Comparative efficacy and life quality effects of surgical stripping,radiofrequency ablation,and cyanoacrylate embolization in patients undergoing treatment for great saphenous vein insufficiency

Abstract

Objectives

To compare traditional surgery with two minimally invasive endo-venous procedures in terms of their long-term effect on the quality of life in great saphenous vein insufficiency (GSV).

Method

This prospective observational study included 217 patients that underwent surgical stripping (n = 62), radiofrequency ablation (n = 70), or cyanoacrylate embolization (n = 85) for the treatment of GSV insufficiency. Venous Clinical Severity Score (VCSS) assessments were made, 36-item Short-Form Health Survey (SF-36) questionnaire and Chronic Venous Insufficiency quality of life Questionnaire (CIVIQ-14) were administered, before and 1 year after the treatments.

Results

Surgical stripping group had significantly higher closure rates than the other groups (p < 0.05). At 12 months, decrease in VCSS scores was less pronounced in the cyanoacrylate embolization group when compared to the other two groups (p < 0.05). Improvement in CIVIQ-14 scores was better in the radiofrequency ablation group when compared to the cyanoacrylate embolization group (p < 0.05). Surgical stripping or radiofrequency ablation groups performed better on several domains of SF-36, when compared to the cyanoacrylate embolization group.

Conclusions

Surgical stripping and radiofrequency ablation seem to provide a better quality of life results at one year in patients undergoing treatment for GSV insufficiency.

Keywords

Saphenous vein insufficiency surgical stripping radiofrequency ablation cyanoacrylate embolization quality of life

Introduction

Chronic venous disease of the lower extremity is among the most common conditions in the adult population¹ that mostly presents itself as great saphenous vein (GSV) or perforator vein insufficiency. In the last two decades, we have witnessed the emergence of minimal invasive surgical procedures such as laser or radiofrequency endovenous thermal ablation as an alternative to traditional surgical stripping for the treatment of GSV insufficiency.² General or regional anesthesia is not usually required in endovenous ablation. Additionally, the classic disadvantages of classical surgery such as postoperative pain, hematoma, ecchymosis, nerve damage, and scarring are eliminated. However, in endovenous procedures, tumescent anesthesia is required that prolongs the procedure and contributes to the intraoperative discomfort due to multiple punctures. With newer application, cyanoacrylate embolization, varicose vein treatment can only be done with local anesthesia.³ On the other hand, there is still no general consensus regarding the most effective method among these approaches. Despite common use of endo-venous closure techniques, traditional stripping remains a frequently performed procedure by surgeons.

It has been clearly established that chronic venous disease (CVD) negatively impacts the quality of life (QoL) and that the treatment of varicose veins leads to an improved QoL.⁴ Until now, studies examining endo-venous procedures as an alternative to traditional surgery have provided limited evidence regarding their effect on QoL, with scarce comparative QoL data for endovenous and traditional surgery. These studies generally compared endovenous laser radiofrequency or foam sclerotherapy with surgery.^5,6

In this study, our aim was to compare traditional surgery with minimally invasive endovenous procedures with short operation and hospitalization times such as radiofrequency ablation (RFA) and cyanoacrylate embolization (CE) in terms of their long-term effect on quality of life.

Methods

Patients

This prospective observational study included a total of 217 patients who underwent venous insufficiency treatment in our clinic between November 2018 and April 2019. The choice of procedure to be applied was decided together with the patients according to the clinical conditions and the patients' preference. The study protocol was approved by the local ethics committee (number 19/224, date October 16, 2018). Patients provided informed consent prior to study entry. CEAP Class C2-6 patients with a GSV diameter >5.5 mm and reflux duration of >500 msec on Doppler ultrasonography were included. Exclusion criteria were the presence of deep venous insufficiency, deep venous thrombosis, saphenous vein thrombosis, arterial disease of the lower extremity, hypercoagulability, recurrent varicose venous surgery, and age <18 years and >70 years. Of the participants, 62, 70, and 85 underwent surgical stripping, radiofrequency ablation, and cyanoacrylate embolization, respectively. Prior to the procedures, all patients underwent physical examination and complete venous Doppler ultrasonography in order to map the sources of reflux in the diseased vessels. Preoperative GSV diameter was measured and patients were classified according to CEAP classification (clinical, etiological, anatomical, and pathophysiological).⁷

Techniques

Surgical stripping

Surgical stripping (SS) was performed under spinal or general anesthesia. Sapheno-femoral junction was explored with an inguinal excision, all branches were ligated and divided. After local phlebectomy was performed for local varicosities, GSV was stripped from inguinal area to just above the medial malleolus using a venostrip. In 12 (19.3%) patients whose venostrip did not reach the medial malleolus, stripping was performed from the knee level. The course of the saphenous vein was compressed for 5 minutes, and hematomas occurring along the vein course were squeezed out from the incisions. The incisions in the leg and inguinal area were sutured. Elastic compression stockings were applied to the leg, with a recommendation to continue the application for 1 week. Patients were discharged on postoperative day 1.

Radiofrequency ablation

For radiofrequency ablation (RF), a 7-cm Closure Fast™ (Covidien, Dublin, Ireland) system was used. The heating apparatus of the device contains a spiral wire that is heated with alternative current at 460 kHz and produces a temperature of 120°C with 20 sec cycles. A thermocouple located at the distal part of the heating element allows maintenance of the temperature at 120°C by regulating the energy. Initiall, sedoanalgesia (midazolam 00.1 mg/kg, fentanyl 1 microgram/kg) was provided to all patients to prevent pain related with multiple injections performed for tumescent anesthesia (500 ml normal saline with 20 ml 1% lidocaine and 5 ml 8.4% sodium bicarbonate). An ultrasound probe covered with a sterile sheath and sterile ultrasound gel were used for the procedures. Then, GSV was catheterized above the knee with percutaneous puncture using a 7 F sheath. The tip of the catheter was placed just under the ostium of the superficial epigastric vein, approximately 1-2 inferior to the sapheno-femoral junction (SFJ). In order to reduce the filling of GSV, patients were positioned in the reverse Trendelenburg position. Anesthetic liquid consisting of adrenaline, bicarbonate, and lidocaine was injected subcutaneously along the course of the saphenous vein under ultrasound guidance. A Doppler ultrasound was used to assess the quality of tumescence and to ascertain that catheter was at least 1 cm beneath the skin. First, 2-therapeutic cycles were delivered to the termination of GSV, then one cycle was delivered to other venous segments. Prior to starting a new cycle, the catheter was positioned in the next segment using shaft markers. Position changes were performed with 6.5 cm intervals, with 5 mm overlap between the two segments. During the whole process of energy delivery, the treated segment was compressed manually or using the ultrasound probe. In order to be able to treat the part of the saphenous vein close to the puncture, first the sheath was removed from the catheter. After ablation, phelebectomies were performed in patients with local varicosities. Elastic compression stockings were applied to the leg. Patients were discharged at postoperative day 1, with an instruction to continue using elastic stockings for 1 week.

Cyanoacrylate embolization

Cyanoacrylate embolization (CE) of the GSV was performed under local anesthesia using a Vein Sealing System (Biolas, FG Grup, Ankara, Turkey). VariClose vials containing 1 ml of sterile polymer-based cyanoacrylate were used as adhesive (Biolas, Ankara, Turkey). The VariClose set includes the following: a 6 F introducer sheath, a 0.035-inch guidewire, a 3-mL injector, an injection gun, an injection adaptor, a labeling 5 F catheter, and a 4 F micro-catheter. The saphenous vein was cannulated percutaneously above the knee under Doppler ultrasound guidance. The introducer sheath was positioned in the saphenous vein, and the labelling catheter was advanced to a point 3 cm distal to the SFJ. The delivery catheter was prepared, and the injection gun was filled with n-butyl cyanoacrylate solution. Then, the micro-catheter was advanced within the 5 F catheter and its position was locked 3 cm distal to the SFJ and the position was ascertained with Doppler US. The proximal segment was compressed with the Doppler US probe, in order to prevent the leakage of the bolus primary into the deep venous system before the administration of the solution. For priming, the precipitation was applied through the micro-catheter system twice, each for 1 second duration. Then, the catheter was withdrawn at a rate of 2 cm/sec and the trigger of the gun was pressed for 5 seconds, with simultaneous compression using the Doppler US probe. In each 5-second application, polymer at a volume of 0.3 mL was administered (0.03 mL/cm). The procedure was continued until all saphenous vein segments were embolized. Patients were discharged on the same day with prescription of elastic compression stockings for 3 days.

Assessments

GSV occlusion rates were determined using venous Doppler ultrasound at postoperative week 1, and at months 1, 6, and 12, during which adverse events were also recorded. Any recanalization, reﬂux, or open segment longer than 5 cm in length was considered a failure

Venous Clinical Severity Score (VCSS) assessments were made preoperatively and at postoperative month 12. VCSS is a scoring tool used to determine the clinical severity of chronic venous insufficiency before and after treatment. The total score ranges between 0 and 30, and is the sum of individual scores for pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, active ulcer number, active ulcer duration, active ulcer size, and use of compression therapy, each scored between 0 and 3. Higher scores represent more severe venous disease.⁸

Preoperative and postoperative (12 months) health related quality of life was assessed using 36-item Short-Form Health Survey (SF-36) questionnaire, and Chronic Venous Insufficiency quality of life Questionnaire (CIVIQ-14) specifically developed for venous disorders. SF-36 quality of life questionnaire provides generic, in-depth measures and it was developed in 1992 by the Rand Corporation. Kocyigit reported the first Turkish validity and reliability study for SF-36 in 1999, which indicated a Cronbach’s Alpha coefficient of greater than 0.70.⁹SF-36 includes items related to change of perceptions in health status within the last four weeks. The questionnaire consists of 36 items under nine domains, including physical and mental components. These nine domains are as follows: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health, health change. Each scale is directly transformed into a 0–100 scale, and the lowest point shows the worst health status. CIVIQ-14 is a quality of life questionnaire specific for chronic venous insufficiency. It contains 14 items in the three following domains with 5 possible answers for each item: pain (three items), physical status (five items), and psychological status (six items). CIVIQ-14 scores are expressed for each of the domains and also as a global index score, ranging between 0 and 100 and indicating better quality of life for higher scores.¹⁰

Statistical analysis

Descriptive data are presented as mean, standard deviation (SD), number and percentage. Normality was tested using Kolmogorov Smirnov test. Intergroup comparisons of quantitative variables were done using one-way ANOVA or Kruskal-Wallis test; and Tukey HSD or Dunn’s test was used as post hoc test. Intragroup comparisons of non-normal quantitative variables were analyzed by Wilcoxon test (change from baseline within each group). Fisher’s exact or chi-square test was used to assess the associations between two qualitative variables. All tests were two-tailed and a p < 0.05 was considered indication for statistically significant. IBM Statistical Package for Social Sciences (SPSS) v.20.0 (Armonk, NY: IBM Corp.) software was used for the analysis of data.

Results

Patients

Table 1 shows demographical and preoperative clinical data of the patients. The three groups did not differ regarding age, gender distribution, great saphenous vein diameter and CEAP classification (p > 0.05 for all). In the surgical stripping group, 55 (88.7%) and 7 (11.2%) of the patients were operated under spinal anesthesia and general anesthesia, respectively.

Table 1.

Demographical and clinical data.

	SS (n = 62)	RFA (n = 70)	CE (n = 85)	p
Age, y (mean ± SD)	37.8 ± 12.8	38.2 ± 11.7	40.0 ± 13.1	0.53
Female gender	35 (56.4%)	45 (64.2%)	57 (67%)	0.41
GSV diameter, mm (mean ± SD)	8.1 ± 2.0	7.6 ± 1.6	7.9 ± 1.6	0.28
CEAP classification
C2-4	48 (77.4%)	57 (81.4%)	67 (78.8%)	0.84
C5-6	14 (22.5%)	13 (18.5%)	18 (21.1%)

Note: Unless otherwise stated, data presented as n (%).

SS: surgical stripping; RFA: radiofrequency ablation; CE: cyanoacrylate embolization; GSV: great saphenous vein; CEAP: clinical, etiological, anatomic and pathophysiological; SD: standard deviation.

Great saphenous vein closure rates and varicose vein regression

Table 2 shows great saphenous vein closure rates in all groups at the end of first week, first month, six months, and 12 months. After the first month, surgical stripping group had significantly higher closure rates than the other groups (p < 0.05 for all). The complete varicose vein regression rate at 6 and 12 months was significantly lower in the cyanoacrylate embolization group than in the other groups (p < 0.05).

Table 2.

Great saphenous vein closure rates and postoperative complications.

	SS (n = 62)	RFA (n = 70)	CE (n = 85)	p
GSV closure rates
Week 1	62 (100.0)	68 (97.1%)	83 (97.6%)	0.431
Month 1	62 (100.0)	64 (91.4%)	74 (87.1%)	0.015
Month 6	62 (100.0)	62 (88.6%)	72 (84.7%)	0.007
Month 12	62 (100.0)	61 (87.1%)	70 (82.4%)	0.003
Complete varicose vein regression
Month 6	58 (93.5%)	64 (91.4%)	41 (48.2%)	0.001
Month 12	59 (95.1%)	65 (92.8%)	45 (52.9%)	0.001
Postoperative complications
Phlebitis	4 (6.4%)	3 (4.2%)	2 (2.3%)	0.48
Phlebitis-like reaction	0	0	8 (9.4%)	0.002
Skin pigmentation	2 (3.2%)	2 (2.8%)	2 (2.3%)	0.95
Ecchymosis	15 (24.2%)	2(2.8%)	3(3.5%)	0.001
Paresthesia	2 (3.2%)	1 (1.4%)	1 (1.1%)	0.63
Deep venous thrombosis	1 (1.6%)	0	0	0.29
Wound complications^a	3 (4.8%)	1 (1.4%)	0	0.34
Any complication	20 (32.3%)	9 (12.9%)	15 (17.6%)	0.016

Note: Data presented as n (%).

GSV: great saphenous vein; SS: surgical stripping; RFA: radiofrequency ablation; CE: cyanoacrylate embolization.

^aAt the access site or incision site.

The radiofrequency ablation and cyanoacrylate embolization groups did not differ regarding great saphenous vein closure rates at any of the time points and at the end of the follow-up. In the radiofrequency ablation and cyanoacrylate embolization groups, 87.1% and 82.3% of saphenous veins were not patent respectively (p = 0.41).

Postoperative complications

Table 2 shows the frequencies of postoperative complications. Three groups had similar frequencies for the following: phlebitis, skin pigmentation, paresthesia, deep venous thrombosis and wound complication (p > 0.05 for all). Ecchymosis was more frequent in the surgical stripping group when compared to other groups (p < 0.05 for both comparisons) and phlebitis like reaction was only seen in the cyanoacrylate embolization group with significantly higher frequency (9.4%) than the others (p < 0.001 for both comparisons). Frequency of any complication was significantly higher in the surgical stripping group when compared to the radiofrequency ablation (p = 0.007) and cyanoacrylate embolization groups (p = 0.040); however, the latter two groups had similar rates of any complication (p = 0.412).

Disease severity and quality of life in the first year

Table 3 shows the comparison of the SF-36, CIVIQ-14 and VCSS scores in the 12th month preoperatively and postoperatively. VCSS scores of all three groups significantly reduced. CIVIQ-14 scores and all nine domains of the SF-36 scores significantly increased at 12 months when compared to baseline (p < 0.001 for all intragroup comparisons). Figure 1 shows the changes from baseline for all disease severity and quality of life parameters. Decrease in VCSS scores was less pronounced in the cyanoacrylate embolization group when compared to other two groups (p < 0.05). Improvement in CIVIQ-14 scores was better in the radiofrequency ablation group when compared to the cyanoacrylate group (p < 0.05). A significant difference between groups was evident for the following SF-36 subdomains: role limitations due to emotional problems, energy/fatigue, social functioning, general health, and health change. Improvements in radiofrequency ablation group was better when compared to the cyanoacrylate embolization group regarding role limitations due to emotional problems, social functioning, and general health subdomains (p < 0.05 for all). On the other hand, improvements in energy/fatigue and health change subdomains were higher in the surgical stripping group when compared to the cyanoacrylate embolization group (p < 0.05 for both).

Table 3.

Preoperative and postoperative disease severity and quality of life scores.

	SS (n = 62)	RFA (n = 70)	CE (n = 85)	p
VCSS
Baseline	8.63 ± 3.95	9.33 ± 4.37	9.11 ± 4.98	0.71
12 months	3.05 ± 1.76	4.07 ± 2.69	4.89 ± 3.2	0.000^a
SF-36
Physical functioning
Baseline	77.5 ± 14.8	73.7 ± 15.8	68.1 ± 17.1	0.000^a
12 months	95.4 ± 5.0	95.7 ± 4.9	86.2 ± 17.2	0.000^b
Role limitations due to physical health
Baseline	74.5 ± 15.3	74.2 ± 15.9	74.1 ± 15.6	0.98
12 months	89.9 ± 13.1	92.5 ± 11.5	85.8 ± 17.8	0.07
Role limitations due to emotional problems
Baseline	58.0 ± 14.7	54.7 ± 16.1	57.2 ± 15.1	0.42
12 months	93.5 ± 13.2	91.9 ± 14.3	81.9 ± 24.4	0.000^b
Energy/fatigue
Baseline	71.2 ± 19.0	66.7 ± 19.4	68.0 ± 19.0	0.33
12 months	89.8 ± 12.1	85.8 ± 11.8	82.2 ± 16.7	0.02^a
Emotional well-being
Baseline	85.5 ± 8.6	85.0 ± 7.4	85.1 ± 7.3	0.47
12 months	95.0 ± 6.2	93.8 ± 6.1	89.9 ± 12.2	0.04^a
Social functioning
Baseline	75.4 ± 13.3	69.4 ± 13.7	71.6 ± 13.8	0.04^c
12 months	95.7 ± 7.4	95.7 ± 7.3	89.1 ± 15.5	0.01^b
Pain
Baseline	68.1 ± 15.6	68.2 ± 15.5	68.4 ± 15.6	0.98
12 months	83.7 ± 12.7	82.1 ± 12.0	77.0 ± 17.0	0.04^a
General health
Baseline	67.2 ± 7.2	64.8 ± 7.3	65.6 ± 7.8	0.09
12 months	87.5 ± 11.1	86.8 ± 10.9	81.8 ± 15.7	0.11
Health change
Baseline	46.7 ± 16.6	44.2 ± 16.0	45.0 ± 16.2	0.68
12 months	87.0 ± 17.9	83.5 ± 18.4	74.7 ± 25.1	0.01^a
CIVIQ-14
Baseline	85.8 ± 6.1	83.8 ± 6.4	82.8 ± 6.4	0.02^a
12 months	96.5 ± 3.0	94.6 ± 3.6	91.6 ± 5.8	0.000^d

SS: surgical stripping; RFA: radiofrequency ablation; CE: cyanoacrylate embolization; VCSS: Venous Clinical Severity Score; CIVIQ-14: Chronic Venous Insufficiency quality of life Questionnaire score; SF-36: Short-Form Health Survey.

^aSS vs. CE.

^bSS and RFA vs. CE.

^cSS vs. RFA.

^dAll groups differed significantly.

Discussion

In this study evaluating the effect of surgical and endovenous procedures used for the treatment of GSV insufficiency over a 1-year period found significant improvements after the treatment in the generic SF-36, disease-specific CIVIQ-14, and clinical VCSS questionnaire scores in all groups. Patients in surgical stripping and radiofrequency ablation groups showed higher improvement in VCSS and in certain SF-36 items, as compared to the patients in cyanoacrylate embolization group. In addition, there was a higher improvement in CIVIQ-14 scores among radiofrequency ablation patients than in cyanoacrylate embolization patients. Therefore, satisfaction with cyanoacrylate embolization following GSV treatment was lower.

Thermal ablation methods were initially based on laser technology, with subsequent introduction of radiofrequency devices. These methods have been developed as an alternative to surgical stripping in the treatment of varicose veins.^11–13 In order to prevent burns and nervous injury in skin and subcutaneous tissues due to high energy released during these procedures, tumescent anesthesia is required. However tumescent anesthesia is associated with multiple punctures in the leg, leading to hematoma and ecchymosis formation. Furthermore, additional sedation may be needed to prevent pain due to multiple injections. Methods such as foam sclerotherapy and cyanoacrylate ablation have been developed to avoid the complications of endovenous ablation as well as to be able to perform the procedure only with local anesthesia.¹⁴ Many studies compared newer methods with more traditional approaches in varicose vein treatment in terms of clinical outcomes and efficacy. Some of these studies also looked at the changes in quality of life after surgery, endovenous thermal ablation, and foam sclerotherapy.^5,6,15 In our study, a comparison of surgical stripping, radiofrequency ablation, and cyanoacrylate embolization used for the treatment of varicosities was performed with respect to clinical results and quality of life effects. Most previous studies utilized the disease-specific measurement tools such as Aberdeen Varicose Vein Questionnaire (AVVQ), CIVIQ-20, and CIVIQ-24, as well as SF-36 and EQ-5D as generic life quality measures.^16–19 In the current study, SF-36 and CIVIQ-14 were used for that purpose.

The negative impact of chronic venous disease (CVD) on QoL of patients has been clearly established, with improvements in QoL after treatment of varicose veins. Previous studies comparing radiofrequency ablation and cyanoacrylate embolization reveal that there was a significant improvement in health-related and disease-specific quality of life scores after the treatment, but no difference was observed between the two groups. Similarly, it was emphasized that there was an improvement in VCSS in both groups.^16–18 Eroglu et al reported that the improvement in VCSS score was much more pronounced in patients who underwent cyanoacrylate embolization than radiofrequency ablation group in the 2-year follow-up.¹⁹ On the other hand, in our study, radiofrequency ablation was superior to cyanoacrylate embolization in terms of improvements in VCSS, CIVIQ-14, and three SF-36 components (role limitations due to emotional problems, social functioning, general health).

In previous reports comparing surgical striping with endovenous methods (radiofrequency ablation, EVLA), a similar improvement in health-related and disease-specific quality of life scores was shown in both treatment groups.^5,6 Lurie et al. reported that the disease-specific CIVIQ-20 QoL score in the first year was better in those who underwent radiofrequency ablation than those performed surgical striping.²⁰ In our study, no differences between surgical stripping and radiofrequency ablation were observed in terms of the change in the quality of life. However, significantly more marked reduction (i.e. improvement) in VCSS and a significantly more marked increase in two SF-36 components (energy/fatigue, and health change) were found in the surgical stripping group as compared to cyanoacrylate embolization group.

As is the case with GSV removal through SS, one of the tools to measure the efficacy of endovenous procedures involves the GSV occlusion rate. The reported GSV occlusion rate for cyanoacrylate embolization at 3 months and 1 year are 96% to 98%, and 75.7% to 98.6%, respectively.³ The corresponding figures for radiofrequency ablation are 97% to 100% and 88% to 97%.^21,22 The observed GSV occlusion rates for cyanoacrylate embolization and radiofrequency ablation at 1 year were also comparable in the current study (p > 0.05).

Most common complications of cyanoacrylate therapy are phlebitis or phlebitis-like skin reactions, which have been reported to range between 11.4% and 20%.²³ In some studies, phlebitis-like skin reactions have been categorized as painless phlebitis, which may occur even in a higher percentage of patients, i.e. up to 25%, depending on the criteria used for definition of these side effects.^24,25 A possible explanation involves the development of delayed hypersensitivity to cyanoacrylate occurring several days after the procedure, with signs and symptoms such as pruritus, swelling, pain, and tenderness together with abnormal cutaneous erythema, with more extensive involvement as compared to phlebitis.²⁶ The reported frequency of phlebitis for radiofrequency ablation vary between 2% and 7%.²² In the present study, all three groups had similar rates of phlebitis, although phlebitis-like reactions were observed in 9.4% of the cyanoacrylate embolization patients versus 0% in the remaining study groups. On the other hand, ecchymosis was more common in the surgical stripping group. Also, percentage of patients with any complication defined as the occurrence of phlebitis, phlebitis-like reaction, skin pigmentation, ecchymosis, paresthesia, deep venous thrombosis, or wound complications was higher in the stripping group When cyanoacrylate is administered intravascularly, it is polymerized due to its interaction with the anions in the plasma and blood, leading to vessel occlusion. Cyanoacrylate is strongly adhered to the vessel wall, inducing an acute inflammatory response progressing to granulomatous inflammation, with subsequent gradual resorption, and transformation of the vessel into a fibrotic cord.³ In a previous study, histopathological examination of the occluded vein sample obtained 5.5 years after the initial cyanoacrylate embolization procedure showed signs of foreign body reaction (vessel occlusion with collagenized mature fibrotic tissue and polymer remnants encapsulated by multi-nucleated giant cells), suggesting that these may represent permanent changes.²⁷ Therefore, the residual firmness along the course of the vein may lead to patient dissatisfaction in some cases undergoing cyanoacrylate embolization.

Varicose veins are generally not life threatening and patients opt to undergo elective intervention due to venous insufficiency symptoms along with considerable cosmetic concerns. Therefore, cosmetic results should also be considered and discussed since patient preference is a priority in the selection of these procedures. In patients not expecting the presence of signs of phlebitis or scars other than small needle entry sites, or failure to achieve complete visual correction of the varicosities may lead to dissatisfaction. In the initial studies, regression of varicose veins rate was reported 47% and 50% in the 6th and 12 months, respectively, after the closure of the great saphenous cyanoacrylate without phlebectomy.^28,29 In another study, the regression of varicose veins rate was reported to be 71.7% in the third month.²⁴ Consistent with the literature, we detected complete regression in varicose veins at 48.2% and 52.9%, respectively, at 6 and 12 months. However, the complete regression of varicose veins was above 90% in patients undergoing radiofrequency ablation or surgical stripping. Cyanoacrylate embolization, although performed under local anesthesia, incomplete disappearance of varicosities may be the cause of patient dissatisfaction, since mini-phlebectomies are not performed in this procedure. In addition to endovascular procedures, which offer the advantages of being practical and having minimal early complications in the treatment of GSV failure, traditional surgical methods may also be preferred on the basis of positive effects on the quality of life in the longer term.

One potential limitation of our study is the relatively small number of patients in each study group. Also, this was a single-center study and interventions were performed by 3 separate surgeons, who performed all three procedures. Although a cost-analysis was not undertaken, it should be stated that a certain amount of payment was made by the patients for the procedures. Since cosmetic concerns may be more marked in younger female patients, it is possible that inclusion of a higher number of patients from different age and sex groups could have yielded different results. Surgical stripping is associated with certain procedural and postoperative differences as compared to endovenous methods.

Conclusion

In conclusion, Surgical stripping and radiofrequency ablation for treatment of GSV insufficiency provide a better quality of life after one year in comparison with cyanoacrylate ablation. Further studies with larger sample size are warranted to confirm these findings.

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Ethical approval

The study protocol was approved by the Ethics Committee of Bezmialem Foundation University for Non-interventional Research (number 19/224, date October 16, 2018).

Guarantor

YA.

Contributorship

Every author meets the international criteria for authorship. All authors reviewed and edited the manuscript and approved the final version.

Acknowledgements

ORCID iD

Yasin Ay

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