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A Systematic Review and Meta-analysis of Randomised Controlled Trials Comparing Endovenous Ablation and Surgical Intervention in Patients with Varicose Vein
Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Rama VI Road, Rachatevi, Bangkok, 10400, ThailandDepartment of Surgery, Faculty of Medicine, Thammasat University Hospital, Thammasat University (Rangsit Campus), Pathumtani, Thailand
Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Rama VI Road, Rachatevi, Bangkok, 10400, Thailand
A systematic review and meta-analysis was conducted to compare clinical outcomes between endovenous laser ablation (EVLA), radiofrequency ablation (RFA), ultrasound-guided foam sclerotherapy (UGFS) and surgery.
Methods
We searched MEDLINE and Scopus from 2000 to August 2011 to identify randomised controlled trials (RCTs) comparing EVLA, RFA, UGFS, and surgery or combinations of these for treatment of varicoses. Differences in clinical outcomes were expressed as pooled risk ratio and unstandardised mean difference for dichotomous and continuous outcomes, respectively. Methodological quality was assessed using Cochrane tools.
Results
Twenty-eight RCTs were included. The primary failure and clinical recurrences were not significantly different between EVLA and RFA versus surgery with the pooled RR of 1.5 (95%CI:0.7, 3.0) and 1.3 (95%CI:0.7, 2.4) respectively for primary failure, and, 0.6 (95%CI:0.3, 1.1) and 0.9 (95%CI:0.6, 1.4) respectively for clinical recurrences. The endovenous techniques had advantages over surgery in lowering wound infections (RR = 0.3 (95%CI:0.1, 0.8) for EVLA), haematoma (RR = 0.5 (95%CI:0.3, 0.8) and 0.4 (95%CI:0.1, 0.8) for EVLA and RFA), and return to normal activities or work (mean differences = −4.9 days (95%CI:−7.1,−2.7) for RFA).
Conclusions
The primary failure and recurrence in EVLA and RFA were non-significantly different compared with surgery. However, they had lower haematoma, less wound infection, less pain and quicker return to normal activities.
A systematic review and meta-analysis of randomised controlled trials was conducted, which aim to compare clinical outcomes between concurrent minimally invasive procedures and surgery for treating varicose veins. All relevant randomised controlled trials published up to August 2011 were included. Treatment comparisons were endovenous laser ablation, radiofrequency ablation, ultrasound-guided foam sclerotherapy and surgery. Clinical relevant outcomes, that is, primary failure, clinical recurrence, postoperative complications, pain and return to normal activities were covered. Evidence and recommendation suggested from our study were provided.
Minimally invasive endovenous procedures (MIEPs) have been recently introduced for treating varicose veins to reduce postoperative complications, speed recovery and improve quality of life (QOL) compared to standard surgery.
These methods have been enthusiastically adopted (i.e., ultrasound-guided foam sclerotherapy (UGFS), radiofrequency ablation (RFA), and endovenous laser ablation (EVLA)), with less surgery and doubling of endovenous procedures during 2007–2008 in the UK.
favoured MIEPs, that is, similar efficacies but less complications, and shorter time to work, these results may bias since pooling effects were mainly based on observation studies or mixed with randomised controlled trials (RCTs). Some RCTs have been later published.
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years.
Reverse foam sclerotherapy of the great saphenous vein with sapheno-femoral ligation compared to standard and invagination stripping: a prospective clinical series.
A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein.
Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study).
We therefore conducted a systematic review and meta-analysis solely of RCTs comparing all relevant outcomes including efficacies (i.e., primary failure and clinical recurrence), postoperative complications (i.e., wound infection, paresthesia, superficial thrombophlebitis, haematoma and ecchymosis), postoperative pain, time return to normal activities or work and QOL between these MIEPs and surgery and between MIEPs themselves.
Methods
Search strategy
We searched in MEDLINE and Scopus from 2000 to 20 August 2011. Search terms were (‘varicose veins’[Mesh], ‘saphenous vein’[Mesh], varicose and saphenous), (radiofrequency, RFA, VNUS, ‘endovenous laser’, EVLT, EVLA, sclerotherapy[Mesh], ‘foam sclerotherapy’, microfoam, stripping and sapheno-femoral ligation) and (obliteration, occlusion, recurrence, recurrent, recanalisation, neovascularisation, reflux, pain, ‘return to normal activities’, ‘return to work’, haematoma, paresthesia, ‘nerve injury’, ‘wound infection’, deep vein thrombosis (DVT) and thromboembolism). Reference lists of previous meta-analyses and all eligible papers were also explored.
Study selection
Identified studies were selected by two independent authors (B.S. and P.N.). Disagreements in selection were reviewed and adjudicated by a third party (A.T). For multiple publications, the relevant data were combined as one publication for analysis.
The inclusion criteria for eligible studies were as follows: RCTs, compared outcomes between any of MIEPs and surgery or between MIEPs in patients with great saphenous vein reflux, reported at least one outcome of interest. Studies were excluded if they were not English or had insufficient data.
Data extraction
B.S. and P.N. extracted data using a standardised extraction form. Disagreements were resolved by consensus and checked by A.T. Corresponding authors were contacted twice for missing information. The mean and SD were estimated from median and range for analysis.
The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.
These considered six domains as follows: was allocation sequence adequately generated?, was allocation adequately concealed?, was knowledge of the allocated interventions adequately blinded?, were incomplete outcomes adequately addressed?, were reports free from selection?, and was there other source of bias (e.g., imbalance of patient characteristic between groups, protocol violation and the method dealing with data (intention to treat or per-protocol analysis))? Disagreements were resolved by A.T.
Outcomes
The primary outcome was failure to completely abolish reflux in the axial vein. Since MIEPs and surgery use different mechanisms to abolish refluxes, each had different failure definitions. Primary failure was recanalisation diagnosed by duplex scan for MIEPs: incomplete stripping, incomplete removal of an intended vein or recanalisation for surgery. Numbers of primary failure at the end of study were used for analysis. Failure to cannulate or pass a guide wire was considered as technical failure, and not analysed.
Secondary outcomes were clinical recurrences assessed by physical examination (e.g., visible or palpable varicose), venous clinical severity scores (VCSSs), postoperative complications (i.e., wound infection, paresthesia, superficial thrombophlebitis, haematoma or ecchymosis), postoperative pain, time return to normal activities or work and QOL measured by Aberdeen varicose vein severity score (AVVSS). The secondary outcomes were measured at the end of study except complications and pain. Since complications were reported at different follow-up times, the maximum numbers were analysed. If a study reported both time return to normal activities and time to work, the former was used. First recorded and highest pain scores by visual analogue scale (VAS) were used to pool. Only thigh haematomas were pooled.
Statistical analysis
Data were pooled if there were at least three studies for each comparison. Risk ratios (RRs) and 95% confidence intervals (CIs) were estimated and pooled. If there was a zero cell, a continuity correction was used. The RRs were pooled using the DerSimonian and Laird if heterogeneity was present, otherwise the inverse variance was applied. For continuous data, mean differences (MDs) along were estimated and pooled using an unstandardised method.
Q test and the degree of heterogeneity (I2) were used to assess heterogeneity. If either I2 ≥ 25% or the Q test was significant, the random-effect model was used. Heterogeneity source was explored by fitting covariables (i.e., mean age, follow-up time and wavelength) in a meta-regression. If the co-variable could reduce the I2, a subgroup or sensitivity analysis of that factor was performed.
Publication bias was assessed by Egger test and funnel plot.
The meta-trim and fill was applied to impute missing studies. Analyses were performed using STATA version 12.0. A p-value <0.05 was considered statistically significant, except for the heterogeneity test, where a 0.10 was used.
Results
Seventy-seven and 66 RCTs from MEDLINE and Scopus were identified (see Fig. 1). After removing duplicates, 91 studies were screened out, leaving 28 studies for data extraction. Among them, 11 RCTs
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years.
Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins.
Comparative outcomes of radiofrequency endoluminal ablation, invagination stripping, and cryostripping in the treatment of great saphenous vein insufficiency.
Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study.
Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).
Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs.
Reverse foam sclerotherapy of the great saphenous vein with sapheno-femoral ligation compared to standard and invagination stripping: a prospective clinical series.
Varisolve® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial.
Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial.
A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein.
Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study).
General characteristics of the eligible studies are presented in Table 1. Sample sizes ranged from 16 to 500 patients involving 28–580 limbs. The mean age ranged from 33 to 55 years, and duration of follow-up was 1 week–5 years. Most included patients were within CEAP C2 category. The risk of bias assessment is presented, the highest quality was other source of bias from applying intention to treat analysis (83%), follows with allocation concealment and selective outcome report (78%) whereas the lowest was blinding (43%) (see Table 2).
Table 1General characteristics of eligible studies.
Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins.
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years.
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).
Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs.
Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study.
Comparative outcomes of radiofrequency endoluminal ablation, invagination stripping, and cryostripping in the treatment of great saphenous vein insufficiency.
Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial.
Varisolve® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial.
Reverse foam sclerotherapy of the great saphenous vein with sapheno-femoral ligation compared to standard and invagination stripping: a prospective clinical series.
Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study).
A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein.
Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years.
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins.
Comparative outcomes of radiofrequency endoluminal ablation, invagination stripping, and cryostripping in the treatment of great saphenous vein insufficiency.
Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study.
Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs.
Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).
Reverse foam sclerotherapy of the great saphenous vein with sapheno-femoral ligation compared to standard and invagination stripping: a prospective clinical series.
Varisolve® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial.
Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial.
A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein.
Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study).
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years.
Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.
Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins.
compared primary failure between EVLA and surgery with 712 and 675 limbs, respectively. The heterogeneity was moderate (Q = 11.60, d.f. = 8, p = 0.170, I2 = 31.1%) with the pooled RR of 1.5 (95%CI:0.7, 3.0) (see Fig. 2A), suggesting that EVLA had 1.5 times higher risk of primary failure than surgery but this was non-significant.
Figure 2Forest plots of intervention effects on primary failure. The size of each square is proportional to percent weight that each study contributed in the pooled risk ratio. The pooled risk ratio is indicated by the diamond. CI, confidence interval; RR, risk ratio.
Fitting age, follow-up time, pull-back type and wavelength in the meta-regression suggest that only wavelength might be a source of heterogeneity. Pooling studies using wavelengths of 810
Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.
Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins.
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years.
yielded homogenous results (I2 = 26.5% and 0%, respectively) with the pooled RR of 0.95 (95% CI:0.39, 2.32) and 2.36 (95% CI:0.96, 5.76), respectively. A subgroup analysis within studies <1- and ≥1-year follow-up resulted in the pooled RR of 3.5 (95% CI:0.7, 17.1) and 1.3 (95% CI:0.5, 3.0), respectively. A sensitivity analysis excluding three studies with different techniques (cryostripping
Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins.
Comparative outcomes of radiofrequency endoluminal ablation, invagination stripping, and cryostripping in the treatment of great saphenous vein insufficiency.
Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study.
compared primary failure between RFA and surgery (n = 381 vs 378 limbs) with low heterogeneity (Q = 7.46, d.f. = 6, p = 0.281, I2 = 19.5%) with a pooled RR of 1.3 (95% CI:0.7, 2.4) (see Fig. 2B). ClosureVNUS was applied to all except one study
Comparative outcomes of radiofrequency endoluminal ablation, invagination stripping, and cryostripping in the treatment of great saphenous vein insufficiency.
yielded the pooled RR of 1.2 (95% CI:0.5, 2.8). The pooled RRs were 0.9 (95% CI:0.3, 2.8) and 2.0 (95% CI:0.8, 5.1) for studies with <1- and ≥1-year follow-up.
Reverse foam sclerotherapy of the great saphenous vein with sapheno-femoral ligation compared to standard and invagination stripping: a prospective clinical series.
Varisolve® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial.
Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial.
compared primary failure between UGFS and surgery with 406 and 350 limbs, respectively. The pooled RR was 2.4 (95%CI:1.6, 3.6) with low heterogeneity (Q = 5.17, d.f. = 4, p = 0.270, I2 = 22.7%) (see Fig. 2C), suggesting that UGFS was about twofold higher risk of failure. Subgroup analysis by follow-up time <1 and ≥1 year yielded the pooled RRs of 1.3 (95% CI:0.6, 2.9) and 3.1 (95% CI:1.8, 5.3), respectively.
A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein.
Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study).
compared primary failure between RFA and EVLA (n = 304 vs 296 limbs) with moderate heterogeneity (Q = 4.39, d.f. = 3, p = 0.222, I2 = 31.7%) with the pooled RR of 1.5 (95% CI:0.7, 3.4) (see Fig. 2D). Pooling studies with
Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study).
A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein.
applying ClosureFast yielded the pooled RR of 0.84 (95% CI:0.30, 2.34) and 2.36 (95% CI:0.55, 10.15), respectively.
Publication bias was assessed and suggested that there was no evidence of publication bias for all comparisons of primary failure except for EVLA versus surgery (see Fig. 3A–D), in which the Egger test and the contour-enhanced funnel plot suggested asymmetry (see Fig. 3A). All except one study fell in the non-significant area, suggesting that the cause of asymmetry may be heterogeneity rather than publication bias. Meta-trim and fill indicated four missing studies, and pooling these with existing nine studies resulted in pooled RR of 1.0 (95% CI:0.4, 2.1).
Figure 3Contour enhanced funnel plots of primary failure between various types of interventions.
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years.
Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.
comparing clinical recurrences between EVLA and surgery were pooled (n = 395 and 397 limbs) with moderate heterogeneity (Q = 6.63, d.f. = 3, p = 0.085, I2 = 54.8%) (see Fig. 4A). The pooled RR was 0.6 (95% CI:0.3, 1.1), indicating that EVLA had 40% less chance of clinical recurrence, but this was non-statistically significant. Source of heterogeneity (i.e., age and follow-up time) could not be identified. A sensitivity analysis was performed by excluding one study
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study.
Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).
reported wound infections between EVLA and RFA versus surgery, respectively. The corresponding pooled RRs were 0.3 (95% CI:0.1, 0.8) and 0.3 (95% CI:0.1, 1.4), with no heterogeneity (Table 3). Comparing overall EVLA and RFA with surgery based on 12 studies yielded a pooled RR of 0.3 (95%CI:0.1, 0.7) (Supplementary Fig. 2), that is, wound infection was significantly reduced by 70% in the endovenous techniques compared with surgery. The estimated number needed to treat (NNT) was 80 subjects to prevent one wound infection.
Table 3Comparisons of postoperative complications between endovenous and surgical techniques.
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins.
reported paresthesia between EVLA and surgery. The RRs were homogeneous with the pooled RR of 0.8 (95% CI:0.6, 1.1), suggesting no difference of paresthesia between groups (see Table 3 and Supplementary Fig. 3A). The RRs of paresthesia between RFA and surgery were moderately heterogeneous across seven studies
Comparative outcomes of radiofrequency endoluminal ablation, invagination stripping, and cryostripping in the treatment of great saphenous vein insufficiency.
Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).
Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs.
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
reported superficial thrombophlebitis between EVLA and surgery with homogeneity (see Table 3 and Supplementary Fig. 4A). The pooled RR was 1.0 (95% CI:0.5, 1.8). The Egger test suggested asymmetry of funnel, adding one missing study by meta-trim and fill in the pooling yielded an RR of 0.9 (95% CI:0.4, 1.8). To minimise confounding effects from tumescence anaesthesia (TA), subgroup analysis according to similarity of applying TA was performed. Two studies
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.
Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).
Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs.
with low heterogeneity. The risk of superficial thrombophlebitis was 2.3 (95% CI:1.1, 5.0) times significantly higher in RFA than surgery (see Table 3 and Supplementary Fig. 4B). None of studies had similarity in applying TA in both intervention groups.
Haematoma
Effects of EVLA versus surgery on haematoma were pooled in four homogeneous studies
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
(see Table 3). The pooled RR was 0.5 (95% CI:0.3, 0.8), that is, EVLA had 50% significant relative risk reduction of haematoma (see Supplementary Fig. 5A). The estimated NNT was 10. Among four studies, one study
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
Comparative outcomes of radiofrequency endoluminal ablation, invagination stripping, and cryostripping in the treatment of great saphenous vein insufficiency.
Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).
Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs.
with the pooled RR of 0.4 (95% CI:0.1, 0.8), suggesting that the risk of haematoma was 60% significantly reduced in RFA relative to surgery. The estimated NNT was four. None of the studies were similar in applying TA.
Ecchymosis
Ecchymosis between EVLA and surgery was highly heterogeneous across six studies
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins.
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins.
in both groups) yield the pooled RR of 0.4 (95% CI:0.2, 0.7).
Postoperative pain
As described in Table 4 and Supplementary Fig. 7, the first-recorded pain was significantly lower after EVLA and RFA than surgery with pooled MD of −0.6 (95% CI:−1.1, −0.2) and −1.6 (95% CI:−2.1, −1.1), respectively. The RFA caused significantly less pain than EVLA with pooled MD of −0.8 (95% CI:−1.5, −0.1).
Table 4Comparisons of postoperative pain, return to normal activities or work and quality of life between various endovenous and surgical techniques.
Comparison arms
Outcomes
No. of studies
Total number of patients
Heterogeneity
Egger test
WMD (95%CI)
Q
P
I2(%)
Beta
P
EVLA vs Surgery
First reported pain
6
1010
7.33
0.198
31.7
1.90
0.599
−0.6 (−1.1, −0.2)
Maximum pain
6
1010
7.59
0.180
34.1
1.84
0.610
−0.6 (−1.0, −0.1)
NA or work
7
1227
164.3
0.000
96.4
−3.87
0.342
−2.7 (−6.0, 0.6)
NA
6
1132
159.1
0.000
96.9
−6.17
0.208
−3.5 (−7.1, 0.0)
AVVSS
6
1122
12.3
0.031
59.2
−0.21
0.862
−0.2 (−0.9, 0.6)
RFA vs Surgery
First reported pain
4
438
0.59
0.899
0
1.85
0.341
−1.6 (−2.1, −1.1)
Maximum pain
4
438
0.98
0.805
0
3.43
0.124
−1.6 (−2.0, −1.1)
NA or work
6
727
38.23
0.000
86.9
−1.71
0.516
−4.9 (−7.1, −2.7)
NA
5
699
30.91
0.000
87.1
−0.74
0.825
−4.2 (−6.5, −2.0)
RFA vs EVLA
First reported pain
4
542
11.65
0.009
74.3
−3.36
0.512
−0.8 (−1.5, −0.1)
Maximum pain
4
542
0.73
0.867
0
1.29
0.252
−1.2 (−1.6, −0.9)
AVVSS, Aberdeen varicose vein severity scores; CI, confidence interval; MD, weight mean difference (mean of group 1 – mean of group 2); NA, return to normal activities; work, return to work.
Maximum pain at days 1–7 was significantly less after EVLA and RFA than surgery with pooled MD of −0.6 (95% CI:−1.0, −0.1) and −1.6 (95% CI:−2.0, −1.1), respectively. The maximum pain after RFA was less than EVLA with an MD of −1.2 (95% CI:−1.6,−0.9).
Return to normal activities or work
Return to normal activities or work was significantly shorter for RFA but not for EVLA compared with surgery with pooled MD of −4.9 days (95% CI:−7.1, −2.7) and −2.7 (95% CI:−6.0, 0.6) days, respectively (see Table 4, Supplementary Fig. 8).
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years.
compared QOL measured at 2–24 months between EVLA versus surgery (see Table 4 and Supplementary Fig. 9). The pooled MD was −0.2 (95%CI:−0.9, 0.6) with heterogeneity. Fitting mean age, disease severity (percent C2-3) and follow-up time in meta-regression did not suggest any source of heterogeneity (data were not shown).
Discussion
Our results suggest primary failure and recurrence rates after EVLA and RFA were not significantly different to surgery. However, EVLA and RFA had 70% lower rates of wound infection, with NNT of 80. Also, both EVLA and RFA reduced haematoma by approximately 50–60%, with NNT of 4–10. Furthermore, patients could return to normal activities or work 3–5 days earlier.
Primary failure of the ablated vein was a surrogate outcome of clinical recurrence.
The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.
Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.
However, the incidence of reflux in tributaries and neovascularisation might differ between the procedures with and without sapheno-femoral ligation (i.e., more reflux in tributaries in the procedures without sapheno-femoral ligation, and more neovascularisation after sapheno-femoral ligation
Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction.
Neovascularisation and recurrence 2 years after varicose vein treatment for sapheno-femoral and great saphenous vein reflux: a comparison of surgery and endovenous laser ablation.
) which may influence long-term effectiveness between endovenous techniques and surgery in addition to primary failure.
Pooling primary failure, reflux in tributaries and neovascularisation together as composite outcomes of clinical recurrence resulted in dilution of the RR of EVLA and RFA versus surgery to 1.1 (95% CI:0.6, 2.2; I2 = 63.4%) and 1.1 (95% CI:0.6, 1.8; I2 = 20.7%), respectively (see Supplementary Fig. 10). Subgroup analysis by follow-up and a sensitivity analysis excluding the cryostripping study
Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins.
did not change effects on efficacy. These results and similarity of clinical recurrences demonstrated similarity of effectiveness of RFA and EVLA to surgery. Although UGFS seems to be inferior to surgery, it is still applied in clinical practise because of its lower cost, safety and repeatability.
For postoperative complications, RFA and EVLA had significantly lower wound infection and haematoma, but similar paresthesia and ecchymosis compared to surgery. By contrast, RFA had significantly more superficial thrombophlebitis than surgery. However, these complications might be confounded by TA. Although subgroup analyses by similar of TA in both interventions showed similar results to overall poolings, these were based on small numbers of studies. A sensitivity analysis excluding the study did not perform concomitant phlebectomy
left complication rates unchanged. Deep venous thrombosis was not pooled because it was rare and most studies reported no event.
Our review suggested that EVLA and RFA had significantly lower pain scores than surgery with MD of −0.6 and −1.7, respectively. These reached clinical significance (at least 0.9) for RFA but not for EVLA.
Return to work was significantly sooner with RFA than with surgery but not for EVLA. This might result from different ablative mechanisms which can cause vein wall perforation in EVLA (810 and 980 nm with bare tip),
Comparison of 980 nm laser and bare-tip fibre with 1470 nm laser and radial fibre in the treatment of great saphenous vein varicosities: a prospective randomised clinical trial.
QOL in EVLA and surgery groups were not significantly different. Although all included studies used the same scale (i.e., AVVSS), pooling was moderate heterogeneity (I2 = 60.1%). None of the sources (e.g., mean age, disease severity and follow-up time) could explain heterogeneity.
Although the primary failures between EVLA and RFA versus surgery were similar to previous meta-analyses,
Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.
Consequently, our estimations of treatment effects were more precise. For instance, we included seven studies in pooling primary failure between EVLA versus surgery compared to four for the Cochrane. The corresponding pooled RRs were 1.5 (95% CI:0.7, 3.0) versus 3.30 (95% CI:0.8, 12.74). In addition, more objective pooling of treatments effects on complications, pain, return to normal activities and QOL were discussed in our review. Furthermore, we assessed effects of RFA versus EVLA and UGFS. Our results about the benefit of less pain and return to normal activities in EVLA and surgery were also consistent with, and more precise than the results from a recent large RCT.
The strength of our study was included only in RCTs, the most powerful design for therapeutic study. We considered all relevant outcomes in all techniques currently used nowadays. Treatment effects were mild to moderate heterogeneities with no evidence of publication bias. Therefore, our results should help physicians decide on the most appropriate interventions for their individual patients. However, we had limitations. Some included studies were correlated data, that is, different interventions were applied to the same subjects. The units of analysis for these studies were number of limbs, but pooling based on summary data did not allow adjustment for this correlation. Duration of follow-up varied across studies with a median of 12 months (range 0.2–60 months). Using summary data did not allow us to explore short, intermediate and long-term primary failures and other clinical outcomes of these interventions. Only few studies
Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study.
with long-term follow-up (36 months or longer) were available. The clinical recurrences of endovenous techniques seemed to be lower but not significant than surgery based on four studies. More studies with long-term follow-up are necessary to update. Only one study
Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.
reported cause of clinical recurrence and thus we could not explore whether truncal ablation or other causes play a role of clinical recurrence. Some clinical outcomes (i.e., clinical recurrence, pain score and QOL) were subjective and 56.5% of included studies were poor methodological qualities from which they did not perform blind assessments. An ascertainment bias of outcome measures might be present. Not all included studies had applied ITT analysis for dealing with data; bias from protocol violation (e.g., exclude cannulation failure, incomplete outcome or protocol violation) might be present.
Summary
In summary, UGFS seems inferior to surgery. Primary failure and recurrence rates with EVLA and RFA were not different compared with surgery, but had a lower rate of complications such as wound infection and haematoma, less pain and shorter return to work. Within the endovenous techniques, RFA seems to be slightly better tolerated than EVLA except that it shows a significantly higher rate of superficial thrombophlebitis.
Acknowledgements
We would like to thank Anthony J. Comerota and Stӧtter Lorenz for providing additional data. This study is a part of Boonying Siriburungwong's training in our Ph.D. program for Clinical Epidemiology, Faculty of Medicine Ramathibodi Hospital and Faculty of Graduate Studies, Mahidol University, Bangkok, Thailand.
Conflicts of Interest
None.
Source of Funding
None.
Appendix A. Supplementary material
Supplementary Fig. 1Forest plot of venous clinical severity score between EVLA and surgery.
Supplementary Fig. 10Forest plots of intervention effects on composite outcomes of clinical recurrence (i.e., primary failure, reflux in tributaries, and neovascularization) between endovenous procedures and surgery.
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.
Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years.
Reverse foam sclerotherapy of the great saphenous vein with sapheno-femoral ligation compared to standard and invagination stripping: a prospective clinical series.
A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein.
Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study).
The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.
Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.
Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins.
Comparative outcomes of radiofrequency endoluminal ablation, invagination stripping, and cryostripping in the treatment of great saphenous vein insufficiency.
Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study.
Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).
Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs.
Varisolve® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial.
Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial.
The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.
Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction.
Neovascularisation and recurrence 2 years after varicose vein treatment for sapheno-femoral and great saphenous vein reflux: a comparison of surgery and endovenous laser ablation.
Comparison of 980 nm laser and bare-tip fibre with 1470 nm laser and radial fibre in the treatment of great saphenous vein varicosities: a prospective randomised clinical trial.
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