Abstract

Purpose A previous meta-analysis has conducted nonrandomized trials for mechanochemical ablation (MOCA). Since medium-term follow-up data from randomized clinical trials (RCTs) are becoming available, we chose to perform a meta-analysis of RCTs to assess the efficacy and safety of MOCA for saphenous vein insufficiency. Methods A systematic search of all RCTs comparing the anatomical success of MOCA for saphenous vein insufficiency to thermal ablation was performed using the PubMed and Cochrane Library databases. We employed the Mantel-Haenszel random-effects meta-analysis of outcomes using RevMan 5.3. Results Four studies (615 patients) were included in this meta-analysis. The MOCA group had 93.4% and 84.5%, whereas the thermal ablation group had 95.8% and 94.8% of anatomical success rate at 1 month (short-term) and a period of more than 6 months but less than 1-year follow-up (mid-term), respectively. According to intention-to-treat analysis, there were similar anatomical successes in MOCA and thermal ablation groups at the short-term follow-up (low-quality evidence; relative risk (RR) = 0.98 (95% CI, 0.94–1.03); P = 0.44; I2 = 53%). The estimated effect of MOCA on anatomical success showed a statistically significant reduction at the mid-term follow-up (moderate-quality evidence; RR = 0.89 (95% CI, 0.84–0.95); P = 0.0002; I2 = 0%). MOCA had fewer incidence of nerve injury, deep vein thrombosis, and skin burns compared to the thermal ablation procedure (low-quality evidence; RR = 0.33 (95% CI, 0.09–1.28); P = 0.11; I2 = 0%). Conclusion MOCA offered fewer major complications but lesser anatomical success at the period of more than 6 months but less than 1-year follow-up than thermal ablation. Trial Registration. This trial is registered with UMIN Clinical Trial Registry (UMIN ID 000036727).

Highlights

  • Saphenous vein insufficiency is the most common chronic venous incompetence of lower limbs

  • All randomized clinical trials (RCTs) comparing the anatomical success of mechanochemical ablation (MOCA) for saphenous vein insufficiency (great saphenous vein (GSV), small saphenous vein (SSV), or both) to the success rate of a thermal ablation procedure were eligible for inclusion in this review

  • According to the meta-analysis using ITT as shown in Table 3, there were similar anatomical successes in the MOCA and thermal ablation groups at the 1-month follow-up

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Summary

Introduction

Saphenous vein insufficiency is the most common chronic venous incompetence of lower limbs. It affects more than 30% of adults [1]. To avoid thermal energy complications, few novel treatments such as sclerotherapy, cyanoacrylate, and mechanochemical ablation (MOCA) have been introduced. The liquid sclerosant causes irreversible damage to the cellular membranes of the endothelium, resulting in the fibrosis of veins [6]. Another technique to produce a nontumescent sclerosantassisted ablation is by means of Flebogrif (Balton, Poland), a device that is scratching the endothelium lining by a dedicated catheter

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