Complications of endovenous ablation in randomized controlled trials

Abstract

Background: Endovenous ablation (EVA) of the great saphenous vein (GSV), with radiofrequency (RFA) or laser ablation (EVLA), has largely replaced the standard ligation and stripping (L&S). Several randomized controlled trials (RCTs) have reported data on efficacy of the ablation with little focus on complications. We analyzed the current literature for short-term complications of EVA as compared with L&S.

Methods: We searched MEDLINE, the Cochrane Central Trials Registry, and individual journals from January 2008 through January 8, 2013 for RCTs comparing RFA and/or EVLA and/or L&S to treat GSV incompetence. We excluded studies using foam sclerotherapy, re-do GSV surgery, or the addition of a high GSV ligation to an EVA procedure. We meta-analysized short-term (<1 year) complications using the Peto odds ratio to elucidate differences between RFA (using the VNUS ClosureFAST catheter; VNUS Medical Technologies, Inc, San Jose, Calif), EVLA, and L&S.

Results: Seventeen RCTs met inclusion criteria. There were 317 patients who underwent RFA with ClosureFAST, 1057 patients who had EVLA, and 975 who had L&S. Seventy percent were female with a mean age of 47.5 years. The majority had CEAP clinical class 2 or 3. There was an overall complication rate of 39.6% in the 2624 limbs analyzed over all procedures. There was no evidence of a difference in the rates of venous thromboembolism. There was a significantly higher rate of wound infection for L&S (2.3%; 95% confidence interval [CI], 1.3%-3.1%) vs EVLA (0.5%; 95% CI, 0.3%-1.3%; P = .006), but not between L&S and RFA (1.5%; 95% CI, 0.4%-3.0%; P = .094). The paresthesia rate was significantly lower with EVLA (3.8%; 95% CI, 2.4%-4.5%) as compared with RFA (5.2%; 95% CI, 3.1%-7.9%; P < .001) and L&S (7.4%; 95% CI, 5.3%-8.3%; P < .001). The rate of thrombophlebitis was significantly lower for L&S (3.0%; 95% CI, 2.9%-4.0%) as compared with RFA (5.5%; 95% CI, 3.0%-7.8%; P = .003) and EVLA (5.6%; 95% CI, 4.2%-7.0%; P = .003). There was no difference in the rate of thermal skin burns between RFA and EVLA.

Conclusions: Endovenous ablation and ligation and stripping of the GSV are not without complications, although usually minor. L&S has a higher wound infection rate and a lower thrombophlebitis rate as compared with EVA. EVLA has a significantly lower rate of paresthesia as compared with RFA and L&S. Thermal skin burns occur with equal frequency in RFA and EVLA.