skin.

Phlebitis is a problem discussed in these reviews by patients who have had the Venaseal procedure.

Never Be the First or the Last to Adopt a New Technology

Technology in the field of varicose vein treatments is evolving extremely rapidly.

Venaseal glue is another step forward but is not without its drawbacks.

Phlebitis in up to twenty per cent of patients is not a minor problem.

Another procedure to get rid of the surface bumps and prevent them from enlarging is usually required to satisfy most patients. That’s a problem.

The fact that this is an implantable device is an issue. It can’t be removed. If there is a foreign body reaction to the glue, that’s a problem.

There is no perfect procedure for treating varicose veins.

Patients need to know all of the facts when presented with treatment options for their varicose veins.

Share on FacebookTweet about this on TwitterShare on Google+Pin on PinterestEmail this to someone