By Eric Wellons, MD

As a physician who treats patients with varicose veins, I have a variety of tools at my disposal that can relieve the significant disability brought on by the symptoms of this common vascular condition, such as achiness and a “heavy” feeling in the legs. In the past, though, I had limited treatment options for patients with tortuous great saphenous veins or accessory saphenous veins.

           While radiofrequency (RF) ablation and laser ablation are effective therapies for varicosities, the catheters we use to perform these procedures can’t access tortuous veins. In some cases, I might have removed individual superficial veins through a simple microphlebectomy in the hope that would provide some relief. Otherwise, patients with tortuous saphenous and accessory saphenous veins generally received conservative treatment in the form of support hose.

However, I have been able to offer effective therapy for venous reflux in patients who have veins that are not amenable to treatment by traditional methods since the Food and Drug Administration approved polidocanol endovenous microfoam (Varithena, BTG) in 2013. While RF and laser ablation are not options for eliminating tortuous veins, foam-based therapies are well suited to this task.

That said, I have chosen not to treat my patients who have varicose veins by preparing and administering physician-compounded foam (PCF), which can be produced by aerosolizing liquid sclerosant with room air.

Many clinicians today use PCF, but I have never felt comfortable offering it as a therapy to my patients. My biggest concern is that PCF is not prepared in a controlled setting, so it’s not a standardized therapy.

We know from lab studies that PCF tends to have a wider distribution of bubble size, both large and small; by contrast, polidocanol endovenous microfoam is made up of small, uniform bubbles. Moreover, polidocanol endovenous microfoam is a more stable preparation than PCF, meaning that it doesn’t degrade as rapidly. That results in greater dwell time, or the length of time the foam is in contact with the vein.^[1]

These differences in physical properties lead me to believe that treatment with polidocanol endovenous microfoam is safer and more likely to produce successful, durable results than PCF. Variation of bubble size has been suggested to be the reason that PCF carries a very small, but important, risk for embolic events and neurological complications, including transient ischemic attacks.^[2]

By contrast, no clinically important neurological or visual complications were reported among subjects treated with varying doses of polidocanol endovenous microfoam in the VANISH-1^[3] and VANISH-2 trials.^{[4] [5]} Moreover, we have clear data from VANISH-1 and VANISH-2 to indicate that polidocanol endovenous microfoam effectively reduces patient-reported symptoms, as measured by the Varicose Veins Symptoms Questionnaire (VVSymQ) score.

A SIMPLE PROCEDURE

I have treated a considerable number of patients with polidocanol endovenous microfoam, and the aspect of the procedure I find most striking is its sheer simplicity.

With the patient supine on a treatment table, we numb the skin over the access point with local anesthetic. I use a butterfly needle, usually a 20-gauge or a size in that range. I typically inject in the superficial varicosity, though I’ll use the saphenous vein if it’s easy to access.

An important benefit of foam is that it is aerosolized liquid, which not only means that it can access tortuous veins, but that you don’t necessarily have to begin the procedure in the vein that you’re targeting.

Instead, polidocanol endovenous microfoam can be injected and guided with pressure from an ultrasound probe into the targeted veins, while using pressure on the saphenofemoral

junction to ensure that the foam doesn’t travel into the central system.

In the majority of procedures, I use one access site, though sometimes I will use two, depending on how the foam travels. The entire procedure takes about 10 minutes.

With regard to the role of imaging, I take a different approach than most physicians, because I always administer polidocanol endovenous microfoam in collaboration with an ultrasound technician. Many, if not most, physicians do the procedure by themselves; the argument in favor of this approach is that it frees up the ultrasound technician to be available to assist in the care of other patients.

But while I am comfortable with my ability to perform ultrasound imaging, I don’t do it 10 times a day, five days a week — like my ultrasound technician does. Because I’ll never be as skilled as he is, having him produce and interpret ultrasound images is safer for our patients and allows the procedure to be performed in a more efficient manner.

AN ADDITIONAL BENEFIT

Several podiatrists have remarked that patients with lower-extremity skin ulcers that have not responded to standard therapies have healed following administration of polidocanol endovenous microfoam for chronic venous insufficiency.

I observed this benefit in a recent patient, a male, age 67, with an ulcer on his left ankle who had previously been treated with venous ablation phlebectomy. Duplex ultrasound indicated persistence of venous insufficiency, so I elected to administer polidocanol endovenous microfoam in the great saphenous vein (GSV) and surrounding lower-extremity varicosities.

In the procedure, the patient was placed in a supine position, with his leg externally rotated. Under ultrasound guidance, we performed mapping, including marking of the major tributaries into the GSV, as well as the location of the perforating veins, both competent and incompetent.

Sterile drapes were applied and the injection site, overlying the GSV, was sterilized and anesthetized with local 1 percent lidocaine cutaneous anesthetic. The procedure was performed with a 21-gauge butterfly needle and the vein was accessed with an angiocatheter. After activating the Varithena canister, a 5mL aliquot of microfoam was withdrawn into the sterile syringe, which was then attached to heparinized saline extension tube for injection of the microfoam into the vascular catheter.

Injection of the polidocanol endovenous microfoam was performed at a rate of 0.5cc to 1cc per second, with the GSV under ultrasound observation.

Next, the treated vein was observed for three to five minutes to identify spasm within the treated segments. The lower extremity was kept elevated at an angle of 45 degrees to 60 degrees and a short stretch wrap was placed on the leg from the distal foot up to the groin. A lightweight overstocking was then placed over the lower extremity.

Following the procedure, the patient received instructions to elevate the leg, pump the foot and walk for 20 minutes. At home, he was advised to walk for seven to 10 minutes every hour until 9 p.m.

At one-week follow-up, I noted tenderness and hardening of the superficial vessel, which was expected. The patient’s varicose veins had reduced bulging and the ulcer had reduced leakage. The patient was extremely satisfied with the result and has been encouraged to repeat the procedure on his opposite extremity.  VTN

Eric Wellons, MD, is a vascular surgeon in Newnan, Georgia, and is affiliated with multiple hospitals in the area, including Piedmont Fayette Hospital and Piedmont Newnan Hospital. He received his medical degree from University of Virginia School of Medicine and has been in practice for more than 20 years. He reports no financial disclosure.

RESOURCES

[1] Carugo, D., et al. Benefits of polidocanol endovenous microfoam (Varithena) compared with physician-compounded foams. Phlebology. 2016;31:283–295.

[2] Sarvananthan, T, et al. Neurological complications of sclerotherapy for varicose veins. Journal of Vascular Surgery. 2012;55:243-251.

[3] King, JT, et al. Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation. European Journal of Vascular and Endovascular Surgery. 2015;50:784-793.

Improves Symptoms and Appearance5

[4] Todd, KL, et al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence. Phlebology. 2014;29:608-618.