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Venous Disease (download the pdf)
Closure Procedure (download the pdf)
What are varicose veins?
Varicose veins – which afflict 10% to 20% of all adults but serve no useful purpose
in the body – 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 body, 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.
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What causes varicose veins?
The normal function of leg veins - both the deep veins in the leg and the superficial
veins, which feed them - 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.
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Why does it occur more in the legs?
Gravity is the culprit. The distance from the feet to the heart is the farthest
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.
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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 (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.
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What are the symptoms?
Varicose veins may ache, and feet and ankles may swell towards day's end, especially
in hot weather. Varicose veins can become sore and inflamed, causing redness of
the skin around them. In some cases, patients may develop venous ulcerations.
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What are venous leg ulcers?
Venous ulcers are areas of the lower leg where the skin has died and exposed the
flesh beneath. Ulcers can range from the size of a penny to completely encircling
the leg. They are painful, odorous open wounds, which weep fluid and can last for
months or even years. Most leg ulcers occur when vein disease is left untreated.
They are most common among older people but can also affect individuals as young
as 18.
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What is the short-term treatment for varicose veins?
"ESES" (pronounced SS) is an easy way to remember the conservative approach. It
stands for "Exercise, Stockings, Elevation and Still." Exercising, wearing
compression hose, elevating and resting the legs will not make the veins go away,
or necessarily prevent them from worsening because the underlying disease (venous
reflux) has not been addressed. However, it may provide some symptomatic relief.
Weight reduction is also helpful.
If there are inflamed areas or an infection, topical antibiotics may be prescribed.
If ulcers develop, medication and dressings should be changed regularly.
There are also potentially longer-term treatment alternatives for visible varicose
veins, such as sclerotherapy and phlebectomy.
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What is sclerotherapy?
A chemical injection, such as a saline or detergent solution, is injected into a
vein, causing it to "spasm" or close up. Other veins then take over its work. This
may bring only temporary success, and varicose veins frequently recur. It is most
effective on smaller surface veins, less than 1-2mm in diameter.
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What is ambulatory phlebectomy?
As with sclerotherapy, ambulatory phlebectomy is a surgical procedure for treating
surface veins. Multiple small incisions are made along a varicose vein and it is
"fished out" of the leg using surgical hooks or forceps. The procedure is done under
local or regional anesthesia, in an operating room or an office procedure room.
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What is vein stripping?
If the source of the reverse blood flow is due to damaged valves in the saphenous
vein, the vein may be removed by a surgical procedure known as vein stripping.
Under general anesthesia, all or part of the vein is tied off and pulled out. The
legs are bandaged after the surgery, but swelling and bruising may last for weeks.
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When is the Closure® procedure used?
Closure is used like vein stripping to eliminate reverse blood flow in the
saphenous vein, but without physically removing the vein, and can be performed
without general anesthesia. Like other venous procedures, the Closure procedure
involves risks and potential complications. All patients should consult their
doctors to determine whether or not they are candidates for this procedure, and if
their conditions present any special risks. Complications reported in medical
literature include numbness or tingling (paresthesia), skin burns, blood clots
and temporary tenderness in the treated limb.
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What is the main difference between arteries and veins?
In simplest terms, arteries pump oxygen-rich blood FROM the heart; veins return
oxygen-depleted blood TO the heart.
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What are the three main categories of veins?
"Deep" leg veins return blood directly to the heart and are in the center of the
leg, near the bones. "Superficial" leg veins are just beneath the skin. They have
less support from surrounding muscles and bones than the deep veins and may thus
develop an area of weakness in the wall. When ballooning of the vein occurs, the
vein becomes varicose. "Perforator" veins serve as connections between the
superficial system and the deep system of leg veins.
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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.
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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 radiofrequency (RF) energy to the vein wall, causing it to heat, collapse,
and seal shut.
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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.
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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.
Three randomized trials of the Closure procedure vs. vein stripping, including the most
recent multi-center comparative trial, show very similar results. In the multi-
center comparative trial, the Closure procedure was superior to vein stripping in
every statistically significant outcome. In the study, 80.5% of patients treated with
the Closure procedure returned to normal activities within one day, versus 46.9% of
patients who underwent vein stripping. Also, Closure patients returned to work 7.7 days
sooner than surgical patients. Patients treated with the Closure procedure had
less postoperative pain, less bruising, faster recovery and fewer overall adverse events.
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How long does the Closure procedure take?
The Closure procedure takes approximately 45-60 minutes, though patients normally spend
2-3 hours at the medical facility due to normal pre- and post-treatment procedures.
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Is the Closure procedure painful?
Patients report feeling little, if any, pain during the Closure procedure. Your physician
will give you a local or regional anesthetic to numb the treatment area.
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Will the procedure require any anesthesia?
The Closure procedure can be performed under local, regional, or general anesthesia.
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How quickly after treatment can I return to normal activities?
Many patients can resume normal activities immediately.2 For a few weeks following
the treatment, your doctor may recommend a regular walking regimen and suggest you
refrain from very strenuous activities (heavy lifting, for example) or prolonged periods
of standing.
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How soon after treatment will my symptoms improve?
Most patients report a noticeable improvement in their symptoms within 1-2 weeks
following the procedure.
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Is there any scarring, bruising, or swelling after the Closure
procedure?
Patients report minimal to no scarring, bruising, or swelling following the Closure
procedure.
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Are there any potential risks and complications associated with the Closure
procedure?
As with any medical intervention, potential risks and complications exist with the
Closure procedure. All patients should consult their doctors to determine if their
conditions present any special risks. Your physician will review potential complications
of the Closure procedure at the consultation, and can be reviewed in the safety
summary. Potential complications can include: vessel perforation, thrombosis,
pulmonary embolism, phlebitis, hematoma, infection, paresthesia (numbness or tingling)
and/or skin burn.
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Is the Closure procedure suitable for everyone?
Only a physician can tell you if the Closure procedure is a viable option for your
vein problem. Experience has shown that many patients with superficial venous reflux
disease can be treated with the Closure procedure.
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How effective is the Closure procedure?
Published data suggests that two years after treatment, 90% of the treated veins
remain closed and free from reflux, the underlying cause of varicose veins.
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What happens to the treated vein left behind in the leg?
The vein simply becomes fibrous tissue after treatment. Over time, the vein will
gradually incorporate into surrounding tissue. One study reported that 89% of treated
veins are indistinguishable from other body tissue one year after the Closure procedure
was performed.
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Is the Closure treatment covered by my insurance?
Many insurance companies are paying for the Closure procedure in part or in full.
Most insurance companies determine coverage for all treatments, including the
Closure procedure, based on medical necessity. The VNUS® Closure procedure has
positive coverage policies with most major health insurers. Your physician can discuss
your insurance coverage further at the time of consultation.
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What are patients saying about the Closure procedure?
98% of patients who have undergone the Closure procedure are willing to recommend
it to a friend or family member with similar leg vein problems.
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