Editor's Choice - A Randomised, Single Blind, Controlled Trial Comparing Flush Endovenous Laser Ablation with Standard Endovenous Laser Ablation of the Great Saphenous Vein.
Objective: The aim of this study was to compare anterior accessory saphenous vein (AASV) reflux after standard endovenous laser ablation (EVLA) with flush EVLA (f-EVLA) of the great saphenous vein (GSV).
Methods: This was as randomised, single blind, controlled trial (Dutch Trial Register, NL5283). Patients with GSV and saphenofemoral junction incompetence and a competent AASV were randomised to standard EVLA or f-EVLA using a 1 470 nm radial fibre. Treatment was blinded both for patients and phlebologists. The primary outcome was AASV reflux assessed at one week and six, twelve, and twenty four months. Secondary outcomes included GSV occlusion, stump length, endovenous heat induced thrombi (EHIT), complications, pain, time to return to daily activities, Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ) score, cosmetic results, and re-interventions.
Results: Fifty-two patients were randomised to standard EVLA and 49 to f-EVLA. After twenty four months, AASV reflux occurred in 21% after standard EVLA and 30% after f-EVLA (risk ratio 1.53, 95% confidence interval 0.64 - 3.66; p = .34). Freedom from AASV reflux was 81% after standard EVLA vs. 74% after f-EVLA (log rank test, χ2 = 0.68, 1 df, p = .41). The GSV occlusion rate was 98% vs. 100%, respectively (p = .33). Mean stump length ± standard deviation was longer after standard EVLA (8 ± 4 mm vs. 4 ± 4 mm; p < .001). Endovenous heat induced thrombosis class I occurred more frequently after f-EVLA (57% vs. 17%; p < .001). Endovenous heat induced thrombosis class II was seen in 2% vs. 6%, respectively (p = .34). The superficial vein thrombosis rate was 2% after standard EVLA (p = .33) and the paraesthesia rate was 4% after f-EVLA (p = .23). Pain levels, time to return to daily activities, and cosmetic results were comparable, as were VCSS and AVVQ scores.
Conclusions: Flush EVLA of the GSV using a radial two ring laser does not reduce AASV reflux at twenty four months compared with standard EVLA.