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

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Abstract

BACKGROUND:

OBJECTIVE

: To review available randomized controlled clinical trials (RCT) data comparing USGFS, RFA, EVLT to HL/S for the treatment of great saphenous varicose veins.

METHODS

: Search methods: The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialized Register (July 2010) and CENTRAL (The Cochrane Library 2010, Issue 3). In addition the authors performed a search of EMBASE (July 2010). Manufacturers of EVLT, RFA and sclerosant equipment were contacted for trial data. Selection criteria: All RCTs of EVLT, RFA, USGFS and HL/S were considered for inclusion. Primary outcomes were recurrent varicosities, recanalization, neovascularization, technical procedure failure or need for re-intervention, patient quality of life (QoL) scores and associated complications. Secondary outcomes were type of anaesthetic, procedure duration, hospital stay and cost. Data collection and analysis: CN, RE, VB, PC, HB and GS independently reviewed, assessed and selected trials which met the inclusion criteria. CN and RE extracted data. The Cochrane Collaboration's tool for assessing risk of bias was used. CN contacted trial authors to clarify details.

MAIN RESULTS:

Thirteen reports from five studies with a combined total of 450 patients were included. Rates of recanalization were higher following EVLT compared with HL/S, both early (within four months) (5/149 versus 0/100; odds ratio (OR) 3.83, 95% confidence interval (CI) 0.45 to 32.64) and late recanalization (after four months) (9/118 versus 1/80; OR 2.97; 95% CI 0.52 to 16.98), although these results were not statistically significant. Technical failure rates favoured EVLT over HL/S (1/149 versus 6/100; OR 0.12, 95% CI 0.02 to 0.75). Recurrence following RFA showed no difference when compared with surgery. Recanalization within four months was observed more frequently following RFA compared with HL/S although not statistically significant (4/105 versus 0/88; OR 7.86, 95% CI 0.41 to 151.28); after four months no difference was observed. Neovascularization was observed more frequently following HL/S compared with RFA, but again this was not statistically significant (3/42 versus 8/51; OR 0.39, 95% CI 0.09 to 1.63). Technical failure was observed less frequently following RFA compared with HL/S although this was not statistically significant (2/106 versus 7/96; OR 0.48, 95% CI 0.01 to 34.25). No randomised clinical trials comparing HL/S versus USGFS met our study inclusion criteria. QoL scores and operative complications were not amenable to meta-analysis.

AUTHORS' CONCLUSIONS:

Currently available clinical trial evidence suggests RFA and EVLT are at least as effective as surgery in the treatment of great saphenous varicose veins. There are insufficient data to comment on USGFS. Further randomized trials are needed. We should aim to report and analyze results in a congruent manner to facilitate future meta-analysis.

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Most cited references 2

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

Hassan Badri, C. P. Coyne, Robin Nesbitt … (2010)

Minimally invasive techniques to treat great saphenous varicose veins include ultrasound-guided foam sclerotherapy (USGFS), radiofrequency ablation (RFA) and endovenous laser therapy (EVLT). Compared with conventional surgery (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. To review available randomised controlled clinical trials (RCT) data comparing USGFS, RFA, EVLT to HL/S for the treatment of great saphenous varicose veins. The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialised Register (July 2010) and CENTRAL (The Cochrane Library 2010, Issue 3). In addition the authors performed a search of EMBASE (July 2010). Manufacturers of EVLT, RFA and sclerosant equipment were contacted for trial data. All RCTs of EVLT, RFA, USGFS and HL/S were considered for inclusion. Primary outcomes were recurrent varicosities, recanalisation, neovascularisation, technical procedure failure or need for re-intervention, patient quality of life (QoL) scores and associated complications. Secondary outcomes were type of anaesthetic, procedure duration, hospital stay and cost. CN, RE, VB, PC, HB and GS independently reviewed, assessed and selected trials which met the inclusion criteria. CN and RE extracted data. The Cochrane Collaboration's tool for assessing risk of bias was used. CN contacted trial authors to clarify details. Thirteen reports from five studies with a combined total of 450 patients were included. Rates of recanalisation were higher following EVLT compared with HL/S, both early (within four months) (5/149 versus 0/100; odds ratio (OR) 3.83, 95% confidence interval (CI) 0.45 to 32.64) and late recanalisation (after four months) (9/118 versus 1/80; OR 2.97 95% CI 0.52 to 16.98), although these results were not statistically significant. Technical failure rates favoured EVLT over HL/S (1/149 versus 6/100; OR 0.12, 95% CI 0.02 to 0.75). Recurrence following RFA showed no difference when compared with surgery. Recanalisation within four months was observed more frequently following RFA compared with HL/S although not statistically significant (4/105 versus 0/88; OR 7.86, 95% CI 0.41 to 151.28); after four months no difference was observed. Neovascularisation was observed more frequently following HL/S compared with RFA, but again this was not statistically significant (3/42 versus 8/51; OR 0.39, 95% CI 0.09 to 1.63). Technical failure was observed less frequently following RFA compared with HL/S although this was not statistically significant (2/106 versus 7/96; OR 0.48, 95% CI 0.01 to 34.25). No randomised clinical trials comparing HL/S versus USGFS met our study inclusion criteria. QoL scores and operative complications were not amenable to meta-analysis. Currently available clinical trial evidence suggests RFA and EVLT are at least as effective as surgery in the treatment of great saphenous varicose veins. There are insufficient data to comment on USGFS. Further randomised trials are needed. We should aim to report and analyse results in a congruent manner to facilitate future meta-analysis.