Results from a Czech study indicate that 1470nm laser treatment of saphenous vein reflux with both radial single-ring and 2ring fibres results in clinical improvement of symptoms and comparable occlusion rates. That said, in the early postoperative period, 2ring laser radial fibre “seems to remove the quality of life limitations associated with traditional single-ring radial fibre use,” said Robert Vlachovsky (Brno, Czech Republic) when he presented his findings at the 2017 European Venous Forum (EVF; 29 June–1 July, Porto, Portugal).
Chronic venous disorder is one of the most prevalent worldwide diseases, affecting approximately 25% of the adult population, Vlachovsky told EVF delegates. It is associated with a full spectrum of clinical symptoms and includes cosmetic concerns and quality of life issues. Chronic venous insufficiency (C3–C6) has a prevalence of approximately 17% worldwide.
Vlachovsky explained that the 1470nm single-radial fibre laser system creates a homogenous effect with less perforation (and therefore less pain and bruising) while sticking to the vein. The 2ring fibre laser gives an even more homogenous distribution of energy into the vein wall, with a less pronounced sticking effect, he said.
Vlachovsky and colleagues conducted their study to compare the clinical efficacy and safety of these two laser systems in endovenous laser ablation of saphenous varicose veins of the lower limb. The study was a non-randomised prospective study of 94 patients with primary varicose veins, treated from January 2013 to September 2015. Patients with CEAP C2–C4 were included, and the lengths of treated great saphenous veins were all >30cm. Great saphenous vein diameter was ≤20mm in a standing position and all patients were older than 20 years. Patient follow-up was performed at days one and seven, and then at three, six and 12 months after the procedure. No adjunctive treatments were performed in the 12 months post-procedure. There were no significant demographic differences between the two groups.
The primary efficacy endpoint was occlusion rate as measured by duplex ultrasound and one and six days, and three and six month post-surgery. The primary safety endpoint was incidence of pain during the same observation period.
The procedures were conducted using a 1470nm laser (ELVeS, Biolitec) with an ultrasound-guided percutaneous approach. Tumescent local anaesthesia was used in the track of the great saphenous vein, with fibre inserted and positioned 1cm distal to the sapheno-femoral junction. The power used was 10W with continuous fibre pullback and the linear endovenous energy dose was 80–94J/cm. Concomitant phlebectomy was used in all patients and thigh compression stockings were worn for three weeks.
For the single-radial fibre group, occlusion rates were 100% at one day and 97.9% at six days, six months and twelve months. For the 2ring fibre group, the occlusion rate was 100% at all time points. The differences were no statistically significant.
Rates of pain in the treated area were 14.8% for the single-radial fibre group and 3% in the 2ring fibre group, but this difference was not significant. Vlachovsky and colleagues also recorded changes in visual analogue scale (VAS) of pain over 12 months of follow-up. The maximum mean VAS for the single-radial fibre group was 20.5±17.6 compared with 6.4±4.4 for the 2ring fibre group (p<0.0001). Bruising was more prominent in the single-radial fibre group (37%) than in the 2ring fibre group (6.5%) (p<0.0001).
The most common postoperative complications in both groups was induration (single-radial fibre group 8.3% vs. 2ring fibre group 4.3%, p=0.118). Other complications in the single-radial fibre group included erythema (6.5%), tenderness (4.3%), and paraesthesia (2.2%). Other complications in the 2ring fibre group included paraesthesia (4.2%) and erythema (2%). There was no equipment failure in this study.
“Endovenous laser treatment of saphenous vein reflux with 1470nm lasers using both fibre types results in clinical improvement of symptoms and comparable occlusion rates,” Vlachovsky concluded, while the 2ring laser single-radial fibre appears to remove quality-of-life limitations associated with traditional single-radial fibre, at least in the early postoperative period.