Mechanochemical ablation versus cyanoacrylate glue closure for treatment of incompetent saphenous veins in C2-C4 patients: Three-year outcomes of a single-centre, single-operator experience.

IF 1.5
Michał-Goran Stanišić
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Abstract

ObjectivesTo compare anatomical and clinical outcomes of mechanochemical ablation (MOCA; ClariVein®) and cyanoacrylate glue closure (CAG; VenaSeal™) for the treatment of incompetent great saphenous veins (GSV) and small saphenous veins (SSV) in patients classified as CEAP C2-C4, with follow-up to 3 years.MethodsRetrospective analysis of a prospectively maintained single-centre, single-operator database. Allocation to MOCA or CAG followed anatomical suitability and patient preference. Duplex follow-up was at 3 and 8 weeks and 6, 12, 24 and 36 months. The primary endpoint was complete occlusion. The venous segment was the unit of analysis; Kaplan-Meier estimates were compared by log-rank test and proportions by Fisher's exact test.ResultsA total of 214 venous segments were treated with MOCA (196 GSV, 18 SSV) and 161 with CAG (148 GSV, 13 SSV). Cohorts were comparable in vein diameter and segment length; CAG patients were older (median 45 vs 39 years). GSV occlusion at 24 months was 94.4% (95% CI 90.2-96.8) for MOCA and 96.6% (95% CI 92.3-98.5) for CAG (Fisher p = .441; log-rank p = .329). SSV occlusion was 77.8% (95% CI 54.8-91.0) in 18 MOCA segments and 100% (95% CI 77.2-100) in 13 CAG segments (Fisher p = .120; log-rank p = .075); with only 31 SSV segments the estimate is imprecise, and the non-significant result is not evidence of equivalence. Three-year results were identical to 24-month data. Symptom improvement was documented in both groups without obvious deterioration in association with late recanalisation; assessment was qualitative, without a validated instrument.ConclusionsCAG showed numerically higher GSV and SSV occlusion than MOCA at two and 3 years, but no difference reached statistical significance and the cohorts were not randomised. No obvious symptomatic deterioration was documented with late MOCA recanalisation, supporting a clinically led rather than duplex-led re-treatment strategy. Adequately powered randomised trials with 3-year follow-up are required.

机械化学消融与氰基丙烯酸酯胶封闭治疗C2-C4患者不功能隐静脉:单中心、单手术经验的三年结果
目的比较机械化学消融(MOCA; ClariVein®)和氰基丙烯酸酯胶封闭(CAG; VenaSeal™)治疗CEAP C2-C4患者不功能大隐静脉(GSV)和小隐静脉(SSV)的解剖和临床结果,随访3年。方法回顾性分析前瞻性维护的单中心、单操作员数据库。MOCA或CAG的分配遵循解剖适应性和患者偏好。双期随访分别为3周和8周,6、12、24和36个月。主要终点为完全闭塞。静脉段为分析单位;Kaplan-Meier估计值采用log-rank检验,比例采用Fisher精确检验。结果MOCA治疗214个静脉段(196个GSV, 18个SSV), CAG治疗161个(148个GSV, 13个SSV)。各组在静脉直径和管段长度上具有可比性;CAG患者年龄较大(中位年龄为45岁vs 39岁)。MOCA 24个月时GSV闭塞率为94.4% (95% CI 90.2-96.8), CAG为96.6% (95% CI 92.3-98.5) (Fisher p = .441; log-rank p = .329)。18个MOCA节段SSV闭塞率为77.8% (95% CI 54.8-91.0), 13个CAG节段SSV闭塞率为100% (95% CI 77.2-100) (Fisher p = 0.120; log-rank p = 0.075);只有31个SSV段的估计是不精确的,不显著的结果不是等效的证据。3年的结果与24个月的数据相同。两组的症状均有改善,未见与晚期再通相关的明显恶化;评估是定性的,没有经过验证的工具。结论scag在2年和3年的GSV和SSV闭塞程度高于MOCA,但差异无统计学意义,队列未随机化。晚期MOCA再通无明显症状恶化记录,支持临床主导而非双导再治疗策略。需要足够有力的随机试验,随访3年。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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