Endovenous ablation therapy (laser or radiofrequency) or foam sclerotherapy versus conventional surgical repair for short saphenous varicose veins.
BACKGROUND Short (or small) saphenous vein (SSV) varices occur as a result of an incompetent sapheno popliteal junction, where the SSV joins the popliteal vein, resulting in reflux in the SSV; they account for about 15% of varicose veins. Untreated varicose veins may sometimes lead to ulceration of the leg, which is difficult to manage. Traditionally, treatment was restricted to surgery or conservative management. Since the 1990s, however, a number of minimally invasive techniques have been developed; these do not normally require a general anaesthetic, are day case procedures with a quicker return to normal activities and avoid the risk of wound infection which may occur following surgery. Nerve injury remains a risk with thermal ablation, but in cases where it does occur, the injury tends to be transient. OBJECTIVES To compare the effectiveness of endovenous laser ablation (EVLA) radiofrequency ablation (RFA) and ultrasound guided foam sclerotherapy (UGFS) versus conventional surgery in the treatment of SSV varices. SEARCH METHODS The Cochrane Vascular Information Specialist searched the Specialised Register (last searched 17 March 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2) We searched clinical trials databases for details of ongoing or unpublished studies. SELECTION CRITERIA We considered all randomised controlled trials (RCTs) comparing EVLA, endovenous RFA or UGFS with conventional surgery in the treatment of SSV varices for inclusion. DATA COLLECTION AND ANALYSIS We independently reviewed, assessed and selected trials that met the inclusion criteria; any disagreements were resolved by discussion. We extracted data and used the Cochrane's tool for assessing risk of bias. When the data permitted, we performed either fixed effect meta analyses with odds ratios (ORs) and 95% confidence intervals (CIs) or random effects meta analyses where there was moderate to significant heterogeneity. MAIN RESULTS We identified three RCTs, all of which compared EVLA with surgery; one also compared UGFS with surgery. There were no trials comparing RFA with surgery. The EVLA versus surgery comparison included 311 participants: 185 received EVLA and 126 received surgery. In the UGFS comparison, each treatment group contained 21 people. For several outcomes in the EVLA comparison, only a single study provided relevant data; as a result, the current review is limited in its ability to demonstrate meaningful results for some planned outcomes. The quality of evidence according to GRADE was moderate to low for the outcome measures in the EVLA versus surgery comparison, but low for the UGFS versus surgery comparison. Reasons for downgrading in the EVLA versus surgery comparison were risk of bias (for some outcomes, the outcome assessors were not blinded; and in one study the EVLA surgery allocation of 2:1 did not appear to be prespecified) imprecision (data were only available from a single small study and the CIs were relatively wide) indirectness (one trial reported results at six months rather than one year and was inadequately powered for SSV varices only analysis) Reasons for downgrading in the UGFS versus surgery comparison were imprecision (only one trial offered UGFS and several participants were missing from the analysis) and a limitation in design (the study was inadequately powered for SSV participants alone).For the EVLA versus surgery comparison, recanalisation or persistence of reflux at six weeks occurred less frequently in the EVLA group than in the surgery group (OR 0.07, 95% CI 0.02 to 0.22; I2 51% 289 participants, 3 studies, moderate quality evidence) Recurrence of reflux at one year was also less frequent in the EVLA group than in the surgery group (OR 0.24, 95% CI 0.07 to 0.77; I2 0% 119 participants, 2 studies, low quality evidence) For the outcome clinical evidence of recurrence (i.e. presence of new visible varicose veins) at one year, there was no difference between the two treatment groups (OR 0.54, 95% CI 0.17 to 1.75; 99 participants, 1 study, low quality evidence) Four participants each in the EVLA and surgery groups required reintervention due to technical failure (99 participants, 1 study, moderate quality evidence) There was no difference between the two treatment groups for disease specific quality of life (QoL) (Aberdeen Varicose Veins Questionnaire) either at six weeks (mean difference (MD) 0.15, 95% CI 1.65 to 1.95; I2 0% 265 participants, 2 studies, moderate quality evidence) or at one year (MD 1.08, 95% CI 3.39 to 1.23; 99 participants, 1 study, low quality evidence) Main complications reported at six weeks were sural nerve injury, wound infection and deep venous thrombosis (DVT) (one DVT case in each treatment group; EVLA: 1/161, 0.6% surgery 1/104, 1% 265 participants, 2 studies, moderate quality evidence).For the UGFS versus surgery comparison, there were insufficient data to detect clear differences between the two treatment groups for the two outcomes recanalisation or persistence of reflux at six weeks (OR 0.34, 95% CI 0.06 to 2.10; 33 participants, 1 study, low quality evidence) and recurrence of reflux at one year (OR 1.19, 95% CI 0.29 to 4.92; 31 participants, 1 study, low quality evidence) No other outcomes could be reported for this comparison because the study data were not stratified according to saphenous vein. AUTHORS' CONCLUSIONS Moderate to low quality evidence exists to suggest that recanalisation or persistence of reflux at six weeks and recurrence of reflux at one year are less frequent when EVLA is performed, compared with conventional surgery. For the UGFS versus conventional surgery comparison, the quality of evidence is assessed to be low; consequently, the effectiveness of UGFS compared with conventional surgery in the treatment of SSV varices is uncertain. Further RCTs for all comparisons are required with longer follow up (at least five years) In addition, measurement of outcomes such as recurrence of reflux, time taken to return to work, duration of procedure, pain, etc. and choice of time points during follow up should be standardised such that future trials evaluating newer technologies can be compared efficiently.
The Cochrane database of systematic reviews