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The Closure^® Procedure: Minimally Invasive Treatment for the Underlying Cause of Varicose Veins.

20-25 million Americans have varicose veins. Venous reflux, often the underlying cause of varicose veins, frequently forces people to dramatically change their lifestyles, especially when they have standing professions and can no longer tolerate being on their feet all day.

Whether the initial cause is genetics, pregnancy, prolonged standing, excess weight, inadequate exercise or a damaged saphenous vein, the physiology of varicose veins is nearly always the same. The valves in the saphenous vein are damaged – physicians call them “incompetent” – and the veins near the skin surface are stretched and distorted from the increased pressure caused by blood flowing in the wrong direction. Venous reflux (caused by incompetent valves) in the saphenous vein is often the underlying cause of varicose veins. Although the condition is rarely life-threatening, it is often painful and unattractive.

The Closure procedure is an outpatient (day surgery) treatment now offered at The Vascular & Vein Center at Maine Heart Surgical Associates.

Historically, patients have had several choices for treating varicose veins, depending on the severity. They could make lifestyle changes, such as eating less, exercising more and wearing support hose. This regimen has proven helpful in somewhat reducing leg pain and further deterioration of the vein, particularly in mild cases. But sooner or later most patients return to their previous lifestyles, and thus their previous symptoms typically re-occur.

Patients could also have the visible varicose veins removed in a procedure called "phlebectomy." This surgical technique was developed in the 1950s. A specially trained physician removes diseased veins through a series of very small punctures or incisions with a variety of specialized hooks. However, phlebectomy alone does not address the incompetent valves in the saphenous vein, which created the problem and can cause varicose veins to recur.

Some physicians thus advocate the removal, or stripping, of the saphenous vein. By removing the saphenous vein, blood is diverted to other veins with competent valves. In many cases, stripping eliminates the pain associated with varicose veins and greatly reduces their potential for recurrence without the need for further intervention. Stripping involves making an incision in the groin region and surgically tying off the top of the saphenous vein. An instrument resembling a thin rod with a bulbous end is then inserted into the saphenous vein and passed through to the upper calf. Another incision is made at the upper calf. The stripping device is then tied to the vein, which is pulled out through the second incision. Recovery after the surgery may last weeks, typically causes significant bruising and can create post-operative pain, nerve damage and poor short-term cosmetic outcomes.

What is VNUS Closure?

The Closure System was developed over a four-year period to treat superficial venous reflux. This patented technology uses a very small catheter and radiofrequency energy to occlude, or seal shut, the saphenous vein. The physician typically makes a single small incision near the knee and inserts the slender Closure Catheter into the saphenous vein. The catheter is then positioned near the groin, energized and slowly withdrawn, sealing the vein shut. There are no stitches, and most patients return to normal activity within a day or two.

The Closure procedure has been the subject of numerous studies and journal articles. The results from a peer-reviewed, multi-center, randomized trial comparing recovery rates and quality of life between patients treated with conventional vein stripping and the Closure procedure (radiofrequency vein ablation) were published in the Journal of Vascular Surgery. This is the third randomized trial showing that patients who receive the Closure procedure consistently experienced less post-operative pain, and returned to normal activities and work faster than patients whose veins were surgically stripped. In addition, published studies found that at 12 and 24 months following the Closure procedure, 90% or more of treated veins remained reflux-free and a significant reduction of limb pain, fatigue and edema was observed. In one study, which also assessed patient satisfaction at 6 months, 98% of patients indicated they would recommend the Closure procedure to a friend with similar leg vein problems. More than 75,000 patients have been treated with the Closure procedure to date. For many patients, the procedure is covered by health insurance.

Like other venous procedures, the Closure procedure involves risks and potential complications. All patients should consult their doctors to determine whether or not they are candidates for this procedure, and if their conditions present any special risks. Complications reported in medical literature include numbness or tingling (paresthesia), skin burns, blood clots and temporary tenderness in the treated limb.

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