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| The ClosureFAST®procedure |
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The VNUS® ClosureFAST® procedure, an alternative treatment option to traditional vein stripping surgery, brings state-of-the-art technology to an age old disease. Over 300,000 Closure (now known as ClosureFAST) procedures had been performed since 1999.
The ClosureFAST procedure is an outpatient (day surgery) procedure performed in doctor’s offices, surgical centers and hospitals. Local anesthesia with mild sedatives can be used to insure comfort during the treatment. After local anesthetic numbing medication is placed, an IV is placed into the diseased vein in the lower leg, a tiny catheter is then inserted through the IV into the vein. The catheter tip is positioned at the highest treatment point usually at the upper leg/ groin area. Local anesthetic is then placed to further numb the vein. The catheter delivers radiofrequency (RF) energy to the vein wall, causing it to heat, collapse and seal shut. The catheter is withdrawn in segments closing the vein behind it. |
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Following the procedure, the catheter is removed, a bandage is placed over the insertion site and your leg may be wrapped typically for 1 day to aid healing. Your doctor may ask you to walk, wear compression stockings, and to refrain from standing for long periods of time following the procedure to help speed your recovery. Many patients resume normal activity within 1-2 days.
Once the diseased vein is closed, other healthy veins take over the blood flow. Circulation is improved. Symptoms should resolve or improve noticeably. Many also notice cosmetic improvement to their vein appearance as a “bonus.”
The new generation VNUS ClosureFAST catheter was introduced and received FDA clearance in August 2006 and is a culmination of approximately four years of research and development. The ClosureFAST catheter is designed to significantly reduce procedure time and enhance ease-of-use for the physician. Like the original VNUS Closure catheter, the ClosureFAST catheter uses RF energy and VNUS RF generators to deliver controlled energy and monitor treatment temperature for the purpose of closing diseased veins. The ClosureFAST procedure minimizes the post-procedure pain and bruising commonly associated with the competitive endovenous laser treatment. Dr. Mimi Lee is the first physician in Arkansas to perform the original ClosureFAST procedure in 2002 and the ClosureFAST procedure in 2007. Dr. Lee has been using ClosureFAST technology ever since 2007. |
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| Highlights of the Closure procedure |
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- Relief of symptoms
- Short recovery with minimal or no scarring, bruising or swelling
- Resume normal activity within 1-2 days
- Outpatient procedure
- Local anesthesia with mild sedatives
- Many patients also see cosmetic benefits (individual cosmetic results may vary)
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| The Closure procedure -- A treatment that works |
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| Clinical results indicate that the Closure procedure can be effective at closing the vein and significantly reducing patient symptoms. |
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| Patient Symptoms Reported at Follow-up1 |
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| Symptom |
Pretreatment |
6 Weeks |
2 Years |
| Leg Pain |
| Leg Fatigue |
| Edema (swelling) |
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| 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 |
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| 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 ClosureFAST procedure, resulting in2: |
- 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
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Some of Dr. Lee’s Patients, before & after Closure Procedure
(Individual patient results may vary)5 |
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| 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. |
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| Treatment |
1 Year |
2 Years |
| Closure6 |
| Vein Stripping7 |
| Ligation7 |
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| Common questions & answers about ClosureFAST: |
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| How is the ClosureFAST procedure different than vein stripping? |
During a stripping procedure, the surgeon makes an incision in your groin and ties off the veins after which it a stripper tool is threaded through the saphenous vein and used to pull the vein out of you leg through a second incision just above your calf.
In the ClosureFAST procedure, there is no need for groin surgery, instead the vein remains in place and is closed using a special (ClosureFAST) catheter inserted through a small puncture. This virtually eliminates the bruising and pain often associated with vein stripping (i.e. this 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 ClosureFAST procedure is performed on an outpatient basis typically using local anesthesia and mild sedatives.
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| How long does the ClosureFAST procedure take? |
Approximately 45-60 minutes, though patients normally spend additional 30 minutes to an hour for pre and post-treatment care.
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| What is the difference between Closure and ClosureFAST procedure? |
The Closure® procedure becomes an alternative treatment option to traditional vein stripping surgery in 1999. The new generation ClosureFAST procedure was introduced in 2006. The ClosureFAST is designed to significantly reduce procedure time and enhance ease-of-use for the physician. Like the original Closure catheter, the ClosureFAST catheter uses RF energy and VNUS RF generators to deliver controlled energy and monitor treatment temperature for the purpose of closing diseased veins. Dr. Mimi Lee is the first physician in Arkansas to perform both the original Closure procedure in 2002 and the ClosureFAST procedure in 2007. Dr. Lee has been using ClosureFAST technology ever since 2007.
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| Is ClosureFAST procedure same as laser (EVLT, endovenous laser treatment) treatment? |
Both ClosureFAST and laser use heat to collapse the vein. However, ClosureFAST uses radiofrequency (RF) energy that works at 120 degree Celsius whereas laser uses laser energy that works at 120 to sometimes 700 degree Celsius, therefore laser produces more heat damage. A recently study published in the Journal of Vascular & Interventional Radiology (JVIR) showed RF thermal ablation (as presented by ClosureFAST system) was significantly superior to endovenous laser thermal ablation as measured by a comprehensive array of post procedural recovery and quality of life parameter. Recovery pain, ecchymosis (bruising), and tenderness were statistically lower in the ClosureFAST group at 48 hours, 1 week, and 2 weeks. Minor complications were more prevalent in the laser group. There were no major complications.
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| Is the procedure painful? |
Patients report feeling little, if any, pain during the ClosureFAST procedure. Dr. Lee will give you local anesthetic to numb the treatment area, in addition to some mild sedatives for relaxation. Patients typically do not require any pain medication after treatment.
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| How quickly after treatment can I return to normal activities? |
Most patients can resume normal activities within 1-2 days. For a few weeks following the treatment, your doctor may recommend a regular walking regimen and suggest that 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 in 1-2 weeks following the procedure.
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| How soon will I notice improvement of my bulging vein appearance? |
The ClosureFAST procedure is a medical procedure that shuts down the malfunctioning vein to improve leg vein circulation and related symptoms. Although most of the patients notice improvement in their vein appearance, small percentages of patients see no significant change in external appearance. The external appearance change usually takes several weeks to become evident. Any residual external veins may further be treated with cosmetic sclerotherapy if desired about 2 months postop.
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| Is the procedure suitable for everyone? |
Dr. Lee will discuss with you if the ClosureFAST procedure is a viable option for your vein problem after your consultation and ultrasound evaluation. Experience has shown that many patients with superficial venous reflux disease can be treated with the procedure.
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| Is age an important consideration for the procedure? |
The most important step in determining whether or not the ClosureFAST procedure is appropriate for you is a complete ultrasound examination. Age alone is not a factor in determining whether or not the procedure is appropriate for you. The procedure has been used to treat patients across a wide range of ages. Dr. Lee has treated many patients in their 80’s.
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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.
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| Is ClosureFAST covered by insurance? |
Many national and regional insurance carriers have issued positive coverage policy for the ClosureFAST procedure and are covering the procedure, including Medicare, Blue Cross Blue Shields, United Healthcare, Aetna, Cigna, AMCO, Coresource, Qualchoice, and most commercial insurances. Dr. Lee's staff can discuss cost, insurance coverage, etc in greater detail during your consultation visit.
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| What potential risks and complications are associated with ClosureFAST? |
| Like other venous procedures, ClosureFAST involves risks and potential complications. Dr. Lee will determine if the ClosureFAST procedure is right for you and if your condition presents any special risks. Rare complications include, but are not limited to bleeding, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, and minor numbness. |
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| Click here to learn more about VNUS Medical Technologies and Varicose Veins. |
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- 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.
- 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.
- 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.
- 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.
- Photos Courtesy of Mimi Lee, MD
- Merchant RF, DePalma RG, Kabnick LS. Endovascular Obliteration of Saphenous Reflux: A Multicenter Study. J Vasc Surg 2002;35:1190-6.
- 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
- Almeida et al. Radiofrequency Endovenous ClosureFAST versus Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-blinded, Randomized Study (RECOVERY Study). J Vasc and Interv Rad 2009; 20: 752-759
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