Abstract:
The management of varicose veins (VVs) has undergone significant change in the last 5 years. Traditional surgery and varicose vein injection is being overtaken by minimally invasive endovascular techniques involving catheters, lasers, radio-frequency ablation and intraoperative duplex scanning.
The use of foam sclerotherapy has also rejuvenated the injection technique and made decision-making about the correct form of treatment for each individual quite difficult. This has led us to question the other more conventional ways of treating such varicosities. (Historically the definitive treatment for varicose veins has been surgical removal).
This written piece of work is based on a literature search and visits to a one-stop VV clinic and a varicose vein theatre.
It focuses on the pre-operative assessment as well as the new management techniques concluding with some thoughts about the strengths and weaknesses of each treatment modality and finally which patients are most suitable for a specific treatment.
Aims:
The aims of my assignment are to review the treatments for varicose veins and look at how the management has evolved over the past decade; to review the evidence regarding interventions (compression hosiery, sclerotherapy, surgery and endovenous techniques) for varicose veins. Reviewing numerous articles has helped me come to my own conclusions in this rapidly developing area of new methods to treat this historic venous disease. The aim of this review is to look at the available interventions and the evidence for their use in patients with VVs.
Method/Methodology: (Put this under the Appendix?)
Systematic literature searches of medical databases (PubMed, EMBASE, MEDLINE(Via PubMed), Web of Science, and The Cochrane Library) was performed in April 2010 to identify suitable studies and reviews that were published from 1994 until the present day.
Also; extended searches were made via internet web sites and manual searching of journals. Recently published, well-conducted systematic reviews and primary studies were selected for inclusion in this systematic review.
Interlending and Document Supply was also used as a service provided by the Lancaster University Library.
Search Strategy:
Key Words: Varicose Veins, Management, Sclerotherapy, Varicose Vein Surgery, Ligation, Stripping, Laser Ablation Varicose Veins (EVLT), Radiofrequency Ablation, Varicose Vein Treatment, Recurrent Varicose Vein.
Using the MESH terms, searching different fields and applying limits.
Introduction:
A decade ago a patient suffering from varicose veins (VVs) was given the option of having injection sclerotherapy or surgery. Only these two techniques have existed for long enough to know about their long term results. However the results have shown high recurrence rates with time. {1 from JLO HARE}
In the past few years we have seen an explosion in the types of minimally invasive treatment technique used for VVs. This has lead to decision making for VVs treatment much more complicated. New techniques include: thermal ablation in the form of endovenous laser ablation (EVLA) or radiofrequency ablation (RFA), and foam sclerotherapy. {2 from JLO HARE}.
Varicose Veins (VVs) are enlarged long tortuous and dilated superficial veins of the leg, generally greater than 3 mm in the upright position. (They can also be found on the abdominal wall, anus, vulva and the oesophagus). They are caused by malfunctioning valves in the veins and decreased elasticity of the vein wall, allowing pooling of blood within the veins, and their subsequent enlargement.
Varicose Veins are often easily visible.
Anatomy:
The short/small saphenous vein (SSV) and the long/great saphenous vein (GSV) are part of the superficial venous system. Most of the blood from the legs is returned to the heart via the deep vein legs; therefore if the GSV becomes varicotic then the blood is sent back to the heart via this collateral blood supply.
Figure 1 - Main superficial veins of the legs commonly affected by varicose veins.
Incompetence at the saphenofemoral junction in the groin is the commonest cause of reflux from the deep to superficial systems, but there are many other potential sites.
Incompetence of calf perforators is not (as was once believed) a common and important problem, and when present it is often corrected by long saphenous vein surgery. (The long and short saphenous veins are also called the great and small saphenous veins5
Epidemiology
Varicose veins are common in many populations. Prevalence rates of 10.4-23.0% in men and 29.5-39.0% in women exist. {[1] from S.Review of Tx for VVs. 2009 LEOPARDI}
They affect between 10% and 25% of the UK adult population {1 from P BACHOO}
Aetiology:
Currently there is no agreement on the sequence of events that ultimately cause the transformation of a vein into a VV. However evidence exists that suggests some key events that do occur:
Vein wall weakness due to alterations in the supporting tissues such as elastin and collagen {11 from P BACHOO)
Venous dilation resulting in valve incompetence and subsequent reflux
{12 from P BACHOO}
Some authors agree on this pathogenesis:
Varicosities occur when there is a lesion in the muscle cell of the vein wall. Fibrosis then develops and this leads to the vessel wall losing it's tone. Dilatation of the vein wall occurs between the valves. Eventually the valve ring also dilates, preventing valve cusps from meeting. This causes venous reflux. This affects the superficial veins and the perforators (SADAT - Browse et al, 1999).
Predisposing factors to the formation of varicose veins include: a positive family history (genetics), increasing age, female gender, multiple pregnancies, obesity and reduced physical activity.
{ Browse NL, Burnand KG, Irvine AT, Wilson NM (1999) Varicose veins; pathology. In: Browse NL, Burnand KG, Irvine AT, Wilson NM, eds. Disease of the Veins. Oxford University Press, New York: 145-62}
History: ?????? SORT OUT??????
Currently, due to the pressure on healthcare resources and waiting times, there is conflict about the appropriateness of using the limited healthcare resources in order to provide interventions for VVs.
The Randomized and Economic Assessment of Conservative and Therapeutic Interventions for Varicose Veins (REACTIV) trial suggests that the cost of varicose vein surgery in the UK is within NICE guidelines for quality adjusted life years {3 from JLO HARE} .
However it does conflict with the rapidly evolving field of minimally invasive venous interventions. Currently there is controversy and uncertainty amongst healthcare professionals and patients.
Clinical Examination and Assessment of patient with VVs:
A patient's suitability for varicose vein treatment is established through clinical examination to look at the source of the venous incompetence and the extent of the veins to be treated.
The patient should be standing upright so that the extent and size of the VVs and any further venous blemishes such as telangectasia may be visible.
The distribution of varicose veins may well suggest that they are related to the long or short saphenous system.
Sometimes a large varicosity that is palpable provides clinical evidence of an incompetent perforating vein. In the past tourniquet tests were used, such as the Trendelenberg test. But theses have been abandoned by vascular specialists as they are inaccurate and out of date, they have been overtook by the use of ultrasonography.
Sites of venous incompetence are best diagnosed by duplex ultrasound scanning {6} which is being done more and more during initial specialist assessment. {7}
Duplex scanning shows both venous anatomy and blood flow and is essential for assessing more complex cases.
Use of a hand-held Doppler machine provides a quick screening test for selecting those who need duplex scanning. {8}
Doppler has been reported to have sensitivity and specificity of 97% and 73% respectively for identification of saphenofemoral junction reflux (SADAT - Kim et al, 2000).
The main indications for a duplex scan are:
Reflux in the popliteal fossa
Recurrent VVs
Complex or unusual VVs
History of DVT.
The duplex scan is the most widely used test for the diagnosis and management of chronic venous disease before a definite treatment plan is made. It can accurately localise valvular reflux, delineate venous anatomy, and rule out any deep venous thrombosis.
Symptoms of Varicose Veins:
Varicose veins can cause a variety of symptoms of discomfort in the legs. The Edinburgh vein study found that the symptoms significantly associated with varicose veins included:
Itching, varicose eczema
Aching pain - most common symptom - results from pressure of dilated vessels on the nerve fibres next to them.
Leg heaviness
Additional symptoms for varicose veins:
Leg fatigue
Superficial thrombophlebitis - rapidly spreading
Recurrent Thrombophlebitis -
External Bleeding
Hyperpigmentation
Lipodermatosclerosis ?
Venous Ulceration
All these symptoms call for a referral to a vascular surgeon or an intervention.
However, patients who present with cosmetic motives cannot be offered treatment for VVs on the NHS. Patients with recurrent deep vein thrombosis or recent deep vein thrombosis are not considered for surgical intervention.
{SADAT - Symptoms - LOOK AT GOLDMAN ET AL Reference.}
Results: 2000 - Treatment Options for Varicose Veins:
(Possibly have an adapted table - as in table 1 from M.J. Gough on Tx options)
There is a vast array of therapies available for treating varicose veins, including conservative therapies, non surgical, surgical and minimally invasive interventions. (See Adapted Table)
Conservative therapies tend to limit disease progression, they are recommended in asymptomatic patients or those with mild to moderate symptoms. Lifestyle changes, including physical exercise and weight loss, as these help promote blood circulation.
Patients would also be discouraged from prolonged sitting or standing and advised to elevate the affected limbs whenever possible to reduce pressure on impaired vein valves.
Compression Support Hosiery/Stockings 200
Compression stockings provide relief for VV symptoms (such as pain, leg heaviness and oedema), whilst improving the venous circulation (haemodynamics). {6 from LEOPARDI}
They do not treat the underlying pathology.
Compression support of the legs has many benefits of use in superficial venous disease. Sometimes compression stockings are used as a first line of treatment/primary treatment method. For instance in patients with symptomatic VVs, Although the precise mechanism is unclear, the external graduated compression (radial compression) of the dilated varicosities helps venous drainage from the superficial system towards the deep venous system. This reduces venous hypertension and the complications that result from it. (SADAT - Sigel et al, 1973; Cornwall et al, 1987; Mayberry et al, 1991).
Classification systems for the level of compression may vary but in the UK compression stockings are divided into three different classes based on their radial compression force:
Class 1 - 15 - 20 mmHg;
Class 2 - 20 - 30 mmHg;
Class 3 - 30 - 40 mmHg.
Usually class 2 compression stockings are used during the day which provide moderate compression.
Compression stockings can also be used as an adjunct after an invasive intervention, such as surgery, sclerotherapy or endovenous ablation therapies. Compression after an intervention reduces the risk of thromboembolism, provides comfort and may also contribute to a quicker recovery time. The optimum period of compression after an intervention is yet to be determined. (However there seem to be few benefits after one week of wearing them). {46 from P BACHOO}
Compression stockings are contraindicated in peripheral vascular disease, so peripheral pulses should always be checked before prescribing them.
Sclerotherapy:
Conventional sclerotherapy is mainly used to treat small varicose veins which includes telangiectasias and reticular veins (FROM SADAT - Baccaglini et al, 1996).
However, there is no real compromise in using sclerotherapy for treating long VVs and perforators (SADAT - Baccaglini et al, 1996).
Sclerotherapy occurs as an outpatient procedure under local anaesthetic, it involves the injection of a liquid chemical/sclerosant into the abnormal vein to initiate inflammation, occlusion and scarring. {6 from LEOPARDI} The damaged vein collapses and eventually fades. The commonly used sclerosing agents are chromated glycerine 25-100%, polidocanol 0.2-1% or sodium salicylate 6-12% (Baccaglini et al, 1996). Ultrasound is used to guide the sclerosant injection directly into the GSV to treat larger and deeper varicosites. {6 from LEOPARDI}.
This technique has been available for many decades {50 from P BACHOO}. It became popular in 1971 when Henry and Fegan published results on its success in treating venous ulcers (51 from P BACHOO}.
It is an ideal choice for the treatment of post-operative veins left behind and VV recurrences.
Sclerotherapy is more effective than compression stockings, but less effective than surgery, at improving symptoms and cosmetic appearance.
Injection sclerotherapy has a 20% to 70% long-term recurrence rate and can persist, compared to surgery. (SADAT - Piachaud and Weddell, 1972; Beresford et al, 1978).
Patients who undergo injection sclerotherapy do suffer from transient phlebitis which usually takes at least 7-10 days to settle. Approximately 25% of patients suffer from skin staining due to the irritant sclerosant, making it an unattractive treatment option for patients.
Foam sclerotherapy mixes air or gas with the sclerosant to produce a foam, allowing a small amount of of sclerosant to cover a larger surface area by displacing blood within the vein.{6 from LEOPARDI}
This means it can spread widely through the lower limb veins (SADAT - Cabrera et al, 2001).
Sclerosant can be injected via a catheter, allowing targeted and selective treatment.{7 form LEOPARDI} under supervision of ultrasound guidance.
The advantages of this therapy include; low cost and short treatment times on an outpatient basis (SADAT - Tessari et al, 2001; Frullini and Cavezzi, 2002).
However, phlebitis remains a problem as it is for injection sclerotherapy. As foam sclerotherapy can be repeated, failure to obliterate the long saphenous vein completely is less of an issue.
Surgery: 300 (US)
Surgery for VVs was first mentioned over a century ago {69 from P BACHOO}, yet it remains at the heart of the treatment for VVs. {70 from P BACHOO}.
Careful informed consent is a vital part of the procedure in order to reduce the risk of medical litigation, since varicose vein surgery is a common cause. ({71 - 74 BACHOO}
Many parts of the procedure can affect the outcome, such as stripping the GSV to minimise chances of recurrence. {75 - 77 BACHOO}
Stripping does, however, increase postoperative morbidity, including pain, bruising and sensory loss in up to 40% of patients.{78 BACHOO}
Although surgery has been perceived to be the gold standard treatment for varicose veins, the patient may just have small varicose veins and the ideal treatment for small veins is non-surgical.
Saphenous Vein High Tie and Stripping:
This is the traditional method of treating symptomatic varicose veins in LSV or SSV. Junction ligation with or without vein stripping is generally appropriate when the GSV and SSV have reflux or incompetence is demonstrated on duplex scanning.
This is usually done as an inpatient procedure under general anaesthetic. Junction ligation involves tying off the vessel at the SFJ or SPJ. {3 from LEOPARDI}
Ligation on its own leads to high rates of VV recurrence.
Thus patients often need to have sclerotherapy afterwards. (This is after care treatment) {8 form LEOPARDI}
In most cases, ligation is accompanied by GSV stripping and is generally regarded as the treatment for choice for VVs. {3 from LEOPARDI}
Following ligation of the GSV and tributary veins, an incision is made in the groin and knee or ankle.
Next a stripper is inserted into the patient's vein and passed either down from the groin to the knee or up from the ankle to the groin.
Then end of the GSV is tied onto the stripper, which is gently withdrawn, removing the vein within it. {9-10 from LEOPARDI}
Complications include bleeding, haematoma formation, wound infection, bruising, pigmentation, nerve damage, patches of numbness in the operated leg and recurrence. The bruising usually settles in 2-3 weeks, but pigmentation may be permanent.
Postoperatively patients are encouraged to mobilize the next day with good analgesic cover usually required in the form of NSAIDs. Compression dressings are removed on the first postoperative day. Some authors advise patients to wear compression stockings for 3-4 weeks and take analgesics as required. Patients can perform day-to-day activities as soon as they feel fit enough to do so, with return to a desk job in 7- 10 days and to physical jobs in 2-3 weeks.
Surgical interventions are necessary when ones symptoms impose on their quality of life.
Phlebectomy:
Following removal of the GSV, calf and thigh varicosities are usually dealt with by individual phlebectomies. The use of phlebectomy instruments allows this to be performed through micro-incisions. {82 BACHOO}
Transilluminated powered phlebectomy is a new device that can remove superficial veins over a wide area using fewer incisions, but it is associated with significant postoperative pain, increased bruising and sensory deficits are common. This method decreases the usual improvements in Health related QoL after varicose vein surgery.{83 - 87 from P BACHOO}
Phlebectomy involves removing abnormal veins below the saphenofemoral junction (SFJ) and saphenopoploteal junction (SPJ), but not including the GSV or SSV.
This procuedure is best used on larger veins without venous reflux. Under Local anaethetic, small incisions are made and large superficial varicosites are removed using a phlebectomy hook.
Avulsions:
Stripping is not done for the LSV below the knee due to the high risk of damage to the saphenous nerve, accompanying avulsions are carried out through 2mm stab incisions which are usually closed with steri strips. However, large incisions may require a single inverted absorbable suture.
They usually come off on their own in 5-7days with no further dressing required.
Isolated avulsions can also be performed in case of isolated varicosities under local anaesthesia with accompanying high tie and stripping especially in cases of recurrences.
Minimally invasive - Endovenous Tecniques:
Modern technology has made it possible for minimally invasive techniques to be developed for the treatment of VVs. These are an alternative for the management of incompetent GSV and SSV. These new techniques include endovenous laser therapy ablation (EVLA) and radiofrequency ablation (RFA).
Although these are done by different technologies, the basic mechanism of action is similar, with initial endothelial and subendothelial thermal damage with organisation of thrombus and subsequent vein wall damage. {88 BACHOO}
The vein may subsequently disappear as normal healing leads to reabsorption and elimination of the vein from the leg.
In both techniques, the procedure can be performed in the conscious patient using regional anaesthesia. The early and intermediate outcomes, occlusion and QoL following RFA/EVLA are summarised in Table * {See TABLE 2 in P.BACHOO and adapt my own table from this}.
EG: (But adapted version of this for the studies I have found).
RFA and Endovenous Laser therapy (ELT), both involve inserting a heat-generating laser fibre or radiofrequency catheter into the incompetent long saphenous vein, positioned just below the SFJ or SPJ, under ultrasound guidance and then ablating the vein in sections. This avoids a groin incision and may lead to less bruising and quicker recovery.
Heat is generated through laser (ELT) or radiofrequency (RFA) energy, and as the fibre or catheter is slowly removed down the length of the vein, endothelial and venous wall damage occurs. This causes contraction of the vein wall and ultimately destruction of the vessel. {11-15 from LEOPARDI}
Disadvantages of these techniques include them requiring dedicated equipment and use of intraoperative duplex ultrasonography, and they take longer to do than conventional surgery in experienced hands. The amount of benefit for patients is variable: obvious VVs still need to be treated, and phlebectomies of large veins are often the main cause of bruising and discomfort after the operation-not the groin incision.
Varying longer term results (two to three years) have been reported, but in general outcomes seem similar to those of surgery. {15 BACHOO?}
It has been suggested that endovenous ablation techniques may lead to less neovascularisation in the groin than surgical dissection, so reducing this cause of recurrence of varicose veins.
Radiofrequency Ablation: (VNUS) (US) 600
Radiofrequency ablation using the VNUS Closure procedure (VNUS Medical Technologies Inc., California) was first used in Europe in 1998.
Since then, it has been used mainly in private settings in the UK.
It involves passage of a radiofrequency ablation catheter into the saphenous vein (long or short) through a small cut-down under ultra- sound guidance with the patient in 30° trendelenberg tilt. This can be done under general anaesthesia, when stab avulsions can be performed simultaneously, or under local anaesthesia with or without sedation. The part of the leg where the vein is ablated is compressed with an Esmark bandage to compress the vein around the catheter. Ablation is performed from just below the saphenofemoral junction downwards with target temperature set at 85±3 °C. In the authors' opinion, a patient with a vein diameter less than 2 mm or more than 12 mm, tortuous vein, or a thrombus in the vein is unsuitable for ablation. Vein occlusion rates 1week after the procedure are between 88 and 100% (Navarro et al, 2001; Tessari et al, 2001; Frullini and Cavessi, 2002; Rautio et al, 2002; Lurie et al, 2003). At 2 years, 85-90% of those treated remain occluded (Navarro et al, 2001; Rautio et al, 2002). Complete absence of symptoms or a significant improve- ment has been seen in 94-100% of patients (Navarro et al, 2001; Frullini and Cavessi, 2002) with patient satisfaction ranging from 92-100% (Cabrera et al, 2001; Navarro et al, 2001; Frullini and Cavessi, 2002; Rautio et al, 2002).
VNUS Closure FAST is a newer way of treating varicose veins, as fast as laser ablation devices, with minimal pain and bruising. The entire procedure, from insertion of the catheter to removal, can be completed in approximately 16 minutes - less than half the time required for previous radiofrequency-based procedures. Since the Closure FAST catheter received Food and Drug Administration clear- ance, many physicians in the USA and Europe have used the device, and it is now widely available.
The complications include thermal injury to the skin (0-3%) or saphenous nerve. Bruising, erythema or clini- cal phlebitis can be clinically significant in a small pro- portion of people. One of the downsides of this treat- ment modality is the high cost of the equipment. However, earlier return to normal activity and work may significantly reduce the number of lost working days.
Endovenous Laser Ablation: (US) 600
RAF and EVLA therapy are now effective methods of treating varicose veins with better cosmetic results and early return to normal activity which may significantly reduce the number of lost working days.
This method uses laser as the means of closing the saphe- nous vein in a similar manner to radiofrequency abla- tion. Min et al (2003) have reported the largest pub- lished experience of this technique with an early success rate of 98% with 93% of long saphenous veins remaining occluded at 2 years after the procedure. Complications include possible damage to the nerves surrounding the vein and burning of the skin, but in expert hands the incidence of complications should be minimal. Clinical studies with greater number of patients need to be reported to assess its efficacy as compared to radiofre- quency ablation and open surgery.
Cryosurgery/Cryostripping:
Investigators found that both surgical stripping and cryostripping of the GSV improved QoL. There was no difference in postoperative pain or sensory deficit at six months. Bruising was significantly less after cryostripping. {79 from P BACHOO}
Discussion: 250
Advantages
Disadvantages
Main Indications /
Preferred Patient Type
Compression Stockings
Patients who are completely unfit
Patients who establish deep vein occlusion or incompetence.
Surgery
Good follow up
Well Established
Well Investigated
Risks and Benefits known.
Usually General Anaesthetic
Long Recovery
Scarring and Pain
The Default Patient
Young and Primary VVs
Low Risk Individuals
Foam Sclerotherapy
Quick
Low Risk
Outpatient procedure
Cheap
Efficacy/Recurrence
Skin Stains/Cosmesis
Risks of CVA/MIs 1 in 10,000?
Default Patient
Redo patients
Unfit patient
EVLT
RFA(VNUS)
Minimal Invasion
Local Anaesthetic
Outpatient basis.
Expensive
No Long term Follow-up
Some Risks
?Efficacy?
Majority of patients with non tortuous and symptomatic GSV Varicosites
Cryostripping
The VV Discussion Table.
Recurrence rate is high in those with larger veins or venous reflux. {4 from LEOPARDI}
This is because they are easily recanalised. (the spontaneous restoration of the lumen of the saphenous vein after occlusion).
Complications…..
How the Mx for VVs has changed over the last 10 years/15 years?
Lots of nasty complications… - haematoma, infection, pain and scarring and sapenous nerve injury…
Which one(s) is the best one to use? And for which patients??
Why? Opinions I have generated over the course of the literature research..
Future directions
Longterm (10 year) Outcomes cannot be measured as these techniques are relatively new.
How Future research may be designed to overcome gaps and challenges faced?
Conclusions: and Evaluation:
SADAT:
Patients suffering from symptomatic varicose veins usu- ally have to wait for long periods before receiving investi- gations and treatment on the NHS. Although the advent of newer endovenous procedures has attracted significant attention because of the benefits of earlier return to work and better cosmetic results, this service is not unavailable on the NHS. It has to be borne in mind that these new techniques have been reported by enthusiasts in private settings, where there is less pressure of audit. There may be unreported complications and hesitation in presenting poorer results. So, before these treatment modalities replace the traditional methods in NHS, large multicen- tre randomized controlled trials have to be conducted. Another concern will be further prolonged waiting times in an already overstretched UK health system if the radi- ofrequency ablation and endovenous laser ablation serv- ice was to be provided on the NHS.
CAMPBELL:
Uncomplicated but symptomatic varicose veins remain a common health-care problem and are associated with reduced QoL. Without exception all interventions, regardless of their associated potential morbidity, considered thus far are efficacious and individually contribute to improved HRQoL. This is achieved at well within the target tariff set by the pub- licly funded health-care system in the UK. All inter- ventions principally abolish truncal reflux and either remove or occlude the incompetent axial venous conduit. Modern endovenous techniques differ from standard surgery in that general anaesthe- sia is not required and they may be performed in set- tings other than standard operating theatres. In order to offer endovenous techniques, clinical evaluation must be combined with detailed non-invasive imaging. If only surgery is to be considered, the role of preoperative duplex imaging remains unclear. At present there appears to be some evidence, albeit of varying quality/grade, to suggest that the endove- 16 nous techniques are superior to surgery in terms of QoL improvement and future recurrence. Future ran- domized studies will hopefully clarify issues of effec- tiveness between treatment options and provide insight into cost-effectiveness in both the short and long term.
Appendix
