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 saphenofemoral 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. One of the
hypotheses is that hypoxia-induced activation of the vascular endothelial cells
lining the residual saphenofemoral stump may stimulate angiogenesis by the
release of growth factors .(1) After endovenous ablation contact of endothelial
or perivascular progenitor cells with the surrounding wounded tissue, which
serves as putative trigger for neovascularization, is avoided. (2) 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 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 fiber/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 a 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. .So it looks reasonable to close up the
GSV including the SFJ ( lasercrossectomy) to prevent neoreflux in the AASV
Bare tip endovenous laser fibers 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 laser fiber,
without a forward laser beam, it is possible to occlude the saphenous vein
including 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

Primary Objective:
To prove that there is less development of recurrence and neoreflux seen from
the AASV originating from the SFJ in the lasercrossectomy group than in the
traditionally treated EVLA group.

Secondary Objectives:
The Lasercrossectomy procedure is safe with similar risk of thrombotic
complications after both treatments.
There will be a difference in severity of venous disease and quality of life
measurements in favour of lasercrossectomy

This is a randomised, half-blinded, single centre study. In this study we will
compare group A (n=50) who will have a laser crossectomy and group B (n=50) who
will have the traditional EVLA both with a radial laser fiber . In two years
follow up the occlusion and recurrence rate, CEAP, quality of life, vein
related symptoms and complications will be evaluated.

Lasercrossectomy

After the patient is positioned on the operating table. DUS-guided percutaneous
access to the GSV at the most distal insufficient part is obtained with 18 G
needle. A 5 F 11 cm sheet is introduced and followed by introduction and exact
positioning of the laser fiber tip just caudal of the terminal valve ( TV)
under DUS guidance . If the AASV is joining the GSV cranial from the
terminal valve the AASV will be ablated by the same fiber . Perivenous
tumescent anesthesia with lidocaine 0.05 %; cold saline (5-10 °C) is
administered under DUS guidance with a roller pump (Nouvag Dispenser DP20).
After complete installment of the tumescent fluid the location of the tip of
the fiber is controlled and eventually repositioned if needed. Laser treatment
is performed with continuous mode with a power of 10 Watt.
At the junction a dose 80 joules is given in 8 seconds without moving the tip,
, followed by slowly withdrawing the fiber delivering a targeted energy dose
that is determined by the diameter of the GSV (0.3-0.4 cm=50 J/cm, 0.4-0.5
cm=60 J/cm, 0.5-0.6 cm=70 J/cm, >0.6 cm=80 J/cm.
One week after the EVLA treatments, sclerotherapy (Aethoxysclerol 0.5-3.0%,
Kreussler) of residual superficial varicose veins is performed by a
phlebologist. Whole leg compression stockings (Struva) are applied for one day
and night week and only during daytime for the rest of the week.

Traditional EVLA
After the patient is positioned on the operating table. DUS-guided percutaneous
access to the GSV at the most distal insufficient part is obtained with 18 G
needle. A 5 F 11 cm sheet is introduced and followed by introduction and
positioning of the laser fiber tip 1,5- 2 cm distal of the SFJ ( cranial of
the superior epigastric vein ) under ultrasonographic( DUS) guidance .
Perivenous tumescent anaesthesia with lidocaine 0.05 %; cold saline (5-10 °C)
is administered under DUS with a roller pump (Nouvag Dispenser DP20). After
complete installment of the tumescent fluid the location of the tip of the
fiber is controlled and eventually repositioned if needed. Laser treatment is
performed with continuous mode with a power of 10 Watt
By slowly withdrawing the fiber a targeted energy dose is delivered that is
determined by the diameter of the GSV (0.3-0.4 cm=50 J/cm, 0.4-0.5 cm=60 J/cm,
0.5-0.6 cm=70 J/cm, >0.6 cm=80 J/cm
One week after the EVLA treatments, sclerotherapy (Aethoxysclerol 0.5-3.0%,
Kreussler) of residual superficial varicose veins is performed by a
phlebologist. Whole leg compression stockings (Struva) are applied for one day
and night week and only during daytime for the rest of the week.

Patients referred to our centre with varicose vein disease and a SFJ and GSV
trunk insufficiency and eligible for endovenous laser treatment are screened
for the study. The observations are conducted after one week, as usual, and
extra duplex scans are carried out after 6 months and 1 and 2 years. During
these control visits, a DUS is performed with special emphasis on the groin area
VCSS are generated by the physician. Participants fill in validated
questionnaires (pain VAS, QoL). The contribution of the participants will
consist of completing the questionnaires and additional controls in our centre.
The technique of endovenous laser treatment is not different than from
non-participants in our center. The preoperative assessment and inclusion, the
postoperative monitoring are done by experienced phlebologists and the
endovenous ablation by very experienced surgeons in venous disease With the
radial fiber EVLA is > 5 years experience in > 1000 cases