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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 29, No 4, July/August 2018
214
AFRICA
of abdominal aortic aneurysms, varicoceles, pelvic congestion
syndromes and arteriovenous malformations.
10
N-butyl-2 cyanoacrylate (NBCA) has been used via the
endovenous route in the treatment of venous insufficiency
and varicose veins, with the aim of biochemical ablation.
11
NBCA rapidly hardens in a polymerisation reaction following
intravenous injection and occludes the vein. In addition, it causes
a local inflammatory reaction in the vein wall and surrounding
tissues.
10,12
However, there are no studies in the literature evaluating
whether NBCA causes systemic inflammation following contact
with the blood circulation.
We attempted to establish whether NBCA caused a
simultaneous systemic inflammatory response in the early period
while causing a local inflammatory reaction in the vein wall and
surrounding tissues in patients who were administered NBCA,
including dimethyl sulfoxide (DMSO), for the treatment of
superficial venous insufficiency. We retrospectively evaluated pre-
and post-interventional blood samples in order to determine this.
Methods
This study was a two-centre, retrospective, non-randomised
investigational study. Ablation treatment with endovenous
NBCA was applied to patients with C3 to C4b grade venous
insufficiency, according to the CEAP (clinical, aetiology, anatomy
and pathophysiology) clinical classification, with sapheno-
femoral junctional insufficiency and a reflux of 0.5 seconds and
longer on duplex ultrasonography, between October 2015 and
February 2016. This treatment was abandoned in patients with a
greater saphenous vein diameter of
>
15 mm and
<
5 mm.
The treatment is contra-indicated in patients who have a
past history of deep venous thrombosis, have femoral vein
insufficiency, congenital vasculopathy, thrombophilia, the
presence of severe systemic disease, and in pregnant and
lactating patients. This procedure was not used in any patient
who had any of these conditions.
Detailed demographic data of the patients who were treated
using endovenous NBCA ablation therapy were collected. Whole
blood count, sedimentation rate, C-reactive protein (CRP) and
blood chemistry were studied in all patients on admission to
the clinic. These examinations were repeated in the second hour
post-intervention.
Patients who were taken into the operating room to
undergo endovascular medical ablation were monitored by the
anaesthesiology team. Subsequently, both legs were re-evaluated
with Doppler ultrasonography. The integrity of the iliac vein
and inferior vena cava in the abdominal region was confirmed
in order not to overlook some rare conditions, such as possible
inferior vena cava agenesis.
Patients were placed in the supine position and the leg and
inguinal region were cleaned and draped in order to perform
the intervention under sterile conditions. With the aid of
Doppler ultrasonography, an appropriate segment of the greater
saphenous vein was selected for catheterisation, and a 5F
introducer sheath was placed following local anaesthesia. The
placement of the catheter was confirmed by ultrasonography.
A 0.035-inch J guidewire was advanced into the sheath.
Ultrasonography was used to determine whether the guidewire
had reached the sapheno-femoral junction and a 4F carrier
catheter was advanced into it. The catheter was confirmed to
be at the sapheno-femoral junction and then withdrawn 3 mm,
and a 3-ml syringe and piston system, which provides NBCA
injection, was positioned. The location of the catheter was
checked again by ultrasonography and it was confirmed not
to be in the sapheno-femoral junction. The junction was then
compressed by the ultrasonography probe and obstructed
The piston of the syringe administered 0.3 ml of NBCA
during each pulse into the saphenous vein and compression
was performed simultaneously. Intravenous administration of
NCBA, which provided medical ablation, was continued while
the catheter was withdrawn rapidly at a rate of 2 cm/s. At the
end of the procedure, compression was continued for five to 10
seconds and the procedure was terminated after the sapheno-
femoral junction was demonstrated by ultrasonography to be
open and the rest of the greater saphenous vein was occluded.
A compression sock was placed on the leg that underwent the
procedure and medium pressure was applied. The patient was
taken to the ward for follow up and repeat testing of the whole
blood count, blood chemistry, CRP and sedimentation rate.
Patients with no complications in the eighth hour postoperatively
were discharged with a follow-up plan of visits on the 10th day,
and one, three, six and 12 months postoperatively.
Statistical analysis
The results were evaluated using SPSS version 17. Changes in
the patients’ values were calculated using the paired-samples
t
-test. The
α
-value was accepted as 0.05. The change in values
by gender was calculated using the independent-samples
t
-test
(
p
< α
was accepted as significant).
Results
A total of 102 patients were treated with endovenous medical
ablation at two centres between October 2015 and February
2016. The mean age of the patients was 51.16
±
1.17 years (range:
25–74); 72 (70.6%) were female and 30 (29.4%) were male. The
mean diameter of the saphenous vein was 7.72
±
2.02 mm (range:
6–14). Among the general risk factors, a positive family history
was present in 31 cases (30.3%), use of tobacco products in 17
(16.7%), hypertension in six (5.9%), abnormal lipid profile in 19
(18.7%), obesity in 24 (23.5%) and diabetes mellitus in five cases
(4.9%) (Table 1).
Table 1. Demographics of the patients
Demographic data
Number (%)
Age (years)
51.16
±
1.17
Gender (female/male)
72 (70.6)/30 (29.4)
Presence of family history
31 (30.3)
Use of tobacco products
17 (16.7)
Hypertension
6 (5.9)
Abnormal lipid profile
19 (18.7)
Obesity (BMI ≥ 30 kg/m
2
)
24 (23.5)
Diabetes mellitus
5 (4.9)
CEAP classification
C3
42 (41.2)
C4a
37 (36.3)
C4b
23 (22.5)
Vein diameter (mm)
7.72
±
2.02
BMI: body mass index; CEAP: clinical, aetiology, anatomy and pathophysiology.