Patients and methods: This was a single-institution, retrospective, observational, cohort study of prospectively collected data. All procedures were performed between January 2019 and February 2021. Ninety-seven patients (54 females, 43 males; mean age: 45.2±11.1 years; range, 18 to 76 years) with lower limb chronic venous disease symptoms refractory to exercise, compression stockings, and pharmacotherapy underwent RFA (n=60) or HLS (n=37). Self-reported pain assessment was performed on the first postoperative day using the numeric rating scale, and duration of return to daily activities was questioned on the 30th postoperative day.

Results: Patients in the RFA group reported significantly less pain compared to patients in the HLS group with median numeric rating scale scores of 1.5 (0-4) versus 4 (2-5), respectively (p<0.001). The RFA group returned to their daily routine significantly sooner compared to the HLS group (1 [1-1] versus 1.5 [1-4] days, respectively; p=0.004).

Conclusion: Radiofrequency ablation is associated with significantly less postoperative pain and earlier return to daily activities compared to HLS in patients with symptomatic GSV insufficiency.

The main pathophysiological mechanism includes compromised venous return toward the right heart with subsequent blood reflux through involved venous segments.[2] Chronic venous reflux causes edema and structural changes in interstitial tissues and creates clinical symptoms associated with CVD.[2,3]

High ligation and stripping (HLS) has been the historical gold standard modality for the treatment of symptomatic patients who have axial great saphenous vein (GSV) reflux with or without saphenofemoral junction reflux, whereas newer thermal ablation techniques, including radiofrequency ablation (RFA), are being more and more commonly adopted.[4] Previous research has shown improved clinical outcomes after RFA in patients with CVD; however, patient-reported outcomes remain relatively understudied.[5,6] The present study aimed to compare short-term patient-reported outcomes of RFA versus HLS in a cohort with symptomatic GSV insufficiency.

Figure 1: Flow diagram.

Diagnosis and treatment
Patients with lower limb CVD symptoms refractory to exercise, compression stockings, and pharmacotherapy underwent DUS imaging in the upright position. Those who had grade 3 or 4 GSV incompetency were considered candidates for intervention. Disease severity was scored using CEAP classification and the Venous Clinical Severity Scale (VCSS). Patients with a GSV diameter of ≥5.5 mm at thigh level without focal dilation were offered to undergo RFA or HLS, and patients with a GSV diameter of <5.5 mm were offered to undergo HLS. Treatment modality was chosen following a patient-surgeon discussion including current evidence of short- and long-term outcomes and possible recurrence mechanisms. Preoperative surgeonperformed, duplex-guided vein mapping was done to mark incompetent GSV segments, incompetent perforators, and superficial varicosities in the upright position. Procedures were performed under general, spinal, or local anesthesia with real-time DUS guidance. Tumescent anesthesia was routinely used during RFA. Thermal ablation was performed at 120°C in 7-cm segments starting 2 cm distally to the saphenofemoral junction in accordance with the manufacturer’s recommendations (ClosureFast RFA System; Medtronic Inc., Minneapolis, MN, USA). Saphenofemoral junction tributaries were ligated during HLS. Perforating veins with reflux flow were ligated where needed, and superficial varicosities were treated by multiple stab phlebectomies during the same session. Patients were encouraged to mobilize as soon as possible after surgery. Treated legs were wrapped with elastic bandages for 24 h, and patients were advised to wear compression stockings afterwards.

Follow-up
All patients were seen at the outpatient clinic on the first, seventh, and 30th postoperative days. Procedural success was evaluated by DUS imaging and was defined as obliteration of the treated GSV segment. Complications were noted. Self-reported pain assessment was performed on the first postoperative day by instructing patients to mark the degree of pain on a numeric rating scale (NRS). The NRS is a scale designed to help patients report their pain level by circling a number from 0 to 10 on a paper strip with 0 meaning “no pain” and 10 meaning “the worst pain you ever experienced.” On the 30th postoperative day, patients were also questioned for the duration taken to return to daily activities by the question, “How many days did it take you to return to your normal daily activities after the procedure?”

Statistical analysis
Statistical analyses were performed using Jamovi version 2.2.5.0 (The Jamovi Project, Sydney, Australia). Qualitative variables were presented as absolute numbers (n) and frequencies (%). Frequencies were compared using Pearson’s chi-squared test or Fischer exact test depending on expected number of observations. Histograms and the Shapiro-Wilk test were used for normality assessment of quantitative variables. Normally distributed quantitative variables were presented as mean ± standard deviation, and nonnormally distributed quantitative variables were presented as median and interquartile range. Means were compared using Student’s or Welch’s t-test according to the homogeneity of variances, and medians were compared using the Mann-Whitney U test. The level of statistical significance was set at a p value of <0.05.

Table 1: Patient demographics

Table 2: Operative details

Fifty-six (93.3%) patients in the RFA group received segmental treatment (55 above-knee and one below-knee ablation), whereas 11 (29.7%) patients in the HLS group underwent segmental treatment (11 above-knee stripping; p<0.001). Majority of patients in both groups were operated on with spinal or local anesthesia (57 [95%] patients in the RFA group vs. 34 [91.9%] patients in the HLS group, p=0.671, Table 2).

Surgical success was achieved in all patients. No patients were lost to follow-up. Patients in the RFA group reported significantly less pain compared to patients in the HLS group with median NRS scores of 1.5 (0-4) versus 4 (2-5) (p<0.001). The RFA group returned to their daily routine significantly sooner compared to the HLS group (1 [1-1] vs. 1.5 [1-4] days, p=0.004). Median length of hospital stay and complication rates were statistically similar between groups (Table 3).

Table 3: Outcomes and complications

Both groups had similar clinical and radiological features except for a significantly larger median GSV diameter in the RFA group. This significant difference was a direct result of reimbursement regulations regarding endovenous RFA treatment, as the Social Security Institution requires patients to have a GSV diameter of ≥5.5 mm for the compensation of an RFA device. Although it was not an objective of our study, considering that patients with larger and smaller veins (RFA and HLS groups, respectively) had similar demographic, clinical, and radiological findings and outcomes, our results show that vein diameter should not be an indicator of necessity for intervention for venous insufficiency. A prospective cohort study from a national registry reported similar results.[10] They compared CEAP classes, VCSS scores, and patient-reported outcomes before and after treatment in patients with a vein diameter of ≥5 mm versus <5 mm, revealed similar symptomatic improvement rates between groups, and concluded that patients should not be denied for intervention based on vein size.[10] There is a discrepancy regarding the inclusion/exclusion of patients based on vein size among previous research. Sincos et al.[6] included patients with a vein diameter of 5 to 12 mm, whereas Subramonia and Lees[7] included those with 3- to 12-mm veins. Helmy ElKaffas et al.[8] did not apply a minimal threshold for the vein diameter, and their maximal threshold was 18 mm. We were able to successfully treat patients with relatively large veins using RFA, therefore believe that large GSV diameter should not discourage surgeons from utilizing this minimally invasive technique for their patients. In fact, Shaikadov et al.[9] demonstrated improved outcomes after RFA compared to HLS in patients with a GSV diameter of ≥14 mm.

Our analysis showed that the majority of patients in the RFA group underwent above-knee treatment, unlike the HLS group, in which the majority underwent complete stripping. We observed similar rates of paresthesia in both groups. There is conflicting evidence from previous research regarding treatment length and nerve injury.[11-15] A recent single-center, retrospective analysis by Liu et al.[11] revealed better outcomes, including less nerve injury, less operative bleeding, reduced operative time, and shorter hospitalization in patients treated with a modified above-knee technique versus those treated by complete stripping. On the contrary, Uncu[12] reported acceptable nerve injury rates in his single-surgeon experience of 102 procedures. There is also ongoing debate on whether proximal or distal stripping is superior to each other with regards to nerve injury.[13-15] Below-knee treatment with endovenous thermal ablation techniques has been mainly avoided due to close anatomical relationship of sensory nerves with superficial veins in the crus. Nerve injury during endovenous thermal ablation treatment of the small saphenous vein is well-studied, unlike during below-knee GSV ablation.[16,17] However, there are recent reports with successful thermal ablation treatment of whole-length or below-knee GSV insufficiency with acceptable nerve injury rates.[18,19] We performed below-knee RFA in patients with crural GSV insufficiency and did not observe nerve injury afterward. Further research is needed to assess safety of thermal venous ablation of below-knee superficial veins.

Groups were comparable in terms of complications, and our complication rates were similar to or lower than results of previous reports.[20-26] This result could have been altered depending on complication definitions. For example, ecchymosis or hematoma, adverse events that are expected to be more common after HLS, were not included in our analysis.

Other researchers reported shorter postintervention hospitalization durations after RFA compared to HLS, whereas length of hospital stay was similar between groups in our study.[6,8] This was most probably due to widespread use of spinal anesthesia in our cohort, which rendered patients to stay longer in the bed after procedures. Others mostly used local anesthesia during RFA, and spinal block or general anesthesia during HLS, therefore observed significantly shorter lengths of stay after RFA.[6,8] Unlike conventional surgery, endovenous ablation techniques can also be performed in outpatient settings.[23] When performed under local anesthesia in the office setting, RFA is associated with significantly reduced hospitalization rates and reduced costs compared to HLS performed in the operating theater.[27-29] Cost-effectiveness was out of the scope of our study. Future research should include this variable when comparing different treatment modalities for venous disease.

There are some limitations to this study. The follow-up duration was short; therefore, we were not able to analyze more robust outcome measures, such as long-term obliteration rates, long-term patient-reported outcomes, and long-term CEAP and VCSS scores. Cost-effectivity analysis could not be performed.

In conclusion, radiofrequency ablation is associated with significantly less postoperative pain and earlier return to daily activities compared to HLS in patients with symptomatic GSV insufficiency. Both procedures have high success and low complication rates in a 30-day follow-up.

Ethics Committee Approval: The study protocol was approved by the Kartal Dr. Lütfi Kırdar City Hospital Clinical Research Ethics Committee (date: 24.04.2019; no: 2019/514/152/4). The study was conducted in accordance with the principles of the Declaration of Helsinki.

Patient Consent for Publication: A written informed consent was obtained from each patient.

Data Sharing Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Author Contributions: Idea/concept, design, control/ supervision, data collection and/or processing, analysis and/ or interpretation, literatüre review, writing the article, critical review, references and funding, materials, approval of the final version: A.C.T.; Idea/concept, design, critical review, approval of the final version: A.O.

Conflict of Interest: The authors declared no conflicts of interest with respect to the authorship and/or publication of this article.

Funding: The authors received no financial support for the research and/or authorship of this article.

1) De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, et al. Editor's choice - European Society for Vascular Surgery (ESVS) 2022 clinical practice guidelines on the management of chronic venous disease of the lower limbs. Eur J Vasc Endovasc Surg 2022;63:184-267. doi: 10.1016/j.ejvs.2021.12.024.

2) Ortega MA, Fraile-Martínez O, García-Montero C, Álvarez-Mon MA, Chaowen C, Ruiz-Grande F, et al. Understanding chronic venous disease: A critical overview of its pathophysiology and medical management. J Clin Med 2021;10:3239. doi: 10.3390/jcm10153239.

3) Salim S, Machin M, Patterson BO, Onida S, Davies AH. Global epidemiology of chronic venous disease: A systematic review with pooled prevalence analysis. Ann Surg 2021;274:971-6. doi: 10.1097/SLA.0000000000004631.

4) Masuda E, Ozsvath K, Vossler J, Woo K, Kistner R, Lurie F, et al. The 2020 appropriate use criteria for chronic lower extremity venous disease of the American Venous Forum, the Society for Vascular Surgery, the American Vein and Lymphatic Society, and the Society of Interventional Radiology. J Vasc Surg Venous Lymphat Disord 2020;8:505-25.e4. doi: 10.1016/j.jvsv.2020.02.001.

5) Akça B, Erdil N, Çolak MC, Dişli OM, Yetiş C, Battaloğlu B. Kronik venöz yetersizliğin aynı seansta büyük safen ven endovenöz radyofrekans ablasyon ve miniflebektomi ile tedavisi. Damar Cer Derg 2017;26:85-90. doi: 10.5606/ tjvs.2017.43.

6) Sincos IR, Baptista APW, Coelho Neto F, Labropoulos N, Alledi LB, Marins EM, et al. Prospective randomized trial comparing radiofrequency ablation and complete saphenous vein stripping in patients with mild to moderate chronic venous disease with a 3-year follow-up. Einstein (Sao Paulo) 2019;17:eAO4526. doi: 10.31744/einstein_ journal/2019AO4526.

7) Subramonia S, Lees T. Randomized clinical trial of radiofrequency ablation or conventional high ligation and stripping for great saphenous varicose veins. Br J Surg 2010;97:328-36. doi: 10.1002/bjs.6867.

8) Helmy ElKaffas K, ElKashef O, ElBaz W. Great saphenous vein radiofrequency ablation versus standard stripping in the management of primary varicose veins-a randomized clinical trial. Angiology 2011;62:49-54. doi:10.1177/0003319710380680.

9) Shaidakov EV, Grigoryan AG, Ilyukhin EA, Bulatov VL, Rosukhovskiy DA. Radiofrequency ablation or stripping of large-diameter incompetent great saphenous varicose veins with C2 or C3 disease. J Vasc Surg Venous Lymphat Disord 2016;4:45-50. doi: 10.1016/j.jvsv.2015.07.007.

10) Bendix SD, Peterson EL, Kabbani LS, Weaver MR, Lin JC. Effect of endovenous ablation assessment stratified by great saphenous vein size, gender, clinical severity, and patientreported outcomes. J Vasc Surg Venous Lymphat Disord 2021;9:128-36. doi: 10.1016/j.jvsv.2020.04.017.

11) Liu P, Peng JL, Zhang F, Wang ZB, Zhang M, Niu XP, et al. Comparison of modified above-knee and conventional surgery with the stripping of the great saphenous vein of varicose veins of the lower extremities: A retrospective study. Comput Math Methods Med 2022;2022:7730960. doi: 10.1155/2022/7730960.

12) Uncu H. Should complete stripping operation to the ankle be avoided in the treatment of primary varicose veins due to greater saphenous vein insufficiency? Acta Cir Bras 2009;24:411-5. doi: 10.1590/s0102-86502009000500013.

13) Milone M, Di Minno MN, Maietta P, Shatalova O, Musella M, Milone F. Great saphenous vein stripping and nerve injury: The role of stripping direction. Int Angiol 2015;34:238-42.

14) Jaworucka-Kaczorowska A, Oszkinis G, Huber J, Wiertel- Krawczuk A, Gabor E, Kaczorowski P. Saphenous vein stripping surgical technique and frequency of saphenous nerve injury. Phlebology 2015;30:210-6. doi:10.1177/0268355514539316.

15) Sam RC, Silverman SH, Bradbury AW. Nerve injuries and varicose vein surgery. Eur J Vasc Endovasc Surg 2004;27:113-20. doi: 10.1016/j.ejvs.2003.11.007.

16) Sanioglu S, Yerebakan H, Ozgen A, Ozdemir HO, Sancar NK, Farsak MB. Mid-calf level as a puncture site is not safe enough for thermal ablation of the small saphenous vein. SAGE Open Med 2017;5:2050312117731474. doi:10.1177/2050312117731474.

17) Elshafei AM, Abdelgawad MS, Saad EM, Fahmy DM, Khafagy T. Radiofrequency ablation of incompetent short saphenous vein: A case series. Indian J Surg 2022 [Article in Press]. doi: 10.1007/s12262-022-03416-1.

18) Gifford SM, Kalra M, Gloviczki P, Duncan AA, Oderich GS, Fleming MD, et al. Reflux in the below-knee great saphenous vein can be safely treated with endovenous ablation. J Vasc Surg Venous Lymphat Disord 2014;2:397-402. doi: 10.1016/j.jvsv.2014.04.004.

19) Zied SA. Whole-length great saphenous varicose veins thermochemical ablation, a novel technique: Safety, efficacy, and mid-term follow-up results. Egypt J Surg 2020;39:889-99. doi: 10.4103/ejs.ejs_102_20.

20) Hamann SAS, Timmer-de Mik L, Fritschy WM, Kuiters GRR, Nijsten TEC, van den Bos RR. Randomized clinical trial of endovenous laser ablation versus direct and indirect radiofrequency ablation for the treatment of great saphenous varicose veins. Br J Surg 2019;106:998-1004. doi: 10.1002/ bjs.11187.

21) Almeida JI, Kaufman J, Göckeritz O, Chopra P, Evans MT, Hoheim DF, et al. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: A multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol 2009;20:752-9. doi: 10.1016/j.jvir.2009.03.008.

22) Shepherd AC, Gohel MS, Brown LC, Metcalfe MJ, Hamish M, Davies AH. Randomized clinical trial of VNUS ClosureFAST radiofrequency ablation versus laser for varicose veins. Br J Surg 2010;97:810-8. doi: 10.1002/ bjs.7091.

23) Yalçın M, Gödekmerdan E, Tayfur KD, Koç A. Endovenöz ablasyon uygulanan 585 hastamızın erken ve orta dönem sonuçları. Damar Cer Derg 2016;25:24-30. doi: 10.9739/ uvcd.2016-51902.

24) Gültekin B, Akay HT, Beyazpınar DS, Akkaya İ, Ersoy Ö, Hatipoğlu A. Vena safena magna yetmezliğinde iki farklı endovenöz ablasyon tekniğinin karşılaştırılması: prospektif randomize klinik çalışma. Damar Cer Derg 2016;25:17-23.

25) Doğancı S, Kaya E, Şahin MA, Güler A, Bolcal C, Yıldırım V, et al. İnvisigrip ile yapılan diz üstü stripping ile klasik stripping metodlarının karşılaştırılması: randomize kontrollü çalışma. Damar Cer Derg 2010;19:1-5.

26) Kemaloğlu C. Retrograde passage of radiofrequency catheter for the endovenous ablation of the great saphenous vein: A modified technique and report of two cases. Cardiovasc Surg Int 2014;1:76-8. doi: 10.5606/e-cvsi.2014.275.

27) Somasundaram SK, Weerasekera A, Worku D, Balasubramanian RK, Lister D, Valenti D, et al. Office based endovenous radiofrequency ablation of truncal veins: A case for moving varicose vein treatment out of operating theatres. Eur J Vasc Endovasc Surg 2019;58:410-4. doi:10.1016/j.ejvs.2019.05.020.

28) Carlton R, Mallick R, Campbell C, Raju A, O'Donnell T, Eaddy M. Evaluating the expected costs and budget impact of interventional therapies for the treatment of chronic venous disease. Am Health Drug Benefits 2015;8:366-74.

29) Lin JC, Nerenz DR, Migliore P, Young R, Shepard AD, Weaver WD. Cost analysis of endovenous catheter ablation versus surgical stripping for treatment of superficial venous insufficiency and varicose vein disease. J Vasc Surg Venous Lymphat Disord 2014;2:98-103. doi: 10.1016/j. jvsv.2013.08.005.