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Closure Procedure
The Closure procedure can be performed on an outpatient basis using either local anesthesia in which the physician numbs the leg before treatment.
The radiofrequency Closure system offers a minimally-invasive treatment alternative for patients with symptomatic superficial venous reflux and varicose veins. |
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The procedure consists of four principal steps:
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Map the Saphenous Vein. A typical procedure begins with noninvasive ultrasound imaging of the varicose vein to trace its location. This allows the physician to determine the site where the Closure catheter will be inserted and to mark the desired position of the catheter tip to begin treatment.
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Insert the Closure Catheter. After the physician accesses the saphenous vein, the Closure catheter is inserted into the vein and advanced to the uppermost segment of the vein. The physician then typically injects a volume of dilute anesthetic fluid into the area surrounding the vein. This numbs the leg, helps squeeze blood out of the vein and provides a fluid layer outside the vein to protect surrounding tissue from heat once the catheter starts delivering RF energy.
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Deliver RF Energy and Withdraw Catheter. Noninvasive ultrasound is used
to confirm the catheter tip position and the physician then activates the
RF generator, causing the electrodes at the tip of the catheter to heat the
vein wall to a target temperature of typically 120 degrees Centigrade for
axial veins such as the saphenous vein and 95 degrees Centigrade for
perforator veins. As the vein wall is heated, the
vein shrinks and the catheter is gradually withdrawn. During catheter
pullback, which typically occurs over 5 to 10 minutes, the RF generator
regularly adjusts the power level to maintain target temperature to
effectively shrink collagen in the vein wall and close the vein over an
extended length.
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Confirm Closing of Vein. After treatment, ultrasound imaging is used to confirm closing of the vein. If a portion of the vein is not closed, the catheter can be reinserted and energy reapplied. After the procedure, the narrowed vein gradually becomes fibrous, sealing the interior of the vein walls and naturally redirecting blood flow to healthy veins. Experienced physicians often complete the procedure in 45 to 60 minutes.
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Procedure Overview
Potential complications include, but are not limited to:
- Vessel perforation
- Thrombosis
- Pulmonary embolism
- Phlebitis
- Hematoma
- Infection
- Paresthesia
- Skin burn
Benefits:
- Relief of symptoms
- Outpatient procedure
- Resume activities typically within a day
- Good cosmetic outcome with minimal or no scarring, bruising, or swelling
As with any medical intervention, potential risks and complications exist with the Closure procedure.
Closure Procedure Before & After Image
Post-Operative Instructions
Post Closure Instructions
- Avoid prolonged sitting or standing.
- Refrain from strenuous activities and heavy lifting for 1 week.
- Walk 5-10 minutes an hour while awake for 1 week.
- Wear compression stockings continuously for the first 24 hours. You may shower after 24 hours, then resume wearing stockings during waking hours for 1 week.
- Follow-up Duplex Scan: 24-72 hours after procedure. Bring loose fitting shorts.
- Pain Medication: Tylenol or Ibuprofen as needed.
It is normal to experience some tenderness and possibly bruising along the areas where local anesthesia was administered. A tethering or pulling sensation is also reported by some patients after the procedure. Continue taking pain medication as needed.
Call immediately if you experience any of the following:
- Prolonged tenderness, redness, or warmth along the treated site
- Moderate to severe pain preventing return to normal activities
- Shortness of breath
- Swelling in the treated limb
Closure Procedure Videos
Closure Procedure Frequently Asked Questions
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.
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 can 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. 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.
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.
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.
Glossary of Terms (Closure® System Terms)
| Artery |
Vessels carrying oxygen-rich blood FROM the heart.
(Veins carry oxygen-depleted blood TO the heart.) |
| Capillary |
Extremely small blood vessel. |
| Catheter |
In the context of the Closure procedure, a slender, 60-100 cm long device designed to move within the vein and close - or occlude - it by delivering radiofrequency energy through a group of specially designed electrodes |
| Closure® |
The Closure procedure is an outpatient (day surgery) treatment performed in hospitals, surgical centers and doctor's offices. Anesthesia is typically used to numb the treatment area. The Closure Catheter is inserted into the vein through a small opening, often using only a single needle stick. The catheter delivers radiofrequency (RF) energy to the vein wall, causing it to heat, collapse and seal shut as the doctor pulls the catheter from the vein. Like other venous procedures, the Closure procedure involves risks and potential complications. Patients should consult their doctors to determine whether or not they are candidates for this procedure, and if their conditions present any special risks. |
| Clot |
Coagulated blood (i.e., a thick, viscous lump of blood). |
| Collagen |
The major protein in connective tissue. It shrinks or thickens when heated. |
| Color duplex |
Ultrasound system, which uses color to indicate the direction of blood flow. This is particularly helpful in visualizing and evaluating both the deep and superficial venous systems. |
| Compression therapy |
A conservative therapy for venous insufficiency. Typically involves compression stockings with varying degrees of pressure to improve blood flow and reduce symptoms caused by venous insufficiency. This therapy may temporarily relieve symptoms; however, does not address the underlying cause of the disease. |
| Deep veins |
Non-surface veins in the leg, which enjoy good structural support from the adjacent bones and muscles. They return blood directly to the heart. |
| Deep vein thrombosis (DVT) |
A formation or presence of a thrombus, or clot, within a deep vein. |
| Dilation |
Enlargement of a vein due to increased internal pressure. |
| Doppler |
Ultrasound device which a technician may use to sense the presence or absence of flow in blood vessels. |
| Edema |
Swelling or inflammation caused by fluid buildup. Frequently occurs in the legs and ankles of people with venous insufficiency. |
| Efficacy |
Effectiveness. |
| Electrode |
In this context, the Closure Catheter has multiple electrodes, which emit radiofrequency energy to close - or occlude - the vein to be treated. |
| Endovenous |
Inside a vein. |
| Hematoma |
A localized mass of clotted blood confined within an organ, tissue or space. |
| Incompetent valves |
See Valves |
| Incompetent vessel |
Blood vessel that doesn't function properly. In most cases, the valves do not close completely, causing reverse blood flow, which contributes to edema and leg pain. |
| Ligation |
Surgical closure of a vessel with sutures or staples. |
| Lumen |
Interior of a blood vessel. |
| Minimally invasive |
Insuring that a treatment involves as little damage to human skin and organs as possible. |
| Microphlebectomy |
See Phlebectomy |
| Occlusion |
The closing of a vessel. |
| Paresthesia |
Numbness or tingling often associated with damage to sensory nerves. |
| Perforator veins |
Veins that serve as connections between the superficial veins and deep veins. |
| Phlebectomy |
Developed in the 1950s, a phlebectomy involves removing diseased veins through a series of very small punctures or incisions with a variety of specialized hooks. It is typically used on varicose veins that are at, or near, the skin's surface, and is a complimentary treatment to the Closure procedure. |
| Phlebologist |
M.D. who specializes in treatment of vein disorders. |
| Prolapse |
Condition in which vein valves are unable to close properly, allowing blood to flow in the wrong direction |
| Radiofrequency energy |
Energy that generates heat by stimulating naturally-occurring molecules in and around tissues. “RF” energy can be used to shrink, cut and/or cauterize tissue, depending on the temperature setting and frequency. |
| RF energy |
Abbreviation for radiofrequency energy. |
| Reflux |
Backward flow. Reflux contributes to the development of
varicose veins when incompetent leg vein valves let blood flow toward the feet instead of the heart. |
| Sapheno-femoral junction |
Intersection near the groin where the saphenous vein and femoral vein join. |
| Saphenous vein |
The long saphenous vein is a large vein running from the ankle to the groin; the short saphenous vein runs up the back of the leg from the ankle to the knee. Problems with valves in these veins often contribute to the development of varicose veins. |
| Sclerotherapy |
Often used to treat small diameter (1-2 mm) surface veins, such as spider veins. The physician injects a liquid, such as highly concentrated saline solution, which destroys and collapses the vein lining. |
| Spider veins |
Small blood vessels near the skin's surface that appear as tiny, twisted, purple lines. |
| Stripping |
Surgical removal of an incompetent vessel, historically considered the standard of care for removing incompetent saphenous veins. Stripping of a saphenous vein typically involves making an incision in the groin region and surgically tying off the top of the vein. An instrument resembling a thin rod with a bulbous end is then inserted into the saphenous vein and passed through to the knee. Another incision is made at the upper calf. The stripping device is then tied to the vein and pulled out through the second incision. |
| Superficial veins |
Veins that are just beneath the skin. Because they enjoy less support from adjacent muscles and bones, they can develop areas of weakness in their walls and are more likely to become varicose than deep veins. |
| Thermocouple |
A temperature measurement component on the Closure Catheter that lets the physician know the precise temperature of tissue being heated. |
| Thrombosis |
Formation or presence of a thrombus, or clot, within a blood vessel. |
| Thrombus |
Blood clot that may block a blood vessel or be attached to the vessel without obstructing the lumen (i.e., interior of the blood vessel). |
| Ulceration |
Formation of an ulcer on the skin. |
| Ulcer (venous) |
Lesion on skin at the ankle caused by tissue deterioration, usually with inflammation and necrosis (dead tissue). |
| Valves |
Flaps of tissue in the leg veins that open and close to prevent blood from flowing backwards. |
| Valvuloplasty |
Surgical placement of a series of sutures along the base of a valve. This can tighten valve components called "leaflets," reduce the vein diameter and prevent prolapse. General anesthesia is required, plus 3-6 days post-operative hospitalization and long-term therapy with anticoagulant drugs. Risks include deep vein thrombosis, infection and bruising. Success rates of 63%-80% have been reported for patients suffering from primary deep venous insufficiency.1 |
| Varicose veins |
Veins with incompetent valves that are elongated, dilated, tortuous, pouched and thickened. An estimated 10%-20% of the general population has varicose veins. It is more frequent among women and all adults after age 50.2 |
| Vein |
See Venous vessels. |
| Venous blood |
Blood which is returning to the heart to pick up oxygen. |
| Venous insufficiency |
Poor or impaired flow of venous blood from the legs and feet to the heart, often characterized by symptoms such as varicose veins, swelling, aching, skin changes and/or venous ulcers. Caused by over-dilation of venous vessels or damaged valves, resulting in pooling of blood. Deep vein thrombosis can also create this condition. Over time, this damages other valves in the veins and speeds progression of venous reflux. |
| Venous vessels |
Veins carrying oxygen-depleted blood TO the heart. (Arterial vessels carry oxygen-rich blood FROM the heart.) |
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