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1.  Endovascular Laser Therapy for Varicose Veins 
Executive Summary
Objective
The objective of the MAS evidence review was to conduct a systematic review of the available evidence on the safety, effectiveness, durability and cost–effectiveness of endovascular laser therapy (ELT) for the treatment of primary symptomatic varicose veins (VV).
Background
The Ontario Health Technology Advisory Committee (OHTAC) met on November 27, 2009 to review the safety, effectiveness, durability and cost-effectiveness of ELT for the treatment of primary VV based on an evidence-based review by the Medical Advisory Secretariat (MAS).
Clinical Condition
VV are tortuous, twisted, or elongated veins. This can be due to existing (inherited) valve dysfunction or decreased vein elasticity (primary venous reflux) or valve damage from prior thrombotic events (secondary venous reflux). The end result is pooling of blood in the veins, increased venous pressure and subsequent vein enlargement. As a result of high venous pressure, branch vessels balloon out leading to varicosities (varicose veins).
Symptoms typically affect the lower extremities and include (but are not limited to): aching, swelling, throbbing, night cramps, restless legs, leg fatigue, itching and burning. Left untreated, venous reflux tends to be progressive, often leading to chronic venous insufficiency (CVI).
A number of complications are associated with untreated venous reflux: including superficial thrombophlebitis as well as variceal rupture and haemorrhage. CVI often results in chronic skin changes referred to as stasis dermatitis. Stasis dermatitis is comprised of a spectrum of cutaneous abnormalities including edema, hyperpigmentation, eczema, lipodermatosclerosis and stasis ulceration. Ulceration represents the disease end point for severe CVI.
CVI is associated with a reduced quality of life particularly in relation to pain, physical function and mobility. In severe cases, VV with ulcers, QOL has been rated to be as bad or worse as other chronic diseases such as back pain and arthritis.
Lower limb VV is a common disease affecting adults and estimated to be the seventh most common reason for physician referral in the US. There is a strong familial predisposition to VV with the risk in offspring being 90% if both parents affected, 20% when neither is affected, and 45% (25% boys, 62% girls) if one parent is affected. Globally, the prevalence of VV ranges from 5% to 15% among men and 3% to 29% among women varying by the age, gender and ethnicity of the study population, survey methods and disease definition and measurement. The annual incidence of VV estimated from the Framingham Study was reported to be 2.6% among women and 1.9% among men and did not vary within the age range (40-89 years) studied.
Approximately 1% of the adult population has a stasis ulcer of venous origin at any one time with 4% at risk. The majority of leg ulcer patients are elderly with simple superficial vein reflux. Stasis ulcers are often lengthy medical problems and can last for several years and, despite effective compression therapy and multilayer bandaging are associated with high recurrence rates. Recent trials involving surgical treatment of superficial vein reflux have resulted in healing and significantly reduced recurrence rates.
Endovascular Laser Therapy for VV
ELT is an image-guided, minimally invasive treatment alternative to surgical stripping of superficial venous reflux. It does not require an operating room or general anesthesia and has been performed in outpatient settings by a variety of medical specialties including surgeons (vascular or general), interventional radiologists and phlebologists. Rather than surgically removing the vein, ELT works by destroying, cauterizing or ablating the refluxing vein segment using heat energy delivered via laser fibre.
Prior to ELT, colour-flow Doppler ultrasonography is used to confirm and map all areas of venous reflux to devise a safe and effective treatment plan. The ELT procedure involves the introduction of a guide wire into the target vein under ultrasound guidance followed by the insertion of an introducer sheath through which an optical fibre carrying the laser energy is advanced. A tumescent anesthetic solution is injected into the soft tissue surrounding the target vein along its entire length. This serves to anaesthetize the vein so that the patient feels no discomfort during the procedure. It also serves to insulate the heat from damaging adjacent structures, including nerves and skin. Once satisfactory positioning has been confirmed with ultrasound, the laser is activated. Both the laser fibre and the sheath are simultaneously, slowly and continuously pulled back along the length of the target vessel. At the end of the procedure, homeostasis is then achieved by applying pressure to the entry point.
Adequate and proper compression stockings and bandages are applied after the procedure to reduce the risk of venous thromboembolism, and to reduce postoperative bruising and tenderness. Patients are encouraged to walk immediately after the procedure and most patients return to work or usual activity within a few days. Follow-up protocols vary, with most patients returning 1-3 weeks later for an initial follow-up visit. At this point, the initial clinical result is assessed and occlusion of the treated vessels is confirmed with ultrasound. Patients often have a second follow-up visit 1-3 months following ELT at which time clinical evaluation and ultrasound are repeated. If required, sclerotherapy may be performed during the ELT procedure or at any follow-up visits.
Regulatory Status
Endovascular laser for the treatment of VV was approved by Health Canada as a class 3 device in 2002. The treatment has been an insured service in Saskatchewan since 2007 and is the only province to insure ELT. Although the treatment is not an insured service in Ontario, it has been provided by various medical specialties since 2002 in over 20 private clinics.
Methods
Literature Search
The MAS evidence-based review was performed as an update to the 2007 health technology review performed by the Australian Medical Services Committee (MSAC) to support public financing decisions. The literature search was performed on August 18, 2009 using standard bibliographic databases for studies published from January 1, 2007 to August 15, 2009. Search alerts were generated and reviewed for additional relevant literature up until October 1, 2009.
Inclusion Criteria
English language full-reports and human studies
Original reports with defined study methodology
Reports including standardized measurements on outcome events such as technical success, safety, effectiveness, durability, quality of life or patient satisfaction
Reports involving ELT for VV (great or small saphenous veins)
Randomized controlled trials (RCTs), systematic reviews and meta-analyses
Cohort and controlled clinical studies involving > 1 month ultrasound imaging follow-up
Exclusion Criteria
Non systematic reviews, letters, comments and editorials
Reports not involving outcome events such as safety, effectiveness, durability, or patient satisfaction following an intervention with ELT
Reports not involving interventions with ELT for VV
Pilot studies or studies with small samples ( < 50 subjects)
Summary of Findings
The MAS evidence search identified 14 systematic reviews, 29 cohort studies on safety and effectiveness, four cost studies and 12 randomized controlled trials involving ELT, six of these comparing endovascular laser with surgical ligation and saphenous vein stripping.
Since 2007, 22 cohort studies involving 10,883 patients undergoing ELT of the great saphenous vein (GSV) have been published. Imaging defined treatment effectiveness of mean vein closure rates were reported to be greater than 90% (range 93%- 99%) at short term follow-up. Longer than one year follow-up was reported in five studies with life table analysis performed in four but the follow up was still limited at three and four years. The overall pooled major adverse event rate, including DVT, PE, skin burns or nerve damage events extracted from these studies, was 0.63% (69/10,883).
The overall level of evidence of randomized trials comparing ELT with surgical ligation and vein stripping (n= 6) was graded as moderate to high. Recovery after treatment was significantly quicker after ELT (return to work median number of days, 4 vs. 17; p= .005). Major adverse events occurring after surgery were higher [(1.8% (n=4) vs. 0.4% (n = 1) 1 but not significantly. Treatment effectiveness as measured by imaging vein absence or closure, symptom relief or quality of life similar in the two treatment groups and both treatments resulted in statistically significantly improvements in these outcomes. Recurrence was low after both treatments at follow up but neovascularization (growth of new vessels, a key predictor of long term recurrence was significantly more common (18% vs. 1%; p = .001) after surgery. Although patient satisfaction was reported to be high (>80%) with both treatments, patient preferences evaluated through recruitment process, physician reports and consumer groups were strongly in favour of ELT. For patients minimal complications, quick recovery and dependability of outpatient scheduling were key considerations.
As clinical effectiveness of the two treatments was similar, a cost-analysis was performed to compare differences in resources and costs between the two procedures. A budget impact analysis for introducing ELT as an insured service was also performed. The average case cost (based on Ontario hospital costs and medical resources) for surgical vein stripping was estimated to be $1,799. Because of the uncertainties with resources associated with ELT, in addition to the device related costs, hospital costs were varied and assumed to be the same as or less than (40%) those for surgery resulting in an average ELT case cost of $2,025 or $1,602.
Based on the historical pattern of surgical vein stripping for varices a 5-year projection was made for annual volumes and costs. In Ontario in 2007/2008, 3481 surgical vein stripping procedures were performed, 28% for repeat procedures. Annual volumes of ELT currently being performed in the province in over 20 private clinics were estimated to be approximately 840. If ELT were publicly reimbursed, it was assumed that it would capture 35% of the vein stripping market in the first year and increase to 55% in subsequent years. Based on these assumptions if ELT were not publicly reimbursed, the province would be paying approximately $5.9 million and if ELT were reimbursed the province would pay $8.2 million if the hospital costs for ELT were the same as surgery and $7.1 million if the hospital costs were less (40%) than surgery.
The conclusions on the comparative outcomes between laser ablation and surgical ligation and saphenous vein stripping are summarized in the table below (ES Table 1).
Outcome comparisons of ELT vs. surgery for VV
The outcomes of the evidence-based review on these treatments based on three different perspectives are summarized below:
Patient Outcomes – ELT vs. Surgery
ELT has a quicker recovery attributable to the decreased pain, lower minor complications, use of local anesthesia with immediate ambulation.
ELT is as effective as surgery in the short term as assessed by imaging anatomic outcomes, symptomatic relief and HRQOL outcomes.
Recurrence is similar but neovascularization, a key predictor of long term recurrence, is significantly higher with surgery.
Patient satisfaction is equally high after both treatments but patient preference is much more strongly for ELT. Surgeons performing ELT are satisfied with treatment outcomes and regularly offer ELT as a treatment alternative to surgery.
Clinical or Technical Advantages – ELT Over Surgery
An endovascular approach can more easily and more precisely treat multilevel disease and difficult to treat areas
ELT is an effective and a less invasive treatment for the elderly with VV and those with venous leg ulcers.
System Outcomes – ELT Replacing Surgery
ELT may offer system advantages in that the treatment can be offered by several medical specialties in outpatient settings and because it does not require an operating theatre or general anesthesia.
The treatment may result in ↓ pre-surgical investigations, decanting of patients from OR, ↓ demand on anesthetists time, ↓ hospital stay, ↓decrease wait time for VV treatment and provide more reliable outpatient scheduling.
Depending on the reimbursement mechanism for the treatment, however, it may also result in closure of outpatient clinics with an increasingly centralization of procedures in selected hospitals with large capital budgets resulting in larger and longer waiting lists.
Procedure costs may be similar for the two treatments but the budget impact may be greater with insurance of ELT because of the transfer of the cases from the private market to the public payer system.
PMCID: PMC3377531  PMID: 23074409
2.  Endovascular Radiofrequency Ablation for Varicose Veins 
Executive Summary
Objective
The objective of the MAS evidence review was to conduct a systematic review of the available evidence on the safety, effectiveness, durability and cost–effectiveness of endovascular radiofrequency ablation (RFA) for the treatment of primary symptomatic varicose veins.
Background
The Ontario Health Technology Advisory Committee (OHTAC) met on August 26th, 2010 to review the safety, effectiveness, durability, and cost-effectiveness of RFA for the treatment of primary symptomatic varicose veins based on an evidence-based review by the Medical Advisory Secretariat (MAS).
Clinical Condition
Varicose veins (VV) are tortuous, twisted, or elongated veins. This can be due to existing (inherited) valve dysfunction or decreased vein elasticity (primary venous reflux) or valve damage from prior thrombotic events (secondary venous reflux). The end result is pooling of blood in the veins, increased venous pressure and subsequent vein enlargement. As a result of high venous pressure, branch vessels balloon out leading to varicosities (varicose veins).
Symptoms typically affect the lower extremities and include (but are not limited to): aching, swelling, throbbing, night cramps, restless legs, leg fatigue, itching and burning. Left untreated, venous reflux tends to be progressive, often leading to chronic venous insufficiency (CVI). A number of complications are associated with untreated venous reflux: including superficial thrombophlebitis as well as variceal rupture and haemorrhage. CVI often results in chronic skin changes referred to as stasis dermatitis. Stasis dermatitis is comprised of a spectrum of cutaneous abnormalities including edema, hyperpigmentation, eczema, lipodermatosclerosis and stasis ulceration. Ulceration represents the disease end point for severe CVI. CVI is associated with a reduced quality of life particularly in relation to pain, physical function and mobility. In severe cases, VV with ulcers, QOL has been rated to be as bad or worse as other chronic diseases such as back pain and arthritis.
Lower limb VV is a very common disease affecting adults – estimated to be the 7th most common reason for physician referral in the US. There is a very strong familial predisposition to VV. The risk in offspring is 90% if both parents affected, 20% when neither affected and 45% (25% boys, 62% girls) if one parent affected. The prevalence of VV worldwide ranges from 5% to 15% among men and 3% to 29% among women varying by the age, gender and ethnicity of the study population, survey methods and disease definition and measurement. The annual incidence of VV estimated from the Framingham Study was reported to be 2.6% among women and 1.9% among men and did not vary within the age range (40-89 years) studied.
Approximately 1% of the adult population has a stasis ulcer of venous origin at any one time with 4% at risk. The majority of leg ulcer patients are elderly with simple superficial vein reflux. Stasis ulcers are often lengthy medical problems and can last for several years and, despite effective compression therapy and multilayer bandaging are associated with high recurrence rates. Recent trials involving surgical treatment of superficial vein reflux have resulted in healing and significantly reduced recurrence rates.
Endovascular Radiofrequency Ablation for Varicose Veins
RFA is an image-guided minimally invasive treatment alternative to surgical stripping of superficial venous reflux. RFA does not require an operating room or general anaesthesia and has been performed in an outpatient setting by a variety of medical specialties including surgeons and interventional radiologists. Rather than surgically removing the vein, RFA works by destroying or ablating the refluxing vein segment using thermal energy delivered through a radiofrequency catheter.
Prior to performing RFA, color-flow Doppler ultrasonography is used to confirm and map all areas of venous reflux to devise a safe and effective treatment plan. The RFA procedure involves the introduction of a guide wire into the target vein under ultrasound guidance followed by the insertion of an introducer sheath through which the RFA catheter is advanced. Once satisfactory positioning has been confirmed with ultrasound, a tumescent anaesthetic solution is injected into the soft tissue surrounding the target vein along its entire length. This serves to anaesthetize the vein, insulate the heat from damaging adjacent structures, including nerves and skin and compresses the vein increasing optimal contact of the vessel wall with the electrodes or expanded prongs of the RF device. The RF generator is then activated and the catheter is slowly pulled along the length of the vein. At the end of the procedure, hemostasis is then achieved by applying pressure to the vein entry point.
Adequate and proper compression stockings and bandages are applied after the procedure to reduce the risk of venous thromboembolism and to reduce postoperative bruising and tenderness. Patients are encouraged to walk immediately after the procedure. Follow-up protocols vary, with most patients returning 1 to 3 weeks later for an initial follow-up visit. At this point, the initial clinical result is assessed and occlusion of the treated vessels is confirmed with ultrasound. Patients often have a second follow-up visit 1 to 3 months following RFA at which time clinical evaluation and ultrasound are repeated. If required, additional procedures such as phlebectomy or sclerotherapy may be performed during the RFA procedure or at any follow-up visits.
Regulatory Status
The Closure System® radiofrequency generator for endovascular thermal ablation of varicose veins was approved by Health Canada as a class 3 device in March 2005, registered under medical device license 67865. The RFA intravascular catheter was approved by Health Canada in November 2007 for the ClosureFast catheter, registered under medical device license 16574. The Closure System® also has regulatory approvals in Australia, Europe (CE Mark) and the United States (FDA clearance). In Ontario, RFA is not an insured service and is currently being introduced in private clinics.
Methods
Literature Search
The MAS evidence–based review was performed to support public financing decisions. The literature search was performed on March 9th, 2010 using standard bibliographic databases for studies published up until March, 2010.
Inclusion Criteria
English language full-reports and human studies Original reports with defined study methodologyReports including standardized measurements on outcome events such as technical success, safety, effectiveness, durability, quality of life or patient satisfaction Reports involving RFA for varicose veins (great or small saphenous veins)Randomized controlled trials (RCTs), systematic reviews and meta-analysesCohort and controlled clinical studies involving ≥ 1 month ultrasound imaging follow-up
Exclusion Criteria
Non systematic reviews, letters, comments and editorials Reports not involving outcome events such as safety, effectiveness, durability, or patient satisfaction following an intervention with RFAReports not involving interventions with RFA for varicose veinsPilot studies or studies with small samples (< 50 subjects)
Summary of Findings
The MAS evidence search on the safety and effectiveness of endovascular RFA ablation of VV identified the following evidence: three HTAs, nine systematic reviews, eight randomized controlled trials (five comparing RFA to surgery and three comparing RFA to ELT), five controlled clinical trials and fourteen cohort case series (four were multicenter registry studies).
The majority (12⁄14) of the cohort studies (3,664) evaluating RFA for VV involved treatment with first generation RFA catheters and the great saphenous vein (GSV) was the target vessel in all studies. Major adverse events were uncommonly reported and the overall pooled major adverse event rate extracted from the cohort studies was 2.9% (105⁄3,664). Imaging defined treatment effectiveness of vein closure rates were variable ranging from 68% to 96% at post-operative follow-up. Vein ablation rate at 6-month follow-up was reported in four studies with rates close to 90%. Only one study reported vein closure rates at 2 years but only for a minority of the eligible cases. The two studies reporting on RFA ablation with the more efficient second generation catheters involved better follow-up and reported higher ablation rates close to 100% at 6-month follow-up with no major adverse events. A large prospective registry trial that recruited over 1,000 patients at thirty-four largely European centers reported on treatment success in six overlapping reports on selected patient subgroups at various follow-up points up to 5 year. However, the follow-up for eligible recruited patients at all time points was low resulting in inadequate estimates of longer term treatment efficacy.
The overall level of evidence of randomized trials comparing RFA with surgical ligation and vein stripping (n = 5) was graded as low to moderate. In all trials RFA ablation was performed with first generation catheters in the setting of the operating theatre under general anaesthesia, usually without tumescent anaesthesia. Procedure times were significantly longer after RFA than surgery. Recovery after treatment was significantly quicker after RFA both with return to usual activity and return to work with on average a one week less of work loss. Major adverse events occurring after surgery were higher [(1.8% (n=4) vs. 0.4% (n = 1) than after RFA but not significantly. Treatment effectiveness measured by imaging defined vein absence or vein closure was comparable in the two treatment groups. Significant improvements in vein symptoms and quality of life over baseline were reported for both treatment groups. Improvements in these outcomes were significantly greater in the RFA group than the surgery group in the peri-operative period but not in later follow-up. Follow-up in these trials was inadequate to evaluate longer term recurrence for either treatment. Patient satisfaction was reported to be high for both treatments but was higher for RFA.
The studies comparing endovascular treatment approaches for VV (RFA and ELT) were more limited. Three RCT studies compared RFA (two with the second generation catheter) with ELT but mainly focused on peri-procedural outcomes such as pain, complications and recovery. Vein ablation rates were not evaluated in the trials, except for one small trial involving bilateral VV. Pain responses in patients undergoing ablation were extremely variable and up to 2 weeks, mean pain levels were significantly less with RFA than ELT ablation but differences were not significant at one month. Recovery, evaluated as return to usual activity or return to work, however, was similar in the treatment groups. Vein symptom and QOL improvements were improved in both groups but were significantly better in the RFA group than the ELT group at 2 weeks, but not at one month. Vein ablation rates were evaluated in several controlled clinical studies comparing the treatments between centers or within centers between individuals or over time. Comparisons in these studies were inconsistent with vein ablation rates for RFA reported to be similar to, higher than and lower than those with ELT.
Economic Analysis
RFA and surgical vein stripping, the main comparator reimbursed by the public system, are comparable in clinical benefits. Hence a cost-analysis was conducted to identify the differences in resources and costs between both procedures and a budgetary impact analysis (BIA) was conducted to project costs over a 5- year period in the province of Ontario. The target population of this economic analysis was patients with symptomatic varicose veins and the primary analytic perspective was that of the Ministry of Health and Long-Term Care.
The average case cost (based on Ontario hospital costs and medical resources) for surgical vein stripping was estimated to be $1,799. In order to calculate a procedural cost for RFA it was assumed that the hospital cost and physician labour fees, excluding anaesthesia and surgical assistance, were the same as vein stripping surgery. The manufacturer also provided details on the generator with a capital cost of $27,500 and a lifespan of 5 years and the disposables (catheter, sheath, guidewire) with a cost of $673 per case. The average case cost for RFA was therefore estimated to be $1,356. One-way sensitivity analysis was also conducted with hospital cost of RFA varied to 60% that of vein stripping surgery (average cost per case = $627.08) to calculate an impact to the province.
Historical volumes of vein stripping surgeries in Ontario were used to project surgeries in a linear fashion up to five years into the future. Volumes for RFA and ELT were calculated based on share capture from the surgery market based on discussion with clinical expert opinion and existing private data based on discussion with the manufacturer. RFA is expected to compete with ELT and capture some of the market. If ELT is reimbursed by the public sector then numbers will continue to increase from previous private data and share capture from the conventional surgical treatment market. Therefore, RFA cases will also increase since it will be capturing a share of the ELT market. A budget impact to the province was then calculated by multiplying volumes by the cost of the procedure.
RFA is comparable in clinical benefits to vein stripping surgery. It has the extra upfront cost of the generator and cost per case for disposables but does not require an operating theater, anaesthetist or surgical assistant fees. The impact to the province is expected to be 5 M by Year 5 with the introduction of new ELT and RFA image guided endovascular technologies and existing surgery for varicose veins.
Conclusion
The conclusions on the comparative outcomes between endovascular RFA and surgical ligation and saphenous vein stripping and between endovascular RFA and laser ablation for VV treatment are summarized in the table below (ES Table 1).
Outcome comparisons of RFA vs. surgery and RFA vs ELT for varicose veins
ELT refers to endovascular laser ablation; RFA, radiofrequency ablation
The outcomes of the evidence-based review on these treatments for VV based on different perspectives are summarized below:
RFA First versus Second Generation Catheters and Segmental Ablation
Ablation with second generation catheters and segmental ablation offered technical advantages with improved ease and significant decreases in procedure time. RFA ablation with second generation catheters is also no longer restricted to smaller (< 12 mm diameter) saphenous veins. The safety profile with the new device and method of energy delivery is as good as or improved over the first generation device. No major adverse events were reported in two multicenter prospective cohort studies in 6 month follow-up with over 500 patients. Post-operative complications such as bruising and pain were significantly less with RFA ablation with second generation catheters than ELT in two RCT trials.RFA treatment with second generation catheters has ablation rates that are higher than with first generation catheters and are more comparable with the consistently high rates of ELT.
Endovascular RFA versus Surgery
RFA has a quicker recovery attributable to decreased pain and lower minor complications.RFA, in the short term was comparable to surgery in treatment effectiveness as assessed by imaging defined anatomic outcomes such as vein closure, flow or reflux. Other treatment outcomes such as symptomatic relief and HRQOL were significantly improved in both groups and between group differences in the early peri-operative period were likely influenced by pain experiences. Longer term follow-up was inadequate to evaluate recurrence after either treatment.Patient satisfaction was high after both treatments but was higher for RFA than surgery.
Endovascular RFA versus ELT
RFA has significantly less post-operative pain than ELT but differences were not significant when pain was adjusted for analgesic use and pain differences between groups did not persist at 1 month follow-up.Treatment effectiveness, measured as symptom relief and QOL improvement were similar between the endovascular treatments in the short term (within 1 month) Treatment effectiveness measured as imaging defined vein ablation was not measured in any RCT trials (only for bilateral VV disease) and results were inconsistently reported in observational trials.Longer term follow-up was not available to assess recurrence after either treatment.
System Outcomes – RFA Replacing Surgery or Competing with ELT
RFA may offer system advantages in that the treatment can be offered by several medical specialties in outpatient settings and because it does not require an operating theatre or general anaesthesia. The treatment may result in decanting of patients from OR with decreased pre-surgical investigations, demand on anaesthetists’ time, hospital stay and wait time for VV treatment. It may also provide more reliable outpatient scheduling. Procedure costs may be less for endovascular approaches than surgery but the budget impact may be greater with insurance of RFA because of the transfer of cases from the private market to the public payer system.Competition between RFA and ELT endovascular approaches is likely to continue to stimulate innovation and technical changes to advance patient care and result in competitive pricing.
PMCID: PMC3377553  PMID: 23074413
3.  Optimising a varicose vein service to reduce recurrence. 
A prospective observational study of 63 legs in 49 patients was undertaken to evaluate the adequacy of primary varicose vein surgery performed by surgical trainees. Appropriate surgery was carried out by a surgical senior house officer (SHO) under direct consultant supervision. All patients underwent pre- and postoperative duplex scanning. The preoperative duplex scan demonstrated incompetence of the saphenofemoral junction (SFJ) or long saphenous vein (LSV) in 59 limbs, a mid-thigh perforator (MTP) in 11 limbs, and saphenopopliteal junction (SPJ) in 5 limbs. Surgery successfully abolished all sites of pre-existing reflux. The postoperative duplex scan revealed that 17 new sites of reflux, not identified preoperatively, had developed in 12 limbs. With a consultant-led service and accurate preoperative identification of sites of reflux, the surgical trainee can adequately perform varicose vein surgery. This would seem a reasonable approach to training and eliminating recurrence owing to inadequate surgery. The development of new sites of reflux within 6 months of varicose vein surgery may be owing to altered venous haemodynamics consequent upon this surgery.
PMCID: PMC2502972  PMID: 9422875
4.  Varicose veins 
Clinical Evidence  2007;2007:0212.
Key Points
Varicose veins are considered to be enlarged tortuous superficial veins of the leg. Varicose veins are caused by poorly functioning valves in the veins, and decreased elasticity of the vein wall, allowing pooling of blood within the veins, and their subsequent enlargement.Varicose veins affect up to 40% of adults and are more common in obese people, and in women who have had more than two pregnancies.
Compression stockings are often used as first-line treatment for varicose veins, but we don't know whether they reduce symptoms compared with no treatment.
Injection sclerotherapy may be more effective than compression stockings, but less effective than surgery, at improving symptoms and cosmetic appearance. We don't know which sclerotherapy agent is the best to use.
Surgery (saphenofemoral ligation,stripping of the long saphenous vein, oravulsion) is likely to be beneficial in reducing recurrence, and improving cosmetic appearance, compared with sclerotherapy alone. We don't know whether stripping the long saphenous vein after saphenofemoral ligation improves outcomes compared with avulsion alone after ligation, or what the best method is for vein stripping. Powered phlebectomy may be as effective as avulsion, but may cause pain, bruising, and discolouration.We don't know whether radiofrequency ablation or self help are effective in people with varicose veins.
PMCID: PMC2943819  PMID: 19450366
5.  Duplex scanning may be used selectively in patients with primary varicose veins. 
Reflux was assessed using hand-held Doppler (HHD) and duplex scanning in 72 patients with primary, previously untreated varicose veins (108 limbs). The aims of the study were (i) to compare the accuracy of HHD assessment with duplex scanning, (ii) to assess the benefit of tourniquet testing and (iii) to identify patients who would benefit from a policy of selective duplex scanning. HHD accurately assesses the saphenofemoral junction (SFJ) and long saphenous vein (LSV) reflux. HHD assessment of the saphenopopliteal junction (SPJ) reflux has a low positive predictive value. A high negative predictive value reflects absent SPJ reflux assessed using HHD accurately. Tourniquet testing is not helpful. Selective duplex scanning of limbs with suspected SPJ reflux, no identifiable site of reflux or posterior thigh perforator reflux on HDD (39% of limbs), would result in the appropriate surgical procedure being performed in 102 (94%) limbs, excessive surgery in 5 (5%) limbs and inadequate surgery in only 1 (1%) limb. The use of selective criteria for duplex scanning would reduce the workload of the vascular laboratory without compromising patient care.
PMCID: PMC2503157  PMID: 10209404
6.  Varicose veins: optimum compression following sclerotherapy. 
There is uncertainty regarding the most satisfactory technique of lower limb compression following sclerotherapy for varicose veins. We have compared a standard bandaging technique with a high pressure compression stocking in a randomised trial. Efficacy was judged on the success of injections, complications of the treatment and patient satisfaction. In the stockinged legs 144 of 156 injections were successful, compared with 117 of 147 in the bandaged group (P less than 0.001) (Chi squared). The incidence of superficial thrombophlebitis was also reduced in the stocking group. In addition, the stocking technique costs less in materials than conventional bandaging. We would recommend compression stockings for evaluation in sclerotherapy of varicose veins.
PMCID: PMC2498276  PMID: 3883876
7.  Varicose veins 
Clinical Evidence  2011;2011:0212.
Introduction
Varicose veins are caused by poorly functioning valves in the veins, and decreased elasticity of the vein wall, allowing pooling of blood within the veins, and their subsequent enlargement. Varicose veins affect up to 40% of adults, and are more common in obese people, and in women who have had more than two pregnancies.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments in adults with varicose veins? We searched: Medline, Embase, The Cochrane Library and other important databases up to January 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 39 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: compression stockings, endovenous laser, injection sclerotherapy, radiofrequency ablation, self-help (advice, avoidance of tight clothing, diet, elevation of legs, exercise), and surgery (stripping, avulsion, powered phlebectomy).
Key Points
Varicose veins are considered to be enlarged tortuous superficial veins of the leg. Varicose veins are caused by poorly functioning valves in the veins, and decreased elasticity of the vein wall, allowing pooling of blood within the veins, and their subsequent enlargement.Varicose veins affect up to 40% of adults and are more common in obese people, and in women who have had more than two pregnancies.
Compression stockings are often used as first-line treatment for varicose veins, but we don't know whether they reduce symptoms compared with no treatment.
Injection sclerotherapy may be more effective than compression stockings, but less effective than surgery, at improving symptoms and cosmetic appearance. We don't know which sclerotherapy agent is the best to use.
Surgery (saphenofemoral ligation, stripping of the great saphenous vein, or avulsion) is likely to be beneficial in reducing recurrence, and improving cosmetic appearance, compared with sclerotherapy alone. We don't know whether stripping the great saphenous vein after saphenofemoral ligation improves outcomes compared with avulsion alone after ligation, or what the best method is for vein stripping.We found insufficient evidence on the effects of powered phlebectomy, radiofrequency ablation, endovenous laser, or self-help.However, endovenous procedures (radiofrequency ablation and endovenous laser) are increasingly used in mainstream clinical practice, and further evidence comparing them to other active treatments is emerging.
PMCID: PMC3217733  PMID: 21477400
8.  Varicose veins: optimum compression after surgery and sclerotherapy. 
Graduated compression stockings are used in both surgical and non-surgical treatment of varicose veins. In a trial of high versus low compression stockings (40 mmHg vs 15 mmHg at ankle) after varicose vein surgery, both were equally effective in controlling bruising and thrombophlebitis, but low compression stockings proved to be more comfortable. In a further trial after sclerotherapy, high compression stockings alone produced comparable results to Elastocrepe bandages with stockings. It is concluded that after varicose vein surgery low compression stockings provide adequate support for the leg and that after sclerotherapy, bandaging is not required if a high compression stocking is used.
PMCID: PMC2499037  PMID: 2690721
9.  Does venous function deteriorate in patients waiting for varicose vein surgery? 
We have looked at the deterioration in the condition of the lower limbs in a group of 36 patients who were waiting for a median time of 20 months for varicose vein surgery, using clinical examination, colour Duplex scanning and photoplethysmograph (95% refilling times). We found a significant deterioration in this group of patients, with four limbs initially unaffected developing reflux on Duplex scanning, of which three had clinical varicose veins (all four were offered surgery), and of the initial 56 involved limbs, 10 further sources of reflux were found (18%), necessitating alteration of the initial planned surgical procedure. No patient developed deep venous insufficiency or ulceration while on the waiting list, although there was one new case of lipodermatosclerosis. However, had surgery been undertaken after the first assessment, 14 patients (25%) would potentially have required further surgery, although accepting this as justification for allowing patients to wait takes no account of patients suffering or quality of life while waiting for operation.
PMCID: PMC1293817  PMID: 8423569
10.  What are the symptoms of varicose veins? Edinburgh vein study cross sectional population survey 
BMJ : British Medical Journal  1999;318(7180):353-356.
Objective
To define the relations between age, sex, lower limb symptoms, and the presence of trunk varicose veins on clinical examination.
Design
Cross sectional population study.
Setting
12 general practices with catchment areas geographically and socioeconomically distributed throughout Edinburgh.
Participants
An age stratified random sample of 1566 people (699 men and 867 women) aged 18-64 selected from the computerised age-sex registers of participating practices.
Main outcome measures
Self administered questionnaire on the presence of lower limb symptoms and physical examination to determine the presence and severity of varicose veins.
Results
Women were significantly more likely than men to report lower limb symptoms such as heaviness or tension, swelling, aching, restless legs, cramps, and itching. The prevalence of symptoms tended to increase with age in both sexes. In men, only itching was significantly related to the presence and severity of trunk varices (linear test for trend, P=0.011). In women there was a significant relation between trunk varices and the symptoms of heaviness or tension (P⩽0.001), aching (P⩽0.001), and itching (P⩽0.005). However, the level of agreement between the presence of symptoms and trunk varices was too low to be of clinical value, especially in men.
Conclusions
Even in the presence of trunk varices, most lower limb symptoms probably have a non-venous cause. Surgical extirpation of trunk varices is unlikely to ameliorate such symptoms in most patients.
Key messagesIn this population survey women were more likely than men to report a wide range of lower limb symptomsIn men, only itching was significantly related to the presence of trunk varicesIn women there was a significant relation between trunk varices and heaviness or tension, aching, and itchingThe level of agreement between the presence of symptoms and trunk varices is probably too low to be clinically usefulA thorough clinical history and examination should be carried out before surgery
PMCID: PMC27720  PMID: 9933194
11.  Effect of Hydroxyethylrutosides on Blood Oxygen Levels and Venous Insufficiency Symptoms in Varicose Veins 
British Medical Journal  1971;2(5754):138-141.
Oxygen levels (tension, saturation, and content) in blood from varicose leg veins were found to be significantly lower than those in blood from normal leg veins at the same site on the limb under the same laboratory conditions. Treatment with hydroxyethylrutosides significantly increased the oxygen levels in blood from varicose veins, and this was associated with an improvement in leg symptoms attributable to venous insufficiency. Hydroxyethylrutosides have been shown to have a beneficial effect on capillary dysfunction in venous stasis.
PMCID: PMC1795604  PMID: 5581491
12.  How Should a Candidate Assess Varicose Veins in the MRCS Clinical Examination? A Vascular Viewpoint 
INTRODUCTION
Varicose veins are a common problem and, therefore, regularly feature in the vascular bay of the MRCS clinical examination. Candidates are still being instructed to perform tests in the examination that are considered by many to be obsolete and inaccurate. Using the current cohort of vascular examiners, we aim to clarify which tests a candidate should be performing when assessing varicose veins. We also aim to assess basic surgical trainees' experience in the use of hand-held Doppler (HHD).
MATERIALS AND METHODS
Postal questionnaires were sent to all English College Court examiners with a declared vascular interest to gain their opinion on what tests should be used in the vascular bay to assess primary varicose veins. E-mail questionnaires were also sent to basic surgical trainees to assess their experience in the use of hand-held Doppler to assess varicose veins.
RESULTS
There was a 100% response rate from the examiners with 93%, 86% and 79% feeling that clinical examination, HHD examination of the SFJ and HHD examination of the SPJ, respectively, should form part of the examination of primary varicose veins in the vascular bay. Only 50% indicated the Trendelenburg test and cough impulse and 57% believed the tap test should form part of the examination of varicose veins. Of the BSTs, 53% believed they could examine varicose veins with HHD. Of the BSTs who could use HHD, 74% had held a vascular SHO post.
DISCUSSION
Published data and opinion show many consultant surgeons have totally abandoned the use of the Trendelenberg, cough, tap and Perthes tests and support the opinion that HHD increases the accuracy of the examination of varicose veins. This study shows the opinions of the examiners supports the evidence-based recommendations that, in the light of easily accessible HHD, the older tests are now outdated. The majority of BSTs who were able to use HHD had held a vascular SHO post (74%) but otherwise it was unlikely that the BST would be comfortable with this skill.
CONCLUSIONS
The Brodie-Trendelenburg (tourniquet) test, cough impulse and tap test are outdated but candidates should be aware of the principles and failings behind them. In the MRCS clinical examination, candidates should examine varicose veins by means of clinical examination and HHD as this is now accepted standard practice. To aid candidate education, the HHD technique should replace traditional clinical tests which continue to be taught in medical school and remain within the classical surgical text books.
doi:10.1308/003588406X98595
PMCID: PMC1963680  PMID: 16720005
Varicose veins; MRCS; Clinical examination; Trendelenberg test; Hand-held Doppler
13.  Clinical examination of varicose veins--a validation study. 
The aim of this study was to determine the accuracy of clinical tests compared to colour duplex imaging in patients with primary varicose veins using a prospective, blinded comparison study. A total of 44 patients (70 limbs) with primary, previously untreated varicose veins presenting to the vascular laboratory of a university teaching hospital were studied. The patients underwent physical examination using the cough test, the tap test, Trendelenbergs' test, Perthes' test and hand-held Doppler (HHD) assessment prior to undergoing colour duplex scanning. Reflux was detected on duplex scanning, at the sapheno-femoral junction in 39/70 limbs (54%), the long saphenous vein in 47/70 limbs (64%) and the sapheno-popliteal junction in 9/70 limbs (13%). The cough test had low sensitivity (0.59) and specificity (0.67). The tap test had low sensitivity (0.18) and high specificity (0.92). The Trendelenberg test had high sensitivity (0.91) but low specificity (0.15). Perthes' test had a high sensitivity (0.97) but low specificity (0.20). Hand-held Doppler assessment of reflux at the sapheno-femoral junction, in the long saphenous vein and at the sapheno-popliteal junction had high sensitivity (0.97, 0.82, and 0.80, respectively) and specificity (0.73, 0.92, and 0.90, respectively) of detecting reflux. Clinical tests used in the examination of patients with primary varicose veins are inaccurate. Assessment using hand-held Doppler is more accurate. Courses and clinical textbooks should be revised to replace these tests with instruction in how to use hand-held Doppler in the clinical examination of patients with varicose veins.
PMCID: PMC2503433  PMID: 10858678
14.  Matrix Metalloproteinases as Potential Targets in the Venous Dilation Associated with Varicose Veins 
Current drug targets  2013;14(3):287-324.
Varicose veins (VVs) are a common venous disease of the lower extremity characterized by incompetent valves, venous reflux, and dilated and tortuous veins. If untreated, VVs could lead to venous thrombosis, thrombophlebitis and chronic venous leg ulcers. Various genetic, hormonal and environmental factors may lead to structural changes in the vein valves and make them incompetent, leading to venous reflux, increased venous pressure and vein wall dilation. Prolonged increases in venous pressure and vein wall tension are thought to increase the expression/activity of matrix metalloproteinases (MMPs). Members of the MMPs family include collagenases, gelatinases, stromelysins, matrilysins, membrane-type MMPs and others. MMPs are known to degrade various components of the extracellular matrix (ECM). MMPs may also affect the endothelium and vascular smooth muscle, causing changes in the vein relaxation and contraction mechanisms. ECs injury also triggers leukocyte infiltration, activation and inflammation, which lead to further vein wall damage. The vein wall dilation and valve dysfunction, and the MMP activation and superimposed inflammation and fibrosis would lead to progressive venous dilation and VVs formation. Surgical ablation is an effective treatment for VVs, but may be associated with high recurrence rate, and other less invasive approaches that target the cause of the disease are needed. MMP inhibitors including endogenous tissue inhibitors (TIMPs) and pharmacological inhibitors such as zinc chelators, doxycycline, batimastat and marimastat, have been used as diagnostic and therapeutic tools in cancer, autoimmune and cardiovascular disease. However, MMP inhibitors may have side effects especially on the musculoskeletal system. With the advent of new genetic and pharmacological tools, specific MMP inhibitors with fewer undesirable effects could be useful to retard the progression and prevent the recurrence of VVs.
PMCID: PMC3584231  PMID: 23316963
MMP; endothelium; vascular smooth muscle; extracellular matrix; chronic venous insufficiency disease; TIMP
15.  The place of duplex scanning for varicose veins and common venous problems. 
Duplex scanning has become the 'gold standard' for confirming reflux and demonstrating anatomy in cases of lower limb venous disease. However, the large numbers of patients presenting with varicose veins (or with skin changes and ulcers) mean that routine use of duplex is impractical, and this investigation has still not become well established in many hospitals. In order to determine the proportion of patients likely to require duplex scanning (and other special tests-photoplethysmography and ascending venography) we reviewed a consecutive series of 201 patients referred to the vascular clinic of a district general hospital with 283 symptomatic limbs affected by varicose veins and/or skin changes and ulcers. Patients were examined clinically and with hand-held Doppler. Duplex scanning was then requested to check for reflux in the popliteal fossa and to examine the groin and residual long saphenous vein in some cases of recurrent varicose veins. Duplex scanning was required in 51 (18%) limbs, venography in 8 (3%), and photoplethysmography in only one limb. In total, special tests were needed in 60 (21%) limbs. Subsequently, 198 (70%) limbs were referred for surgery. We would now (in 1996) duplex scan every case with popliteal fossa reflux and most recurrences. Had all these been scanned, then 79 (28%) would have had special tests. This knowledge should help in planning the implications of a duplex scanning service for varicose veins, skin changes and ulcers.
PMCID: PMC2502872  PMID: 8943629
16.  Histopathological changes in venous grafts and in varicose and non-varicose veins. 
Journal of Clinical Pathology  1993;46(7):603-606.
AIMS--To examine veins histologically from different sites in the body to study the effect of venous pressure; and to examine veins used as aortocoronary grafts. METHODS--The axillary vein, femoral vein at the inguinal ligament, the short saphenous vein at the knee and the long saphenous vein at the ankle were removed from 24 necropsy cases of patients aged 2 months to 80 years. Fifteen varicose saphenous veins and 12 aortocoronary grafts removed at surgery were obtained. All were examined histologically. RESULTS--Varying degrees of intimal thickening composed of collagen, elastin, and smooth muscle were found. These changes were most noticeable in the varicose veins. Intimal changes were also seen related to valves and to adjacent arteries. No clinically relevant lipid was seen in the native veins, though atheromatous changes were seen in the grafts. CONCLUSIONS--Venous changes are related to venous pressure, to local haemodynamic effects, and probably to hypoxia. The changes are often focal and seem to be sequential in their formation. True atheroma is seen in the aortocoronary grafts but is not seen in native veins and this may be the result of additional factors.
Images
PMCID: PMC501385  PMID: 8157743
17.  Ultrasound Doppler Evaluation of the Pattern of Involvement of Varicose Veins in Indian Patients 
The Indian Journal of Surgery  2010;73(2):125-130.
Doppler evaluation of lower limb veins was performed to evaluate the pattern of involvement of various sites of incompetence in Indian patients with varicose veins. A prospective Doppler study of 100 consecutive limbs in patients who presented with varicose veins to the vascular surgery department of a tertiary care hospital in India. The Clinico-Etiological Anatomical and Pathological (CEAP) classification was applied for assessment. Doppler evaluation of both superficial and deep venous system of the lower limbs was performed. The data of various sites of reflux was analysed to find the patterns of venous involvement in the affected patients. Superficial venous reflux was seen in all the patients. Deep venous reflux was seen in 50% of the lower limbs examined. Doppler is a simple non-invasive test, and is well tolerated by the patients. Deep venous reflux is common in Indian population, though it rarely occurs in isolation, and is usually associated with superficial reflux.
doi:10.1007/s12262-010-0195-0
PMCID: PMC3077159  PMID: 22468062
Varicose veins; Lower limb; Doppler evaluation; Venous reflux
18.  Ca2+-Dependent Contraction by the Saponoside Escin in Rat Vena Cava. Implications in Venotonic Treatment of Varicose Veins 
Background
Saponosides (horse chestnut seed extract, escin) and flavonoids (diosmin, Daflon 500) exhibit venotonic properties that have been utilized in treatment of varicose veins. However, the cellular mechanisms underlying the venotonic properties of escin and diosmin are unclear. Because Ca2+ is a major regulator of venous smooth muscle (VSM) function, we tested the hypothesis that escin and diosmin promote Ca2+-dependent venous contraction.
Methods
Rings of inferior vena cava (IVC) from male rats were suspended in a tissue bath for measurement of isometric contraction. Following control contraction to 96 mM KCl, the effects of escin and diosmin (10−10 to 10−4 M) on vein contraction were measured. To test the role of intracellular Ca2+ release, the vein response to escin and diosmin was measured in Ca2+-free (2mM EGTA) Krebs. To test for Ca2+-dependent effects, IVC segments were pretreated with escin or diosmin (10−4 M) in 0 Ca2+ Krebs, then extracellular CaCl2 (0.1, 0.3, 0.6, 1, 2.5 mM) was added and the [Ca2+]e-contraction relationship was constructed. To test for synergistic effects of diosmin, IVC segments were pretreated with diosmin (10−4 M) then stimulated with KCl (16 to 96 mM) or escin (10−10 to 10−4 M) and vein contraction was measured. Contraction data were presented as mg/mg tissue (means±SEM).
Results
In IVC segments incubated in normal Krebs (2.5 mM Ca2+), escin caused concentration-dependent contraction (max 104.3±19.6 at 10−4 M). Escin-induced contraction was not a rigor state, because after washing with Krebs the veins returned to a relaxed state. In Ca2+-free Krebs, there was essentially no contraction to escin. In escin-treated veins incubated in 0 Ca2+ Krebs, stepwise addition of extracellular CaCl2 caused corresponding increases in contraction (max 80.0±11.1 at 2.5 mM). In the absence of escin, the α-adrenergic agonist phenylephrine (PHE, 10−5 M), angiotensin II (AngII, 10−6 M), and membrane depolarization by KCl (96 mM) caused significant contraction (122.5±45.1, 114.2±12.2 and 221.7±35.4, respectively). In IVC segments pretreated with escin (10−4 M), the contractile response to PHE (9.7±2.6), AngII (36.0±9.1) and KCl (82.3±10.2) was significantly reduced. Diosmin (10−4 M) caused small contraction in normal Krebs (11.7±1.9) and Ca2+-free Krebs (4.2±2.2). In diosmin-treated veins incubated in 0 Ca2+ Krebs, addition of extracellular CaCl2 caused minimal contraction. Diosmin did not enhance the IVC contraction to PHE, AngII, or escin, but enhanced the contractile response to KCl (24 to 51 mM).
Conclusion
In rat IVC, escin induces extracellular Ca2+-dependent contraction, but disrupts α-adrenergic and AT1R receptor-mediated pathways, and depolarization-induced contraction. The initial venotonic benefits of escin may be offset by disruption of vein response to endogenous venoconstrictors, limiting its long-term therapeutic benefits in varicose veins. Diosmin does not cause venous contraction or potentiate the venotonic effects of endogenous venoconstrictors or escin ex vivo, and its use as venotonic may need to be further evaluated.
doi:10.1016/j.jvs.2011.01.043
PMCID: PMC3140579  PMID: 21498026
escin; diosmin; varicose veins; vascular smooth muscle; calcium
19.  Pre- and Postoperative Evaluation by Photoplethysmography in Patients Receiving Surgery for Lower-Limb Varicose Veins 
Objective. To evaluate the effectiveness of surgery in treating primary varicose veins in the lower limbs by photoplethysmography (PPG) and duplex mapping (DM). Method. Forty-eight lower limbs were clinically evaluated according to the CEAP classification system and subjected to PPG and DM exams. Each limb had a venous refill time (VRT) of <20 seconds and a normal deep vein system (DVS) by DM. Results. The mean pre- and postoperative VRTs were 13.79 and 26.43 seconds, respectively (P < 0.0001). After surgery, 42 limbs (87.50%) had normal results by PPG (VRT > 20 seconds). Four limbs (8.33%) showed improved VRTs, but the VRTs did not reach 20 seconds. In the 2 limbs (4.17%) that maintained their original VRTs, the DM exams showed the presence of insufficient perforating veins. Conclusion. In most cases, PPG allows for a satisfactory evaluation of the outcome of varicose vein surgery.
doi:10.1155/2014/562782
PMCID: PMC3950472  PMID: 24696783
20.  Postoperative limb compression in reduction of haemorrhage after varicose vein surgery. 
In varicose vein surgery, significant postoperative morbidity results from subcutaneous haematoma formation and limb swelling after saphenous vein stripping. We investigated the effectiveness of a high-compression short-stretch adhesive bandage compared with non-adhesive crêpe in reducing haemorrhage after stripping of varicose veins. Using 99mTc-labelled red blood cells, the degree of postoperative bleeding was assessed in 10 patients with bilateral varicose veins allocated for stripping and ligation. High-compression adhesive bandaging was applied to the experimental limb and a non-adhesive bandage to the contralateral control limb. Results show that adequate compression bandaging can decrease subcutaneous haematoma formation after stripping of varicose veins.
Images
PMCID: PMC2497785  PMID: 8386491
21.  Venous leg ulcers 
Clinical Evidence  2011;2011:1902.
Introduction
Leg ulcers usually occur secondary to venous reflux or obstruction, but 20% of people with leg ulcers have arterial disease, with or without venous disorders. Between 1.5 and 3.0/1000 people have active leg ulcers. Prevalence increases with age to about 20/1000 in people aged over 80 years.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of standard treatments, adjuvant treatments, and organisational interventions for venous leg ulcers? What are the effects of advice about self-help interventions in people receiving usual care for venous leg ulcers? What are the effects of interventions to prevent recurrence of venous leg ulcers? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2011 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 101 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: compression bandages and stockings, cultured allogenic (single or bilayer) skin replacement, debriding agents, dressings (cellulose, collagen, film, foam, hyaluronic acid-derived, semi-occlusive alginate), hydrocolloid (occlusive) dressings in the presence of compression, intermittent pneumatic compression, intravenous prostaglandin E1, larval therapy, laser treatment (low-level), leg ulcer clinics, multilayer elastic system, multilayer elastomeric (or non-elastomeric) high-compression regimens or bandages, oral treatments (aspirin, flavonoids, pentoxifylline, rutosides, stanozolol, sulodexide, thromboxane alpha2 antagonists, zinc), peri-ulcer injection of granulocyte-macrophage colony-stimulating factor, self-help (advice to elevate leg, to keep leg active, to modify diet, to stop smoking, to reduce weight), short-stretch bandages, single-layer non-elastic system, skin grafting, superficial vein surgery, systemic mesoglycan, therapeutic ultrasound, and topical treatments (antimicrobial agents, autologous platelet lysate, calcitonin gene-related peptide plus vasoactive intestinal polypeptide, freeze-dried keratinocyte lysate, mesoglycan, negative pressure, recombinant keratinocyte growth factor, platelet-derived growth factor).
Key Points
Leg ulcers are usually secondary to venous reflux or obstruction, but 20% of people with leg ulcers have arterial disease, with or without venous disorders.
Compression bandages and stockings heal more ulcers compared with no compression, but we don't know which bandaging technique is most effective. Compression is used for people with ulcers caused by venous disease who have an adequate arterial supply to the foot, and who don't have diabetes or rheumatoid arthritis.The effectiveness of compression bandages depends on the skill of the person applying them.We don't know whether intermittent pneumatic compression is beneficial compared with compression bandages or stockings.
Occlusive (hydrocolloid) dressings are no more effective than simple low-adherent dressings in people treated with compression, but we don't know whether semi-occlusive dressings are beneficial.
Peri-ulcer injections of granulocyte-macrophage colony-stimulating factor may increase healing, but we don't know whether other locally applied agents are beneficial, as we found few trials.
Oral pentoxifylline increases ulcer healing in people receiving compression, and oral flavonoids, sulodexide, and mesoglycan may also be effective. We don't know whether therapeutic ultrasound, oral aspirin, rutosides, thromboxane alpha2 antagonists, zinc, debriding agents, intravenous prostaglandin E1, superficial vein surgery, skin grafting, topical antimicrobial agents, leg ulcer clinics, laser treatment, or advice to elevate legs, increase activity, lose weight, change diet, or give up smoking increase healing of ulcers in people treated with compression. Larval therapy is not likely to be beneficial as it has no impact on healing and is painful.
Compression bandages and stockings reduce recurrence of ulcers compared with no compression, and should ideally be worn for life. Superficial vein surgery may also reduce recurrence, but we don't know whether systemic drug treatment is effective.
PMCID: PMC3275133  PMID: 22189344
22.  www.Accurate Information for Varicose Vein patients.com? 
INTRODUCTION
The aim of this study was to review the information available to the public regarding the treatment of varicose veins on dedicated UK-based websites.
PATIENTS AND METHODS
Websites were identified by using the Google® search engine. All identified websites were examined, noting the range of treatments explained and their stated potential complications. Website ownership was also recorded.
RESULTS
A total of 49 websites were identified, belonging to individual physicians (21), private clinics or groups (15), national institutions (4) and device/drug manufacturers (4). Five websites were simply redirecting portals and, hence, were excluded from further analysis. Treatment methods discussed were conventional surgery (32), endovenous laser [EVLA] and/or radiofrequency ablation [RFA] (31), and ultrasound-guided foam sclerotherapy [UGFS] (27). Only 19 websites (43%) discussed all treatment methods. Complications mentioned following surgery were: cutaneous nerve damage (56%), recurrence (56%), infection (53%), bleeding (41%) and venous thrombo-embolism (38%). Complications following EVLA/RFA were: cutaneous nerve damage (42%), recurrence (42%), venous thrombo-embolism (39%) and burns (35%). Complications following UGFS were: pigmentation (59%), venous thrombo-embolism (48%), ulceration (41%), recurrence (41%), allergy (26%) and visual disturbance (26%).
CONCLUSIONS
Over 50% of the websites examined did not mention all the management methods now available for varicose veins. More importantly, the majority of the websites did not warn of the common complications of intervention. Currently, information on the Internet cannot be relied upon to supplement informed consent and may actually generate unrealistic patient expectations.
doi:10.1308/003588408X318219
PMCID: PMC2728301  PMID: 18831866
Endovenous ablation; Complication; Varicose veins; Internet
23.  Morbidity of varicose vein surgery: auditing the benefit of changing clinical practice. 
During two consecutive study periods (24 months and 16 months), 997 patients (1322 legs) with varicose veins underwent surgical treatment in Huddersfield Royal Infirmary, using a variety of surgical techniques. The average length of stay was 1.5 days, and 95.5% of patients had a hospital stay of less than 2 days. Complications occurred in seven inpatients. A further 16 patients developed complications requiring readmission to hospital (10 minor and intermediate; 6 major). The complication rate appeared to be operator-dependent: an increased complication rate (particularly major complications) occurred after surgery by junior surgeons. Major complications included femoral vein injury (1 patient), postoperative deep venous thrombosis (4 patients), pulmonary embolism (1 patient) and groin lymphatic fistula requiring reoperation (1 patient). Between the first and second study period, a change in policy regarding the type of bandaging used and the use of postoperative antiembolic stockings occurred and appears to have reduced the incidence of thromboembolic complications from 0.7% to 0.2%. Varicose vein surgery is not without major complications though, fortunately, there was no mortality in this series. These complications can be minimised with good surgical technique and better supervision of surgical trainees. Modification of postoperative management can further enhance the safety of this procedure.
PMCID: PMC2502581  PMID: 8712648
24.  A prospective randomised trial of tourniquet in varicose vein surgery. 
A prospective randomised trial of 50 patients was carried out to assess the autoclavable Lofquist cuff (Boazal, Sweden) as a tourniquet in varicose vein surgery and determine the effect on bleeding, bruising, cosmesis and patient pain and activity. Patients undergoing unilateral long saphenous vein ligation, stripping and avulsions were randomised to tourniquet or no tourniquet. Lofquist cuffs were applied after inflation to 120 mmHg to the upper thigh for the duration of the surgery. Varicose vein grade, duration of surgery, blood loss, extent of bruising at 7 days, pain and activity scores over the first week, and wound complications and cosmetic result at 6 weeks were recorded. Patients' age, sex, and varicose vein grade were similar in the two groups. Peroperative blood loss (median, range) was significantly reduced in the tourniquet group (0 ml, 0-20 ml) compared to the no tourniquet group (125 ml, 20-300; P < 0.01). Operative time and thigh bruising (median, range) were also reduced in the tourniquet group (30 min, 11-47 min; 72 cm2, 30-429 cm2), respectively, compared to the no tourniquet group (37 min, 18-50 min; 179 cm2, 24-669 cm2) both (P < 0.01). There was no difference in pain and activity scores in the two groups and cosmetic results were also similar. The use of the Lofquist cuff tourniquet during varicose vein surgery reduces peroperative blood loss, operative time and postoperative bruising without any obvious drawbacks.
PMCID: PMC2503503  PMID: 10932665
25.  An integrated approach in the treatment of varicose ulcer 
Ancient Science of Life  2013;32(3):161-164.
Venous ulcers (stasis ulcers, varicose ulcers) are the wounds occurring due to inappropriate functioning of venous valves, usually of the legs. It is one of the most serious chronic venous insufficiency complications. The overall incidence rate is 0.76% in men and 1.42% in women. When a venous valve gets damaged, it prevents the backflow of blood, which causes pressure in the veins that leads to hypertension and, in turn, venous ulcers. These are mostly along the medial distal leg, which is often very painful, can bleed, and get infected. Treating varicose ulcers is a difficult task to the physician and a nightmare to the suffering patients, though a good number of the treatment principles are mentioned and practiced in allied sciences. In Ayurveda, this condition is considered as duṣṭa vraṇa. It can be managed with the specific s’odhana therapy. So, the same treatment protocol was used to treat the case discussed here, i.e. with Nitya virecana and by Basti karma. The wound was successfully treated and, therefore, is discussed in detail.
doi:10.4103/0257-7941.123000
PMCID: PMC3902537  PMID: 24501445
Basti karma; Dustha vrana; Nitya virechana; varicose ulcer

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