Comparison of radiofrequency ablation and conventional surgery in the treatment of varicose veins

Jibin Leons; Jomine Jose; Binni John

doi:10.4103/ksj.ksj_33_22

ORIGINAL ARTICLE

Year : 2022 | Volume : 28 | Issue : 2 | Page : 129-132

Comparison of radiofrequency ablation and conventional surgery in the treatment of varicose veins

Jibin Leons, Jomine Jose, Binni John
Department of General Surgery, Medical College, Kottayam, Kerala, India

Date of Submission	16-Oct-2022
Date of Decision	08-Nov-2022
Date of Acceptance	03-Dec-2022
Date of Web Publication	30-Jan-2023

Correspondence Address:
Dr. Jibin Leons
Department of General Surgery, Medical College Hospital, Kottayam - 686 008, Kerala
India

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ksj.ksj_33_22

Abstract

Background: This retrospective study was aimed to compare the outcomes between radiofrequency ablation (RFA) and conventional surgery which included the Trendelenburg procedure, multiple perforator ligation, hook phlebectomy and stripping for the treatment of varicose veins using Clinical, Etiological, Anatomical, and Pathophysiological classification (CEAP) and Venous Clinical Severity Score (VCSS) in a tertiary care centre. Materials and Methods: The pre-operative and post-operative CEAP classification and VCSS were calculated. The satisfaction from the surgery was assessed using a structured questionnaire and data analysed using IBM SPSS software. Results: The majority of the patients in the study belonged to the age group of 41–50 years. Females comprised 58% and housewives comprised 35% of the total patients. Patients with a body mass index of 18.5–24.9 constituted almost 44%. Twenty-four individuals had a family history of varicose veins. Doppler studies showed that at 83%, the most common pathology was sapheno-femoral junction (SFJ) and perforator incompetence. Five per cent of individuals had perforator incompetence alone. Thirty-four per cent of the individuals underwent RFA. The improvement in CEAP was 3.03 ± 1.513 in RFA group and 2.91 ± 1.279 in conventional surgery group; statistical analysis did not show any significant difference between the groups. The post-operative VCSS improved from 7.94 ± 1.718 in conventional surgery group and 7.38 ± 1.706 in RFA group to 1.52 ± 1.070 and 1.03 ± 0.577, respectively. The most common problem after surgery was saphenous neuralgia (8%). The severity of pain in the 1^st week after the intervention was 'very mild' for most of the patients who underwent RFA (47.1%), and moderate for those in conventional surgery group (37.9%). The average days to return to normal activity were 10.26 ± 3.96 and 3.44 ± 1.637 in conventional surgery and RFA groups, respectively, whereas the average days to return to work were 17.41 ± 5.418 and 9.50 ± 1.846 days, respectively. Conclusion: The results indicate that both RFA and conventional surgeries in the form of the Trendelenburg procedure, stripping, phlebectomy and perforator ligation provide comparable relief of symptoms and clinical improvement when applied for the treatment of varicose veins. However, RFA may offer a significant advantage over conventional surgery in terms of faster recovery and early return to normal life and work.

Keywords: Clinical, Etiological, Anatomical, and Pathophysiological classification, hook phlebectomy and stripping of varicose veins, multiple perforator ligation, radiofrequency ablation, Trendelenburg procedure, Venous Clinical Severity Score

How to cite this article:
Leons J, Jose J, John B. Comparison of radiofrequency ablation and conventional surgery in the treatment of varicose veins. Kerala Surg J 2022;28:129-32

How to cite this URL:
Leons J, Jose J, John B. Comparison of radiofrequency ablation and conventional surgery in the treatment of varicose veins. Kerala Surg J [serial online] 2022 [cited 2023 Mar 25];28:129-32. Available from: http://www.keralasurgj.com/text.asp?2022/28/2/129/368590

Introduction

Chronic venous insufficiency (CVI) of the lower limbs is a common problem in adults. It commonly presents as dilated tortuous veins in the lower limbs called varicose veins. Various studies show that every sixth man and every fifth woman have CVI,^[1] and it is considered as the price that humans have had to pay for the upright posture that we have obtained over the course of evolution. Over the years, high ligation plus stripping was considered the gold standard in the treatment of symptomatic varicose veins. With the advent of newer less invasive techniques such as endovenous laser ablation therapy (EVLT), radiofrequency ablation (RFA) and foam sclerotherapy and with the reduction of the cost of portable ultrasound (US) machines, there is a shift in the standard of care for varicose vein patients. These minimally invasive procedures are considered to have equal or better efficacy than conventional surgery, with reduced post-operative morbidity and faster recovery.^[2],[3],[4]

Materials and Methods

The objective of the study was to compare the post-operative outcomes of patients who underwent RFA and conventional surgery for the treatment of varicose veins using Clinical, Etiological, Anatomical, and Pathophysiological classification (CEAP)^[5] and Venous Clinical Severity Score (VCSS).^[6] A descriptive study was performed for 12 months in the department of general surgery on patients who underwent surgical treatment for varicose veins.

The sample size was calculated using data from the previous study 'randomised clinical trial of RFA or conventional high ligation and stripping for great saphenous varicose veins', published in the British Journal of Surgery in 2010.^[7] According to the formula, N = (Zα + Zß) 2 × pq/d², P = (p1 + p2)/2, N = sample size, Zα = 1.96, Zß = 0.84, p1 = proportion of patients completely satisfied with surgery in RFA group = 57.4%, p2 = proportion of patients completely satisfied with surgery in conventional surgery group = 26.8%, P = (p1 + p2)/2 = 42, q = 1 − P = 58, d = allowable error = 5%–20% of p. N = (1.96 + 0.84) 2 × 0.42 × 0.58/(0.05) 2 = 94. The sample size was calculated as 100. Study tools included case record, structured questionnaire, CEAP classification, VCSS and consent. Patients who underwent conventional surgery or RFA for varicose veins during the study period were included, whereas those with deep-vein thrombosis, acute superficial thrombophlebitis, symptoms or signs, peripheral arterial insufficiency, severe systemic comorbidities, deep-vein reflux in pre-operative Doppler study and Sapheno-popliteal junction incompetence were excluded.

Patients who underwent surgery for varicose veins from the general surgery department were contacted for review. After obtaining their written informed consent, data were collected from these patients, and their case records, their pre-operative and post-operative CEAP classification and VCSS were calculated. Their satisfaction with the surgery was assessed using a structured questionnaire. The information regarding sociodemographic details of the patients, details of surgery, risk factors for varicose veins and complications associated with the surgery, were recorded in a predesigned pro forma. Data were analysed using descriptive statistics. Data were entered into a Microsoft Excel sheet and analysed by SPSS version 16 (IBM, Armonk, New York, United States). The level of significance was a P < 0.05 and high level of significance was a P < 0.001.

Results

The two treatment methods, RFA and conventional surgeries were compared statistically to find out whether there was any significant difference between the outcomes of these surgical procedures. The null hypothesis was assumed: 'there is no significant difference between the two procedures. Using the Chi-square test, all individual variables were checked for significance. Since 2 × 2 tables were used, the degree of freedom was 1. If the Chi-square value was >3.84, the P value was <0.05 and the difference was considered statistically significant.

In the study conducted, 66% of the individuals underwent conventional surgery in the form of Trendelenburg procedure, multiple perforator ligation, stripping or hook phlebectomy, whereas 34% of them underwent RFA as the primary procedure. The majority were female when compared to males who were about 42% of the individuals. Thirty-three per cent of the patients belonged to 31–50 years, followed by 18% of 31–50 and 51–60, followed by other age groups.

Housewives constituted 35%, followed by unskilled (31%), semi-skilled (15%), skilled (13%) and teachers (6%). Unskilled occupations comprised manual labourers and watchmen. Semi-skilled occupations comprised hotel workers – 15 and barbers – 11. Skilled occupations were tailors, drivers and carpenters. The body mass index of the participants ranged from 18.5 to 24.9 in 44%, 25 to 29.9 in 35%, >30 in 13% and <18.5 in 8%. Nine per cent of the patients had bilateral involvement and the rest had unilateral pathology. A family history of varicose veins was reported in 24% of cases. Fourteen per cent of the patients had previous treatments for varicose veins. Doppler study showed that SFJ + perforator incompetence were seen in 83%, SFJ incompetence alone in 12% and perforator incompetence alone in 5%.

The most common procedure in the study was Trendelenburg operation along with stripping of great saphenous vein (GSV) and hook phlebectomy (42%), RFA + foam sclerotherapy (34%), Trendelenburg procedure + multiple perforator ligation (20%), Trendelenburg procedure + stripping of GSV + multiple perforator ligation (2%), and Trendelenburg procedure + stripping of GSV + multiple perforator ligation + US-guided foam sclerotherapy (2%). Most of the patients who underwent surgery were of the CEAP classification C4b, and four patients had active ulcers at the time of surgery [Table 1]. This shows the late presentation of the patients, as the disease is asymptomatic in the initial phase and merely considered cosmetic by most patients.

Table 1: Pre-operative clinical, etiological, anatomical, and pathophysiological classification (clinical)

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The mean CEAP (clinical) score improved from 4.01 ± 0.795 in conventional surgery group and 4.06 ± 0.998 in RFA group to 0.99 ± 0.889 and 1.03 ± 1.1.4, respectively. The P value was more than 0.05; hence there was no significant difference between the two procedures with respect to change in CEAP score from baseline. The post-operative VCSS improved from 7.94 ± 1.718 in conventional surgery group to 7.38 ± 1.706 in RFA group to 1.52 ± 1.070 and 1.03 ± 0.577, respectively. The P value was more than 0.05. Hence, there was no significant difference between the two procedures with respect to change in VCSS from baseline. The change in VCSS from baseline in conventional surgery group was 6.42 ± 1.954 (n = 66) and in RFA group was 6.35 ± 1.968 (n = 34) with P = 0.863.

Seventy-seven per cent of the patients were pleased with the result of surgery immediately after the surgery, 75.8% after the conventional surgery and 79.4% after RFA, but this difference was not statistically significant (P = 0.671). Eighty-five per cent of the patients were pleased with the result of surgery after the 1^st few months, 80.3% in the conventional surgery group and 94.1% in the RFA group, and this difference was statistically significant (P = 0.05).

Among the conventional surgery group, 43.9% of the patients had no recurrence, compared to 47.1% in RFA group. About 40.9% had a few symptoms, whereas 15.2% had symptoms as bad as before the surgery (P > 0.888) and hence not significant. There was no significant difference between the two procedures when individuals are asked about recurrent varicose veins symptoms. The extent of varicosity in the operated legs before and after surgery varied, but the variations between the two procedures were not statistically different [Table 2].

Table 2: Varicose veins in the limbs that underwent surgery

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Statistical analysis of data regarding the requirement of further treatment for varicose veins showed no significant difference between the procedures (χ² = 0.875, P = 0.831). Overall 73.5% of patients in RFA group and 65.2% of patients in conventional surgery group required no further treatment for varicose. About 6.1% in conventional surgery group and 5.9% in RFA group required surgery.

The majority of the patients did not have any permanent problems in their legs following surgery. The most common problem was symptoms of saphenous neuralgia, which was seen in 8.8% of patients in RFA group and 7.6% of patients in conventional surgery group. Other problems, such as numbness and skin pigmentation, were not seen in any patients of RFA group. Data analysis showed no significant statistical difference between the studied groups (P = 0.268). The severity of pain following varicose surgery in the 1^st week was comparable in both groups, data analysis showed no significant difference between both RFA and conventional surgery (P = 0.27). About 47.1% of patients in RFA group had very mild pain and 17.6% had no pain at all. However, almost 37.9% of patients in conventional surgery group had moderate pain. The patients who had RFA returned to normal activities in 3.44 days, whereas patients after regular surgery returned to normal activity in 10.26 days (P < 0.000).

Discussion

The retrospective study was aimed at comparing the outcomes between RFA and conventional surgery which included the Trendelenburg procedure, multiple perforator ligation, hook phlebectomy and stripping of varicose veins.

Using the CEAP classification, the proportion of individuals in the study was C4 – 58%, C5 – 20%, C3 – 11% and C2 – 7% and there were four individuals with active venous ulcers who underwent surgery. The post-operative CEAP improved to the following proportions, C0 – 35%, C1 – 39%, C2 – 20% and C3 and C4 – 3% each. The improvement in CEAP was 3.03 ± 1.513 in RFA group and 2.91 ± 1.279 in conventional surgery group. Statistical analysis did not show any significant difference between the groups. The post-operative VCSS improved from 7.94 ± 1.718 in conventional surgery group and 7.38 ± 1.706 in RFA group to 1.52 ± 1.070 and 1.03 ± 0.577, respectively. Statistical analysis of the improvement of VCSS between the groups did not show any significant improvement in RFA compared to conventional surgery. This is in line with a study published in 2011 by Rasmussen et al. in the British Journal of Surgery, on 500 patients which found all these treatment modalities to be equally efficacious and resulted in a similar improvement in VCSS and quality of life.^[4]

Satisfaction rates of surgery after 1^st month were 80.3% in conventional surgery group and 94.1% in RFA group. Thompson et al. came to a similar conclusion that RFA results in a generally better quality of life scores than conventional surgery in their study.^[8] Regarding recurrent symptoms of varicose veins, 56.1% of patients after conventional surgery and 53% of patients in RFA group complained of some form of recurrent symptoms. Regarding the requirement for further treatment for symptoms of varicose veins, 65.2% of patients who underwent conventional surgery and 73.5% of patients who underwent RFA did not require any further treatment for varicose veins in the operated limbs. Regarding recurrent symptoms, 14% of patients required injections for pain, 12% were still using compression stockings and only six underwent surgery in the form of foam sclerotherapy. Long-term (5-year) recurrences were around 25% in a study by Kostas et al. which suggests that the recurrence of varicose veins after surgery is not uncommon.^[9] Regarding permanent problems in the operated legs, the most common problem included saphenous neuralgia which affected around 8% of the patients, 3% of patients developed tattooing on the skin, 3% had skin pigmentation and 83% of the patients developed no permanent problems in the skin of the operated limb. These rates are much less compared to previous studies which reported incidence rates of around 17% for minor and 0.8% for major complications.^[10]

The severity of pain in the 1^st week after the intervention was 'very mild' for most of the patients who underwent RFA (47.1%) and moderate for those in conventional surgery group (37.9%). However, statistical analysis did not show any significant difference in both types of interventions. The average days to return to normal activity were 10.26 ± 3.96 and 3.44 ± 1.637 in conventional surgery and RFA groups, respectively, whereas the average days to return to work were 17.41 ± 5.418 and 9.50 ± 1.846 days, respectively. Statistical analysis showed a significant difference in both these methods of intervention, RFA being significantly better compared to conventional surgery. Tashkandi et al., in a comparative study of RFA versus open surgery, found RFA to be a viable alternative to open repair, requiring less invasive anaesthesia, fewer laboratory tests and reducing hospital length of stay.^[11]

Limitations

The limitation of the study could be the memory bias of the study individuals.

Conclusion

The results indicate that both RFA and conventional surgeries in the form of the Trendelenburg procedure, stripping, phlebectomy, and perforator ligation provide adequate relief of symptoms and clinical improvement when applied for the treatment of varicose veins. However, RFA may offer a significant advantage over conventional surgery in terms of faster recovery and early return to normal life and work. RFA also showed lesser post-operative pain and more patient satisfaction in the early post-operative phase, however, comparable to conventional surgery. More information is needed on the long-term results and recurrence rates to understand the precise role RFA could play in the treatment of primary varicose veins. It would also necessitate long-term cost-effectiveness or cost–benefit analysis of these procedures.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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