Cost‐effectiveness of treatments for superficial venous reflux in patients with chronic venous ulceration

Epstein, David; Gohel, M.S.; Heatley, Francine; Davies, AH

doi:10.1002/bjs5.56

Cited by 12 publications

(10 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…73 In case of ulceration, the most cost-effective approach resulted to be surgical vs. just compression, while not enough data regarding the other techniques are available. 74 A detailed cost-effectiveness analysis should also include the EHIT sonographic surveillance and the real clinical need of it, considering the extremely low incidence of this complication. A major step forward must be taken in future researches by identifying the most meaningful post-procedural key outcome measures, so to provide homogeneous data collections.…”

Section: Discussionmentioning

confidence: 99%

Global guidelines trends and controversies in lower limb venous and lymphatic disease

et al. 2019

View full text Add to dashboard Cite

Guidelines are fundamental in addressing everyday clinical indications and in reporting the current evidence-based data of related scientific investigations. At the same time, a spatial and temporal issue can limit their value. Indeed, variability in the recommendations can be found both among the same nation different scientific societies and among different nations/continents. On the other side, Garcia already published in 2014 data showing how, after three years in average, one out of five recommendations gets outdated (Martinez Garcia LM, Sanabria AJ, Garcia Alvarez E, et al. The validity of recommendations from clinical guidelines: a survival analysis. CMAJ 2014;186(16):1211–1219). The present document reports a narrative literature revision on the major international recommendations in lower limb venous and lymphatic disease management, focusing on the different countries’ guidelines, trends and controversies from all the continents, while identifying new evidence-based data potentially influencing future guidelines. World renowned experts’ opinions are also provided. The document has been written following the recorded round tables scientific discussions held at the vWINter international meeting (22–26 January 2019; Cortina d’Ampezzo, Italy) and the pre- and post-meeting literature search performed by the leading experts.

show abstract

Section: Discussionmentioning

confidence: 99%

Global guidelines trends and controversies in lower limb venous and lymphatic disease

et al. 2019

View full text Add to dashboard Cite

show abstract

“…If early ablation results in lower recurrence risk in addition to reducing the time to healing, then even greater cost-effectiveness may be present over the lifetime of the patient. 74 The economic analysis protocol envisaged a within-trial cost-effectiveness analysis at 1 year and a decision model [for details, see the health economic plan on the project web page: www.journalslibrary.nihr.ac.uk/ programmes/hta/11129197/#/ (accessed 18 April 2019)]. The purpose of the decision model was to extrapolate recurrence rates in order to assess whether or not early ablation might be cost-effective over a patient's lifetime.…”

Section: Costs and Cost-effectivenessmentioning

confidence: 99%

“…Nevertheless, the analysis showed that even if early ablation reduced the rate of recurrence only, and did not have an impact on healing, this strategy would be very cost-effective over a patient's lifetime. 74…”

Section: Costs and Cost-effectivenessmentioning

confidence: 99%

Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT

Gohel

Heatley

Liu

et al. 2019

Health Technol Assess

Self Cite

View full text Add to dashboard Cite

Background Venous ulceration is a common and costly health-care issue worldwide, with poor healing rates greatly affecting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence, but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence; however, the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear. Objectives To determine the clinical effectiveness and cost-effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration. Design A pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial with a health economic evaluation. Setting Secondary care vascular centres in England. Participants Patients aged ≥ 18 years with a venous leg ulcer of between 6 weeks’ and 6 months’ duration and an ankle–brachial pressure index of ≥ 0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux. Interventions Participants were randomised 1 : 1 to either early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed). Main outcome measures The primary outcome measure was time from randomisation to ulcer healing, confirmed by blinded assessment. Secondary outcomes included 24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs). All analyses were performed on an intention-to-treat basis. Results A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation). Baseline characteristics were similar between the two groups. Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68; p = 0.001]. Median time to ulcer healing was 56 (95% CI 49 to 66) days in the early ablation group and 82 (95% CI 69 to 92) days in the deferred ablation group. The ulcer healing rate at 24 weeks was 85.6% in the early ablation group, compared with 76.3% in the deferred ablation group. Median ulcer-free time was 306 [interquartile range (IQR) 240–328] days in the early ablation group and 278 (IQR 175–324) days in the deferred endovenous ablation group (p = 0.002). The most common complications of superficial endovenous ablation were pain and deep-vein thrombosis. Differences in repeated measures of Aberdeen Varicose Vein Questionnaire scores (p < 0.001), EuroQol-5 Dimensions index values (p = 0.03) and Short Form questionnaire-36 items body pain (p = 0.05) over the follow-up period were observed, in favour of early ablation. The mean difference in total costs between the early ablation and deferred ablation groups was £163 [standard error (SE) £318; p = 0.607]; however, there was a substantial and statistically significant gain in QALY over 1 year [mean difference between groups 0.041 (SE 0.017) QALYs; p = 0.017]. The incremental cost-effectiveness ratio of early ablation at 1 year was £3976 per QALY, with a high probability (89%) of being more cost-effective than deferred ablation at conventional UK decision-making thresholds (currently £20,000 per QALY). Sensitivity analyses using alternative statistical models give qualitatively similar results. Limitations Only 7% of screened patients were recruited, treatment regimens varied significantly and technical success was assessed only in the early ablation group. Conclusions Early endovenous ablation of superficial venous reflux, in addition to compression therapy and wound dressings, reduces the time to healing of venous leg ulcers, increases ulcer-free time and is highly likely to be cost-effective. Future work Longer-term follow-up is ongoing and will determine if early ablation will affect recurrence rates in the medium and long term. Trial registration Current Controlled Trials ISRCTN02335796. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 24. See the NIHR Journals Library website for further project information.

show abstract

“…Evidence from other randomized trials suggests that surgical intervention for superficial reflux reduces recurrence, compared with compression therapy alone. If early endovenous ablation can impact on both healing and recurrence, it could be even more cost‐effective over the patient's lifetime. In the EVRA study, there were insufficient recurrences over 1 year to permit meaningful comparison.…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration

Epstein

Gohel

Heatley

et al. 2019

British Journal of Surgery

Self Cite

View full text Add to dashboard Cite

Background: Treatment of superficial venous reflux in addition to compression therapy accelerates venous leg ulcer healing and reduces ulcer recurrence. The aim of this study was to evaluate the costs and cost-effectiveness of early versus delayed endovenous treatment of patients with venous leg ulcers.Methods: This was a within-trial cost-utility analysis with a 1-year time horizon using data from the EVRA (Early Venous Reflux Ablation) trial. The study compared early versus deferred endovenous ablation for superficial venous truncal reflux in patients with a venous leg ulcer. The outcome measure was the cost per quality-adjusted life-year (QALY) over 1 year. Sensitivity analyses were conducted with alternative methods of handling missing data, alternative preference weights for health-related quality of life, and per protocol.Results: After early intervention, the mean(s.e.m.) cost was higher (difference in cost per patient £163(318) (€184(358))) and early intervention was associated with more QALYs at 1 year (mean(s.e.m.) difference 0⋅041(0⋅017)). The incremental cost-effectiveness ratio (ICER) was £3976 (€4482) per QALY. There was an 89 per cent probability that early venous intervention is cost-effective at a threshold of £20 000 (€22 546)/QALY. Sensitivity analyses produced similar results, confirming that early treatment of superficial reflux is highly likely to be cost-effective.Conclusion: Early treatment of superficial reflux is highly likely to be cost-effective in patients with venous leg ulcers over 1 year. Registration number: ISRCTN02335796 (http://www.isrctn.com). * The full list of EVRA trial investigators can be found under the heading Collaborators

show abstract

Cost‐effectiveness of treatments for superficial venous reflux in patients with chronic venous ulceration

Cited by 12 publications

References 28 publications

Global guidelines trends and controversies in lower limb venous and lymphatic disease

Global guidelines trends and controversies in lower limb venous and lymphatic disease

Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT

Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration

Contact Info

Product

Resources

About