Registry of the treatment of primary insufficiency of the great saphenous vein with a diameter >/= 12 mm, antero-lateral branches, or great saphenous vein insufficiency below the knee with mechano-chemical endovenous ablation (MOCA)

Varicose veins are a common problem in the World. From epidemiological studies
we know that a quarter of the adult population suffers from some sort of
varicose veins. Women suffer two to three times more often from varicose veins
than men. The occurrence of varicose veins increase with increasing age and is
one of the top ten complaints for which patients visit their general
practitioner. De main risk factors for developing varicose veins are enduring
standing or sitting, pregnancy, female gender and age. Symptoms are divers and
vary from cosmetic complaints to difficult to treat venous ulcers.
Last few years endovenous techniques have been developed for the primary
treatment of insufficient varicose veins. Radiofrequent ablation (RFA)is,
besides endovenous laser ablation (EVLA), an accepted technique and is
frequently applied in clinical practice. This technique, that uses heat, has
the important advantage that the treatment can be performed using a slight
local anaesthesia. Besides that, RFA causes less hematoma, pain, a superior
cosmetic and patient are able to restart daily activities sooner than compared
to the classical surgical treatment. Because RFA using heat technology, damage
can occur in the surrounding tissues. That is the reason for using tumiscentie
anaesthesia, for which multiple injections are needed. A column of liquid is
placed surrounding the vein. Many patients experience this column as
inconvenient and despite this form of anaesthesia part of the treated patient
population experiences pain after the treatment that can last up to weeks.
A newer endovenous technique is mechano-chemical ablation (MOCA) has been
developed, using the ClariVein system. This technique uses intentional
mechanical damage to the endothelium of the vene by means of a rotating
catheter. At the same time a sclerosans is injected, and as a result the vene
occludes. So this technique does not use heat technology. Tumescent anaesthesia
is therefore not needed and complications related to techniques using heat (RFA
and EVLA) such as burning, pain, hematoma, indurations, and paresthesia could
be reduced or even be prevented.
MOCA proved to be a safe and effective alternative treatment for both
insufficient great saphenous veins (GSV) and small saphenous veins (SSV).
Especially for the treatment of the below-knee GSV and the treatment of
superficial branches (such as the antero-lateral branches), there is a risk for
damaging nerves that are in the close proximity of these veins.
In a series of 50 patients treated with EVLA for insufficient GSV above the
knee, a technical success of 100% was reported after a median follow-up of 7
months, but this was accompanied by nerve damage in 8%. A recent study
evaluating MOCA for the treatment of SSV reported an anatomical success of 96%
without any nerve damage or other major complications. Therefore, MOCA could be
an alternative for the treatment of various insufficient varicose vein
segments without causing nerve damage.
The choice of treatment for patients with both above and below knee GSV
insufficiency is nowadays only endovenous ablation of the above-knee segment.
However, Theivacumar and co-workers recently showed that in these patients
there is a significant residual reflux in approximately 41% of treated legs.
These patients clearly showed less clinical improvement and approximately 90%
of these patients needed additional treatment.
Up to now it is unknown whether treatment with MOCA can yield comparable
results when used to treat insufficient GSV with diameters >= 12 mm,
insufficient antero-lateral branches and insufficient GSV below the knee. The
goal of this registry study is to provide insight in the safety and efficacy of
treatment of the above described insufficient varicose vein segments.

The goal of this registry study is to provide insight in the safety and
efficacy of treatment with MOCA for primary insufficiency of the GSV with a
diameter >/=12mm, insufficient antero-lateral branches (<12 mm) and
insifficincy of the GSV below the knee (<12mm).

The MOCA-XL study is a multicenter prospective registry study in the Rijnstate
Hospital Arnhem and the Antonius Hospital Nieuwegein. In total 90 patients will
be treated after they provided signed informed consent. Three different groups
of patients will be included; 30 patients will be included with primary
insufficiency of the GSV with diameters >/= 12 mm, 30 patients with
insufficient antero-lateral branches (<12mm), and 30 patients with below-knee
GSV insufficiency (<12mm).
Clinical state of patients will be evaluated using CEAP classification VCSS
(Venous Clinical Severity Score) pre-treatment, and 4 weeks and 1 year after
treatment to evaluate clinical success. Both visits are according to standard
clinical care in both hospitals. During these visits an ultrasound scan will be
performed to evaluate the technical success (to determine if the segments are
still occluded). Patients will be asked to fill out the Aberdeen Varicose Vein
Questionnaire and the RAND 36 short form questionnaire on these visits as well
to evaluate disease specific and general health status. Finally, during
procedure and until two weeks after treatment patients will be asked to report
pain scores using the linear VAS score. If needed, patients can be
additionally treated 6 weeks after MOCA, according to current standard care.

Treatment with mechano-chemical ablation

Patients will be asked to fill out the Aberdeen Varicose Vein Questionnaire and
the RAND 36 short form questionnaire pre-treatment, 4 weeks and 1 year after
treatment. Additionally, they will be asked to report pain scores using the
linear VAS score two weeks after treatment.(in total ca 40 minutes)
A possible risk of MOCA is allergy for the used sclerosans. The safety and
efficacy of MOCA for the treatment of GSV (up to 12 mm in diameter) and SSV
insufficiency was shown before, but remains to be evaluated for treatment of
insufficiency of GSV >/= 12 mm, antero-lateral branches (<12mm) and GSV below
the knee (<12mm) and long term results are unknown. The known side effects of
other endovenous treatment modalities can also occur when patients are treated
using MOCA, such as bleeding from puncture site, infection of the puncture
site, hematoma, and pain.