VNUS Radiofrequency for Treatment of Varicose Veins
Innovative VNUS Radiofrequency, Laser and Other Options for Treatment of Varicose Veins
Venous Reflux Disease
Traditional and Minimally Invasive techniques
Once the vein valves are damaged or “incompetent” they cannot generally be repaired with a great deal of success. The veins themselves do not have a crucial function and if removed will not result in any problems with the return of the blood to the heart. In fact, these veins are frequently removed in patients with heart disease to use in heart bypass operations. Therefore, the surgical treatment of varicose veins is by removing or obliterating these superficial veins. The traditional method is open surgery but newer techniques of minimally invasive endovenous surgery (Laser EVLT, or radiofrequency VNUS ablation techniques) have also become available in the past decade.
This section explains the traditional open surgery and the newer minimally invasive (endovenous) techniques offering detailed descriptions of each. Please click on the links to open the pages as necessary
Traditional open surgery for varicose veins
The traditional procedure of choice is sapheno-femoral ligation (or sapheno- popliteal junction) and stripping of the long saphenous vein (or short saphenous vein) with or without multiple stab avulsions of the tributaries of these main truncal veins. It is otherwise known as high tie, strip, and avulsions. This is performed under a general anaesthetic and the procedure duration is approximately 20 – 60 mins depending on the extent of surgery required, whether one or both legs are being treated, and whether first time surgery, or a re-do operation is carried out.
The procedure of high tie, strip, and avulsions
The procedure involves a horizontal incision in the top of the leg approximately 1-2 inches (2.5 – 5 cms). The sapheno-femoral junction is then dissected out and divided with ends of veins suture closed. The long saphnous vein is then stripped out through the lower end of the thigh by making a small (1/4 inches or 0.5 cm) incision to allow delivery of the vein. A metal or plastic stripper is required for this purpose which is passed through the vein lumen down the thigh and grasped through the small incision previously made in the lower thigh.
Once the main trunk of the vein is removed, the tributaries of this vein can be avulsed through stab incisions (1-2 mm) and hooked out using a special instrument. The number of these stab incisions depends on the number of these tributaries present and how extensive the varicosities are.
Following surgery, the wounds are closed (with absorbable sutures), the leg is bandaged in a compressive dressing and patient then transferred to the recovery area to come through the general anasethetic. The recovery process is varied depending patient’s susceptibility to anaesthesia and may take ½ hour to several hours. Most procedures carried out in the morning allow patients to return home the same day. Prior to discharge, the bandage is replaced by compression stockings which should be kept on for around 2 weeks. It is possible to take a shower after about 2 to 3 days following surgery. A follow up visit is arranged around 4-6 weeks after discharge to ensure quality control. It is expected that the legs will develop a variable amount of bruising which will settle with time.
Pros and Cons of open surgery
The advantage of open surgery is in its long term history of success. It is a very effective and durable and safe procedure in hands of experts that has proven success and history of decades of experience. It also confers the advantage of removing all the veins that contribute to symptoms in one operation; also, it can be applied to any patient with varicose veins.
The disadvantages are that the surgery requires a general anaesthetic and an incision in the top of the leg is needed (both are avoided in minimally invasive techniques – see below).
Newer anaesthetic techniques have made modern general ansesthesia a very safe practice which means the vast majority of people will have no serious ill effects from the anaesthetic; however, less serious side effects still can be encountered such as nausea and vomiting.
Complications of open surgery
Broadly speaking, the nature of these is similar to minimally invasive procedures. The techniques vary however, in the frequency of the complications.
The success of any open surgery procedure is measured by:
Effective removal of the varicose veins responsible for symptoms
Early complications (such as infection, bleeding, pain, deep vein thrombosis, haematoma)
Late complications (numbness, scarring, discolouration, nerve damage, and recurrence of veins)
Acceptability by patients
It is argued that adequate removal of long saphenous vein (stripping main truncal superficial vein) in expert hands along with avulsion of tributaries results in effectively treating the cause of high venous pressure (and hence varicose veins) within the leg. What’s more this can all be done during the same procedure if carried out under general anaesthetic.
Infection following surgery
Any wound can become infected and this also applies to surgical wounds. However, because the theatre environment is clean and experienced surgeons are careful with the handling of tissues and wound closure, the incidence is very low indeed. To further lessen the chance of infection we give a dose of prophylactic antibiotics during the procedure and advise patients to avoid soaking in a bath or Jacuzzi for a week after the operation – brief showers are fine from the second or third day after surgery.
Methecillin Resistant Staphylococcus Aureus or MRSA is a common cause for concern specially with patients being treated in hospitals. Colonisation of skin with MRSA is frequently found in the population and this bacteria causes no harm on intact skin. If it contaminates a surgical wound however, it can delay healing or even cause an infection which is more serious and can be life threatening if it gets into the blood to cause septicaemia. With procedures such as varicose vein surgery it is very uncommon for patients to develop problems with MRSA as hospital exposure is quite short (mostly day case treatment). Most people are nowadays screened for MRSA prior to their surgery and if found on skin or nose, surgery can be postponed for eradication prior to re-scheduling the operation. Eradication can sometimes be difficult to achieve and in those circumstances a decision needs to be made to whether proceed to surgery given the small potential risks.
Acceptability by the patients
Beyond the first 2 weeks following varicose vein surgery, most patients report very satisfactory results with surgery in terms of removal of the varicose veins and the source of their symptoms. Most return to normal daily activities and work within 10 days to 2 weeks, able to function without the dull, dragging pain associated with varicose veins. However, in circumstances where both legs have varicose veins, most patients choose to deal with one leg at a time to reduce the postoperative discomfort.
Bruising and pain
Post-operative bruising and lumpiness is the norm – especially where there have been many varicosities. This clears completely with time. Sometimes a tender red line may appear on the inside of the thigh in the first week or two after the operation. If it appears following open surgery it is related to bleeding into the space that the long truncal vein (the long saphenous or the short saphenous veins) occupied causing a haematoma (collection of blood). In the context of minimally invasive surgery it is due to thrombophlebitis. In either case, it can be a source of pain or discomfort but will settle in about 2 weeks. It is not an infection – merely the body’s reaction to blood clot in the strip track or the residual vein which has been treated by LASER or VNUS Radiofrequency.
Also, given the more invasive nature of open surgery, some patients experience pain from the surgical site. Careful surgery and the use of long-acting local anaesthetic injections in the wound allows better post operative pain control and permits the all-important early mobilization.
Late complications
Occasionally, tiny skin nerves may be bruised, leading to numb areas; but this usually clears in the months after the operation. It is most unusual for experienced surgeons to damage the larger nerves - the saphenous and sural nerves - to the extent that there are permanently numb areas. With difficult redo surgery behind the knee there are reports of damage to a nerve in that area (the common peroneal nerve) which results in permanent weakness to some of the muscles to the foot.
Deep vein thrombosis is a reported major but thankfully rare complication. The patients are encouraged to elevate their legs (when not walking) and to wear support stockings until they are fully mobile to reduce risks of DVT further.
Recurrence of varicose veins is a perennial problem no matter which technique is used. Now a days, and in the context of open surgery performed by an experienced vascular surgeon, this should be a much reduced event. Never the less, this still happens more often than should. Recurrence rates of 13% after 2 years and 62% after 6.5 years have been observed. Most of these are only manifest on ultrasound scanning and may not necessary indicate a return to initial symptoms.
There is evidence to suggest that it is caused in most cases by a process known as “neo-vascularisation”. This simply refers to a process of new vessel formation following injury (or trauma of surgery) to allow improved healing in damaged tissues. However, this is an unfavourable outcome in the setting of varicose vein surgery as it can result in re-establishment of the connections between the superficial and the deep veins. Ultimately, it can lead to re-appearance of varicosed tributaries (side branches) as a consequence of increased pressure within the superficial venous system.
Minimally invasive (endovenous) technique
The concept of minimally invasive surgery (endovenous surgery), whether by laser (EVLT) or with radiofrequency (VNUS) techniques is to replicate the effect of surgery in removing the source of increased pressure (venous reflux) within the superficial veins . They do this by obliterating the junction between the superficial and deep veins (Sapheno-femoral junction) and stopping the flow within the main trunk of the superficial vein in the leg (long saphenous vein). Successful endovenous ablation requires delivering enough heat to cause irreversible injury to the vein (leading to occlusion) without causing heat injury to surrounding tissues and skin. In the case of foam sclerotherapy is involves adequate perfusion of the foam sclerosant solution into the truncal vein and branches to cause permanent occlusion. In terms of efficacy, the results of EVLT, VNUS, and sclerotherapy are similar.
The advantages of the minimally invasive techniques are that they achieve this without the need for a surgical incision the groin (top of the leg) and can be carried out without general anasesthetic. They achieve this by causing blockage and scarring inside the main superficial vein without a need for removing this vein. The blocked vein shrinks and eventually disappears with time.
These “key-hole” methods of treating veins are generally significantly less painful than “traditional” high tie and strip surgery. However, the body can react to the treated vein and give rise to discomfort along its course on the inside of the thigh or back of the calf. The medical term for this reaction of the body to the altered vein is thrombophlebitis. If it occurs the discomfort is usually tolerable. However, if bothersome, it responds nicely to medication like Nurofen or Voltarol.
Radiofrequency VNUS technique
This technique can be carried out under local anaesthetic and without any need for surgical cuts. It can be carried out as an outpatient procedure and patients are allowed (and in fact are encouraged) to start walking almost as soon as the procedure is completed.
Radiofrequency (RF) catheters were first used in the endovenous treatment of varicose veins over 50 years ago. It uses a small electrical current to heat the tip of the catheter placed inside the vein. Today the most effective RF method uses the ClosureFAST catheter technique by VNUS Medical Technologies.
Detailed procedure of VNUS radiofrequency ablation
A disposable catheter (fine tube) is introduced into the main leaky varicose vein (at the level of the inner side of the knee) through a small opening in the skin. The catheter is then passed up the vein in the thigh to the level of the junction with the deep vein (sapheno-femoral junction). Local anaesthetic (tumescent solution of 300m of normal saline, 50 ml of 1% lidocaine with 1:100,000 adrenaline ) is introduced around the vein. This has the effect of dissipating the heat produced by the VNUS catheter and reduces pain. The surgeon will position the closure catheter into the diseased vein under ultrasound guidance. The tiny radiofrequency powered catheter will deliver a computer controlled high frequency electrical current (heat) to the diseased vein wall leading to shrinkage and complete closure of the varicose veins. After the diseased vein segment is closed the catheter is pulled back and the cycle repeated all the way down the thigh to the point of entry of the catheter into the skin. Once the long truncal vein (long saphenous vein) is closed blood flow is re-routed to other healthy veins in the limb. Following the procedure, full length class II compression hosiery (stockings) is applied and worn for 2 weeks, removed only for showering. Immediate ambulation is encouraged and the patients return to normal activities within 24 hours. The occluded varicose veins will then be obliterated and slowly removed by the body in the following months.
The RF catheter delivers heat energy to the vein wall resulting in thrombosis and structural damage to the vein wall protein leading to contraction and fibrosis of the vein. The RF heat energy is similar to that produced by the EVLT technique (68 J/cm) with the difference that the upper most segment receives a second cycle of treatment to ensure adequate closure of this important first part of the vein. The RF technique works best when the catheter is in direct contact with the vein wall to effectively deliver the heat energy. The procedure is therefore carried out with the leg in the trendelenberg (elevated) position.
What is ClosureFAST VNUS technique?
Recently, a newer version of the VNUS catheter has been introduced with improved efficacy and shorter treatment cycles. Unlike the older VNUS device, the ClosureFAST catheter delivers a higher energy at 120° C with 20 second treatment cycles to 6.5cm segments of vein at a time. The older VNUS catheters would deliver heat at 85°C using a continuous pull back of 2.5-3cm/sec. A given 45cm segment of the truncal vein (e.g.; the long saphenous vein) will take 3-5min to treat with the ClosureFAST catheter compared to 18-24min with the older VNUS catheters.
How good are the results of the VNUS technique?
The success of any VNUS procedure is measured by:
Effective removal of the varicose veins responsible for symptoms
Early complications (such as infection, bleeding, pain, deep vein thrombosis, haematoma)
Late complications (numbness, scarring, discolouration, nerve damage, and recurrence of veins)
Acceptability by patients
Results indicate that immediate closure of the truncal vein using VNUS technique is very encouraging with the majority of reports in the literature indicate that 90% of the veins remain occluded at 2 years and one recent study observed persistent closure rate of 88% at 3 years.
The advantages of VNUS ablation include; no need for general ansaethetic or a cut in the groin, less postoperative pain, earlier ambulation and return to work compared to open surgery. Also, available literature indicates better acceptability by patients according to results of quality of life questionnaires filled in by patients after their procedures.
Reported complications following VNUS technique occlusion of varicose veins include deep vein thrombosis (DVT), paraesthesia (usually numbness), pain, bruising, localized heat injury to skin, haematoma (collection of blood under skin) and superficial thrombophlebitis (pain, inflammation along the course of treated vein). The most serious of these, DVT, is generally less than 1% (although we have not seen a case in our practice). Paraesthesia occurs in 2-16% of patients but is temporary in majority of cases.
Laser EVLT technique
This technique can be carried out under local anaesthetic and without any need for surgical cuts. It can be carried out as an outpatient procedure and patients are allowed (and in fact are encouraged) to start walking almost as soon as the procedure is completed.
Detailed procedure of Laser EVLT ablation
The laser fibre is introduced into the main leaky varicose vein (at the level of the inner side of the knee) through a very small opening in the skin. The fibre is then passed up the vein in the thigh through the long saphnoeus vein to the level of the junction with the deep vein (sapheno-femoral junction). Local anaesthetic (tumescent solution of 300m of normal saline, 50 ml of 1% lidocaine with 1:100,000 adrenaline ) is introduced around the vein. This has the effect of dissipating the heat produced by the VNUS catheter and reduces pain. The surgeon will then position the closure fibre into the diseased varicose vein under ultrasound guidance. The fibre will deliver laser light (heat) to the diseased varicose vein wall leading to shrinkage and complete closure of the varicose veins. After the diseased vein segment is closed the fibre is pulled back and the cycle repeated all the way down the thigh to the point of entry into the skin. Once the long truncal vein (long saphenous vein) is closed blood flow is re-routed to other healthy veins in the limb. Following the procedure, full length class II compression hosiery (stockings) is applied and worn for 2 weeks, removed only for showering. Immediate ambulation is encouraged and the patients return to normal activities within 24 hours.
The occluded varicose veins will then be obliterated and slowly removed by the body in the following months.
Unlike radiofrequency ablation for which there is a standard treatment protocol using a single device, laser ablation can be performed using a variety of laser sources and intensities of energy delivery.
Most studies describing EVLT have used either 810nm or 980nm diode lasers as this is the range at which red cells absorb red/infrared light (800-1000nm). In fact, the available evidence suggest that the type of laser used is not as important as the laser heat dose in achieving adequate vein occlusion.
How good are the results of Laser EVLT ablation?
The success of any EVLT procedure is measured by:
Effective removal of the varicose veins responsible for symptoms
Early complications (such as infection, bleeding, pain, deep vein thrombosis, haematoma)
Late complications (numbness, scarring, discolouration, nerve damage, and recurrence of veins)
Acceptability by patients
The occlusion rates (how many of the treated veins remain closed) after EVLT are in most series over 95% in the short term (about one month) and although this number reduces (some veins re-open) on follow up in good hands this is still between 85%- 95% after 1-2 years. It is unlikely for veins to recur (re-open) after this time.
Complications of EVLT are similar to open surgery although infection, bleeding, and haematoma are noticeably less frequent. It is difficult to be certain about other complications such as deep vein thrombosis, numbness, or nerve damage because the true incidence of these are not well documented in open surgery and there are wide variation in what is reported.
The key to successful ablation is adequate closure in the first treatment. In majority of cases of recurrence the vein has either not completely closed off (residual flow persists) or is closed off by thrombosis only. This indicates inadequate laser energy delivery to the vein wall which is crucial for ablation. In this instances laser heat only produces a thrombotic closure (clot in the vein) which can recanalise with time. The required energy for success is reported to be around 60-80 J/cm of vein treated with a laser pulse duration of > 1 second. As well as thrombosis, this also brings about damage to the vein wall by causing structural damage to the protein in the wall resulting in contracture and fibrosis of the entire vein segment treated.
Other advantages of laser ablation include; no need for general ansaethetic or a cut in the groin, less postoperative pain, earlier ambulation and return to work compared to surgery. Also, available literature indicates better acceptability by patients according to results of quality of life questionnaires filled in by patients after their procedures.
Foam sclerotherapy techniques
Sclerotherapy has been in use in the UK mainly for treatment of spider or reticular veins(smaller skin veins unrelated to varicose veins). Its use for larger truncal varicosities has received some attention in recent years.
Detailed procedure of foam sclerotherapy ablation
The sclerosant solution, usually Sodium Tetradecyl Sulphate (STD) 1-3% or Polydocanol 0.5-1%, causes an occlusion(thrombosis) of the veins by inducing inflammation of the inner lining of the vein wall. Using it as a foam allows a smaller volume of the solution being used to avoid toxicity.
Foam sclerotherapy is usually carried out under local anaesthetic with patient lying down flat. Using ultrasound the position of the vein is determined and a cannula (a fine needle) is placed through the skin into the vein. The foam solution is introduced in the vein under and followed using ultrasound as it fills the vein up. More than one cannula may need to be inserted if different veins are being sclerosed.
Once the long truncal vein (long saphenous vein) is closed blood flow is re-routed to other healthy veins in the limb. The occluded varicose veins will then be obliterated and slowly removed by the body in the following months.
How good are the results of foam sclerotherapy ablation?
The success of any foam sclerotherapy procedure is measured by:
Effective removal of the varicose veins responsible for symptoms
Early complications (such as infection, bleeding, pain, deep vein thrombosis, haematoma)
Late complications (numbness, scarring, discolouration, nerve damage, and recurrence of veins)
Acceptability by patients
Limited available evidence suggests that, performed efficiently, foam sclerotherapy achieves comparable results to surgery both in terms of causing fibrosis and disappearance (92% at 1 month and 82% at 1 year).
Foam injection sclerotherapy produces an intense thrombophlebitis (inflammatory process extending outside the vein wall) which can be painful and frequently leave brown skin-staining that may not resolve. The incidence of this in the available literature is around 4.7%. Furthermore, the recurrence rate is significantly higher than endovenous and traditional surgery.
Although the complication rates of sclerotherapy are generally minor, more serious adverse events have been reported. These include deep vein thrombosis and anaphylaxis (sudden allergic reaction to the sclerosant solution). An additional worrisome side-effect is that the foam may travel in the blood stream to the brain and cause visual disturbances, migraine and even stroke. For these reasons, the National Institute for Clinical Excellence (NICE) in the UK has advised that it should only be used with special arrangements for consent and audit, or in research settings. We only recommend it in certain unusual situations; for example in treatment of side branch veins left after treatment of varicose veins; i.e.; micro-injection foam sclerotherapy.
Quality of life questionnaires filled in by patients after surgery also indicate better patient acceptability of foam sclerotherapy compared to surgery and earlier mobilisation and return to work.
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