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FREQUENTLY
ASKED QUESTIONS
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 radiofrequency (RF) 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.
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.1
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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.
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.
Will
the procedure require any anesthesia?
The Closure procedure can be performed under local,
regional, or general anesthesia.
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.
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.
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.
Is
the Closure procedure suitable for everyone?
Only a physician call 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.
Is
age an important consideration for the Closure procedure?
The most important step in determining whether or not
the Closure procedure is appropriate for you is a complete
ultrasound examination by your physician or qualified
clinician. Age alone is not a factor in determining
whether or not the Closure procedure is appropriate
for you. The Closure procedure has been used to treat
patients across a wide range of ages.
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.3,4,5
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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.6
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.
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.7
1
Lurie F, Creton D, Eklof B, Kabnick LS, Kistner
RL, Pichot O, et al. Prospective randomized study of
endovenous radiofrequency obliteration (Closure) versus
ligation and stripping in a selected patient population
(EVOLVES study). J Vasc Surg 2003;38:207-14.
2
Goldman, H. Closure of the greater saphenous vein
with endo radiofrequency thermal heating of the vein
wall in combination with ambulatory phlebectomy: preliminary
6-month follow-up. Dermatology Surg 2000; 26:452-456.
3
Merchant RF, DePalma RG, Kabnick LS. Endovascular
obliteration of saphenous reflux: a multicenter study.
J Vasc Surg 2002;35:1190-6.
4&7
Weiss RA, et al. Controlled Radiofrequency
Endovenous Occlusion Using a Unique Radiofrequency Catheter
Under Duplex Guidance to Eliminate Saphenous Varicose
Vein Reflux: A 2-Year Follow-up, Dermatologic Surgery,
Jan 2002; 28:1: 38-42
5
Whiteley, MS, Holstock JM, Price BA, Scott MJ,
Gallagher TM. Radiofrequency Ablation of Refluxing Great
Saphenous Systems, Giacomini Veins, and Incompetent
Perforating Veins using VNUS Closure and TRLOP technique.
Abstract from Journal of Endovascular Therapy 2003;
10:I-46.
6
Pichot O, Sessa C, Chandler JG, Nuta M, Perrin
M. Role of duplex imaging in endovenous obliteration
for primary venous insufficiency. J. Endovasc Ther 2000;7:451-9.
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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.
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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 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.
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 get sore and inflamed, causing redness of
the skin around them. In some cases, patients may develop
venous ulcerations.
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.
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.
What
is ambulatory phlebectomy?
As with sclerotherapy, ambulatory phlebectomy is a surgical
procedure for treating surface veins in which 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.
When
is Closure 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.
Each patient should consult their doctor to determine
whether or not they are a candidate for this procedure,
and if their condition presents any special risks. Complications
reported in medical literature include numbness or tingling
(paresthesia) skin burns, blood clots, temporary tenderness
in the treated limb.
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.
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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