Tomy; lasercrossectomy versus EVLA

For ten years ago High (Flush) Ligation and Stripping (HL/S) of the Great Saphenous Vein (GSV) was the standard treatment for GSV incompetence. During the procedure all tributaries entering the sapheno-femoral junction (SFJ) were ligated and/or resected, followed by stripping of the thigh portion of the GSV. Inadequate ligation of the sapheno-femoral Junction (SFJ) and these tributaries is suggested to be one of the causes of recurrent varicosities. However, current minimally invasive techniques that abolish axial vein reflux do not specifically interrupt these tributaries and critics of these techniques believe that this may compromise their durability. Duplex Ultrasound (DUS)-findings after HL/S revealed that besides inadequate ligation the majority of recurrence was secondary to neovascularisation at the SFJ. However on the other hand, endovenous procedures are associated with a risk for recanalization and neoreflux in persistent open junctional tributaries. Several RCT’s comparing endovenous ablation with HL/S showing apparently more neoreflux in groin related tributaries, especially the anterior accessory saphenous vein (AASV) after endovenous ablation in comparison with HL/S. (3-6, 7) One of the reasons can be the positioning of the tip of the fibre/catheter not close enough to the SFJ. This will increase the risk leaving a residual stump with open tributaries that arises the possibility that they become incompetent by pressure through an incompetent terminal valve which cause neoreflux.(8) To diminish the prevalence of SFJ recurrence caused by incompetent accessory veins after endovenous ablation it could be wise to avoid a residual GSV stump formation if possible analogous to open surgery. In most cases, if present, the AASV joins the GSV closest to the SFJ to prevent neoreflux in the AASV.

Bare tip endovenous laser fibres and ClosureFAST RFA catheters both have a forward thrust of heat associated with the technique. That’s why many authors advise to stay about 1,5- 2 cm of the confluence to prevent intimal damage at the SFJ which can provoke a heat induced thrombus (EHIT) or deep venous thrombosis (DVT). (9) It is assumed that with the use of a radial two ring laser fibre, without a forward laser beam, it is possible to occlude the saphenous vein more close the SFJ in a safe way.(10) To prove that this occlusion leads to less varicose vein recurrence caused by axial neoreflux in AASV, we want to study patients in which a visible AASV is present before treatment. (50% of patients) (7, 11) It is also important to investigate what happens with the other tributaries in both groups and if occlusion will induce neovascularization.

ABR nr. 52367 Tomy study Investigator: JA Lawson

Sponsor: Biolitec versie 1.1 Coordinator: SA Gauw

Version number: 1.0; may 2015 8 of 43

Objective:

The aim of this randomized controlled study is to detect less clinical AASV recurrence with neoreflux at 1 and 2 years follow-up after Laser crossectomy in comparison with usual EVLA
using a 1470 nm radial two rings fibre. (Biolitec)

The aim of this randomized controlled study is to find a difference in clinical AASV recurrence with neoreflux at 1 and 2 years follow-up after Laser crossectomy in comparison with usual EVLA using a 1470 nm radial two rings fibre. (Biolitec)

4 x in 2 years

EVLA and lasercrossectomy