Endovenous laser ablation versus mechano-chemical endovenous ablation in the treatment of great saphenous incompetence: a multicentric, randomized controlled trial

Varicose veins are a common problem in the Western world. Epidemiological
studies show that 25% of adults have some form of varicose veins. Women are two
to three times more affected than men. The incidence of varicose veins
increases steadily with age and are among the top ten of the complaints that
people visit their GP. The main risk factors include prolonged standing or
sitting, pregnancy, sex and age. Symptoms of varicose veins are variable and
range from cosmetic complaints to venous ulcers.
Stripping the great saphenous vein (GSV) has been the gold standard for GSV
incompetence for more than 100 years. Surgery is performed under regional or
general anesthesia and has a high recurrence rate of 18-40% in 5 years. In
addition, surgery can leads to significant postoperative symptoms, particularly
pain and hematoma formation and the risk of injury to the saphenous nerve.
Recently, endovenous techniques has been developed for the treatment of
varicose veins. Endovenous laser ablation (EVLA) is an accepted technique
nowadays and is frequently used in practice. This technique, which uses heat as
treatment source, can be performed with local anesthesia. In addition, EVLA
causes less hematoma formation, pain, and superior cosmetics and earlier
resumption of normal activities and work compared to traditional surgical
stripping.
Thermal ablative modalities are at higher risk to damage the surrounding
tissues of the vein. For this reason, patients are treated with tumiscence
anesthesia, which requires multiple punctures around the vein. With tumescence
anesthesia a liquid column is injected around the vessel, which is a painfull
experience by most patients. Despite tumiscence anesthesia still a subset of
patients have postoperative pain, which can last up to weeks.

A new innovative technique, mechano-chemical endovenous ablation (MECEA), using
the ClariVeinTM system was recently developed. This technique uses a rotating
wire in a catheter to create mechanical damage to the endothelium of the
vessel. At the same time a sclerosans is injected at the end of the catheter,
occluding the vein. With MECEA no heating of the vein is used. Tumiscence
anesthesia is redundant and complications that occur in thermal ablative
modalities, such as pain, hematoma formation, induration and paresthesias could
be reduced.
In Europe, the ClariVein device is registrered on April 26, 2010, CE 558 723.
Results of the first human study in USA showed that occlussion percentage after
6 months was 97%. In this study, 30 patients with primary GSV insufficiency
were treated without tumescence anesthesia or sedation. The average age was 55
years. The diameter of the GSV near the saphenofemoral junction was 8.1 mm on
average . The treated section of the saphenous vein magna averaged 36 cm. After
a follow-up of 6 monthsm, 29 of the 30 treated GSV were occluded . Echymosis
were seen in 3 patients. In addition, there was no deep vein thrombosis or
related complications to sclerosans.
We have recently reported a second study on the safety and efficacy of MECEA in
30 patients. The success rate after 6 weeks was 97%. With duplex examination
recanalization was observed in 1 patient. This patient underwent a successful
recurrent treatment with MECEA. Three patients had an open segment of the
proximal GSV. Therefore, the treatment protocol was adapted, positioning the
tip of the rotating wire closer to the saphenofemoral junction. The mean
treatment time was 20 minutes and patients had median pain scores of 4 during
treatment (visual analog scale 0-10). The 'Venous Clinical Severity Score ", an
objective measure of varices-specific symptoms improved after treatment.
Patients were very satisfacted after treatment with an average of 8.8 (0-10
scale). Near the injection site, small ecchymosis were observed in 9 patients.

The Clari-laser study is designed to evaluate the following questions:

1. What is the succes rate of MECEA versus EVLA on short and long term?
2. Are the results after treatment both clinically and technically comparable?
3. What are the per-and post-procedural complications of MECEA versus EVLA?
4. What are the pain scores of patients during treatment and 2 weeks after
treatment of MECEA versus EVLA?
5. Are there differences between intervention duration of MECEA versus EVLA?
6. What are the costs of treatment of MECEA versus EVLA?
7.Does quality of life improve after treatment, MECEA versus EVLA?

814 patients with primary great saphenous incompetence magna are included in
the Clari-laser study after signing informed consent . The preprocedural status
will be determined by the CEAP score and VCSS (Venous Clinical Severity Score).
After randomization, the GSV is obliterated in day treatment:
- Group / arm 1: endovenous laser ablation (EVLA)
- Group / arm 2: mechano-chemical endovenous ablation (MECEA)


After 4 weeks, 6 months, 1 year, 2 years and 5 years patients are seen on the
outpatient clinic to observe the clinical success after treatment objectively.
During this visit, a duplex examination is also performed to assess if the GSV
remains obliterated. Duplex examination is done according to a standardized
protocol.
Also, pain scores after treatment are evaluated using a linear VAS score of
0-10. To assess secondary endpoints, SF-36 healthy nature test and the recently
validated "Dutch translated Aberdeen varicose Vein Questionnaire are used. Both
questionnaires are completed preoperatively, after 4 weeks, 6 months, 1 year,
2 years and 5 years of follow-up. After 4 weeks, any small branch varicosities
can be treated.

Endovenous laser ablation

Endovenous laser therapy or ablation is a minimally invasive treatment for
varicose vein incompetence. This technique uses laser light to heat the greater
saphenous vein. The endovenous catheter is inserted into the vein and laser
energy is delivered to the endothelium with collapsing and sealing of the vein
as effect. During the Clari-laser study, all participating centers are using
the same laser equipment.
The procedure starts with ultrasound guided puncture of the vein with a needle.
Through the needle a guidewire inserted into the vein. After the guidewire is
in place, the needle is removed, and a small cutaneous incision of 3 mm is
made. An introducer sheath will pass over the guidewire and is positioned a few
centimeters below the saphenofemoral junction. Subsequently, the laser fiber
can be introduced after removing the guidewire.
The exact positioning of the laserfiber is the most pivotal step in endovenous
laser ablation, and is performed under ultrasound guidance, 1.5 to 2 cm distal
to the saphenofemoral junction. Then, tumiscence anesthesia is administrered
around the great saphenous vein. The fiber laser is activated and withdrawn at
an average speed of 2mm/sec, depending on the diameter of the VSM, until the
entire vein is treated with 60-70 J / cm. After treatment, the deep venous
system is controlled by ultrasound. Eventually, the treated vein develops into
to scar tissue.
During the procedure, special safety glasses are worn by patient and staff. A
supportive compression stocking (Class 2, 30-40 mmHg) will be applied for 24
hours continuously and for 2 weeks daily. Patients can resume to normal
activities directly after the procedure


Mechano-Endovenous Chemical Ablation (MECEA)

MECEA is a new technique for endovenous treatment of great saphenous
imcompetence using the ClariVein devive. ClariVein device is an infusion
catheter which is designed to administer a sclerosant in the incompetent vein
through an opening at the end of the catheter. A iron wire extends through the
whole catheter, with a small iron ball at the end. The catheter, together with
iron wire are connected to a motorized handle that allows rotation of the metal
wire.
The incompetent vein is punctured with a 17-gauge needle, usually at the knee.
A 4 Fr or 5Fr introduction sheath is introduced into the vein, over a short
guidewire. Then, the Clarivein catheter is introduced and placed 0.5 cm below
the saphenofemoral junction without using a guidewire. Importantly, the
position of the catheter is controlled by ultrasound, as with other endovenous
techniques, to minimize the risk of deep venous thrombosis after treatment. The
iron ball at the end of the wire improves ultrasound-guided detection and is
easy to visualize. The patient is placed in a neutral horizontal position, when
wire is activated with a motorized handle. The purpose of the rotating wirer is
fourfold: (1) promoting the coagulation activation by minimal mechanical damage
to the endothelium, (2) inducing a vasospasm which reduces the diameter of the
vein, (3) increasing the action of sclerosans by an increase in surface, (4)
ensuring an even distribution of the sclerosans at the endothelium.
For 5 seconds, the rotating wire is activated to induce vasospasm. Then the
rotating wire is slowly withdrawn with a speed of about 7 seconds per
centimeter, while the sclerosans is continuously injected. After the ClariVein
system is removed, the patient receives a compression stocking with a pressure
of 20-30 mmHg for two weeks, on daily basis. Patients are asked to walk
immediately after treatment and advised to to resume daily activities as soon
as possible.
Polidocanol (Aethoxysklerol) is used as sclerosans, which is the only
registered sclerosans in the Netherlands and is often used for sclerotherapy of
reticular veins. The maximum amount Aethoxysklerol depends on the weight of the
patient and will always be less than 2 mg / kg. The first proximal segment of
the VSM (10 cm) is treated with Aethoxysklerol 2%, when the remainder part of
the greater saphenous vein is treated with Aethoxysklerol 1.5%.
Prior to treatment, the maximum allowable amount Aethoxysklerol is determined
for each patient. Then the length of the treated vein is measured. Both values
are listed on the study form. After treatment, the deep venous system
controlled by ultrasound.

Patients with primary great saphenous incompetence are treated in an outpatient
setting. The puncture site of the catheter is not different from other
endovenous techniques.
In addition, patient have 5 duplex examinations in the postoperative period ( 4
weeks, 6 months, 1 year, 2 years, 5 years), which is four times higher than
with regular treatment. After all duplex examinations patients, 2 quality of
live questionairs are completed.