Endovenous Laser Treatment for Varicose Veins in Patients with Active Ulcers

Viarengo, Luiz Marcelo Aiello; Potério-Filho, João; Potério, Glória Maria Braga; Menezes, Fábio Hüsemann; Meirelles, Guilherme Vieira

doi:10.1097/00042728-200710000-00014

Cited by 2 publications

(2 citation statements)

References 10 publications

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“…29 Despite the widespread acceptance of endovenous modalities, few published prospective studies have reported outcomes in patients with leg ulcers. The Cochrane systematic review did not identify any eligible RCTs; 30 another systematic review 31 identified one RCT 32 and, although this trial did not meet the quality criteria for inclusion in the Cochrane review, it found that endovenous thermal ablation significantly increased the probability of ulcer healing compared with compression alone [risk ratio 3.40, 95% confidence interval (CI) 1.65 to 6.98]. One retrospective cohort study of 170 patients with active or healed leg ulceration (195 legs) treated with EVLA achieved excellent healing rates and low recurrence rates of 16%, as did another study of 173 legs, which noted that ulcer healing and recurrence rates were similar to those seen with surgical stripping.…”

Section: Other Relevant Researchmentioning

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

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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.

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Section: Other Relevant Researchmentioning

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

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“…Therefore, during the ablation process, it is necessary to administrate energy capable of generating elevated temperatures to effectively close the venous segment being treated. 12,13 Some factors that may have influenced our high occlusion rate were: all patients were subjected to tumescence of the vein to be treated; all were in the Trendelenburg position; and a 600 micron radial fiber was used. The larger the diameter of the fiber, the higher the final temperature reached and the better the distribution and conduction of heat to the wall of the vein.…”

Section: Discussionmentioning

confidence: 99%

Resultados do tratamento do refluxo de veias safenas com endolaser 1.470 nm e correlação com o grau de insuficiência venosa

et al. 2021

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Resumo Contexto Pacientes com doença venosa crônica avançada são mais propensos a exigir outros procedimentos para recidiva de veias varicosas. Ainda não está estabelecido se a gravidade da insuficiência venosa é um fator que influencia a taxa de oclusão de veias safenas tratadas por endolaser. Objetivos Analisar a taxa de oclusão dos segmentos venosos tratados com endolaser e correlacionar com o Venous Clinical Severity Score (VCSS) e a classificação Clínica-Etiológica-Anatômica-Patológica (CEAP) dos pacientes. Métodos Análise retrospectiva de coorte de pacientes operados com endolaser 1.470 nm entre novembro/2012 a março/2020. Foram realizadas estatística descritiva e curva de sobrevida de Kaplan-Meier com regressão de Cox para grupos de VCSS e CEAP. Resultados Foram analisados 170 pacientes e 180 segmentos venosos; a idade média foi de 44,3 ± 9,2, sendo a maioria do sexo feminino (71%). A densidade de energia média utilizada na veia safena magna foi 49,2 ± 8,3 J/cm. As principais complicações foram dor no trajeto da safena (12,2%) e parestesias após 6 meses (17,2%). Não houve diferença na taxa de oclusão venosa entre grupos com VCSS ≤ 7 e VCSS > 7 (p = 0,067). O grupo de pacientes com CEAP agrupada C4-C5-C6 teve taxa de oclusão menor em relação ao grupo C2-C3 [hazard ratio (HR) = 3,22; intervalo de confiança (IC) 1,85, 5,61; p = 0,001]. Conclusões As taxas de oclusão de segmentos venosos tratados com endolaser foram menores na presença de classificações CEAP avançadas. Nesses pacientes, provavelmente deve-se despender mais energia para o tratamento eficaz das safenas.

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Endovenous Laser Treatment for Varicose Veins in Patients with Active Ulcers

Cited by 2 publications

References 10 publications

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

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

Resultados do tratamento do refluxo de veias safenas com endolaser 1.470 nm e correlação com o grau de insuficiência venosa

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