title: 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.
authors.affiliation: The Cardiovascular Center, Tufts Medical Center, Boston, Mass.
authors.forename: Meghan
authors.initials: M
authors.lastname: Dermody
authors.affiliation: The Cardiovascular Center, Tufts Medical Center, Boston, Mass. Electronic address: todonnell@tuftsmedicalcenter.org.
authors.forename: Thomas F
authors.initials: TF
authors.lastname: O'Donnell
authors.affiliation: Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Mass.
authors.forename: Ethan M
authors.initials: EM
authors.lastname: Balk