Introduction
Reticular varicose veins, or spider veins and telangiectasias can be found in more than 30% of adults in the general population [1, 2]. This condition does not lead to serious threats to the health of patients but being a significant cosmetic defect can reduce the quality of life, especially in females. A large number of patients ask for treatment due to cosmetic reasons and sclerotherapy is the method of choice [3, 4].
Sclerotherapy allows to eliminate pathologic vessels with a good result in most patients. Up to six months after the treatment improvement is registered in more than 90% of patients regardless of the sclerosing agent used [5, 6]. At the same time, sclerotherapy has some adverse effects that may impair cosmetic results. The most common is skin hyperpigmentation along the course of sclerosed veins with the rate up to 50% [7].
Many vascular specialists are are convinced that the use of compression stockings after sclerotherapy can reduce the risk of hyperpigmentation. In some studies effect of compression on the overall cosmetic result was confirmed while data regarding hyperpigmentation are heterogeneous [8, 9]. Taking into account lack of data international consensus concluded that the duration of compression should be based on clinical judgment, i.e. physician who performs sclerotherapy should decide whether or not compression is used and for how long [10].
Aim — to compare establish an impact of extended compression after sclerotherapy on the rate and severity of hyperpigmentation in patients with reticular varicose veins and telangiectasias.
Material and methods
We consecutively included patients with reticular varicose veins and/or telangiectasias (C1 according to CEAP) who agreed to undergo sclerotherapy in a comparative non-randomized study. Patients were recruited from December 2021 to April 2022.
Inclusion criteria
The presence of reticular varicose veins and telangiectasias on one or both lower extremities, the absence of great saphenous vein, small saphenous vein, anterior accessory saphenous veins’ reflux, absence of varicose veins, absence of any other treatment for venous disease during the study period, patient's ability to attend a follow-up examination, signed informed consent.
Exclusion criteria
C2—C6 disease, previous invasive procedures for varicose veins on any of the lower extremities, absence of visible spider veins and telangiectasias, history of deep vein thrombosis, postthrombotic sequalae in deep veins on any lower extremities on duplex ultrasound, intolerance of compression stockings and/or sclerosing agent.
Sample size
Calculated by Fleiss method with correction for continuity. We used data on the hyperpigmentation rate earlier in a pilot study where the rates were 47 and 83% in patients who used extended compression and those who didn’t use compression after sclerotherapy, respectively. in the absence and presence of prolonged compression, respectively. With a dropout rate of 10%, study power of 80% and a significance level of 0.05 it was necessary to enroll 36 patients in groups.
Study groups
In no extended compression (noEC) group patients were prescribed to use compression for 24 hours a day for three days after each procedure. It was allowed to take stockings off for 1—2 hours in the morning and in the evening. Between procedures and after completing sclerotherapy patients did not use compression.
In extended compression (EC) group patients use compression the same way after each sclerotherapy session. Between sessions and after completing sclerotherapy patients used compression stockings at least 5 days a week for about 8 hours a day.
All the patients were supplied with class 2 thigh-length compression stockings (VenoTrain micro, Bauerfeind, Germany).
Sclerotherapy
Sclerotherapy was performed with polidocanol 0.5% for telangiectasias and 1% for spider veins in a liquid form. The number of procedures depended on a surface affected by pathological vessels.
Follow-up
Beyond inclusion visit patients came for sclerotherapy sessions. After the last one they visited investigator every month. The last assessment was made at four months after the first sclerotherapy session.
Outcomes
The primary end-point was the rate of skin hyperpigmentation at 4 months after beginning of sclerotherapy. Secondary end-points were:
— severity of hyperpigmentation at 4 months;
— cosmetic result of treatment;
— incidence of telangiectatic matting;
— rate of persisting telangiectatic matting at 4 months;
— quality of life (QoL);
— discomfort while wearing compression stockings (EC group);
— rates of adverse events (AEs);
— rate of interrupted compression.
Assessment Tools
Hyperpigmentation was defined as an increase in skin color from light to dark brown along the course of sclerosed vessels. The severity of hyperpigmentation was assessed by a physician using a scale, where 0 means no hyperpigmentation, 1 — mild, 2 — moderate and 3 — severe hyperpigmentation. For this assessment the darkest spot was chosen.
Cosmetic defect before and after sclerotherapy was assessed by patients with a 100 mm visual analogue scale (VAS).
Telangiectatic matting was defined as the appearance of a new very small red telangiectasias at the area where sclerotherapy was performed.
Quality of life was assessed using the CIVIQ-20 vein-specific questionnaire.
The discomfort while using compression stockings was assessed with a 100 mm VAS, where 0 corresponded to «Stockings were perfect. Nothing did bother me» and 100 corresponds to «Discomfort was severe. I had to take off a stockings».
Interrupted treatment was registered when patient refused to wear compression stockings.
Approval
The study protocol was approved by the Ethics Committee of the Razumovsky Saratov State Medical University (No. 3, 09.11.2021) and was registered in Russian Registry of Treatment of Chronic Venous Disease https://www.venousregistry.org/index.php (RRT_CVD 2.014).
Statistical analysis. Descriptive data are presented as absolute (abs.) and relative values (%) with a standard deviation. Quantitative variables between groups were compared with Mann—Whitney test. Qualitative variables were compared with Fisher's exact test. Publicly available online statistical calculators were used. Significance level was set at p<0.05.
Results
72 patients were included. Main characteristics of noEC and EC groups are presented in Table 1. Groups had similar characteristics regarding gender, age, anthropometric data, duration of the disease, severity of a cosmetic defect, QoL, as well as in the amount of treatment performed (number of sessions).
Table 1. Patient characteristics
|
Parameter |
noEC group (n=36) |
EC group (n=36) |
p |
|
Age, years (min—max) |
36±7 (23—48) |
38±7 (23—50) |
0.233 |
|
Males |
1 (3%) |
0 |
‒ |
|
Females |
35 (97%) |
36 (100%) |
‒ |
|
BMI, kg/m2 |
23.0±4.0 |
23.0±3.6 |
0.952 |
|
Disease duration, years |
10.0±4.6 |
10.6±4.0 |
0.430 |
|
Cosmetic defect, VAS, mm (min—max) |
75±21 (1.8—10) |
71±20 (2.9—10) |
0.177 |
|
QoL, global score (min—max) |
83±14 (34—100) |
78±17 (38—100) |
0.180 |
|
Number of sclerotherapy sessions |
1.3±0.6 |
1.4±0.6 |
0.704 |
Two patients from the noEC group did not come for the last assessment. The results are presented in Table 2. In the noEC group hyperpigmentation was registered significantly more often and it was more severe. Telangiectatic matting developed with the similar rates in both groups but at the last visit this AE was registered more often in noEC group.
Table 2. Study results
|
Parameter |
noEC group (n=34) |
EC group (n=36) |
p |
|
Hyperpigmentation rate |
10 (29%) |
2 (5.6%) |
0.011 |
|
Hyperpigmentation severity |
0.53±0.8 |
0.08±0.36 |
0.041 |
|
Cosmetic defect VAS, mm (min—max) |
26±24 (0—95) |
31±26 (0—99) |
0.342 |
|
Telangiectatic matting incidence rate |
12 (33%) |
14 (39%) |
0.807 |
|
Telangiectatic matting persistence at 4 months |
6 (17.6%) |
1 (2.8%) |
0.052 |
|
QoL global score, (min—max) |
89±10 (59—100) |
86±13 (40—100) |
0.342 |
Changes of cosmetic defect and QoL before and after sclerotherapy are presented in Table 3. A significant improvement in aesthetic complaints and in QoL was found in both groups.
Table 3. Cosmetic defect and QoL before and after sclerotherapy
|
Group |
Cosmetic defect, VAS, before treatment |
Cosmetic defect, VAS, after treatment |
p |
QoL global score, before treatment |
QoL global score, after treatment |
p |
|
noEC group (n=34) |
75±21 |
26±24 |
<0.0001 |
83±14 |
89±10 |
0.011 |
|
EC group (n=36) |
71±20 |
31±26 |
<0.0001 |
78±17 |
86±13 |
0.0002 |
Discomfort related to compression stockings was assessed by EC group patients. The average VAS score was 17 (median 3). Only three patients rated discomfort as more than 70, while five reported no discomfort at all and 16 rated it as less than 10. In all cases discomfort did not affect the overall favorable perception of stockings. Therefore, no cases of interrupted compression were registered.
Discussion
We conducted a non-randomized study in which rate and severity of hyperpigmentation after sclerotherapy in C1 patients were compared under extended compression regime and in no extended compression group. For EC class 2 thigh-length compression stockings (VenoTrain micro, Bauerfeind) for 4 months after the start of treatment was used.
We have demonstrated that EC is associated with a lower rate of hyperpigmentation. 29% of those who did not use EC manifested with hyperpigmentation at 4 months while only 6% of patients who used EC had a hyperpigmentation (p=0.011). The severity of hyperpigmentation was also less in EC group.
While the need and duration of postprocedural compression is a subject of discussion for decades the data on this are scarce. Just a few studies were conducted on this subject. R.A. Weiss et al. compared sclerotherapy results in four small groups of 10 patients each (no compression, 3 days, 7 days and 3 weeks of compression with 20—23 mmHg stockings). At 6 weeks, 3 and 6 months a significant decrease in hyperpigmentation rate was registered with the lowest rate related to the longest compression use period [8]. P. Kern et al. randomized patients to class 2 compression stockings use for 3 weeks and no compression. At 6 weeks after procedure the frequency of hyperpigmentation was 8% and 9%, respectively [9]. O.V. Bukina et al. demonstrated 38.3% hyperpigmentation rate after treatment with a detergent sclerosant solution and 2.6% with a hypertonic glucose solution at 2 months. Both groups’ patients used compression for 5 days after procedure [11].
The rate of telangiectatic matting was lower in patients who used EC — 2.8% vs 17.6% in noEC group (p=0.052). A similar trendwas found by R.A. Weiss et al. in patients who used compression compared to those who did not [8]. At the same time, Kern P. et al. found no difference in matting rates [9].
Nevertheless, our data cannot be compared with the results of the mentioned studies as they assessed sclerotherapy for telangiectasias only and after a single session only. We present the results of a full course of sclerotherapy when not only telangiectasias, but also spider veins were treated with up to four treatment sessions. This increases the risk of side effects. Moreover, compression duration did not exceed 3 weeks in referenced studies, while our patients used compression for 4 months. A similar treatment strategy reported Rabe et al. who compared the efficacy of polidocanol versus sodium tetradecyl sulfate in class C1 patients with [12]. They used 0.5% polidocanol for telangiectasias and 1% for reticular varicose veins and performed one to three sessions as we did. The duration of compression was also similar. The authors recommended daytime compression use with a final assessment at 6 months after the last procedure. A change in skin color was recorded in 26.6% of cases while telangiectatic matting was registered in 3.2% patients. While we found the same rate of matting, skin color changes were registered more often. At the same time this definition may be somewhat different from hyperpigmentation that may explain the difference with our data.
As for the overall cosmetic result of sclerotherapy R.A. Weiss and P. Kern demonstrated better results with extended postprocedural compression. We found no differences between EC and noEC groups. Cosmetic improvement was achieved in both groups’ patients. At the same time in our study cosmetic defect was assessed by patients themselves while in a referenced publications results were assessed by physicians by measuring a clearing of a skin surface.
Thigh-length class 2 compression stockings VenoTrain micro (Bauerfeind, Germany) were perceived by patients as comfortable and convenient to use. None of the patients refused to use it during the entire follow-up period. No AEs related to compression stockings were registered.
Limitations. Our study has some limitations the most serious of which is that it’s not randomized. We believe that this was to some extent balanced by enrollment of consecutive patients and by a sample size calculation based on a data from preliminary pilot study.
Conclusions
Sclerotherapy in C1 patients leads to a significant reduction of aesthetic defect. Extended postprocedural compression with class 2 compression stockings leads to a decrease of hyperpigmentation and telangiectatic matting rates comparing with no compression regime at four months after treatment start. A decrease in severity of hyperpigmentation has also confirmed.
Author contributions:
Research concept and design — R.G. Chabbarov, A.G. Pyatnitsky, I.A. Zolotukhin
Collection of the data — A.K. Sanbaev, O.I. Efremova, R.G. Chabbarov, A.G. Pyatnitsky
Statistical analysis — A.K. Sanbaev, O.I. Efremova, I.A. Zolotukhin
Writing — A.K. Sanbaev, O.I. Efremova, I.A. Zolotukhin
Editing — R.G. Chabbarov, A.G. Pyatnitsky, I.A. Zolotukhin
Conflict of interest
The study was supported by the Nikamed Company. Zolotukhin I.A. received honoraria for lectures from Servier, Innotec, Dominanta-Service, Medi and Nikamed Companies.