Advertisement

Editor's Choice – Role of Compression After Radiofrequency Ablation of Varicose Veins: A Randomised Controlled Trial

Open ArchivePublished:April 08, 2020DOI:https://doi.org/10.1016/j.ejvs.2020.03.014

      Objective

      Post-procedure limb compression, hitherto routine following open varicose vein surgery, has been extended to endovenous procedures. However, no robust evidence exists to support this practice. Most of the previous studies have focused on the ideal duration of compression. This study evaluates the clinical and patient reported outcomes with and without post-procedure leg compression following radiofrequency ablation (RFA).

      Methods

      This single centre, prospective, non-inferiority randomised controlled trial recruited adult patients, into two groups (A: RFA with compression stocking for two weeks, B: RFA alone). The primary outcome was ultrasound determined target vein obliteration at 12 weeks. Secondary outcome measures included a Quality of Life (QoL) score [Aberdeen Varicose Vein Severity Score (AVSS) and Revised Venous Clinical Severity Score (RVCSS)], patient satisfaction, pain score, and complications.

      Results

      In total, 100 consecutive patients were recruited (A: 51; B: 49) classified as clinical class C2–C6 of the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification. At 12 weeks the occlusion rate of the target vein was similar in both groups at 98% (n = 47) and 98% (n = 45), respectively (p = 1.0). There was no statistically significant difference in mean AVSS 6 vs. 5.0 (mean difference −1, 95% CI −2 – 3, p = .57) and mean RVCSS 3 vs. 4 (mean difference 1, 95% CI −1 – 2, p = .46) scores at 12 weeks. Comparable patient satisfaction scores were observed (p = .72) and pain score 2.0 vs. 2.0 (p = .92) were achieved in both groups. Two patients in each group developed deep vein thrombosis at two weeks follow up (p = 1.0 for above the knee and p = 1.0 for below the knee).

      Conclusion

      The clinical and patient reported outcomes following RFA without compression are no worse than with compression. This trial supports the conclusion that the widely practised use of compression after RFA adds no clinical benefit for the patients. However, a much larger study, preferably a multicentre trial, may be required to confirm this conclusion.

      Keywords

      This study examined the effect of post-procedure leg compression in a full range of patients with superficial truncal incompetence treated exclusively with radiofrequency ablation (RFA). There was no significant difference in the target vein occlusion rate, quality of life, venous clinical severity score, patient satisfaction, and pain score with or without compression. This study provides further evidence that varicose vein patients undergoing RFA may not require post-procedure compression.

      Introduction

      Varicose veins are relatively common, with a reported prevalence ranging between 10% and 30% worldwide.
      • Callam M.
      • Ruckley C.
      • Harper D.
      • Dale J.
      Chronic ulceration of the leg: extent of the problem and provision of care.
      ,
      • Callam M.
      Epidemiology of varicose veins.
      With the advent of minimally invasive techniques, endovenous techniques including radiofrequency ablation (RFA), endovenous laser therapy, and foam sclerotherapy have become the preferred treatment options.
      National Institute for Health and Clinical Excellence (NICE)
      Varicose Veins: diagnosis and management – clinical guideline [CG168].
      The use of post-procedure limb compression, following endovenous treatment of varicose veins has been widely practised to reduce procedure related side effects including venous thrombosis, pain, extensive bruising,
      • Rasmussen L.
      • Bjoern L.
      • Lawaetz M.
      • Blemings A.
      • Lawaetz B.
      • Eklof B.
      Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
      haematoma, oedema,
      • Trevor J.
      • Rhodes J.
      • Hardy J.
      • Makin G.
      Postoperative limb compression in reduction of haemorrhage after varicose vein surgery.
      inflammation, or thrombophlebitis.
      • Shouler P.
      • Runchman P.
      Varicose veins: optimum compression after surgery and sclerotherapy.
      There is, however, limited high level evidence to support this practice.
      • Partsch H.
      • Hafner J.
      • Lattimer C.
      • Mosti G.
      • Neumann M.
      • Urbanek T.
      • et al.
      Indications for medical compression stockings in venous and lymphatic disorders: an evidence-based consensus statement.
      The main drawback of limb compression is patient compliance as a result of discomfort associated with limb compression, and movement restriction. A meta-analysis failed to demonstrate significant difference in outcome or complications between patients who had compression for four to six weeks compared with those who had compression for only seven to ten days following open varicose vein surgery of ligation, stripping, and avulsions.
      • Huang T.
      • Chen S.
      • Bai C.
      • Wu C.
      • Tam K.
      The optimal duration of compression therapy following varicose vein surgery: a meta-analysis of randomized controlled trials.
      There is no consensus either on the duration of compression therapy following endovenous therapy. A recent survey of members of the Society of Vascular Surgeons of Great Britain and Ireland (141 surgeons, 68 vascular units) reported a significant variability in duration (mean 10 days, range 2–42 days) in post-operative compression regime following endovenous therapy for varicose veins.
      • El-Sheikha J.
      • Nandhra S.
      • Carradice D.
      • Acey C.
      • Smith G.
      • Campbell B.
      • et al.
      Compression regimes after endovenous ablation for superficial venous insufficiency – a survey of members of the Vascular Society of Great Britain and Ireland.
      The beneficial effect of compression therapy following endovenous therapy is also variable. A randomised controlled trial (RCT) of the duration of compression therapy after varicose vein surgery concluded that there was no significant difference in complications and patient satisfaction in the group that received compression for a shorter period (one vs. three weeks).
      • Biswas S.
      • Clark A.
      • Shields D.
      Randomised clinical trial of the duration of compression therapy after varicose vein surgery.
      Similarly, an RCT investigated the need for limb compression following foam sclerotherapy of truncal lower limb veins and found no significant difference between compression and no compression in terms of side effects, patient satisfaction, and the rates of successful obliteration of the target vessel.
      • Hamel-Desnos C.
      • Guias B.
      • Desnos P.
      • Mesgard A.
      Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression.
      The benefits of compression therapy following endovenous treatment have recently been questioned. Krasznai and colleagues
      • Krasznai A.
      • Sigterman T.
      • Troquay S.
      • Houtermans-Auckel J.
      • Snoeijs M.
      • Rensma H.
      • et al.
      A randomised controlled trial comparing compression therapy after radiofrequency ablation for primary great saphenous vein incompetence.
      reported no significant difference in post-operative pain or recovery time in patients who received compression for 4 h compared with those who had compression for 72 h following RFA. A prospective non-randomised study did not find additional benefit for vein occlusion rate, superficial thrombophlebitis, and deep vein thrombosis in prescribing compression therapy following endovenous laser ablation.
      • Kokkosis A.
      • Schanzer H.
      Compression therapy is not necessary after endovenous ablation therapy for the treatment of varicose veins.
      Ayo et al. compared seven days compression vs. no compression and reported no difference in clinical (vein obliteration) and patient reported outcomes (pain, ecchymosis, and quality of life) following endovenous ablation.
      • Ayo D.
      • Blumberg S.
      • Rockman C.
      • Sadek M.
      • Cayne N.
      • Adelman M.
      • et al.
      Compression versus no compression after endovenous ablation of the great saphenous vein: a randomized controlled trial.
      In their study of 71 patients and 85 limbs, 91% of patients were treated with RFA. The rest had endovenous laser therapy (EVLT). While these studies raise doubts about the necessity for post-procedure compression, the present study is the first to investigate the role of post-procedure compression where all the veins were exclusively ablated using RFA.
      The aim of this study was to comparatively investigate efficacy, complications, and patient satisfaction following RFA of superficial truncal incompetence, with and without post-procedure limb compression.

      Methods

      Study design

      This was a single centre, prospective, non-inferiority RCT. The study included 100 consecutive patients classified as C2–C6 according to the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification. The C6 patients included had small ulcers <2 cm in diameter with little or no exudate and were not already in compression. A duplex ultrasound scan (DUS) was used for pre-operative assessment of varicose veins. With the patient in a standing position, reflux was diagnosed when there was at least 0.5 s of flow reversal in the segment of vein being examined.
      • Labropolous N.
      • Tiongson J.
      • Pryor L.
      • Tassiopoulos A.K.
      • Kang S.S.
      • Ashraf Mansour M.
      • et al.
      Definition of venous reflux in lower-extremity veins.
      Following informed consent, patients with suitable varicose veins, opting for RFA treatment were recruited to the study between April 2015 and November 2017. Target veins that were very tortuous or superficial to the saphenous fascia and very close to the skin (with attendant higher risk of thermal skin injury) were deemed unsuitable.
      Inclusion criteria for patients were age >18 years, having superficial truncal incompetence of the great and small saphenous veins, consent for RFA, suitable for day case surgery, and CEAP (C2–C6).
      Exclusion criteria for patients were age <18 years, BMI >40, refused consent, not suitable for RFA, secondary varicose veins, previous deep venous thrombosis (DVT), active ulceration already on compression, pregnancy, Lycra allergy, ankle brachial pressure index (ABPI) < 0.9.
      Ethical approval was granted by Regional NHS National Research Ethics Service with Reference Number 15/NW/0179. The study was registered with International Standard Randomised Controlled Trial Number (ISRCTN) 18119345.

      Study end points

      The primary outcome was successful target vein obliteration as determined by duplex ultrasound scan (DUS) at 10–12 weeks. The target vein was deemed occluded if no more than 2 cm of the stump between the treated vein and the deep vein junction was patent and at least 90% of treated length had been obliterated. Secondary outcome measures included changes in quality of life (QoL), disease severity, patient satisfaction and complications. QoL and disease severity were assessed using the Aberdeen Varicose Vein Severity Score (AVSS)
      • Smith J.
      • Garratt A.
      • Guest M.
      • Greenhalgh R.
      • Davies A.
      Evaluating and improving health-related quality of life in patients with varicose veins.
      and Venous Clinical Severity Score (RVCSS),
      • Rutherford R.
      • Padberg F.
      • Comerota A.
      • Kistner R.
      • Meissner M.
      • Moneta G.
      Venous severity scoring: an adjunct to venous outcome assessment.
      respectively. The AVSS (AVVQ) was completed by the patient with assistance from the Vascular Specialist Nurse if required; the RVCSS was completed by the Vascular Specialist Nurse.
      Patient satisfaction was measured using a Likert scale patient satisfaction questionnaire (Fig. 1). Complications were recorded during a patient's routine follow up. Patients were followed up to 12 weeks following the procedures as per study protocol.
      Figure 1
      Figure 1Radiofrequency ablation post-treatment satisfaction questionnaire.

      Randomisation

      Randomisation took place on the day of surgery by way of sealed opaque envelopes generated from a table of random numbers.
      • Higgins J.
      • Green S.
      Review: cochrane handbook for systematic reviews for interventions, Version 5.1.0, published 3/2011.
      Each patient completed the AVSS and RVCSS on the day of surgery. Every participant was measured for a Class 2 above knee stocking pre-operatively and the stocking was brought into the treatment room. The sealed envelope was opened by the patient at the completion of the procedure. Apart from the post-operative compression, every other aspect of the treatment and follow up was identical for both arms. The vein to be treated was marked pre-operatively using a portable Ultrasound Machine (Sonosite® MicroMaxx Bothel, WA, USA).

      RFA procedure

      The Covidien (Medtronic) VNUS Closure Fast™ system (Covidien LP, 710 Medtronic Parkway Minneapolis, MN, USA) was used for delivering the RFA treatment. Tumescent anaesthesia (using 20 mL 1% lignocaine + 1:200,000 adrenaline in 450 mL of 0.9% NaCl + 10 mL of 8.4% sodium bicarbonate) was administered under ultrasound guidance. The patient was placed in Trendelenburg position prior to the commencement of thermal ablation. Delivery of energy to the radiofrequency (RF) probe is fully automated and delivered via the VNUS RFGPlus RF generator. Each effective RFA cycle lasts 20 s and is programmed to achieve the target temperature of 120° within five seconds. Any ineffective RFA cycle was repeated. The most proximal segment received two cycles of treatment. During a cycle of RFA the operator applied pressure over the treated area. A single 4/0 absorbable suture was applied to the puncture site to prevent bleeding. A class II compression stocking (23–32 mmHg ankle pressure) was applied to patients randomised to the compression stocking group. The compression stocking was worn for two weeks, day and night during the first week, and daytime only during the second week. The patient was usually discharged from hospital within two hours of the procedure being completed.
      • Joh J.
      • Kim W.
      • Jung I.
      • Park K.
      • Lee T.
      • Kang J.
      Consensus for the treatment of varicose vein with radiofrequency ablation.
      Each patient was given a single 40 mg dose of enoxaparin peri-operatively. No analgesics were prescribed but patients were advised to take paracetamol as required.
      For every truncal vein the accessible linear segment was treated, except when the vein was too close to the skin to avoid thermal skin injury; for the great saphenous vein (GSV), treatment did not extend beyond the level of mid calf to avoid saphenous neuropathy. No adjunctive sclerotherapy or phlebectomy was performed.

      Follow up

      Each patient was given a patient satisfaction questionnaire to complete at home and this questionnaire was submitted when they attended for review at two, and 12–14 weeks post-operatively in accordance with study protocol. During these reviews any complications were recorded, and the size of any bruising documented. DUS was performed at two weeks and 12–14 weeks, except where a complication such as DVT was suspected prior to this date. The AVSS and RVCSS were completed at the 12–14 week follow up.
      • Partsch H.
      • Hafner J.
      • Lattimer C.
      • Mosti G.
      • Neumann M.
      • Urbanek T.
      • et al.
      Indications for medical compression stockings in venous and lymphatic disorders: an evidence-based consensus statement.

      Power calculation and statistics

      This trial was a parallel group non-inferiority RCT. The null hypothesis was that the outcome of RFA treatment of varicose veins without post-treatment compression was no worse than the same procedure with compression. Assuming 90% power, a Type 1 error of 5%, and a planned success rate of 97.5% for patients receiving compression, the required number of patients to show that the success rate in patients not receiving compression was no less than 2.5% lower than this in absolute terms, was 40 in each arm of the trial. However, to increase the robustness of the results including potential dropout and given the low probability of adverse events in this trial, ethical approval was granted to extend the total sample size to 100.
      The analysis of the obliteration of the target vein and all a priori important variables of interest was by multivariable logistic regression, a standard statistical method for dealing with outcomes that can be expressed as success/failure and which can jointly account for the effects of two or more independent variables.
      • McCullagh P.
      • Nelder J.A.
      Analysis of QoL data was by multivariable linear regression. Forward stepwise and backward elimination approaches were undertaken to confirm the consistency of findings of the regression analyses. Because the assumptions of normality were violated by some variables, non-parametric tests were also carried out. Given the small proportion of loss to follow up and the high success rate of the treatment, no attempt was made to include patients with missing data in the analyses, as it would have made very little differences to the inferences. All analyses were performed blind, on an intention to treat basis, using Stata software (StataCorp LLC, College Station, TX, USA).
      StataCorp
      Stata statistical software: release 13.

      Results

      The CONSORT flow diagram is shown in Fig. 2.
      Figure 2
      Figure 2CONSORT flow diagram of patient enrolment, allocation, and analysis to study three month outcome with or without compression stockings after radiofrequency ablation for varicose veins in a randomised controlled trial. BMI = body mass index; DVT = deep vein thrombosis; AVSS = Aberdeen Varicose Vein Severity Score; RVCSS = Revised Venous Clinical Severity Score; US = ultrasound.
      There were no significant differences in the baseline characteristics between the study arms prior to intervention. Age and sex distributions were similar. The mean AVSS and RVCSS were 18 and 10 for “Compression” and 16 and 10 for “No compression” groups, respectively (Table 1).
      Table 1Baseline characteristics of patients studied for three month outcome with or without compression stockings after radiofrequency ablation for varicose veins in a randomised controlled trial
      VariablesCompression

      A (n = 51)
      No compression

      B (n = 49)
      Difference (A – B)
      Difference (A − B) refers to value in compression arm (control) minus value in experimental (no compression) arm presented as mean (95% CI).
      p value
      p value of difference between experimental and control arm (based on t test for continuous data and Fisher's exact test for categorical data).
      Age – years62.6 ± 14.058.1 ± 16.64.4 (−1.7 –10.5).15
      Gender males27 (53)28 (57)−0.04 (−0.23 – 0.15).69
      CEAP.78
       27 (14)7 (14)
       311 (22)11 (23)
       428 (55)22 (45)
       53 (6)6 (12)
       62 (4)3 (6)
      Venous system.26
       GSV42 (82)38 (78)
       GSV + SSV3 (6)1 (2.0)
       GSV + AAGSV1 (2.0)0 (0.0)
       SSV5 (10)10 (20)
      Diameter of largest vein to be treated – mm8.9 ± 3.48.9 ± 3.40.07 (−1.26 – 1.40).91
      Compression stockings prior to allocations14 (28)13 (27).55
      Duration of surgery – min43 ± 1541 ± 132 (−4 – 7.0).64
      AVSS18 ± 816 ± 72 (−5 – 1).19
      RVCSS10 ± 310 ± 40 (−2 – 1).74
      Data are presented as n (%) or mean ± standard deviation unless stated otherwise. AAGSV = anterior accessory of the great saphenous vein; AVSS = Aberdeen Varicose Vein Severity Score; CEAP = Clinical-Etiological-Anatomical-Pathophysiological classification of chronic venous disorders; GSV = great saphenous vein; RVCSS = Revised Venous Clinical Severity Score; SSV = small saphenous vein.
      Difference (A − B) refers to value in compression arm (control) minus value in experimental (no compression) arm presented as mean (95% CI).
      p value of difference between experimental and control arm (based on t test for continuous data and Fisher's exact test for categorical data).
      Comorbidities encountered in the study population were evenly distributed between the two groups and included atrial fibrillation, alcohol abuse, bleeding veins, diabetes, Raynaud's syndrome, aortic aneurysm, previous DVT in a contralateral limb, spina bifida, and thrombophlebitis.
      The great saphenous vein was the sole target vein in approximately 80% of cases. There was a higher proportion of CEAP C3–C5 in the present patient group because of the restriction imposed by service commissioners which meant that many C2 patients were denied NHS treatment except when complicated by bleeding or thrombophlebitis. This policy was also responsible for the slower than anticipated rate of recruitment into the study. Of the procedures, 99% were performed using tumescent local anaesthesia. One patient in the control arm had general anaesthesia because of needle phobia.
      Overall, a 94% follow up rate was achieved at 12–14 weeks (93% vs. 94% in the Compression vs. No compression groups, respectively, p = .89), and 7% did not return the questionnaire. Occlusion rates of the target veins at two weeks were identical to the rates at 12–14 weeks. Occlusion at two weeks, therefore, accurately predicted occlusion at 12–14 weeks.
      The primary outcome data (Table 2) show a comparable occlusion rate of 98% achieved in both groups. Similarly, patient satisfaction (92% vs. 91%; p = .72), pain score (1.9 vs. 2.0; p = .92), and post-procedural pain free state (45% vs. 49%; p = .52) were not significantly different between the Compression and No compression groups, respectively. On the other hand, two patients (4%) on the Compression arm and one patient (2%) on the No compression arm regretted the procedure (p = .48). The QoL and venous disease severity (AVSS 6 vs. 5.0 [p = .57]; RVCSS 3 vs. 4 [p = .46]) were also similar at the end of 12–14 weeks follow up. There was no difference in complications between the two groups (Table 2). Two patients had calf DVT at their two week scans. No anticoagulation was given. Repeat scan after four weeks showed no propagation. At 12 weeks there was no residual DVT. Two other patients had thrombus extending from the treated GSV into the CFV. These two patients were anticoagulated for six weeks and repeat scan showed no extension. None of the patients found with DVT on scanning had any symptoms. One patient provided a satisfaction score but did not attend for the scan to determine the primary outcome of vein occlusion.
      Table 2Twelve to fourteen week follow up data by allocation to radiofrequency ablation treatment for varicose veins with or without compression stockings post treatment in a randomised controlled trial
      OutcomesCompression

      A (n = 48)
      No compression

      B (n = 46)
      Difference

      A – B
      Difference (A − B) refers to value in compression arm (control) minus value in no compression (experimental) arm presented as mean (95% CI).
      p value
      p value of difference between experimental and control arm (based on t test for continuous data and Fisher's exact test for categorical data); p value ≤ .050 is considered significant.
      Occlusions47 (98)45 (98)1.0
      Patient satisfaction.72
       Very satisfied38 (75)37 (76)
       Satisfied6 (12)4 (8)
       Neutral1 (2)2 (4)
       Somewhat satisfied0 (0)1 (2)
       Not satisfied3 (6)1 (2)
      Regret having had procedure
      Regret rate calculated from patients' answers to question 3 “Do you regret having had the procedure” in radiofrequency ablation post-treatment satisfaction questionnaire (Fig. 1).
      .48
       02 (4)1 (2)
       62 (4)2 (4)
       744 (86)42 (86)
      Pain score2 ± 22 ± 21.0
      Duration of pain.52
       No pain23 (45)24 (49)
       12 h4 (8)6 (12)
       24 h4 (8)1 (2)
       One week20 (39)18 (37)
      AVSS6 ± 65 ± 60 (−2 – 3).57
      RVCSS3 ± 24 ± 31 (−1 – 1).46
      DVT
      DVTs were picked up at the two week scan in asymptomatic patients. No residual DVTs were seen at the 12–14 week scan.
      Below knee1 (2)1 (2)0.00 (−0.09 – 0.09)1.0
      Above knee1 (2)1 (2)0.00 (−0.09 – 0.09)1.0
      Data are presented as n (%) or mean ± standard deviation unless stated otherwise. AVSS = Aberdeen Varicose Vein Severity Score; DVT = deep vein thrombosis; RVCSS = Revised Venous Clinical Severity Score.
      Regret rate calculated from patients' answers to question 3 “Do you regret having had the procedure” in radiofrequency ablation post-treatment satisfaction questionnaire (Fig. 1).
      Difference (A − B) refers to value in compression arm (control) minus value in no compression (experimental) arm presented as mean (95% CI).
      p value of difference between experimental and control arm (based on t test for continuous data and Fisher's exact test for categorical data); p value ≤ .050 is considered significant.
      § DVTs were picked up at the two week scan in asymptomatic patients. No residual DVTs were seen at the 12–14 week scan.
      Patient characteristics (age, gender, comorbidities, diagnosis, vein diameter, baseline varicose vein or compression treatment, and pre-operative AVSS and RVCSS) did not predict the success or failure of the treatment. Similarly, trial characteristics (length of procedure, volume of tumescent, treatment allocation, painfulness of procedure) did not affect the primary outcome.
      Kruskal–Wallis equality of populations rank tests of various variables at 10–12 weeks post-procedure (Table 3) showed that vein occlusion and satisfaction with the procedure significantly predicted follow up AVSS score. One unit increase in vein occlusion and satisfaction with procedures reduced the AVSS score by 17 (p = .010) and 2 (p < .001), respectively. None of the other parameters were observed to have a significant effect on follow up AVSS score
      Table 3Kruskal–Wallis equality of population rank tests for follow up Aberdeen Varicose Vein Severity Score (AVSS) at 10–12 weeks after radiofrequency ablation for varicose veins
      VariablePatients – np
      Age group.40
       18 – 294
       30 – 395
       40 – 4911
       50 – 5924
       60 – 6922
       70 – 7917
       ≥8011
      Gender.30
       Male51
       Female42
      Baseline CEAP.98
       Varicose veins13
       Oedema22
       Pigmentation of eczema, etc.47
       Healed venous ulcer7
       Active venous ulcer4
      Diagnosis.54
       GSV75
       GSV + SSV3
       GSV + AAGSV1
       SSV14
      Comorbidities.23
       No84
       Yes9
      Previous varicose vein treatment.080
       No75
       Yes18
      Compression use before surgery.25
       No69
       Yes24
      Diameter of vein – mm.61
       <716
       ≥7 – 8.530
       ≥8.5 – 10.325
       ≥10.322
      Pre-operative AVSS.77
       0 – 1120
       12 – 1627
       17 – 2019
       21 – 3737
      Pre-operative RVCSS.35
       0 – 943
       109
       11 – 1323
       14 – 2018
      Length of surgery – min.71
       <3014
       30 – <4548
       45 – <6018
       60 – <7512
       ≥751
      Number of RF cycles.070
       0 – 951
       10 – 1226
       13 – 1616
      Volume of tumescent – mL.13
       <25022
       250 – <45044
       450 – 60027
      Vein occlusion.001
       No2
       Yes91
      Painfulness of procedure.51
       0 – 252
       3 – 429
       5 – 711
      Satisfaction with procedure.001
       04
       31
       43
       610
       775
      AAGSV = anterior accessory of the great saphenous vein; AVSS = Aberdeen Varicose Vein Severity Score; CEAP = Clinical-Etiological-Anatomical-Pathophysiological classification of chronic venous disorders; DVT = deep vein thrombosis; GSV = great saphenous vein; RF = radiofrequency; RVCSS = Revised Venous Clinical Severity Score; SSV = small saphenous vein.
      p ≤ .05 is regarded as significant.
      Similarly, Table 4 shows that vein occlusion and satisfaction with procedure predicted a decrease in RVCSS score by 0.678 (p = .001) and 5.64 (p = .007), respectively. There was a tendency for high pre-procedure RVCSS to be associated with higher RVCSS at the end of the follow up period, but this relationship was not linear. Both AVSS and RVCSS were higher for those patients in whom occlusion of the target vein was not achieved.
      Table 4Kruskal–Wallis equality of population rank tests for follow up Revised Venous Clinical Severity Score (RVCSS) at 10–12 weeks after radiofrequency ablation for varicose veins
      VariablePatients – np
      Age group.14
       18 – 293
       30 – 395
       40 – 4912
       50 – 5924
       60 – 6917
       70 – 7912
      Gender.030
       Male53
       Female42
      Baseline CEAP95.12
       Varicose veins13
       Oedema22
       Pigmentation of eczema, etc.48
       Healed venous ulcer7
       Active venous ulcer5
      Diagnosis.57
       GSV76
       GSV + SSV4
       GSV + AAGSV1
       AAGSV14
      Comorbidities.080
       No85
       Yes10
      Previous varicose vein treatment.22
       No77
       Yes18
      Compression use before surgery.35
       No69
       Yes26
      Diameter of vein – mm.43
       <718
       ≥7 – 8.530
       ≥8.5 – 10.325
       ≥10.322
      Pre-operative AVSS.10
       0 – 1120
       12 – 1627
       17 – 2019
       21 – 2729
      Pre-operative RVCSS.007
       0 – 943
       109
       11 – 1323
       14 – 2020
      Length of surgery – min.17
       <3014
       30 – <4548
       45 – <6019
       60 – <7513
       ≥751
      Number of RF cycles.20
       0 – 951
       10 – 1228
       13 – 1616
      Volume of tumescent – mL.14
       100 – <25022
       250 – <45045
       450 – 60028
      Painfulness of procedure.91
       0 – 253
       3 – 429
       5 – 711
      Satisfaction with procedure.001
       04
       31
       43
       610
       775
      Vein occlusion.007
       No2
       Yes92
      AAGSV = anterior accessory of the great saphenous vein; AVSS = Aberdeen Varicose Vein Severity Score; CEAP = Clinical-Etiological-Anatomical-Pathophysiological classification of chronic venous disorders; DVT = deep vein thrombosis; GSV = great saphenous vein; RF = radiofrequency; RVCSS = Revised Venous Clinical Severity Score; SSV = small saphenous vein.
      p ≤ .05 is regarded as significant.
      No patient suffered a specific complication from compression, but nine patients (20% of patients in the compression arm) complained about difficulty wearing the stocking and/or discomfort associated with wearing it. One patient described wearing the stocking as “awful,” and two patients complained of excessive itching.
      Patients were asked (see Fig. 1) to rate their improvement on weeks 1, 2, 4, and 6 post-procedure on a scale of 0–7 with 0 being “No improvement” and 7 being “Definite improvement.” This, combined with data on when they became pain free, could be surrogate markers for when the patients returned to normal activity. By the end of Week 1, 62% of the Compression group and 63% of the No compression group scored 7. By the end of the second week the respective figures were 94% and 95%. There was therefore no significant difference between the two groups.

      Discussion

      The present study has shown that the target vein occlusion rate was not influenced by whether post-procedure compression was worn or not following RFA of varicose veins, where phlebectomies have not been performed adjunctively. Similarly, there was no evidence that QoL scores, patient satisfaction, and complications were inferior in the group that had no post-procedure compression.
      The benefits of endovenous techniques in the treatment of varicose veins are now established.
      • Rautio T.
      • Ohinmaa A.
      • Perälä J.
      • Ohtonen P.
      • Heikkinen T.
      • Wiik H.
      • et al.
      Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs.
      ,
      • Pan Y.
      • Zhao J.
      • Mei J.
      • Shao M.
      • Zhang J.
      Comparison of endovenous laser ablation and high ligation and stripping for varicose vein treatment: a meta-analysis.
      Endovenous ablation (RFA and EVLT) causes venous occlusion through intimal thermal injury, thrombosis, and subsequent fibrosis of the vein. While external pressure applied at the time of procedure may be beneficial,
      • Passariello F.
      • Goldman M.
      • Mordon S.
      • Corcos L.
      • Vaghi M.
      • Zeh R.
      The mechanism of action of LASER and radiofrequency in great saphenous vein thermal ablation.
      the role of compression post thermal ablation has not been established.
      • El-Sheikha J.
      • Carradice D.
      • Nandhra S.
      • Leung C.
      • Smith G.
      • Campbell B.
      • et al.
      Systematic review of compression following treatment for varicose veins.
      A RCT in patients with GSV incompetence not associated with ulceration, who were treated with EVLT, favoured a minimum 48 h compression therapy duration, although the greatest benefit was achieved with one week of compression.
      • Bakker N.A.
      • Schieven L.W.
      • Bruins R.M.G.
      • Van der Berg M.
      • Hissink R.J.
      Compression stockings after endovenous laser ablation of the great saphenous vein: a prospective randomized controlled trial.
      It may be said that the improvement in symptoms noted with four hours, 48 h, or one week compression therapy is part of the natural healing process independent of duration of compression. The present trial, for the first time, has proposed that compression therapy may not be required in patients treated exclusively with RFA for varicose veins.
      With comparable baseline characteristics, the present study showed a target vein occlusion rate of 98% with or without compression at 12 week follow up. This is consistent with the findings of Kokkosis and Schanzer, whose no compression arm achieved 100% occlusion rate compared with 91% in the compression group following endovenous laser ablation.
      • Kokkosis A.
      • Schanzer H.
      Compression therapy is not necessary after endovenous ablation therapy for the treatment of varicose veins.
      Ayo and colleagues
      • Ayo D.
      • Blumberg S.
      • Rockman C.
      • Sadek M.
      • Cayne N.
      • Adelman M.
      • et al.
      Compression versus no compression after endovenous ablation of the great saphenous vein: a randomized controlled trial.
      reported 100% occlusion rate in both arms, compression and no compression. While their study may be generalisable to endothermal ablation (91% RFA and 9% EVLT), the present study applies specifically to patients treated wholly by RFA. The present results, which confirm Ayo's findings, strongly suggest that not employing compression therapy following RFA does not reduce the rate of target vein occlusion. They also suggest that reported non-occlusion of target vein (2% in each group) is not related to the use of compression therapy. The present study also explored factors that may be associated with short term non-occlusion in both groups. It was found that age, comorbidities, vein diameter, length of procedure, number of RF cycles, or recurrent varicose veins did not affect success or failure in both groups of patients. The two failures (one in each group) had fewer RF cycles, suggesting that a shorter length of target vein available for treatment may be associated with failure. Technical reasons such as optimum catheter position, incorrect technique, incorrect limb position, and ineffective tumescent application are possible causes of primary failure.
      • Taha A.
      • Elbadawy A.
      • Hasaballah A.
      Endovenous radiofrequency ablation of lower extremity varicose veins: short-term outcomes of the initial experience.
      This is similar to reports from another retrospective study using prospectively registered data with one year follow up reported in 2017.
      • Jin H.
      • Ohe H.
      • Hwang J.
      • Kim S.
      • Kim J.
      • Park S.
      • et al.
      Radiofrequency ablation of varicose veins improves venous clinical severity score despite failure of complete closure of the saphenous vein after 1 year.
      Approximately 92% of patients were satisfied with the procedures. This was consistent with low pain score (under 2) in both groups and a comparable regret rate. Post-operative pain had resolved in over 60% of patients in both groups within 24 h of the procedure. These findings suggest that compression therapy does not contribute towards better pain control. One RCT
      • Elderman J.
      • Krasznai A.
      • Voogd A.
      • Hulsewé K.
      • Sikkink C.
      Role of compression stockings after endovenous laser therapy for primary varicosis.
      was identified (n = 79) that assessed pain at two days, 14 days, and six weeks comparing compression for two weeks with no compression after an initial 24 h bandage in patients undergoing EVLT. The study reported a higher pain score in the no compression arm. The same study also reported greater satisfaction in the compression arm at two days (4.44 vs. 4.15), two weeks (4.33 vs. 3.95), and six weeks (4.59 vs. 4.18). However, the study may have had insufficient power to test the hypothesis. Ye K et al.
      • Ye K.
      • Wang R.
      • Qin J.
      • Yang X.
      • Yin M.
      • Liu X.
      • et al.
      Post-operative benefit of compression therapy after endovenous laser ablation for uncomplicated varicose veins: a randomised clinical trial.
      compared elastic bandage for 24 h followed by elastic compression stocking for at least two weeks (n = 200) with elastic bandage alone (n = 200), and reported a comparable pain score at 24 h and lower pain score at one week with compression therapy following EVLT. However, pain score data were collected from only approximately 40% of patients. Significantly, they did not find any difference in QoL improvement nor in the “Mean time to return to work.” Unlike the present study, Ye K studied exclusively C2 patients and also performed “high ligation” (in addition to EVLA), in all their patients. However, similar to the present study, they did not perform adjunctive phlebectomy or sclerotherapy.
      The present findings agree with those of Ayo et al.
      • Ayo D.
      • Blumberg S.
      • Rockman C.
      • Sadek M.
      • Cayne N.
      • Adelman M.
      • et al.
      Compression versus no compression after endovenous ablation of the great saphenous vein: a randomized controlled trial.
      in terms of the effect on quality of life and disease severity scores (AVSS, RVCSS), and also confirm their finding that compression had no effect on post-procedure pain. There was no increased rate of complications in the No compression group, as also found by Krasznai et al.,
      • Krasznai A.
      • Sigterman T.
      • Troquay S.
      • Houtermans-Auckel J.
      • Snoeijs M.
      • Rensma H.
      • et al.
      A randomised controlled trial comparing compression therapy after radiofrequency ablation for primary great saphenous vein incompetence.
      Kokkosis and Schanzer,
      • Kokkosis A.
      • Schanzer H.
      Compression therapy is not necessary after endovenous ablation therapy for the treatment of varicose veins.
      and Ayo.
      • Ayo D.
      • Blumberg S.
      • Rockman C.
      • Sadek M.
      • Cayne N.
      • Adelman M.
      • et al.
      Compression versus no compression after endovenous ablation of the great saphenous vein: a randomized controlled trial.
      There are, however, significant differences in methodology between the present study and that of Krasznai et al. in that the No compression arm did receive initial compression bandaging for four hours and they did not assess the occlusion rate of the target veins. With no difference in outcome between the groups in the present study, and given that 20% of patients would find the wearing of compression stockings uncomfortable, the prescription of compression post-RFA may no longer be justifiable.
      Factors predicting the 12 week follow up clinical severity and QoL scores were explored, and it was found that successful occlusion of the treated target vein and patient satisfaction predicted improved AVSS and RVCSS scores. Those who are satisfied with the treatment outcome are therefore more likely to have had successful target vein occlusion and, in turn, low AVSS and RVCSS scores. It could be argued, therefore, that significantly improved AVSS and/or RVCSS should be accepted as a successful outcome without the need for post-procedure duplex scanning. Only in those in whom there is no significant fall in these scores, should a scan become necessary. Extrapolating from the present study, this should be ∼2% of the patient population. A high pre-operative RVCSS was found to be associated with a higher (but still significantly reduced) post-procedure RVCSS score among those with successful obliteration of the target vein. This is not thought to have a significant clinical implication, except to be aware of the association. There is no obvious explanation for the finding of post-procedure RVCSS in general being higher for males compared with females. No obvious clinical or practical application of this finding is seen, and it is unclear whether future studies will confirm the finding.
      The method of randomisation and the fact that both the chief investigator and the statistician were blinded to the allocated group reduced the risk of bias. The low dropout rate in this study reduced the risk of type 2 error. The study was not powered to detect the difference in DVT rate, given its very low incidence. One limitation of the study is that it is from a single centre and it only reports short term results. In this regard, it is similar to the study by Ayo et al., which had a follow up period of 90 days. Long term follow up analysis may give further insight into differences in success rates based on compression therapy use. The present authors plan recall of patients for clinical and sonographic review after 24 months. Meanwhile, the results of this study may provide reliable scientific evidence which was not available during preparation of the recently published American guidelines on compression therapy after endothermal ablation of varicose veins.
      • Lurie F.
      • Lal B.K.
      • Antignani P.L.
      • Blebea J.
      • Bush R.
      • Caprini J.
      • et al.
      Compression therapy after invasive treatment of superficial veins of the lower extremities: clinical practice guidelines of the American venous Forum, society for vascular surgery, American College of phlebology, society for vascular medicine, and international union of phlebology.
      The present authors accept that the place or duration of compression post-RFA is far from settled, but expect that this study will contribute to development of the body of knowledge on the subject. Whereas earlier studies concentrated on the duration of compression, the present study and that of Ayo et al.
      • Ayo D.
      • Blumberg S.
      • Rockman C.
      • Sadek M.
      • Cayne N.
      • Adelman M.
      • et al.
      Compression versus no compression after endovenous ablation of the great saphenous vein: a randomized controlled trial.
      have moved the discussion on to answering the question of whether compression is required at all following RFA in situations where phlebectomies have not been performed. This is consistent with a publication by the National Institute for Health and Care Excellence (NICE) in the UK,
      National Institute for Health and Clinical Excellence (NICE)
      Varicose Veins: diagnosis and management – clinical guideline [CG168].
      which highlighted the knowledge gap in the role of compression following endothermal ablation. This study is also a partial response to the European Society for Vascular Surgery (ESVS) guidelines,
      • Wittens C.
      • Davies A.H.
      • Bækgaard N.
      • Broholm R.
      • Cavezzi A.
      • Chastanet S.
      • et al.
      European Society for Vascular Surgery. Editor's choice – management of chronic venous disease: clinical practice guidelines of the European Society for Vascular Surgery (ESVS).
      which recommended the need for further studies in this area. If the present findings are confirmed by larger studies, it is likely that the current recommendation of post-procedural compression for all cases of open surgery and endovenous superficial vein procedures will be revised.
      In conclusion, the physician and patient reported outcomes following RFA without compression are no worse than with compression. This trial supports the conclusion that the widely practised use of compression post RFA may add no clinical benefit to the patients. However, a much larger study, preferably a multicentre trial, may be required to confirm this conclusion.

      Conflict of Interest

      None.

      Funding

      Royal Bolton Hospital Research Grant (Reference IRAS 69699 ).

      References

        • Callam M.
        • Ruckley C.
        • Harper D.
        • Dale J.
        Chronic ulceration of the leg: extent of the problem and provision of care.
        BMJ. 1985; 290: 1855-1856
        • Callam M.
        Epidemiology of varicose veins.
        Br J Surg. 1994; 81: 167-173
        • National Institute for Health and Clinical Excellence (NICE)
        Varicose Veins: diagnosis and management – clinical guideline [CG168].
        • Rasmussen L.
        • Bjoern L.
        • Lawaetz M.
        • Blemings A.
        • Lawaetz B.
        • Eklof B.
        Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.
        J Vasc Surg. 2007; 46: 308-315
        • Trevor J.
        • Rhodes J.
        • Hardy J.
        • Makin G.
        Postoperative limb compression in reduction of haemorrhage after varicose vein surgery.
        Ann R Coll Surg Engl. 1993; 75: 119-122
        • Shouler P.
        • Runchman P.
        Varicose veins: optimum compression after surgery and sclerotherapy.
        Ann R Coll Surg Engl. 1989; 71: 402-404
        • Partsch H.
        • Hafner J.
        • Lattimer C.
        • Mosti G.
        • Neumann M.
        • Urbanek T.
        • et al.
        Indications for medical compression stockings in venous and lymphatic disorders: an evidence-based consensus statement.
        Phlebology. 2008; 27: 193-219
        • Huang T.
        • Chen S.
        • Bai C.
        • Wu C.
        • Tam K.
        The optimal duration of compression therapy following varicose vein surgery: a meta-analysis of randomized controlled trials.
        J Vasc Surg. 2013; 57: 1174-1175
        • El-Sheikha J.
        • Nandhra S.
        • Carradice D.
        • Acey C.
        • Smith G.
        • Campbell B.
        • et al.
        Compression regimes after endovenous ablation for superficial venous insufficiency – a survey of members of the Vascular Society of Great Britain and Ireland.
        Phlebology. 2015; 31: 16-22
        • Biswas S.
        • Clark A.
        • Shields D.
        Randomised clinical trial of the duration of compression therapy after varicose vein surgery.
        Eur J Vasc Endovasc Surg. 2007; 33: 631-637
        • Hamel-Desnos C.
        • Guias B.
        • Desnos P.
        • Mesgard A.
        Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression.
        Eur J Vasc Endovasc Surg. 2010; 39: 500-507
        • Krasznai A.
        • Sigterman T.
        • Troquay S.
        • Houtermans-Auckel J.
        • Snoeijs M.
        • Rensma H.
        • et al.
        A randomised controlled trial comparing compression therapy after radiofrequency ablation for primary great saphenous vein incompetence.
        Phlebology. 2015; 31: 118-124
        • Kokkosis A.
        • Schanzer H.
        Compression therapy is not necessary after endovenous ablation therapy for the treatment of varicose veins.
        Clin Surg. 2017; 2: 1700
        • Ayo D.
        • Blumberg S.
        • Rockman C.
        • Sadek M.
        • Cayne N.
        • Adelman M.
        • et al.
        Compression versus no compression after endovenous ablation of the great saphenous vein: a randomized controlled trial.
        Ann Vasc Surg. 2017; 38: 72-77
        • Labropolous N.
        • Tiongson J.
        • Pryor L.
        • Tassiopoulos A.K.
        • Kang S.S.
        • Ashraf Mansour M.
        • et al.
        Definition of venous reflux in lower-extremity veins.
        J Vasc Surg. 2003; 38: 793-798
        • Smith J.
        • Garratt A.
        • Guest M.
        • Greenhalgh R.
        • Davies A.
        Evaluating and improving health-related quality of life in patients with varicose veins.
        J Vasc Surg. 1999; 30: 710-719
        • Rutherford R.
        • Padberg F.
        • Comerota A.
        • Kistner R.
        • Meissner M.
        • Moneta G.
        Venous severity scoring: an adjunct to venous outcome assessment.
        J Vasc Surg. 2000; 31: 1307-1312
        • Higgins J.
        • Green S.
        Review: cochrane handbook for systematic reviews for interventions, Version 5.1.0, published 3/2011.
        in: Research synthesis methods. vol. 2. 2011: 126-130
        • Joh J.
        • Kim W.
        • Jung I.
        • Park K.
        • Lee T.
        • Kang J.
        Consensus for the treatment of varicose vein with radiofrequency ablation.
        Vasc Specialist Int. 2014; 30: 105-112
        • McCullagh P.
        • Nelder J.A.
        2nd ed. Generalized linear models. vol. 37. Chapman and Hall/CRC Press, 1989
        • StataCorp
        Stata statistical software: release 13.
        StataCorp LP. - Open Access Library, College Station, TX2013 ([Internet]. Oalib.com. 2019)
        http://www.oalib.com/references/5814356
        Date accessed: April 9, 2019
        • Rautio T.
        • Ohinmaa A.
        • Perälä J.
        • Ohtonen P.
        • Heikkinen T.
        • Wiik H.
        • et al.
        Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs.
        J Vasc Surg. 2002; 35: 958-965
        • Pan Y.
        • Zhao J.
        • Mei J.
        • Shao M.
        • Zhang J.
        Comparison of endovenous laser ablation and high ligation and stripping for varicose vein treatment: a meta-analysis.
        Phlebology. 2013; 29: 109-119
        • Passariello F.
        • Goldman M.
        • Mordon S.
        • Corcos L.
        • Vaghi M.
        • Zeh R.
        The mechanism of action of LASER and radiofrequency in great saphenous vein thermal ablation.
        Acta Phlebol. 2010; 11: 35-39
        • El-Sheikha J.
        • Carradice D.
        • Nandhra S.
        • Leung C.
        • Smith G.
        • Campbell B.
        • et al.
        Systematic review of compression following treatment for varicose veins.
        Br J Surg. 2015; 102: 719-725
        • Bakker N.A.
        • Schieven L.W.
        • Bruins R.M.G.
        • Van der Berg M.
        • Hissink R.J.
        Compression stockings after endovenous laser ablation of the great saphenous vein: a prospective randomized controlled trial.
        Eur J Vasc Endovasc Surg. 2013; 46: 588-592
        • Taha A.
        • Elbadawy A.
        • Hasaballah A.
        Endovenous radiofrequency ablation of lower extremity varicose veins: short-term outcomes of the initial experience.
        Egypt J Surg. 2018; 37: 185
        • Jin H.
        • Ohe H.
        • Hwang J.
        • Kim S.
        • Kim J.
        • Park S.
        • et al.
        Radiofrequency ablation of varicose veins improves venous clinical severity score despite failure of complete closure of the saphenous vein after 1 year.
        Asian J Surg. 2017; 40: 48-54
        • Elderman J.
        • Krasznai A.
        • Voogd A.
        • Hulsewé K.
        • Sikkink C.
        Role of compression stockings after endovenous laser therapy for primary varicosis.
        J Vasc Surg. 2014; 2: 289-296
        • Ye K.
        • Wang R.
        • Qin J.
        • Yang X.
        • Yin M.
        • Liu X.
        • et al.
        Post-operative benefit of compression therapy after endovenous laser ablation for uncomplicated varicose veins: a randomised clinical trial.
        Eur J Vasc Endovasc Surg. 2016; 52: 847-853
        • Lurie F.
        • Lal B.K.
        • Antignani P.L.
        • Blebea J.
        • Bush R.
        • Caprini J.
        • et al.
        Compression therapy after invasive treatment of superficial veins of the lower extremities: clinical practice guidelines of the American venous Forum, society for vascular surgery, American College of phlebology, society for vascular medicine, and international union of phlebology.
        J Vasc Surg. 2019; 7: 17-28
        • Wittens C.
        • Davies A.H.
        • Bækgaard N.
        • Broholm R.
        • Cavezzi A.
        • Chastanet S.
        • et al.
        European Society for Vascular Surgery. Editor's choice – management of chronic venous disease: clinical practice guidelines of the European Society for Vascular Surgery (ESVS).
        Eur J Vasc Endovasc Surg. 2015; 49: 678-737

      Comments

      Commenting Guidelines

      To submit a comment for a journal article, please use the space above and note the following:

      • We will review submitted comments as soon as possible, striving for within two business days.
      • This forum is intended for constructive dialogue. Comments that are commercial or promotional in nature, pertain to specific medical cases, are not relevant to the article for which they have been submitted, or are otherwise inappropriate will not be posted.
      • We require that commenters identify themselves with names and affiliations.
      • Comments must be in compliance with our Terms & Conditions.
      • Comments are not peer-reviewed.