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How is the Closure procedure different
from vein stripping? |
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How does it work to treat superficial
venous reflux? |
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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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 long does the Closure procedure take?
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| 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? |
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Is there any scarring, bruising, or swelling
after the Closure procedure? |
| Most patients report a noticeable
improvement in their symptoms within 1-2 weeks following the
procedure. |
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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? |
Is the Closure procedure suitable for
everyone? |
| 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. |
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?
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What happens to the treated vein left
behind in the leg? |
| 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 |
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? |
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What are patients saying about the Closure
procedure? |
| 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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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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