Comparison of Two Different Safety Distances to Sapheno-femoral Junction for EndoVenous Laser Ablation Treatment of Great Saphenous Vein Incompetence: a Prospective Randomized Double-blind Study

Introduction and background information Chronic venous disease is one of the most common diseases in the western world and worldwide with a prevalence of 83,6%. It is a chronic progressive disease, which causes a significant burden on health systems, treatment and care of these patients.

There are different methods for treatment of insufficiency of the GSV, which have good evidence: open surgery and minimally invasive techniques including ultrasound-guided foam sclerotherapy (UGFS), radiofrequency ablation (RFA) and endovenous laser ablation (EVLA). UGFS and thermal ablation techniques such as EVLA have become widely used alternatives to surgery for the treatment of venous reflux. The safety and efficacy of EVLA has been demonstrated in several studies. According to guidelines of the European Venous Forum (EVF), the International Union of Angiology (IUA) and the European Society for Vascular Surgery (ESVS) the treatment of GSV reflux with EVLA is recommended in preference to surgery, Grade of Recommendation 1A.

Rationale of the project Recurrence of varicose veins after successful treatment remains a problem and has been reported in up to 30% of patients after EVLA. Treatment with EVLA aims at complete obliteration of the vein in the treated area. According to the literature a safety distance of 1-2 cm from the sapheno-femoral junction (SFJ) is obligatory in all patients undergoing EVLA of the GSV. In earlier trials laser systems equipped with a bare fibre were used, which emit shorter wavelength of 810 nm antegrade with an absorption maximum in the range of haemoglobin. A new generation of laser devices with a wavelength of 1470 nm has been introduced in recent years. The absorption coefficient of water at 1470 nm is significantly higher than in the wavelength range of 810 - 1064 nm, which results in a much better control of the laser energy applied. The patented radial (360°) fibre ensures radial delivery of energy inducing homogenous photothermal destruction of the vein wall. By avoiding perforation of the vein wall and associated thermal irritation of the surrounding tissue, post-operative pain is minimized, as are ecchymosis and other side effects noticed with the previously used bare fibres.

In prospective studies it has been demonstrated that EVLA of the GSV using radial fibres has fewer side effects compared to EVLA of the GSV using bare fibre. It is not known whether the use of radial fibres results in a complete vascular closure of GSV up to the SFJ, and whether a remaining non-occluded vessel stump could be a cause of recurrence. Applying EVLA without keeping a distance of 1-2 cm to the SFJ is used with increasing frequency by many specialists, but there is no controlled data about this topic.

At our department the investigators use a 1470 nm laser with radial fibres without keeping a distance to SFJ and have no complications observed so far.