Keywords chronic venous insufficiency - endovenous laser ablation - varicose
Introduction
Chronic venous insufficiency (CVI), affecting approximately 15 to 20% of population,[1 ] is known to be an important cause of morbidity in the young and results in loss
of wages for those affected.[2 ] There are significant affected numbers seen in the rural population of India. In
one study from central India, 84% patients seen in the outpatient department (OPD)
over a year were rural, whereas 15% were urban; the average monthly OPD attendance
in the center was 23, out of which 20 belonged to rural areas and only 3 to urban
areas.[3 ] Additionally, only a minority of patients with a long-term indication for the treatment
of CVI or related conditions receive the needed therapy.[4 ]
In India, CVI has been identified as a common surgical problem in low socioeconomic
groups.[5 ] Occupations involving prolonged standing and vigorous physical muscular activity
lead to a high risk of developing CVI.[6 ] Increased venous pressure due to dysfunction or incompetence of venous valves results
in superficial veins at multiple levels, leading to CVI. CVI is categorized as primary
or secondary CVI. Primary CVI includes reflux at the saphenofemoral and saphenofemoral
popliteal junctions, and segmental intrinsic reflux in the great saphenous vein (GSV)
and small saphenous vein (SSV), whereas secondary CVI involves varicosities in patients
with a previous history of deep vein thrombosis. Primary CVI is more common than secondary
CVI, with the latter affecting approximately 18 to 28% of limbs.[7 ]
[8 ] Patients usually complain of pain and heaviness in calf precipitated after prolonged
standing. Leg fatigue, itching, and the presence of varicosities in lower limbs eventually
lead to leg ulceration known as classic venous ulcer.[9 ]
[10 ]
[11 ] Classic presentations of venous ulcers are along the medial aspect of the ankle,
with the ulcer having a red base and an irregular shallow bed, and surrounding changes
of stasis dermatitis. Unusually, these ulcers may be located along the posterior aspect
of the ankle.
Both surgical and nonsurgical methods are used for treating CVI. Ablation therapy
such as endovenous laser ablation (EVLA), radiofrequency ablation (RFA), and foam
sclerotherapy are nonsurgical methods.[12 ] Surgical methods include ligation and stripping, subfascial endoscopic perforator
surgery, and microphlebectomy.
To the best of our knowledge, while EVLA is being used regularly for the treatment
of CVI, data on pain scores and quality of life (QoL) after EVLA in rural patients
in Central India are scarce. We therefore wanted to evaluate change in pain and QoL
among rural patients after EVLA treatment in a pilot study.
Methods
This study was designed as a prospective, observational pilot study for 2 months from
July to September 2018. The study received approval from the institutional ethics
committee. Twenty patients with symptomatic CVI in lower extremities presenting to
the Interventional Radiology Department, Acharya Vinoba Bhave Rural Hospital, were
selected through purposive sampling.
Patients meeting the following inclusion criteria were enrolled in the study: patients
with valvular incompetence (i.e., reflux > 1 second) in superficial lower limb veins
documented with color Doppler or Duplex ultrasound scanning and symptomatic patients
with clinical–etiological–anatomical–pathophysiological (CEAP) C3 class or higher
venous disease.[13 ] Patients with the following characteristics were excluded: active deep venous thrombosis,
deep venous valve insufficiency, superficial venous thrombophlebitis at the time of
procedure, patient currently pregnant or breast-feeding a child, severe coagulopathy
that is resistant to correction, inability to coagulate, a history of reaction to
contrast medium, or prior surgeries for varicose veins.
For ultrasound, a color duplex ultrasound scanner, Aloka Prosound Alpha-7 (Aloka Co.
Ltd.), with a linear array transducer of high frequency was used. For EVLA, a Biolitec
diode laser of 15 W and a wavelength of 1,470 nm along with radial fiber 5F vascular
sheath and Terumo 0.035-inch hydrophilic guidewire were used. The EVLA procedure took
place in the Interventional Radiology Cath Laboratory. For perforator and tortuous
GSV/SSV, bare fiber was used, whereas, for straight/nontortuous veins, radial fiber
was used.
Upon enrollment, patients were classified according to the CEAP classification. EVLA
procedure was performed under local anesthesia using all aseptic precautions. Percutaneous
access was established for the GSV and SSV. Then anesthesia was given along GSV using
a mixture of 20 mL of 2% lignocaine diluted with 500 mL of normal saline with the
help of 23G hypodermic needle. This was followed by laser ablation of the affected
vein with standard protocol.[14 ]
Pain assessment using the visual analog scale (VAS) was performed before and after
the laser ablation procedure.[15 ] VAS score was evaluated and compared across time intervals (pre- vs. postprocedure).
In addition to evaluation using VAS, patients answered the Aberdeen Varicose Vein
Questionnaire (AVVQ) before and 6 weeks after the EVLA procedure ([Table 1 ]).[16 ] We used AVVQ without manikin.[17 ]
Table 1
Key to options in the AVVQ
Sr. no.
Question
Option 1
Option 2
Option 3
Option 4
Abbreviation: AVVQ, Aberdeen Varicose Vein Questionnaire.
1
Leg involved
Right Leg
Left Leg
Both Legs
–
2
In the last 2 wk for how many days did your veins cause you pain or ache?
None at all
Between 1 and 5 d
Between 6 and 10 d
> 10 d
3
During the last 2 wk, on how many days did you take pain killing tablets for your
varicose vein?
None at all
Between 1 and 5 d
Between 6 and 10 d
> 10 d
4
In the last 2 wk, how much ankle swelling have you had?
None at all
Between 1 and 5 d
Between 6 and 10 d
> 10 d
5
In the last 2 wk, have you worn support stockings or tights?
No
Yes, those I bought myself without prescription
Yes, those were prescribed by my doctor and I wear them occasionally
Yes, those were prescribed by my doctor and I wear them every day
6
In the past 2 wk, have you had any itching in association with your varicose vein?
No
Yes, above the knee only
Yes, below the knee only
Yes, above and below the knee
7
Do you have stasis dermatitis caused by tiny blood vessels in the skin in association
with the varicose vein?
Yes
No
–
–
8
Do you have rash or eczema in the area of your ankle?
Yes
No
–
–
9
Do you have a skin ulcer associated with your varicose vein?
Yes
No
–
–
10
Does the appearance of your varicose veins cause you concern?
No
Yes, their appearance causes me slight concern
Yes, their appearance causes me moderate concern
Yes, their appearance causes me a great deal of concern
11
Does the appearance of your varicose veins influence your choice of clothing including
tights?
No
Occasionally
Often
Always
12
During the last 2 wk, have your varicose veins interfered with your work, housework,
or other activities?
No
I have been able to work, but my work has suffered to a slight extent
I have been able to work, but my work has suffered to a moderate extent
My veins have prevented me from working 1 d or more
13
During the last 2 wk, have your varicose veins interfered with your leisure activities?
No
Yes, my enjoyment has suffered to a slight extent
Yes, my enjoyment has suffered to a moderate extent
Yes, my veins have prevented me from taking part in any leisure activities
After the procedure, patients received antibiotics and analgesics for 5 days along
with compression stockings. Patients were reevaluated on days 3 to 5 postprocedure
to rule out any postprocedural complications. At the sixth week, patients answered
the AVVQ (for QoL index) again and were evaluated for the status of residual disease.
The primary objective of the study was assessing change in pain scores before versus
after EVLA under local anesthesia using VAS. The secondary objective was to assess
QoL improvement in patients who undergo EVLA.
Continuous data were expressed as means ± standard deviation (SD) or as median and
range, whereas questionnaire responses were quantified in percentages. Demographic
and clinical measures were compared using paired Student's t -test for parametric variables and Wilcoxon's signed rank Test for nonparametric variables.
SPSS version 22.0 (IBM Corp.) and Graph Pad Prism v6.0 (GraphPad Software) were used
for analysis. A p -value of 0.05 was considered as the threshold of significance for null hypothesis
significance testing.
Results
The average age of the patients was 42.7 years. The average age was 44.16 years in
males (12 patients) and 40.5 years in females (8 patients). The male:female sex ratio
was 1.5:1.
Preprocedure Evaluation
The preprocedural mean pain on VAS was 5.80 ± 1.64, with a standard error mean of
0.36.
[Table 2 ] shows the distribution of responses to the AVVQ before EVLA procedure ([Table 2 ]). Of the 20 patients with symptomatic CVI in lower extremities, the majority (11
patients) had right leg involvement, 7 patients had left leg involvement, and 2 patients
had bilateral involvement ([Table 2 ]).
Table 2
Distribution of responses to AVVQ (preprocedure)
Sr. no.
Question
Option 1
Option 2
Option 3
Option 4
Total
Abbreviation: AVVQ, Aberdeen Varicose Vein Questionnaire.
Note: Refer to [Table 1 ] to see options for each question in the questionnaire.
1
Leg involved
11 (55%)
7 (35%)
2 (10%)
–
20 (100%)
2
In the last 2 wk, for how many days did your veins cause you pain or ache?
1 (5%)
1 (5%)
2 (10%)
16 (80%)
20 (100%)
3
During the last 2 wk, on how many days did you take pain killing tablets for your
varicose vein?
6 (30%)
1 (5%)
1 (5%)
12 (60%)
20 (100%)
4
In the last 2 wk, how much ankle swelling have you had?
5 (25%)
1 (5%)
2 (10%)
12 (60%)
20 (100%)
5
In the last 2 wk, have you worn support stockings or tights?
2 (10%)
4 (20%)
2 (10%)
12 (60%)
20 (100%)
6
In the past 2 wk, have you had any itching in association with your varicose vein?
6 (30%)
2 (10%)
9 (45%)
3 (15%)
20 (100%)
7
Do you have stasis dermatitis caused by tiny blood vessels in the skin in association
with the varicose vein?
17 (85%)
3 (15%)
–
–
20 (100%)
8
Do you have rash or eczema in the area of your ankle?
7 (35%)
13 (65%)
–
–
20 (100%)
9
Do you have a skin ulcer associated with your varicose vein?
5 (25%)
15 (75%)
–
–
20 (100%)
10
Does the appearance of your varicose veins cause you concern?
7 (35%)
7 (35%)
4 (20%)
2 (10%)
20 (100%)
11
Does the appearance of your varicose veins influence your choice of clothing including
tights?
4 (20%)
10 (50%)
2 (10%)
4 (20%)
20 (100%)
12
During the last 2 wk, have your varicose veins interfered with your work, housework,
or other activities?
2 (10%)
8 (40%)
6 (30%)
4 (20%)
20 (100%)
13
During the last 2 wk, have your varicose veins interfered with your leisure activities?
4 (20%)
10 (50%)
2 (10%)
4 (20%)
20 (100%)
Prior to EVLA procedure, patient's QoL in our cohort was affected by CVI as follows:
in the last 2 weeks before the procedure, 16 (80%) patients had pain since 10 days
or more, whereas 12 (60%) patients had taken analgesics for more than 10 days. A similar
number of cases reported ankle swelling for more than 10 days as well as wearing prescribed
support stockings or tights daily. Itching and stasis dermatitis were common complaints
(14 and 17 patients, respectively). Rash and skin ulcers were uncommon occurrences.
Patients also consistently reported that the appearance of varicose veins caused them
concern (65% patients), influenced their choice of clothing (80% patients), interfered
with their work (90%), and interfered with their leisure activities (80%).
Intraprocedure Evaluation
The mean pain on VAS was reduced to 4.00 ± 1.29, with a standard error mean of 0.29
during EVLA procedure. Six patients experienced moderate needle prick pain, whereas
12 patients experienced heat and pain during ablation of the vein.
Postprocedural Evaluation
The mean pain on VAS was further reduced to 2.55± 1.19, with a standard error mean
of 0.26.
[Table 3 ] shows the postprocedural (6 weeks after EVLA) distribution of responses to AVVQ.
Compared with the preprocedural evaluation, we found dramatic increase in the numbers
of patients reporting improved QoL. In the last 2 weeks of the follow-up, 15 (75%)
patients had no pain associated with the varicose veins compared with just 1 patient
before EVLA. Similarly, the numbers of those taking analgesics for > 10 days (two
patients), those having ankle swelling for > 10 days (two patients), and those who
wore prescribed stockings every day (four patients) were reduced compared with preprocedure
when the majority had these issues.
Table 3
Distribution of responses to AVVQ (postprocedure)
Sr. no.
Question
Option 1
Option 2
Option 3
Option 4
Total
Abbreviation: AVVQ, Aberdeen Varicose Vein Questionnaire.
Note: refer to [Table 1 ] to see options for each question in the questionnaire.
1
Leg involved
11 (55%)
7 (35%)
2 (10%)
–
20 (100%)
2
In the last 2 wk, for how many days did your veins cause you pain or ache?
15 (75%)
2 (10%)
2 (10%)
1 (5%)
20 (100%)
3
During the last 2 wk, on how many days did you take pain killing tablets for your
varicose vein?
14 (70%)
1 (5%)
3 (15%)
2 (10%)
20 (100%)
4
In the last 2 wk, how much ankle swelling have you had?
12 (60%)
2 (10%)
4 (20%)
2 (10%)
20 (100%)
5
In the last 2 wk, have you worn support stockings or tights?
10 (50%)
4 (20%)
2 (10%)
4 (20%)
20 (100%)
6
In the past 2 wk, have you had any itching in association with your varicose vein?
12 (60%)
2 (10%)
4 (20%)
2 (10%)
20 (100%)
7
Do you have stasis dermatitis caused by tiny blood vessels in the skin in association
with the varicose vein?
6 (30%)
14 (70%)
–
–
20 (100%)
8
Do you have rash or eczema in the area of your ankle?
4 (20%)
16 (80%)
–
–
20 (100%)
9
Do you have a skin ulcer associated with your varicose vein?
2 (10%)
18 (90%)
–
–
20 (100%)
10
Does the appearance of your varicose veins cause you concern?
13 (65%)
1 (5%)
5 (25%)
1 (5%)
20 (100%)
11
Does the appearance of your varicose veins influence your choice of clothing including
tights?
11 (55%)
3 (15%)
4 (20%)
2 (10%)
20 (100%)
12
During the last 2 wk, have your varicose veins interfered with your work, housework,
or other activities?
12 (60%)
2 (10%)
4 (20%)
2 (10%)
20 (100%)
13
During the last 2 wk, have your varicose veins interfered with your leisure activities?
14 (70%)
2 (10%)
2 (10%)
2 (10%)
20 (100%)
After EVLA, the numbers of those who no longer suffered from itching doubled, whereas
those who no longer had stasis dermatitis more than quadrupled (from just 3 patients
earlier to 14 after EVLA). Rash and skin ulcers became even more uncommon (80–90%
patients reported that they did not have these issues).
After EVLA, fewer patients reported that the appearance of their diseased veins caused
them concern (35% patients, down from 65%), that it influenced their choice of clothing
(45% patients, down from 80%), that it interfered with their work (40% patients, down
from 90%), and also interfered with their leisure activities (30%, down from 80%).
Statistically significant difference was observed between pre- and postprocedural
mean scores in every question of AVVQ (p < 0.05) except for (related to rash/eczema) and (related to skin ulcers) (using Wilcoxon's
signed rank test)[18 ] ([Table 4 ]).
Table 4
Comparison of quality-of-life improvement score in patients with chronic venous insufficiency
by AVVQ using Wilcoxon's signed rank test
Question no.
Preprocedure
Postprocedure
z -Value
p -Value
Mean
SD
Mean
SD
Abbreviations: AVVQ, Aberdeen Varicose Vein Questionnaire; NS, nonsignificant; S,
significant; SD, standard deviation.
1
1.55
0.68
1.55
0.68
–
–
2
3.65
0.81
1.45
0.88
9.314
0.0001, S
3
2.95
1.39
1.65
1.08
4.466
0.0001, S
4
3.05
1.31
1.80
1.10
4.802
0.0001, S
5
3.20
1.10
2.00
1.21
5.080
0.0001, S
6
2.45
1.09
1.80
1.10
3.115
0.006, S
7
1.15
0.36
1.70
0.47
4.819
0.0001, S
8
1.65
0.48
1.80
0.41
1.831
0.083, NS
9
1.75
0.44
1.90
0.30
1.831
0.083, NS
10
2.05
0.99
1.70
1.03
3.199
0.005, S
11
2.30
1.03
1.85
1.08
3.943
0.001, S
12
2.60
0.94
1.80
1.10
5.812
0.0001, S
13
2.30
1.03
1.60
1.04
6.658
0.0001, S
Visual analog scale score was measured pre-, intra-, and postprocedure; the observations
are provided in [Table 5 ] and the statistical comparison is provided in [Table 6 ] and [Fig. 1 ].
Fig. 1 Comparison of pain on visual analog scale in different time intervals.
Table 5
Comparison of pain on VAS in different time intervals: descriptive statistics
Mean
N
Standard deviation
Standard error mean
Abbreviation: VAS, visual analog scale.
Preprocedure
5.80
20
1.64
0.36
Intraprocedure
4.00
20
1.29
0.29
Postprocedure
2.55
20
1.19
0.26
Table 6
Student's paired t-test
Paired differences
t
df
p -Value
Mean
Standard deviation
Standard error mean
95% confidence interval of the difference
Lower
Upper
Abbreviation: df, degree of freedom.
Pre- and intraprocedure
1.80
0.89
0.20
1.38
2.21
9.000
19
0.0001, S
Pre- and postprocedure
3.25
1.20
0.27
2.68
3.81
12.027
19
0.0001, S
Intra- and postprocedure
1.45
0.68
0.15
1.12
1.77
9.448
19
0.0001, S
The disease progression was decreased in 14 patients, constant in 4 patients, and
increased in 2 patients.
Discussion
A pilot study of 20 rural patients with symptomatic CVI in lower extremities presenting
to the Interventional Radiology department over 2 months showed that pain scores reduced
from pre- to post-EVLA procedure and QoL improved significantly in several aspects.
Advanced treatment for CVI includes EVLA and RFA. The first application of thermal
endovenous ablation using 810-nm diode laser was published by Navarro et al[19 ] in 2001. Since then, numerous studies using different wavelengths and types of lasers
have demonstrated effectiveness.[20 ] In parallel to advances in laser technology, studies were performed concerning thermal
ablation and saphenous vein using radiofrequency energy, and in 2002, Weiss and Weiss
reported the first patient receiving thermal ablation using radiofrequency energy.[21 ] Doganci and Demirkilic reported fewer side effects and better patient satisfaction
in high wavelength laser energy and radial fiber treatment compared with low wavelength
laser energy and bare fiber.[22 ] Glue injections in GSV/SSV are recent advances for the ablation of veins.[23 ]
EVLA acts through occlusion and fibrosis of vessel lumen by applying thermal energy
on the vessel wall of affected veins. t -test was statistically significant, as seen in [Table 6 ] and [Fig. 1 ]. Our findings are similar to those in the study by Houtermans-Auckel et al.[25 ]
The AVVQ comprising 13 questions is used for measuring QoL in patients with varicose
veins of the leg.[16 ] There are questions relating to the amount of pain experienced, ankle swelling,
interference with social and domestic activities, and cosmetic aspects of varicose
veins. In our cohort, we found statistically significant improvement in mean AVVQ
scores after treatment. AVVQ scores improved at 6 weeks Compared with surgical management
of CVI incorporating surgical ligation, EVLA has more promising long-term follow-up.[24 ] Diagnosis and management of CVI in the rural population of India is necessary, particularly
since patients from this demographic tend to have long-standing disease with late
presentation. In contrast, patients from urban areas tend to present earlier and are
more concerned with early skin changes.[3 ]
Mean pain on VAS reduced from 5.80 ± 1.64 before EVLA to 2.55 ± 1.19 six weeks after
the procedure. The pre-to postprocedure comparisons using Student's paired for all
questions except for and (p = 0.083) related to skin rash/eczema and skin ulcers, respectively ([Table 4 ]) and ([Fig. 2 ]). We hypothesize that with longer follow-up, we might find significant reduction
in these two aspects as well. Our study is congruent with studies such as the one
by Lat-timer et al,[26 ] in which the majority responded to change and had improved AVVQ scores after procedure.[27 ]
[28 ]
[29 ]
Fig. 2 Comparison of mean Aberdeen Varicose Vein Questionnaire (AVVQ) score pre- and postprocedure.
During the sixth week of follow-up, disease progression was decreased in 14 patients.
It was found out to be constant in four patients due to severity of the disease and
chronicity, with multiple underlying perforator and superficial varicosities postablation.
The patients with the disease remaining constant were advised subsequent treatment
measures such as extended use of stockings, calf-pumping exercises, percutaneous sclerotherapy,
microphlebectomy and wound management using platelet-rich plasma injection,[30 ] and platelet-rich fibrin for wound healing as per suitability of the case. Two cases
had progression of disease. These were further evaluated for the etiopathogenesis
of progression and the evaluation of developing complications. One patient had developed
a minor complication of superficial thrombophlebitis postprocedure and was prescribed
management with antibiotics and local magnesium sulfate dressing.[31 ]
Ours was a pilot study, which by definition has a small sample size designed to be
executed within our existing resources. Additionally, the follow-up period was short.
We acknowledge these limitations. A larger sample size is likely to help improve the
quality of evidence demonstrated by our study. We hope that the evidence presented
through this study justifies acquiring the necessary resources and time for a larger
and longer study that produces more robust evidence.
In conclusion, VAS comparison shows better pain scores postprocedure than preprocedure,
suggestive of improvement in pain associated with CVI. Post-EVLA, significant improvement
is reported by patients in AVVQ, suggesting improvement in QoL. Thus, 1470-nm EVLA
using in rural patients with CVI may have a significant effect on QoL and pain.
Institutional Review Board Statement
This study was reviewed and approved by the ethics committee of Jawaharlal Nehru Medical
College on March 28, 2018.
Biostatistics Statement
The statistical methods and results were reviewed and verified by a member of the
medical statistics of Jawaharlal Nehru Medical College.
