https://www.srcv.ro/ghiduri/Managementul%20pacientilor%20cu%20boala%20venoasa%20cronica%20-%20Ghidurile%20SVS%20-%20American%20Venous%20Forum.pdf

The care of patients with varicose veins and associated chronic venous diseases: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum

https://repub.eur.nl/pub/78905/Chronic-Venous-Disease.pdf

Editor's Choice - Management of Chronic Venous Disease: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS).

Background: This randomized trial compared four treatments for varicose great saphenous veins (GSVs). Methods: Five hundred consecutive patients (580 legs) with GSV reflux were randomized to endovenous laser ablation (980 and 1470 nm, bare fibre), radiofrequency ablation, ultrasound-guided foam sclerotherapy or surgical stripping using tumescent local anaesthesia with light sedation. Miniphlebectomies were also performed. The patients were examined with duplex imaging before surgery, and after 3 days, 1 month and 1 year. Results: At 1 year, seven (5· 8p er cent), six (4·8 per cent), 20 (16·3 per cent) and four (4· 8p er cent) of the GSVs were patent and refluxing in the laser, radiofrequency, foam and stripping groups respectively (P < 0·001). One patient developed a pulmonary embolus after foam sclerotherapy and one a deep vein thrombosis after surgical stripping. No other major complications were recorded. The mean(s.d.) postintervention pain scores (scale 0‐10) were 2·58(2·41), 1·21(1·72), 1·60(2·04) and 2·25(2·23) respectively (P < 0·001). The median (range) time to return to normal function was 2 (0‐25), 1 (0‐30), 1 (0‐30) and 4 (0‐30) days respectively (P < 0·001). The time off work, corrected for weekends, was 3·6 (0‐46), 2·9 (0‐14), 2·9 (0‐33) and 4·3 (0‐42) days respectively (P < 0·001). Disease-specific quality-of-life and Short Form 36 (SF-36  ) scores had improved in all groups by 1-year follow-up. In the SF-36  domains bodily pain and physical functioning, the radiofrequency and foam groups performed better in the short term than the others. Conclusion: All treatments were efficacious. The technical failure rate was highest after foam sclerotherapy, but both radiofrequency ablation and foam were associated with a faster recovery and less postoperative pain than endovenous laser ablation and stripping.

/pdf/randomized-clinical-trial-comparing-endovenous-laser-58lx4sfmzq.pdf

Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins.

Disclaimer Due to the evolving field of medicine, new research may, in due course, modify the recommendations presented in this document. At the time of publication, every attempt has been made to ensure that the information provided is up to date and accurate. It is the responsibility of the treating physician to determine the best treatment for the patient. The authors, committee members, editors, and publishers cannot be held responsible for any legal issues that may arise from the citation of this statement. Rules of evidence Management of patients with chronic venous disorders has been traditionally undertaken subjectively among physicians, often resulting in less than optimal strategies. In this document, a systematic approach has been developed with recommendations based upon cumulative evidence from the literature. Levels of evidence and grades of recommendation range from Level I and Grade A to Level III and Grade C. Level I evidence and Grade A recommendations derive from scientifically sound randomized clinical trials in which the results are clear-cut. Level II evidence and Grade B recommendations derive from clinical studies in which the results among trials often point to inconsistencies. Level III evidence and Grade C recommendations result from poorly designed trials or from small case series.1, 2 Meta-analysis Meta-analyses are included in the present document but there should be caution as to their possible abuse. Certain studies may be included in a meta-analysis carelessly without sufficiently understanding of substantive issues, ignoring relevant variables, using heterogenous findings or interpreting results with a bias.3 It has been demonstrated that the outcomes of 12 large randomized controlled trials were not predicted accurately 35% of the time by the meta-analyses published previously on the same topics.4

Management of chronic venous disorders of the lower limbs: guidelines according to scientific evidence.

Background
Minimally invasive techniques to treat great saphenous varicose veins include ultrasound-guided foam sclerotherapy (UGFS), radiofrequency ablation (RFA) and endovenous laser therapy (EVLT). Compared with flush saphenofemoral ligation with stripping, also referred to as open surgery or high ligation and stripping (HL/S), proposed benefits include fewer complications, quicker return to work, improved quality of life (QoL) scores, reduced need for general anaesthesia and equivalent recurrence rates. This is an update of a review first published in 2011.

Objectives
To determine whether endovenous ablation (radiofrequency and laser) and foam sclerotherapy have any advantages or disadvantages in comparison with open surgical saphenofemoral ligation and stripping of great saphenous vein varices.

Search methods
For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched January 2014) and CENTRAL (2013, Issue 12). Clinical trials databases were also searched for details of ongoing or unpublished studies.

Selection criteria
All randomised controlled trials (RCTs) of UGFS, EVLT, RFA and HL/S were considered for inclusion. Primary outcomes were recurrent varicosities, recanalisation, neovascularisation, technical procedure failure, patient QoL scores and associated complications.

Data collection and analysis
CN and RB independently reviewed, assessed and selected trials which met the inclusion criteria. CN and RB extracted data and used the Cochrane Collaboration's tool for assessing risk of bias. CN and RB contacted trial authors to clarify details as needed.

Main results
For this update, eight additional studies were included making a total of 13 included studies with a combined total of 3081 randomised patients. Three studies compared UGFS with surgery, eight compared EVLT with surgery and five compared RFA with surgery (two studies had two or more comparisons with surgery). Study quality, evaluated through the six domains of risk of bias, was generally moderate for all included studies, however no study blinded participants, researchers and clinicians or outcome assessors. Also, nearly all included studies had other sources of bias. The overall quality of the evidence was moderate due to the variations in the reporting of results, which limited meaningful meta-analyses for the majority of proposed outcome measures. For the comparison UGFS versus surgery, the findings may have indicated no difference in the rate of recurrences in the surgical group when measured by clinicians, and no difference between the groups for symptomatic recurrence (odds ratio (OR) 1.74, 95% confidence interval (CI) 0.97 to 3.12; P = 0.06 and OR 1.28, 95% CI 0.66 to 2.49, respectively). Recanalisation and neovascularisation were only evaluated in a single study. Recanalisation at 4 months an OR of 5.05 (95% CI 1.67 to 15.28) and for neovascularisation an OR of 0.05 (95% CI 0.00 to 0.94). There was no difference in the rate of technical failure between the two groups (OR 0.44, 95% CI 0.12 to 1.57). For EVLT versus surgery, there were no differences between the treatment groups for either clinician noted or symptomatic recurrence (OR 0.72, 95% CI 0.43 to 1.22; P = 0.22 and OR 0.87, 95% CI 0.47 to 1.62; P = 0.67, respectively). Both early and late recanalisation were no different between the two treatment groups (OR 1.05, 95% CI 0.09 to 12.77; P = 0.97 and OR 4.14, 95% CI 0.76 to 22.65; P = 0.10). Neovascularisation and technical failure were both statistically reduced in the laser treatment group (OR 0.05, 95% CI 0.01 to 0.22; P < 0.0001 and OR 0.29, 95% CI 0.14 to 0.60; P = 0.0009, respectively). Long-term (five-year) outcomes were evaluated in one study so no association could be derived,but it appeared that EVLT and surgery maintained similar findings. Comparing RFA versus surgery, there were no differences in clinician noted recurrence (OR 0.82, 95% CI 0.49 to 1.39; P = 0.47); symptomatic noted recurrence was only evaluated in a single study. There were also no differences between the treatment groups for recanalisation (early or late) (OR 0.68, 95% CI 0.01 to 81.18; P = 0.87 and OR 1.09, 95% CI 0.39 to 3.04; P = 0.87, respectively), neovascularisation (OR 0.31, 95% CI 0.06 to 1.65; P = 0.17) or technical failure (OR 0.82, 95% CI 0.07 to 10.10; P = 0.88).

QoL scores, operative complications and pain were not amenable to meta-analysis, however quality of life generally increased similarly in all treatment groups and complications were generally low, especially major complications. Pain reporting varied greatly between the studies but in general pain was similar between the treatment groups.

Authors' conclusions
Currently available clinical trial evidence suggests that UGFS, EVLT and RFA are at least as effective as surgery in the treatment of great saphenous varicose veins. Due to large incompatibilities between trials and different time point measurements for outcomes, the evidence is lacking in robustness. Further randomised trials are needed, which should aim to report and analyse results in a congruent manner to facilitate future meta-analysis.

Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices

https://www.jvascsurg.org/article/S0741-5214(07)01896-4/pdf

Franz Hieller

Papers

High ligation combined with stripping and endovenous laser ablation of the great saphenous vein: Early results of a randomized controlled study