Frequently Asked Questions About The Closure Procedure and Venous Disease

Q1 How can superficial venous reflux be alleviated by endovenous treatment using either Venefit (VNUS) or Endovenous Laser Therapy (EVLT)?

Unfortunately, damaged valves cannot be repaired, and therefore the remaining course of action is to redirect the flow of blood to those veins whose valves are still properly functioning. In the past, surgical stripping or removal of the offending vein has been the preferred technique. Endovenous treatments (VNUS and EVLT) offer a less severe method to seal the offending vein, after which the properly functioning veins will resume where the diseased vein "left off", draining the excess of blood from the legs.

Q2 What are the differences between vein stripping and VNUS or EVLT treatment?

The stripping process involves making an incision in the groin and a subsequent ligation (tying off) of the problem vein, after which a stripping instrument will be threaded through the saphenous vein up to the point of the first incision. This instrument will then be used to pull the vein through a second incision directly above the calf. So there is a 4cm cut in the groin, with the vein being stripped through another incision around the knee. This leads to considerable bruising and the wounds need to be stitched or sutured.

VNUS or EVLT by comparison, does not involve the surgical incision at the groin, but rather involves the placement of a tube or catheter into a small perforation in the vein. There is a small stab wound which does not require stitching, less bruising and collateral tissue damage, and a more cosmetic result. The procedure can be performed under local anaesthetic, although general anaesthesia is available if patients prefer it.

Three randomized trials, one of which was the most current multi-centre trial, were recently conducted, highlighting the comparable results between vein stripping and VNUS Closure™. VNUS is better tolerated than vein stripping procedure in all areas of statistical relevance. Notably, the patients who had undergone the VNUS procedure returned to their everyday pursuits more quickly than those who had undergone vein stripping: 80.5% of the former were able to do so compared to only 46.9% of the latter.

The comparatively shorter recovery time associated with Venefit has also allowed patients to return to work 7.7 days earlier than those undergoing surgery. The quicker recovery time from Closure™ was accompanied by significantly less bruising or post- operative discomfort, and fewer complications.1

Q3 Is endovenous treatment a lengthy one?

The actual treatment of the vein only takes three to five minutes of operating time, however the overall operation may take up to an hour depending on the ancillary treatments which may accompany VNUS or EVLT. These can include phlebectomy or sclerotherapy.

Q4 Should pain be expected during or after an endovenous procedure?

The surgeon performing the treatment will apply topical (local) anaesthetic to the area being treated, which will prevent all pain. As such, testimonials from patients experiencing either minimal pain, or any pain whatsoever, have been few and far between.

Q5 Will I have to be anesthetised during this procedure?

Yes. We routinely use local anaesthesia. In addition some patients request sedation or even general anaesthesia, in which case they will have a supervising anaesthetist present.

Q6 How soon will I be able to resume my daily activities after treatment?

Many who undergo this procedure can return to their everyday pursuits at once.2 Please note occasionally patients can have pain from bruising for around two weeks, but this is unusual after Venefit (VNUS). All patients will be prescribed pain killers (analgesics) after treatment which they should take if they feel any pain. There is no requirement to walk any particular distance daily after surgery, but patients should remain mobile, and some patients have reported that walking can aid recovery. Lengthy and uninterrupted standing, as well as against more physically demanding forms of exercise (e.g. lifting heavy weights) are to be avoided initially.

If patients need ancillary treatments such as venous avulsions or phlebectomy they may experience pain from bruising which can delay their recovery.

Q7 How long will it take for symptoms to diminish after treatment is received?

The majority of patients will enjoy a reduction of their symptoms within a week or two of the treatment's completion.

Q8 Will endovenous surgery result in any sort of cosmetic damage?

According to previous patient testimonials, there is very little scarring and patients have found that the cosmetic result is a great improvement on the appearance of their legs. It can take up to a year for all scars to settle down in some patients.

Q9 What types of complications or side effects might result from Venefit treatment?

It is wise to take the same precautions with the VNUS or EVLT procedure as it would for any other medical treatment: as such, there should always be a consultation beforehand with a qualified doctor or physician, in order to determine the extent and health risk of the patient's present condition. This will involve the determination of any possible post-procedure effects, which can also be reviewed in the safety summary.

Potential adverse effects can include the following:
- A sensation of burning skin
- Bruising
- Phlebitis
- Deep vein thrombosis and pulmonary embolism are unlikely
- Pulmonary embolism
- Thrombosis
- Paresthesia(pain, pins and needles or numbness)

Q10 Can anyone undergo endovenous surgery?

Almost all patients with varicose veins can be treated by VNUS or EVLT. Age, chronic disease, medication (including warfarin and blood thinners) and inability to tolerate anaesthesia, are not contraindications per se. If in doubt, consult with a vascular surgeon to determine the feasibility of this method.

Q11 Does one's age have any bearing on the effectiveness of the Venefit (VNUS) or EVLT (laser) procedure?

No. Age is not a determinant of the effectiveness of this treatment. Again, consultation with a surgeon is essential to determining how useful this process will be for each individual. In particular, a full ultrasound exam should be requested prior to treatment.

Q12 What is the success rate for endovenous surgery?

According to research conducted for several peer-reviewed medical journals, more than 90% of the veins affected with venous reflux (the primary factor leading to varicose veins) will remain sealed, and will not be susceptible to further reflux issues.3,4,5 My own study shows that 98.8% remain closed.

Q13 What will be the eventual fate of the treated leg vein?

Upon successful treatment, the vein will become assimilated into the tissue surrounding it: that is, it will simply be absorbed by the body, however it can be felt as a scar, albeit painless, within the leg for a number of months.6

Q14 Do health insurers acknowledge the Venefit (VNUS), and EVLT (laser) treatment as worthy of coverage?

Yes. All insurers cover these newer procedures just as they have covered the older, more invasive open options. These issues can be discussed in full during consultations with your physician.

Q15 Are there any testimonials from patients?

A full 98% of the patients surveyed have claimed that they would recommend this procedure to others suffering similar problems with leg veins (e.g. family members and close acquaintances).7

Venous Disease

Q16 Please tell me more specifics about varicose veins.

Varicose veins, normally recognisable from their blue-ish hue, are veins that are abnormally twisted or elongated. They are sub-categorized into three varieties, i.e. trunk, reticular and telangiectasia (the distinct patterning in the latter causes them to be known more commonly as "spider veins" or "star burst" veins). Their most common area of occurrence, by far, is in the legs, although this is not their exclusive site of appearance. The discolouration of varicose veins points to the way in which they malfunction: the state of 'valve incompetence', following from a weakened vein wall, stresses the veins by making them hold an abnormal amount of fluid. This in turn causes the blood to seep into the connecting tissue, resulting in a feeling of heaviness in the swollen leg(s) and even staining of the tissue.

In addition to their being cosmetically unpleasant, varicose veins also contribute to secondary conditions such as swollen feet and / or ankles, irritable or itchy skin and complications like skin staining, lipodermatosclerosis and varicose eczema. The veins are most prevalent on the inner leg, from groin level down to the ankle, and the rear of the calf - this said, they may appear anywhere along the leg. It is crucial to seek proper treatment for varicosities before severe complications such as ulceration occurs.

Q17 What are some reasons for varicose veins' appearance?

Healthily functioning veins, which include both the deep veins and the superficial or near-surface veins, return blood back to the heart, particularly during exercise. In fact, 95% of the blood which returns from the leg to the heart does so through the deep veins, which are not the varicose veins we treat. The deep veins also work in concert with the superficial veins to cool the body, a process that occurs when the former transfer blood to the latter.

Numerous valves exist in the veins to properly direct the flow of blood. Therefore, valvular incompetence or malfunction can result in retrograde flow (that is venous reflux), which means blood is allowed to pool within the superficial veins of the leg.

Treatment of varicose veins, and the retrograde flow that occurs within them, needs the veins to be either destroyed as they are in endovenous surgery or sclerotherapy, or removed as they are in the older open surgical method.

Q18 Why are the legs the most common site of varicose veins?

The incidence of varicose veins is more common in the legs because of the greater distance blood must travel from the heart to the legs and feet. This results in increased pressure being placed on veins in these areas, therefore an intolerable amount of pressure will lead to swelling and twisting of the superficial veins.

Q19 What type of person is most likely to suffer from varicose veins?

While there can be a genetic predisposition to varicose veins, there are many other non-genetic contributing factors, such as pregnancy, obesity, previous vein disease such as deep vein thrombosis, or situations that require long periods of unrelieved standing (e.g. retail work). For women, the onset of menopause is often cited as a time in which varicose veins will appear - as with pregnancy and puberty, such periods of rapid hormonal change have much to do with varicose veins' appearance.

Incidentally, the occurrence of varicose veins is also higher in females (>25%) than in males (>15%), while the prevalence of varicose veins reaches 50% in adults aged 50 or higher.

Q20 What are some adverse effects associated with varicose veins?

Swelling of the feet and ankles is widely reported by individuals with varicose vein problems, especially during the evening and on warm days. Varicose veins also ache or become sore, and will - owing to venous eczema - cause redness, itching or inflammation of the skin, and concurrent irritability. Some advanced cases, in which bacterial infection causes further deterioration of the skin can develop cellulitis (infection of the skin) or phlebitis (infection of the vein and surrounding skin). Untreated varicose vein disease can lead to venous ulcers (a.k.a. stasis ulcers).

Q21 What is meant by a 'venous leg ulcer'?

These are wounds that occur due to improperly functioning valves in the venous systems of the lower leg, visible as patches where dead skin has exposed the flesh beneath them. Their occurrence is much higher among older patients, yet there have also been individuals as young as 18 who suffer from leg ulcers.
Whatever their size (which can range from being a few centimetres in diameter to encompassing an entire side of the leg) they are foul smelling, considerably painful, and prone to fluid leakage. Their duration can be from several months to years, generally appearing if lesser symptoms of venous malfunction have been neglected.

Q22 What can be done about varicose veins in the short term?

The simple daily regimen for dealing with varicose veins is known by the acronym "ESES" (pronounced "S.S."), which stands for "Exercise, Stockings, Elevation, and Still". This method may have some side health benefits including excess weight loss, as well as alleviating some symptoms. However, the activities involved in this regimen - wearing elastic stockings (30 to 40mmHg pressure), keeping legs raised and rested, and avoiding a sedentary life - are ultimately ineffective for both eliminating varicose veins and for preventing the progression of their severity. This is because the "ESES" method does not concentrate on the source of the problem, i.e. venous reflux.

Topical antibiotics are sometimes prescribed but are generally not useful. If surrounding cellulitis (skin redness due to infection) develops, oral and even intravenous antibiotic therapy is required.

Wound dressings and medicated creams should be applied under medical/nursing advice.

Sclerotherapy and phlebectomy are two of the more common long-term treatments for unsightly varicose veins.

Q23 What is meant by 'sclerotherapy'?

Sclerotherapy is a treatment by which veins, particularly to so-called "feeder veins" that lead to the development of "spider veins", are forced shut by means of an injected sclerosing solution. This can be a liquid or a foam, depending on the situation. Though this is a popular means of providing temporary relief, varicose veins will generally reappear after sclerotherapy if there is major underlying venous incompetence. In most cases an ultrasound scan should be performed before sclerotherapy is commenced to avoid disappointing results.

Q24 What is 'ambulatory phlebectomy'

Ambulatory phlebectomy is a surgical method that - like sclerotherapy - targets the surface veins. It involves making multiple 2-3mm incisions in the skin, after which the varicose vein will be extracted, one segment at a time, with either forceps or surgical hooks. A local or regional anaesthetic is injected prior to the incision making, and the procedure takes place either in an operating room or the "procedure room" of a physician's office. This procedure is frequently performed as an accompaniment to Endovenous surgery (VNUS or EVLT).

Q25 What is involved in the 'vein stripping' procedure?

Vein stripping is a surgical procedure which was used to treat major varicose veins. It usually required general anaesthesia, involved larger incisions/ stitches and slow return to full activity. During this procedure, the vein is either removed completely or in segments (Swollen or bruised legs may persist afterwards for a period of 1-2 weeks; a common complication of the surgery). This procedure is rarely if ever required nowadays.

Q26 When should I consider endovenous surgery by either Venefit (VNUS) or Endovenous laser therapy (EVLT)?

Endovenous surgery is similar to vein stripping in that it targets the saphenous vein and stops retrograde flow of blood in the leg that causes varicose veins. It shares many of the postoperative complications of vein stripping, making pre-operative consultation with a surgeon, and assessment of risks and benefits, a clear prerequisite.

Paresthesia - the feeling of pain, pins and needles and numbness (more commonly known as the "falling asleep") can occasionally occur, may take up to two years to recover, and can sometimes be permanent. Blood clots, a temporary sensation of heightened sensitivity in the operated area, and an ankle swelling are also reported complications, but are rare.

Q27 What is the difference between veins and arteries?

Arteries are those blood vessels which carry oxygenated blood from the heart to the bodies organs (two notable exceptions are pulmonary and umbilical arteries, which deliver de-oxygenated blood). Veins essentially reverse this process by transporting de-oxygenated blood back to the heart.

Q28 How many different categories of veins exist?

Deep veins, superficial veins, and perforator veins are the three categories of veins in the leg. Deep veins, as noted in the previous answer, return de-oxygenated blood to the heart and are situated close to the leg bones in the centre of the limb. Superficial veins, meanwhile, are much closer to the skin's surface, and carry a much lower volume of blood than deep veins. They are also not as well supported by the nearby tissues as deep veins are, which makes them more susceptible to becoming swollen and tortuous. These will then turn into varicose veins once they have expanded abnormally. Lastly, the perforator veins act as a 'bridge' between the aforementioned types of vein, transferring blood from the superficial venous system to the deep veins.

1 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.

2 Goldman, H. Closure of the greater saphenous vein with endo radiofrequency thermal heating of the vein wall in combination with ambulatory phlebectomy: preliminary 6-month follow-up. Dermatology Surg 2000; 26:452-456.

3 Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of saphenous reflux: a multicenter study. J Vasc Surg 2002;35:1190-6.

4&7 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

5 Whiteley, MS, Holstock JM, Price BA, Scott MJ, Gallagher TM. Radiofrequency Ablation of Refluxing Great Saphenous Systems, Giacomini Veins, and Incompetent Perforating Veins using VNUS Closure and TRLOP technique. Abstract from Journal of Endovascular Therapy 2003; 10:I-46.

6 Pichot O, Sessa C, Chandler JG, Nuta M, Perrin M. Role of duplex imaging in endovenous obliteration for primary venous insufficiency. J. Endovasc Ther 2000;7:451-9.

The VNUS Closure™ procedures treat leg veins in the superficial and perforating systems that have venous reflux, the underlying cause of varicose veins. Patients with thrombus (blood clots) in the vein segment to be treated should not have the VNUS Closure procedures. Individual results may vary based on each patient’s condition. As with all medical procedures, potential risk and complications exist including vessel perforation (when the catheter punctures the vein wall), thrombosis, pulmonary embolism (when a blood clot travels to the lungs), phlebitis (inflammation of the vein), infection, nerve damage, arteriovenous fistula (an abnormal connection between an artery and a vein), hematoma (bruising), and skin burn. Consult with a physician to receive more information.

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