About Venous Disease: Understanding Superficial Venous Reflux

Your legs are made up of a network of veins. Healthy leg veins contain valves that open and close to assist the return of blood back to the heart. Venous reflux disease develops when the valves that keep blood flowing out of the legs and back to the heart become damaged or diseased. This can cause blood to pool in your legs and lead to symptoms such as pain, swelling, swollen limbs, leg heaviness and fatigue, skin changes and skin ulcers, and varicose veins.

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The Closure® procedure

The VNUS® Closure procedure, an alternative treatment option to traditional vein stripping surgery, brings state-of-the-art technology to an age-old disease.

The Closure procedure is performed on an outpatient basis. Using ultrasound, your physician will position the Closure catheter into the diseased vein, through a small opening in the skin. The tiny catheter delivers radiofrequency (RF) energy to the vein wall. As the RF energy is delivered and the catheter is withdrawn, the vein wall is heated, causing the collagen in the wall to shrink and the vein to close. Once the diseased vein is closed, blood is re-routed to other healthy veins.

Following the procedure, a simple bandage is placed over the insertion site, and additional compression may be provided to aid healing. Your doctor may encourage you to walk, and to refrain from extended standing and strenuous activities for a period of time.

Patients who undergo the Closure procedure typically resume normal activities within a day.

Watch this short video on the procedure:

Highlights of the Closure® procedure

• Relief of symptoms
  
• Resume normal activity within a day
  
• Outpatient procedure
  
• Local or general anesthesia
  
• Good cosmetic outcome with minimal to no scarring, bruising or swelling

Q&A: Venous Disease

What are varicose veins?

Varicose veins--which afflict 10% to 20% of all adults --are swollen, twisted, blue veins that are close to the surface of the skin. Because valves in them are damaged, they hold more blood at higher pressure than normal. That forces fluid into the surrounding tissue, making the affected leg swell and feel heavy.

Unsightly and uncomfortable, varicose leg veins can promote swelling in the ankles and feet and itching of the skin. They may occur in almost any part of the leg but are most often seen in the back of the calf or on the inside of the leg between the groin and the ankle. Left untreated, patient symptoms are likely to worsen with some possibly leading to venous ulceration.

What causes varicose veins?

The normal function of leg veins - both the deep veins in the leg and the superficial veins - is to carry blood back to the heart. During walking, for instance, the calf muscle acts as a pump, contracting veins and forcing blood back to the heart.

To prevent blood from flowing in the wrong direction, veins have numerous valves. If the valves fail (a cause of venous reflux), blood flows back into superficial veins and back down the leg. This results in veins enlarging and becoming varicose. The process is like blowing air into a balloon without letting the air flow out again- the balloon swells.

To succeed, treatment must stop this reverse flow at the highest site or sites of valve failure. In the legs, veins close to the surface of the skin drain into larger veins, such as the saphenous vein, which run up to the groin. Damaged valves in the saphenous vein are often the cause of reversed blood flow back down into the surface veins.

Why does it occur more in the legs?

Gravity is the culprit. The distance from the feet to the heart is the furthest blood has to travel in the body. Consequently, those vessels experience a great deal of pressure. If vein valves can't handle it, the backflow of blood can cause the surface veins to become swollen and distorted.

Who is at risk for varicose veins?

Conditions contributing to varicose veins include genetics, obesity, pregnancy, hormonal changes at menopause, work or hobbies requiring extended standing, and past vein diseases such as thrombophlebitis (i.e. inflammation of a vein as a blood clot forms.) Women suffer from varicose veins more than men, and the incidence increases to 50% of people over age 50.

Q&A: The Closure® procedure

What is superficial venous reflux?

Superficial venous reflux is a condition that develops when the valves that usually keep blood flowing out of your legs become damaged or diseased. This causes blood to pool in your legs. Common symptoms of superficial venous reflux include pain, swelling, leg heaviness and fatigue, as well as varicose veins in your legs.

What is the Closure procedure?

The Closure procedure is a minimally invasive treatment for superficial venous reflux. A thin catheter is inserted into the vein through a small opening. The catheter delivers thermal energy to the vein wall, causing it to heat, collapse, and seal shut.

How does it work to treat superficial venous reflux?

Since valves can't be repaired, the only alternative is to re-route blood flow through healthy veins. Traditionally, this has been done by surgically removing (stripping) the troublesome vein from your leg. The Closure procedure provides a less invasive alternative to vein stripping by simply closing the problem vein instead. Once the diseased vein is closed, other healthy veins take over and empty blood from your legs.

How is the Closure procedure different from vein stripping?

During a stripping procedure, the surgeon makes an incision in your groin and ties off the vein, after which a stripper tool is threaded through the saphenous vein and used to pull the vein out of your leg through a second incision just above your calf.

In the Closure procedure, there is no need for groin surgery. Instead, the vein remains in place and is closed using a special (Closure) catheter inserted through a small puncture. This may eliminate the bruising and pain often associated with vein stripping (i.e., that may result from the tearing of side branch veins while the saphenous vein is pulled out). Vein stripping is usually performed in an operating room, under a general anesthetic, while the Closure procedure is performed on an outpatient basis, typically using local or regional anesthesia.

Is the Closure procedure painful?

Although some people are more sensitive than others, patients generally report little pain. Some have said they can feel a little heat when the catheter is energized.

Will the procedure require any anesthesia?

The Closure procedure can be performed under local, regional, or general anesthesia.

As with any medical procedure, the Closure® procedure is not suitable for all people and there are associated risks and considerations. You should consult your physician to determine if the Closure procedure is right for you, and to discuss any special risks your individual condition may present.

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

Contraindications:
Patients with thrombus in the vein segment to be treated.

PRECAUTION: For patients with a pacemaker, internal defibrillator or other active implanted device, consult the cardiologist and the manufacturer of the active implanted device. Continuous patient monitoring during the procedure is recommended. Evaluate the patient and the implanted active device post procedure. Keep all power cords and the attached sterile cable away from the location of the pacemaker or leads, defibrillator or the implanted active device.

CAUTION: In patients with an aneurysm in the vein segment to be treated, the vein wall may be thinner in the area of the aneurysm. To effectively occlude a vein with an aneurysmal segment, additional tumescent infiltration may be needed over the aneurysmal segment, and the treatment of the vein should include segments proximal and distal to the aneurysmal segment.

CAUTION: No data exists regarding the use of this catheter in patients with documented peripheral arterial disease. The same care should be taken in the treatment of patients with significant peripheral arterial disease as would be taken with a traditional vein ligation and stripping procedure.

Potential Risks & Complications:

• Potential complications include, but are not limited to, the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, adjacent nerve injury, skin burns.
• Treatment of veins located very close to the skin surface may result in a skin burn.
  
• Adjacent nerve injury is higher with treatment at or below the calf.