The Closure® Procedure -- A Treatment That Works

Clinical results indicate that the Closure procedure can be effective at closing the vein and significantly reducing patient symptoms.

Patient Symptoms Reported at Follow-up

Symptom	Pretreatment	8 Weeks	2 Years
Leg Pain	85%	6%	5%
Leg Fatigue	85%	12%	5%
Edema (swelling)	19%	8%	0%

 

 

Prior to the Closure procedure, 85% of patients reported leg pain. After the Closure procedure, 94% of patients at six weeks and 95% of patients at two years did not report residual leg pain.

Three randomized trials of the Closure procedure versus vein stripping, including the most recent multi-center comparative trial published August 2003 in the Journal of Vascular Surgery, show very similar results. In the most recent trial every statistically significant outcome was in favor of the Closure procedure, resulting in:

• Return to normal activities within one day for 80.5% of Closure treated patients versus 46.9% of patients who underwent vein stripping surgery
• Less post-operative pain and limitation of physical activity
• Return to work 7.7 days sooner than vein stripping patients
• Higher quality of life scores than vein stripping

Typical Cosmetic Results: Before and After the Closure Procedure

Pre-treatment	Typical results 2 weeks post-Closure

 

Percent of Legs Without Varicose Veins at Follow-up

The Closure procedure may be as effective as vein stripping in delaying the reappearance of varicose veins.

Treatment	1 Year	2 Years
Closure	90%	87%
Vein Stripping	85%	75%
Ligation	86%	57%

 

References for this report will be furnished upon request.

Safety Summary

As with any medical intervention, potential risks and complications exist with the Closure procedure. You should consult your physician to determine if your individual condition presents any special risks. Although a summary of potential complications of the Closure procedure is provided, you are encouraged to review these with your doctor at the time of the consultation.

Indication:

The Closure System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Contraindication:

Patients with thrombus in the vein segment to be treated.

Potential Risks & Complications:

• Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthsia, skin burn.
• Treatment of veins located very close to the skin surface may result in a skin burn.
• Paresthesia may occur from the thermal damage to adjacent sensory nerves. The risk of paresthesia is higher with treatment at or below the calf.

Caution:

What Patients Are Saying About Closure®

Patients are highly satisfied with the Closure procedure.

FACT: 98% of patients who have undergone the Closure procedure are willing to recommend it to a friend or family member.

VNUS Closure is a revolutionary catheter treatment for greater and small saphenous veins. This utilizes using radio frequency energy to heat the inside of the vein to close it by internal heating destruction.This procedure involves a miniscule incision in the leg using la catheter and local anesthesia. After the procedure is completed, compression bandages and a leg wrap are applied and the patient is able to walk out of the office.

Step 1

Catheter tip positioned 2cm distal to the saphenofemoral junction. Tumescent fluid is administered.

Step 2

7cm vein segment treated all at once during 20-second treatment cycle. Additional vein segment treated serially.

Step 3

Catheter shaft allows fast and accurate catheter re-positioning between treatment cycles. No energy is delivered during the re-positioning.

Step 4

Treatment of 45cm vein takes 3-5 minutes (seven treatment segments).

RFS Closure

This is an endovenous ablation technique that utilizes radiofrequency energy to heat the inside of smaller incompetent veins or “perforators”. This is accomplished through a pin- point incision and placement of a catheter with local anesthesia. The radiofrequency unit is used to heat the cathetet, and in turn, the vessel to 90-95 degrees Celcius.  When done, a steri-strip bandaid and gauze pad is applied. Compression garments go over these dressings and the patient walks out of the office and can resume their usual daily activities.

This is a technique developed many years ago using a needle and sclerosing agent (a chemical injected inside the vein to cause irritation and closure) that allows us to visually, or by ultrasound guidance, place a needle tip inside a vessel. The injection of the sclerosing agent causes a displacement of blood.  The vessel then turns white or blanches and swells and becoming irritated, and usually turning red, inhibiting the blood from returning. Typically, each vein will require more than one injection. In addition, the same technique can be used to treat less visible veins by ultrasound guidance. After treatment, compression stockings are worn and regular activities can be resumed. Sclerotherapy sessions are usually done no sooner than 4-6 weeks apart to allow proper healing between treatments.

Prior to treatment, a complete medical history is taken and a thorough examination made in order to determine, among other things, how long the problem has existed, are there any ongoing causative factors, and if there are any associated symptoms. Normally, an ultrasound study is not indicated, unless the spider veins are found in conjunction with larger varicose veins. If your spider veins are found in conjunction with varicose veins, and i the valves in your greater saphenous vein are broken, an Endovascular Laser Venous System may be recommended before Microsclerotherapy is undertaken. Pre-procedure instructions may include the elimination of certain medications which are know to aggravate spider veins, and the elimination or minimization of any medications know to cause excessive bruising or bleeding.

If your spider veins are found in conjunction with varicose veins, then the larger varicose veins are usually treated first (but NOT by microsclerotherapy, which is only appropriate for spider veins). After the skin is thoroughly cleansed with alcohol, a small amount of sclerosing (hardening) solution is injected directly into the spider vein using a syringe with a very tiny needle. The vein immediately disappears, then returns in about 10-15 seconds and is actually MORE prominent than it was before treatment started. The irritated vein then fades away over a few weeks.

The solution displaces the blood within the vein, causing it to blanch or turn white. The solution then causes the vessel to become irritated and swell shut, prohibiting the blood from reentering the vein. The skin may be kneaded to help disperse the solution and reduce bruising. Each vein may require several injections and most disappear in a few weeks

After your treatment, you are NOT wrapped in compression bandages, but we may put a simple small band-aid over the injection site to protect your clothing. You then simply walk out of the office and immediately resume normal daily activities.

The Benefits and Expected Results

- Gets rid of unsightly spider veins

- Normalizes skin blood flow

- No incisions, so no scars

- Does not interfere with normal activities

- Safe, virtually painless, in-office treatment

Labial/Groin Venous Disease Treatments As in the above sclerotherapy description, we are able to treat labial varicosities with microinjection techniques. This is a very common problem often not mentioned because of embarrassment or lack of understanding. It is commonly seen post pregnancy in addition to just being a part of varicose vein disease in general.

In addition to limb treatments, we offer laser therapy/sclerotherapy for facial telangectasias and spider veins in our Aesthetic Center.