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Frequently Asked Closure Questions

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Q:   Is this procedure covered by insurance?

A:   Many insurance companies are paying for the Closure procedure in part or in full including HMSA, UHA, Tricare, HMAA, HMA, Medicare, and most Blue Cross plans.

Dr. Ly's Actual Client — Closure Procedure

Most insurance companies determine coverage for all treatments, including the Closure system vein treatment procedure offered by Aloha Dermatology and Laser Center based on medical necessity.

Varicose veins are more than just a cosmetic nuisance. They are a symptom of a progressive, underlying condition, "superficial venous reflux disease."

Most patients treated with the Aloha Dermatology and Laser Center Vein's treatment procedures report marked improvement in their symptoms -- including the cosmetic ones.

Dr. Ly and her staff can discuss your coverage further at the time of the consultation and for those patients without benefits or qualifying insurance, Aloha Dermatology and Laser Center offers convenient payment options.

Q:  What are Varicose Veins?

A:   If you're over 40, you probably see them; those little purple veins that suddenly seem to appear on your legs. Veins are the soft, thin-walled tubes that return blood from the arms and legs to the heart. Because veins work against the force of gravity, they have valves that allow forward blood flow, but not reverse. Your legs and arms have two major types of veins: superficial and deep. The superficial veins are near the surface of the skin and are often visible. The deep veins are located near the bones and are surrounded by muscle. Connecting the deep and superficial veins is a third type of vein, the perforator vein. Contraction (squeezing) of the muscles in the arms and legs with exercise helps blood flow in the veins.

Varicose veins are enlarged, bulging superficial veins that can be felt beneath the skin, generally larger than 3-mm in diameter. They are usually located on the inside of the calf or thigh and develop due to weakness of the vein wall and loss of valve function. Under the pressure of gravity, they continue to enlarge, and in the course of time, they may become elongated, twisted, pouched, and thickened.

Spider veins or telangiectasia are tiny dilated, veins, usually less than 1-mm in diameter, located at the surface skin layers. Spider veins cannot be felt. Veins larger than the spider veins, but still under 3-mm are called reticular veins.

Q:  How Common are Varicose Veins?

A:   Venous problems are probably among the most common chronic conditions in North America and Western Europe. They are less common in the Mediterranean, South America, and India , and even less so in the Far East and Africa. In one study from Southern California, venous problems were present in 33 percent of women and 17 percent of men. Varicose veins occur almost as often in women as in men, however, spider veins were more frequent in women. A large U.S. survey, the Framingham study, reported that 27 percent of the American adult population had some form of venous disease in their legs. It is estimated that at least 20 to 25 million Americans have varicose veins.

Q:   How does Venous disease progress if not treated?

Stage 2
Simple varicose veins
Stage 3
Ankle oedema of venous origin (not foot oedema)
Stage 4 and 5
Skin Changes and
Healed venous ulcer
Stage 6
An open venous ulcer

Q:   What is superficial venous reflux?

A:   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

Q:   What is the Closure® procedure?

A:   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.

Q:   How does it work to treat superficial venous reflux?

A:   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.

Q:   How is this procedure different from vein stripping?

A:   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

Q:   How is this procedure different from Endovenous Laser (EVL)?

A:   Endovenous laser ablation (EVL) is a minimally invasive surgical procedure that uses laser heat to treat varicose veins. Laser energy is delivered to the inside of the great saphenous vein via an optical fiber that is inserted into the vein. When the laser is fired, it emits thermal energy at over 700 degrees Centigrade, perforating and destroying the vein walls and boiling the blood inside the vessel. The laser is repeatedly or continuously fired as the laser fiber is gradually withdrawn along the course of the vein, until the entire vessel is sealed by thermal damage and blood clotting.

Studies indicate that the laser procedure is frequently uncomfortable for patients . In September 2003, the Journal of Vascular Surgery reported that two-thirds of EVL patients had post-operative pain, sometimes lasting several weeks, and more than half used prescription pain medication. Also, the laser energy frequently perforates the vein walls, forcing blood into the surrounding tissues and causing bruising and discoloration that can last weeks . Symptoms of pain and bruising are significantly higher with laser than with the radiofrequency-based VNUS Closure procedure, as confirmed by an independent comparative study.

Clinical data from one-year and two-year follow-up studies has shown EVL to be over 90% effective in keeping veins sealed, meaning less than one in ten patients experienced a recurrence of their venous reflux.

Physicians performing EVL have experienced an additional drawback to the technique … the absence of technical feedback during the procedure. Unlike the VNUS® ClosureFASTTM catheter , EVL devices do not provide the real-time data on variations in vein size or blood volume that would allow the physician to adjust how the laser energy is delivered or how fast the optical fiber is withdrawn. The lack of guidance can result in vein wall perforations or large blood clots .

Q:   How long does the Closure procedure take?

A:   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. one could expect to go back to work the next day.

Q:   Is this procedure of Dr Ly's painful?

A:   Patients report feeling little, if any, pain during and after the procedure. Your physician will give you a local or regional anesthetic to numb the treatment area.

Q:   Will the procedure require any anesthesia?

A:   The Closure procedure can be performed under local, regional, or general anesthesia.

Q:   How quickly can I resume normal activity?

A:   Patients are walking immediately following the procedure, and patients typically resume normal activities within one day. 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.

Q:   How soon will my symptoms improve?

A:   Many patients notice an immediate relief of symptoms such as pain, leg heaviness and fatigue. The full benefits of the procedure may take 1-2 weeks.

Q:   Is there any scarring, bruising, or swelling after the procedure?

A:   Patients report minimal to no scarring, bruising, or swelling following the Closure procedure.

Q:   Are there any potential risks and complications associated with the Closure procedure?

A:   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.
View a Power Point Presentation from the Vein Coalition

Q:   Is the Closure procedure suitable for everyone?

A:   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.

Q:   Is age an important consideration for the Closure procedure?

A:   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.

Q:   How effective is the Closure procedure?

A:   Data from a prospective multicenter study have shown 97.4% vein occlusion 1 year post-treatment.3

Q:   What happens to the treated vein left behind in the leg?

A:   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.4

Q:   What are patients saying about the Closure procedure?

A:   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.

Q:   What if I need the vein for bypass surgery in the future?

A:   The Closure procedure treats diseased veins only, which are not appropriate for bypass surgery. Physicians can use other healthy vessels should bypass surgery be necessary.

Safety Summary

As with any medical intervention, potential risks and complications exist with the Closure procedure. Please consult Dr Ly to receive further information.

The Closure System is intended for endovascular coagulation of blood vessels in patients with superficial venous reflux. It is contraindicated in patients with thrombus in the vein segment to be treated.

Potential complications include, but are not limited to, vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia, skin burn.

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