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QUESTIONS & ANSWERS: 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
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.
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
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.
For more
information or a consultation, please contact us at (920) 746-1060.
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