Randomized clinical trial of 940- <i>versus</i> 1470-nm endovenous laser ablation for great saphenous vein incompetence

Malskat, Wendy S J; Giang, Jenny; Maeseneer, M. De; Nijsten, Tamar; Bos, R.R. van den

doi:10.1002/bjs.10035

Cited by 32 publications

(28 citation statements)

References 23 publications

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“…RFA revealed superior results in complication rates and postoperative pain in most of the studies [ 3 – 6 ]. Developments in laser catheters have led to improvements in EVLA results, and it is thought that the new catheters could end this superiority of RFA [ 7 , 8 ]. However, this hypothesis has not been sufficiently questioned.…”

Section: Resultsmentioning

confidence: 99%

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Effects of Two Current Great Saphenous Vein Thermal Ablation Methods on Visual Analog Scale and Quality of Life

Sanioglu

Yerebakan

Farsak

2017

BioMed Research International

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Background The aim of the study is to compare the current two endovenous thermal ablation methods by examining the effects on the visual analog scale (VAS) and the short form-36® quality of life index. Methods Ninety-six patients who underwent unilateral endovenous thermal ablation of great saphenous vein were included. ClosureFast™ catheters were used in the RFA group and 1470 nm radial fiber laser catheters were used in the EVLA group. Results The RFA group consisted of 41 patients and the EVLA group consisted of 55 patients. The preoperative baseline characteristics of both groups were similar. On the day of operation, VAS values were 2.8 ± 1.1 in the RFA group and 3.6 ± 1.8 in the EVLA group (p = 0.02). Comparisons of short form-36 parameters in both groups showed them to be similar except the pain detected at postoperative 1st week (48.1 ± 5.4 for RFA, 44.9 ± 7.6 for EVLA, p = 0.04). Conclusion Results in postprocedural quality of life were found to be similar in both of the techniques. However, in terms of postoperative pain, radiofrequency ablation is still superior to the 1470 nm radial fiber laser catheters.

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Section: Resultsmentioning

confidence: 99%

“…Because of this, new studies are needed with the use of new generation catheters with high wave length and new tip designs. Advances in laser catheters may alter the results and end the superiority of the RFA [ 7 – 9 ].…”

Section: Introductionmentioning

confidence: 99%

Effects of Two Current Great Saphenous Vein Thermal Ablation Methods on Visual Analog Scale and Quality of Life

Sanioglu

Yerebakan

Farsak

2017

BioMed Research International

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“…The hypothesis was that differences in quality of the study, follow up, wavelength, energy, and outcome definition may lead to different proportions of success; it was expected that low study quality, longer follow up, 10 lower amount of energy 9,11 used, and defining occlusion as outcome (instead of absence of reflux) would result in a lower success rate, differences between wavelengths was not expected. 12 Subgroup analysis was performed to test these hypotheses and included wavelengths (short [810, 940, and 980 nm], long [1470, 1500, and 1920 nm]) amount of energy ( 50 J/cm, > 50 J/cm), duration of follow up ( 1 year, > 1 year), definition of outcome (occlusion, no reflux), and quality of the studies (low risk of bias, unclear/high risk of bias). To compare the pooled proportions of the success rates between the subgroups, univariable and multivariable meta-regression was used in which a two sided p value < 0.05 indicated statistical significance.…”

Section: Discussionmentioning

confidence: 99%

“…Malskat 12 Hirokawa 17 Mendes−Pinto 22 Vuylsteke 24 Doganci 21 Vuylsteke 23 Sydnor 39 Gauw 32 Malskat 12 Hirokawa 17 Rass 36 van der Velden 5 van den Bos 38 Rasmussen 16 Samuel 37 Carradice 26 Disselhoff 30 Nordon 34 Christenson 27 Doganci 21 Gale 31 Goode 14 Pronk 35 Vuylsteke 23 Carradice 25 Darwood 28 Theivacumar 18 Kabnick 33 Desmyttere 29 1/SE) can result in funnel plot asymmetry without publication bias. 13 Therefore, an alternative funnel plot (sample size vs. log odds) was constructed and visually inspected.…”

Section: Random Effects Modelmentioning

confidence: 99%

Commonly Used Endovenous Laser Ablation (EVLA) Parameters Do Not Influence Efficacy: Results of a Systematic Review and Meta-Analysis

Malskat

Engels²,

Hollestein

et al. 2019

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDSThis study shows that all previously studied parameters of endovenous laser ablation (EVLA; wavelengths, administered energy, and definitions of outcome) have no influence on the EVLA treatment success rate. The overall success rate of EVLA is proven to be high (92%), confirming that EVLA is a highly effective treatment for incompetent great saphenous veins (GSVs), with increasing follow up. In clinical practice, this means that it is likely there will be a good treatment effect after EVLA, regardless of which (clinically studied) parameters are used.Objectives: The objective of this systematic review and meta-analysis was to summarise available randomised controlled trials (RCTs) of EVLA efficacy, and to define the differences in success rate of variations in wavelength, administered energy, outcome definition, and follow up period. Methods: A literature search was conducted in Embase, Medline (Ovid-SP), Cochrane Central Database, and Web of Science from inception to November 2017. RCTs with follow up of more than three months were included. The studied outcome was the proportion of patients with EVLA treatment success, defined as absence of reflux or occlusion of the great saphenous vein (GSV). Pooled proportions of anatomical success were compared. Subgroup and meta-regression analysis included wavelengths (short [810, 940, and 980 nm], long [1470, 1500, and 1920 nm]), amount of energy ( 50 J/cm, > 50 J/cm), follow up ( 1 year, > 1 year), outcome definition (occlusion, no reflux), and quality of the studies (low risk of bias, unclear/high risk of bias). Results: Twenty-eight RCTs, with a total of 2829 GSVs were included. The overall success rate of EVLA was 92% (95% CI 90e94%, I 2 ¼ 68%). In subgroup analysis, no statistically significant differences were found for long or short wavelengths (95% [95% CI 91e97%] vs. 92% [95% CI 89e94%], p ¼ .15), high or low administered energy (93% [95% CI 89e95%] vs. 92% [95% CI 90e94%], p ¼ .99), long or short follow up (89% [95% CI 84e93%] vs. 93% [95% CI 91e95%], p ¼ .13) and outcome definition (occlusion group 94% [95% CI 91e96%] vs. absence of reflux group 91% [95% CI 87e94%], p ¼ .26). Studies with low risk of bias reported a significantly higher success rate than high or unclear risk of bias (93% [95% CI 90e95%] vs. 89% [95% CI 83e93%], p ¼ .04). Conclusions: The overall success rate of EVLA is high (92%), even with increasing follow up. Commonly used parameters of EVLA (wavelength, administered energy, and outcome definition) have no influence on the treatment success rate.

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“…These patients were excluded from follow‐up, but their data were included in the ITT and LOCF analyses. It should also be noted that a 980‐nm fibre was used for EVLA, whereas 1470 nm is currently the preferred wavelength as it might be associated with less postoperative pain.…”

Section: Discussionmentioning

confidence: 99%

Randomized clinical trial of endovenous laser ablationversusdirect and indirect radiofrequency ablation for the treatment of great saphenous varicose veins

Hamann

Mik

Fritschy

et al. 2019

British Journal of Surgery

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Background The current treatment strategy for many patients with varicose veins is endovenous thermal ablation. The most common forms of this are endovenous laser ablation (EVLA) and radiofrequency ablation (RFA). However, at present there is no clear consensus on which of these treatments is superior. The objective of this study was to compare EVLA with two forms of RFA: direct RFA (dRFA; radiofrequency‐induced thermotherapy) and indirect RFA (iRFA; VNUS ClosureFast™). Methods Patients with symptomatic great saphenous vein (GSV) incompetence were randomized to receive EVLA, dRFA or iRFA. Patients were followed up at 2 weeks, 6 and 12 months. The primary outcome was GSV occlusion rate. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ) score and adverse events. Results Some 450 patients received the allocated treatment (EVLA, 148; dRFA, 152; iRFA, 150). The intention‐to‐treat analysis showed occlusion rates of 75·0 (95 per cent c.i. 68·0 to 82·0), 59·9 (52·1 to 67·7) and 81·3 (75·1 to 87·6) per cent respectively after 1 year ( P = 0·007 for EVLA versus dRFA, P < 0·001 for dRFA versus iRFA, P = 0·208 for EVLA versus iRFA). VCSS improved significantly for all treatments with no significant differences between them. AVVQ scores also improved significantly for all treatments, but iRFA had significantly better scores than dRFA at 12 months. Significantly more adverse events were reported after treatment with EVLA (103) than after dRFA (61) and iRFA (65), especially more pain. Conclusion Primary GSV occlusion rates were better after iRFA and EVLA than dRFA. All three interventions were effective in improving the clinical severity of varicose veins at 1 year.

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Randomized clinical trial of 940- versus 1470-nm endovenous laser ablation for great saphenous vein incompetence

Abstract: NCT01637181 (http://www.clinicaltrials.gov).

Cited by 32 publications

References 23 publications

Effects of Two Current Great Saphenous Vein Thermal Ablation Methods on Visual Analog Scale and Quality of Life

Effects of Two Current Great Saphenous Vein Thermal Ablation Methods on Visual Analog Scale and Quality of Life

Commonly Used Endovenous Laser Ablation (EVLA) Parameters Do Not Influence Efficacy: Results of a Systematic Review and Meta-Analysis

Randomized clinical trial of endovenous laser ablationversusdirect and indirect radiofrequency ablation for the treatment of great saphenous varicose veins

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