Interventions for great saphenous vein incompetence
Abstract
Background
Great saphenous vein (GSV) incompetence, causing varicose veins and venous insufficiency, makes up the majority of lower‐limb superficial venous diseases. Treatment options for GSV incompetence include surgery (also known as high ligation and stripping), laser and radiofrequency ablation, and ultrasound‐guided foam sclerotherapy. Newer treatments include cyanoacrylate glue, mechanochemical ablation, and endovenous steam ablation. These techniques avoid the need for a general anaesthetic, and may result in fewer complications and improved quality of life (QoL). These treatments should be compared to inform decisions on treatment for varicosities in the GSV. This is an update of a Cochrane Review first published in 2011.
Objectives
To assess the effects of endovenous laser ablation (EVLA), radiofrequency ablation (RFA), endovenous steam ablation (EVSA), ultrasound‐guided foam sclerotherapy (UGFS), cyanoacrylate glue, mechanochemical ablation (MOCA) and high ligation and stripping (HL/S) for the treatment of varicosities of the great saphenous vein (GSV).
Search methods
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases, and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 2 November 2020. We undertook reference checking to identify additional studies.
Selection criteria
We included randomised controlled trials (RCTs) treating participants for varicosities of the GSV using EVLA, RFA, EVSA, UGFS, cyanoacrylate glue, MOCA or HL/S. Key outcomes of interest are technical success, recurrence, complications and QoL.
Data collection and analysis
Two review authors independently selected trials, applied Cochrane's risk of bias tool, and extracted data. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) and assessed the certainty of evidence using GRADE.
Main results
We identified 11 new RCTs for this update. Therefore, we included 24 RCTs with 5135 participants. Duration of follow‐up ranged from five weeks to eight years. Five comparisons included single trials. For comparisons with more than one trial, we could only pool data for 'technical success' and 'recurrence' due to heterogeneity in outcome definitions and time points reported. All trials had some risk of bias concerns. Here we report the clinically most relevant comparisons.
EVLA versus RFA
Technical success was comparable up to five years (OR 0.98, 95% CI 0.41 to 2.38; 5 studies, 780 participants; moderate‐certainty evidence); over five years, there was no evidence of a difference (OR 0.85, 95% CI 0.30 to 2.41; 1 study, 291 participants; low‐certainty evidence). One study reported recurrence, showing no clear difference at three years (OR 1.53, 95% CI 0.78 to 2.99; 291 participants; low‐certainty evidence), but a benefit for RFA may be seen at five years (OR 2.77, 95% CI 1.52 to 5.06; 291 participants; low‐certainty evidence).
EVLA versus UGFS
Technical success may be better in EVLA participants up to five years (OR 6.13, 95% CI 0.98 to 38.27; 3 studies, 588 participants; low‐certainty evidence), and over five years (OR 6.47, 95% CI 2.60 to 16.10; 3 studies, 534 participants; low‐certainty evidence). There was no clear difference in recurrence up to three years and at five years (OR 0.68, 95% CI 0.20 to 2.36; 2 studies, 443 participants; and OR 1.08, 95% CI 0.40 to 2.87; 2 studies, 418 participants; very low‐certainty evidence, respectively).
EVLA versus HL/S
Technical success may be better in EVLA participants up to five years (OR 2.31, 95% CI 1.27 to 4.23; 6 studies, 1051 participants; low‐certainty evidence). No clear difference in technical success was seen at five years and beyond (OR 0.93, 95% CI 0.57 to 1.50; 5 studies, 874 participants; low‐certainty evidence). Recurrence was comparable within three years and at 5 years (OR 0.78, 95% CI 0.47 to 1.29; 7 studies, 1459 participants; and OR 1.09, 95% CI 0.68 to 1.76; 7 studies, 1267 participants; moderate‐certainty evidence, respectively).
RFA versus MOCA
There was no clear difference in technical success (OR 1.76, 95% CI 0.06 to 54.15; 3 studies, 435 participants; low‐certainty evidence), or recurrence (OR 1.00, 95% CI 0.21 to 4.81; 3 studies, 389 participants; low‐certainty evidence). Long‐term data are not available.
RFA versus HL/S
No clear difference in technical success was detected up to five years (OR 5.71, 95% CI 0.64 to 50.81; 2 studies, 318 participants; low‐certainty evidence); over five years, there was no evidence of a difference (OR 0.88, 95% CI 0.29 to 2.69; 1 study, 289 participants; low‐certainty evidence). No clear difference in recurrence was detected up to three years (OR 0.93, 95% CI 0.58 to 1.51; 4 studies, 546 participants; moderate‐certainty evidence); but a possible long‐term benefit for RFA was seen (OR 0.41, 95% CI 0.22 to 0.75; 1 study, 289 participants; low‐certainty evidence).
UGFS versus HL/S
Meta‐analysis showed a possible benefit for HL/S compared with UGFS in technical success up to five years (OR 0.32, 95% CI 0.11 to 0.94; 4 studies, 954 participants; low‐certainty evidence), and over five years (OR 0.09, 95% CI 0.03 to 0.30; 3 studies, 525 participants; moderate‐certainty evidence). No clear difference was detected in recurrence up to three years (OR 1.81, 95% CI 0.87 to 3.77; 3 studies, 822 participants; low‐certainty evidence), and after five years (OR 1.24, 95% CI 0.57 to 2.71; 3 studies, 639 participants; low‐certainty evidence).
Complications were generally low for all interventions, but due to different definitions and time points, we were unable to draw conclusions (very‐low certainty evidence). Similarly, most studies evaluated QoL but used different questionnaires at variable time points. Rates of QoL improvement were comparable between interventions at follow‐up (moderate‐certainty evidence).
Authors' conclusions
Our conclusions are limited due to the relatively small number of studies for each comparison and differences in outcome definitions and time points reported. Technical success was comparable between most modalities. EVLA may offer improved technical success compared to UGFS or HL/S. HL/S may have improved technical success compared to UGFS. No evidence of a difference was detected in recurrence, except for a possible long‐term benefit for RFA compared to EVLA or HL/S. Studies which provide more evidence on the breadth of treatments are needed. Future trials should seek to standardise clinical terminology of outcome measures and the time points at which they are measured.
PICOs
Plain language summary
Which procedures are best for treating varicose veins in the leg?
Key messages
We are uncertain about which treatments are best for varicose veins because we found only a small number of studies that compared the different types of treatment, and because studies differed in how they measured results.
‐ All currently available varicose vein treatments are similar in terms of whether the treatment fully destroys the vein, or stops blood from pooling in the legs, or both (technical success).
‐ We need studies that provide more evidence on all the available treatments.
What are varicose veins?
Varicose veins are bulging, twisty veins close to the skin’s surface that usually occur in the legs. They are caused by chronic venous insufficiency, which is when your veins do not manage to help blood to flow back up to your heart efficiently, and blood pools in your legs. About one‐third of adults are thought to have chronic venous insufficiency. Women are more likely than men to have varicose veins.
Varicose veins can be painful, itchy and unsightly, especially when standing and walking. Occasionally, they may result in skin changes or sores (ulcers) on the leg that take more than two weeks to heal.
How are varicose veins treated?
Varicose veins can be treated using a variety of procedures.
Traditionally, surgery was used to remove the main surface vein (called the ‘great saphenous vein’, which runs from the groin to the ankle) and any connected varicose veins through small openings in the leg. People having this procedure (known as ‘high ligation and stripping’) need to have a general anaesthetic to make them unconscious and stop them from feeling pain or moving while the surgery is done.
More recently, several treatments have emerged where the procedure is done inside the vein (endovenous), using a very fine tube. These treatments involve sealing the main vein in the thigh by deliberately damaging the vein wall. There are two main types of treatment:
‐ heat‐based, where heat energy from lasers, radio waves or steam, is used to damage the vein wall;
‐ chemical‐based, where chemicals (including foam or glue) are used to damage and consequently seal the vein.
These newer treatments are done using a local anaesthetic, meaning you do not feel pain in your legs during the procedure but you remain awake.
What did we want to find out?
We wanted to compare all the currently available treatments for varicose veins to find out which is best in terms of:
‐ short‐ and long‐term technical success (whether the treatment fully destroys the vein, or stops blood from pooling in the legs, or both);
‐ stopping varicose veins from returning (recurrence);
‐ avoiding unwanted effects; and
‐ improving people’s well‐being.
What did we do?
We searched for studies that compared treatments for varicose veins in men and women of any age.
We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes.
What did we find?
We found 24 studies that involved 5135 people with mild to severe varicose veins. The studies followed people for between 5 weeks to 8 years after their treatment. The majority of the people in the studies were women.
The studies took place in private and public clinics and hospitals in 10 different countries: Austria, Denmark, Egypt, Finland, France, Germany, the Netherlands, Turkey, the United Kingdom and the USA.
The studies we found did not investigate all possible treatments for varicose veins, especially newer treatments.
Main results
Technical success
Most treatments are equally likely to fully destroy the vein or prevent blood pooling in the legs, or both. However:
‐ heat‐based endovenous treatment with a laser may be more successful than traditional surgery;
‐ both heat‐based laser treatment and surgery may be more successful than chemical‐based endovenous treatment with a foam chemical.
Recurrence rates
Most treatments were similarly successful at stopping varicose veins from recurring.
Heat‐based radio wave endovenous treatment may be better than both laser endovenous treatment and surgery at preventing varicose veins from recurring in the longer term.
Unwanted effects
Unwanted effects were generally low for all treatments. The studies reported very few serious unwanted effects requiring treatment, both in the short and long term.
Well‐being
People in the studies said they had improved well‐being regardless of the treatment they received.
What are the limitations of the evidence?
Our confidence in the evidence ranges from moderate to very low because of:
‐ concerns over how the studies were carried out (people in most of the studies were aware of which treatment they were getting, as were the researchers assessing treatment data, which could affect the studies’ results);
‐ similar studies did not get the same results; and
‐ only a small number of studies contributed data to each result.
We were not able to reach firm conclusions about which of the treatments compared is best.
How up to date is this evidence?
This Cochrane Review updates our previous review. The evidence is current to November 2020
Authors' conclusions
Summary of findings
| EVLA compared to RFA for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with RFA | Risk with EVLA | |||||
| Technical success (< 5 years) | Study population | OR 0.98 | 780 | ⊕⊕⊕⊝ | ||
| 975 per 1000 | 974 per 1000 | |||||
| Technical success (> 5 years) | Study population | OR 0.85 | 291 | ⊕⊕⊝⊝ | ||
| 952 per 1000 | 944 per | |||||
| Recurrence (< 5 years) | Study population | OR 1.53 | 291 | ⊕⊕⊝⊝ | ||
| 116 per 1000 | 167 per 1000 | |||||
| Long‐term recurrence (> 5 years) | Study population | OR 2.77 | 291 | ⊕⊕⊝⊝ | ||
| 129 per 1000 | 291 per 1000 | |||||
| Complications (up to 8 years) | See comment | ⊕⊝⊝⊝ | Analysis was prevented as studies reported minor and major complications using different definitions and at varying time points. Results of individual studies were inconsistent with each other so we are not able to draw any conclusions. | |||
| QoL (up to 8 years) | See comment | ⊕⊕⊝⊝ | The majority of studies for this comparison showed no difference in QoL scores between the two variables. Nordon 2011 showed no difference in improvement using AVVQ and EQ‐5D at three months. There was no difference in AVVQ or SF‐12 (in either the physical or mental component SF‐12) at 6 months in Shepherd 2010. Rasmussen 2011 found no difference in SF‐36 at 1 month or AVVQ at 3 years. Recovery 2009 reported improved global QoL scores in RFA at 7 and 14 days post‐operation but comparable by 1 month. Syndor 2017 did not measure QoL. | |||
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by one level due to risk of bias concerns. | ||||||
| EVLA compared to UGFS for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with UGFS | Risk with EVLA | |||||
| Technical success (< 5 years) | Study population | OR 6.13 | 588 (3 studies) | ⊕⊕⊝⊝ | ||
| 802 per 1000 | 961 per | |||||
| Technical success (> 5 years) | Study population | OR 6.47 | 534 | ⊕⊕⊝⊝ | ||
| 626 per 1000 | 915 per | |||||
| Recurrence (< 5 years) | Study population | OR 0.68 | 443 | ⊕⊝⊝⊝ | ||
| 186 per 1000 | 134 per 1000 | |||||
| Long‐term recurrence (> 5 years) | Study population | OR 1.08 | 418 | ⊕⊝⊝⊝ | ||
| 232 per 1000 | 246 per | |||||
| Complications (up to 8 years) | See comment | ⊕⊝⊝⊝ | All three studies reported on this outcome but using different definitions and at varying time points. Rasmussen 2011 reported more phlebitis and hyperpigmentation rates amongst the UGFS group. In Vernermo 2016, skin pigmentation was more common in the UGFS group but haematomas were seen more often after EVLA compared to UGFS at 1 month. Magna 2013 reported two cases of hyperpigmentation in EVLA participants compared to one case in UGFS at 3 months. | |||
| QoL (up to 8 years) | See comment | ⊕⊕⊕⊝ moderated | Magna 2013 reported no significant differences between EVLA and UGFS at 3 months and 1 year in CIVIQ2 and EQ‐5D scores. In Rasmussen 2011, UGFS was deemed to be better for bodily pain and physical functioning in the SF‐36 score initially. AVVSS showed no difference between comparisons at 1 month. Vernermo 2016 found no significant difference in median AVVSS between the treatment groups at 1 year | |||
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by two levels due to risk of bias concerns and inconsistency. | ||||||
| EVLA compared to HL/S for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with HL/S (surgery) | Risk with EVLA | |||||
| Technical success (< 5 years) | Study population | OR 2.31 | 1051 | ⊕⊕⊝⊝ | ||
| 933 per | 970 per | |||||
| Technical success (> 5 years) | Study population | OR 0.93 (0.57 to 1.50) | 874 | ⊕⊕⊝⊝ | ||
| 917 per | 911 per | |||||
| Recurrence (< 5 years) | Study population | OR 0.78 | 1459 | ⊕⊕⊕⊝ moderateb | ||
| 179 per 1000 | 146 per | |||||
| Long‐term recurrence (> 5 years) | Study population | OR 1.09 | 1267 | ⊕⊕⊕⊝ moderateb | ||
| 328 per 1000 | 347 per | |||||
| Complications (up to 8 years) | See comment | ‐ | ⊕⊝⊝⊝ | Analysis was prevented as studies reported minor and major complications using different definitions and at varying time points. Slightly higher rates of early haematomas and wound problems were possibly seen with HL/S (surgery); and EVLA may be associated with slightly more phlebitis. | ||
| QoL (up to 8 years) | See comment | ‐ | ⊕⊕⊕⊝ moderateb | Rates of improvement in QoL were comparable between both treatment groups in all studies. | ||
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by two levels due to risk of bias concerns and imprecision. | ||||||
| RFA compared to MOCA for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with MOCA | Risk with RFA | |||||
| Technical success (< 5 years) | Study population | OR 1.76 | 435 | ⊕⊕⊝⊝ | ||
| 983 per 1000 | 990 per 1000 | |||||
| Technical success (> 5 years) | See comment | ‐ | ‐ | ‐ | Data for this time point are not yet available. | |
| Recurrence (< 5 years) | Study population | OR 1.00 | 389 | ⊕⊕⊝⊝ | ||
| 117 per 1000 | 117 per 1000 | |||||
| Long‐term recurrence (≥ 5 years) | See comment | ‐ | ‐ | ‐ | Data for this time point are not yet available. | |
| Complications (up to 1 year) | See comment | ‐ | ‐ | ⊕⊝⊝⊝ | Analysis was prevented as studies reported minor and major complications using different definitions and at varying time points, but rates were similar between treatment groups. | |
| QoL (AVVQ, EQ‐5D) (up to 1 year) | See comment | ‐ | ‐ | ⊕⊕⊕⊝ moderatec | No differences detected between groups at any time point during the studies. | |
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by two levels due to risk of bias concerns and inconsistency. | ||||||
| RFA compared to HL/S for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with HL/S (surgery) | Risk with RFA | |||||
| Technical success (< 5 years) | Study population | OR 5.71 | 318 | ⊕⊕⊝⊝ lowa | ||
| 974 per | 995 per 1000 | |||||
| Technical success (> 5 years) | Study population | OR 0.88 | 289 | ⊕⊕⊝⊝ lowb | ||
| 958 per | 952 per 1000 | |||||
| Recurrence (< 5 years) | Study population | OR 0.93 | 546 | ⊕⊕⊕⊝ moderatec | ||
| 147 per 1000 | 138 per 1000 | |||||
| Long‐term recurrence (> 5 years) | Study population | OR 0.41 | 289 | ⊕⊕⊝⊝ lowb | ||
| 268 per | 130 per 1000 | |||||
| Complications (up to 8 years) | See comment | ⊕⊝⊝⊝ | Analysis was prevented as studies reported minor and major complications using different definitions and at varying time points. Overall the number of complications was low, but surgery may be associated with slightly higher rates of wound problems, haematomas and saphenous nerve injuries and more phlebitis was seen after RFA. | |||
| QoL (up to 8 years) | See comment | ⊕⊕⊕⊝ moderatec | None of the studies detected a difference between treatment arms by four months. | |||
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by two levels due to risk of bias concerns and inconsistency. | ||||||
| UGFS compared to HL/S for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with HL/S (surgery) | Risk with UGFS | |||||
| Technical success (< 5 years) | Study population | OR 0.32 | 954 | ⊕⊕⊝⊝ | ||
| 888 per | 718 per | |||||
| Technical success (> 5 years) | Study population | OR 0.09 | 525 | ⊕⊕⊕⊝ moderateb | ||
| 929 per | 542 per | |||||
| Recurrence (< 5 years) | Study population | OR 1.81 | 822 | ⊕⊕⊝⊝ | ||
| 168 per 1000 | 267 per 1000 | |||||
| Long‐term recurrence (≥ 5 years) | Study population | OR 1.24 | 639 | ⊕⊕⊝⊝ | ||
| 380 per 1000 | 432 per 1000 | |||||
| Complications (up to 8 years) | See comment | 639 (3 studies) | ⊕⊝⊝⊝ | Analysis was prevented as studies reported minor and major complications using different definitions and at varying time points. | ||
| QoL (up to 8 years) | See comment | 930 (4 studies) | ⊕⊕⊕⊝ moderateb | None of the five included studies showed evidence of a difference in QoL scores between the two treatment groups. | ||
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by two levels due to risk of bias concerns and inconsistency. | ||||||
Background
Varicose veins of the lower limbs are dilated, tortuous, superficial veins. They can be painful, itchy or unsightly, especially when standing and walking. Occasionally, they may result in skin changes or leg ulcers. Varicose veins have been previously treated with surgery to remove the veins, by stripping them to the level of the knee (high ligation and stripping (HL/S)). Newer, less invasive treatments seal the main leaking vein in the thigh by using heat, chemical irritants (sclerosants) or adhesives (glue). These techniques potentially result in less pain after the procedure, fewer complications, and a quicker return to work and normal activities with improved quality of life. They also avoid the need for a general anaesthetic. The results of these newer treatments need to be compared to high ligation and stripping (HL/S) and to one another.
Description of the condition
The great saphenous vein (GSV) and small saphenous vein (SSV) are the main components of the superficial veins of the leg. The GSV runs from the ankle to the saphenofemoral junction in the groin and is responsible for the majority of varicose veins. The normal venous system relies on a complex mechanism consisting of valves, muscle pumps and pressure changes to overcome the forces of gravity, positional changes and pressure changes within the thorax and abdomen. Disruption of the normal function of the deep or superficial venous system will result in retrograde flow, also known as venous incompetence. Venous incompetence is thought to occur through a number of mechanisms. The ascending valvular incompetence theory describes the failing of valves and the loss of antegrade flow (from the ankle to the heart), of blood from the high‐pressured venous system, venous pooling and resulting venous hypertension (Corcos 1996; Corcos 2000; Trendelenburg 1890). There are other associated mechanisms at play, such as raised ankle venous pressure, inflammation and leakage of blood constituents into the surrounding tissue. These make up the vicious cycle of venous disease as inflammation leads to further venous disruption and failure of the venous mechanisms (Jones 2009; Labropoulos 2005; Pascarella 2005; Takase 2004).
The Clinical, Etiological, Anatomical and Pathophysiological (CEAP) classification for chronic venous disease is used to standardise its reporting. The clinical classes of the CEAP classification are shown in Table 1. The tool is validated in clinical practice and focuses primarily on clinical classification (Carpentier 2003).
| C0 | No visible signs of venous disease |
| C1 | Spider veins, telangiectases or reticular veins (diameter < 3 mm) |
| C2 | Varicose veins (with a diameter > 3 mm) |
| C3 | Varicose veins with oedema |
| C4 | Varicose veins with trophic skin lesions secondary to chronic venous insufficiency |
| C4a | Pigmentation, purpura, eczema |
| C4b | Lipodermatosclerosis, atrophie blanche |
| C5 | Healed venous ulcer |
| C6 | Active venous ulcer |
The commonest manifestation of superficial venous incompetence (SVI) is palpable, tortuous, dilated vessels known as varicose veins. Longstanding incompetence, sometimes termed chronic venous insufficiency (CVI), is estimated to affect one third of the adult population (NICE 2013b), 60% to 70% of which is due to saphenofemoral, or GSV, valvular incompetence (Labropoulos 1994). Prevalence of CVI increases with age and risk factors including trauma, history of deep vein thrombosis (DVT), multiple pregnancies, obesity and occupations involving prolonged periods of standing. People may be asymptomatic or complain of mild symptoms such as aching, pain and poor cosmetic appearance. Rabe 2010 reported that in the Bonn Vein Study II 31.8% of people with GSV reflux and C2 disease progressed to more severe disease during 6.6 years of follow up but were not shown to progress to ulcers during the available follow‐up.
Description of the intervention
The traditional treatment of GSV incompetence is by open surgery (Sarin 1992). This involves a small groin incision to perform flush ligation of the saphenofemoral junction (SFJ) and ligation of any tributaries. The GSV is then removed by a process called 'stripping' using a wire or flexible PIN‐stripper. Phlebectomies (small stab incisions) can also then be performed with a vein hook (or through transilluminated powered phlebectomy) to remove any visible or preoperatively‐marked varicosities of the truncal or non‐saphenous veins within the calf or GSV branches within the thigh (Darwood 2008; Nesbitt 2014; Subramonia 2010). The exact role and impact of phlebectomies on the overall outcome for people with venous incompetence are important, but the treatment of choice per se is beyond the scope of this review.
SFJ ligation and stripping (HL/S) is usually performed as a day case procedure, usually under general anaesthesia, within an operating theatre setting. Post‐operative recovery and return to work is usually between two and three weeks; however, in some cases, this may be prolonged up to six weeks (HELP‐1 2011; Subramonia 2010). Overall complication rates following SFJ ligation and stripping are reported as between 17% to 20% (Critchley 1997; HELP‐1 2011). Recognised complications include pain, dysaesthesia, paraesthesia, bruising, haematoma, wound infection, lymphatic leaks, venous thromboembolism (deep vein thrombosis (DVT) and pulmonary embolus (PE)) and damage to major veins, arteries and nerves (CLASS 2014; Critchley 1997; Subramonia 2010). The need for general anaesthesia or spinal anaesthesia also subjects individuals to further risk of complications (i.e. allergic reaction to anaesthetic agents, damage to teeth during intubation, post‐operative nausea and vomiting).
Endovenous treatments
In the past two decades, endovenous procedures for treating SVI have emerged. These procedures rely on a catheter or device inserted into the vein under ultrasound guidance. They are minimally invasive, utilise local anaesthesia and do not require surgical incisions or exposures. These procedures potentially offer more acceptable treatments for GSV varicosities if outcomes are equivalent to or better than conventional surgery. These techniques can be divided into thermal tumescent treatments and non‐thermal non‐tumescent treatments.
Thermal treatments rely on the use of heat energy to damage the vein wall and lead to occlusion and fibrosis. Non‐thermal interventions predominantly rely on the use of a chemical sclerosant or, more recently, a glue that causes inflammatory and chemical damage to the vein wall, which can also be used in combination with mechanical agitation and maceration of the intima.
Thermal tumescent interventions
Endovenous thermal ablation is the use of heat to close the vein. The devices available are endovenous laser ablation (EVLA), radiofrequency ablation (RFA) or steam ablation (EVSA). There are a number of manufacturers, designs and differences within each of these categories. However, for clarity, we have adopted umbrella terminology in this review.
EVLA, RFA and EVSA are performed using tumescent anaesthesia, where local anaesthetic is injected under ultrasound guidance along the length of the vein. The benefit of this approach is four‐fold: (1) analgesia (pain relief): provided during and after the procedure; (2) compression: the perivenous dilute anaesthetic solution compresses the vein wall onto the endovenous catheter due to the increased hydrostatic pressure within the saphenous sheath; (3) hydrodissection: simultaneously, perivenous nervous structures are moved away from heat within the vein by means of hydrodissection, to protect adjacent structures such as nerves; and (4) heat sink: as the fluid is typically cool, it acts as a heat sink, reducing the risk of neurological sequelae and burns (Joh 2014).
Endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) are established interventions with an improved complication profile and reduced recovery time compared to open surgery (CLASS 2014; HELP‐1 2011; LAST 2014; Subramonia 2010). In addition, they do not require general anaesthesia. In 2013, the National Institute for Health and Care Excellence (NICE) recommended the use of endovenous ablation as the first line treatment intervention for duplex ultrasound‐confirmed varicose veins and truncal incompetence (NICE 2013a).
Various types of laser fibres, wavelengths and radial tips are available for EVLA. For the purposes of this clinically‐orientated review, we have grouped these under one category, accepting that there may be nuanced advantages and disadvantages for each laser type. In EVLA, the GSV is cannulated under ultrasound guidance at the most distal point of reflux with an optical laser fibre. This is then advanced to just below the SFJ. The proximity to the junction varies by manufacturer but is typically 2 cm. Tumescent anaesthesia is then infiltrated, surrounding the EVLA catheter under duplex ultrasound (DUS) guidance. Ablation of the vessel occurs as the laser is activated and then slowly withdrawn retrograde (the rate varies depending on manufacturer recommendation). The operator simultaneously compresses the vein, delivering between 60 and 80 J/cm (Darwood 2008). EVLA can be performed using sedation, local or general anaesthesia in addition to tumescence. Complications include phlebitis, pain, bruising, burns and sensory disturbances. Min 2003 showed 93% duplex ultrasound‐proven occlusion at two years following EVLA for GSV varicosities, with all recurrences occurring within the first nine months.
RFA is performed under a similar principle to EVLA; however, luminal occlusion is induced through heat from radiofrequency energy controlled by a thermocouple. As in EVLA, the GSV is cannulated distally and the catheter electrode is positioned just below the SFJ then surrounded with tumescent anaesthesia. The catheter is then withdrawn by segments along the length of the vein whilst under compression. Normal activity following the procedure is encouraged. Complications such as phlebitis, sensory disturbance and burns are uncommon and have reduced since the introduction of tumescence. Arteriovenous fistulation is a recognised but rare complication (< 0.15%) (Rudarakanchana 2012; Weiss 2019).
Endovenous steam ablation (EVSA) works in a similar way to EVLA and RFA, where a catheter is advanced under ultrasound guidance into the target vein. This then allows 'superheated' steam (pressurised) to be pumped into the vein once tumescent has been infiltrated. The result is venous occlusion through thermal damage to the vein wall. Histological examination post intervention shows vein wall fibrosis and inflammation, destruction of endothelium, alterations of elastic and collagen fibres and reduction of the lumen (LAST 2014). Proposed benefits of steam sclerosis include use of lower temperatures (120 oC) compared to EVLA (temperatures of up to 600 oC reported), with fewer thermal injuries and reduced post‐operative pain (LAST 2014). EVSA is reported to not produce potentially harmful exogenous substances and some data on cost‐effectiveness exist (LAST 2014). The catheter in EVSA is also more flexible than those used in RFA and EVLA, which enables access to more tortuous vessels and perforator branches (Van den Bos 2011). Occlusion rates are reported to range from 85 to 100% (Woźniak 2015).
Non‐thermal, non‐tumescent interventions (NTNT)
The initial technique of non‐thermal interventions for GSV incompetence was that of ultrasound‐guided foam sclerotherapy (UGFS). UGFS is the recommended second line technique in the United Kingdom (UK) for the treatment of varicose veins as per NICE guidance (NICE 2013a). Under ultrasound guidance, the vein is cannulated and a foam sclerosant is injected, causing inflammation of the endothelial and subendothelial layers of the wall and hence fibrosis and obliteration of the vein. Various types of foam are available. However, initial success rates have been reported as low and repeated treatments are frequently required (Devereux 2014; Proebstle 2015). The procedure may be associated with poor post‐procedural cosmesis, with skin staining and ‘lumpiness’ reported. There is also a risk of visual disturbances and very low risk of stroke (NICE 2013b). People are also required to wear compression stockings following the procedure. The major advantage of non‐thermal interventions over thermal interventions is that they can be performed in outpatient departments and without any systemic analgesia. In addition, in those with lipodermatosclerosis or ulceration, UGFS can be useful as the infiltration of perivenous tumescence is not required.
More recently, there has been increasing use of other non‐thermal treatments for GSV insufficiency. These also do not require the use of tumescence (which can be painful and itself cause complications). Additionally, they do not subject individuals to the risk of thermal injury and are therefore known as non‐tumescent non‐thermal (NTNT) techniques (Leung 2016; Shepherd 2010).
Mechanochemical ablation (MOCA) is a NTNT technique which obliterates the venous lumen through the use of a rotating catheter tip, causing vasospasm and mechanical damage to endothelial cells. Further chemical injury is induced through the concomitant injection of a liquid sclerosant (Leung 2016; Tang 2017). The procedure only requires local anaesthesia and individuals are encouraged to mobilise immediately following the procedure. MOCA is reported to have lower rates of post‐procedural pain and enhanced recovery times in comparison with other endovenous techniques (Leung 2016). Tang 2017 reported a complication rate of 4.3% (which predominantly consisted of superficial self‐resolving phlebitis), and no major complications were reported. Occlusion rates between 94% to 97% are reported (Tang 2017).
Cyanoacrylate embolisation consists of the injection of cyanoacrylate glue within the vein via a hand‐held delivery gun. Under ultrasound guidance, the incompetent GSV is cannulated distally and a catheter inserted to 5 cm below the SFJ. Cyanoacrylate is then injected with alternating compression and pullback every few minutes for the length of the vein. Cyanoacrylate achieves immediate occlusion by chemically bonding the opposing vein walls together (Morrison 2015). The glue causes fibrotic degradation of the vein via a granulomatous foreign body and inflammatory vein wall reaction (Proebstle 2015). Tumescent anaesthesia is not required and manufacturers state that there no need for people to wear compression stockings post intervention. As the procedure is intraluminal, there is reduced risk of damage to perivenous nervous structures. Side effects predominantly consist of self‐limiting phlebitic reactions and wound infections (Gibson 2017). However, thrombus extension into the deep venous system has been reported with the consequent risk of migration to pulmonary vasculature (Proebstle 2015).
How the intervention might work
All the interventions aim to occlude the incompetent great saphenous vein (GSV). The endovenous interventions outlined above all broadly rely on endoluminal venous damage by means of: thermal energy (EVLA/RFA/EVSA) (Goode 2010; Khilnani 2010; Van den Bos 2011); chemical irritation (UGFS/MOCA) (Mueller 2013; Tessari 2001; Van Eekeren 2014); or adhesion (cyanoacrylate) (Lane 2017).
The outcome is venous endothelial damage which results in venous inflammation and subsequent sclerosis and scarring as the vein heals following the endothelial obliteration. This leads to venous occlusion. All methods described require the application of DUS to enable cannulation of the GSV at the lowest point of reflux, and each method is suitable for the majority of axial venous incompetence.
There has been a large increase in the uptake of these methods and their application in routine practice continues in both the NHS and private sector. The advent of the 2013 NICE guidelines has facilitated a paradigm shift in the management of GSV incompetence (Coughlin 2015; NICE 2013a). Surgery by means of open ligation and stripping is still performed but it is no longer the gold standard intervention. Surgical treatment aims to physically disconnect the GSV from its junction and then remove the length of GSV by stripping. This is an effective treatment but carries a greater morbidity in terms of the need for general anaesthesia, post‐operative complications and a longer recovery.
Why it is important to do this review
This is an update of a Cochrane Review first published in 2011, and previously updated in 2014 (Nesbitt 2011; Nesbitt 2014). Since the previous version of this Cochrane Review was published, new UK NICE guidance (NICE 2013a) and subsequent European guidance on the management of chronic venous incompetence (Wittens 2015) have been published. Furthermore, the development of newer endovenous devices has resulted in a wider range of technologies that can be used to treat this disease. As outlined above, these have varying levels of supporting evidence, and they differ in their underlying application and treatment methods. This has sparked an increase in venous literature comparing existing treatments with newer interventions and reporting on long‐term outcomes. This Cochrane Review considers the full breadth of treatment options for GSV incompetence and compares these options. Therefore, this review has a wider scope compared to previous versions of this review (Nesbitt 2011; Nesbitt 2014). We present the current evidence to provide the venous practitioner and wider healthcare community an up‐to‐date resource to enable accurate, evidence‐based decision‐making that can be tailored to individuals. The review is aimed at highlighting the strengths and weaknesses within the entire field of GSV interventions (open surgery, endovenous thermal and endovenous non‐thermal techniques) in order to answer key questions of day‐to‐day venous practice: which method is currently the most technically effective and which method offers long‐term benefits and lowest recurrence rates.
Objectives
To assess the effects of endovenous laser ablation (EVLA), radiofrequency ablation (RFA), endovenous steam ablation (EVSA), ultrasound‐guided foam sclerotherapy (UGFS), cyanoacrylate glue, mechanochemical ablation (MOCA) and high ligation and stripping (HL/S) for the treatment of varicosities of the great saphenous vein (GSV).
Methods
Criteria for considering studies for this review
Types of studies
We included randomised control trials (RCTs) which compared interventions for treating varicosities of the great saphenous vein (GSV). We excluded studies which:
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included participants who underwent a combination of interventions (for instance, endovenous laser ablation (EVLA) or radiofrequency ablation (RFA) with high ligation and stripping (HL/S));
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treated all other axes of superficial venous incompetence such as small saphenous vein (SSV), perforating veins or varicosities of tributaries, anterior thigh or accessory GSV veins (AAGSV);
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treated telangiectasias or thread veins;
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did not provide data (subgroup analysis) for participants who had both GSV and SSV varicosities treated;
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included recurrent treatment (i.e. participants underwent previous treatment for GSV varicosities);
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included participants who received simultaneous treatment of bilateral GSV insufficiency with different interventions (e.g. one limb treated with EVLA and the other limb with ultrasound‐guided foam sclerotherapy (UGFS);
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involved CHIVA and ASVAL, as these are axial‐preserving techniques.
Types of participants
We included men and women of any age, with duplex ultrasound‐proven varicosities of the great saphenous system, who were suitable to undergo any of the treatment interventions. The focus of this review was on the management of C2 to C4 grade varicose veins. People with varicose veins with healed leg ulcer (C5) or active leg ulcer (C6) were excluded from this Cochrane Review. Endovenous thermal ablation for treating venous leg ulcers is evaluated in a separate Cochrane Review (Samuel 2013).
Types of interventions
We included these interventions:
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endovenous laser ablation (EVLA);
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radiofrequency ablation (RFA);
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endovenous steam ablation (EVSA);
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ultrasound‐guided foam sclerotherapy (UGFS);
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cyanoacrylate glue;
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mechanochemical ablation (MOCA);
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SFJ ligation and stripping (surgery) (HL/S).
We planned to include these comparisons:
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endovenous laser ablation versus radiofrequency ablation;
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endovenous laser ablation versus endovenous steam ablation;
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endovenous laser ablation versus ultrasound‐guided foam sclerotherapy;
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endovenous laser ablation versus cyanoacrylate glue;
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endovenous laser ablation versus mechanochemical ablation;
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endovenous laser ablation versus SFJ ligation and stripping;
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radiofrequency ablation versus endovenous steam ablation;
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radiofrequency ablation versus ultrasound‐guided foam sclerotherapy;
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radiofrequency ablation versus cyanoacrylate glue;
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radiofrequency ablation versus mechanochemical ablation;
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radiofrequency ablation versus SFJ ligation and stripping;
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endovenous steam ablation versus ultrasound‐guided foam sclerotherapy;
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endovenous steam ablation versus cyanoacrylate glue;
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endovenous steam ablation versus mechanochemical ablation;
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endovenous steam ablation versus SFJ ligation and stripping;
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ultrasound‐guided foam sclerotherapy versus cyanoacrylate glue;
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ultrasound‐guided foam sclerotherapy versus mechanochemical ablation;
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ultrasound‐guided foam sclerotherapy versus SFJ ligation and stripping;
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cyanoacrylate glue versus mechanochemical ablation;
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cyanoacrylate glue versus SFJ ligation and stripping;
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mechanochemical ablation versus SFJ ligation and stripping.
Types of outcome measures
Primary outcomes
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Early technical success: defined as complete anatomical obliteration, or absence of reflux, within the GSV at around six weeks, on duplex ultrasound (DUS) (standard criterion of one second of reflux was used)
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Long‐term technical success: defined as complete anatomical obliteration, or absence of reflux, within the GSV on DUS at five years or more
Secondary outcomes
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Recurrence: clinical definition as reported by the clinician or participant at least one year following intervention. We expanded this outcome to include the term recanalisation. We have outlined the definition where reported by the included studies.
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Post‐operative complications within three months (early) and beyond three months (late)
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Minor complications are defined as those not requiring intervention, such as wound or thigh haematoma, saphenous nerve injury, thermal injury, bruising and phlebitis.
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Major complications are defined as those requiring intervention, such as venous thromboembolism (VTE), respiratory distress and wound complications.
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Quality of life (QoL): measured by generic QoL scores pre‐ and post‐intervention (e.g. Aberdeen Varicose Vein Symptom Severity score (AVVSS, also referred to as the Aberdeen Varicose Vein Questionnaire, AVVQ), Short Form 36 (SF‐36))
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Pain: participant‐reported pain post‐operatively. This could be reported via visual analogue scales or number of analgesic tablets taken.
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Venous Clinical Severity Score (VCSS) pre‐ and post‐intervention
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Length of procedure
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Hospital stay: whether the intervention was performed as a day case procedure or required an inpatient admission
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Return to normal activities or work (days)
Search methods for identification of studies
Electronic searches
The Cochrane Vascular Information Specialist conducted systematic searches of the following databases for randomised controlled trials and controlled clinical trials without language, publication year or publication status restrictions.
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Cochrane Vascular Specialised Register via the Cochrane Register of Studies (CRS‐Web searched on 2 November 2020).
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Cochrane Central Register of Controlled Trials (CENTRAL) Cochrane Register of Studies Online (CRSO 2020, Issue 10).
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MEDLINE (Ovid MEDLINE Epub Ahead of Print, In‐Process & Other Non‐Indexed Citations, Ovid MEDLINE Daily and Ovid MEDLINE) (searched from 1 January 2017 to 2 November 2020).
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Embase Ovid (searched from 1 January 2017 to 2 November 2020).
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CINAHL Ebsco (searched from 1 January 2017 to 2 November 2020).
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AMED Ovid (searched from 1 January 2017 to 2 November 2020).
The Information Specialist modelled search strategies for other databases on the search strategy designed for CENTRAL. Where appropriate, they were combined with adaptations of the highly sensitive search strategy designed by the Cochrane Collaboration for identifying randomised controlled trials and controlled clinical trials (as described in the Cochrane Handbook for Systematic Reviews of Interventions Chapter 6, Lefebvre 2011). Search strategies for major databases are provided in Appendix 1 and Appendix 2.
The Information Specialist searched these trials registries on 2 November 2020:
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World Health Organization International Clinical Trials Registry Platform (who.int/trialsearch);
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ClinicalTrials.gov (clinicaltrials.gov).
Searching other resources
We cross‐checked reference lists from relevant RCTs and meta‐analyses to ensure the inclusion of all appropriate studies.
Data collection and analysis
Selection of studies
Two review authors (JW and SN) independently screened the trials identified by the literature search for eligibility. We resolved disagreements by consulting a third review author (GS).
Data extraction and management
Two review authors (JW and SN) independently extracted data. A third review author (CN) then cross‐checked data extraction.
We extracted the following data from the included RCTs.
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Methods: aim of study, study design, unit of allocation, start and end date, duration, country, intention‐to‐treat analysis, ethical approval.
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Participants: setting, consent, number of participants randomised, number of participants analysed, exclusions post‐randomisation, loss to follow‐up, age (median), sex, co‐morbidities, number of bilateral limbs, inclusion and exclusion criteria.
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Interventions: treatment, control, duration, timing, delivery, providers.
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Outcomes: primary and secondary outcomes, time points measured and recorded, outcome definition, person measuring, unit of measurement, power.
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Other: funding, conflicts of interest.
Assessment of risk of bias in included studies
Two review authors (JW and SN) independently assessed the included studies using Cochrane's risk of bias tool (Higgins 2011). This tool assesses bias in seven different domains (random sequence generation, allocation concealment (selection bias), performance bias, detection bias, attrition bias, reporting bias and other bias), with each domain being assessed as being at high, low or unclear risk of bias, depending on each review author’s judgement. We resolved any disagreements through discussion with a third review author (GS).
Measures of treatment effect
We used odds ratios (OR) with 95% confidence intervals (CI) as the measure of effect for each of the dichotomous outcomes. When data were available, we planned to used mean difference (MD) and standard deviation (SD) to report outcomes with continuous scales of measurement. We also planned to attempt to standardise and combine data where different studies used different scales (i.e. using standardised mean difference (SMD) and SD). We carried out analyses at different time points, as reported by the trials. We based our calculations on an intention‐to‐treat approach.
Unit of analysis issues
We intended to use the participant as the unit of analysis. Where studies used ‘legs or limbs’ as their unit of analysis, we contacted study authors to clarify the number of participants. If we were unable to obtain this information, we used ‘legs/limbs’ as the unit of analysis for technical success, recurrence and VCSS. QoL was reported using a variety of QoL assessment tools.
Dealing with missing data
We contacted study authors to request missing data or answer queries where required.
Assessment of heterogeneity
We noted and explored heterogeneity in the data, using previously identified characteristics of the studies, particularly assessments of risk of bias. The I2 statistic was used to determine heterogeneity. We considered I2 values greater than 50% to indicate the possible presence of heterogeneity, as in the previous version of this review (Nesbitt 2014), and as suggested by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
Assessment of reporting biases
We planned to construct funnel plots to evaluate reporting bias, for meta‐analyses including 10 or more studies (Higgins 2011).
Data synthesis
We calculated a summary statistic for each outcome (where there were sufficient data), using Review Manager 5 (Review Manager 2014). We used a fixed‐effect model unless heterogeneity was detected (I2 values greater than 50%), in which case, we planned to use a random‐effects model.
Subgroup analysis and investigation of heterogeneity
We planned to undertake subgroup analyses to examine the stability of the results in relation to a number of factors, including participant type. However, due to the lack of outcome data reported by categories of interest, we did not perform subgroup analysis at this time.
Sensitivity analysis
We planned to exclude from meta‐analysis those studies deemed to have a high risk of bias in four or more bias domains.
Summary of findings and assessment of the certainty of the evidence
We created summary of findings (SOF) tables using the GRADEpro Guideline Development Tool to present the main findings of the review for the time point at which the most relevant data were available from the included studies (Atkins 2004; GRADEpro GDT). The population consisted of people with varicosities of the great saphenous vein (GSV) system. We created one SOF table for comparisons of most clinical relevance and which included data from more than one study. We included in our SOF tables the main outcomes listed under Types of outcome measures that we considered essential for decision‐making; namely, technical success (under and over five years), recurrence (under and over five years), complications, and quality of life. We evaluated the certainty of the evidence using the GRADE approach (Guyatt 2008). We assigned one of four levels of certainty: high, moderate, low or very low, based on overall risk of bias, directness of evidence, inconsistency of results, precision of estimates, and risk of publication bias, as previously described (Higgins 2011).
Results
Description of studies
Results of the search
See Figure 1.
Study flow diagram
Included studies
We included a total of 24 studies in this review. This includes 11 new studies (18 reports) (Calik 2019; Lane 2017; LAST 2014; MARADONA 2019; Morrison 2015; Nordon 2011; Recovery 2009; Shepherd 2010; Syndor 2017; Vähäaho 2019; Vernermo 2016), in addition to the 13 from the previous version of the review (Darwood 2008; EVOLVeS 2003; Flessenkämper 2013; FOAM 2010; Helmy ElKaffas 2011; HELP‐1 2011; Magna 2013; Pronk 2010; Rasmussen 2007; Rasmussen 2011; Rautio 2002; RELACS 2012; Subramonia 2010). We also included additional reports of the long‐term follow‐up (greater than five years) for this update for seven studies (Flessenkämper 2013; FOAM 2010; HELP‐1 2011; Magna 2013; Pronk 2010; Rasmussen 2011; RELACS 2012). See the Characteristics of included studies tables.
All studies were RCTs in single, double and multi‐centre settings. Trials were conducted in a variety of private and public clinics and hospitals in countries including Turkey, Egypt, UK, USA, Finland, Germany, Denmark, Netherlands, Austria and France. The unit of analysis was considered to be the 'participants' in the majority of studies, with six studies reporting 'limbs' or 'legs' as the unit of analysis (Darwood 2008; EVOLVeS 2003; LAST 2014; Magna 2013; Pronk 2010; Rasmussen 2011). Calik 2019 involved a small number of bilaterally treated participants and refers to 'procedures' as their unit of analysis.
The studies included in this review randomised a total of 5135 participants and analysed 4422. Sample sizes in the studies ranged from 33 (Rautio 2002), to 500 participants (Rasmussen 2011); see sample study size in Table 2. In keeping with the epidemiology of venous insufficiency, a female predominance of participants was seen. Participants analysed ranged in age from 18 (Rasmussen 2011), to 86 years old (Syndor 2017). The age and sex of study participants for all trials is given in Table 3.
| EVLA versus RFA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | RFA | |
| 159 | 157 | 78 | 79 | |
| 250 292 legs | 213 245 legs | 107 121 legs | 106 124 legs | |
| 87 legs | 87 legs | 41 legs | 46 legs | |
| 131 | 115 | 55 | 60 | |
| 200 | 153 | 79 | 74 | |
| EVLA versus EVSA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | EVSA | |
| 217 237 legs | 199 legs | 92 legs | 107 legs | |
| EVLA versus UGFS | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | UGFS | |
| 160 legs | 155 legs | 78 legs | 77 legs | |
| 250 289 legs | 214 244 legs | 107 121 legs | 107 123 legs | |
| 159 | 145 | 73 | 72 | |
| EVLA versus CA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | CA | |
| 400 | 355 | 174 | 181 | |
| EVLA versus MOCA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | MOCA | |
| 99 | 88 | 33 | 55 | |
| EVLA versus HL/S (surgery) | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | HL/S (surgery) | |
| 118 136 legs | 95 114 legs | 80 legs | 34 legs | |
| 301 | 255 | 127 | 128 | |
| 280 | 237 | 124 | 113 | |
| 160 legs | 146 legs | 78 legs | 68 legs | |
| 122 130 legs | 130 legs | 62 legs | 68 legs | |
| 121 137 legs | 88 | 47 | 41 | |
| 250 287 legs | 204 229 legs | 107 121 legs | 97 108 legs | |
| 400 | 316 | 173 | 143 | |
| 152 | 134 | 73 | 61 | |
| RFA versus UGFS | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | RFA | UGFS | |
| 250 292 legs | 213 247 legs | 106 124 legs | 107 123 legs | |
| RFA versus CA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | RFA | CA | |
| 222 | 208 | 104 | 104 | |
| RFA versus MOCA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | RFA | MOCA | |
| 170 | 129 | 60 | 69 | |
| 213 | 200 | 99 | 101 | |
| 98 | 84 | 29 | 55 | |
| RFA versus HL/S (surgery) | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | RFA | HL/S (surgery) | |
| 85 86 legs | 80 legs | 44 legs | 36 legs | |
| 180 | 162 | 81 | 81 | |
| 250 290 legs | 203 232 legs | 106 124 legs | 97 108 legs | |
| 33 | 28 | 15 | 13 | |
| 93 | 88 | 47 | 41 | |
| UGFS versus HL/S (surgery) | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | UGFS | HL/S (surgery) | |
| 460 | 390 | 213 | 177 | |
| 160 legs | 145 legs | 77 legs | 68 legs | |
| 250 286 legs | 204 231 legs | 107 123 legs | 97 108 legs | |
| 155 | 133 | 72 | 61 | |
aStudy includes multiple comparisons of different interventions.
bStudy includes third treatment arm not included within this review.
CA: cyanoacrylate glue
EVLA: endovenous laser ablation
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
MOCA: mechanochemical ablation
RFA: radio frequency ablation
UGFS: ultrasound‐guided foam sclerotherapy
| EVLA versus RFA | ||||
| Study | Age (years) | Sex (F:M) | ||
| EVLA | RFA | EVLA | RFA | |
| 46.7 (14.4) mean (SD) | 46.9 (15.1) mean (SD) | 54:26 | 45:34 | |
| 52 (18 ‐ 74) mean (range) | 51 (23 ‐ 75) mean (range) | 90:35 | 88:37 | |
| 51.6 (12.8) mean (SD) | 52.4 (15.3) mean (SD) | 31:10 | 29:17 | |
| 48 (16) mean (SD) | 49 (15) mean (SD) | 42:22 | 47:20 | |
| 48.5 (23 ‐ 86) mean (range) | 47 (19 ‐ 86) mean (range) | 77:23 | 80:20 | |
| EVLA versus EVSA | ||||
| Study | Age (years) | Sex (F:M) | ||
| EVLA | EVSA | EVLA | EVSA | |
| 55 (12) mean (SD) | 56 (13) mean (SD) | 61:45 62:48 (legs) | 73:39 76:41 (legs) | |
| EVLA versus UGFS | ||||
| Study | Age (years) | Sex (F:M) | ||
| EVLA | UGFS | EVLA | UGFS | |
| 49 (15.03) mean (SD) | 56 (13.30) mean (SD) | 54:24 | 52:25 | |
| 52 (18 ‐ 74) mean (range) | 51 (18 ‐ 75) mean (range) | 90:35 | 94:30 | |
| 47 (13.4) [20 ‐ 73] mean (SD) [range] | 48.3 (12.7) [20 ‐ 73] mean (SD) [range] | 55:18 | 58:18 | |
| EVLA versus CA | ||||
| Study | Age (years) | Sex (F:M) | ||
| EVLA | CA | EVLA | CA | |
| 38.4 (11.9) mean (SD) | 38.6 (11.6) mean (SD) | 114:86 | 109:91 | |
| EVLA versus MOCA | ||||
| Study | Age (years) | Ses (F:M) | ||
| EVLA | MOCA | EVLA | MOCA | |
| 49.5 (11.9) mean (SD) | 50.9 (12.0) mean (SD) | N/A | N/A | |
| EVLA versus HL/S (surgery) | ||||
| Study | Age (years) | Sex (F:M) | ||
| EVLA | HL/S (surgery) | EVLA | HL/S (surgery) | |
| EVLT1: 42 (30.5 ‐ 54.5); EVLT2: 52 (35 ‐ 59); mean (IQR) | 49 (38.5 ‐ 57.5) mean (IQR) | EVLT1: 22:16 EVLT2: 16:11 | 16:14 | |
| 47.4 (12.9) mean (SD) | 47.7 (11.5) mean (SD) | 97:45 | 112:47 | |
| 49 (14) mean (SD) | 49 (13) mean (SD) | 85:54 | 90:47 | |
| 49 (15.03) mean (SD) | 52 (15.59) mean (SD) | 54:24 | 46:22 | |
| 49 (11.0) mean (SD) | 50 (10.5) mean (SD) | 46:16 | 53:15 | |
| 53 (26 ‐ 79) mean (range) | 54 (22 ‐ 78) mean (range) | 41:21 | 43:16 | |
| 52 (18 ‐ 74) mean (SD) | 50 (19 ‐ 72) mean (range) | 90:35 | 95:29 | |
| 47.9 (10.9) mean (SD) | 48.0 (10.7) mean (SD) | 113:48 | 124:61 | |
| 47 (13.4) [20 ‐ 73] mean (SD) [range] | 47.3 (11.3) [27 ‐ 75] mean (SD) [range] | 55:18 | 55:10 | |
| RFA versus UGFS | ||||
| Study | Age (years) | Sex (F:M) | ||
| RFA | UGFS | RFA | UGFS | |
| 51 (23 ‐ 75) mean (range) | 51 (18 ‐ 75) mean (range) | 88:37 | 94:30 | |
| RFA versus CA | ||||
| Study | Age (years) | Sex (F:M) | ||
| RFA | CA | RFA | CA | |
| 50.5 (25.6 ‐ 70.1) mean (range) | 49.0 (26.6 ‐ 70.6) mean (range) | 93:21 | 83:25 | |
| RFA versus MOCA | ||||
| Study | Age (years) | Sex (F:M) | ||
| RFA | MOCA | RFA | MOCA | |
| 58 (median) | 54.5 (median) | 50:33 | 50:37 | |
| 53.4 (22.6 ‐ 77.9) median (range) | 54.9 (16.3 ‐ 18.2) median (range) | 63:43 | 67:40 | |
| 50.3 (13.9) mean (SD) | 50.9 (12.0) mean (SD) | N/A | N/A | |
| RFA versus HL/S (surgery) | ||||
| Study | Age (years) | Sex (F:M) | ||
| RFA | HL/S (surgery) | RFA | HL/S (surgery) | |
| 49 (4) mean (SD) | 47 (4) mean (SD) | 32:12 | 26:10 | |
| 33.1 (2.6) mean (SD) | 34.9 (3.7) mean (SD) | 48:42 | 45:45 | |
| 51 (23 ‐ 75) mean (range) | 50 (19 ‐ 72) mean (range) | 88:37 | 95:29 | |
| 33 (6.7) mean (SD) | 38 (6.8) mean (SD) | 14:1 | 12:1 | |
| 47 (38 ‐ 58) median (IQR) | 45 (37 ‐ 53) median (IQR) | 34:13 | 27:14 | |
| UGFS versus HL/S (surgery) | ||||
| Study | Age (years) | Sex (F:M) | ||
| UGFS | HL/S (surgery) | UGFS | HL/S (surgery) | |
| 55.8 (13.4) mean (SD) | 54.6 (13.4) mean (SD) | 175:58 | 162:65 | |
| 56 (13.30) mean (SD) | 52 (15.59) mean (SD) | 52:25 | 46:22 | |
| 51 (18 ‐ 75) mean (range) | 50 (19 ‐ 72) mean (range) | 94:30 | 95:29 | |
| 48.3 (12.7) [20 ‐ 73] mean (SD) [range] | 47.3 (11.3) [27 ‐ 75] mean (SD) [range] | 58:18 | 55:10 | |
CA: cyanoacrylate glue
EVLA: endovenous laser ablation (same as EVLT)
EVLT: endovenous laser therapy
EVSA: endovenous steam ablation
F: female
HL/S: high ligation and stripping
IQR: interquartile range
M: male
MOCA: mechanochemical ablation
RFA: radio frequency ablation
SD: standard deviation
UGFS: ultrasound‐guided foam sclerotherapy
Five studies compared endovenous laser ablation (EVLA) to radiofrequency ablation (RFA) (Nordon 2011; Rasmussen 2011; Recovery 2009; Shepherd 2010; Syndor 2017). Only LAST 2014 compared EVLA with endovenous steam ablation (EVSA). Three studies compared EVLA with ultrasound‐guided foam sclerotherapy (UGFS) (Magna 2013; Rasmussen 2011; Vernermo 2016). Calik 2019 was the only study to compare EVLA to cyanoacrylate glue. Only one study compared endovenous laser ablation (EVLA) to mechanochemical ablation (MOCA) (Vähäaho 2019). Nine studies compared EVLA to SFJ ligation and stripping (HL/S; surgery) (Darwood 2008; Flessenkämper 2013; HELP‐1 2011; Magna 2013; Pronk 2010; Rasmussen 2007; Rasmussen 2011; RELACS 2012; Vernermo 2016). The types of laser used in these trials can be found in Table 4. Rasmussen 2011 solely compared RFA with UGFS. Morrison 2015 was the only trial to compare RFA with cyanoacrylate glue. Three studies compared RFA with MOCA (Lane 2017; MARADONA 2019; Vähäaho 2019). Five studies compared RFA with SFJ ligation and stripping (EVOLVeS 2003; Helmy ElKaffas 2011; Rasmussen 2011; Rautio 2002; Subramonia 2010). Ultrasound‐guided foam sclerotherapy was compared with SFJ ligation and stripping in four studies (FOAM 2010; Magna 2013; Rasmussen 2011; Vernermo 2016).
| Study | Laser | Pulsed/continuous | Energy | Technique |
| 1470 nm diode | not stated | 15 W | withdrawn at 2.08 ± 0.6 cm/s | |
| 810 nm diode | 1) pulsed | 12 W | 1 s pulses, 1 s intervals | |
| 2) continuous | 14 W | withdrawn 2 ‐ 3 mm/s | ||
| 980 nm diode | continuous | 30 W | not indicated | |
| 810 nm diode | continuous | 14 W | not indicated | |
| 940 nm diode | continuous | 12 W | not indicated | |
| 940 nm diode | continuous | not indicated | not indicated | |
| 810 nm diode | continuous | 12 W | withdrawn 2 mm/s | |
| 980 nm diode | continuous | 12 W | not indicated | |
| 980 nm diode | pulsed | 12 W | 1.5 s pulses, 1.5 s intervals | |
| 980 nm diode | 1) pulsed | not indicated | not indicated | |
| 2) continuous | ||||
| 1470 nm diode | 1) pulsed | |||
| 2) continuous | ||||
| 980 nm diode | continuous | 12 W | not indicated | |
| 810 nm diode | continuous | 20 W | not indicated | |
| 980 nm diode | continuous | 11 W | not indicated | |
| 980 nm diode | continuous | 10 W | not indicated | |
| 1470 nm diode | pulsed | 10 W | 1.5 s impulse | |
| 980 nm diode | pulsed | 12 W | 1.5 s impulse | |
| 1470 nm diode | pulsed | 12 W | 1.5 s impulse |
cm: centimetre
mm: millimetre
nm: nanometre
s: seconds
W: watts
Four studies compared multiple interventions. Magna 2013 and Vernermo 2016 analysed endovenous laser ablation, ultrasound‐guided foam sclerotherapy and SFJ ligation and stripping against each other. Rasmussen 2011 also analysed these, with the addition of radiofrequency ablation (RFA). Vähäaho 2019 compared EVLA, RFA and MOCA, but it was only powered to compare MOCA against thermal ablation. Hence, we have not included their outcomes for RFA or EVLA within our comparison of these two interventions. Flessenkämper 2013 included a comparison arm which was not included within the scope of this study (EVLA plus high ligation); therefore, we did not include these participants.
We identified no published RCTs which met the inclusion criteria for the following comparisons.
-
Radiofrequency ablation versus endovenous steam ablation.
-
Endovenous steam ablation versus ultrasound‐guided foam sclerotherapy.
-
Endovenous steam ablation versus cyanoacrylate glue.
-
Endovenous steam ablation versus mechanochemical ablation.
-
Endovenous steam ablation versus SFJ ligation and stripping.
-
Ultrasound‐guided foam sclerotherapy versus cyanoacrylate glue.
-
Ultrasound‐guided foam sclerotherapy versus mechanochemical ablation.
-
Cyanoacrylate glue versus mechanochemical ablation.
-
Cyanoacrylate glue versus SFJ ligation and stripping.
-
Mechanochemical ablation versus SFJ ligation and stripping.
The duration of follow‐up for included trials ranged from five weeks (Subramonia 2010), to eight years (FOAM 2010). The outcome measures for each of the included trials can be found in Table 5.
| Technique | Study | Outcome measure | ||||||||
| Technical success | Complications | Recurrence/ recanalisation | Pain | QoL Score | VCSS | Duration of procedure | Inpatient/day case | Return to normal activities/work | ||
| EVLA versus RFA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| ✓ | ✓ | ✓ | ✓ | |||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| EVLA versus EVSA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| EVLA versus UGFS | ✓ | ✓ | ✓ | ✓ | ||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| EVLA versus CA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| EVLA versus MOCA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| EVLA versus HL/S (surgery) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| ✓ | ✓ | ✓ | ✓ | |||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| RFA versus UGFS | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| RFA versus CA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| RFA versus MOCA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| RFA versusHL/S(surgery) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| UGFS versus HL/S (surgery) | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| ✓ | ✓ | ✓ | ✓ | |||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
CA: cyanoacrylate glue
EVLA: endovenous laser ablation
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
MOCA: mechanochemical ablation
QoL: quality of life
RFA: radio frequency ablation
UGFS: ultrasound‐guided foam sclerotherapy
VCSS: Venous Clinical Severity Score
Excluded studies
We excluded 20 new studies for this update (Basela 2011; Campos 2015; CLASS 2014; De Oliveira 2018; Desai 2009; dos Santos 2020; Eroglu 2018; Honek 2019; Jindal 2018; Karathanos 2019; Kikuchi 2009; Leon 2018; Leung 2019; Mendes 2016; Mozafar 2014; Oster 2018; Ovali 2019; Shadid 2015; Sincos 2018; Tawfik 2020). Due to the wider scope of this update, we included two studies which were previously excluded (Recovery 2009; Shepherd 2010).
The total number of excluded studies is 33 (Basela 2011; Campos 2015; Chant 1972; Christenson 2010; CLASS 2014; Compagna 2010; De Medeiros 2006; De Oliveira 2018; Desai 2009; Disselhoff 2008; dos Santos 2020; Einarsson 1993; Eroglu 2018; Figueiredo 2009; Honek 2019; Jindal 2018; Kalodiki 2012; Karathanos 2019; Kikuchi 2009; Lattimer 2012; Leon 2018; Leung 2019; Lin 2007; Mendes 2016; Mozafar 2014; Oster 2018; Ouvry 2008; Ovali 2019; Shadid 2015; Sincos 2018; Stotter 2005; Tawfik 2020; Wright 2006). See Characteristics of excluded studies table.
A common reason for exclusion was the combination of GSV and small saphenous vein (SSV) participants within the context of a trial. This was the case for CLASS 2014, Eroglu 2018, Figueiredo 2009, Sincos 2018 and Wright 2006. We were unable to obtain GSV data to allow meta‐analysis where applicable. Some studies included techniques not covered within the scope of this review as they are novel or hybrid techniques. These included cryostripping (Disselhoff 2008; Stotter 2005), ligation and axial ablation by foam or EVLA (Compagna 2010; De Medeiros 2006; Kalodiki 2012), RFA plus UGFS (Leon 2018), and ligation of the SFJ only (Mozafar 2014). dos Santos 2020 compared UGFS with UGFS plus tumescence. Honek 2019 compared different types of laser generator in EVLA. Tawfik 2020 performed additional UGFS to EVLA and/or ablated small or accessory veins and/or used foam injections for severely tortuous anterior saphenous vein and superficial varicosities. Lattimer 2012 combined EVLA with phlebectomies versus UGFS. Three studies were excluded as the techniques included liquid sclerotherapy (Chant 1972; Einarsson 1993; Ouvry 2008). Three studies were found not to be randomised controlled trials and therefore were not included (Basela 2011; Ovali 2019; Shadid 2015). Three studies were found to offer simultaneous treatment to both limbs and therefore were excluded (Christenson 2010; Jindal 2018; Mendes 2016). Campos 2015, De Oliveira 2018, and Leung 2019 were excluded due to the inclusion of participants with CEAP C5 or C6 disease, or both. Karathanos 2019 and Oster 2018 included participants with CEAP class C2 to C6. Two studies were conference abstracts only with no data available after contacting authors (Desai 2009; Kikuchi 2009). One study was found to be in a language besides English and despite translation, no meaningful data could be extracted (Lin 2007).
Ongoing studies
We identified four new ongoing studies for this update (Belramman 2018; Cho 2020; NCT04526626; NCT04534244). See Characteristics of ongoing studies.
Studies awaiting classification
We identified four studies from a top‐up search and will incorporate these into the next version of this review (Belramman 2020; Morrison 2020; Rai 2019; Vähäaho 2021). See Characteristics of studies awaiting classification.
Risk of bias in included studies
Risk of bias within each of the included studies is discussed in the Characteristics of included studies section and illustrated by Figure 2 and Figure 3. In summary, there was a significant risk of bias in the majority of included studies that limited our certainty in the evidence. The greatest areas of weakness included the lack of both study personnel and participant blinding that may have introduced observer and performance bias. It is accepted, however, that a number of these interventions differ significantly in the way in which they are performed. It would be impossible to blind a participant to a general anaesthesia open surgical operation compared to a local anaesthesia endovenous procedure. However, some of these difficulties could be mitigated by study personnel blinding.
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies
Methodological quality summary: review authors' judgements about methodological quality for each domain for each included study
Allocation
Nine studies were at unclear risk of bias as it was unclear whether their methods were truly random or they gave insufficient descriptions of generation methods used (EVOLVeS 2003; Helmy ElKaffas 2011; HELP‐1 2011; Rasmussen 2011; Recovery 2009; RELACS 2012; Subramonia 2010; Syndor 2017; Vernermo 2016). The remaining 15 studies thoroughly reported their random sequence methods so were at low risk (Calik 2019; Darwood 2008; Flessenkämper 2013; FOAM 2010; Lane 2017; LAST 2014; Magna 2013; MARADONA 2019; Morrison 2015; Nordon 2011; Pronk 2010; Rasmussen 2007; Rautio 2002; Shepherd 2010; Vähäaho 2019).
Risk of bias due to allocation concealment was deemed to be high within three studies, as methods of concealment were not described (Helmy ElKaffas 2011; MARADONA 2019; RELACS 2012). The single‐blinded Recovery 2009 study was deemed to be at unclear risk, as they only stated that they did not discuss the allocated treatment with the participant. Shepherd 2010 was also deemed to be at unclear risk of allocation bias as they only stated they used Internet randomisation. The other 19 studies were judged to be at low risk of allocation concealment bias as methods of allocation concealment were adequately described (Calik 2019; Darwood 2008; EVOLVeS 2003; Flessenkämper 2013; FOAM 2010; HELP‐1 2011; Lane 2017; LAST 2014; Magna 2013; Morrison 2015; Nordon 2011; Pronk 2010; Rasmussen 2007; Rasmussen 2011; Rautio 2002; Subramonia 2010; Syndor 2017; Vähäaho 2019; Vernermo 2016).
Blinding
Syndor 2017 was the only double‐blinded RCT amongst the included studies and was therefore deemed to be at low risk of performance and detection bias. The Recovery 2009 and Shepherd 2010 studies were single‐blinded trials (participants were blinded but the assessors were not blinded), thus conferring a low risk of bias in performance bias and high risk for detection. In Nordon 2011, the participants were blinded (low risk of performance bias) but assessor was blinded until the three‐month follow‐up scan, so this was judged to be at unclear risk of detection bias. Lane 2017 and MARADONA 2019 were deemed at high risk of performance bias as participants were not blinded but deemed at low risk of detection bias because of blinded duplex ultrasound scanning. The remaining 18 studies were all deemed to have a high risk of performance and detection bias, as none of the participants or assessors were blinded (Calik 2019; Darwood 2008; EVOLVeS 2003; Flessenkämper 2013; FOAM 2010; Helmy ElKaffas 2011; HELP‐1 2011; LAST 2014; Magna 2013; Morrison 2015; Pronk 2010; Rasmussen 2007; Rasmussen 2011; Rautio 2002; RELACS 2012; Subramonia 2010; Vähäaho 2019; Vernermo 2016). It is appreciated that some interventions compared do not lend themselves to participant blinding.
Incomplete outcome data
Four studies were determined to be at high risk of attrition bias (Calik 2019; EVOLVeS 2003; Pronk 2010; Recovery 2009). Calik 2019 did not always state the number of participants analysed for outcomes at follow‐up intervals, and they did not provide a cohort diagram. EVOLVeS 2003 provided details on all missing data. However, we noted an imbalance in the study treatment groups. There were also discrepancies between missing outcomes and explanations for these in the two‐year follow‐up paper. Pronk 2010 stated that two participants were lost at six weeks' follow‐up, but gave no explanations. There was also an unexplained discrepancy between study groups and participant follow‐up at one year. Recovery 2009 did not discuss their dropouts and the number of participants analysed for outcomes at follow‐up was not given. Six studies were deemed to be at unclear risk of attrition bias as dropouts were reported but no explanation given (Flessenkämper 2013; LAST 2014; MARADONA 2019; Nordon 2011; Syndor 2017; Vähäaho 2019). The remaining 14 studies were deemed to be at low risk of attrition bias (Darwood 2008; FOAM 2010; Helmy ElKaffas 2011; HELP‐1 2011; Lane 2017; Magna 2013; Morrison 2015; Rasmussen 2007; Rasmussen 2011; Rautio 2002; RELACS 2012; Shepherd 2010; Subramonia 2010; Vernermo 2016).
Selective reporting
The majority of studies had low risk of reporting bias as all predefined outcomes were reported. Magna 2013 did not report on several complications outlined in their methods, whilst Morrison 2015 did not report on analgesia use as planned, so we judged these studies to be at unclear risk of reporting bias. Calik 2019 did not explicitly state the outcome measures they intended to report.
Other potential sources of bias
The majority of studies (as shown in Table 6) used concomitant phlebectomies in their treatment groups, often at the discretion of the treating practitioner. This potentially introduces bias into outcomes such as life measures, pain and return to work. Some studies, including Calik 2019, Darwood 2008, LAST 2014 and Recovery 2009, tried to mitigate this potential source of bias by offering phlebectomies several weeks or months after the initial index procedure.
| EVLA versus RFA | ||
| Study | Additional phlebectomies | |
| EVLA | RFA | |
| yes | yes | |
| yes | yes | |
| after 30 days | after 30 days | |
| yes | yes | |
| yes | yes | |
| EVLA versus EVSA | ||
| Study | Additional phlebectomies | |
| EVLA | EVSA | |
| after 3 months | after 3 months | |
| EVLA versus UGFS | ||
| Study | Additional phlebectomies | |
| EVLA | UGFS | |
| yes | yes | |
| yes | yes | |
| yes | no | |
| EVLA versus CA | ||
| Study | Additional phlebectomies | |
| EVLA | CA | |
| after 3 months | after 3 months | |
| EVLA versus MOCA | ||
| Study | Additional phlebectomies | |
| EVLA | MOCA | |
| yes | yes | |
| EVLA versus HL/S (surgery) | ||
| Study | Additional phlebectomies | |
| EVLA | HL/S (surgery) | |
| yes ‐ at 6 weeks | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| RFA versus UGFS | ||
| Study | Additional phlebectomies | |
| RFA | UGFS | |
| yes | yes | |
| RFA versus CA | ||
| Study | Additional phlebectomies | |
| RFA | CA | |
| no | no | |
| RFA versus MOCA | ||
| Study | Additional phlebectomies | |
| RFA | MOCA | |
| yes | yes | |
| no | yes | |
| yes | yes | |
| RFA versus HL/S (surgery) | ||
| Study | Additional phlebectomies | |
| RFA | HL/S (surgery) | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| UGFS versus HL/S (surgery) | ||
| Study | Additional phlebectomies | |
| UGFS | HL/S (surgery | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| no | yes | |
aParticipants were offered ambulatory phlebectomy or UGFS.
CA: cyanoacrylate glue
EVLA: endovenous laser ablation
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
RFA: radio frequency ablation
MOCA: mechanochemical ablation
UGFS: ultrasound‐guided foam sclerotherapy
Only Rautio 2002 and Lane 2017 were found to be at low risk of other potential sources of bias. Calik 2019 was found to be at high risk of bias. The remaining 21 trials had potential sources of bias which were deemed to be of unclear risk.
In the Calik 2019 study, bilateral limbs were evaluated. The study authors made no attempt to account for the impact this may have had on outcomes such as pain and return to work. It was not explicitly stated whether each limb received the same treatment. Although the study population was 400 participants, study authors had performed no power analysis. Also, Calik 2019 did not specify definitions for occlusion, partial and total recanalisation and used the Wong‐Baker FACES pain scale, which is a paediatric pain assessment scale.
Darwood 2008 were unable to meet their necessary sample size. Therefore, the study authors declared that their sample size was insufficient to permit statistical testing for equivalence. The study also included participants who underwent bilateral treatment: these were allocated the same treatment on both limbs; however, they were not stratified within the results. Participants who underwent SFJ ligation and stripping also underwent concomitant phlebectomies. Those who were allocated to EVLA could request injection sclerotherapy for residual varicosities at six weeks. There was no stratification for these participants, and this could potentially add a risk of bias to participant satisfaction and QoL scores. We also noted that one participant randomised to SFJ ligation and stripping underwent EVLA, and was followed up in the EVLA cohort, showing no analysis with intention‐to‐treat.
The EVOLVeS 2003 study received financial support from VNUS Medical Technologies (manufacturers of RFA catheters). The trial centres were also proctored by the company, introducing a potential source of bias. The trial also included one participant who underwent treatment of both limbs. The participant was only randomised once and each limb was treated as a separate episode after a period of three months.
Flessenkämper 2013 calculated that 469 participants were required in the trial, but only 449 were randomised, meaning the study is potentially underpowered. A further source of bias is the admission of a number of participants undergoing concomitant phlebectomies within their respective treatments arms. This procedure could impact upon pain scores, QoL and return to work.
Mini‐phlebectomies were also performed at the operating surgeon's discretion in the FOAM 2010 study in both the SFJ ligation and stripping and UGFS arms. Although the numbers of such participants were given, this procedure could alter the pain and other outcomes.
In Helmy ElKaffas 2011, it was unclear whether participants undergoing bilateral treatment were included or excluded. Concomitant phlebectomies were performed in both the RFA and SFJ ligation and stripping groups. Although the numbers of such procedures were given for both groups, there was no analysis of the impact that this could have had on outcomes such as complications, length of procedure and hospital stay, so this omission introduces a potential source of bias. In addition, some participants required UGFS for persistent varicosities following RFA. However, the timeframe for the additional procedure was not discussed and the only subanalysis of this group was a financial one.
As with other studies, the concomitant use of phlebectomies within HELP‐1 2011 introduced a potential source of bias. The study was also possibly underpowered: a power calculation described a need for 120 participants in each group, but only 113 were available for follow‐up in the surgery group.
LAST 2014 was also underpowered: power calculations required a total of 116 participants per study group, but there were only 92 and 107 participants in the EVLA and EVSA arms, respectively, due to dropouts. In addition, the protocol for the amount of energy required for EVSA was changed during the trial. In LAST 2014 the legs of participants with bilateral GSV incompetence were included separately, provided that there was at least 3 months between the two treatments.
The Magna 2013 trial also included simultaneously treated bilateral limbs. The study authors did not indicate how they analysed the impact of this on quality of life and other measures, conferring a potential risk of bias. The methods stated the intention of performing additional phlebectomies at the time of the initial procedure, but in several cases, the procedure was undertaken at three months. There was no subanalysis for this group of participants. The trial was also possibly underpowered: their power calculation stated that 240 participants would be required, but only 223 were analysed.
Trialists stopped enrolling participants in the MARADONA 2019 study earlier than planned. This was because reimbursement of MOCA treatment was suspended for treatments for class CEAP C3 disease and lower. The study was therefore only able to recruit 46% of the calculated required number of participants and was significantly underpowered for the anatomic success outcome measure. The trial also consequently included a higher proportion of participants with more severe chronic venous insufficiency compared to other such trials.
Additional sources of potential bias within the Morrison 2015 trial included the fact that the authors of the study were paid consultants of Sapheon, a company which manufactures cyanoacrylate glue. However, independent evaluation of ultrasound images was undertaken. The study stated that there were 31 missing or uninterruptible ultrasound scan (USS) reports. Attempts to account for this were made by the study authors by analysing the outcomes via various models for inputting missing data.
In order to blind their participants, Nordon 2011 performed RFA and EVLA under general anaesthesia, whilst all other studies performed these interventions under spinal or conscious sedation. The use of general anaesthesia could have an impact on pain scores, duration of hospital stay, QoL scores and expose participants to risk of anaesthetic‐related complications avoided when the procedure is performed under block or local techniques. The use of general anaesthetic in these procedures is not standard practice, and thus potentially confers a risk of bias.
Pronk 2010 performed both EVLA and SFJ ligation and stripping under tumescent anaesthesia. Other studies evaluating SFJ ligation and stripping have not uniformly used this anaesthetic modality; therefore, it may confer an advantage in the Pronk 2010 trial and impact upon outcomes such as participant‐reported post‐operative pain, QoL, hospital stay and return to normal activities. The study was potentially underpowered: power calculations described a need for 120 participants in each treatment arm, yet only 113 participants were available for follow‐up in the surgery group. The study is unclear about participants who underwent simultaneous bilateral intervention. The study authors claimed participants were only randomised to an intervention once, but the number randomised is reported as legs (130) and not participants (n = 122).
The inclusion of participants with simultaneous bilateral varicosities, with no subsequent stratification within the results, introduces a possible further source of bias in Rasmussen 2007. However, all participants with bilateral disease received the same intervention.
Contrary to the inclusion criteria of this review, Rasmussen 2011 also included a small number of participants who had had previous SFJ ligation on the basis that they had recanalised their GSV and had a patent, refluxing SFJ and GSV. There was no stratification of these participants within the study's results or amongst the treatment arms, conferring a potential source of bias. The technique for EVLA was not uniform within Rasmussen 2011, with different methods, energies and diodes used amongst the trial centres. The trialists also analysed their results by limbs not participants.
We judged the Recovery 2009 study to have an unclear risk of further bias as it was sponsored by VNUS Medical Technologies, who manufacture radiofrequency ablation catheters.
In the RELACS 2012 study, there was no clear consensus on the number of additional phlebectomies, thereby impacting upon the outcomes of pain, QoL and return to normal activities. After three months, those with apparent residual varices and perforators could be treated with additional phlebectomies or sclerotherapy. This trial was also possibly underpowered: a total of 180 participants per treatment group was calculated, but after dropouts and losses to follow‐up, the EVLA group had 173 and SFJ ligation and stripping group had 143.
Shepherd 2010 allowed for additional phlebectomies at the time of the procedure, as well as treatment for SSV and anterior thigh vein incompetence. The study authors stated that pain analysis was subsequently adjusted to make allowances for this. The study included participants undergoing concurrent treatment of bilateral disease. The most symptomatic limb (participant‐reported) was randomised and both limbs received the same intervention. However, this approach impacts on pain and return to normal activities, suggesting a possible risk of bias.
The Subramonia 2010 trial included five participants with recurrent varicose veins, but there was no stratification of these individuals in the results. This could introduce potential bias into results such as pain, return to normal activities and QoL. The trial also Included 12 participants with bilateral varicose veins (randomised on one occasion to the same treatment, with a minimum of six weeks between treatment of the limbs, thus treating each limb as a separate case).
In Syndor 2017, it was noted that there was a vast range in the time frames at which participants were being followed up. For instance, the initial follow‐up review ranged from one to 29 days, and participants who were followed up at one year were being included within the analysis of outcome measures at the six‐week review. Therefore, potentially, participants who could have had complications at six weeks were being missed as they were only seen at one year, by which point, the complication may have resolved ‐ this introduces a risk of bias. Participants underwent concomitant phlebectomies and UGFS, an approach not undertaken in other studies, thereby impacting on the risk of bias for outcomes such as pain, QoL and return to normal activities. No power calculations were performed.
Vähäaho 2019 did not manage to recruit the calculated required sample size (132 instead of 160 participants). Concomitant phlebectomies were also performed, which could impact upon pain and complications such as saphenous nerve injury.
The authors of Vernermo 2016 state that, "Owing to the operating surgeon's preference, five patients originally randomised to EVLA were treated with surgery but, because the analysis was made according to intention to treat, these patients were analysed in EVLA group". There was no further clarification why the surgeon preferred to undertake surgery in these individuals, and no subanalysis. The EVLA diode was also changed from a 980‐nm diode to a 1470‐nm diode during the course of the trial. In comparison to other trials, the sclerosant used in the UGFS arm was more concentrated (air to sclerosant ratio 2:1).
Effects of interventions
See: Summary of findings 1 Endovenous laser ablation (EVLA) compared to radiofrequency ablation (RFA) for great saphenous vein (GSV) incompetence; Summary of findings 2 Endovenous laser ablation (EVLA) compared to ultrasound‐guided foam sclerotherapy (UGFS) for great saphenous vein (GSV) incompetence; Summary of findings 3 Endovenous laser ablation (EVLA) compared to SFJ ligation and stripping (HL/S) for great saphenous vein (GSV) incompetence; Summary of findings 4 Radiofrequency ablation (RFA) compared to mechanochemical ablation (MOCA) for great saphenous vein incompetence; Summary of findings 5 Radiofrequency ablation (RFA) compared to SFJ ligation and stripping (HL/S) for great saphenous vein (GSV) incompetence; Summary of findings 6 Ultrasound‐guided foam sclerotherapy (UGFS) compared to SFJ ligation and stripping (HL/S) for great saphenous vein (GSV) incompetence
Study authors reported on outcomes using different definitions and at different time points, which impacted our ability to carry out analyses. We provide a brief description of how studies reported on outcomes below. We then present the results by comparison to allow consistent reporting between analyses and the summary of findings tables.
Technical success
We defined technical success as complete anatomical obliteration or absence of reflux within the GSV at six weeks on duplex ultrasound (DUS; standard criterion of 1 second (s) of reflux on DUS). This was evaluated in 18 studies at different time points (Calik 2019; Darwood 2008; FOAM 2010; HELP‐1 2011; Lane 2017; LAST 2014; Magna 2013; MARADONA 2019; Morrison 2015; Nordon 2011; Rasmussen 2007; Rasmussen 2011; Rautio 2002; Recovery 2009; Shepherd 2010; Syndor 2017; Vähäaho 2019; Vernermo 2016). Three trials reported technical success at four weeks (Calik 2019; Recovery 2009; Morrison 2015). As Calik 2019 and Morrison 2015 were the sole studies for their comparison, their data were included. Vähäaho 2019 reported on technical success at 30 days. The results of these studies are shown in Table 7. Rasmussen 2011 reported on technical failure which they defined as "an open refluxing segment of 10cm or more at follow up". We were therefore able to extrapolate their technical success rate from the figures they presented. The primary outcome in Flessenkämper 2013 was inguinal reflux, which they defined as 'any reflux from the SFJ into the GSV lasting > 0.5 seconds'. Due to the manner in which they reported these data, we were unable to extrapolate this and include it within our technical success analysis. We defined long‐term technical success as complete anatomical obliteration, or absence of reflux, within the GSV on DUS at five years or greater. Five trials reported on this (HELP‐1 2011; Magna 2013; Rasmussen 2007; Rasmussen 2011; Vernermo 2016).
| EVLA versus RFA | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | RFA | |
| Nordon 2011 3 months | 65/68 (96) | 68/70 (97) |
| Rasmussen 2011 1 month 5 yr | 143/144 (99) 136/144 (94) | 148/148 (100) 140/147 (95) |
| Recovery 2009 1 month | 41/41 (100) | 46/46 (100) |
| Shepherd 2010 6 months | 50/54 (93) | 50/56 (89) |
| Syndor 2017 6 months | 77/79 (97) | 72/74 (97) |
| EVLA versus EVSA | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | EVSA | |
| LAST 2014 1 yr | 88/92 (96) | all 93/107 (87) higha 68/74 (92) |
| EVLA versus UGFS | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | UGFS | |
| Magna 2013 1 yr 5 yr | 69/78 (88) 49/63 (77) | 56/77 (73) 15/67 (23) |
| Rasmussen 2011 1 month 5 yr | 143/144 (99) 136/144 (94) | 142/144 (99) 124/144 (86) |
| Vernermo 2016 1 yr 5 yr | 71/73 (93) 51/57 (89) | 37/72 (51) 30/59 (51) |
| EVLA versus CA | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | CA | |
| Calik 2019 1 yr | 203/204 (99) | 208/208 (100) |
| EVLA versus MOCA | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | MOCA | |
| Vähäaho 2019 30 days | 33/33 (100) | 55/55 (100) |
| EVLA versus HL/S (surgery) | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | HL/S (surgery) | |
| Darwood 2008b 3 months | EVLT1. 41/42 (97) EVLT2. 26/29 (89) | 28/32 (87) |
| HELP‐1 2011 1 yr | 136/137 (99) 100/108 (92) | 122/137 (89) 94/110 (85) |
| Magna 2013 1 yr 5 yr | 69/78 (88) 49/63 (78) | 60/68 (88) 53/63 (85) |
| Rasmussen 2007 1 month 5 yr | 66/69 (96) 66/69 (96) | 66/68 (97) 66/68 (97) |
| Rasmussen 2011 1 month 5 yr | 143/144 (99) 136/144 (94) | 139/142 (98) 136/142 (96) |
| Vernermo 2016 1 yr 5 yr | 71/73 (93) 51/57 (89) | 59/61 (97) 48/50 (96) |
| RFA versus UGFS | ||
| Study ‐ time point | Technical success (%) | |
| RFA | UGFS | |
| Rasmussen 2011 1 month 5 yr | 148/148 (100) 140/147 (95) | 142/144 (99) 124/144 (86) |
| RFA versus CA | ||
| Study ‐ time point | Technical success (%) | |
| RFA | CA | |
| Morrison 2015 1 month | 95/110 (85) | 115/115 (100) |
| RFA versus MOCA | ||
| Study ‐ time point | Technical success (%) | |
| RFA | MOCA | |
| Lane 2017 6 months | 67/68 (98) | 77/77 (100) |
| MARADONA 2019 30 days | 103/103 (100) | 99/103 (96) |
| Vähäaho 2019 30 days | 29/29 (100) | 55/55 (100) |
| RFA versus HL/S (surgery) | ||
| Study ‐ time point | Technical success (%) | |
| RFA | HL/S (surgery) | |
| Rasmussen 2011 1 months 5 yr | 148/148 (100) 140/147 (95) | 139/142 (98) 136/142 (96) |
| Rautio 2002 mean 50 days | 15/15 (100) | 12/13 (92) |
| UGFS versus HL/S (surgery) | ||
| Study ‐ time point | Technical success (%) | |
| UGFS | HL/S (surgery) | |
| FOAM 2010 2 yr | 139/213 (65) | 140/177 (79) |
| Magna 2013 1 yr 5 yr | 56/77 (73) 15/67 (22) | 60/68 (88) 53/63 (84) |
| Rasmussen 2011 1 month 5 yr | 142/144 (99) 124/144 (86) | 139/142 (98) 136/142 (96) |
| Vernermo 2016 1 yr 5 yr | 37/72 (51) 30/59 (51) | 59/61 (97) 48/50 (96) |
aHigh dose of steam
bReported as limbs and not participants
CA: cyanoacrylate glue
EVLA: endovenous laser ablation (same as EVLT)
EVLT: endovenous laser therapy
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
MOCA: mechanochemical ablation
RFA: radiofrequency ablation
UGFS: ultrasound‐guided foam sclerotherapy
yr: year(s)
Recurrence
We used the clinical definition reported by the clinician or the participant themselves. Definitions of recurrence used by the individual studies varied and are provided in the Characteristics of included studies tables. Fifteen studies reported recurrence (Calik 2019; EVOLVeS 2003; Flessenkämper 2013; FOAM 2010; Helmy ElKaffas 2011; HELP‐1 2011; Lane 2017; MARADONA 2019; Magna 2013; Pronk 2010; Rasmussen 2007; Rasmussen 2011; Rautio 2002; RELACS 2012; Vähäaho 2019). See Table 8 for recurrence data.
| EVLA versus RFA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yr | |
| EVLA | RFA | |
| No results | ||
| Rasmussen 2011 3 yr | 24/144 (17) | 17/147 (12) |
| No results | ||
| No results | ||
| Mention 'recurrent symptoms' but do not specify what this entails | ||
| EVLA versus EVSA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yr | |
| EVLA | EVSA | |
| No results | ||
| EVLA versus UGFS | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| EVLA | UGFS | |
| Magna 2013 1 yr | 9/78 (12) | 21/77 (27) |
| Rasmussen 2011 3 yr | 24/144 (17) | 20/144 (14) |
| No results | ||
| EVLA versus CA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| EVLA | CA | |
| Calik 2019 1 yr | 5/204 (2) | 2/208 (1) |
| EVLA versus MOCA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| EVLA | MOCA | |
| Vähäaho 2019 1 yr | 0/33 (0) | 10/55 (18) |
| EVLA versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| EVLA | HL/S (surgery) | |
| Darwood 2008a 1 yr | No results | |
| Flessenkämper 2013 2 yr | 20/112 (17.8) | 11/94(11.7) |
| HELP‐1 2011 1 yr | 5/124 (4) | 23/113 (20) |
| Magna 2013 1 yr | 9/78 (12) | 6/68 (9) |
| Pronk 2010 1 yr | 5/62 (8) | 5/68 (7) |
| Rasmussen 2007 2 yr | 18/69 (26) | 25/68 (37) |
| Rasmussen 2011a 3 yr | 24/144 (17) | 22/143 (15) |
| RELACS 2012 2 yr | 28/173 (16) | 33/143 (23) |
| no results | ||
| RFA versus UGFS | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| RFA | UGFS | |
| 17/147 (12) | 20/144 (14) | |
| RFA versus CA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| RFA | CA | |
| no results | ||
| RFA versus MOCA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| RFA | MOCA | |
| 4/68 (6) | 3/77 (4) | |
| MARADONA 2019 2 yr | 21/76 (28) | 12/81 (15) |
| Vähäaho 2019 1 yr | 0/32 (0) | 10/55 (18) |
| RFA versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| RFA | HL/S (surgery) | |
| EVOLVeS 2003 2 yr | 5/36 (14) | 6/29 (21) |
| Helmy ElKaffas 2011 2 yr | 12/81 (15) | 9/81 (11) |
| Rasmussen 2011a 3 yr | 17/148 (11) | 22/143 (15) |
| Rautio 2002 2 yr | 5/15 (33) | 2/13 (15) |
| not reported | ||
| UGFS versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| UGFS | HL/S (surgery) | |
| FOAM 2010 2 yr | 75/213 (35) | 37/177 (21) |
| Magna 2013 1 yr | 21/77 (27) | 6/68 (9) |
| Rasmussen 2011a 3 yr | 20/144 (14) | 22/143 (15) |
| not reported | ||
aReported as limbs and not participants
CA: cyanoacrylate glue
EVLA: endovenous laser ablation
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
MOCA: mechanochemical ablation
RFA: radio frequency ablation
UGFS: ultrasound‐guided foam sclerotherapy
yr: year(s)
Five year and longer‐term follow‐up data of Flessenkämper 2013, FOAM 2010, HELP‐1 2011, Magna 2013, Pronk 2010, Rasmussen 2007, Rasmussen 2011 and RELACS 2012 were also available (see Table 9).
| EVLA versus RFA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| EVLA | RFA | |
| 42/144 (29) | 19/147 (13) | |
| EVLA versus EVSA ‐ no data | ||
| EVLA versus UGFS | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| EVLA | UGFS | |
| 14/63 (22) | 21/67 (31) | |
| 42/144 (29) | 28/144(19) | |
| EVLA versus CA ‐ no data | ||
| EVLA versus MOCA ‐ no data | ||
| EVLA versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| EVLA | HL/S (surgery) | |
| 11/45 (24) | 14/53 (26) | |
| 29/108 (27) | 47/110 (43) | |
| 14/63 (22) | 8/63 (13) | |
| 19/61 (31) | 4/60 (7) | |
| 25/69 (36) | 24/68 (35) | |
| 42/144 (29) | 38/142 (27) | |
| 69/152 (45) | 70/129 (54) | |
| RFA versus UGFS | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| RFA | UGFS | |
| 19/147 (13) | 28/144 (19) | |
| RFA versus CA ‐ no data | ||
| RFA versus MOCA ‐ no data | ||
| RFA versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| RFA | HL/S (surgery) | |
| 19/147 (13) | 38/142 (27) | |
| UGFS versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| UGFS | HL/S (surgery) | |
| FOAM 2010 8 yr | 86/120 (72) | 71/103 (69) |
| 21/67 (31) | 8/63 (13) | |
| 28/144 (19) | 38/142 (27) | |
aReported as limbs and not participants
CA: cyanoacrylate glue
EVLA: endovenous laser ablation
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
MOCA: mechanochemical ablation
RFA: radiofrequency ablation
UGFS: ultrasound‐guided foam sclerotherapy
Rates of recurrence were not reported for the comparisons EVLA versus EVSA and RFA versus cyanoacrylate glue.
Post‐operative complications
All 24 included studies reported rates of post‐operative complications. Unfortunately, we could not perform meta‐analysis due to the considerable array of different terms used within the studies to report adverse events (for instance, 'paraesthesia', 'numbness', 'regional neurological sensory deficit' and 'saphenous nerve injury' were reported separately amongst trials). There was a lack of uniformity in the time points at which these events were measured. Therefore, we divided post‐operative adverse events into minor (i.e. not requiring intervention) and major (i.e. requiring intervention) within the first three months (early) and beyond three months (late) for this review. Within minor complications, we collated rates of haematoma, saphenous nerve injury, thermal injury or inflammation, wound problems (groin/stab), bruising and pigmentation and phlebitis from the included studies. Major complications included wound problems and 'other', further described in the footnotes to the tables. Complication rates are shown in Table 10 (early ≤ 3 months) and Table 11 (late > 3 months). Where complications were recorded at multiple time points during and after the first three months (e.g. in EVOLVeS 2003; Nesbitt 2014), we documented the highest rate of said event.
| Early post‐operative complications (within three months) | ||||||||||||||||
| EVLA versus RFA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA |
| 2/78 (2.6) | 1/77 (1.3) | 2/78 (2.6) | 1/76 (1.3) | 0/78 (0) | 0/76 (0) | 2/78 (2.6) | 1/76 (1.3) | 0/78 (0) | 0/76 (0) | |||||||
| 1/125 (0.8) | 0/121 (0) | 3/125 (2.4) | 6/121 (5) | 3/125 (2.4) | 8/121 (6.6 | 4/125 (3.2) | 12/121 (9.9) | 0/125 (0) | 1/121 (0.8) | 0/125 (0) | 0/121 (0) | |||||
| 2/41 (4.9) | 1/46 (2.2) | 0/41 (0) | 1/46 (2.2) | 6/41 (14.6) | 0/46 (0) | 1/41 (2.2) | 0/46 (0) | |||||||||
| 2/64 (3) | 0/67 (0) | 5/64 (8) | 8/67 (12) | 1/64 (2) | 2/67 (3) | 2/64 (3) | 6/67 (9) | 5/64 (7) | 5/67 (7) | 2/64 (3) | 4/67 (6) | 0/64 (0) | 1/67 (1) PE | |||
| 9/96 (9.4) | 13/97 (13.7) | 0/96 (0) | 0/97 (0) | 3/96 (3.1) | 3/97 (3.1) | 1/96 (1) | 1/97 (1.0) | 3/96 (3.1) | 2/97 (2.1) | 0/96 (0) | 0/97 (0) | |||||
| EVLA versus EVSA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA |
| 0/109 (0) | 1/117 (0.9) | 0/109 (0) | 0/117 (0) | 0/109 (0) | 0/117 (0) | 10/109 (9.2) | 10/117 (8.5) | 0/109 (0) | 0/117 (0) | 1/109 (0.9) DVT | 0/117 (0) | |||||
| EVLA versus UGFS | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS |
| 2/78 (2.6) | 1/77 (1.3) | 2/78 (2.6) | 1/77 (1.3) | 0/78 (0) | 0/77 (0) | 0/78 (0) | 0/77 (0) | |||||||||
| 1/125 (0.8) | 1/124 (0.8) | 3/125 (2.4) | 2/124 (1.6) | 3/125 (2.4) | 8/124 (6.5) | 4/125 (3.2) | 17/124 (13.7) | 0/125 (0) | 4/124 (3.2) | 0/125 (0) | 1/124 (0.8) | |||||
| 31/73 (42) | 14/72 (20) | 1/73 (1) | 2/72 (2) | 3/73 (5) | 50/72 (67) | 3/73 (4) | 0/72 (0) | |||||||||
| EVLA versus CA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA |
| 28/200 (11) | 6/200 (3) | 63/200 (31) | 31/200 (15.5) | 14/200 (7) | 7/200 (3.5) | 2/200 (1) | ||||||||||
| EVLA versus MOCA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA |
| 4/34 (12) | 0/65 (0) | 0/34 (0) | 1/65 (1.5) | |||||||||||||
| EVLA versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S |
| 0/80 (0) | 0/32 (0) | 1/80 (1) | 4/32 (13) | 1/80 (1) | 2/32 (6) | 9/80 (11) | 0/32 (0) | 0/80 (0) | 2/32 (6) | 0/80 (0) | 1/32c (3) | |||||
| 24/142 (17) | 23/159 (15) | 68/142 (48) | 108/159 (68) | 1/142 (0.7) | 1/159 (0.6) | |||||||||||
| 1/137 (0.7) | 11/133 (8.3) | 4/137 (2.9) | 13/133 (9.8) | 5/137 (3.6) | 3/133 (2.2) | 4/137 (2.9) | 6/133 (4.5) | 2/137 (1.5) | 8/133 (6) | |||||||
| 2/78 (2.6) | 4/68 (5.9) | 2/78 (2.6) | 0/68 (0) | 0/78 (0) | 3/68 (4.4) | 0/78 (0) | 0/68 (0) | |||||||||
| 2/62 (3) | 1/68 (1) | |||||||||||||||
| 3/69d (5) | 5/68 (8) | 1/69 (2) | 1/68 (5.9) | 0/69 (0) | 0/68 (0) | 0/69 (0) | 1/68 (2) | 7/69 (11) | 15/68 (25) | 2/69 (3) | 2/68 (3) | 0/69 (0) | 1/68e (2) | 0/69 (0) | 0/68 (0) | |
| 1/125 (0.8) | 1/119 (0.8) | 3/125 (2.4) | 5/119 (4.2) | 3/125 (2.4) | 6/119 (5) | 4/125 (3.2) | 5/119 (4.2) | 0/125 (0) | 0/119 (0.8) | 0/125 (0) | 1/119 (0.8) | |||||
| 169/185 (91) | 145/161 (90) | 20/185 (10.8) | 4/161 (2.5) | 1/185 (0.5) | 0/161 (0) | 3/185 (1.6) | 1/161 (0.6) | |||||||||
| 31/73 (42) | 40/65 (62) | 1/73 (1) | 2/65 (3) | 3/73 (4) | 3/65 (4) | 3/73 (4) | 3/65 (4) | |||||||||
| RFA versus UGFS | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS |
| 0/121 (0) | 1/124 (0.8) | 6/121 (0.8) | 2/124 (1.6) | 8/121 (6.6) | 8/124 (6.5) | 12/121 (9.9) | 17/124 (13.7) | 1/121 (0.8) | 4/124 (3.2) | 0/121 (0) | 1/124 (0.8) | |||||
| RFA versus CA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA |
| 3/114 (3) | 3/108 (3) | 1/114 (1) | 0/108 (0) | 16/114 (14) | 22/108 (20) | 1/114 (1) | 1/114 (1) | 0/114 (0) | 0/108 (0) | |||||||
| RFA versus MOCA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA |
| 15/104 (14) | 14/105 (13) | 3/104 (3) | 1/105 (1) | 0/104 (0) | 0/105 (0) | 0/105 (0) | 1/104 (1) | 2/104 (2) | 7/105 (7) | 8/104 (8) | 12/105 (11) | 3/104 (3) | ||||
| 1/65 (1.5) | 0/65 (0) | |||||||||||||||
| RFA versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S |
| 6/44 (14) | 18/36 (50) | 10/44 (23) | 5/36 (4.2) | 14/44 (32) | 23/36 (64) | 0/44 (0) | 2/36 (6)f | 0/44 (0) | 0/36 (0) | |||||||
| 1/90 (1.1) | 30/90 (33.3) | 9/90 (10) | 3/90 (3.3) | 0/90 (0) | 0/90 (0) | 6/90 (6.6) | 0/90 (0) | 0/90 (0) | 3/90 (3.3) | 0/90 (0) | 1/90 (1.1) | |||||
| 0/121 (0) | 1/119 (0.8) | 6/121 (4.9) | 5/119 (4.2) | 8/121 (6.6) | 6/119 (5) | 12/121 (9.9) | 5/119 (4.2) | 1/121 (0.8) | 1/119 (0.8) | 0/121 (0) | 1/119 (0.8) | |||||
| 1/15 (7) | 4/13 (31) | 2/15 (13) | 3/13 (23) | 1/15 (7) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 3/15 (20) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | |
| 0/47 (0) | 0/47 (0) | 9/47 (19) | 20/41 (49) | 0/47 (0) | 0/41 (0) | 0/47 (0) | 7/41 (17) | 5/47 (11) | 0/41 (0) | 0/47 (0) | 0/41 (0) | 0/47 (0) | 0/41 (0) | 0/47 (0) | 0/41 (0) | |
| UGFS versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S |
| 0/217 (0) | 3/176 (1.7) | 0/217 (0) | 6/176 (3.4) | 17/217 (7.8) | 0/176 (0) | 0/217 (0) | 4/176 (2.3) | 0/176 (0) | 0/217 (0.9) | |||||||
| 1/77 (1.3) | 4/68 (5.9) | 1/77 (1.3) | 0/68 (0) | 0/77 (0) | 3/68 (4.4) | 0/77 (0) | 0/68 (0) | |||||||||
| 1/124 (0.8) | 1/119 (0.8) | 2/124 (1.6) | 5/119 (4.2) | 8/124 (6.5) | 6/119 (5) | 17/124 (14) | 5/119 (4.2) | 4/124 (3.2) | 1/119 (0.8) | 1/124 (0.8) | 1/119 (0.8) | |||||
| 14/72 (20) | 40/65 (62) | 2/72 (2) | 2/65 (3) | 5/72 (7) | 3/65 (4) | 0/72 (0) | 3/65 (4) | |||||||||
aResults only available per limb, not per participant
bTwo participants developed DVTs.
cPost‐operative acute respiratory distress syndrome (requiring seven days intensive therapy unit (ITU) support) following aspiration post‐operatively
dIn one participant, the saphenous thrombus extended into the femoral vein; it resolved without intervention.
eGroin infection requiring antibiotics
fIncludes one participant who required debridement and intravenous antibiotics for a 'thigh and calf infection'
CA: cyanoacrylate glue
DVT: deep vein thrombosis
EVLA: endovenous laser ablation
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
MOCA: mechanochemical ablation
PE: pulmonary embolism
RFA: radio frequency ablation
UGFS: ultrasound‐guided foam sclerotherapy
| Late post‐operative complications (after three months) | ||||||||||||||||
| EVLA versus RFA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA |
| 8/79 (10.3) | 6/74 (8.33) | 0/79 (0) | 0/74 (0) | 10/79 (12.66) | 6/74 (8.11) | 0/79 (0) | 2/74 (2.7) | 0/79 (0) | 0/74 (0) | 0/79 (0) | 0/74 (0) | |||||
| EVLA versus EVSA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA |
| 0/98 (0) | 2/107 (1.9) | 0/98 (0) | 3/107 (2.8) | |||||||||||||
| EVLA versus UGFS | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS |
| 0/78 (0) | 1/77 (1.3) | 1/78 (1.3) | 1/77 (1.3) | |||||||||||||
| EVLA versus CA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA |
| 13/200 (7) | 2/200 (1.1) | 3/200 (1.6) | 1/200 (0.5) | 0/200 (0) | 0/200 (0) | 2/200 (1.1) | 0/200 (0) | |||||||||
| EVLA versus MOCA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA |
| 3/33 (11) | 0/55 (0) | 3/33 (11) | 6/55 (11) | |||||||||||||
| EVLA versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S |
| 0/80 (0) | 0/34 (0) | 0/80 (0) | 1/34 (3) | 0/80 (0) | 0/34 (0) | 0/80 (0) | 0/34 (0) | 0/80 (0) | 0/34 (0) | 0/80 (0) | 0/34 (0) | 0/80 (0) | 0/34 (0) | 0/80 (0) | 0/34 (0) | |
| 23/127 (18) | 5/128 (4) | 12/127 (9.4) | 14/128 (11) | |||||||||||||
| 0/78 (0) | 1/68 (1.5) | 1/78 (1.3) | 0/68 (0) | |||||||||||||
| 0/96 (0) | 0/68 (0) | 0/96 (0) | 1/68 (2) | 0/96 (0) | 0/68 (0) | 0/96 (0) | 0/68 (0) | 0/96 (0) | 0/68 (0) | 0/96 (0) | 0/68 (0) | 0/96 (0) | 0/68 (0) | 0/96 (0) | 0/68 (0) | |
| RFA versus UGFS | ||||||||||||||||
| Study | Minor (requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS |
| RFA versus CA | ||||||||||||||||
| Study | Minor (requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA |
| 0/84 (0) | 1/86 (1.2) | |||||||||||||||
| RFA versus MOCA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA |
| 2/29 (6.9) | 0/55 (0) | 4/29 (13.8) | ||||||||||||||
| RFA versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S |
| 0/43 (0) | 3/34 (9) | 0/43 (0) | 0/34 (0) | 0/43 (0) | 0/34 (0) | 0/43 (0) | 0/34 (0) | 0/43 (0) | 1/34 (3) | 0/43 (0) | 2/34 (6) | 0/43 (0) | 0/34 (0) | 0/43 (0) | 0/34 (0) | |
| 0/15 (0) | 0/13 (0) | 1/15 (0) | 5/13 (38) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | |
| UGFS versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S |
| 12/213 (5.6) | 2/177 (1.1) | |||||||||||||||
| 1/77 (1.3) | 1/68 (1.5) | |||||||||||||||
aResults only available per limb, not per participant
CA: cyanoacrylate glue
EVLA: endovenous laser ablation
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
MOCA: mechanochemical ablation
RFA: radio frequency ablation
UGFS: ultrasound‐guided foam sclerotherapy
Quality of life (QoL)
Twenty‐two studies reported on QoL (Calik 2019; Darwood 2008; EVOLVeS 2003; Flessenkämper 2013; FOAM 2010; HELP‐1 2011; Lane 2017; LAST 2014; Magna 2013; MARADONA 2019; Morrison 2015; Nordon 2011; Pronk 2010; Rasmussen 2007; Rasmussen 2011; Rautio 2002; Recovery 2009; RELACS 2012; Shepherd 2010; Subramonia 2010; Vähäaho 2019; Vernermo 2016). Meta‐analysis was not possible due to different questionnaires being used at different time points. See Table 12.
| Technique | Study | Quality of life score | |||||||
| V‐Q/SymQ | AVVSS | CIVIQ2 | SF‐12 | SF‐36 | RAND‐36 | EQ‐5D | SF‐6D | ||
| EVLA versus RFA | ✓ | ||||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| ✓ | |||||||||
| EVLA versus EVSA | ✓ | ||||||||
| EVLA versus UGFS | ✓ | ✓ | |||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| EVLA versus CA | ✓ | ||||||||
| EVLA versus MOCA | ✓ | ||||||||
| EVLA versus HL/S (surgery) | ✓ | ||||||||
| ✓ | |||||||||
| ✓ | ✓ | ✓ | ✓ | ||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| ✓ | ✓ | ||||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| ✓ | |||||||||
| RFA versus UGFS | ✓ | ✓ | |||||||
| RFA versus CA | ✓ | ✓ | |||||||
| RFA versus MOCA | ✓ | ✓ | |||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| RFA versus HL/S (surgery) | ✓ | ||||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| ✓ | ✓ | ||||||||
| RFA versus UGFS | ✓ | ✓ | |||||||
| UGFS versus HL/S (surgery) | ✓ | ||||||||
| ✓ | ✓ | ||||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
AVVSS: Aberdeen Varicose Vein Symptom Severity Score
CA: cyanoacrylate glue
CIVIQ2: Chronic Venous Insufficiency Quality of Life Questionnaire
EQ‐5D: EuroQol‐5D
EVLA: endovenous laser ablation
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
MOCA: mechanochemical ablation
RAND‐36: Short term RAND‐36 (validated for Finland)
RFA: radiofrequency ablation
SF‐12: Medical Outcomes Study Short Form 12
SF‐36: Medical Outcomes Study Short Form 36
SF‐6D: variation of the Medical Outcomes Study Short Form 36
UGFS: ultrasound‐guided foam sclerotherapy
V‐Q/SymQ: VEINES‐QoL/Sym questionnaire
Venous Clinical Severity Score (VCSS)
Thirteen studies reported on VCSS (Calik 2019; EVOLVeS 2003; FOAM 2010; Lane 2017; LAST 2014; MARADONA 2019; Morrison 2015; Rasmussen 2007; Rasmussen 2011; Rautio 2002; Recovery 2009; Shepherd 2010; Syndor 2017). However, meaningful meta‐analysis was prevented for each comparison by the limited studies available and by the different time points measured. Some studies presented the mean baseline and final score without calculating the mean difference. Other studies gave only the change in scores pre‐ and post‐intervention. We have collated and presented the results of the included studies in Table 13.
| EVLA versus RFA | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| EVLA | RFA | EVLA | RFA | EVLA | RFA | |
| Recovery 2009 mean (SD) 1 month | 4.9 (2.8) | 4.7 (3.1) | 3.2 (1.8) | 2.7 (2.2) | ||
| Rasmussen 2011 mean (SD) 3 yr | 2.68 (2.25) | 2.95 (2.06) | 0.34 (1.3) | 0.44 (1.82) | 3.3 | 3.7 |
| Shepherd 2010 mean (SD) 6 months | 4.7 (2.1) | 5.1 (2.1) | 1.4 (1.8) | 1.4 (1.7) | ||
| Syndor 2017 median (range) 6 months | 5 (2 ‐ 26) | 5 (1 ‐ 20) | 1 (0 ‐ 18) | 1 (0 ‐ 6) | ||
| EVLA versus EVSA | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | |
| LAST 2014 change after 12 weeks (95% CI) | not given | not given | not given | not given | ‐2.5 (‐2.1 to ‐2.93) | all ‐2.9 (‐2.4 to ‐3.5) hIgha ‐2.69 (‐2.34 to ‐3.04) |
| EVLA versus UGFS | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | |
| Rasmussen 2011 mean (SD) 3 yr | 2.68 (2.25) | 2.66 (1.45) | 0.34 (1.3) | 0.15 (0.4) | ||
| EVLA versus CA | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| EVLA | CA | EVLA | CA | EVLA | CA | |
| Calik 2019 mean (SD) 1 yr | 5.8 (1.9) | 5.7 (1.9) | 1.3 (0.9) | 1.3 (0.9) | ||
| EVLA versus MOCA ‐ no data | ||||||
| EVLA versus HL/S (surgery) | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| EVLA | HL/S (surgery) | EVLA | HL/S (surgery) | EVLA | HL/S (surgery) | |
| Rasmussen 2007 mean (SD) 5 yr | 2.8 (1.7) | 2.4 (1.4) | 0.4 (0.9) | 2.4 (1.4) | ||
| Rasmussen 2011 mean (SD) 3 yr | 2.68 (2.25) | 2.75 (1.62) | 0.34 (1.3) | 0.3 (0.5) | ||
| RFA versus UGFS | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| RFA | UGFS | RFA | UGFS | RFA | UGFS | |
| Rasmussen 2011 mean (SD) 3 yr | 2.95 (2.06) | 2.66 (1.45) | 0.44 (1.82) | 0.15 (0.4) | ||
| RFA versus CA | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| RFA | CA | RFA | CA | RFA | CA | |
| Morrison 2015 mean (SD) 3 months | 5.6 (2.6) | 5.5 (2.6) | 2.0 (2.0) | 1.9 (1.6) | ||
| RFA versus MOCA | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| RFA | MOCA | RFA | MOCA | RFA | MOCA | |
| Lane 2017 median (range) 6 months | 5 | 6 | 2 (1 ‐ 5) | 2 (1 ‐ 4) | ||
| MARADONA 2019 median (IQR) 2 yr | individually reported | individually reported | individually reported | individually reported | 4 (3 ‐ 5) | 3 (2 ‐ 5) |
| RFA versus HL/S (surgery) | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| RFA | HL/S (surgery) | RFA | HL/S (surgery) | RFA | HL/S (surgery) | |
| EVOLVeS 2003 mean (SD) 2 yr | 4.8 (0.34) | 4.39 (0.38) | unable to read from graph | |||
| Rasmussen 2011 mean (SD) 3 yr | 2.95 (2.06) | 2.75 (1.62) | 0.44 (1.82) | 0.3 (0.5) | ||
| Rautio 2002 median (range) 3 yr change ‐ mean (SD) | 4 (4 ‐ 6) | 5 (4 ‐ 9) | ‐ 4.3 (2.3) | ‐4 (‐1.2) | ||
| UGFS versus HL/S (surgery) | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| UGFS | HL/S (surgery) | UGFS | HL/S (surgery) | UGFS | HL/S (surgery) | |
| FOAM 2010 mean (SD) 2 yr | 3.2 (1.9) | 3.5 (2.2) | 1.7 (1.2) | 1.9 (1.4) | ‐1.49 | ‐1.75 |
| Rasmussen 2011 mean (SD) 3 yr | 2.66 (1.45) | 2.75 (1.62) | 0.15 (0.4) | 0.3 (0.5) | ||
aHigh dose of steam
CA: cyanoacrylate glue
CI: confidence interval
EVLA: endovenous laser ablation
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
IQR: interquartile range
MOCA: mechanochemical ablation
RFA: radiofrequency ablation
SD: standard deviation
UGFS: ultrasound‐guided foam sclerotherapy
yr: year(s)
Length of procedure
Eleven studies reported on length of procedure (Calik 2019; EVOLVeS 2003; Helmy ElKaffas 2011; HELP‐1 2011; MARADONA 2019; Morrison 2015; Nordon 2011; Rasmussen 2011; Rautio 2002; Subramonia 2010; Syndor 2017). The results of the length of procedure for the reporting trials are shown in Table 14. What defines the start and end points of a 'procedure' is ambiguous, which is reflected in the various ways the included trials have reported length of procedure. Syndor 2017 presents the median ablation and procedure time with the range; Rasmussen 2011 reports on the mean 'surgeon's time' and range; Subramonia 2010 on theatre and procedure times with the median values and the interquartile range; whilst Rautio 2002 gives the mean operating time, room time and recovery time with standard deviation (SD).
| EVLA versus RFA | ||
| Study | Time (min) | |
| EVLA | RFA | |
| Nordon 2011 median (range) | 30 (10 ‐ 60) | 30 (15 ‐ 60) |
| Rasmussen 2011 mean (range)a | 26 (12 ‐ 80) | 27 (12 ‐ 80) |
| Syndor 2017 median (range) | total procedure 23.5 (8 ‐ 95) total ablation time 5 (1 ‐ 18) | total procedure 21 (6 ‐ 64) total ablation time 4 (1 ‐ 14) |
| EVLA versus EVSA ‐ no data | ||
| EVLA versus UGFS | ||
| Study | Time (min) | |
| EVLA | UGFS | |
| Rasmussen 2011 mean (range)a | 26 (12 ‐ 80) | 19 (5 ‐ 145) |
| EVLA versus CA | ||
| Study | Time (min) | |
| EVLA | CA | |
| Calik 2019 mean (SD) | 31.7 (8.8) | 13 (3.4) |
| EVLA versus MOCA ‐ no data | ||
| EVLA versus HL/S (surgery) | ||
| Study | Time (min) | |
| EVLA | HL/S (surgery) | |
| HELP‐1 2011 mean (SD) | 61 (14) | 67 (16) |
| Rasmussen 2011 mean (range)a | 26 (12 ‐ 80) | 32 (15 ‐ 80) |
| Vernermo 2016 mean (SD) [range] | 83 (17) [50 ‐ 139] | 95 (19) [62 ‐ 155] |
| RFA versus UGFS | ||
| Study | Time (min) | |
| RFA | UGFS | |
| Rasmussen 2011 mean (range)a | 27 (12 ‐ 80) | 19 (5 ‐ 145) |
| RFA versus CA | ||
| Study | Time (min) | |
| RFA | CA | |
| Morrison 2015 mean (range) | 19 (5 ‐ 46) | 24 (11 ‐ 40) |
| RFA versus MOCA | ||
| Study | Time (min) procedural time | |
| RFA | MOCA | |
| MARADONA 2019 mean (IQR) | 13 (4 ‐ 85) | 12 (5 ‐ 45) |
| RFA versus HL/S (surgery) | ||
| Study | Time (min) | |
| RFA | HL/S (surgery) | |
| EVOLVeS 2003 mean (SD) | 74 (10) | 89 (12) |
| Helmy ElKaffas 2011 mean (SD) | 40 (12) | 45 (13) |
| Rasmussen 2011 mean (range)a | 27 (12 ‐ 80) | 32 (15 ‐ 80) |
| Rautio 2002 mean (SD) | Operating time: 75 (16.6) Operating room time: 115 (18.3) Recovery room time: 227 (57.6) | Operating time: 57 (11) Operating room time: 99 (12.9) Recovery room time: 198 (40.7) |
| Subramonia 2010 median (IQR) | Theatre time: 82 (73 ‐ 91) Procedure time: 76 (67 ‐ 84) | Theatre time: 55 (48 ‐ 63) Procedure time: 48 (39 ‐ 54) |
| UGFS versus HL/S (surgery) | ||
| Study | Time (min) | |
| UGFS | HL/S (surgery) | |
| Rasmussen 2011 mean (range)a | 19 (5 ‐ 145) | 32 (15 ‐ 80) |
aSurgeon's time
CA: cyanoacrylate glue
EVLA: endovenous laser ablation
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
IQR: interquartile range
min: minutes
MOCA: mechanochemical ablation
RFA: radiofrequency ablation
SD: standard deviation
UGFS: ultrasound‐guided foam sclerotherapy
Duration of hospital stay
The majority of the included studies reported that procedures were performed in day case surgical units or outpatient settings. Ten studies explicitly stated whether all participants were discharged home the same day or whether some required inpatient admission post‐intervention (Darwood 2008; EVOLVeS 2003; Flessenkämper 2013; FOAM 2010; Helmy ElKaffas 2011; HELP‐1 2011; Morrison 2015; Pronk 2010; Rasmussen 2007; Shepherd 2010). See Table 15 for details. For the most part, these procedures were performed as day cases.
| EVLA versus RFA | ||
| Study | Length of hospital stay % day case | |
| EVLA | RFA | |
| 98a | 95.5b | |
| EVLA versus EVSA ‐ no data | ||
| EVLA versus UGFS ‐ no data | ||
| EVLA versus CA ‐ no data | ||
| EVLA versus MOCA ‐ no data | ||
| EVLA versus HL/S (surgery) | ||
| Study | Length of hospital stay % day case | |
| EVLA | HL/S (surgery) | |
| 100 | 100 | |
| ~100 | ~100 | |
| 100 | 78.8 | |
| 100 | 100 | |
| 100 | 100 | |
| RFA versus UGFS ‐ no data | ||
| RFA versus CA | ||
| Study | Length of hospital stay % day case | |
| RFA | CA | |
| 100 | 100 | |
| RFA versus MOCA ‐ no data | ||
| RFA versus HL/S (surgery) | ||
| Study | Length of hospital stay % day case | |
| RFA | HL/S (surgery) | |
| 95c | 86d | |
| hours in hospital | 14 (SD 3.6) [12 to 18] | 30 (SD 11.5) [18 to 48] |
| 93.3 | 92.3 | |
| UGFS versus HL/S (surgery) | ||
| Study | Length of hospital stay % day case | |
| UGFS | HL/S (surgery) | |
| not indicated | 100 | |
aOne participant required overnight admission due to post‐operative nausea.
bOne participant required overnight admission for pain requiring opioids, one for nausea and one for hypotension secondary to general anaesthesia.
cTwo participants kept overnight
dFive participants kept overnight
CA: cyanoacrylate glue
EVLA: endovenous laser ablation
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
MOCA: mechanochemical ablation
RFA: radiofrequency ablation
UGFS: ultrasound‐guided foam sclerotherapy
Return to normal activities (days)
Table 16 illustrates the time taken by participants to return to work or normal activities following the intervention within their respective trials. Studies have presented this outcome as either parametric or non‐parametric data (mean, median, range, interquartile range (IQR)), or in the case of Shepherd 2010, the percentage of participants to return to work within a certain time frame. We were not able to perform meta‐analysis.
| EVLA versus RFA | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | RFA | EVLA | RFA | |
| Nordon 2011 median (range) | 7 (1 ‐ 60)a | 9 (0 ‐ 28) | ||
| Rasmussen 2011 median (range) | 3.6 (0 ‐ 46) | 2.9 (0 ‐ 14) | 3.6 (0 ‐ 46) | 1 (0 ‐ 30) |
| n returned to work at 3 days 14 (41%) 7 days 27 (71%) | n returned to work at 3 days 15 (37%) 7 days 29 (71%) | n returned to normal at 3 days 25 (50%) 7 days 37 (74%) | n returned to normal at 3 days 37 (60%) 7 days 48 (77%) | |
| EVLA versus EVSA | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | EVSA | EVLA | EVSA | |
| LAST 2014 mean (95% CI) | 4.2 (3.4 ‐ 5) | all 1.6 (1 ‐ 2.1) highb 1.6 (0.9 ‐ 2.3) | ||
| EVLA versus UGFS | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | UGFS | EVLA | UGFS | |
| Rasmussen 2011 median (range) | 3.6 (0 ‐ 46) | 2.9 (0 ‐ 33) | 2 (0 ‐ 25) | 1 (0 ‐ 30) |
| Vernermo 2016 mean (SD) [range] | 8 (5) [0 ‐ 29] | 1 (3) [0 ‐ 21] | ||
| EVLA versus CA | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | CA | EVLA | CA | |
| Calik 2019 mean (SD) | 2.9 (1.8) | 1.5 (0.6) | ||
| EVLA versus MOCA | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | MOCA | EVLA | MOCA | |
| Vähäaho 2019c mean | actual 5.3 perceived 8.6 | actual 4.3 perceived 7.8 | ||
| EVLA versus HL/S (surgery) | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | HL/S (surgery) | EVLA | HL/S (surgery) | |
| Darwood 2008d median (IQR) | EVLT1: 4 (2.5 ‐ 7) EVLT2: 4 (1 ‐ 12) | 17 (7.25 ‐ 33.25) | EVLT1: 2 (0 ‐ 7) EVLT2: 2 (0 ‐ 7) | 7 (2 ‐ 26) |
| HELP‐1 2011 median (range) | 4 (2 ‐ 14) | 14 (13 ‐ 28) | 3 (1 ‐ 10) | 14 (7 ‐ 25) |
| Pronk 2010 mean (SD) | 4.38 (5.43) | 4.15 (3.72) | 3.16 (4.34) | 3.20 (4.01) |
| Rasmussen 2007 mean (SD) | 7 (6) | 7.6 (4.9) | 6.9 (7) | 7.7 (6.1) |
| Rasmussen 2011 median (range) | 3.6 (0 ‐ 46) | 4.3 (0 ‐ 42) | 2 (0 ‐ 25) | 4 (0 ‐ 30) |
| RELACS 2012 mean | 10.4 | 11.8 | 4.8 | 4 |
| Vernermo 2016 mean (SD) [range] | 8 (5) [0 ‐ 29] | 12 (6) [0 ‐ 33] | ||
| RFA versus UGFS | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| RFA | UGFS | RFA | UGFS | |
| Rasmussen 2011 median (range) | 2.9 (0 ‐ 14) | 2.9 (0 ‐ 33) | 1 (0 ‐ 30) | 1 (0 ‐ 30) |
| RFA versus CA ‐ no data | ||||
| RFA versus MOCA | ||||
| Study | Time to return to work (days) | Time to return normal activities | ||
| RFA | MOCA | RFA | MOCA | |
| Lane 2017 median (IQR) | 2 (2 ‐ 7) | 3 (1 ‐ 7) | 2 (1 ‐ 7) | 2 (1 ‐ 4) |
| MARADONA 2019 mean (range) | 2.98 (0 ‐ 15) | 2.28 (0 ‐13) | 1.43 (0 ‐ 6) | 1 (0 ‐ 6) |
| Vähäaho 2019c mean | actual 4.7 perceived 6.4 | actual 4.3 perceived 7.8 | ||
| RFA versus HL/S (surgery) | ||||
| Study | Time to return to work (days) | Time to return normal activities | ||
| RFA | HL/S (surgery) | RFA | HL/S (surgery) | |
| EVOLVeS 2003e mean | 4.7 | 12.4 | 1.15 | 3.89 |
| Helmy ElKaffas 2011 mean (SD) | 3 (3) | 7 (2.6) | ||
| Rasmussen 2011 median (range) | 2.9 (0 ‐ 14) | 4.3 (0 ‐ 42) | 1 (0 ‐ 30) | 4 (0 ‐ 30) |
| Rautio 2002c mean (SD) | actual: 6.5 (3.3) perceived: 6.1 (4.4) | actual: 15.6 (6) perceived: 19.2 (10) | no data | no data |
| Subramonia 2010 median (IQR) | 10 (4 ‐ 13) | 18.5 (11 ‐ 28) | 3 (0 ‐ 7) | 12.5 (4 ‐ 21) |
| UGFS versus HL/S (surgery) | ||||
| Study | Time to return to work (days) | Time to return normal activities | ||
| UGFS | HL/S (surgery) | UGFS | HL/S (surgery) | |
| Rasmussen 2011 median (range) | 2.9 (0 ‐ 33) | 4.3 (0 ‐ 42) | 1 (0 ‐ 30) | 4 (0 ‐ 30) |
| Vernermo 2016 mean (SD) [range] | 1 (3) [0 ‐ 21] | 12 (6) [0 ‐ 33] | ||
aThree outliers at 42, 60, 60 days
bHigh dose of steam
cSick leave days taken and participant's own perception of required sick leave
dPresented both laser techniques separately
eAdjusted according to the number of phlebectomies performed, and the type of anaesthetic used
CA: cyanoacrylate glue
CI: confidence interval
EVLA: endovenous laser ablation (same as EVLT)
EVLT: endovenous laser therapy
EVSA: endovenous steam ablation
HL/S: high ligation and stripping
IQR: interquartile range
MOCA: mechanochemical ablation
RFA: radiofrequency ablation
SD: standard deviation
UGFS: ultrasound‐guided foam sclerotherapy
Endovenous laser ablation (EVLA) versus radiofrequency ablation (RFA)
See summary of findings Table 1.
Five studies compared EVLA to RFA (Nordon 2011; Rasmussen 2011; Recovery 2009; Shepherd 2010; Syndor 2017).
Technical success
These studies reported technical success at one month, three months, six weeks and six months, respectively. Pooling the data from these studies showed little or no differences to success rates within five years (OR 0.98, 95% CI 0.41 to 2.38; I 2 = 0%; 5 studies, 780 participants; moderate‐certainty evidence; Analysis 1.1).
Only Rasmussen 2011 provided data for five years or beyond, and no evidence of a difference in success rates was seen (OR 0.85, 95% CI 0.30 to 2.41; I 2 = 0%; 1 study, 291 participants; low‐certainty evidence; Analysis 1.2).
We downgraded the certainty of the evidence from high to moderate due to risk of bias concerns.
Recurrence
Only Rasmussen 2011 reported on recurrence in the comparison EVLA versus RFA. At three years, there was no clear difference in recurrence between the groups (OR 1.53; 95% CI 0.78 to 2.99; 291 participants; low‐certainty evidence; Analysis 1.3).
Rasmussen 2011 also reported five‐year recurrence rates, which favoured RFA (OR 2.77; 95% CI 1.52 to 5.06; 291 participants; low‐certainty evidence; Analysis 1.4). We downgraded the certainty of the evidence from high to low due to risk of bias concerns and possible imprecision as a result of wide CIs.
Post‐operative complications
We were not able to undertake meta‐analysis for post‐operative complications due to different definitions and time points used. Nordon 2011 evaluated complications at one week and reported a 2.6% rate of skin burns, a 1.3% rate of paraesthesia and a 2.6% rate of thrombophlebitis with EVLA, compared to rates of 1.3%, 2.6% and 1.3%, respectively, with RFA. Rasmussen 2011 reported phlebitis in 12 of their RFA participants compared to four in EVLA participants at one month. There were six cases of paraesthesia and eight cases of hyperpigmentation, with three of each seen with EVLA. Recovery 2009 reported complications at 48 hours, one week, two weeks and one month: 22% of EVLA participants had a complication compared with 4% of RFA participants at one of these time points. Six participants (14.6%) had phlebitis with EVLA compared with zero with RFA. Two participants (4.9%) reported paraesthesia following EVLA (2.2% with RFA), and there was one case of deep vein thrombosis (DVT) following EVLA. In Shepherd 2010, there was a higher rate of complications within the RFA group. Eight participants (12%) developed paraesthesia after RFA compared to five (8%) in EVLA; six participants (9%) had skin staining after RFA compared to two (3%) in EVLA; and one participant developed pulmonary embolism (PE) two weeks after RFA. Syndor 2017 showed comparable rates of phlebitis in EVLA and RFA (1.04% and 1.03%) and hyperpigmentation (3.16% and 3.13%). More paraesthesia was seen following RFA (13.68%) compared to EVLA (9.38%). Results of individual studies were inconsistent with each other, so we are not able to draw any conclusions (very low‐certainty evidence). See Table 10 and Table 11.
Quality of life (QoL)
Due to the variety of different QoL questionnaires used and scores recorded at different time points amongst the included trials, we decided it was inappropriate to combine these for meta‐analysis (see Table 12). The majority of studies for this comparison showed no clear difference in QoL scores between the two treatments compared. Nordon 2011 found no difference in improvement in QoL using the Aberdeen Varicose Vein Questionnaire (AVVQ) and EuroQol‐5D (EQ‐5D) at three months between EVLA and RFA. The mean (SD) AVVQ reduction in the EVLA group was 5.9 (6.1) and 6.2 (5.9) in the RFA group (P = 0.12). The mean improvement in EQ‐5D was 0.22 (0.3) in EVLA and 0.16 (0.3) with RFA (P = 0.66). Shepherd 2010 showed comparable improvements in QoL between treatment groups at six months: mean (SD) AVVQ improved in EVLA from 18.9 (9.8) to 10.9 (8.7) at six months; and from 20.6 (9.4) to 10.2 (9.4) in RFA. The mean (SD) SF‐12 physical component score (PCS) improved from 48.1 (10.1) in EVLA to 51.4 (9.6) and from 48.9 (9.5) to 51.7 (9.3) in RFA at six months. Rasmussen 2011 found that the Aberdeen Varicose Vein Symptom Severity Score (AVVSS) improved in all groups from three days onwards (P < 0.001) with no difference between the groups at any time point. Mean (SD) AVVSS at baseline was 17.94 (9) in EVLA and 18.74 in RFA, improving to 4.61 (5.8) and 4.43 (6.58), respectively, at three years. Rasmussen 2011 reported no difference in Medical Outcomes Study Short Form 36 (SF‐36) at one month. Recovery 2009 reported changes in mean (SD) global QoL scores were better in RFA at 7 and 14 days post operation; (RFA 27.7 (11.5) and 23 (6.1) compared to EVLA 33.7 (13.7) and 29.5 (8.5), respectively). By one month, they were comparable (RFA 22.7 (5) versus EVLA 22.2 (3.3)). Syndor 2017 did not evaluate QoL measures in their study. We assessed the certainty of the evidence for this outcome as moderate, downgrading for concerns regarding risk of bias.
Pain
All studies reported reduced pain in the RFA groups compared to EVLA. Nordon 2011 showed RFA participants took less analgesia during the week after the procedure (median 0 mg ibuprofen; range 0 to 600 mg, compared to median of 200 mg; range 0 to 1050 mg in EVLA group). Median post‐procedural pain scores were higher in EVLA than in RFA: reporting at day one (28 versus 9.5 (P = 0.001)); day three (23.5 versus 6 (P = 0.001)); and day seven (13.5 versus 0 (P = 0.001)), respectively. Recovery 2009 reported significantly lower mean pain levels (SD) on visual analogue system (VAS) at 48 hours in participants who had RFA (0.7 (0.9) versus 1.9 (1.6); P < 0.001); one week (0.2 (0.6) versus 1.8 (1.8) P < 0.001), and two weeks (0.1 (0.4) versus 1.2 (1.7) P < 0.001). In Rasmussen 2011, mean pain scores on VAS at 10 days in EVLA and RFA were 2.58 (2.4) and 1.21 (1.72), respectively. Shepherd 2010 reported that participants who had RFA reported less pain over the first 10 days with mean (SD) VAS score of 22 (19.8) compared to 34.3 (21.1) in EVLA. Also, participants who underwent RFA took fewer analgesic tablets with a mean (SD) consumption of 8.8 (9.5) tablets over three days compared to 14.2 (10.7) in the EVLA group. In Syndor 2017, the median post‐procedure pain score (on a scale of one to ten) was five in the EVLA group compared to two in RFA on initial evaluation (median day of evaluation was five in EVLA (range 1 to 29 days) and six in RFA (range 1 to 9 days).
Venous Clinical Severity Score (VCSS)
Four trials reported on change in VCSS, showing comparable rates between groups at final follow‐up (Rasmussen 2011; Recovery 2009; Shepherd 2010; Syndor 2017). Rasmussen 2011 reported that the VCSS improved significantly in all groups (P < 0.001) with no difference between groups at any evaluated time point through three years. Mean (SD) VCSS at baseline was 2.68 (2.25) in EVLA and 2.95 (2.06) in RFA; at three years, this was 0.34 (1.3) and 0.44 (1.82), respectively. Recovery 2009 reported no difference between treatment groups at baseline. In the RFA group, mean VCSS scores were reduced compared with EVLA at 48 hours (4.7 versus 5.3, P < 0.001), one week (4.2 versus 5.9, P < 0.001); and two weeks (4 vs 5.3; P = 0.0035); there was no difference by one month (2.7 versus 3.2; P = 0.28). In Shepherd 2010, VCSS was comparable between the two groups at six months, with mean improvement of 3.3 in EVLA (initial 4.7 and 1.4 at six months) and 3.7 in RFA (initial 5.1 and 1.4 at six months). Syndor 2017 found participants in both groups demonstrated a reduction in VCSS at six months from baseline. Median (range) VCSS improved from 5 (2 to 26) at baseline to 1 (0 to 18) at six months in EVLA and from 5 (1 to 20) to 1 (0 to 6) with RFA. See Table 13.
Length of procedure
The duration of the procedure was similar between treatment groups. However, the reporting trials used different time points, metrics and terminology, thus impeding analysis. Nordon 2011 reported the median procedural time (range) was 30 minutes (10 to 60 minutes) with EVLA and 30 minutes (15 to 60 minutes) with RFA. In Rasmussen 2011, mean (range) surgeon's time was 26 minutes (12 to 80 minutes) for EVLA and 27 minutes (12 to 80 minutes) with RFA. In Syndor 2017, median (range) total procedure time was 23.5 minutes (8 to 95 minutes) with EVLA and 21 minutes (6 to 64 minutes) with RFA. See Table 14.
Duration of hospital stay
Shepherd 2010 explicitly stated all procedures were day case procedures. Despite their intention to perform all procedures as day case procedures, four participants (3.1%) required overnight admission: three participants in the RFA groups for nausea, hypotension secondary to general anaesthesia or pain requiring opoid analgesia, and one participant in the EVLA group for post‐operative nausea. See Table 15.
Return to normal activities
Three trials reported on return to work and normal activities (Nordon 2011; Rasmussen 2011; Shepherd 2010). Results were comparable but studies evaluated this outcome by different means. Nordon 2011 reported median (range) return to work was seven days (1 to 60 days) after EVLA compared with nine days after RFA (1 to 28 days). In Rasmussen 2011, median (range) return to normal activities was 2 days (0 to 25 days) and to work was 3.6 days (0 to 46 days) compared with 1 day (0 to 30 days) and 2.9 days (0 to 14 days) with RFA. Shepherd 2010 reported 74% of participants had returned to normal activities and 71% had returned to work at seven days following EVLA. This was comparable with RFA, with 77% of participants at normal levels of activity and 71% back at work by seven days. See Table 16.
Endovenous laser ablation (EVLA) versus endovenous steam ablation (EVSA)
Only LAST 2014 compared EVLA with EVSA.
Technical success
In LAST 2014, no clear difference in success was seen between the groups (OR 1.94, 95% CI 0.53 to 7.15; 1 study, 166 participants; Analysis 2.1). There were no reports of data for five years or beyond.
Recurrence
LAST 2014 did not report this outcome.
Post‐operative complications
Complication profiles were similar between the two groups. Participants had similar rates of thrombophlebitis following treatment (10 participants in each group at two weeks) and one participant in the EVLA group developed a DVT. Two participants within the EVSA group had nerve injury reported at two weeks. See Table 10 and Table 11.
Quality of life
LAST 2014 reported that the EQ‐5D and EQ visual analogue scale scores were comparable for EVSA and EVLA at 12 weeks.
Pain
LAST 2014 reported that the EVSA group had less post‐procedural pain (mean VAS score in EVLA of 5.6 and 2.6 in EVSA; P < 0.001); and a shorter duration of analgesic use (mean 0.9 days compared with 3.3 days in EVLA; P < 0.001).
Venous Clinical Severity Score (VCSS)
Changes in VCSS between baseline and 12 weeks were similar between the two treatment arms: ‐2.69 (95% CI ‐2.34 to ‐3.04) in ESVS and ‐2.51 (95% CI ‐2.10 to ‐2.93) in the EVLA group. See Table 13.
Length of procedure
LAST 2014 did not report this outcome.
Duration of hospital stay
LAST 2014 did not report this outcome.
Return to normal activities
Convalescence was measured as the number of days lost from work or normal activities. Participants undergoing EVSA had a mean return to normal activity of 1.6 days (95% CI 1 to 2.1), compared to 4.2 days (95% CI 3.4 to 5) with EVLA. See Table 16.
Endovenous laser ablation (EVLA) versus ultrasound‐guided foam sclerotherapy (UGFS)
See summary of findings Table 2.
Three studies compared EVLA with UGFS (Magna 2013; Rasmussen 2011; Vernermo 2016).
Technical success
Three studies evaluated EVLA compared to UGFS for technical success up to five years (Magna 2013; Rasmussen 2011; Vernermo 2016). Two of these also reported data for greater than five‐year follow‐up (Magna 2013; Vernermo 2016). Meta‐analysis showed technical success may be improved in those undergoing EVLA up to five years (OR 6.13, 95% CI 0.98 to 38.27; 3 studies, 588 participants; low‐certainty evidence; Analysis 3.1); and over five years follow‐up (OR 6.47, 95% CI 2.60 to 16.10; 3 studies, 534 participants; low‐certainty evidence; Analysis 3.2) noting the wide CIs. Heterogeneity was detected at up to and over five years so a random‐effects method was used (I2 = 78% and I2 = 68%, respectively). We downgraded the certainty of the evidence from high to low due to risk of bias concerns and inconsistency.
Recurrence
Two studies compared recurrence in EVLA and UGFS at one and three years, respectively (Magna 2013; Rasmussen 2011), and showed no clear difference between the groups (OR 0.68, 95% CI 0.20 to 2.36; 2 studies, 443 participants; very low‐certainty evidence; Analysis 3.3). Five‐year recurrence rates were also available for both studies and again no clear differences were seen (OR 1.08, 95% CI 0.40 to 2.87; 2 studies, 418 participants; very low‐certainty evidence; Analysis 3.4). Heterogeneity was detected so a random‐effects model was used (I2 = 82% and 76%, respectively). We downgraded the certainty of the evidence due to risk of bias concerns, inconsistency and imprecision.
Post‐operative complications
All three studies reported on post‐operative complications. However, meta‐analysis was impeded by the different definitions of complications used amongst trials and the varying time points at which complications were assessed. At one month, Rasmussen 2011 reported an iliac vein thrombosis with subsequent pulmonary embolism in one participant who had undergone UGFS one week prior. Phlebitis rates were higher amongst the UGFS group and were seen in 17 participants compared to 4 in the EVLA group. UGFS also had higher rates of hyperpigmentation at one month with eight cases compared to three within the EVLA arm. In Vernermo 2016, skin pigmentation was common in the UGFS arm at one month ‐ seen in 67% of participants compared to 4% in the EVLA group. Vernermo 2016 found haematomas in 42% of participants undergoing EVLA compared to 20% of UGFS participants at one month. Magna 2013 reported two cases of hyperpigmentation in EVLA participants compared to one case in UGFS at three months. We downgraded to very‐low certainty evidence due to risk of bias concerns, inconsistency, imprecision and possible publication bias. See Table 10 and Table 11.
Quality of life
All three studies reported on this outcome but evaluated QoL using different questionnaires at different time points. Magna 2013 reported no significant differences between EVLA and UGFS at three months and one year in Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ2) and EQ‐5D scores. While in Rasmussen 2011, UGFS was deemed to be better with regard to bodily pain and physical functioning in the SF‐36 score initially, but showed no difference between comparisons at one month. Vernermo 2016 found no significant difference in median AVVSS between the treatment groups at one year. We assessed the overall certainty of evidence for QoL as moderate, downgrading by one step due to risk of bias concerns.
Pain
Two studies evaluated pain scores, with both reporting lower post‐procedural pain with UGFS compared to EVLA treatment, but we were not able to undertake meta‐analysis as data were not reported for both studies (Rasmussen 2011; Vernermo 2016). Vernermo 2016 reported pain after treatment was significantly reduced (lower VAS score) both at the time of discharge, and one week following UGFS treatment compared with EVLA. In Rasmussen 2011, less pain was reported during the first ten days after UGFS treatment (mean (SD) VAS score was 1.6 (2.04) in the UGFS group and 2.58 (2.4) in the EVLA group).
Venous Clinical Severity Score (VCSS)
VCSS was only analysed by Rasmussen 2011, who found that VCSS improved in all groups from baseline, with no difference between treatment arms at any evaluated time point. Initial mean (SD) VCSS improved from 2.68 (2.25) to 0.34 (1.3) in EVLA compared to 2.66 (1.45) to 0.15 (0.4) in UGFS. See Table 13.
Length of procedure
Rasmussen 2011 was the only study which evaluated length of procedure as surgeon's time. Mean surgeon's time was 26 minutes in the EVLA group (range 12 to 80 minutes) and 19 minutes in the UGFS group (range 5 to 145 minutes).
Duration of hospital stay
No studies reported on duration of hospital stay.
Return to normal activities
Vernermo 2016 reported the mean duration of sick leave, and this was eight days in the EVLA group (range 0 to 29 days) and one day in the UGFS (range 0 to 21 days).
Endovenous laser ablation (EVLA) versus cyanoacrylate glue
Calik 2019 was the sole trial to evaluate this comparison. We assessed it as having a high risk of bias in five bias categories, but we included it as it was the sole RCT found for this comparison.
Technical success
Calik 2019 evaluated technical success at 1‐, 3‐, 6‐ and 12‐month follow‐up. As the one‐month data is the closest to our definition of technical success (complete anatomical obliteration, or absence of reflux, within the GSV around six weeks on DUS) we have used this time point in our analysis. Occlusion rates showed no evidence of a difference between the treatment groups (OR 0.33, 95% CI 0.01 to 8.03; 1 study, 412 participants; Analysis 4.1). At 12 months, there was no clear difference in recurrence between groups (OR 2.59, 95% CI 0.50 to 13.49; 1 study, 412 participants). These participants had no clinically significant symptoms. There were no long‐term data available.
Recurrence
There were two recanalisations in the cyanoacrylate glue group and five within the EVLA group, and results showed no evidence of a difference in recanalisation rates at one year (OR 2.59, 95% CI 0.50 to 13.49; 1 study, 412 participants; Analysis 4.2). There were no long‐term data available.
Post‐operative complications
Higher rates of post‐procedural induration, bruising and paraesthesia were reported following EVLA at one week, but there was no difference by the three‐month time point except for paraesthesia, which was reported in 13 EVLA participants and 2 cyanoacrylate glue participants (P < 0.001). Two DVTs were found within the EVLA group. See Table 10 and Table 11.
Quality of life
Quality of life was evaluated via the CIVIQ2 score. The mean CIVIQ2 scores demonstrated meaningful improvement in all groups at follow‐up (P < 0.001) with no clear difference between cyanoacrylate glue and EVLA groups reported. The mean pre‐procedural score was 41.4 in the EVLA group, improving to 12.8 at one year. In the cyanoacrylate glue group, the mean pre‐procedural score was 40.6 and 12.3 at one year.
Pain
Calik 2019 evaluated participant‐reported pain using the Wong‐Baker FACES pain rating scale. At one week, participants who had undergone EVLA had a higher mean pain score (5.4 (SD 3.7)) than participants who underwent cyanoacrylate glue (2.8 (SD 3.1); P < 0.001). However, at three months, there was no evidence of a difference between the mean pain scores 0.7 (SD 0.5) and 0.6 (SD 0.4), respectively (P < 0.46).
Venous Clinical Severity Score (VCSS)
At one year, VCSS (SD) had declined from 5.8 (1.9) to 1.3 (0.9) (P < 0.001) for the EVLA group, and from 5.7 (1.9) to 1.3 (0.9) (P < 0.001) for the cyanoacrylate glue group, with no evidence of difference between groups. See Table 13.
Length of procedure
The mean operative time (SD) was longer for the EVLA group (31.7 (8.8) minutes) than for cyanoacrylate glue group (13 (3.4) minutes) (P < 0.001). See Table 14.
Duration of hospital stay
Calik 2019 did not evaluate this outcome.
Return to normal activities
Amongst the cyanoacrylate glue group, there was a faster return to daily activities (1.5 days) compared to participants who underwent EVLA (2.9 days; P < 0.001). Results are summarised below under 'Narrative summaries' and detailed within Table 16.
Endovenous laser ablation (EVLA) versus mechanochemical ablation (MOCA)
One study compared EVLA with MOCA (Vähäaho 2019).
Technical success
At one month, all treated great saphenous veins were occluded, regardless of treatment modality (Analysis 5.1). There were no long‐term data available.
Recurrence
Ten participants within the MOCA treatment group had ultrasound‐proven recanalisation at one year compared to none in the EVLA group (OR 0.06, 95% CI 0.00 to 1.14; 1 study, 88 participants; Analysis 5.2). There were no long‐term data available.
Post‐operative complications
Three participants in the EVLA group reported sensory disturbance at one year; no nerve injuries were seen in the MOCA group. There was one superficial infection seen in the MOCA treatment group. See Table 10 and Table 11.
Quality of life
Mean AVVQ at baseline was 16.1 in EVLA group and 15.8 in the MOCA group. By year one, all had improved and there was no evidence of a difference between the treatment groups reported by the study authors (mean AVVQ in EVLA was 5.3, and in MOCA 6.2 (P = 0.9).
Pain
Vähäaho 2019 evaluated pain using the visual analogue system (VAS) and recorded scores as zero to ten. During the procedure, the mean VAS pain score was 3.9 for EVLA and 4.6 for MOCA (P = 0.12). The study authors reported that use of extra periprocedural sedative (propofol) was less in participants undergoing MOCA than in participants undergoing thermal ablation (P < 0.001). The use of fentanyl and diazepam periprocedurally did not differ between treatment groups (P = 0.12 and P = 0.41, respectively). Prior to discharge, pain scores were found to be similar between interventions (P = 0.18), as well as at one week (P = 0.92). The amount of post‐operative analgesia consumed by participants did not differ (P = 0.12).
Venous Clinical Severity Score (VCSS)
Vähäaho 2019 did not report on this outcome.
Length of procedure
Vähäaho 2019 did not report on this outcome.
Duration of hospital stay
Vähäaho 2019 did not explicitly mention whether all procedures were performed as day case surgery.
Return to normal activities
Participants undergoing EVLA took a mean of 5.3 days sick leave compared to 4.3 days in those undergoing MOCA. See Table 16.
Endovenous laser ablation (EVLA) versus SFJ ligation and stripping (HL/S, surgery)
See summary of findings Table 3.
Nine studies compared EVLA with SFJ ligation and stripping (Darwood 2008; Flessenkämper 2013; HELP‐1 2011; Magna 2013; Pronk 2010; Rasmussen 2007; Rasmussen 2011; RELACS 2012; Vernermo 2016).
Technical success
A total of six studies compared technical success in EVLA and SFJ ligation and stripping (Darwood 2008; HELP‐1 2011; Magna 2013; Rasmussen 2007: Rasmussen 2011; Vernermo 2016); with five studies also reporting five‐year data (HELP‐1 2011; Magna 2013; Rasmussen 2007: Rasmussen 2011; Vernermo 2016).
There was a possible benefit in technical success at less than five years in the EVLA group (OR 2.31, 95% CI 1.27 to 4.23; 6 studies, 1051 participants; low‐certainty evidence; Analysis 6.1). There was no clear difference seen at five years and beyond (OR 0.93, 95% CI 0.57 to 1.50; 5 studies, 874 participants; low‐certainty evidence; Analysis 6.2). We downgraded the certainty of the evidence from high to low due to risk of bias concerns and imprecision. See summary of findings Table 3.
Recurrence
Seven studies reported on recurrence (one to three years) between EVLA and SFJ ligation and stripping (Flessenkämper 2013; HELP‐1 2011; Magna 2013; Pronk 2010; Rasmussen 2007; Rasmussen 2011; RELACS 2012). We were able to pool these data. Meta‐analysis showed no clear difference in recurrence rate between the EVLA or surgery group up to 5 years (OR 0.78, 95% CI 0.47 to 1.29; 7 studies, 1459 participants; moderate‐certainty evidence; Analysis 6.3).
Five‐year data was available also from seven studies (Flessenkämper 2013; HELP‐1 2011; Magna 2013; Pronk 2010; Rasmussen 2007; Rasmussen 2011; RELACS 2012). Pooling showed no clear difference in recurrence rates (OR 1.09, 95% CI 0.68 to 1.76; 7 studies, 1267 participants; moderate‐certainty evidence; Analysis 6.4). Heterogeneity was detected so a random‐effects model was used (I2 = 62% and I2 = 70%, respectively). We downgraded from high to moderate certainty due to the lack of blinding inherent within these studies.
Post‐operative complications
We were not able to undertake meta‐analysis for post‐operative complications because the included trials used different definitions and time points. Darwood 2008 reported higher rates of phlebitis amongst EVLA participants (11%) compared to SFJ ligation and stripping (0%). Neurosensory loss was reported in 13% of SFJ ligation and stripping participants compared to 1% in EVLA. One participant undergoing SFJ ligation and stripping developed acute respiratory distress syndrome after aspirating on extubation and required intensive care unit (ICU) care for seven days. Flessenkämper 2013 reported similar rates of saphenous nerve injury between groups at two months (15% and 17%, respectively); early bruising and pigmentation was higher in the SFJ ligation and stripping group (68%) compared to the EVLA group (47.9%). HELP‐1 2011 reported higher rates of sensory disturbance (9.8%), haematoma (8.3%) and infection (8%) following SFJ ligation and stripping compared to EVLA (4%, 1% and 1.5%, respectively). Magna 2013 reported low rates of complications at three months' follow‐up. Paraesthesia was reported in 5.9% of SFJ ligation and stripping participants compared to 2.6% with EVLA; 2.6% of EVLA participants had hyperpigmentation, none was seen with SFJ ligation and stripping. Pronk 2010 reported low levels of complications in their trial: paraesthesia was seen in 3% of their EVLA participants and 1% of SFJ ligation and stripping participants. Rasmussen 2007 reported higher rates of bruising at 12 days following SFJ ligation and stripping (25%) compared to EVLA (11%) (P > 0.05). Paraesthesia was slightly higher following SFJ ligation and stripping (4.2%) than EVLA (2.4%) as was hyperpigmentation (5% compared to 2.45) in Rasmussen 2011. High levels of bruising were reported with each treatment group (90.1% in both) in RELACS 2012. Phlebitis was more pronounced in the EVLA group (10.8% versus 2.5%) as was pigmentation (32% versus 12%). At one month, higher rates of haematoma were seen with SFJ ligation and stripping (62%) compared with EVLA (42%). We downgraded to very low‐certainty evidence due to risk of bias concerns, inconsistency, imprecision and possible publication bias. See Table 10 and Table 11.
Quality of life
Darwood 2008 reported that the AVVSS improved at three months and was similar between groups (P = 0.694). At baseline, AVVSS (SD) was 11.76 (9.81 ‐ 19.44), improving to 5.6 (1.45 ‐ 8.2) at three months in the EVLA group, while in the SFJ ligation and stripping group, baseline AVVSS was 14.02 (9.49 ‐ 19.16), improving to 5.32 (1.03 ‐ 7.66) at three months. HELP‐1 2011 found that AVVSS, EQ‐5D and several domains of the SF‐36 showed deterioration within the first post‐operative week for both treatment groups (P < 0.001). However, these scores improved for the rest of the duration of the follow‐up period (P < 0.001), with no statistical difference seen between either groups at any time point for AVVSS and EQ‐5D, and none after four weeks in the SF‐36. For the SF‐6D (a variation of SF‐36), the EVLA group was seen to have significantly better scores than the surgical group (P = 0.003). Magna 2013 showed improvement in both CIVIQ2 and EQ‐5D scores at three months but no significant difference in score was seen between either groups. Within the EVLA group in Pronk 2010, the EQ‐5D scores for daily activity were better than for those in the surgery group on day one (P = 0.01). However, the EVLA group had lower mobility scores on days seven and ten (P < 0.01, P = 0.01, respectively) than the surgery group. At six months and five years, there was no change in EQ‐5D in either EVLA or surgery groups. Rasmussen 2007 showed significant improvements at five years in the AVVSS and SF‐36 scores with no significant differences in outcomes between the groups. Rasmussen 2011 showed the AVVSS improved from baseline from day three onwards (P > 0.001) with no difference at any evaluated time point. SF‐36 scores showed improvement in all domains at some time point with no difference between groups. The RELACS 2012 study demonstrated that CIVIQ scores remained stable up to five years after treatment, without significant differences between the two groups. Vernermo 2016 reported that the AVVSS was improved from baseline with no difference between EVLA and SFJ ligation and stripping. We downgraded the certainty of the evidence from high to moderate due to risk of bias concerns.
Pain
We were not able to undertake meta‐analysis for pain because the included trials used different definitions, methods of measuring the outcome and evaluation times. Darwood 2008 evaluated daily pain scores through use of an ungraded visual analogue pain score over the first week, and found no difference between interventions at any time point. Median (IQR) duration of analgesic use was six days (3 to 7) with EVLA, and four days (1 to 7) with SFJ ligation and stripping. Flessenkämper 2013 reported no difference in pain during the first five days following intervention (P = 0.12). The HELP‐1 2011 study reported that the EVLA group reported less pain from day one compared with the SFJ ligation and stripping group (P = 0.004 to P < 0.001), with a resultant increase in the latter group's analgesic consumption over the same period (P = 0.012 to P = 0.001). Pronk 2010 demonstrated higher mean pain scores (SD) following EVLA compared with SFJ ligation and stripping at day 7 (3.74 (2.72) versus 1.78 (1.94), P < 0.01), day 10 (2.65 (2.21) versus 1.18 (1.49), P < 0.01), and day 14 (1.66 (2.04) versus 0.77 (1.46), P = 0.01). However, periprocedural pain scores were higher with SFJ ligation and stripping, with a mean (SD) periprocedural pain score of 3.39 (2.57) versus EVLA pain score of 2.21 (2.4); P = 0.02. The higher pain in EVLA could possibly be attributed to the use of tumescent analgesia with SFJ ligation and stripping. Within the Rasmussen 2007 trial, VAS pain scores were not significantly statistically different between groups (P < 0.01). No difference in the mean use of analgesia was found, with 12 tablets consumed in the EVLA group and 12.9 in the SFJ ligation and stripping group. Rasmussen 2011 reported no difference in mean pain score (SD) within ten days, with a score of 2.58 (2.41) in EVLA and 2.25 (2.23) with SFJ ligation and stripping. RELACS 2012 reported similar mean (SD) VAS pain scores during the first post‐operative week between EVLA (1.6 (0.8)) and SFJ ligation and stripping (1.3 (0.6)) (P = 0.005). Duration of pain (SD) was 8 (6) days in EVLA and 17 (20) days in SFJ ligation and stripping.
Venous Clinical Severity Score (VCSS)
Four studies reported on VCSS with comparable improvements in scores between interventions. Darwood 2008 reported that, following treatment, VCSS improved from a median (IQR) of 4 (1 ‐ 3) to 0 (0 ‐ 1) (P < 0.001). HELP‐1 2011 reported that both groups showed a similar improvement in VCSS from a median of 4 (3 ‐ 5) to 1 (0 ‐ 3) by three months (P < 0.001). This was maintained up to a year with no difference between interventions at any evaluation point. Rasmussen 2007 found mean VCSS (SD) improved from baseline from 2.8 (1.7) to 0.4 (0.9) at five years in EVLA and from 2.4 (1.4) to 2.4 (1.4) with SFJ ligation and stripping. Scores were not seen to differ between interventions at any time point. Rasmussen 2011 reported improvement in both groups (P > 0.001), with no difference at any time point over three years. The mean (SD) VCSS at baseline was 2.68 (2.25) for EVLA and 2.75 (1.62) for SFJ ligation and stripping. This had improved to 0.34 (1.3) and 0.3 (0.5) by three years. See Table 13.
Length of procedure
Three studies reported on length of procedure. HELP‐1 2011 reported that EVLA took longer, with a mean time (SD) of 67 minutes (16) compared to 61 minutes (14) with SFJ ligation and stripping. Rasmussen 2011 reported a mean surgeon's time (range) of 26 minutes (12 to 80) with EVLA and 32 minutes (15 to 80) with SFJ ligation and stripping. Vernermo 2016 reported a mean (SD) duration of treatment of 83 (17) minutes (range 50 to 139 minutes) in EVLA compared to 95 (19) minutes (range 62 to 155 minutes) with SFJ ligation and stripping. See Table 14.
Duration of hospital stay
Darwood 2008, Flessenkämper 2013, Pronk 2010 and Rasmussen 2007 stated that all their procedures were undertaken in an outpatient setting. HELP‐1 2011 reported that 21.2% of their participants undergoing SFJ ligation and stripping required inpatient admission due to their unsuitability for day case general anaesthesia. See Table 15.
Return to normal activities
Seven studies evaluated return to normal activities and work. The majority of studies demonstrated that participants undergoing EVLA returned to work faster. Darwood 2008 found that participants undergoing EVLA returned to work faster than with SFJ ligation and stripping, with a median time to return to work (IQR) of four days (2.5 to 7) in the EVLA group compared to 17 days (7.25 to 33.25) with SFJ ligation and stripping. Median (IQR) return to normal activities was two days (0 to 7) and seven days (2 to 26), respectively. HELP‐1 2011 reported a median (range) return to work of four days (2 to 14 days) and a median (range) return to normal activities of three days (1 to 10 days) with EVLA, compared to 14 days (13 to 28) and 14 days (7 to 25), respectively with SFJ ligation and stripping. Mean return to work was comparable between interventions in Pronk 2010, with a mean return (SD) of 4.38 (5.43) in EVLA and 4.15 (3.72) SFJ ligation and stripping. Mean (SD) return to normal activities was 3.16 days (4.34) in EVLA and 3.20 days (4.01) with SFJ ligation and stripping. In Rasmussen 2007, mean (SD) return to normal activities (6.9 days (7) versus 7.7 days (6.1)), and mean (SD) time to resume work (7 days (6) versus 7.6 days (4.9)) was comparable between EVLA and SFJ ligation and stripping. Rasmussen 2011 reported no difference between EVLA and SFJ ligation and stripping concerning return to normal activities and work (P = 0.18 and P = 0.26, respectively). The median time to return to work (range) was 3.6 days (0 to 46 days) in EVLA and 4.3 days (0 to 42 days) with SFJ ligation and stripping. Median time to return to normal activities was 2 days (0 to 25 days) and 4 days (0 to 30 days). RELACS 2012 reported a mean return to basic activity of 4 days with EVLA and 4.8 days with SFJ ligation and stripping; the ability to work or perform comparable tasks was achieved after 10.4 days and 11.8 days, respectively, for the two groups. Vernermo 2016 reported a mean (range) length of sick leave of 8 days (0 to 29 days) after EVLA and 12 days (0 to 33 days) following SFJ ligation and stripping. See Table 16.
Radiofrequency ablation (RFA) versus ultrasound‐guided foam sclerotherapy (UGFS)
Only Rasmussen 2011 compared RFA with UGFS.
Technical success
There was no clear benefit to either treatment in technical success up to 5 years (OR 5.21, 95% CI 0.25 to 109.48; 1 study, 292 participants; Analysis 7.1) with a notably wide CI.
Rasmussen 2011 also reported on long‐term technical success with a possible benefit to RFA treatment detected (OR 3.23, 95% CI 1.32 to 7.89; 1 study, 291 participants; Analysis 7.2).
Recurrence
Rasmussen 2011 evaluated recurrence in RFA against UGFS at three years, and results show no clear difference (OR 0.81, 95% CI 0.41 to 1.62; 1 study, 291 participants; Analysis 7.3).
Five‐year comparison data was also available and again showed no clear difference (OR 0.61, 95% CI 0.33 to 1.16; 1 study, 291 participants; Analysis 7.4).
Post‐operative complications
One participant developed an iliac vein thrombosis and subsequent pulmonary embolus one week post‐UGFS. Equal levels of hyperpigmentation were seen between groups. More episodes of phlebitis were recorded in the UGFS group than in RFA (12 versus 17). See Table 10 and Table 11.
Quality of life
Rasmussen 2011 did not present data but reported that "for all groups in all domains there was statistically significant improvement in most scores from pre‐treatment to one year. At three days participants treated with UGFS and RFA had significantly better scores for bodily pain, physical functioning and role‐physical, this difference went by one month".
Pain
In Rasmussen 2011, the mean (SD) pain score (VAS) for the first 10 days post‐procedure was 1.21 (1.72) and 1.6 (2.04) in RFA and UGFS, respectively.
Venous Clinical Severity Score (VCSS)
Mean (SD) VCSS at baseline was 2.95 (2.06) in RFA and 2.06 (1.45) in UGFS, reducing to 0.44 (1.82) and 0.15 (0.4), respectively, at three years. See Table 13.
Length of procedure
The length of procedure was recorded as 'surgeon's time' within the trial. The median surgeon's time for RFA was 27 minutes (range of 12 to 80 minutes) compared to 19 minutes (range of 5 to 145 minutes) with UGFS. See Table 14.
Duration of hospital stay
Rasmussen 2011 did not report upon duration of hospital stay.
Return to normal activities
The median time to return to normal activities was one day in both groups, with a range of 0 to 30 days. The median time to return to work was 2.9 days in both groups, with a range of 0 to 14 days in the RFA group and 0 to 33 days in the UGFS group. See Table 16.
Radiofrequency ablation (RFA) versus cyanoacrylate glue
Morrison 2015 was the only trial to compare RFA with cyanoacrylate glue.
Technical success
Morrison 2015 reported technical success at one and three months. We report the one‐month results in this review as these are closest to the primary outcome of six‐week technical success. There were increased occlusions in the cyanoacrylate glue group compared to RFA (OR 0.03, 95% CI 0.00 to 0.54; 1 study, 215 participants; Analysis 8.1). The two‐year follow‐up results (n = 171) found there to be equivalent technical success for cyanoacrylate glue: 82/86 (95.3%) and RFA: (94.0% (79/84). Follow‐up data were also available for 36 months, and the study authors reported that at this time point, occlusion was comparable between cyanoacrylate glue (94.4%, 68/72) and RFA (91.9%, 68/74) (P = 0.75).
Recurrence
The two‐year follow‐up identified 12/86 recanalisations in the cyanoacrylate glue group and only 1/84 in the RFA group. This was non‐inferior.
Post‐operative complications
Within the first three months, three participants in each treatment group were reported to have paraesthesia. There were 16/84 episodes of phlebitis with RFA and 22/86 with cyanoacrylate glue. Between three and twelve months, there was one DVT within the RFA arm, one case of endovenous heat‐induced thrombosis with RFA, and one participant with chronic phlebitis who had undergone cyanoacrylate glue. See Table 10 and Table 11.
Quality of life
Morrison 2015 demonstrated that at one year, QoL, as measured by the EQ‐5D, increased by small and similar amounts in both RFA and cyanoacrylate glue groups (P = 0.12). At 36 months, there was no statistical difference between cyanoacrylate glue and RFA in both AVVQ (P = 0.45) and EQ‐5D (P = 0.4). See Table 12.
Pain
Morrison 2015 found there was no difference in the pain experienced between the two treatment arms during the 24 hours before the day three visit (P = 0.36).
Venous Clinical Severity Score (VCSS)
VCSS was evaluated at baseline and was to found to have improved by approximately 3.5 points at three months (P > 0.01). Initial VCSS was 5.6 in RFA and 5.5 in cyanoacrylate glue, improving to 2 and 1.9, respectively. There was no difference between treatment groups. See Table 13.
Length of procedure
Mean procedural time was five minutes longer for cyanoacrylate glue (24 minutes) than RFA (19 minutes) (P < 0.01). See Table 14.
Duration of hospital stay
All interventions were undertaken as day case procedures.
Return to normal activities
Morrison 2015 did not evaluate post‐operative return to activity.
Radiofrequency ablation (RFA) versus mechanochemical ablation (MOCA)
See summary of findings Table 4.
Three studies compared RFA with MOCA (Lane 2017; MARADONA 2019; Vähäaho 2019).
Technical success
All three studies compared technical success rates in RFA and MOCA (Lane 2017; MARADONA 2019; Vähäaho 2019). Both Vähäaho 2019 and MARADONA 2019 reported on technical success at 30 days, while Lane 2017 reported technical success rates at 6 months. Following discussion between all review authors it was felt inclusion in meta‐analysis was warranted. Meta‐analysis showed no clear evidence of a benefit for RFA over MOCA (OR 1.76, 95% CI 0.06 to 54.15; 3 studies, 435 participants; low‐certainty evidence; Analysis 9.1), noting the wide CI. We downgraded by two levels due to risk of bias concerns and inconsistency. A random‐effects model was used as heterogeneity was detected (I2 = 60%).
No long‐term data were available.
Recurrence
All three studies compared recurrence rates for RFA versus MOCA (Lane 2017; MARADONA 2019; Vähäaho 2019). Meta‐analysis did not show a clear benefit for one intervention over the other (OR 1.00, 95% CI 0.21 to 4.81; 3 studies, 389 participants; low‐certainty evidence; Analysis 9.2). We downgraded by two levels due to risk of bias concerns and inconsistency. A random‐effects model was used as heterogeneity was detected (I2 = 67%).
No long‐term data were available.
Post‐operative complications
All three studies reported on complication rates, which were similar between treatment arms. In the MARADONA 2019 trial, there was one DVT at one year in the RFA group. Lane 2017 showed equal rates of DVTs between groups. In Vähäaho 2019, two participants who had undergone RFA were found to have sensory disturbance; none was seen in the MOCA group. We were unable to perform meta‐analysis because the trials used different definitions and evaluated complications at different time points. We downgraded to very‐low certainty evidence due to risk of bias concerns, inconsistency and possible publication bias. See Table 10 and Table 11.
Quality of life
All studies evaluated quality of life scores. For disease‐specific quality of life (AVVQ), the Lane 2017 study authors report that there was no difference at any time point during the study. At one month, mean AVVQ was 12.1 (7.3 to 21.2) for MOCA versus 12.9 (6.6 to 20.4) for RFA (P = 0.80); and 11.8 (7.2 to 20.5) for MOCA versus 9.4 (3.6 to 21.4) for RFA at six months (P = 0.51). Between groups, there was no significant difference in EQ‐5D QoL at one month (MOCA 0.76 (0.659 to 1.00) versus RFA –0.76 (0.69 to 1) (P = 0.94)); or at six months (MOCA 0.76 (0.69 to 1.00) versus RFA 0.76 (0.49 to 1.00) (P = 0.13)).
The MARADONA 2019 trial reported "no difference were observed between groups in drawn blocks and total AVVQ scores at 1‐ and 2‐year follow‐up". AVVQ improvement at one year was 90% in MOCA and 78% RFA (P = 0.19). At two years, this was 88% and 89%, respectively (P = 0.90). Participants who underwent RFA demonstrated an improvement in physical functioning at one year on the SF‐36, whilst in MOCA, there were significant improvements in physical and social functioning, both physical and emotional role functioning, mental health and pain. In Vähäaho 2019, the mean AVVQ at baseline was 16.1 in EVLA participants and 15.8 in MOCA. By year one, all had improved and there was no statistically difference (mean AVVQ 5.3 in EVLA and 6.2 in MOCA; P = 0.90).
We downgraded the certainty of evidence by one level due to risk of bias concerns.
Pain
This was the primary outcome for Lane 2017. The study authors reported that the maximum periprocedural pain score, measured on a visual analogue scale, was significantly lower following MOCA (median 15 mm (IQR 7 mm to 36 mm)) compared with the score following RFA (34 mm (IQR 16 mm to 34 mm)) (P = 0.003). In the MARADONA 2019 trial, lower pain scores were seen in the first two weeks after MOCA. Median pain score in this group was 0.2 with a range of 0 to 0.8; and in participants undergoing RFA, the median pain score was 0.5 with a range of 0.2 to 1.3 (P = 0.01). However, the analgesic requirement was similar. Pain was evaluated using a visual analogue system (VAS) in Vähäaho 2019 and ranked from 0 to 10. During the procedure, the mean VAS pain score was 3.5 for RFA and 4.6 for MOCA (P = 0.12). The use of extra periprocedural sedative (propofol) was found to be significantly less in participants undergoing MOCA (P < 0.001) than in participants undergoing RFA. The use of fentanyl and diazepam periprocedurally did not differ between treatment groups (P = 0.11 and P = 0.41, respectively). Prior to discharge, pain scores were found to be similar between interventions (P = 0.18) as well as at one week (P = 0.92). The amount of post‐operative analgesia consumed by participants did not differ (P = 0.12).
Venous Clinical Severity Score (VCSS)
Both Lane 2017 and MARADONA 2019 reported on VCSS. The Lane 2017 study authors reported that, between groups, there was no significant difference for VCSS at either one month (MOCA 2 (1 to 4) versus RFA 3 (1 to 5), P = 0.1); or six months (MOCA 2 (1 to 4) versus RFA 2 (1 to 5), P = 0.54)). MARADONA 2019 reported on the components of VCSS individually, precluding meta‐analysis. They found no difference in VCSS between groups at baseline. Absolute VCSSs were similar in both arms at one and two years with a comparable improvement compared to baseline (P = 0.05). See Table 13.
Length of procedure
Only the MARADONA 2019 trial reported on this outcome, and showed that times were similar, with RFA taking an average of 13 minutes (range 4 to 85 minutes) and MOCA taking 12 minutes (range 5 to 45 minutes). See Table 14.
Duration of hospital stay
No study explicitly stated their rates of day case or inpatient procedures. See Table 15.
Return to normal activities
All studies reported on return to daily activities or work, with no difference found between participants within the RFA or MOCA arms. See Table 16.
Radiofrequency ablation (RFA) versus SFJ ligation and stripping (HL/S, surgery)
See summary of findings Table 5.
Five studies compared RFA with SFJ ligation and stripping (EVOLVeS 2003; Helmy ElKaffas 2011; Rasmussen 2011; Rautio 2002; Subramonia 2010).
Technical success
Three studies comparing RFA with SFJ ligation and stripping reported on this outcome (EVOLVeS 2003; Rasmussen 2011; Rautio 2002). The EVOLVeS 2003 trial reported that in "many cases the GSV was completely obliterated by the intervention"; however, authors did not give actual figures to allow inclusion into the meta‐analysis. Combining the under five year data from Rasmussen 2011 and Rautio 2002 showed no clear difference in the technical success of the two procedures (OR 5.71, 95% CI 0.64 to 50.81; 2 studies, 318 participants; low‐certainty evidence; Analysis 10.1). We downgraded the certainty of the evidence from high to low due to risk of bias concerns and inconsistency, reflected in the wide CI.
Rasmussen 2011 reported data for over five years and no evidence of a difference was demonstrated (OR 0.88, 95% CI 0.29 to 2.69; 1 study, 289 participants; low‐certainty evidence; Analysis 10.2).
Recurrence
Four studies assessed recurrence at two and three years for RFA versus SFJ ligation and stripping (EVOLVeS 2003; Helmy ElKaffas 2011; Rasmussen 2011; Rautio 2002). No clear difference was detected between the groups (OR 0.93, 95% CI 0.58 to 1.51; 4 studies, 546 participants; moderate‐certainty evidence; Analysis 10.3). We downgraded the certainty of the evidence from high to moderate due to risk of bias concerns.
Rasmussen 2011 also reported long‐term data, and a possible benefit to RFA treatment was seen (OR 0.41, 95% CI 0.22 to 0.75; 1 study, 289 participants; low‐certainty evidence; Analysis 10.4).
Post‐operative complications
All five studies reported complications. We were not able to undertake meta‐analysis for complications because the trials used different definitions and time points. While the number of complications was low in the studies, surgery was associated with higher rates of wound problems, haematomas and saphenous nerve injuries within both the early and late comparisons. More phlebitis was seen with RFA. EVOLVeS 2003 reported more paraesthesia in participants undergoing RFA at one week (23.3%) compared to SFJ ligation and stripping (13.9%). In the SFJ ligation and stripping group, two participants developed wound infections; one settled with antibiotics while the other required surgical debridement and admission for intravenous antibiotic therapy. Helmy ElKaffas 2011 found more cases of paraesthesia with RFA (10%) compared with SFJ ligation and stripping (3%), and more episodes of thrombophlebitis (six cases compared to none with SFJ ligation and stripping). There was one iliofemoral DVT with SFJ ligation and stripping and higher rates of haematoma (seen in 30 participants compared to one with RFA). Three participants developed groin infections requiring parenteral antibiotics. Rasmussen 2011 reported one case of popliteal vein thrombosis with SFJ ligation and stripping at one month. There were more cases of phlebitis following RFA (12) compared to SFJ ligation and stripping (five). Rautio 2002 reported more saphenous nerve injuries (23%) with SFJ ligation and stripping than RFA (13%), higher rates of haematomas were also seen (31% compared to 7% with RFA). Among the RFA group, 20% developed clinical thrombophlebitis and 7% had thermal skin injuries; no cases of either these complications were seen with SFJ ligation and stripping. Subramonia 2010 reported numbness in 49% of participants undergoing SFJ ligation and stripping at one week compared to 19% of those undergoing RFA. Groin wound problems were present in 17% of SFJ ligation and stripping participants while 11% of RFA participants had hyperpigmentation at initial follow‐up. We downgraded the certainty of the evidence to very low due to risk of bias concerns, inconsistency, imprecision and possible publication bias. See Table 10 and Table 11.
Quality of life
Four studies evaluated QoL scores (EVOLVeS Study; Rasmussen 2011; Rautio 2002; Subramonia 2010). Rautio 2002 demonstrated improved QoL scores within all subgroups of RAND‐36 (a validation version of the SF‐36 for Finland), and reported that physical functioning was restored faster in the RFA group. Median difference from baseline for physical functioning/role functioning was 0 in RFA and five with SFJ ligation and stripping at four weeks. Subramonia 2010 showed significant improvement in AVVSS QoL scores following treatment, with no difference between the groups (mean improvement in QoL score was ‐9.12 in RFA compared to ‐8.24 with SFJ ligation and stripping). Using the Venous Insufficiency Epidemiological and Economics Study (VEINES)‐QoL/Sym questionnaire (V‐Q/SymQ) at five weeks, improvement was reported with RFA compared with SFJ ligation and stripping (mean improvement 12.62 versus 9.94; 95% CI ‐1.65 to 7.01; P = 0.22). The EVOLVeS Study reported significant improvement via the CIVIQ2 QoL tool (global score and bodily pain) in participants undergoing RFA at 72 hours and one week, with the mean difference in global score ‐3 and ‐9.2 in RFA compared with 13.3 and 3.7 with SFJ ligation and stripping. However, the magnitude of the difference was negligible by four months. The EVOLVeS Study adjusted their figures for the number of adjunctive procedures undertaken. Rasmussen 2011 found improved AVVQ from day three onwards, with no difference between groups at any time point (mean (SD) AVVSS at baseline was 18.74 (8.63) for RFA and 19.3 (8.46) for SFJ ligation and stripping, reduced to 4.43 (6.58) and 4.0 (4.87), respectively, at three years). Their SF‐36 results demonstrated comparable short‐ and medium‐term benefits overall. However, participants who underwent SFJ ligation and stripping had poorer bodily pain and physical function domains compared to participants in the RFA group in the three‐day follow‐up. This difference was not seen at one month. We downgraded the certainty of the evidence from high to moderate due to risk of bias concerns.
Pain
Four studies comparing RFA with SFJ ligation and stripping reported less post‐operative pain and analgesic consumption within the RFA arm (EVOLVeS 2003; Rasmussen 2011; Rautio 2002; Subramonia 2010). The EVOLVeS 2003 study reported statistically significant differences in the pain scores recorded at 72 hours and one week post‐intervention (P < 0.001, for both time points). Rautio 2002 found less ibuprofen consumption in RFA participants compared to surgical participants (average daily number of 600 mg ibuprofen tablets (SD) 0.4 (0.49) versus 1.3 (1.09); P = 0.004). Mean pain scores at rest, standing and walking in RFA participants were reported as lower than surgical participants. This was especially so between the fifth to fourteenth post‐operative day. The average VAS (SD) score at rest was 0.7 (0.5) for RFA and 1.7 (1.3) for SFJ ligation and stripping; on standing, 1.3 (0.7) versus 2.6 (1.9), respectively; and on walking, 1.8 (0.8) versus 3 (1.8), respectively (Rautio 2002). In Rasmussen 2011, the mean pain (SD) score for the first ten days was 1.21 (1.72) in RFA and 2.25 (2.23) in surgery. The number of phlebectomies did not affect pain scores. In Subramonia 2010, the median pain score during the first week post‐intervention was higher in surgical participants (P = 0.001), whilst the duration of analgesic consumption was lower for RFA participants (P = 0.001).
Venous Clinical Severity Score (VCSS)
Three studies reported on change in VCSS and demonstrated comparable rates of improvement between RFA and surgery (EVOLVeS 2003; Rasmussen 2011; Rautio 2002). We were not able to undertake meta‐analysis for VCSS because the trials used different time points. EVOLVeS 2003 found improved changes in VCSS for RFA over SFJ ligation and stripping at 72 hours (P > 0.05) and one week (P > 0.5). This difference disappeared at subsequent follow‐ups. In Rautio 2002, the average decrease (SD) in VCSS at three years was 4.3 (2.3) in RFA and 4 (1.2) after surgery (P = 0.7). Rasmussen 2011 reported that VCSS improved in all groups with no difference between groups at any time point. See Table 13.
Length of procedure
Five studies reported on the length of procedure but we were not able to undertake meta‐analysis for length of procedure because the studies defined the procedure differently (EVOLVeS 2003; Helmy ElKaffas 2011; Rasmussen 2011; Rautio 2002; Subramonia 2010). EVOLVeS 2003 reported mean treatment time (SD) as 74 minutes (10) and 89 minutes (12) for RFA and SFJ ligation and stripping, respectively. In Helmy ElKaffas 2011, the mean (SD) procedure time was 40 (10) minutes for RFA and 45 (13) minutes for SFJ ligation and stripping. Rasmussen 2011 recorded the mean surgeon's time (range) as 27 (12 to 80) minutes for RFA and 32 (15 to 80) minutes for SFJ ligation and stripping. In Subramonia 2010, median theatre time (IQR) was 82 (73 to 91) minutes for RFA and 55 (48 to 63) minutes for SFJ ligation and stripping; procedural time was 76 (67 to 84) minutes for RFA and 48 (39 to 54) minutes for SFJ ligation and stripping. Mean operating time (SD) in Rautio 2002 was 75 (16.6) minutes in RFA and 57 (11) minutes for SFJ ligation and stripping. See Table 14.
Duration of hospital stay
Three studies reported on duration of hospital stay (EVOLVeS 2003; Helmy ElKaffas 2011; Rautio 2002). EVOLVeS 2003 reported that 95% of their RFA procedures were day case compared to 86% with SFJ ligation and stripping. In Rautio 2002, one participant in each treatment group stayed overnight for social reasons; 93.3% of RFA procedures were undertaken as day case and 92.3% with SFJ ligation and stripping. Helmy ElKaffas 2011 reported that RFA participants stayed in hospital for 14 hours (SD 3.6 hours (range 12 to 18 hours)), as compared to 30 hours (SD 11.5 hours (range 18 to 48 hours)) with SFJ ligation and stripping. See Table 15.
Return to normal activities
Five studies reported on return to normal activities, but we were not able to undertake meta‐analysis due to differing measurements used (EVOLVeS 2003; Helmy ElKaffas 2011; Rasmussen 2011; Rautio 2002; Subramonia 2010). In EVOLVeS 2003, mean return to normal activities was adjusted for the type of anaesthetic and number of adjunctive procedures. The study reported that participants who were given general anaesthesia took longer to return to work. Mean return to normal activities was 1.15 days with RFA and 3.89 days with SFJ ligation and stripping; return to work was 4.74 and 12.4 days, respectively. In Helmy ElKaffas 2011, time to return to normal physical activity was three (SD 3) days for RFA and seven (SD 2.6) days for SFJ ligation and stripping. Median time to resume work in Rasmussen 2011 was 2.9 days (range 0 to 14 days) for RFA compared to 4.3 days (range 0 to 42 days) in SFJ ligation and stripping; return to normal activities was one day (range 0 to 30 days) in RFA and four days (0 to 30 days) with SFJ ligation and stripping. Rautio 2002 found mean sick leave was shorter with RFA, with a mean of 6.5 (SD 3.3) days taken compared with 15.6 (SD 6) days with SFJ ligation and stripping. In Subramonia 2010, mean return to work and normal activities was 10 days (IQR 4 to 13 days) and three days (IQR 0 to 7) with RFA compared to 18.5 days (IQR 11 to 28) and 12.5 days with SFJ ligation and stripping of GSV respectively. See Table 16.
Ultrasound‐guided foam sclerotherapy (UGFS) versus SFJ ligation and stripping (HL/S, surgery)
See summary of findings Table 6.
Four studies compared ultrasound‐guided foam sclerotherapy to SFJ ligation and stripping (FOAM 2010; Magna 2013; Rasmussen 2011; Vernermo 2016).
Technical success
All four studies assessed technical success between UGFS and SFJ ligation and stripping (FOAM 2010 (two years); Magna 2013 (one year and five years); Rasmussen 2011 (one month and five years); and Vernermo 2016 (one year and five years). Pooling the early data shows a possible benefit for SFJ ligation and stripping compared to UGFS (OR 0.32, 95% CI 0.11 to 0.94; 4 studies, 954 participants; low‐certainty evidence; Analysis 11.1). This indicates UGFS may be inferior to surgery. Heterogeneity was detected so a random‐effects model was used (I2 = 78%). We downgraded the certainty of the evidence from high to low due to risk of bias concerns and inconsistency.
Three studies reported data for over five years (Magna 2013; Rasmussen 2011; Vernermo 2016). In the more than five‐year follow‐up, the probability of technical success was lower in the UGFS than the SFJ ligation and stripping group (OR 0.09, 95% CI 0.03 to 0.30; 3 studies, 525 participants; moderate‐certainty evidence; Analysis 11.2). Heterogeneity was detected so a random‐effects model was used (I2 = 73%). We downgraded the certainty of the evidence due to risk of bias concerns.
Recurrence
Three trials compared recurrence in UGFS and SFJ ligation and stripping between one and three years (FOAM 2010; Magna 2013; Rasmussen 2011). Pooling the data did not show a clear difference (OR 1.81, 95% CI 0.87 to 3.77; 3 studies, 822 participants; low‐certainty evidence; Analysis 11.3).
Five‐year data were also available from these studies and, again, no clear difference was detected (OR 1.24, 95% CI 0.57 to 2.71; 3 studies, 639 participants; low‐certainty evidence; Analysis 11.4).
Heterogeneity was detected so a random‐effects model was used (I2 = 72% and I2 = 76%, respectively). We downgraded the certainty of the evidence from high to low due to risk of bias concerns and inconsistency.
Post‐operative complications
All four studies reported on complication rates (FOAM 2010; Magna 2013; Rasmussen 2011; Vernermo 2016). FOAM 2010 reported a higher rate of phlebitis with UGFS (17 participants out of 230) compared to none with SFJ ligation and stripping. Six of 200 participants who underwent SFJ ligation and stripping developed paraesthesia compared to none with UGFS. There was one DVT and one PE in the UGFS group one week post‐procedure. At two years, hyperpigmentation was seen in 12 of the 213 UGFS participants and in two of 200 in the SFJ ligation and stripping group. In Magna 2013, the frequency of reported complications was low, with one reported case of paraesthesia following UGFS and four with SFJ ligation and stripping at three months; and one reported case in each group at one year. Magna 2013 reported three cases of wound infection in the SFJ ligation and stripping arm and none in the UGFS arm. Rasmussen 2011 reported one DVT in each group at one month. Rates of phlebitis were higher with UGFS (17 cases compared to 12 in SFJ ligation and stripping), whilst more participants who underwent SFJ ligation and stripping had paraesthesia at one month (six participants versus two with UGFS). Vernermo 2016 reported at one month that skin pigmentation was more common after UGFS (67%) compared to SFJ ligation and stripping (5%); rates of paraesthesia were comparable (2% vs 3%); and 91% of participants who underwent UGFS had palpable lumps compared to 54% with SFJ ligation and stripping. We downgraded the certainty of the evidence from high to very low due to risk of bias concerns, inconsistency and possible publication bias. See Table 10 and Table 11.
Quality of life
None of the four included studies showed any difference in QoL scores between the two treatment groups. The FOAM 2010 study found no difference in improvement between EQ‐5D scores at two years. The change from baseline to two years was 0.064 and 0.061 in UGFS and SFJ ligation and stripping, respectively (P = 0.89). Magna 2013 excluded participants who had undergone bilateral interventions from their analysis, and reported that CIVIQ and EQ‐5D improved in all groups with no difference seen at two years. Rasmussen 2011 reported no significant difference between groups in the improvement of the SF‐36 score at one month. Vernermo 2016 reported no difference between treatment groups in AVVSS at one year, and similarly at five years, the mean AVVSS was 11.2 (95% CI 8.5 to 14) in the UGFS group and 8.7 (95% CI 6.7 to 10.7) in the SFJ ligation and stripping (P = 0.64). We downgraded the certainty of the evidence from high to moderate due to risk of bias concerns.
Pain
Three studies evaluated pain between UGFS and SFJ ligation and stripping treatment groups (FOAM 2010; Rasmussen 2011; Vernermo 2016). Rasmussen 2011 reported that participants who underwent UGFS had less post‐operative pain than those who had surgery: mean (SD) score during the first ten days was 1.6 (2.04) in UGFS, and 2.25 (2.23) for surgery (P < 0.001). The number of phlebectomies was not found to alter pain scores. Vernermo 2016 also showed participants had a lower VAS pain score after UGFS, both at discharge and one week post‐procedure. FOAM 2010 found that the intervention did not greatly influence pain, with similar scores for 'more', 'stable' or 'less' pain at 3, 12 and 24 months, for both surgery and UGFS.
Venous Clinical Severity Score (VCSS)
Two studies reported on change in VCSS (FOAM 2010; Rasmussen 2011). In FOAM 2010, no difference was detected at different time points. At baseline, the mean (SD) VCSS was 3.2 (1.9) in UGFS and 3.5 (2.2) in SFJ ligation and stripping. This score had improved in both groups to 1.7 (1.2) and 1.9 (1.4), respectively, at two years. By eight years, VCSS had deteriorated to 5.4 (3.3) and 4.6 (2.9) in each group, showing regression to worse scores when compared to baseline. Rasmussen 2011 reported that the VCSS score improved in both groups, with no difference between groups at any time point over three years. See Table 13.
Length of procedure
Rasmussen 2011 was the sole study to evaluate length of procedure as surgeon's time. Mean surgeon's time (range) in the UGFS group was 19 (5 to 145) minutes compared to 32 (15 to 80) minutes in SFJ ligation and stripping. See Table 14.
Duration of hospital stay
Only FOAM 2010 reported duration of hospital stay, with 100% of cases undertaken as day cases. See Table 15.
Return to normal activities
Two trials reported on return to normal activities, with participants undergoing UGFS possibly returning to normal activities faster. Rasmussen 2011 reported a median (range) return to work of one (0 to 21) day with UGFS, and 12 (0 to 33) days with SFJ ligation and stripping. Vernermo 2016 reported median (range) sick leave of 2.9 (0 to 33) days with UGFS and 4.3 (0 to 42) days with SFJ ligation and stripping. See Table 16.
Reporting bias and subgroup analysis
As none of the analyses included more than the ten studies required to create meaningful funnel plots, we could not evaluate reporting bias. None of the studies presented outcome data by the predefined variables of interest, so we did not perform subgroup analysis.
Sensitivity analysis
We planned to carry out sensitivity analyses by excluding studies that had a high risk of bias in four or more bias domains. Only one study, Calik 2019, had four or more bias domains at high risk. As this study was the only study in the comparison 'EVLA versus cyanoacrylate glue', we were unable to carry out this analysis.
Discussion
Summary of main results
This Cochrane Review included 24 studies with a total of 5135 randomised participants. Some studies involved multiple comparisons of interventions (Magna 2013; Rasmussen 2011; Vähäaho 2019; Vernermo 2016), or a comparison group not included in our analysis (Flessenkämper 2013). The duration of follow‐up ranged from five weeks (Subramonia 2010), to eight years (FOAM 2010). We did not find studies to provide results for all possible comparisons, especially newer treatments (see Types of interventions). Single studies provided evidence for five comparisons. When more than one study reported on a particular comparison, we were only able to pool the outcomes of technical success and recurrence due to heterogeneity in how the studies defined outcomes and reported time points. All studies had some risk of bias concerns. This has limited our ability to draw firm conclusions. Below, we report on the clinically most relevant comparisons. Details for all comparison and outcomes can be found in the Effects of interventions section.
EVLA versus RFA
See summary of findings Table 1.
Five studies reported on technical success (Nordon 2011; Rasmussen 2011; Recovery 2009; Shepherd 2010; Syndor 2017). Their data demonstrated that the rate of technical success was comparable between RFA and EVLA to five years (OR 0.98, 95% CI 0.41 to 2.38; 5 studies, 780 participants; moderate‐certainty evidence; Analysis 1.1).
Only Rasmussen 2011 provided data for long‐term technical success, and no evidence of a difference in success rates was seen (OR 0.85, 95% CI 0.30 to 2.41; 291 participants; low‐certainty evidence; Analysis 1.2).
Only Rasmussen 2011 reported on recurrence and there was no clear difference between the groups at three years (OR 1.53, 95% CI 0.78 to 2.99; 291 participants; low‐certainty evidence; Analysis 1.3). Five‐year recurrence rates were also reported and favoured RFA (OR 2.77, 95% CI 1.52 to 5.06; 291 participants; low‐certainty evidence; Analysis 1.4).
Complication rates were recorded by all five studies using different definitions and time points, which prevented meta‐analysis. Results of individual studies were inconsistent with each other, so we are not able to draw any conclusions (very low‐certainty evidence).
The included trials used different QoL questionnaires at different time points, so we decided it was inappropriate to combine these for meta‐analysis. Improvement in QoL scores over follow‐up were similar between the two procedures in Nordon 2011, Rasmussen 2007 and Shepherd 2010. Recovery 2009 reported improved global QoL scores in the RFA group at 7 and 14 days post‐operation compared to EVLA, but by one month they were comparable. Syndor 2017 did not evaluate QoL measures in their study. We assessed the certainty of the evidence for this outcome as low.
All studies reported reduced pain in the RFA groups compared to EVLA. Nordon 2011 showed RFA participants took less analgesia during the week post‐procedure and post‐procedural pain scores were less following RFA at days one, three and seven. In Rasmussen 2011, mean pain scores on VAS at ten days were less in the RFA group compared to EVLA. Recovery 2009 reported significantly lower pain levels on VAS in participants who had RFA, at 48 hours, one week and two weeks. Shepherd 2010 reported lower mean (SD) VAS in RFA over the first ten days compared to EVLA, and a lower consumption of analgesic tablets over three days. In Syndor 2017, the median post‐procedural pain scores on a scale of one to ten were worse in the EVLA group compared to RFA, on initial evaluation.
Four trials reported on change in VCSS, showing comparable rates between both groups at final follow‐up (Rasmussen 2011; Recovery 2009; Shepherd 2010; Syndor 2017). Rasmussen 2011 reported that the VCSS improved significantly in all groups (P < 0.001), with no difference between groups at any evaluated time point through three years. Recovery 2009 reported no difference between treatment groups at baseline, and reduced VCSS scores in the RFA group compared with EVLA at 48 hours, one week and two weeks, but no difference was detected by one month. In Shepherd 2010, VCSS was comparable between the two groups at six months. Syndor 2017 found participants in both groups demonstrated a reduction in VCSS at six months from baseline. See Table 13 .
The duration of the procedure was similar in the three reporting studies. However, the reporting trials used different time points, metrics and terminology, impeding analysis (Nordon 2011; Rasmussen 2011; Syndor 2017). See Table 14 .
Shepherd 2010 was the sole trial to explicitly state that all procedures were intended to be day cases. However, 3.1% of participants required inpatient admission. See Table 15.
Three trials reported on return to work and normal activities (Nordon 2011; Rasmussen 2011; Shepherd 2010). Results were comparable between treatment groups but studies evaluated this outcome by different means, making it difficult to draw conclusions. See Table 16.
It is worth noting that we compared studies on a statistical front only. There are a number of radiofrequency devices historically available, and the same is true for laser devices. We did not sub‐define these modalities.
EVLA versus EVSA
Only one study compared EVLA and EVSA (LAST 2014 ). At one year, rates of technical success were comparable between high dose EVSA and EVLA (OR 1.94, 95% CI 0.53 to 7.15; 166 participants; Analysis 2.1). No long‐term data were available.
Complication profiles were similar between both treatment groups, as were reports of QoL. For QoL, LAST 2014 evaluated AVVQ, EQ‐5D and EQ VAS at baseline and after 12 weeks; improvement in scores were found to be comparable between EVLA and EVSA groups.
Participants who underwent EVSA reported less post‐procedural pain and had a shorter duration of analgesic consumption than participants who had EVLA. Convalescence was measured as the number of days lost from work or normal activities, with participants in the EVSA group returning to normal activity faster than those in the EVLA group. Rates of recurrence, length of procedure and duration of hospital stay were not reported.
EVLA versus UGFS
See summary of findings Table 2.
Three studies compared EVLA with UGFS (Magna 2013; Rasmussen 2011; Vernermo 2016). Technical success may be improved in participants undergoing EVLA, both up to five years (OR 6.13, 95% CI 0.98 to 38.27; 3 studies, 588 participants; low‐certainty evidence; Analysis 3.1), and over five years' follow‐up (OR 6.47, 95% CI 2.60 to 16.10; 3 studies, 534 participants; low‐certainty evidence; Analysis 3.2).
Two studies evaluated recurrence (Magna 2013; Rasmussen 2011), and showed no clear difference between the groups (OR 0.68, 95% CI 0.20 to 2.36; 2 studies, 443 participants; very low‐certainty evidence; Analysis 3.3). Five‐year recurrence rates were also available for both studies, and again no clear differences were seen (OR 1.08, 95% CI 0.40 to 2.87; 2 studies, 418 participants; very low‐certainty evidence).
All three studies reported on post‐operative complications. However, meta‐analysis was impeded because the studies used different definitions of complications and assessed complications at varying time points. Rasmussen 2011 reported more phlebitis and hyperpigmentation rates amongst the UGFS group compared to the EVLA group. In Vernermo 2016, skin pigmentation was more common in the UGFS arm compared to EVLA, but haematomas were seen more often after EVLA compared to UGFS at one month. Magna 2013 reported two cases of hyperpigmentation in EVLA participants compared to one case in UGFS at three months (very low‐certainty evidence).
Each of the three studies evaluated QoL using different questionnaires at different time frames. No differences were detected beyond one month by any measurement (Magna 2013; Rasmussen 2011; Vernermo 2016). We assessed the certainty of the evidence for this outcome as moderate.
Two studies evaluated pain scores, with both reporting lower post‐procedural pain with UGFS compared to EVLA treatment (Rasmussen 2011; Vernermo 2016).
Only Rasmussen 2011 analysed VCSS, finding no difference between treatment arms at any evaluated time point.
Again, Rasmussen 2011 was the sole study which evaluated length of procedure as surgeon's time. Mean surgeon's time was 26 minutes in EVLA (range 12 to 80 minutes) and 19 minutes in UGFS (range 5 to 145 minutes).
Participants undergoing UGFS returned to work faster in the two studies which reported this outcome. Rasmussen 2011 reported the median time to return to work (range) as 3.6 days (0 to 46 days) in the EVLA group and 2.9 days (0 to 42 days) in the UGFS group. The mean duration of sick leave in Vernermo 2016 was eight days in EVLA (range 0 to 29 days) and one day in UGFS (range 0 to 21 days). No studies reported on duration of hospital stay.
EVLA versus cyanoacrylate glue
Calik 2019 was the sole trial to evaluate EVLA against cyanoacrylate glue. The trial analysed occlusion rates at one, three, six and twelve months. There was no evidence of a difference in occlusion rates at one month (OR 0.33, 95% CI 0.01 to 8.03; 412 participants; Analysis 4.1). Similarly, results showed no evidence of difference in recanalisation rates at one year (OR 2.59, 95% CI 0.50 to 13.49; 412 participants; Analysis 4.2).
Higher rates of post‐procedural induration, bruising and paraesthesia were seen following EVLA at one week compared to cyanoacrylate glue, but there was no difference by the three‐month time point, except for paraesthesia which was more common after EVLA. Two DVTs were found within the EVLA group. Both groups demonstrated improved QoL at follow‐up, but there was no clear difference between the groups.
Calik 2019 evaluated periprocedural pain levels using the Wong‐Baker FACES pain score. Pain scores were lower in the cyanoacrylate glue group at one week, but by three months they were comparable. There were improvements in VCSS in both groups post‐operatively, although there was no evidence of a difference between groups.
The operative time was longer for EVLA than for cyanoacrylate glue, and there was a faster return to daily activities in the cyanoacrylate glue group. Calik 2019 did not evaluate duration of hospital stay.
EVLA versus MOCA
Vähäaho 2019 was the only trial which compared EVLA to MOCA. At one month, they found 100% occlusion rates of the GSV via DUS amongst both treatment groups. There were no long‐term data available.
At one year, 100% of the participants who underwent EVLA treatment still had GSV occlusion, while ten participants in the MOCA treatment group showed recanalisation of the GSV (OR 0.06, 95% CI 0.00 to 1.14; 88 participants; Analysis 5.2).
Three participants in the EVLA group reported sensory disturbance at one year; no nerve injuries were seen in the MOCA group. There was one superficial infection seen in the MOCA treatment group. There was no evidence of a difference between the treatment groups in QoL at one year. The VAS pain score prior to discharge and at one week post‐procedure was similar between treatment modalities, and there was no difference between the amount of painkillers required. Participants undergoing EVLA took a mean of 5.3 days sick leave compared to 4.3 days in those undergoing MOCA. Vähäaho 2019 did not report change in VCSS, duration of procedure and duration of hospital stay.
EVLA versus SFJ ligation and stripping (HL/S, surgery)
See summary of findings Table 3.
Nine trials compared EVLA with SFJ ligation and stripping. There was a possible benefit to technical success at less than five years in the EVLA group (OR 2.31, 95% CI 1.27 to 4.23; 6 studies, 1051 participants; low‐certainty evidence; Analysis 6.1). No clear difference in results were seen at five years and beyond (OR 0.93, 95% CI 0.57 to 1.50; 5 studies, 874 participants; low‐certainty evidence; Analysis 6.2). We downgraded the certainty of the evidence from high to low due to risk of bias concerns and imprecision. See summary of findings Table 3.
Seven studies analysed recurrence, showing it to be comparable between groups within three years post‐intervention (OR 0.78, 95% CI 0.47 to 1.29; 7 studies, 1459 participants; moderate‐certainty evidence; Analysis 6.3). Similar results were seen with five year data (OR 1.09, 95% CI 0.68 to 1.76; 7 studies, 1267 participants; moderate‐certainty evidence; Analysis 6.4).
All studies reported on complications. However, the reporting studies used different definitions and evaluation time points, impeding accurate comparison of post‐operative complications. Slightly higher rates of early haematomas and wound problems may be seen with SFJ ligation and stripping. EVLA may be associated with slightly higher rates of phlebitis. We assessed the certainty of the evidence for this outcome as very low.
All studies evaluated QoL scores using a variety of different questionnaires at variable time points, impeding accurate comparison. Rates of improvement were comparable between interventions in all studies (moderate‐certainty evidence).
The studies analysed pain in a wide variety of ways, precluding accurate meta‐analysis. The majority of studies reported comparable post‐operative pain scores between interventions (Darwood 2008; Flessenkämper 2013; Rasmussen 2007; Rasmussen 2011; RELACS 2012 ). HELP‐1 2011 reported higher pain scores and analgesic consumption with SFJ ligation and stripping. Pronk 2010 reported higher mean post‐operative pain scores with EVLA.
Four trials reported change in VCSS, with comparable improvements in scores between interventions (Darwood 2008; HELP‐1 2011; Rasmussen 2007; Rasmussen 2011).
Three studies measured length of procedure (non‐comparably), using various different definitions and metrics, with no clear difference seen in the times taken (HELP‐1 2011; Rasmussen 2011; Vernermo 2016).
Four trials conducted all their procedures as day case (Darwood 2008; Flessenkämper 2013; Pronk 2010; Rasmussen 2007). One study reported that 21% of participants required admission following SFJ ligation and stripping (HELP‐1 2011).
Seven studies reported on time to return to work or normal activity. EVLA was associated with a quicker return to work and normal activity in three of the trials (Darwood 2008; HELP‐1 2011; Vernermo 2016). Four studies reported comparable rates of return to work and normal activity (Pronk 2010; Rasmussen 2007; Rasmussen 2011; RELACS 2012). The disparity in methodology, definitions and metrics within the studies should be borne in mind before drawing conclusions.
RFA versus UGFS
Rasmussen 2011 was the sole study comparing these interventions. Technical success rates did not clearly favour one treatment compared to another, at up to 5 years (OR 5.21, 95% CI 0.25 to 109.48; 1 study, 292 participants; Analysis 7.1). There may be a benefit for RFA at five years (OR 3.23, 95% CI 1.32 to 7.89; 1 study, 291 participants; Analysis 7.2). Three‐ and five‐year recurrence rates showed no clear difference between the treatment groups (OR 0.81, 95% CI 0.41 to 1.62; 1 study, 291 participants; Analysis 7.3; and OR 0.61, 95% CI 0.33 to 1.16; 1 study, 291 participants; Analysis 7.4, respectively).
One participant developed an iliac vein thrombosis and subsequent pulmonary embolus one week post‐UGFS. Equal levels of hyperpigmentation were seen between groups. More episodes of phlebitis were recorded in the UGFS group than in RFA (12 versus 17). Rasmussen 2011 evaluated quality of life using the SF‐36. There was no evidence of a difference in the mean (SD) pain score (VAS) between the RFA and UGFS groups during the first ten days post‐procedure. It was noted that the number of concomitant phlebectomies did not alter the pain scores. The VCSS score improved in both groups, with no difference between groups at any time point over three years. No clear differences were detected in pain between groups. The VCSS reduced from baseline in both groups, with no clear difference between groups by three years. Rasmussen 2011 recorded the length of procedure as 'surgeon's time' within the trial, and there was no clear difference in procedure time between treatment groups. The return to normal activities and return to work time was comparable between groups. Rasmussen 2011 did not report upon duration of hospital stay.
RFA versus cyanoacrylate glue
Morrison 2015 was the only included trial comparing these interventions. There were increased occlusions in the cyanoacrylate glue group compared to the RFA group after one month (OR 0.03, 95% CI 0.00 to 0.54; 1 study, 215 participants; Analysis 8.1). The study reported a final time point of 36 months, showing comparable occlusions in cyanoacrylate glue (94.4%, 68/72) compared to RFA (91.9%, 68/74) (P = 0.75).
The two‐year follow‐up identified 12 recanalisations in the cyanoacrylate glue group and only one in the RFA group. Within the first three months, there were similar reports of paraesthesia and phlebitis between RFA and cyanoacrylate glue groups. QoL scores were seen to improve throughout the trial duration, and by three years, there was no clear difference between RFA and cyanoacrylate glue in both AVVQ (P = 0.45) and EQ‐5D (P = 0.4). There was no difference in the pain experienced between the two treatment arms, or in VCSS between treatment groups. Mean procedural time was five minutes longer for cyanoacrylate glue (24 minutes) than for RFA (19 minutes) (P < 0.01). All interventions were undertaken as day case procedures. Morrison 2015 did not evaluate post‐operative return to activity.
RFA versus MOCA
See summary of findings Table 4.
Three trials compared RFA to MOCA (Lane 2017; MARADONA 2019; Vähäaho 2019). All three trials reported on technical success. Pooling the data showed no clear evidence of a benefit for RFA over MOCA (OR 1.76, 95% CI 0.06 to 54.15; 3 studies, 435 participants; low‐certainty evidence; Analysis 9.1). No long‐term data were available.
The evaluation of recurrence rates amongst the trials did not show a clear benefit for one intervention over the other (OR 1.00, 95% CI 0.21 to 4.81; 3 studies, 389 participants; low‐certainty evidence; Analysis 9.2). No long‐term data were available.
All three studies reported on complication rates, which were similar between treatment arms (very low‐certainty evidence). All three studies reported on QoL and found no significant difference between treatment arms (moderate‐certainty evidence).
All three studies evaluated rates of post‐procedural pain, but the differing time points and assessment modalities prevented formal meta‐analysis. Lane 2017 reported on maximum pain experienced (measured by VAS) and reported that it was significantly less in the MOCA group. MARADONA 2019 and Vähäaho 2019 showed similar rates of analgesic consumption post‐operatively. The MARADONA 2019 study demonstrated lower median pain scores for MOCA during the first two post‐operative weeks, while Vähäaho 2019 reported similar scores between the groups, using VAS, in the first post‐operative week. Lane 2017 evaluated VCSS at one and six months, and MARADONA 2019 at one and two years. Both trials showed comparable improvement in VCSS between modalities. Only MARADONA 2019 reported on the duration of procedures, which showed they were similar. No study explicitly stated their rates of day case or inpatient procedures. All studies reported on return to daily activities or work, with no difference found between participants within the RFA or MOCA arms.
RFA versus SFJ ligation and stripping (HL/S, surgery)
See summary of findings Table 5.
Five studies compared RFA with surgery (EVOLVeS 2003; Helmy ElKaffas 2011; Rasmussen 2011; Rautio 2002; Subramonia 2010).
Two studies reported data for technical success up to five years (Rasmussen 2011; Rautio 2002). No clear difference in technical success was detected between groups (OR 5.71, 95% CI 0.64 to 50.81; 2 studies, 318 participants; low‐certainty evidence; Analysis 10.1). Rasmussen 2011 reported data for over five years, and no evidence of a difference was demonstrated (OR 0.88, 95% CI 0.29 to 2.69; 1 study, 289 participants; low‐certainty evidence; Analysis 10.2).
Four studies compared recurrence rates between RFA and surgery (EVOLVeS 2003; Helmy ElKaffas 2011; Rasmussen 2011; Rautio 2002). No clear difference was detected between the groups at two and three years (OR 0.93, 95% CI 0.58 to 1.51; 4 studies, 546 participants; moderate‐certainty evidence; Analysis 10.3). Long‐term data were also reported by Rasmussen 2011, and a possible benefit to RFA treatment was seen (OR 0.41, 95% CI 0.22 to 0.75; 1 study, 289 participants; low‐certainty evidence; Analysis 10.4).
All five studies reported complications, but meta‐analysis was impeded because the studies used different definitions and evaluated complications at different time points. While the number of complications was low for all studies, surgery may be associated with slightly higher rates of wound problems, haematomas and saphenous nerve injuries within both the early and late comparisons. More phlebitis was seen after RFA (very low‐certainty evidence). See Table 10 and Table 11.
Four studies evaluated QoL scores. The EVOLVeS Study reported improvement via the CIVIQ2 QoL tool (global score and bodily pain) in RFA over SFJ ligation and stripping at 72 hours and one week, but this difference was negligible by four months. Rautio 2002 demonstrated improved QoL scores within all subgroups of RAND‐36 (a validation version of the SF‐36 for Finland), and reported that physical functioning was restored faster in the RFA group. Subramonia 2010 did not demonstrate a clear difference in groups using V‐Q/SymQ or AVVSS. Rasmussen 2011 found no difference in improvement between groups using the AVVQ and SF‐36 by one month, but reported poorer bodily pain and physical function domains with SFJ ligation and stripping initially. Overall, we assessed QoL evidence as moderate‐certainty.
Four studies reported on post‐operative pain, with higher pain scores and analgesic consumption with SFJ ligation and stripping compared to RFA (EVOLVeS 2003; Rasmussen 2011; Rautio 2002; Subramonia 2010).
Three studies reported on change in VCSS, and demonstrated comparable rates of improvement between RFA and surgery (EVOLVeS 2003; Rasmussen 2011; Rautio 2002).
Three studies indicated that RFA may be faster to perform, while two studies found surgery was faster. The discrepancy between the five trials reporting length of procedure may be due to the discrepancy in the definitions used (EVOLVeS 2003; Helmy ElKaffas 2011; Rasmussen 2011; Rautio 2002; Subramonia 2010). We cannot draw any conclusions.
Three studies reported on duration of hospital stay, and all five reported more hospital admissions for SFJ ligation and stripping (EVOLVeS 2003; Helmy ElKaffas 2011; Rautio 2002).
All five studies indicated that time to return to work and normal activities was shorter amongst participants who underwent RFA (EVOLVeS 2003; Helmy ElKaffas 2011; Rasmussen 2011; Rautio 2002; Subramonia 2010). However, this conclusion is tentative due to the lack of standardisation in the measurement of this outcome by reporting studies.
UGFS versus SFJ ligation and stripping (HL/S, surgery)
See summary of findings Table 6.
Four studies compared ultrasound‐guided foam sclerotherapy to SFJ ligation and stripping (FOAM 2010; Magna 2013; Rasmussen 2011; Vernermo 2016).
Pooling the early data shows a possible benefit for SFJ ligation and stripping compared to UGFS in technical success (OR 0.32, 95% CI 0.11 to 0.94; 4 studies, 954 participants; low‐certainty evidence; Analysis 11.1). Similarly, in the more than five years follow‐up, the probability of technical success is lower in the UGFS than the surgery group (OR 0.09, 95% CI 0.03 to 0.30; 3 studies, 525 participants; moderate‐certainty evidence; Analysis 11.2).
Three trials compared recurrence in UGFS and SFJ ligation and stripping (FOAM 2010; Magna 2013; Rasmussen 2011). No clear difference was detected between the procedures at one and three years (OR 1.81, 95% CI 0.87 to 3.77; 3 studies, 822 participants; low‐certainty evidence; Analysis 11.3), or after five years (OR 1.24, 95% CI 0.57 to 2.71; 3 studies, 639 participants; low‐certainty evidence; Analysis 11.4).
All four studies reported on complication rates. We were not able to pool the data and cannot draw any conclusions because the trials reported different complications and time points (very low‐certainty evidence).
The studies used a variety of QoL scores and time points to evaluate the interventions, preventing meta‐analysis. No difference in QoL was detected between treatment groups in any of the studies during follow‐up (moderate‐certainty evidence).
Of the three studies evaluating pain between UGFS and SFJ ligation and stripping, two studies reported lower post‐operative pain after UGFS (Rasmussen 2011; Vernermo 2016), and the other found pain was comparable between UGFS and SFJ ligation and stripping groups (FOAM 2010).
Two studies reported on change in VCSS, with no differences detected between groups at any time points in either study (FOAM 2010; Rasmussen 2011).
Rasmussen 2011 was the sole study which evaluated length of procedure as 'surgeon's time', with no clear difference detected between groups.
FOAM 2010 was the only study to report duration of hospital stay, with 100% of cases undertaken as day case.
Two trials reported on return to normal activities, with participants undergoing UGFS possibly returning to normal activities sooner (Rasmussen 2011; Vernermo 2016).
Overall completeness and applicability of evidence
We identified no RCTs for ten of the comparisons we hoped to review. We found only one RCT for the following comparisons: EVLA versus EVSA, EVLA versus cyanoacrylate glue, EVLA versus MOCA, RFA versus UGFS and RFA versus cyanoacrylate glue. The trial for EVSA did not report on recurrence rates. We identified no new trials for the comparison of RFA and SFJ ligation and stripping of GSV. This update included long‐term follow‐up data (greater than five years) on recurrence and technical success, which was not available in earlier versions of this Cochrane Review. The validity of this review has been hampered by lack of standardisation in the reporting of outcomes methods with regard to follow‐up time points, metrics and terminology used by the included trials. This has significantly impeded our ability to perform accurate meta‐analysis for the majority of outcomes, echoing the sentiments of the previous version of the review in 2014 (Nesbitt 2014). This review focused on the management of C2 to C4 grade varicose veins. We excluded varicose veins with healed ulcers (C5) or active ulcers (C6) from this Cochrane Review.
A number of studies included interventions for bilateral GSV incompetence, and this fact also hampered meta‐analysis (Calik 2019; Darwood 2008; EVOLVeS 2003; LAST 2014; Magna 2013; Pronk 2010; Rasmussen 2007; Rasmussen 2011; Recovery 2009; Shepherd 2010; Subramonia 2010). In Darwood 2008, Pronk 2010, Rasmussen 2007, Rasmussen 2011 and Shepherd 2010, participants were randomised and received the same treatment on the same day, but trialists made no separate stratification of bilateral and unilateral participants. EVOLVeS 2003, LAST 2014 and Subramonia 2010 waited over six weeks (three months in LAST 2014) from the initial procedure to randomise the other limb. This reality brings into question the reliability of the results for these participants, as ongoing disease in the second untreated limb may have impacted on the QoL outcomes, and results cannot accurately represent the outcome of the intervention.
Studies reported different complications, used different definitions to describe complications (such as symptomatic DVT) and measured complications at different time points. In addition, the complications reported can vary by the extent of venous treatment or stripping. This Cochrane Review did not assess this variation, but it should be noted as an impact on the strength of the complication results.
Quality of life and patient‐reported outcome measures are valuable metrics for assessing interventional success. Unfortunately, the studies included in this review employed a variety of quality of life tools, and reported them in different ways, meaning we could not pool the results. This represents a significant limitation to the patient‐level power of this review. Technical outcomes can be useful in guiding practitioners and patients alike, but more consistent and rigorous quality of life assessment would be of value in future venous literature.
Three studies allowed the inclusion of participants who had residual ultrasound‐proven SFJ reflux despite previous surgery (Rasmussen 2007; Rasmussen 2011; Subramonia 2010). In Rasmussen 2011 and Rasmussen 2007, 5.6% and 16% of randomised limbs had recurrence, respectively. Subramonia 2010 gave no breakdown of participants. None of the studies provided stratification of these participants.
Some varicosities are not amenable to endovenous treatments (i.e. they are too tortuous or are greater than 1.2 cm in diameter with extensive superficial varicosities). These can only be treated with open surgical methods. Conversely, not all participants are able to undergo general anaesthesia and open surgery. Tumescent and non‐tumescent techniques are now a feasible option in the treatment of venous insufficiency within this participant group.
Quality of the evidence
See summary of findings Table 1; summary of findings Table 2; summary of findings Table 3; summary of findings Table 4; summary of findings Table 5; summary of findings Table 6.
Overall, the lack of standardisation amongst trials for reporting their findings led to a lack of comparable data. This prevented meta‐analysis for many outcomes. We downgraded the certainty of the evidence for all outcomes as a result of concerns about detection and performance bias arising from a lack of blinding in the majority of the included studies. Other risk of bias concerns arose from attrition bias (missing data not explained by the study authors) or other potential risk of bias concerns (reasons included evaluation of bilateral limbs, underpowered studies, participants also underwent phlebectomies, etc.; see Risk of bias in included studies). We downgraded some outcomes further for imprecision as they involved limited numbers of participants from a small number of studies. Where studies reported conflicting or heterogenous results for an outcome, we downgraded for inconsistency. For the outcome of complications, studies reported different complications, used different definitions to describe complications (such as symptomatic DVT) and measured these at different time points. It was not unusual for different studies to have effects in opposite directions for the same complication, or have wide confidence intervals. Therefore, for each comparison, we downgraded the certainty of the evidence for outcome complications by three levels (risk of bias concerns, inconsistency, imprecision and possible publication bias).
Potential biases in the review process
We excluded several trials as they treated both GSV and SSV but provided no subgroup analysis (See Excluded studies for further details).
Within this review, we used the number of participants analysed for meta‐analysis as opposed to the number of participants randomised (as in the intention‐to‐treat method). This was due to discrepancies between the two numbers. Trials often noted that participants would drop out following randomisation as they were unhappy with the treatment arm to which they had been allocated (predominantly surgery).
As none of the studies which included bilateral treatment of varicose veins provided any stratification, we were unable to exclude them from this review. This has introduced a potential bias as simultaneous bilateral treatment of varicose veins impacts on outcome measures, such as procedural time, quality of life scores, pain and duration of hospital stay.
Agreements and disagreements with other studies or reviews
National Institute for Health and Care Excellence (NICE) guidelines recommend an hierarchical approach, with endothermal ablation preferred. According to the guidelines, if endothermal ablation is unsuitable, “offer ultrasound‐guided foam sclerotherapy", and if "ultrasound‐guided foam sclerotherapy is unsuitable, offer surgery” (NICE 2013a). These recommendations are based on cost‐effectiveness analysis. The Gloviczki 2012 review of guidelines, recommended by the Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) Venous Guideline Committee, reported that endovenous thermal ablation (EVLA or RFA) is preferential to SFJ ligation and stripping for the treatment of GSV incompetence (recommendation: GRADE 1 (strong), level of evidence: B (medium quality)). They did not support the use of one endothermal technique over another. UGFS was also suggested as an option to treat the incompetent saphenous vein; however, the recommendation for this was weak and based on low‐ to very low‐quality evidence.
A meta‐analysis by Kheirelseid 2018 compared long‐term recurrence rates after conventional surgery versus endovenous treatments. This analysis included nine RCTs, including three trials rejected for this Cochrane Review because their comparisons did not meet the inclusion criteria of this Cochrane review (Disselhoff 2008; Disselhoff 2011; Kalteis 2015). In keeping with this Cochrane Review, Kheirelseid 2018 found no statistical difference between EVLA and surgery for recurrence (36.6% versus 33.3%, respectively; pooled RR 1.35, 95% CI 0.76 to 2.37; P = 0.3). UGFS had a higher recurrence rate than EVLA (68.6% versus 24.4%; RR 6.08, 95% CI 1.62 to 22.82; P = 0.007). Recurrence was lower in surgery participants compared to UGFS (68.6% versus 18.1%; RR 8.88, 95% CI 1.67 to 47.14; P < 0.01). UGFS was also found to be inferior to RFA. They, too, were unable to comment on QoL measures due to the heterogeneity of how this outcome was reported.
A meta‐analysis by Hamann 2017 compared the five‐year efficacy of surgery, endovenous laser therapy (EVLT, equivalent to EVLA) and UGFS. Their primary outcome was anatomical success, and secondary outcomes were recurrent reflux rate and changes in disease‐specific QoL (AVVQ, CIVIQ). They included three RCTs and ten follow‐ups of RCTs. Of these, seven are included within this review. In an attempt to overcome the wide variation of definitions of anatomical success and recurrent reflux, Hamann 2017 standardised the definitions to be able to pool the data together, which could significantly impact on the results. As reported in this review, UGFS was found to be inferior at five years compared to EVLA and HL/S with regard to anatomical success. Hamann 2017 demonstrated high rates of recurrent reflux. VCSS scores were comparable between EVLA and SFJ ligation and stripping.
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies
Methodological quality summary: review authors' judgements about methodological quality for each domain for each included study
Comparison 1: Endovenous laser ablation versus radiofrequency ablation, Outcome 1: Technical success < 5 years
Comparison 1: Endovenous laser ablation versus radiofrequency ablation, Outcome 2: Long‐term technical success > 5 years
Comparison 1: Endovenous laser ablation versus radiofrequency ablation, Outcome 3: Recurrence
Comparison 1: Endovenous laser ablation versus radiofrequency ablation, Outcome 4: Long‐term recurrence > 5 years
Comparison 2: Endovenous laser ablation versus endovenous steam ablation, Outcome 1: Technical success < 5 years
Comparison 3: Endovenous laser ablation versus ultrasound‐guided foam sclerotherapy, Outcome 1: Technical success < 5 years
Comparison 3: Endovenous laser ablation versus ultrasound‐guided foam sclerotherapy, Outcome 2: Technical success > 5 years
Comparison 3: Endovenous laser ablation versus ultrasound‐guided foam sclerotherapy, Outcome 3: Recurrence
Comparison 3: Endovenous laser ablation versus ultrasound‐guided foam sclerotherapy, Outcome 4: Long‐term recurrence > 5 years
Comparison 4: Endovenous laser ablation versus cyanoacrylate glue, Outcome 1: Technical success < 5 years
Comparison 4: Endovenous laser ablation versus cyanoacrylate glue, Outcome 2: Recurrence
Comparison 5: Endovenous laser ablation versus mechanochemical ablation, Outcome 1: Technical success < 5 years
Comparison 5: Endovenous laser ablation versus mechanochemical ablation, Outcome 2: Recurrence
Comparison 6: Endovenous laser ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 1: Technical success < 5 years
Comparison 6: Endovenous laser ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 2: Technical success > 5 years
Comparison 6: Endovenous laser ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 3: Recurrence
Comparison 6: Endovenous laser ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 4: Long‐term recurrence > 5 years
Comparison 7: Radiofrequency ablation versus ultrasound‐guided foam sclerotherapy, Outcome 1: Technical success < 5 years
Comparison 7: Radiofrequency ablation versus ultrasound‐guided foam sclerotherapy, Outcome 2: Long‐term technical success > 5
Comparison 7: Radiofrequency ablation versus ultrasound‐guided foam sclerotherapy, Outcome 3: Recurrence
Comparison 7: Radiofrequency ablation versus ultrasound‐guided foam sclerotherapy, Outcome 4: Long‐term recurrence > 5 years
Comparison 8: Radiofrequency ablation versus cyanoacrylate glue, Outcome 1: Technical success < 5 years
Comparison 9: Radiofrequency ablation versus mechanochemical ablation, Outcome 1: Technical success < 5 years
Comparison 9: Radiofrequency ablation versus mechanochemical ablation, Outcome 2: Recurrence
Comparison 10: Radiofrequency ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 1: Technical success < 5 years
Comparison 10: Radiofrequency ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 2: Technical success > 5 years
Comparison 10: Radiofrequency ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 3: Recurrence
Comparison 10: Radiofrequency ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 4: Long‐term recurrence > 5 years
Comparison 11: Ultrasound‐guided foam sclerotherapy versus SFJ ligation and stripping (HL/S, surgery), Outcome 1: Technical success < 5 years
Comparison 11: Ultrasound‐guided foam sclerotherapy versus SFJ ligation and stripping (HL/S, surgery), Outcome 2: Technical success > 5 years
Comparison 11: Ultrasound‐guided foam sclerotherapy versus SFJ ligation and stripping (HL/S, surgery), Outcome 3: Recurrence
Comparison 11: Ultrasound‐guided foam sclerotherapy versus SFJ ligation and stripping (HL/S, surgery), Outcome 4: Long‐term recurrence (≥ 5 years)
| EVLA compared to RFA for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with RFA | Risk with EVLA | |||||
| Technical success (< 5 years) | Study population | OR 0.98 | 780 | ⊕⊕⊕⊝ | ||
| 975 per 1000 | 974 per 1000 | |||||
| Technical success (> 5 years) | Study population | OR 0.85 | 291 | ⊕⊕⊝⊝ | ||
| 952 per 1000 | 944 per | |||||
| Recurrence (< 5 years) | Study population | OR 1.53 | 291 | ⊕⊕⊝⊝ | ||
| 116 per 1000 | 167 per 1000 | |||||
| Long‐term recurrence (> 5 years) | Study population | OR 2.77 | 291 | ⊕⊕⊝⊝ | ||
| 129 per 1000 | 291 per 1000 | |||||
| Complications (up to 8 years) | See comment | ⊕⊝⊝⊝ | Analysis was prevented as studies reported minor and major complications using different definitions and at varying time points. Results of individual studies were inconsistent with each other so we are not able to draw any conclusions. | |||
| QoL (up to 8 years) | See comment | ⊕⊕⊝⊝ | The majority of studies for this comparison showed no difference in QoL scores between the two variables. Nordon 2011 showed no difference in improvement using AVVQ and EQ‐5D at three months. There was no difference in AVVQ or SF‐12 (in either the physical or mental component SF‐12) at 6 months in Shepherd 2010. Rasmussen 2011 found no difference in SF‐36 at 1 month or AVVQ at 3 years. Recovery 2009 reported improved global QoL scores in RFA at 7 and 14 days post‐operation but comparable by 1 month. Syndor 2017 did not measure QoL. | |||
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by one level due to risk of bias concerns. | ||||||
| EVLA compared to UGFS for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with UGFS | Risk with EVLA | |||||
| Technical success (< 5 years) | Study population | OR 6.13 | 588 (3 studies) | ⊕⊕⊝⊝ | ||
| 802 per 1000 | 961 per | |||||
| Technical success (> 5 years) | Study population | OR 6.47 | 534 | ⊕⊕⊝⊝ | ||
| 626 per 1000 | 915 per | |||||
| Recurrence (< 5 years) | Study population | OR 0.68 | 443 | ⊕⊝⊝⊝ | ||
| 186 per 1000 | 134 per 1000 | |||||
| Long‐term recurrence (> 5 years) | Study population | OR 1.08 | 418 | ⊕⊝⊝⊝ | ||
| 232 per 1000 | 246 per | |||||
| Complications (up to 8 years) | See comment | ⊕⊝⊝⊝ | All three studies reported on this outcome but using different definitions and at varying time points. Rasmussen 2011 reported more phlebitis and hyperpigmentation rates amongst the UGFS group. In Vernermo 2016, skin pigmentation was more common in the UGFS group but haematomas were seen more often after EVLA compared to UGFS at 1 month. Magna 2013 reported two cases of hyperpigmentation in EVLA participants compared to one case in UGFS at 3 months. | |||
| QoL (up to 8 years) | See comment | ⊕⊕⊕⊝ moderated | Magna 2013 reported no significant differences between EVLA and UGFS at 3 months and 1 year in CIVIQ2 and EQ‐5D scores. In Rasmussen 2011, UGFS was deemed to be better for bodily pain and physical functioning in the SF‐36 score initially. AVVSS showed no difference between comparisons at 1 month. Vernermo 2016 found no significant difference in median AVVSS between the treatment groups at 1 year | |||
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by two levels due to risk of bias concerns and inconsistency. | ||||||
| EVLA compared to HL/S for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with HL/S (surgery) | Risk with EVLA | |||||
| Technical success (< 5 years) | Study population | OR 2.31 | 1051 | ⊕⊕⊝⊝ | ||
| 933 per | 970 per | |||||
| Technical success (> 5 years) | Study population | OR 0.93 (0.57 to 1.50) | 874 | ⊕⊕⊝⊝ | ||
| 917 per | 911 per | |||||
| Recurrence (< 5 years) | Study population | OR 0.78 | 1459 | ⊕⊕⊕⊝ moderateb | ||
| 179 per 1000 | 146 per | |||||
| Long‐term recurrence (> 5 years) | Study population | OR 1.09 | 1267 | ⊕⊕⊕⊝ moderateb | ||
| 328 per 1000 | 347 per | |||||
| Complications (up to 8 years) | See comment | ‐ | ⊕⊝⊝⊝ | Analysis was prevented as studies reported minor and major complications using different definitions and at varying time points. Slightly higher rates of early haematomas and wound problems were possibly seen with HL/S (surgery); and EVLA may be associated with slightly more phlebitis. | ||
| QoL (up to 8 years) | See comment | ‐ | ⊕⊕⊕⊝ moderateb | Rates of improvement in QoL were comparable between both treatment groups in all studies. | ||
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by two levels due to risk of bias concerns and imprecision. | ||||||
| RFA compared to MOCA for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with MOCA | Risk with RFA | |||||
| Technical success (< 5 years) | Study population | OR 1.76 | 435 | ⊕⊕⊝⊝ | ||
| 983 per 1000 | 990 per 1000 | |||||
| Technical success (> 5 years) | See comment | ‐ | ‐ | ‐ | Data for this time point are not yet available. | |
| Recurrence (< 5 years) | Study population | OR 1.00 | 389 | ⊕⊕⊝⊝ | ||
| 117 per 1000 | 117 per 1000 | |||||
| Long‐term recurrence (≥ 5 years) | See comment | ‐ | ‐ | ‐ | Data for this time point are not yet available. | |
| Complications (up to 1 year) | See comment | ‐ | ‐ | ⊕⊝⊝⊝ | Analysis was prevented as studies reported minor and major complications using different definitions and at varying time points, but rates were similar between treatment groups. | |
| QoL (AVVQ, EQ‐5D) (up to 1 year) | See comment | ‐ | ‐ | ⊕⊕⊕⊝ moderatec | No differences detected between groups at any time point during the studies. | |
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by two levels due to risk of bias concerns and inconsistency. | ||||||
| RFA compared to HL/S for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with HL/S (surgery) | Risk with RFA | |||||
| Technical success (< 5 years) | Study population | OR 5.71 | 318 | ⊕⊕⊝⊝ lowa | ||
| 974 per | 995 per 1000 | |||||
| Technical success (> 5 years) | Study population | OR 0.88 | 289 | ⊕⊕⊝⊝ lowb | ||
| 958 per | 952 per 1000 | |||||
| Recurrence (< 5 years) | Study population | OR 0.93 | 546 | ⊕⊕⊕⊝ moderatec | ||
| 147 per 1000 | 138 per 1000 | |||||
| Long‐term recurrence (> 5 years) | Study population | OR 0.41 | 289 | ⊕⊕⊝⊝ lowb | ||
| 268 per | 130 per 1000 | |||||
| Complications (up to 8 years) | See comment | ⊕⊝⊝⊝ | Analysis was prevented as studies reported minor and major complications using different definitions and at varying time points. Overall the number of complications was low, but surgery may be associated with slightly higher rates of wound problems, haematomas and saphenous nerve injuries and more phlebitis was seen after RFA. | |||
| QoL (up to 8 years) | See comment | ⊕⊕⊕⊝ moderatec | None of the studies detected a difference between treatment arms by four months. | |||
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by two levels due to risk of bias concerns and inconsistency. | ||||||
| UGFS compared to HL/S for GSV incompetence | ||||||
| Patient or population: people with GSV incompetence | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with HL/S (surgery) | Risk with UGFS | |||||
| Technical success (< 5 years) | Study population | OR 0.32 | 954 | ⊕⊕⊝⊝ | ||
| 888 per | 718 per | |||||
| Technical success (> 5 years) | Study population | OR 0.09 | 525 | ⊕⊕⊕⊝ moderateb | ||
| 929 per | 542 per | |||||
| Recurrence (< 5 years) | Study population | OR 1.81 | 822 | ⊕⊕⊝⊝ | ||
| 168 per 1000 | 267 per 1000 | |||||
| Long‐term recurrence (≥ 5 years) | Study population | OR 1.24 | 639 | ⊕⊕⊝⊝ | ||
| 380 per 1000 | 432 per 1000 | |||||
| Complications (up to 8 years) | See comment | 639 (3 studies) | ⊕⊝⊝⊝ | Analysis was prevented as studies reported minor and major complications using different definitions and at varying time points. | ||
| QoL (up to 8 years) | See comment | 930 (4 studies) | ⊕⊕⊕⊝ moderateb | None of the five included studies showed evidence of a difference in QoL scores between the two treatment groups. | ||
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded by two levels due to risk of bias concerns and inconsistency. | ||||||
| C0 | No visible signs of venous disease |
| C1 | Spider veins, telangiectases or reticular veins (diameter < 3 mm) |
| C2 | Varicose veins (with a diameter > 3 mm) |
| C3 | Varicose veins with oedema |
| C4 | Varicose veins with trophic skin lesions secondary to chronic venous insufficiency |
| C4a | Pigmentation, purpura, eczema |
| C4b | Lipodermatosclerosis, atrophie blanche |
| C5 | Healed venous ulcer |
| C6 | Active venous ulcer |
| EVLA versus RFA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | RFA | |
| 159 | 157 | 78 | 79 | |
| 250 292 legs | 213 245 legs | 107 121 legs | 106 124 legs | |
| 87 legs | 87 legs | 41 legs | 46 legs | |
| 131 | 115 | 55 | 60 | |
| 200 | 153 | 79 | 74 | |
| EVLA versus EVSA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | EVSA | |
| 217 237 legs | 199 legs | 92 legs | 107 legs | |
| EVLA versus UGFS | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | UGFS | |
| 160 legs | 155 legs | 78 legs | 77 legs | |
| 250 289 legs | 214 244 legs | 107 121 legs | 107 123 legs | |
| 159 | 145 | 73 | 72 | |
| EVLA versus CA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | CA | |
| 400 | 355 | 174 | 181 | |
| EVLA versus MOCA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | MOCA | |
| 99 | 88 | 33 | 55 | |
| EVLA versus HL/S (surgery) | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | EVLA | HL/S (surgery) | |
| 118 136 legs | 95 114 legs | 80 legs | 34 legs | |
| 301 | 255 | 127 | 128 | |
| 280 | 237 | 124 | 113 | |
| 160 legs | 146 legs | 78 legs | 68 legs | |
| 122 130 legs | 130 legs | 62 legs | 68 legs | |
| 121 137 legs | 88 | 47 | 41 | |
| 250 287 legs | 204 229 legs | 107 121 legs | 97 108 legs | |
| 400 | 316 | 173 | 143 | |
| 152 | 134 | 73 | 61 | |
| RFA versus UGFS | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | RFA | UGFS | |
| 250 292 legs | 213 247 legs | 106 124 legs | 107 123 legs | |
| RFA versus CA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | RFA | CA | |
| 222 | 208 | 104 | 104 | |
| RFA versus MOCA | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | RFA | MOCA | |
| 170 | 129 | 60 | 69 | |
| 213 | 200 | 99 | 101 | |
| 98 | 84 | 29 | 55 | |
| RFA versus HL/S (surgery) | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | RFA | HL/S (surgery) | |
| 85 86 legs | 80 legs | 44 legs | 36 legs | |
| 180 | 162 | 81 | 81 | |
| 250 290 legs | 203 232 legs | 106 124 legs | 97 108 legs | |
| 33 | 28 | 15 | 13 | |
| 93 | 88 | 47 | 41 | |
| UGFS versus HL/S (surgery) | ||||
| Study | Participants randomised | Participants analysed | ||
| Overall | Overall | UGFS | HL/S (surgery) | |
| 460 | 390 | 213 | 177 | |
| 160 legs | 145 legs | 77 legs | 68 legs | |
| 250 286 legs | 204 231 legs | 107 123 legs | 97 108 legs | |
| 155 | 133 | 72 | 61 | |
| aStudy includes multiple comparisons of different interventions. CA: cyanoacrylate glue | ||||
| EVLA versus RFA | ||||
| Study | Age (years) | Sex (F:M) | ||
| EVLA | RFA | EVLA | RFA | |
| 46.7 (14.4) mean (SD) | 46.9 (15.1) mean (SD) | 54:26 | 45:34 | |
| 52 (18 ‐ 74) mean (range) | 51 (23 ‐ 75) mean (range) | 90:35 | 88:37 | |
| 51.6 (12.8) mean (SD) | 52.4 (15.3) mean (SD) | 31:10 | 29:17 | |
| 48 (16) mean (SD) | 49 (15) mean (SD) | 42:22 | 47:20 | |
| 48.5 (23 ‐ 86) mean (range) | 47 (19 ‐ 86) mean (range) | 77:23 | 80:20 | |
| EVLA versus EVSA | ||||
| Study | Age (years) | Sex (F:M) | ||
| EVLA | EVSA | EVLA | EVSA | |
| 55 (12) mean (SD) | 56 (13) mean (SD) | 61:45 62:48 (legs) | 73:39 76:41 (legs) | |
| EVLA versus UGFS | ||||
| Study | Age (years) | Sex (F:M) | ||
| EVLA | UGFS | EVLA | UGFS | |
| 49 (15.03) mean (SD) | 56 (13.30) mean (SD) | 54:24 | 52:25 | |
| 52 (18 ‐ 74) mean (range) | 51 (18 ‐ 75) mean (range) | 90:35 | 94:30 | |
| 47 (13.4) [20 ‐ 73] mean (SD) [range] | 48.3 (12.7) [20 ‐ 73] mean (SD) [range] | 55:18 | 58:18 | |
| EVLA versus CA | ||||
| Study | Age (years) | Sex (F:M) | ||
| EVLA | CA | EVLA | CA | |
| 38.4 (11.9) mean (SD) | 38.6 (11.6) mean (SD) | 114:86 | 109:91 | |
| EVLA versus MOCA | ||||
| Study | Age (years) | Ses (F:M) | ||
| EVLA | MOCA | EVLA | MOCA | |
| 49.5 (11.9) mean (SD) | 50.9 (12.0) mean (SD) | N/A | N/A | |
| EVLA versus HL/S (surgery) | ||||
| Study | Age (years) | Sex (F:M) | ||
| EVLA | HL/S (surgery) | EVLA | HL/S (surgery) | |
| EVLT1: 42 (30.5 ‐ 54.5); EVLT2: 52 (35 ‐ 59); mean (IQR) | 49 (38.5 ‐ 57.5) mean (IQR) | EVLT1: 22:16 EVLT2: 16:11 | 16:14 | |
| 47.4 (12.9) mean (SD) | 47.7 (11.5) mean (SD) | 97:45 | 112:47 | |
| 49 (14) mean (SD) | 49 (13) mean (SD) | 85:54 | 90:47 | |
| 49 (15.03) mean (SD) | 52 (15.59) mean (SD) | 54:24 | 46:22 | |
| 49 (11.0) mean (SD) | 50 (10.5) mean (SD) | 46:16 | 53:15 | |
| 53 (26 ‐ 79) mean (range) | 54 (22 ‐ 78) mean (range) | 41:21 | 43:16 | |
| 52 (18 ‐ 74) mean (SD) | 50 (19 ‐ 72) mean (range) | 90:35 | 95:29 | |
| 47.9 (10.9) mean (SD) | 48.0 (10.7) mean (SD) | 113:48 | 124:61 | |
| 47 (13.4) [20 ‐ 73] mean (SD) [range] | 47.3 (11.3) [27 ‐ 75] mean (SD) [range] | 55:18 | 55:10 | |
| RFA versus UGFS | ||||
| Study | Age (years) | Sex (F:M) | ||
| RFA | UGFS | RFA | UGFS | |
| 51 (23 ‐ 75) mean (range) | 51 (18 ‐ 75) mean (range) | 88:37 | 94:30 | |
| RFA versus CA | ||||
| Study | Age (years) | Sex (F:M) | ||
| RFA | CA | RFA | CA | |
| 50.5 (25.6 ‐ 70.1) mean (range) | 49.0 (26.6 ‐ 70.6) mean (range) | 93:21 | 83:25 | |
| RFA versus MOCA | ||||
| Study | Age (years) | Sex (F:M) | ||
| RFA | MOCA | RFA | MOCA | |
| 58 (median) | 54.5 (median) | 50:33 | 50:37 | |
| 53.4 (22.6 ‐ 77.9) median (range) | 54.9 (16.3 ‐ 18.2) median (range) | 63:43 | 67:40 | |
| 50.3 (13.9) mean (SD) | 50.9 (12.0) mean (SD) | N/A | N/A | |
| RFA versus HL/S (surgery) | ||||
| Study | Age (years) | Sex (F:M) | ||
| RFA | HL/S (surgery) | RFA | HL/S (surgery) | |
| 49 (4) mean (SD) | 47 (4) mean (SD) | 32:12 | 26:10 | |
| 33.1 (2.6) mean (SD) | 34.9 (3.7) mean (SD) | 48:42 | 45:45 | |
| 51 (23 ‐ 75) mean (range) | 50 (19 ‐ 72) mean (range) | 88:37 | 95:29 | |
| 33 (6.7) mean (SD) | 38 (6.8) mean (SD) | 14:1 | 12:1 | |
| 47 (38 ‐ 58) median (IQR) | 45 (37 ‐ 53) median (IQR) | 34:13 | 27:14 | |
| UGFS versus HL/S (surgery) | ||||
| Study | Age (years) | Sex (F:M) | ||
| UGFS | HL/S (surgery) | UGFS | HL/S (surgery) | |
| 55.8 (13.4) mean (SD) | 54.6 (13.4) mean (SD) | 175:58 | 162:65 | |
| 56 (13.30) mean (SD) | 52 (15.59) mean (SD) | 52:25 | 46:22 | |
| 51 (18 ‐ 75) mean (range) | 50 (19 ‐ 72) mean (range) | 94:30 | 95:29 | |
| 48.3 (12.7) [20 ‐ 73] mean (SD) [range] | 47.3 (11.3) [27 ‐ 75] mean (SD) [range] | 58:18 | 55:10 | |
| CA: cyanoacrylate glue | ||||
| Study | Laser | Pulsed/continuous | Energy | Technique |
| 1470 nm diode | not stated | 15 W | withdrawn at 2.08 ± 0.6 cm/s | |
| 810 nm diode | 1) pulsed | 12 W | 1 s pulses, 1 s intervals | |
| 2) continuous | 14 W | withdrawn 2 ‐ 3 mm/s | ||
| 980 nm diode | continuous | 30 W | not indicated | |
| 810 nm diode | continuous | 14 W | not indicated | |
| 940 nm diode | continuous | 12 W | not indicated | |
| 940 nm diode | continuous | not indicated | not indicated | |
| 810 nm diode | continuous | 12 W | withdrawn 2 mm/s | |
| 980 nm diode | continuous | 12 W | not indicated | |
| 980 nm diode | pulsed | 12 W | 1.5 s pulses, 1.5 s intervals | |
| 980 nm diode | 1) pulsed | not indicated | not indicated | |
| 2) continuous | ||||
| 1470 nm diode | 1) pulsed | |||
| 2) continuous | ||||
| 980 nm diode | continuous | 12 W | not indicated | |
| 810 nm diode | continuous | 20 W | not indicated | |
| 980 nm diode | continuous | 11 W | not indicated | |
| 980 nm diode | continuous | 10 W | not indicated | |
| 1470 nm diode | pulsed | 10 W | 1.5 s impulse | |
| 980 nm diode | pulsed | 12 W | 1.5 s impulse | |
| 1470 nm diode | pulsed | 12 W | 1.5 s impulse | |
| cm: centimetre | ||||
| Technique | Study | Outcome measure | ||||||||
| Technical success | Complications | Recurrence/ recanalisation | Pain | QoL Score | VCSS | Duration of procedure | Inpatient/day case | Return to normal activities/work | ||
| EVLA versus RFA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| ✓ | ✓ | ✓ | ✓ | |||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| EVLA versus EVSA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| EVLA versus UGFS | ✓ | ✓ | ✓ | ✓ | ||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| EVLA versus CA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| EVLA versus MOCA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| EVLA versus HL/S (surgery) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| ✓ | ✓ | ✓ | ✓ | |||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| RFA versus UGFS | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| RFA versus CA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| RFA versus MOCA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| RFA versusHL/S(surgery) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| UGFS versus HL/S (surgery) | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| ✓ | ✓ | ✓ | ✓ | |||||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| CA: cyanoacrylate glue | ||||||||||
| EVLA versus RFA | ||
| Study | Additional phlebectomies | |
| EVLA | RFA | |
| yes | yes | |
| yes | yes | |
| after 30 days | after 30 days | |
| yes | yes | |
| yes | yes | |
| EVLA versus EVSA | ||
| Study | Additional phlebectomies | |
| EVLA | EVSA | |
| after 3 months | after 3 months | |
| EVLA versus UGFS | ||
| Study | Additional phlebectomies | |
| EVLA | UGFS | |
| yes | yes | |
| yes | yes | |
| yes | no | |
| EVLA versus CA | ||
| Study | Additional phlebectomies | |
| EVLA | CA | |
| after 3 months | after 3 months | |
| EVLA versus MOCA | ||
| Study | Additional phlebectomies | |
| EVLA | MOCA | |
| yes | yes | |
| EVLA versus HL/S (surgery) | ||
| Study | Additional phlebectomies | |
| EVLA | HL/S (surgery) | |
| yes ‐ at 6 weeks | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| RFA versus UGFS | ||
| Study | Additional phlebectomies | |
| RFA | UGFS | |
| yes | yes | |
| RFA versus CA | ||
| Study | Additional phlebectomies | |
| RFA | CA | |
| no | no | |
| RFA versus MOCA | ||
| Study | Additional phlebectomies | |
| RFA | MOCA | |
| yes | yes | |
| no | yes | |
| yes | yes | |
| RFA versus HL/S (surgery) | ||
| Study | Additional phlebectomies | |
| RFA | HL/S (surgery) | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| UGFS versus HL/S (surgery) | ||
| Study | Additional phlebectomies | |
| UGFS | HL/S (surgery | |
| yes | yes | |
| yes | yes | |
| yes | yes | |
| no | yes | |
| aParticipants were offered ambulatory phlebectomy or UGFS. CA: cyanoacrylate glue | ||
| EVLA versus RFA | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | RFA | |
| Nordon 2011 3 months | 65/68 (96) | 68/70 (97) |
| Rasmussen 2011 1 month 5 yr | 143/144 (99) 136/144 (94) | 148/148 (100) 140/147 (95) |
| Recovery 2009 1 month | 41/41 (100) | 46/46 (100) |
| Shepherd 2010 6 months | 50/54 (93) | 50/56 (89) |
| Syndor 2017 6 months | 77/79 (97) | 72/74 (97) |
| EVLA versus EVSA | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | EVSA | |
| LAST 2014 1 yr | 88/92 (96) | all 93/107 (87) higha 68/74 (92) |
| EVLA versus UGFS | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | UGFS | |
| Magna 2013 1 yr 5 yr | 69/78 (88) 49/63 (77) | 56/77 (73) 15/67 (23) |
| Rasmussen 2011 1 month 5 yr | 143/144 (99) 136/144 (94) | 142/144 (99) 124/144 (86) |
| Vernermo 2016 1 yr 5 yr | 71/73 (93) 51/57 (89) | 37/72 (51) 30/59 (51) |
| EVLA versus CA | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | CA | |
| Calik 2019 1 yr | 203/204 (99) | 208/208 (100) |
| EVLA versus MOCA | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | MOCA | |
| Vähäaho 2019 30 days | 33/33 (100) | 55/55 (100) |
| EVLA versus HL/S (surgery) | ||
| Study ‐ time point | Technical success (%) | |
| EVLA | HL/S (surgery) | |
| Darwood 2008b 3 months | EVLT1. 41/42 (97) EVLT2. 26/29 (89) | 28/32 (87) |
| HELP‐1 2011 1 yr | 136/137 (99) 100/108 (92) | 122/137 (89) 94/110 (85) |
| Magna 2013 1 yr 5 yr | 69/78 (88) 49/63 (78) | 60/68 (88) 53/63 (85) |
| Rasmussen 2007 1 month 5 yr | 66/69 (96) 66/69 (96) | 66/68 (97) 66/68 (97) |
| Rasmussen 2011 1 month 5 yr | 143/144 (99) 136/144 (94) | 139/142 (98) 136/142 (96) |
| Vernermo 2016 1 yr 5 yr | 71/73 (93) 51/57 (89) | 59/61 (97) 48/50 (96) |
| RFA versus UGFS | ||
| Study ‐ time point | Technical success (%) | |
| RFA | UGFS | |
| Rasmussen 2011 1 month 5 yr | 148/148 (100) 140/147 (95) | 142/144 (99) 124/144 (86) |
| RFA versus CA | ||
| Study ‐ time point | Technical success (%) | |
| RFA | CA | |
| Morrison 2015 1 month | 95/110 (85) | 115/115 (100) |
| RFA versus MOCA | ||
| Study ‐ time point | Technical success (%) | |
| RFA | MOCA | |
| Lane 2017 6 months | 67/68 (98) | 77/77 (100) |
| MARADONA 2019 30 days | 103/103 (100) | 99/103 (96) |
| Vähäaho 2019 30 days | 29/29 (100) | 55/55 (100) |
| RFA versus HL/S (surgery) | ||
| Study ‐ time point | Technical success (%) | |
| RFA | HL/S (surgery) | |
| Rasmussen 2011 1 months 5 yr | 148/148 (100) 140/147 (95) | 139/142 (98) 136/142 (96) |
| Rautio 2002 mean 50 days | 15/15 (100) | 12/13 (92) |
| UGFS versus HL/S (surgery) | ||
| Study ‐ time point | Technical success (%) | |
| UGFS | HL/S (surgery) | |
| FOAM 2010 2 yr | 139/213 (65) | 140/177 (79) |
| Magna 2013 1 yr 5 yr | 56/77 (73) 15/67 (22) | 60/68 (88) 53/63 (84) |
| Rasmussen 2011 1 month 5 yr | 142/144 (99) 124/144 (86) | 139/142 (98) 136/142 (96) |
| Vernermo 2016 1 yr 5 yr | 37/72 (51) 30/59 (51) | 59/61 (97) 48/50 (96) |
| aHigh dose of steam CA: cyanoacrylate glue | ||
| EVLA versus RFA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yr | |
| EVLA | RFA | |
| No results | ||
| Rasmussen 2011 3 yr | 24/144 (17) | 17/147 (12) |
| No results | ||
| No results | ||
| Mention 'recurrent symptoms' but do not specify what this entails | ||
| EVLA versus EVSA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yr | |
| EVLA | EVSA | |
| No results | ||
| EVLA versus UGFS | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| EVLA | UGFS | |
| Magna 2013 1 yr | 9/78 (12) | 21/77 (27) |
| Rasmussen 2011 3 yr | 24/144 (17) | 20/144 (14) |
| No results | ||
| EVLA versus CA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| EVLA | CA | |
| Calik 2019 1 yr | 5/204 (2) | 2/208 (1) |
| EVLA versus MOCA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| EVLA | MOCA | |
| Vähäaho 2019 1 yr | 0/33 (0) | 10/55 (18) |
| EVLA versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| EVLA | HL/S (surgery) | |
| Darwood 2008a 1 yr | No results | |
| Flessenkämper 2013 2 yr | 20/112 (17.8) | 11/94(11.7) |
| HELP‐1 2011 1 yr | 5/124 (4) | 23/113 (20) |
| Magna 2013 1 yr | 9/78 (12) | 6/68 (9) |
| Pronk 2010 1 yr | 5/62 (8) | 5/68 (7) |
| Rasmussen 2007 2 yr | 18/69 (26) | 25/68 (37) |
| Rasmussen 2011a 3 yr | 24/144 (17) | 22/143 (15) |
| RELACS 2012 2 yr | 28/173 (16) | 33/143 (23) |
| no results | ||
| RFA versus UGFS | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| RFA | UGFS | |
| 17/147 (12) | 20/144 (14) | |
| RFA versus CA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| RFA | CA | |
| no results | ||
| RFA versus MOCA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| RFA | MOCA | |
| 4/68 (6) | 3/77 (4) | |
| MARADONA 2019 2 yr | 21/76 (28) | 12/81 (15) |
| Vähäaho 2019 1 yr | 0/32 (0) | 10/55 (18) |
| RFA versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| RFA | HL/S (surgery) | |
| EVOLVeS 2003 2 yr | 5/36 (14) | 6/29 (21) |
| Helmy ElKaffas 2011 2 yr | 12/81 (15) | 9/81 (11) |
| Rasmussen 2011a 3 yr | 17/148 (11) | 22/143 (15) |
| Rautio 2002 2 yr | 5/15 (33) | 2/13 (15) |
| not reported | ||
| UGFS versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) < 5 yrs | |
| UGFS | HL/S (surgery) | |
| FOAM 2010 2 yr | 75/213 (35) | 37/177 (21) |
| Magna 2013 1 yr | 21/77 (27) | 6/68 (9) |
| Rasmussen 2011a 3 yr | 20/144 (14) | 22/143 (15) |
| not reported | ||
| aReported as limbs and not participants CA: cyanoacrylate glue | ||
| EVLA versus RFA | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| EVLA | RFA | |
| 42/144 (29) | 19/147 (13) | |
| EVLA versus EVSA ‐ no data | ||
| EVLA versus UGFS | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| EVLA | UGFS | |
| 14/63 (22) | 21/67 (31) | |
| 42/144 (29) | 28/144(19) | |
| EVLA versus CA ‐ no data | ||
| EVLA versus MOCA ‐ no data | ||
| EVLA versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| EVLA | HL/S (surgery) | |
| 11/45 (24) | 14/53 (26) | |
| 29/108 (27) | 47/110 (43) | |
| 14/63 (22) | 8/63 (13) | |
| 19/61 (31) | 4/60 (7) | |
| 25/69 (36) | 24/68 (35) | |
| 42/144 (29) | 38/142 (27) | |
| 69/152 (45) | 70/129 (54) | |
| RFA versus UGFS | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| RFA | UGFS | |
| 19/147 (13) | 28/144 (19) | |
| RFA versus CA ‐ no data | ||
| RFA versus MOCA ‐ no data | ||
| RFA versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| RFA | HL/S (surgery) | |
| 19/147 (13) | 38/142 (27) | |
| UGFS versus HL/S (surgery) | ||
| Study ‐ final time point | Recurrence noted at final time point (%) | |
| UGFS | HL/S (surgery) | |
| FOAM 2010 8 yr | 86/120 (72) | 71/103 (69) |
| 21/67 (31) | 8/63 (13) | |
| 28/144 (19) | 38/142 (27) | |
| aReported as limbs and not participants CA: cyanoacrylate glue | ||
| Early post‐operative complications (within three months) | ||||||||||||||||
| EVLA versus RFA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA |
| 2/78 (2.6) | 1/77 (1.3) | 2/78 (2.6) | 1/76 (1.3) | 0/78 (0) | 0/76 (0) | 2/78 (2.6) | 1/76 (1.3) | 0/78 (0) | 0/76 (0) | |||||||
| 1/125 (0.8) | 0/121 (0) | 3/125 (2.4) | 6/121 (5) | 3/125 (2.4) | 8/121 (6.6 | 4/125 (3.2) | 12/121 (9.9) | 0/125 (0) | 1/121 (0.8) | 0/125 (0) | 0/121 (0) | |||||
| 2/41 (4.9) | 1/46 (2.2) | 0/41 (0) | 1/46 (2.2) | 6/41 (14.6) | 0/46 (0) | 1/41 (2.2) | 0/46 (0) | |||||||||
| 2/64 (3) | 0/67 (0) | 5/64 (8) | 8/67 (12) | 1/64 (2) | 2/67 (3) | 2/64 (3) | 6/67 (9) | 5/64 (7) | 5/67 (7) | 2/64 (3) | 4/67 (6) | 0/64 (0) | 1/67 (1) PE | |||
| 9/96 (9.4) | 13/97 (13.7) | 0/96 (0) | 0/97 (0) | 3/96 (3.1) | 3/97 (3.1) | 1/96 (1) | 1/97 (1.0) | 3/96 (3.1) | 2/97 (2.1) | 0/96 (0) | 0/97 (0) | |||||
| EVLA versus EVSA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA |
| 0/109 (0) | 1/117 (0.9) | 0/109 (0) | 0/117 (0) | 0/109 (0) | 0/117 (0) | 10/109 (9.2) | 10/117 (8.5) | 0/109 (0) | 0/117 (0) | 1/109 (0.9) DVT | 0/117 (0) | |||||
| EVLA versus UGFS | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS |
| 2/78 (2.6) | 1/77 (1.3) | 2/78 (2.6) | 1/77 (1.3) | 0/78 (0) | 0/77 (0) | 0/78 (0) | 0/77 (0) | |||||||||
| 1/125 (0.8) | 1/124 (0.8) | 3/125 (2.4) | 2/124 (1.6) | 3/125 (2.4) | 8/124 (6.5) | 4/125 (3.2) | 17/124 (13.7) | 0/125 (0) | 4/124 (3.2) | 0/125 (0) | 1/124 (0.8) | |||||
| 31/73 (42) | 14/72 (20) | 1/73 (1) | 2/72 (2) | 3/73 (5) | 50/72 (67) | 3/73 (4) | 0/72 (0) | |||||||||
| EVLA versus CA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA |
| 28/200 (11) | 6/200 (3) | 63/200 (31) | 31/200 (15.5) | 14/200 (7) | 7/200 (3.5) | 2/200 (1) | ||||||||||
| EVLA versus MOCA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA |
| 4/34 (12) | 0/65 (0) | 0/34 (0) | 1/65 (1.5) | |||||||||||||
| EVLA versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S |
| 0/80 (0) | 0/32 (0) | 1/80 (1) | 4/32 (13) | 1/80 (1) | 2/32 (6) | 9/80 (11) | 0/32 (0) | 0/80 (0) | 2/32 (6) | 0/80 (0) | 1/32c (3) | |||||
| 24/142 (17) | 23/159 (15) | 68/142 (48) | 108/159 (68) | 1/142 (0.7) | 1/159 (0.6) | |||||||||||
| 1/137 (0.7) | 11/133 (8.3) | 4/137 (2.9) | 13/133 (9.8) | 5/137 (3.6) | 3/133 (2.2) | 4/137 (2.9) | 6/133 (4.5) | 2/137 (1.5) | 8/133 (6) | |||||||
| 2/78 (2.6) | 4/68 (5.9) | 2/78 (2.6) | 0/68 (0) | 0/78 (0) | 3/68 (4.4) | 0/78 (0) | 0/68 (0) | |||||||||
| 2/62 (3) | 1/68 (1) | |||||||||||||||
| 3/69d (5) | 5/68 (8) | 1/69 (2) | 1/68 (5.9) | 0/69 (0) | 0/68 (0) | 0/69 (0) | 1/68 (2) | 7/69 (11) | 15/68 (25) | 2/69 (3) | 2/68 (3) | 0/69 (0) | 1/68e (2) | 0/69 (0) | 0/68 (0) | |
| 1/125 (0.8) | 1/119 (0.8) | 3/125 (2.4) | 5/119 (4.2) | 3/125 (2.4) | 6/119 (5) | 4/125 (3.2) | 5/119 (4.2) | 0/125 (0) | 0/119 (0.8) | 0/125 (0) | 1/119 (0.8) | |||||
| 169/185 (91) | 145/161 (90) | 20/185 (10.8) | 4/161 (2.5) | 1/185 (0.5) | 0/161 (0) | 3/185 (1.6) | 1/161 (0.6) | |||||||||
| 31/73 (42) | 40/65 (62) | 1/73 (1) | 2/65 (3) | 3/73 (4) | 3/65 (4) | 3/73 (4) | 3/65 (4) | |||||||||
| RFA versus UGFS | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS |
| 0/121 (0) | 1/124 (0.8) | 6/121 (0.8) | 2/124 (1.6) | 8/121 (6.6) | 8/124 (6.5) | 12/121 (9.9) | 17/124 (13.7) | 1/121 (0.8) | 4/124 (3.2) | 0/121 (0) | 1/124 (0.8) | |||||
| RFA versus CA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA |
| 3/114 (3) | 3/108 (3) | 1/114 (1) | 0/108 (0) | 16/114 (14) | 22/108 (20) | 1/114 (1) | 1/114 (1) | 0/114 (0) | 0/108 (0) | |||||||
| RFA versus MOCA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA |
| 15/104 (14) | 14/105 (13) | 3/104 (3) | 1/105 (1) | 0/104 (0) | 0/105 (0) | 0/105 (0) | 1/104 (1) | 2/104 (2) | 7/105 (7) | 8/104 (8) | 12/105 (11) | 3/104 (3) | ||||
| 1/65 (1.5) | 0/65 (0) | |||||||||||||||
| RFA versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S |
| 6/44 (14) | 18/36 (50) | 10/44 (23) | 5/36 (4.2) | 14/44 (32) | 23/36 (64) | 0/44 (0) | 2/36 (6)f | 0/44 (0) | 0/36 (0) | |||||||
| 1/90 (1.1) | 30/90 (33.3) | 9/90 (10) | 3/90 (3.3) | 0/90 (0) | 0/90 (0) | 6/90 (6.6) | 0/90 (0) | 0/90 (0) | 3/90 (3.3) | 0/90 (0) | 1/90 (1.1) | |||||
| 0/121 (0) | 1/119 (0.8) | 6/121 (4.9) | 5/119 (4.2) | 8/121 (6.6) | 6/119 (5) | 12/121 (9.9) | 5/119 (4.2) | 1/121 (0.8) | 1/119 (0.8) | 0/121 (0) | 1/119 (0.8) | |||||
| 1/15 (7) | 4/13 (31) | 2/15 (13) | 3/13 (23) | 1/15 (7) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 3/15 (20) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | |
| 0/47 (0) | 0/47 (0) | 9/47 (19) | 20/41 (49) | 0/47 (0) | 0/41 (0) | 0/47 (0) | 7/41 (17) | 5/47 (11) | 0/41 (0) | 0/47 (0) | 0/41 (0) | 0/47 (0) | 0/41 (0) | 0/47 (0) | 0/41 (0) | |
| UGFS versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S |
| 0/217 (0) | 3/176 (1.7) | 0/217 (0) | 6/176 (3.4) | 17/217 (7.8) | 0/176 (0) | 0/217 (0) | 4/176 (2.3) | 0/176 (0) | 0/217 (0.9) | |||||||
| 1/77 (1.3) | 4/68 (5.9) | 1/77 (1.3) | 0/68 (0) | 0/77 (0) | 3/68 (4.4) | 0/77 (0) | 0/68 (0) | |||||||||
| 1/124 (0.8) | 1/119 (0.8) | 2/124 (1.6) | 5/119 (4.2) | 8/124 (6.5) | 6/119 (5) | 17/124 (14) | 5/119 (4.2) | 4/124 (3.2) | 1/119 (0.8) | 1/124 (0.8) | 1/119 (0.8) | |||||
| 14/72 (20) | 40/65 (62) | 2/72 (2) | 2/65 (3) | 5/72 (7) | 3/65 (4) | 0/72 (0) | 3/65 (4) | |||||||||
| aResults only available per limb, not per participant CA: cyanoacrylate glue | ||||||||||||||||
| Late post‐operative complications (after three months) | ||||||||||||||||
| EVLA versus RFA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA | EVLA | RFA |
| 8/79 (10.3) | 6/74 (8.33) | 0/79 (0) | 0/74 (0) | 10/79 (12.66) | 6/74 (8.11) | 0/79 (0) | 2/74 (2.7) | 0/79 (0) | 0/74 (0) | 0/79 (0) | 0/74 (0) | |||||
| EVLA versus EVSA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | EVLA | EVSA |
| 0/98 (0) | 2/107 (1.9) | 0/98 (0) | 3/107 (2.8) | |||||||||||||
| EVLA versus UGFS | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | EVLA | UGFS |
| 0/78 (0) | 1/77 (1.3) | 1/78 (1.3) | 1/77 (1.3) | |||||||||||||
| EVLA versus CA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA | EVLA | CA |
| 13/200 (7) | 2/200 (1.1) | 3/200 (1.6) | 1/200 (0.5) | 0/200 (0) | 0/200 (0) | 2/200 (1.1) | 0/200 (0) | |||||||||
| EVLA versus MOCA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA | EVLA | MOCA |
| 3/33 (11) | 0/55 (0) | 3/33 (11) | 6/55 (11) | |||||||||||||
| EVLA versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S | EVLA | HL/S |
| 0/80 (0) | 0/34 (0) | 0/80 (0) | 1/34 (3) | 0/80 (0) | 0/34 (0) | 0/80 (0) | 0/34 (0) | 0/80 (0) | 0/34 (0) | 0/80 (0) | 0/34 (0) | 0/80 (0) | 0/34 (0) | 0/80 (0) | 0/34 (0) | |
| 23/127 (18) | 5/128 (4) | 12/127 (9.4) | 14/128 (11) | |||||||||||||
| 0/78 (0) | 1/68 (1.5) | 1/78 (1.3) | 0/68 (0) | |||||||||||||
| 0/96 (0) | 0/68 (0) | 0/96 (0) | 1/68 (2) | 0/96 (0) | 0/68 (0) | 0/96 (0) | 0/68 (0) | 0/96 (0) | 0/68 (0) | 0/96 (0) | 0/68 (0) | 0/96 (0) | 0/68 (0) | 0/96 (0) | 0/68 (0) | |
| RFA versus UGFS | ||||||||||||||||
| Study | Minor (requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS | RFA | UGFS |
| RFA versus CA | ||||||||||||||||
| Study | Minor (requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA | RFA | CA |
| 0/84 (0) | 1/86 (1.2) | |||||||||||||||
| RFA versus MOCA | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA | RFA | MOCA |
| 2/29 (6.9) | 0/55 (0) | 4/29 (13.8) | ||||||||||||||
| RFA versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S | RFA | HL/S |
| 0/43 (0) | 3/34 (9) | 0/43 (0) | 0/34 (0) | 0/43 (0) | 0/34 (0) | 0/43 (0) | 0/34 (0) | 0/43 (0) | 1/34 (3) | 0/43 (0) | 2/34 (6) | 0/43 (0) | 0/34 (0) | 0/43 (0) | 0/34 (0) | |
| 0/15 (0) | 0/13 (0) | 1/15 (0) | 5/13 (38) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | 0/15 (0) | 0/13 (0) | |
| UGFS versus HL/S (surgery) | ||||||||||||||||
| Study | Minor (not requiring intervention) (%) | Major (requiring intervention) (%) | ||||||||||||||
| Adverse event | Haematoma (wound or thigh) | Saphenous nerve injury | Thermal injury/ inflammation | Wound problems (groin/stab) | Bruising and pigmentation | Phlebitis | Wound problems | Other | ||||||||
| Technique | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S | UGFS | HL/S |
| 12/213 (5.6) | 2/177 (1.1) | |||||||||||||||
| 1/77 (1.3) | 1/68 (1.5) | |||||||||||||||
| aResults only available per limb, not per participant CA: cyanoacrylate glue | ||||||||||||||||
| Technique | Study | Quality of life score | |||||||
| V‐Q/SymQ | AVVSS | CIVIQ2 | SF‐12 | SF‐36 | RAND‐36 | EQ‐5D | SF‐6D | ||
| EVLA versus RFA | ✓ | ||||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| ✓ | |||||||||
| EVLA versus EVSA | ✓ | ||||||||
| EVLA versus UGFS | ✓ | ✓ | |||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| EVLA versus CA | ✓ | ||||||||
| EVLA versus MOCA | ✓ | ||||||||
| EVLA versus HL/S (surgery) | ✓ | ||||||||
| ✓ | |||||||||
| ✓ | ✓ | ✓ | ✓ | ||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| ✓ | ✓ | ||||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| ✓ | |||||||||
| RFA versus UGFS | ✓ | ✓ | |||||||
| RFA versus CA | ✓ | ✓ | |||||||
| RFA versus MOCA | ✓ | ✓ | |||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| RFA versus HL/S (surgery) | ✓ | ||||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| ✓ | ✓ | ||||||||
| RFA versus UGFS | ✓ | ✓ | |||||||
| UGFS versus HL/S (surgery) | ✓ | ||||||||
| ✓ | ✓ | ||||||||
| ✓ | ✓ | ||||||||
| ✓ | |||||||||
| AVVSS: Aberdeen Varicose Vein Symptom Severity Score | |||||||||
| EVLA versus RFA | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| EVLA | RFA | EVLA | RFA | EVLA | RFA | |
| Recovery 2009 mean (SD) 1 month | 4.9 (2.8) | 4.7 (3.1) | 3.2 (1.8) | 2.7 (2.2) | ||
| Rasmussen 2011 mean (SD) 3 yr | 2.68 (2.25) | 2.95 (2.06) | 0.34 (1.3) | 0.44 (1.82) | 3.3 | 3.7 |
| Shepherd 2010 mean (SD) 6 months | 4.7 (2.1) | 5.1 (2.1) | 1.4 (1.8) | 1.4 (1.7) | ||
| Syndor 2017 median (range) 6 months | 5 (2 ‐ 26) | 5 (1 ‐ 20) | 1 (0 ‐ 18) | 1 (0 ‐ 6) | ||
| EVLA versus EVSA | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| EVLA | EVSA | EVLA | EVSA | EVLA | EVSA | |
| LAST 2014 change after 12 weeks (95% CI) | not given | not given | not given | not given | ‐2.5 (‐2.1 to ‐2.93) | all ‐2.9 (‐2.4 to ‐3.5) hIgha ‐2.69 (‐2.34 to ‐3.04) |
| EVLA versus UGFS | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| EVLA | UGFS | EVLA | UGFS | EVLA | UGFS | |
| Rasmussen 2011 mean (SD) 3 yr | 2.68 (2.25) | 2.66 (1.45) | 0.34 (1.3) | 0.15 (0.4) | ||
| EVLA versus CA | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| EVLA | CA | EVLA | CA | EVLA | CA | |
| Calik 2019 mean (SD) 1 yr | 5.8 (1.9) | 5.7 (1.9) | 1.3 (0.9) | 1.3 (0.9) | ||
| EVLA versus MOCA ‐ no data | ||||||
| EVLA versus HL/S (surgery) | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| EVLA | HL/S (surgery) | EVLA | HL/S (surgery) | EVLA | HL/S (surgery) | |
| Rasmussen 2007 mean (SD) 5 yr | 2.8 (1.7) | 2.4 (1.4) | 0.4 (0.9) | 2.4 (1.4) | ||
| Rasmussen 2011 mean (SD) 3 yr | 2.68 (2.25) | 2.75 (1.62) | 0.34 (1.3) | 0.3 (0.5) | ||
| RFA versus UGFS | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| RFA | UGFS | RFA | UGFS | RFA | UGFS | |
| Rasmussen 2011 mean (SD) 3 yr | 2.95 (2.06) | 2.66 (1.45) | 0.44 (1.82) | 0.15 (0.4) | ||
| RFA versus CA | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| RFA | CA | RFA | CA | RFA | CA | |
| Morrison 2015 mean (SD) 3 months | 5.6 (2.6) | 5.5 (2.6) | 2.0 (2.0) | 1.9 (1.6) | ||
| RFA versus MOCA | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| RFA | MOCA | RFA | MOCA | RFA | MOCA | |
| Lane 2017 median (range) 6 months | 5 | 6 | 2 (1 ‐ 5) | 2 (1 ‐ 4) | ||
| MARADONA 2019 median (IQR) 2 yr | individually reported | individually reported | individually reported | individually reported | 4 (3 ‐ 5) | 3 (2 ‐ 5) |
| RFA versus HL/S (surgery) | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| RFA | HL/S (surgery) | RFA | HL/S (surgery) | RFA | HL/S (surgery) | |
| EVOLVeS 2003 mean (SD) 2 yr | 4.8 (0.34) | 4.39 (0.38) | unable to read from graph | |||
| Rasmussen 2011 mean (SD) 3 yr | 2.95 (2.06) | 2.75 (1.62) | 0.44 (1.82) | 0.3 (0.5) | ||
| Rautio 2002 median (range) 3 yr change ‐ mean (SD) | 4 (4 ‐ 6) | 5 (4 ‐ 9) | ‐ 4.3 (2.3) | ‐4 (‐1.2) | ||
| UGFS versus HL/S (surgery) | ||||||
| Study ‐ final time point | Initial VCSS | Final VCSS | Change in VCSS | |||
| UGFS | HL/S (surgery) | UGFS | HL/S (surgery) | UGFS | HL/S (surgery) | |
| FOAM 2010 mean (SD) 2 yr | 3.2 (1.9) | 3.5 (2.2) | 1.7 (1.2) | 1.9 (1.4) | ‐1.49 | ‐1.75 |
| Rasmussen 2011 mean (SD) 3 yr | 2.66 (1.45) | 2.75 (1.62) | 0.15 (0.4) | 0.3 (0.5) | ||
| aHigh dose of steam CA: cyanoacrylate glue | ||||||
| EVLA versus RFA | ||
| Study | Time (min) | |
| EVLA | RFA | |
| Nordon 2011 median (range) | 30 (10 ‐ 60) | 30 (15 ‐ 60) |
| Rasmussen 2011 mean (range)a | 26 (12 ‐ 80) | 27 (12 ‐ 80) |
| Syndor 2017 median (range) | total procedure 23.5 (8 ‐ 95) total ablation time 5 (1 ‐ 18) | total procedure 21 (6 ‐ 64) total ablation time 4 (1 ‐ 14) |
| EVLA versus EVSA ‐ no data | ||
| EVLA versus UGFS | ||
| Study | Time (min) | |
| EVLA | UGFS | |
| Rasmussen 2011 mean (range)a | 26 (12 ‐ 80) | 19 (5 ‐ 145) |
| EVLA versus CA | ||
| Study | Time (min) | |
| EVLA | CA | |
| Calik 2019 mean (SD) | 31.7 (8.8) | 13 (3.4) |
| EVLA versus MOCA ‐ no data | ||
| EVLA versus HL/S (surgery) | ||
| Study | Time (min) | |
| EVLA | HL/S (surgery) | |
| HELP‐1 2011 mean (SD) | 61 (14) | 67 (16) |
| Rasmussen 2011 mean (range)a | 26 (12 ‐ 80) | 32 (15 ‐ 80) |
| Vernermo 2016 mean (SD) [range] | 83 (17) [50 ‐ 139] | 95 (19) [62 ‐ 155] |
| RFA versus UGFS | ||
| Study | Time (min) | |
| RFA | UGFS | |
| Rasmussen 2011 mean (range)a | 27 (12 ‐ 80) | 19 (5 ‐ 145) |
| RFA versus CA | ||
| Study | Time (min) | |
| RFA | CA | |
| Morrison 2015 mean (range) | 19 (5 ‐ 46) | 24 (11 ‐ 40) |
| RFA versus MOCA | ||
| Study | Time (min) procedural time | |
| RFA | MOCA | |
| MARADONA 2019 mean (IQR) | 13 (4 ‐ 85) | 12 (5 ‐ 45) |
| RFA versus HL/S (surgery) | ||
| Study | Time (min) | |
| RFA | HL/S (surgery) | |
| EVOLVeS 2003 mean (SD) | 74 (10) | 89 (12) |
| Helmy ElKaffas 2011 mean (SD) | 40 (12) | 45 (13) |
| Rasmussen 2011 mean (range)a | 27 (12 ‐ 80) | 32 (15 ‐ 80) |
| Rautio 2002 mean (SD) | Operating time: 75 (16.6) Operating room time: 115 (18.3) Recovery room time: 227 (57.6) | Operating time: 57 (11) Operating room time: 99 (12.9) Recovery room time: 198 (40.7) |
| Subramonia 2010 median (IQR) | Theatre time: 82 (73 ‐ 91) Procedure time: 76 (67 ‐ 84) | Theatre time: 55 (48 ‐ 63) Procedure time: 48 (39 ‐ 54) |
| UGFS versus HL/S (surgery) | ||
| Study | Time (min) | |
| UGFS | HL/S (surgery) | |
| Rasmussen 2011 mean (range)a | 19 (5 ‐ 145) | 32 (15 ‐ 80) |
| aSurgeon's time CA: cyanoacrylate glue | ||
| EVLA versus RFA | ||
| Study | Length of hospital stay % day case | |
| EVLA | RFA | |
| 98a | 95.5b | |
| EVLA versus EVSA ‐ no data | ||
| EVLA versus UGFS ‐ no data | ||
| EVLA versus CA ‐ no data | ||
| EVLA versus MOCA ‐ no data | ||
| EVLA versus HL/S (surgery) | ||
| Study | Length of hospital stay % day case | |
| EVLA | HL/S (surgery) | |
| 100 | 100 | |
| ~100 | ~100 | |
| 100 | 78.8 | |
| 100 | 100 | |
| 100 | 100 | |
| RFA versus UGFS ‐ no data | ||
| RFA versus CA | ||
| Study | Length of hospital stay % day case | |
| RFA | CA | |
| 100 | 100 | |
| RFA versus MOCA ‐ no data | ||
| RFA versus HL/S (surgery) | ||
| Study | Length of hospital stay % day case | |
| RFA | HL/S (surgery) | |
| 95c | 86d | |
| hours in hospital | 14 (SD 3.6) [12 to 18] | 30 (SD 11.5) [18 to 48] |
| 93.3 | 92.3 | |
| UGFS versus HL/S (surgery) | ||
| Study | Length of hospital stay % day case | |
| UGFS | HL/S (surgery) | |
| not indicated | 100 | |
| aOne participant required overnight admission due to post‐operative nausea. CA: cyanoacrylate glue | ||
| EVLA versus RFA | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | RFA | EVLA | RFA | |
| Nordon 2011 median (range) | 7 (1 ‐ 60)a | 9 (0 ‐ 28) | ||
| Rasmussen 2011 median (range) | 3.6 (0 ‐ 46) | 2.9 (0 ‐ 14) | 3.6 (0 ‐ 46) | 1 (0 ‐ 30) |
| n returned to work at 3 days 14 (41%) 7 days 27 (71%) | n returned to work at 3 days 15 (37%) 7 days 29 (71%) | n returned to normal at 3 days 25 (50%) 7 days 37 (74%) | n returned to normal at 3 days 37 (60%) 7 days 48 (77%) | |
| EVLA versus EVSA | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | EVSA | EVLA | EVSA | |
| LAST 2014 mean (95% CI) | 4.2 (3.4 ‐ 5) | all 1.6 (1 ‐ 2.1) highb 1.6 (0.9 ‐ 2.3) | ||
| EVLA versus UGFS | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | UGFS | EVLA | UGFS | |
| Rasmussen 2011 median (range) | 3.6 (0 ‐ 46) | 2.9 (0 ‐ 33) | 2 (0 ‐ 25) | 1 (0 ‐ 30) |
| Vernermo 2016 mean (SD) [range] | 8 (5) [0 ‐ 29] | 1 (3) [0 ‐ 21] | ||
| EVLA versus CA | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | CA | EVLA | CA | |
| Calik 2019 mean (SD) | 2.9 (1.8) | 1.5 (0.6) | ||
| EVLA versus MOCA | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | MOCA | EVLA | MOCA | |
| Vähäaho 2019c mean | actual 5.3 perceived 8.6 | actual 4.3 perceived 7.8 | ||
| EVLA versus HL/S (surgery) | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| EVLA | HL/S (surgery) | EVLA | HL/S (surgery) | |
| Darwood 2008d median (IQR) | EVLT1: 4 (2.5 ‐ 7) EVLT2: 4 (1 ‐ 12) | 17 (7.25 ‐ 33.25) | EVLT1: 2 (0 ‐ 7) EVLT2: 2 (0 ‐ 7) | 7 (2 ‐ 26) |
| HELP‐1 2011 median (range) | 4 (2 ‐ 14) | 14 (13 ‐ 28) | 3 (1 ‐ 10) | 14 (7 ‐ 25) |
| Pronk 2010 mean (SD) | 4.38 (5.43) | 4.15 (3.72) | 3.16 (4.34) | 3.20 (4.01) |
| Rasmussen 2007 mean (SD) | 7 (6) | 7.6 (4.9) | 6.9 (7) | 7.7 (6.1) |
| Rasmussen 2011 median (range) | 3.6 (0 ‐ 46) | 4.3 (0 ‐ 42) | 2 (0 ‐ 25) | 4 (0 ‐ 30) |
| RELACS 2012 mean | 10.4 | 11.8 | 4.8 | 4 |
| Vernermo 2016 mean (SD) [range] | 8 (5) [0 ‐ 29] | 12 (6) [0 ‐ 33] | ||
| RFA versus UGFS | ||||
| Study | Time to return to work (days) | Time to return normal activities (days) | ||
| RFA | UGFS | RFA | UGFS | |
| Rasmussen 2011 median (range) | 2.9 (0 ‐ 14) | 2.9 (0 ‐ 33) | 1 (0 ‐ 30) | 1 (0 ‐ 30) |
| RFA versus CA ‐ no data | ||||
| RFA versus MOCA | ||||
| Study | Time to return to work (days) | Time to return normal activities | ||
| RFA | MOCA | RFA | MOCA | |
| Lane 2017 median (IQR) | 2 (2 ‐ 7) | 3 (1 ‐ 7) | 2 (1 ‐ 7) | 2 (1 ‐ 4) |
| MARADONA 2019 mean (range) | 2.98 (0 ‐ 15) | 2.28 (0 ‐13) | 1.43 (0 ‐ 6) | 1 (0 ‐ 6) |
| Vähäaho 2019c mean | actual 4.7 perceived 6.4 | actual 4.3 perceived 7.8 | ||
| RFA versus HL/S (surgery) | ||||
| Study | Time to return to work (days) | Time to return normal activities | ||
| RFA | HL/S (surgery) | RFA | HL/S (surgery) | |
| EVOLVeS 2003e mean | 4.7 | 12.4 | 1.15 | 3.89 |
| Helmy ElKaffas 2011 mean (SD) | 3 (3) | 7 (2.6) | ||
| Rasmussen 2011 median (range) | 2.9 (0 ‐ 14) | 4.3 (0 ‐ 42) | 1 (0 ‐ 30) | 4 (0 ‐ 30) |
| Rautio 2002c mean (SD) | actual: 6.5 (3.3) perceived: 6.1 (4.4) | actual: 15.6 (6) perceived: 19.2 (10) | no data | no data |
| Subramonia 2010 median (IQR) | 10 (4 ‐ 13) | 18.5 (11 ‐ 28) | 3 (0 ‐ 7) | 12.5 (4 ‐ 21) |
| UGFS versus HL/S (surgery) | ||||
| Study | Time to return to work (days) | Time to return normal activities | ||
| UGFS | HL/S (surgery) | UGFS | HL/S (surgery) | |
| Rasmussen 2011 median (range) | 2.9 (0 ‐ 33) | 4.3 (0 ‐ 42) | 1 (0 ‐ 30) | 4 (0 ‐ 30) |
| Vernermo 2016 mean (SD) [range] | 1 (3) [0 ‐ 21] | 12 (6) [0 ‐ 33] | ||
| aThree outliers at 42, 60, 60 days CA: cyanoacrylate glue | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Technical success < 5 years Show forest plot | 5 | 780 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.98 [0.41, 2.38] |
| 1.2 Long‐term technical success > 5 years Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 1.3 Recurrence Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 1.4 Long‐term recurrence > 5 years Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Technical success < 5 years Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Technical success < 5 years Show forest plot | 3 | 588 | Odds Ratio (M‐H, Random, 95% CI) | 6.13 [0.98, 38.27] |
| 3.2 Technical success > 5 years Show forest plot | 3 | 534 | Odds Ratio (M‐H, Random, 95% CI) | 6.47 [2.60, 16.10] |
| 3.3 Recurrence Show forest plot | 2 | 443 | Odds Ratio (M‐H, Random, 95% CI) | 0.68 [0.20, 2.36] |
| 3.4 Long‐term recurrence > 5 years Show forest plot | 2 | 418 | Odds Ratio (M‐H, Random, 95% CI) | 1.08 [0.40, 2.87] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Technical success < 5 years Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 4.2 Recurrence Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 5.1 Technical success < 5 years Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 5.2 Recurrence Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 6.1 Technical success < 5 years Show forest plot | 6 | 1051 | Odds Ratio (M‐H, Fixed, 95% CI) | 2.31 [1.27, 4.23] |
| 6.2 Technical success > 5 years Show forest plot | 5 | 874 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.93 [0.57, 1.50] |
| 6.3 Recurrence Show forest plot | 7 | 1459 | Odds Ratio (M‐H, Random, 95% CI) | 0.78 [0.47, 1.29] |
| 6.4 Long‐term recurrence > 5 years Show forest plot | 7 | 1267 | Odds Ratio (M‐H, Random, 95% CI) | 1.09 [0.68, 1.76] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 7.1 Technical success < 5 years Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 7.2 Long‐term technical success > 5 Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 7.3 Recurrence Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 7.4 Long‐term recurrence > 5 years Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 8.1 Technical success < 5 years Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 9.1 Technical success < 5 years Show forest plot | 3 | 435 | Odds Ratio (M‐H, Random, 95% CI) | 1.76 [0.06, 54.15] |
| 9.2 Recurrence Show forest plot | 3 | 389 | Odds Ratio (M‐H, Random, 95% CI) | 1.00 [0.21, 4.81] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 10.1 Technical success < 5 years Show forest plot | 2 | 318 | Odds Ratio (M‐H, Fixed, 95% CI) | 5.71 [0.64, 50.81] |
| 10.2 Technical success > 5 years Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 10.3 Recurrence Show forest plot | 4 | 546 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.93 [0.58, 1.51] |
| 10.4 Long‐term recurrence > 5 years Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 11.1 Technical success < 5 years Show forest plot | 4 | 954 | Odds Ratio (M‐H, Random, 95% CI) | 0.32 [0.11, 0.94] |
| 11.2 Technical success > 5 years Show forest plot | 3 | 525 | Odds Ratio (M‐H, Random, 95% CI) | 0.09 [0.03, 0.30] |
| 11.3 Recurrence Show forest plot | 3 | 822 | Odds Ratio (M‐H, Random, 95% CI) | 1.81 [0.87, 3.77] |
| 11.4 Long‐term recurrence (≥ 5 years) Show forest plot | 3 | 639 | Odds Ratio (M‐H, Random, 95% CI) | 1.24 [0.57, 2.71] |
