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Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices

Lookup NU author(s): Craig Nesbitt, Vish Bhattacharya, Professor Gerard Stansby

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Abstract

BackgroundMinimally invasive techniques to treat great saphenous varicose veins include ultrasound-guided foam sclerotherapy (UGFS), radiofrequency ablation (RFA) and endovenous laser therapy (EVLT). Compared with flush saphenofemoral ligation with stripping, also referred to as open surgery or high ligation and stripping (HL/S), proposed benefits include fewer complications, quicker return to work, improved quality of life (QoL) scores, reduced need for general anaesthesia and equivalent recurrence rates. This is an update of a review first published in 2011.ObjectivesTo determine whether endovenous ablation (radiofrequency and laser) and foam sclerotherapy have any advantages or disadvantages in comparison with open surgical saphenofemoral ligation and stripping of great saphenous vein varices.Search methodsFor this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched January 2014) andCENTRAL (2013, Issue 12). Clinical trials databases were also searched for details of ongoing or unpublished studies.Selection criteriaAll randomised controlled trials (RCTs) of UGFS, EVLT, RFA and HL/S were considered for inclusion. Primary outcomes were recurrent varicosities, recanalisation, neovascularisation, technical procedure failure, patient QoL scores and associated complications.Data collection and analysisCN and RB independently reviewed, assessed and selected trials which met the inclusion criteria. CN and RB extracted data and used the Cochrane Collaboration's tool for assessing risk of bias. CN and RB contacted trial authors to clarify details as needed.Main resultsFor this update, eight additional studies were included making a total of 13 included studies with a combined total of 3081 randomised patients. Three studies compared UGFS with surgery, eight compared EVLT with surgery and five compared RFA with surgery (two studies had two or more comparisons with surgery). Study quality, evaluated through the six domains of risk of bias, was generally moderate for all included studies, however no study blinded participants, researchers and clinicians or outcome assessors. Also, nearly all included studies had other sources of bias. The overall quality of the evidence was moderate due to the variations in the reporting of results, which limited meaningful meta-analyses for the majority of proposed outcome measures. For the comparison UGFS versus surgery, the findings may have indicated no difference in the rate of recurrences in the surgical group when measured by clinicians, and no difference between the groups for symptomatic recurrence (odds ratio (OR) 1.74, 95% confidence interval (CI) 0.97 to 3.12; P = 0.06 and OR 1.28, 95% CI 0.66 to 2.49, respectively). Recanalisation and neovascularisation were only evaluated in a single study. Recanalisation at < 4 months had an OR of 0.66 (95% CI 0.20 to 2.12), recanalisation > 4 months an OR of 5.05 (95% CI 1.67 to 15.28) and for neovascularisation anOR of 0.05 (95% CI 0.00 to 0.94). There was no difference in the rate of technical failure between the two groups (OR 0.44, 95% CI 0.12 to 1.57). For EVLT versus surgery, there were no differences between the treatment groups for either clinician noted or symptomatic recurrence (OR 0.72, 95% CI 0.43 to 1.22; P = 0.22 and OR 0.87, 95% CI 0.47 to 1.62; P = 0.67, respectively). Both early and late recanalisation were no different between the two treatment groups (OR 1.05, 95% CI 0.09 to 12.77; P = 0.97 and OR 4.14, 95% CI 0.76 to 22.65; P = 0.10). Neovascularisation and technical failure were both statistically reduced in the laser treatment group (OR 0.05, 95% CI 0.01 to 0.22; P < 0.0001 and OR 0.29, 95% CI 0.14 to 0.60; P = 0.0009, respectively). Long-term (five-year) outcomes were evaluated in one study so no association could be derived, but it appeared that EVLT and surgery maintained similar findings. Comparing RFA versus surgery, there were no differences in clin


Publication metadata

Author(s): Nesbitt C, Bedenis R, Bhattacharya V, Stansby G

Publication type: Review

Publication status: Published

Journal: Cochrane Database of Systematic Reviews

Year: 2014

Issue: 7

Pages: 1-95

Online publication date: 30/07/2014

ISSN (print): 1469-493X

ISSN (electronic): 1361-6137

Publisher: WILEY-BLACKWELL

URL: http://dx.doi.org/10.1002/14651858.CD005624.pub3

DOI: 10.1002/14651858.CD005624.pub3


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