Dataset Information

Cost-effectiveness analysis of five procedures for great saphenous vein reflux in a Norwegian healthcare setting or societal setting.

ABSTRACT:

Objective

The aim of this work was to estimate cost-effectiveness of five common procedures for varicose vein surgery (high ligation and stripping, radiofrequency ablation, endovenous laser ablation, steam vein sclerosis and cyanoacrylate glue) in a Norwegian setting from both a societal and a healthcare payer perspective.

Design

Cost-effectiveness analysis using decision tree modelling.

Methods

A structured literature search was conducted to estimate the clinical effectiveness and the rate of complications in the five methods. Data on costs and health-related quality of life associated with varicose vein disease were also collected. With the aid of an expert panel, a structured decision tree was developed. A 1-year perspective was modelled, and a variety of common complications were included. Monte Carlo simulation was used for probabilistic sensitivity analyses.

Results

The laser ablation strategy was the most cost-effective option from a societal perspective, with an incremental cost-effectiveness ratio of €8448 compared to a no-treatment alternative, and had a 42% probability of being cost-effective using the Norwegian willingness-to-pay threshold of €59,880. From a healthcare payer perspective, however, the steam vein sclerosis strategy was the most cost-effective with an incremental cost-effectiveness ratio of €4072 compared to a no-treatment alternative, and this strategy had a 50% probability of being cost-effective.

Conclusion

Results from this study did depend upon the perspective chosen for analyses. Although recent endovenous surgical procedures (including laser ablation and steam vein sclerosis) provide clinically effective treatment for advanced, symptomatic varicose vein disease, availability of high-level data is currently limiting the cost-effectiveness analyses.

SUBMITTER: Inderhaug E

PROVIDER: S-EPMC6153534 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Project description:INTRODUCTION:Endovenous ablations are the new standard procedures for treatment of great saphenous vein reflux including endovenous laser ablation (EVLA), radio frequency ablation (RFA), endovenous steam ablation (EVSA), mechanochemical ablation (MOCA), cyanoacrylate injection and ultrasound-guided foam sclerotherapy (UGFS). EVLA and RFA have demonstrated similar anatomical success for short-term outcome, but results are controversial for longer term (?5 years). Additional evidences from randomised controlled trials have been published. This study is, therefore, conducted to, directly and indirectly, compare outcomes among all procedures stratifying by short-term and long-term follow-up. METHODS AND ANALYSIS:Medline and Scopus will be searched from 2000 to September 2018 with predefined search strategy. Interventions of interest are open surgery (ie, saphenofemoral or high ligation (HL) with stripping) and endovenous ablations (ie, EVLA, RFA, EVSA, MOCA, cyanoacrylate injection and UGFS). The primary outcome is anatomical success. Two independent reviewers will select studies, extract data and assess risk of bias. Disagreement will be adjudicated by the third party. Outcomes will be directly pooled if there are at least three studies in that comparison. A fixed-effect model will be used unless heterogeneity is present, in which case a random-effect model will be applied. Sources of heterogeneity will be explored using meta-regression analysis, and sub-group analysis will be done accordingly. Publication bias will be assessed using Egger's test and funnel plot. A network meta-analysis will be applied to indirect compare all interventions including RFA, EVLA, EVLA with HL, UGFS, UGFS with HL and HL with stripping. Probability of being best intervention will be estimated and ranked. Inconsistency assumption will be checked using a design-by-treatment interaction model. ETHICS AND DISSEMINATION:Ethical approval is not required for systematic review and network meta-analysis. The study will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42018096794.

Project description:BackgroundVascular adventitia contains progenitor cells and is shown to participate in vascular remolding. Progenitor cells are recruited into the venous thrombi in mice to promote neovascularization. We hypothesized that the adventitial progenitor cells of human great saphenous vein (HGSV-AdPC) enhance the resolution of venous thrombosis via neovascularization.MethodsHuman great saphenous vein (HGSV) was harvested from the patients with great saphenous vein varicose and sectioned for immunohistochemistry, or minced for progenitor cell primary culture, or placed in sodium dodecyl sulfate solution for decellularization. Human venous thrombi were collected from patients with great saphenous vein varicose and superficial thrombophlebitis. Infrarenal abdominal aorta of New Zealand white rabbits was replaced with interposing decellularized vessel, and the patency of the grafts was confirmed by ultrasonic examination. Animal venous thrombi in the left infrarenal vena cava of mice were produced with Prolene suture ligation and ophthalmic force clipping of this portion. After HGSVs were digested by collagenase, the CD34+CD117+ HGSV-AdPC were isolated on FACS system, labelled with CM-Dil, and transplanted into the adventitia of infrarenal vena cava of nude mice. The percentage of thrombus organization area to the thrombus area was calculated as the organization rate. The thrombus cell, endothelial cells, and macrophages in the thrombi were counted in sections. Cell smears and frozen sections of human saphenous veins and venous thrombi were labeled with Sca1, CD34, CD117, Flk1, CD31, and F4/80 antibodies. The CD34+CD117+ HGSV-AdPC were cultured in endothelial growth medium with vascular endothelial growth factor (VEGF) to induce endothelial cell differentiation and analyzed with real time-PCR, Western blotting, and tube formation assays.ResultsImmunohistochemical staining showed that the CD34+CD117+ cells were located within the adventitia of HGSVs, and many CD34+ and CD117+ cells have emerged in the human venous thrombi. The number of progenitor cells within the marginal area of 7 days mice thrombi was shown to be Sca1+ ≈21%, CD34+ ≈12%, CD117+ ≈9%, and Flk1+ ≈5%. Many CD34+adventitial progenitor cells have migrated into the decellularized vessels. FACS showed that the number of CD34+CD117+ HGSV-AdPC in primary cultured cells as 1.2 ± 0.07%. After CD34+CD117+HGSV-AdPC were transplanted into the adventitia of nude mice vena cava with venous thrombi, the organization rate, nucleate cell count, endothelial cells, and macrophage cells of thrombi were shown to be significantly increased. The transplanted CD34+CD117+ HGSV-AdPC at the adventitia have crossed the vein wall, entered the venous thrombi, and differentiated into endothelial cells. The CD34+CD117+ HGSV-AdPC in the culture medium in the presence of VEGF-promoted gene and protein expression of endothelial cell markers in vitro and induced tube formation.ConclusionsHGSV-AdPC could cross the vein wall and migrate from the adventitia into the venous thrombi. Increased HGSV-AdPC in the adventitia has enhanced the resolution of venous thrombi via differentiating into endothelial cells of neovascularization.