Treatment of varicose veins can be largely divided into two categories: conservative treatment and invasive treatment. Conservative treatment includes compression stockings and venoactive drugs. The invasive treatments are sclerotherapy, surgery, endovenous thermal ablation, or endovenous non-thermal and non-tumescent ablation. Generally, invasive treatment is indicated for patients with symptomatic varicose veins of CEAP clinical stage C2-C6, while conservative management is usually recommended for patients with CEAP classification C0-C1, even when saphenous vein reflux and leg discomfort are combined. Invasive treatment for patients at the stage of CEAP C0-C1 is controversial, without definite practical guidelines. Once pathological changes develop in the vein wall and valves, however, the disease can progress through a vicious cycle of inflammation and leukocyte recruitment that leads to further venous deterioration and dysfunction (
This study aims to study the clinical efficacy of invasive treatment for incompetent saphenous vein in patients with CEAP C0-C1 chronic venous disease.
From February 2015 to December 2019, symptomatic patients with CEAP C0-C1 chronic venous disease and an incompetent saphenous vein who underwent surgery or radiofrequency ablation were enrolled in this study. The exclusion criteria were as follows: 1) previous history of varicose vein treatment including injection sclerotherapy or 2) deep vein thrombosis or its sequelae.
During the physical examination, clinicians graded the clinical severity of the venous disease according to the CEAP classification.
At baseline and at each follow-up visit, disease severity and disease-related quality of life were appraised by the Venous Clinical Severity Score (VCSS) and the Aberdeen Varicose Vein Questionnaire (AVVQ).
All patients who were scheduled to undergo varicose vein surgery underwent duplex ultrasonography (DUS) (LOGIQ5 PRO 5∼12 MHz linear probe; GE HealthCare, Sungnam, South Korea). The entire venous system from the groin to the ankle, including the deep, superficial, and perforating veins, was examined. Evaluations were conducted on a non-weightbearing limb with patients in the standing position. Venous reflux in the saphenous vein was defined as retrograde flow lasting longer than 0.5 seconds after manual compression and decompression of the distal vein.
Treatment options were either surgery or radiofrequency ablation (RFA) and were conducted in the study period, where RFA is the preferred main treatment. Surgical treatment was performed by modified high ligation and stripping, and it was performed when the subcutaneous distance between the anterior vein wall and the skin was less than 0.5 cm along most of the length of the great saphenous vein (GSV) to be treated. Veins in this condition can lead to complications, such as the formation of a cord-like mass or pigmentation on the skin. In cases involving the small saphenous vein (SSV) in which the diameter of the SSV was less than 2.2 mm, surgery was the preferred treatment method, because the diameter of the vein was narrower than the diameter of the radiofrequency catheter. Other indications for surgery were patient preference and patients who preferred the procedure with a lower cost that was covered by the National Health Insurance Service. Both treatments, high ligation and stripping or RFA, were performed from the groin to the knee crease and combined with stab avulsions of tributary varicosities. In every case, the GSV below the knee (BK-GSV) was preserved. In modified high ligation, intraoperative ultrasound-guided mapping preceded groin incision for an accurate approach to the saphenofemoral junction (SFJ) with minimal dissection and physiologic inguinal drainage to the SFJ was preserved rather than flush ligation of the SFJ. Furthermore, stripping of the GSV above the knee was performed after perivenous injection of cold tumescent solution, 500 ml of cold saline (<5℃) mixed with epinephrine (1:100,000), for the prevention of postoperative hematoma.
After conventional surgery or RFA, patients were required to wear compression stockings all day for 1 week. Patients underwent follow-up DUS in the outpatient clinic at 6 and 12 months postoperatively. Postoperative resolution of reflux status of the BK-GSV was defined as reversed blood flow in the BK-GSV for less than 0.5 seconds. If reflux in the BK-GSV persisted postoperatively, we evaluated the subsequent change of reflux status of the BK-GSV and remaining symptoms.
The data were analyzed using Statistical Package for the Social Sciences (IBM SPSS Statistics, version 21; SPSS Inc., Chicago, IL). Student’s t-test, χ2 test, and Fisher’s exact test were used to identify group differences. A probability value less than 0.05 was regarded as statistically significant.
A total of 37 patients (48 limbs) with CEAP C0-C1 CVD were included in this study. Male patients numbered 6 (16.2%) and female patients, 31 (83.8%). The mean age was 50 years (range, 21∼83 years). The distribution of CEAP score in the limbs of the patients in this study was as follows: C0, n=11 (22.9%); and C1, n=37 (77.1%).
Patients complained of preoperative leg symptoms including leg pain (n=29, 60.4%), swelling (n=23, 47.9%), heaviness (n=28, 63.6%), and itching (n=5, 11.4%).
The saphenous veins treated were the SSV in 25 limbs (52.1%), the unilateral GSV in 18 limbs (37.5%), and the bilateral GSV in 5 limbs (10.4%).
The treatment methods were as follows: radiofrequency ablation (33 limbs, 68.7%) and surgery (15 limbs, 31.3%). Additional therapy for tributary veins were sclerotherapy for 15 limbs (34%) and phlebectomy for 3 limbs (6.8%).
There were no postoperative complications, such as nerve injury, hematoma formation, wound infection, thrombophlebitis, or deep vein thrombosis.
The numbers of patients who underwent a postoperative follow-up DUS study after 6 and 12 months were 37 (48 limbs, 100%) and 19 patients (23 limbs, 62.2%), respectively.
In all treated limbs, there was neither neovascularization at the SFJ and saphenopopliteal junction (SPJ) nor recanalization of the treated GSV and SSV.
The postoperative VCSS and AVVQ were significantly improved at 6 and 12 months after surgery compared with the preoperative scores (p<0.01) (Fig. 1 and 2).
Fig. 1. Comparison of pre- and postoperative VCSS at 6 and 12 months.
Fig. 2. Comparison of pre- and postoperative AVVQ at 6 and 12 months.
The postoperative VCSS and AVVSS were assessed according to the treatment (Table 1). The preoperative VCSS and AVVQ were not statistically different between the two treatment groups. The postoperative VCSS and AVVQ significantly decreased after a procedure, irrespective of the type of treatment, compared with the preoperative VCSS and AVVQ (p<0.01).
Table 1 . Comparison of VCSS and AVVQ according to the treatment
| 6 months | Follow up | Surgery (N=12) | RFA (N=25) | p |
|---|---|---|---|---|
| VCSS | Pre-op | 1.3±0.5 | 1.6±0.9 | 0.43 |
| 6 months | 0.4±0.7 | 0.2±0.4 | 0.23 | |
| p | <0.01 | <0.01 | ||
| PI | 62.5±64.4 | 84.7±33.9 | 0.18 | |
| AVVQ | Pre-op | 11.3±8.1 | 12.9±7.0 | 0.55 |
| 6 months | 9.4±8.4 | 6.3±4.9 | 0.16 | |
| p | <0.01 | <0.01 | ||
| PI | 18.5±75.5 | 39.1±51.0 | 0.33 | |
| 12 months | Follow up | Surgery (N=7) | RFA (N=12) | p |
| VCSS | Pre-op | 1.1±0.4 | 1.3±0.9 | 0.60 |
| 12 months | 0.1±0.4 | 0.0 | 0.20 | |
| p | <0.01 | <0.01 | ||
| PI | 92.8±18.9 | 100 | 0.20 | |
| AVVQ | Pre-op | 11.2±8.3 | 13.8±6.9 | 0.46 |
| 12 months | 4.9±3.8 | 6.5±4.5 | 0.46 | |
| p | <0.01 | <0.01 | ||
| PI | 59.6±21.5 | 42.4±41.3 | 0.33 | |
VCSS: venous clinical severity score, AVVQ: aberdeen varicose vein severity score, RFA: radiofrequency ablation, PI: percent improvement.
Patients with CEAP C0-C1 CVD, even those with leg symptoms and an incompetent saphenous vein combined, are usually recommended to undergo conservative management such as compression stockings and venoactive drugs. Although conservative management is helpful for symptomatic relief (
The prevalence of incompetent saphenous veins in limbs with CEAP C0-C1 CVD has not been previously reported. Unpublished data from our hospital demonstrated that 43.8% of the limbs with CEAP C0-C1 CVD showed an incompetent saphenous vein on a preoperative DUS. Therefore, at least 43.8% of the limbs with CEAP C0-C1 CVD could progress to CEAP C2-C6 with only conservative management.
In the present study, no patients suffered postoperative complications, such as nerve injury or hematoma. Although the GSV from the groin to the ankle was incompetent, stripping or endovenous ablation was performed only to the level of the knee to prevent nerve injury. In cases involving the SSV, stripping or endovenous ablation was performed after meticulous ultrasound-guided mapping of the distance between the SSV and the sural nerve. For prevention of hematoma formation along the strip-tract, stripping was preceded by a perivenous injection of a cold tumescent solution that included epinephrine, and compression was done for about 2 minutes after stripping.
In this study, the VCSS and AVVQ improved significantly after invasive treatment, irrespective of treatment type; early invasive treatment of incompetent saphenous veins in patients with limbs with CEAP C0-C1 CVD could benefit the quality of life by the improvement of venous hemodynamics.
Furthermore, phlebectomy is performed through the skin opening made by 18 gauge needle puncture and suturing is not necessary for phlebectomy wound. Therefore esthetical satisfaction also seems to be reflected in the postoperative AVVQ scores. This study has some limitations. It was a retrospective study with a small number of patients. To validate the efficacy of invasive treatment for incompetent saphenous veins in limbs with CEAP C0-C1 CVD, a prospective, randomized, comparative study is necessary, with a control group of conservative management.
In conclusion, the present study demonstrated that quality of life improved after treatment of incompetent saphenous veins in patients with symptomatic CEAP C0-C1 CVD, regardless of treatment type.
The author declares no potential conflict of interest.
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