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Meta-Analysis
. 2023 Jul 27;7(7):CD009494.
doi: 10.1002/14651858.CD009494.pub3.

Endovenous ablation for venous leg ulcers

Paris L Cai  1 , Louise H Hitchman  1 , Abduraheem H Mohamed  1 , George E Smith  1 , Ian Chetter  1 , Daniel Carradice  1
Affiliations
Meta-Analysis

Endovenous ablation for venous leg ulcers

Paris L Cai et al. Cochrane Database Syst Rev. .

Abstract

Background: Venous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The longstanding mainstay treatment for VLUs is compression therapy. Surgical removal of incompetent veins reduces the risk of ulcer recurrence. However, open surgery is an unpopular option amongst people with VLU, and many people are unsuitable for it. The efficacy of the newer, minimally-invasive endovenous techniques has been established in uncomplicated superficial venous disease, and these techniques can also be used in the management of VLU. When used with compression, endovenous ablation aims to further reduce pressure in the veins of the leg, which may impact ulcer healing.

Objectives: To determine the effects of superficial endovenous ablation on the healing and recurrence of venous leg ulcers and the quality of life of people with venous ulcer disease.

Search methods: In April 2022 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scrutinised reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions on the language of publication, but there was a restriction on publication year from 1998 to April 2022 as superficial endovenous ablation is a comparatively new technology.

Selection criteria: Randomised controlled trials (RCTs) comparing endovenous ablative techniques with compression versus compression therapy alone for the treatment of VLU were eligible for inclusion. Studies needed to have assessed at least one of the following primary review outcomes related to objective measures of ulcer healing such as: proportion of ulcers healed at a given time point; time to complete healing; change in ulcer size; proportion of ulcers recurring over a given time period or at a specific point; or ulcer-free days. Secondary outcomes of interest were patient-reported quality of life, economic data and adverse events.

Data collection and analysis: Two reviewers independently assessed studies for eligibility, extracted data, carried out risk of bias assessment using the Cochrane RoB 1 tool, and assessed GRADE certainty of evidence.

Main results: The previous version of this review found no RCTs meeting the inclusion criteria. In this update, we identified two eligible RCTs and included them in a meta-analysis. There was a total of 506 participants with an active VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5 months ± 96.4 months in the VUERT trial. Both trials randomised participants to endovenous treatment and compression or compression alone, however the compression alone group in the EVRA trial received deferred endovenous treatment (after ulcer healing or from six months). There is high-certainty evidence that combined endovenous ablation and compression compared with compression therapy alone, or compression with deferred endovenous treatment, improves time to complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I2 = 0%; 2 studies, 466 participants). There is moderate-certainty evidence that the proportion of ulcers healed at 90 days is probably higher with combined endovenous ablation and compression compared with compression therapy alone or compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI 1.00 to 1.30; I2 = 0%; 2 studies, 466 participants). There is low-certainty evidence showing an unclear effect on ulcer recurrence at one year in people with healed ulcers with combined endovenous treatment and compression when compared with compression alone or compression with deferred endovenous treatment (RR 0.29, 95% CI 0.03 to 2.48; I2 = 78%; 2 studies, 460 participants). There is also low-certainty evidence that the median number of ulcer-free days at one year may not differ (306 (interquartile range (IQR) 240 to 328) days versus 278 (IQR 175 to 324) days) following combined endovenous treatment and compression when compared with compression and deferred endovenous treatment; (1 study, 450 participants). There is low-certainty evidence of an unclear effect in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I2 = 78%, 2 studies, 506 participants). The addition of endovenous ablation to compression is probably cost-effective at one year (99% probability at GBP 20,000/QALY; 1 study; moderate-certainty evidence).

Authors' conclusions: Endovenous ablation of superficial venous incompetence in combination with compression improves leg ulcer healing when compared with compression alone. This conclusion is based on high-certainty evidence. There is moderate-certainty evidence to suggest that it is probably cost-effective at one year and low certainty evidence of unclear effects on recurrence and complications. Further research is needed to explore the additional benefit of endovenous ablation in ulcers of greater than six months duration and the optimal modality of endovenous ablation.

Trial registration: ClinicalTrials.gov NCT03363633.

PubMed Disclaimer

Conflict of interest statement

Paris L Cai: I work as a health professional.

Louise H Hitchman: I work as a health professional.

Abduraheem H Mohamed: I work as a health professional.

George E Smith: I have received consultancy fees and payments/honoraria for lectures from BSN Medical Inc. (now part of Essity Medical Solutions).

Ian Chetter: I work as a health professional. I have worked as a consultant and developed training materials for the technology companies Angiodynamics and Medtronic, and I have also been a collaborator/co‐author on one of the included trials. I was not involved in extracting data or assessing risk of bias for this trial.

Daniel Carradice: I work as a health professional. I have worked as a consultant and developed training materials for the technology companies Angiodynamics and Medtronic, and I have also been a collaborator/co‐author on one of the included trials. I was not involved in extracting data or assessing risk of bias for this trial.

Figures

1
1
Study flow diagram (PRISMA) for all search results.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
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Figure 4: Forest plot of time to ulcer healing
5
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Figure 5: Forest plot of proportion of ulcers healed at 90 days
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Figure 6: Forest plot of proportion of ulcers healed at one year (NB participants in the compression alone group in Gohel 2018 were offered ablation from 6 months)
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Figure 7: forest plot of ulcer recurrence (NB participants in the compression alone group of Gohel 2018 were offered ablation following ulcer healing)
1.1
1.1. Analysis
Comparison 1: Endovenous ablation and compression vs compression alone for venous leg ulcers, Outcome 1: Ulcer healing
1.2
1.2. Analysis
Comparison 1: Endovenous ablation and compression vs compression alone for venous leg ulcers, Outcome 2: Proportion of ulcers healed at 90 days
1.3
1.3. Analysis
Comparison 1: Endovenous ablation and compression vs compression alone for venous leg ulcers, Outcome 3: Proportion of ulcers healed at one year
1.4
1.4. Analysis
Comparison 1: Endovenous ablation and compression vs compression alone for venous leg ulcers, Outcome 4: Ulcer recurrence
1.5
1.5. Analysis
Comparison 1: Endovenous ablation and compression vs compression alone for venous leg ulcers, Outcome 5: Thromboembolism (complications)
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References

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