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

医学 氰基丙烯酸酯 外科 静脉曲张 闭塞 大隐静脉 临床终点 胶水 复式(建筑) 隐静脉 静脉 烧蚀 血管疾病 回顾性队列研究 双工扫描 前瞻性队列研究 压力袜 结束语(心理学) 双重超声检查 随机对照试验
作者
Michał-Goran Stanišić
出处
期刊:Phlebology [SAGE Publishing]
卷期号:: 2683555261492365-2683555261492365
标识
DOI:10.1177/02683555261492365
摘要

Objectives To 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. Methods Retrospective 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. Results A 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. Conclusions CAG 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.
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