The numbers for US men and women who have developed venous disease of the legs, varicose veins, spider veins, are compelling. According to the Venous Disease Coalition, a professional and public health organizations dedicated to building awareness for venous disease...33% of women and 17% of men have varicose veins which translates to at least 20 to 25 million Americans. Taken collectively, 27% of adults have some form of venous disease of the legs
This Q&A primer on venous disease will layout the facts … the treatments and expectations.
The VNUS Closure® Procedure Featuring ClosureFAST™ Catheter
What is the VNUS Closure procedure?
The VNUS Closure procedure is the first minimally-invasive surgical treatment for venous reflux disease, which causes varicose veins. The Closure procedure uses radiofrequency (RF) energy to occlude, or close, the saphenous vein. A catheter is used to deliver heat to the vein wall. As the energy is delivered and the catheter is withdrawn, the vein wall is heated causing the collagen in the wall to shrink and the vein to close. Once the diseased vein is closed, blood is re-routed to other healthy veins.
How does ClosureFAST work?
The VNUS ClosureFAST catheter uses bipolar radiofrequency energy to deliver thermal energy into the vein wall. The vein is heated and maintained at a precise temperature. The passage of heat through the vein wall shrinks the vessel and causes it to collapse around the catheter. When the catheter is withdrawn, the vein remains closed.
Among other advances, the longer ClosureFAST heating element can treat a seven-centimeter length of vein all at once in just 20 seconds. This allows the physician to treat the full length of saphenous vein (averaging 45 centimeters) in just 3-5 minutes - up to 6 times faster than our previous technology.
How has ClosureFAST performed since its introduction in 2008?
Early clinical feedback has shown that the VNUS ClosureFAST catheter has demonstrated highly effective vein occlusion while still providing a rapid and mild patient recovery for which RF has been known. Published studies of the original Closure catheters found that at 12 and 24 months following the Closure procedure, over 90% of treated veins remained reflux-free with a significant reduction of pain, fatigue and swelling1. Similar results are expected with the ClosureFAST catheter.
What are the patient benefits with ClosureFAST?
The VNUS Closure procedure is minimally invasive and requires no actual removal of tissue. It’s performed under local anesthesia, generally in an ambulatory center or a doctor’s office, and most patients walk out after the procedure with virtually no pain or bruising.
What are the patient benefits of the Closure procedure compared to laser ablation?
Laser ablation, which uses laser light rather than RF to heat and occlude the vein, tends to produce significant pain, bruising and discomfort in the treated area. The Closure procedure can be performed just as quickly as laser ablation but without the uncomfortable side effects.
How long does the ClosureFAST procedure take?
Approximately 20 minutes, though patients may spend 2-3 hours at the medical facility due to normal pre- and post-treatment procedures.
Does it hurt?
Although some people are more sensitive than others, patients generally report little pain. Some have said they can feel a little heat when the catheter is energized.
What happens following the ClosureFAST procedure?
Most patients are home within hours of the procedure and have a follow-up visit with the physician within three days. The normal post-operative regimen consists of walking (to prevent clotting) and wearing compression hose on the treated area for a few days.
Does the Closure Procedure eliminate all varicose veins?
No. Over a period of years, skin which has been deformed by varicose veins undergoes a structural change. While the Closure procedure treats the venous disease that is the underlying cause of varicose veins, the damage done to the veins by years of reflux may be irreversible. In such cases, physicians typically perform additional procedures, such as phlebectomy, to remove the remaining varicose veins at the time the Closure procedure is done.
Can all varicose vein patients be treated with the Closure procedure?
It’s the physician’s call, but the vast majority of patients with superficial venous reflux disease can be successfully treated with the Closure procedure. Patients with thrombus in the vein segment to be treated are not considered candidates for the procedure.
Is ClosureFAST covered by insurance?
It’s covered by many medical insurance plans if the physician’s diagnosis indicates a medical necessity. Closure procedures performed for purely cosmetic reasons are not covered by insurance.
What potential risks and complications are associated with the Closure procedure?
As with all venous procedures, the Closure procedure presents risks and potential complications, including vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin burns and paresthesia. All patients should consult their physicians to determine their risk of complications.
1. Weiss RA, et al. Controlled Radiofrequency Endovenous Occlusion Using a Unique Radiofrequency Catheter Under Duplex Guidance to Eliminate Saphenous Varicose Vein Reflux: A 2-Year Follow-up, Dermatologic Surgery, Jan 2002; 28:1: 38-42 [Click here to return to copy above]
The Basics of Venous Reflux Disease
What is venous reflux disease?
Venous reflux disease occurs in leg veins, particularly the saphenous veins, which are designed to carry blood back to the heart. To prevent blood from flowing in the wrong direction these veins have numerous valves. When the valves fail, blood flows back down (refluxes) and pools up in the leg veins, causing them to swell. Venous reflux is therefore the underlying cause of varicose veins.
What are varicose veins?
Varicose veins are swollen, twisted, often-unsightly blue veins in the legs, close to the surface of the skin. Because their valves are damaged, varicose veins hold more blood at higher pressure than normal veins, forcing fluid into the surrounding tissue causing swelling, and often pain. They generally occur in the legs.
What are spider veins?
Spider veins are small clusters of red, blue or purple veins that lay closer to
the surface of the skin than varicose veins. They can look like tree branches or
spider webs and most commonly appear on the thighs, calves and ankles. Spider
veins cause no pain or discomfort and so are considered a "cosmetic" problem.
They are easily treated by a technique known as "sclerotherapy" With this
treatment, a solution is injected into an incompetent (leaky) vein, causing it
to "spasm" or close up.
What are the symptoms?
Varicose veins may ache and itch, and legs can become tired, heavy and painful. The feet and ankles may swell because of poor blood flow. Left untreated, varicose veins can eventually rupture or cause leg ulcers.
Who is at risk for varicose veins?
Half of us over 50 are one large group with women being more at risk than men. Genetics are a risk factor for varicose veins; as are obesity and pregnancy, and people whose jobs require extended standing are particularly vulnerable.
What is the conservative treatment for varicose veins?
Walking, wearing compression hose, elevating and resting the legs may relieve some of the symptoms of varicose veins (weight reduction is also helpful), and may prevent the condition from worsening. Should the veins continue to deteriorate however, more aggressive procedures may be required.
The Treatments & Expectations
What is sclerotherapy?
With this treatment, a solution is injected into an incompetent (leaky) vein, causing it to “spasm” or close up. Sclerotherapy is most effective on smaller surface veins, known as spider veins.
What is ambulatory phlebectomy?
Ambulatory phlebectomy is a surgical procedure for treating surface veins. A few, small incisions are made along a varicose vein and it is "fished out" of the leg using surgical hooks or forceps. The procedure is performed under local anesthesia in a doctor’s office.
What is vein stripping?
Vein stripping is the surgical removal of a diseased saphenous vein. Under general anesthesia, incisions are made in the groin and lower leg, and all or part of the vein is tied off and removed. As new procedures have evolved, vein stripping has become a rarely used technique.
What is an ablation procedure?
Ablation procedures are minimally invasive surgical treatments for venous reflux disease, which causes varicose veins. Laser or radiofrequency (RF) energy is used to close the saphenous vein. A catheter delivers heat to the vein wall, causing the collagen in the wall to shrink and the vein to close. Once the diseased vein is closed, blood is re-routed to other healthy veins. It’s performed under local anesthesia, generally in a doctor’s office and while taking approximately 20-minutes, patients may spend 2-3 hours at the medical facility due to normal pre- and post-treatment procedures.
- Patients can then leave with virtually no pain and Ablation provides rapid and mild patient recovery.
- The post-operative regimen consists of walking and wearing compression hose on the treated area for a few days.
Does the Ablation Procedure eliminate all varicose veins?
Most of the time. While the procedure treats the venous disease that is the underlying cause of varicose veins, the damage done to the veins by years of reflux may be irreversible. In such cases, physicians typically perform phlebectomy, to remove the remaining varicose veins at the time the ablation procedure is done.
Will medical insurance cover these procedures?
In most cases these procedures are covered by medical insurance plans if the physician’s diagnosis indicates a medical necessity. Procedures performed for purely cosmetic reasons are usually not covered by insurance.
What potential risks and complications are associated with these procedures?
As with all venous procedures, risks are present and potential complications can include thrombosis, pulmonary embolism, hematoma, infection, skin burns and paresthesia. Complications are rare, however all patients should consult their physicians to determine their risk of complications.
