Abstract
Objective
Several studies have shown that, in the short term, treatment outcomes following endothermal ablation of varicose veins without the prescription of post procedural compression are not inferior to outcomes when compression is routinely prescribed. This follow-up to our randomized controlled trial (RCT) published in 2020 explores whether the non-inferiority persists into the medium to long term.
Methods
All 94 patients from the RCT were recalled at 27 months after their initial radiofrequency ablation (RFA) procedure. The procedural details, randomization, and inclusion and exclusion criteria were described in the original RCT paper. Consent was obtained for further venous duplex ultrasound scan at 27 to 61 months after the initial procedure. The successful target vein closure at this juncture represented our primary outcome. Secondary outcomes include disease severity, measured using the Aberdeen Varicose Vein Severity Score (AVSS) and the Revised Venous Clinical Severity Score (RVCSS), post-procedural pain measured using Likert scale, and number of days taken for patients to return to work or normal activities.
Results
Thirty-one of 48 patients (64.6%) in the compression group and 29 of 46 patients (63%) in the no-compression group were evaluated. The mean duration of follow-up was 43 and 42 months in the compression and no-compression group, respectively. The target vein occlusion rate evaluated at this longer-term follow up were 80.7% and 79.3% in the compression and no-compression groups, respectively. There was no significant difference between the two groups (P = .37). Secondary outcomes of quality of life and disease severity measured using AVSS and RVCSS showed no significant difference between the two groups (post-procedural AVSS mean score 5.2 in the compression group vs 8.3 in the no-compression group [95% confidence interval (CI), −7.3 to 1.1; P = .14]; post-procedural RVCSS mean score 1.5 in the compression group vs 1.8 in the no-compression group [95% CI, −1.1 to 0.7; P = .59]). Patient satisfaction was similar in both groups (mean score 6.4 in the compression group vs 5.9 in the no-compression group [95% CI, −0.22 to 1.17; P = .18]), and the number of days taken for patients to return to work were also comparable (mean of 11.9 days in the compression group vs 12.6 days in the no-compression group [95% CI, −7.7 to 6.2; P = .83]).
Conclusions
This study provided some evidence to support no additional benefit of compression use after RFA at a longer term follow-up of 3 years. However, larger, suitably powered studies would be beneficial to confirm this.
Keywords: Radiofrequency ablation, Varicose vein, Post-procedural, Compression therapy
Article Highlights.
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Type of Research: Single-center, prospective, randomized controlled follow-up study
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Key Findings: Compression therapy post-radiofrequency ablation for varicose vein was evaluated in 31 patients in the compression group and 29 patients in the no-compression group. There was no significant difference in the target vein occlusion rate between the two groups (80.7% vs 79.3% in compression vs no compression; P = .37).
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Take Home Message: Compression therapy after radiofrequency ablation of varicose veins provides no additional benefit when compared with no compression, and this effect persisted in the medium to long term.
Varicose veins are prevalent,1,2 and the commonly reported signs and symptoms include leg heaviness, itching, oedema, pain, and skin changes,3 which can significantly impact quality of life. Interventional modalities have now shifted from open surgical repair to endovenous techniques, which are safe and effective4,5 and now widely accepted as the recommended standard of care for patients who are suitable.6,7 Current available endovenous interventions include endothermal ablation techniques, which are radiofrequency ablation (RFA) and endovenous laser therapy (EVLT).
The use of post-procedural compression following endothermal ablation follows the rationale of enhancing and maintaining vein closure, in addition to reducing venous thrombosis, bruising, thrombophlebitis, and post-procedural pain.8 The use of compression therapy after endothermal ablation is commonplace; however, there is a wide disparity among clinicians as to the optimum compression regime, as shown in the 2016 survey of consultant members of the Vascular Society of Great Britain and Ireland.9
Two recent systematic reviews and meta-analyses evaluating four and six studies, respectively, looking at endothermal ablation therapy (552 and 1045 patients), published from 2014 to 2021, suggest that compression therapy reduces postoperative pain and time to return to normal activities, with no other demonstrable benefits in terms of vein occlusion rates, quality of life, and complication rates.10,11 A recent randomized controlled trial (RCT) published in 2022 investigating post-procedural pain and patient satisfaction after RFA and foam sclerotherapy observed non-inferiority in no compression to compression on postoperative pain scores.12 Another retrospective study suggested increased swelling and discomfort with compression therapy following RFA, mechanochemical ablation, and sclerotherapy.13
Despite emerging evidence lending support to no compression after endothermal therapy, the latest recommendation from the European Society for Vascular Surgery (ESVS) 2022 guidelines states that post-procedural compression therapy following endovenous thermal ablation should be considered (Class IIa, Level A evidence), with the acknowledgment of the heterogeneity in the vast number of trials prohibiting direct comparison.6 The American Venous Forum guidelines 2023 also conveyed a Grade 2, Level B evidence on post-endothermal ablation compression treatment.8 The growing number of conflicting study results render this issue controversial, with no unanimity among clinicians on its indication and benefits.
This current study, which is a follow-up study on the RCT investigating the role of compression therapy after RFA of varicose veins,14 aims to report the longer-term efficacy and patient satisfaction. By publishing the 42 months follow-up results, we aim to monitor whether the clinical and patient-reported outcomes of the first study, which suggested no additional clinical benefit for compression therapy, continues beyond the initial 12 weeks of follow-up.
Methods
Study design and endpoints
This was a single-center, prospective study, which included all the patients enrolled in the first RCT.
All 94 patients from the RCT were recalled at 27 months after their initial RFA procedure. The procedural details, randomization, and inclusion and exclusion criteria were described in the first RCT paper.14 Consent was obtained for a further venous duplex ultrasound scan (DUS) at 27 to 61 months after the initial procedure. Ethical approval was previously obtained for our initial study, from which a follow-up recall was deemed necessary; therefore, no further ethical approval was sought. As per the previous RCT, 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. The successful target vein closure at this juncture represented our primary outcome. Secondary outcomes of quality of life (QoL) and disease severity were assessed using the Aberdeen Varicose Vein Severity Score (AVSS) and the Revised Venous Clinical Severity Score (RVCSS). Patient satisfaction questionnaire measured using a Likert scale was also distributed for patient completion, with an additional question of “time taken to return to work or normal activities” (Supplementary Fig, online only).
Data management and statistical analysis
Patients’ results were collected, anonymised and entered into Microsoft Excel spreadsheets. Tabulations, 95% confidence intervals (CIs), and 2-sided 5% significance tests (comparisons of means and proportions) were carried out using Stata v14.15
Results
Patients’ baseline characteristics are presented in Table I. All 94 patients from our primary study were invited for further review. Thirty-one of 48 patients (64.6%) in the compression group and 29 of 46 patients (63%) in the no-compression group responded to our invite and attended further follow-up. There was no significant difference in patient demographics between the two groups. The majority of veins ablated were the great saphenous vein (GSV) in both groups (90% in compression group, 79% in no-compression group), and most patients had CEAP 3 to 5 disease.
Table I.
Baseline characteristics of the study population
| Variable | Compression (n = 31) | No compression (n = 29) | Difference (95% CI) | P-value |
|---|---|---|---|---|
| Age, years | 67.3 (13.6) | 68.4 (13.2) | −1.2 (−8.1 to 5.7) | .73 |
| Sex, female | 16 (51.6) | 16 (55.2) | .78 | |
| Vein | ||||
| GSV | 28 (90.3) | 23 (79.3) | ||
| GSV/AATV | 1 (3.2) | 1 (3.5) | ||
| GSV/SSV | 1 (3.2) | 0 (0.0) | ||
| SSV | 1 (3.3) | 4 (13.8) | ||
| SSV/AATV | 0 (0.0) | 1 (3.5) | .38 |
AATV, Anterior accessory saphenous vein; CI, confidence interval; GSV, great saphenous vein; SSV, small saphenous vein.
Data are presented as number (%) or mean (standard deviation).
Outcome measures are presented in Table II. The mean duration of follow-up was 43 and 42 months in the compression and no-compression group, respectively. The primary outcome of target vein occlusion evaluated at this medium- to longer-term follow-up was 80.7% in the compression and 79.3% in the no-compression group, with no significant difference between the two groups (P = .37). Secondary outcomes of QoL and disease severity measured using AVSS and RVCSS showed no significant difference between the two groups (post-procedural AVSS mean score 5.2 in compression group vs 8.3 in no-compression group [95% CI, for difference, −7.3 to 1.1; P = .14]; post-procedural VCSS mean score 1.5 in compression group vs 1.8 in no-compression group [95% CI for difference, −1.1 to 0.7; P = .59]). Patient satisfaction with the procedure was similar in both groups (mean score 6.4 in compression group vs 5.9 in no-compression group [95% CI for difference, −0.22 to 1.17; P = .18]), and the number of days taken for patients to return to work or normal activities were also comparable (mean of 11.9 days in compression group vs 12.6 days in no-compression group [95% CI for difference, −7.7 to 6.2; P = .83]).
Table II.
Outcome measures
| Variable | Compression A (n = 31) | No compression (n = 29) | Difference (95% CI) | P-value |
|---|---|---|---|---|
| Duration of follow-up, months | 43.0 (9.4) | 41.9 (9.7) | 1.3 (−3.8 to 6.1) | .65 |
| Duplex scan patency | ||||
| Not patent | 25 (80.7) | 23 (79.3) | ||
| Patent | 5 (16.1)) | 4 (13.8) | ||
| Missing | 1 (3.2) | 2 (6.9) | .79 | |
| Duplex scan competence | ||||
| Occluded | 25 (80.7) | 23 (79.3) | ||
| Patent but competent | 4 (12.9) | 1 (3.5) | ||
| Patent but incompetent | 1 (3.2) | 3 (10.3) | ||
| Missing | 1 (3.2) | 2 (6.9) | .37 | |
| Pre AVSS | 17.4 (8.7) | 15.3 (7.8) | 2.1 (−2.2 to 6.4) | .33 |
| Post AVSS | 5.2 (6.1) | 8.3 (9.9) | −3.1 (−7.3 to 1.1) | .14 |
| Pre VCSS | 9.6 (3.3) | 10.4 (3.8) | −0.8 (−2.6 to 1.0) | .38 |
| Post VCSS | 1.5 (1.6) | 1.8 (1.8) | −0.2 (−1.1 to 0.7) | .59 |
| First satisfaction | 6.7 (0.7) | 6.7 (0.9) | 0.02 (−0.40 to 0.44) | .92 |
| Second satisfaction | 6.4 (1.1) | 5.9 (1.5) | 0.47 (−0.22 to 1.17) | .18 |
| Return to work, days | 11.9 (10.4) | 12.6 (14.5) | −0.7 (−7.7 to 6.2) | .83 |
AVSS, Aberdeen Varicose Vein Severity Score; CI, confidence interval; VCSS, Venous Clinical Severity Score.
Data are presented as number (%) or mean (standard deviation).
Discussion
Our follow-up study showed that there remains no significant difference in target vein occlusion rate between the compression and the no-compression groups at the medium- to longer-term follow-up. The occlusion rate in our initial RCT were 98% in each arm,14 whereas in our follow-up RCT, these were 81% and 79% in the compression and no-compression arms, respectively. The approximately 20% recurrence rate, which appears to be high, remains consistent with reported recurrences rate in current literature, which range from 10% up to 33%.16,17 Secondary outcomes of QoL measure, patient satisfaction, and days taken to return to work or normal activities were also comparable between the two groups. In our initial RCT, mean patient satisfaction scores measured using Likert scale were 6.7 in both arms,14 whereas in our follow-up RCT, these were 6.4 and 5.9 in the compression and no-compression arms, respectively. There was no significant differences in the time taken to return to work or normal activities, and post-procedural AVSS scores remained low in both groups.
Our results are similar to those of Ayo et al,18 an RCT that evaluated compression vs no compression therapy after endovenous ablation (majority RFA, 91%). Their study reported 100% target vein occlusion rate in both arms and no significant difference in patient-reported outcome of post-procedural pain.18 A more recent, non-inferiority RCT performed by Pihlaja et al19 demonstrated no difference in vein occlusion rates, time to return to normal activity, and pain score for patients who had full compression for two days and then daytime only for five days vs patients who had no compression at all. This finding is consistent with our results; however, the main difference to our study was the shorter duration of compression therapy (total of 7 days in Pihlaja et al’s study vs a total of 14 days in our study) and their use of concomitant foam sclerotherapy in addition to RFA19 (RFA only in our study).
The COMETA trial also generated similar findings of no difference in occlusion rates for the compression and no-compression groups after endothermal ablation with either RFA or EVLT with or without additional phlebectomies or foam sclerotherapy.20 However, the study suggested that compression may be advantageous in the first few days post-intervention, especially for patients who had concurrent phlebectomies, as they had better pain scores.20 This may indicate that perhaps concurrent phlebectomies contribute to more pain than endothermal ablation alone, and further studies are required to investigate this.
Recent meta-analyses performed by Hu et al, Zhang et al, and Ma et al also arrived at similar conclusions of no additional advantage for compression therapy except for better postoperative pain relief.10,11,21 Even so, the difference in pain scores between compression and no compression groups was small and may not be clinically significant. From the meta-analyses, there was no difference in QoL outcomes between compression and no compression groups,10,11,21 which suggested that measurement of pain using the visual analogue scale can be problematic and subjective as it did not correlate with QoL outcomes. It could also be postulated that the short-term postoperative pain was not sufficiently significant to negatively impact on overall QoL as perceived by patients.
Patient compliance for compression therapy is frequently poor with common complaints of application difficulty, sweating, itching, exudation lesions of lower legs, and poor cosmetic appearance.22,23 This represents one of the main barriers to the use of compression therapy, yet it is still widely prescribed by most surgeons despite no clear demonstrable benefit.9 There is a current, ongoing non-inferiority RCT investigating the short-term use of compression therapy post-endothermal treatment of varicose veins, comparing compression for a total of 48 hours vs 7 days, with a primary endpoint of target vein occlusion rate at 3 months and secondary endpoints of pain, QoL, clinical severity of varicose veins, postoperative complications, time to return to regular work, and patient compliance.24 The rationale for adopting a short-term compression therapy is to improve patient compliance while still providing some form of compression for post-procedural pain relief. The study protocol is available, and results are currently awaited. However, based on our study results, which exclusively investigated RFA only, we have shown that both clinical and patient-reported outcomes persisted beyond the initial 12-week follow up, with satisfactory target vein occlusion rates and AVSS and RVCSS scores. More importantly, there was no significant difference in outcomes between patients who had compression therapy compared with those who did not, thereby questioning the rationale of traditionally employed, post-procedural compression use.
Recommendations from current global clinical guidelines6,8 advocate for compression therapy after endothermal venous ablation. However, it must be noted that there is no strong evidence behind this recommendation. In addition, there is no separate recommendations for RFA and EVLT, despite studies showing that patients who underwent EVLT experienced more pain compared with those who underwent RFA.25,26 In the United Kingdom, the National Institute for Health and Care Excellence (NICE) guidance states that if compression therapy is offered after interventional treatment of varicose veins, this should not exceed 7 days.27 Our study may, therefore, be able to provide further evidence to reduce the unnecessary use of compression therapy after RFA of varicose veins.
This is the only study thus far that reported longer-term outcomes beyond the 6-month period as reported in other studies. One main limitation of this study is the small number of patients evaluated due to loss to follow-up. In our initial study, 40 patients were required in each arm based on power calculation of 90%, a Type 1 error of 5%, and a planned success rate of 97.5%. The final number of patients analyzed in our follow-up study is evidently less than ideal, therefore rendering the study to be slightly underpowered (due to patient attrition). This may limit the ability in detecting clinically important differences between the two arms or the presence of adverse outcomes. The main reason for the loss to follow-up was the lack of response from patients to attend further assessment that necessitated physical attendance for further duplex scanning, and this might have been inconvenient for some patients. For this reason, further larger, suitably powered studies are required to confirm our findings. We also did not perform any further evaluation of other postoperative complications during this longer-term follow-up; therefore, we are unable to comment on this aspect, which may be important to consider in future studies.
Conclusion
This study provided some evidence to support no additional benefit of compression use after RFA at a longer-term follow-up of 3 years. However, larger, suitably powered studies would be beneficial to confirm this.
Author Contributions
Conception and design: MO
Analysis and interpretation: CH, DM, MO
Data collection: CH, MO
Writing the article: CH, MO
Critical revision of the article: CH, DM, MO
Final approval of the article: CH, DM, MO
Statistical analysis: DM
Obtained funding: MO
Overall responsibility: MO
Funding
This study was partially funded by the Bolton Hospitals NHS Foundation Trust Research Department.
Disclosures
None.
Acknowledgments
The authors thank Paula Thompson for her contribution in data collection and Sheila Ashworth for her secretarial support.
Footnotes
The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.
Appendix
The CME exam for this article can be accessed athttp://www.jvsvenous.org/cme/home.
Additional material for this article may be found online at www.jvsvenous.org.
Appendix (online only)
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