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Clinical results indicate that the Closure procedure can be effective
at closing the vein and significantly reducing patient symptoms.
Patient Symptoms Reported at Follow-up(1)
Symptom
|
Pretreatment
|
6 Weeks
|
2 Years
|
Leg Pain
Leg Fatigue
Edema(swelling) |
85%
85%
19% |
6%
12%
8% |
5%
5%
0% |
Prior to the Closure procedure, 85% of patients reported leg pain.
After the Closure procedure, 94% of patients at six weeks and 95%
of patients at two years did not report residual leg pain.
Three randomized trials of the Closure procedure versus vein stripping,
including the most recent multi-center comparative trial published
August 2003 in the Journal of Vascular Surgery, show very similar
results.(2),(3),(4) In
the most recent trial every statistically significant outcome was
in favor of the Closure procedure, resulting in(2):
Return to normal activities within one day
for 80.5% of Closure treated patients versus 46.9% of patients
who underwent vein stripping surgery
Less post-operative pain and limitation of
physical activity
Return to work 7.7 days sooner than vein
stripping patients
Higher quality of life scores than vein stripping
Typical Cosmetic Results: Before and After the Closure Procedure(5)
Pre-treatment Typical results 2 weeks
post-Closure
Percent of Legs Without Varicose Veins at Follow-up
The Closure procedure may be as effective as vein stripping in delaying
the reappearance of varicose veins.
Treatment
|
1 Year
|
2 Years
|
Closure(6)
Vein Stripping(7)
Ligation(7) |
90%
85%
86% |
87%
75%
57% |
1 Weiss, R, et al. Controlled Radiogrequency Endovenous Occlusion
Using a Unique Radiofrequency Catheter Under Duplex Guidance to
Eliminate Saphenous Varicose Vein Reflux: A 2-Year Follow-up. Dermatol
Surg 2002; 28:38-42.
2 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.
3 Stötter L. Schaaf I, Fendl R, Bockelbrink A. Randomized Study
to Compare the Closure Procedure, Invagination Stripping and Cryo
Stripping for Treatment of the Greater Saphenous Vein. Abstract
submitted to German Society for Phlebology for presentation Sept.
2003.
4 Rautio T, Ohinmaa A, Perälä J, Ohtonen P, Heikkinen
T, Wiik H, et al. Endovenous obliteration versus conventional stripping
operation in the treatment of primary varicose veins: A randomized
controlled trial with comparison of costs. J Vasc Surg 2002;35:958-65.
5 Photos Courtesy of Robert Merchant, M.D.
6 Merchant RF, DePalma RG, Kabnick LS. Endovascular Obliteration
of Saphenous Reflux: A Multicenter Study. J Vasc Surg 2002;35:1190-6.
7 Jones L et al. Neovascularisation is the Principal Cause of Varicose
Vein Recurrence: Results of a Randomized Trial Of Stripping The
Long Saphenous Vein. Eur J Vasc Endovasc Surg 1996;12:442-445
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