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经皮腔内血管动静脉瘘的系统评价汇总数据和个体参与者数据荟萃分析。

A systematic review aggregated data and individual participant data meta-analysis of percutaneous endovascular arteriovenous fistula.

机构信息

Department of Vascular Surgery, Aristotle University of Thessaloniki, AHEPA University General Hospital, Thessaloniki, Greece.

Department of Vascular Surgery, Aristotle University of Thessaloniki, AHEPA University General Hospital, Thessaloniki, Greece.

出版信息

J Vasc Surg. 2023 Apr;77(4):1252-1261.e3. doi: 10.1016/j.jvs.2022.10.039. Epub 2022 Oct 31.

Abstract

OBJECTIVE

To assess the short-term and mid-term safety and efficacy of percutaneous endovascular arteriovenous fistula (pAVF) creation.

METHODS

A systematic search was implemented corresponding to the PRISMA 2020 and the PRISMA for individual participant data (IPD) systematic reviews 2015. Aggregated data from the included studies were obtained and meta-analyzed regarding both the overall pAVF efficacy and the comparison of pAVF with surgical AVF (sAVF). We performed a two-stage IPD meta-analysis for studies comparing pAVF and sAVF regarding primary and secondary patency. Primary end points included primary patency, secondary patency, and functional cannulation.

RESULTS

Eighteen studies with 1863 patients were included. The overall pAVF, primary patency, secondary patency, functional cannulation and abandonment rates were 54.01% (95% confidence interval [CI], 40.69-66.79), 87.27% (95% CI, 81.53-91.42), 79.94% (95% CI, 65.94-89.13), and 15.58% (95% CI, 7.77-28.79), respectively. The overall pAVF, technical success, maturation, reintervention per person-years and mean time to maturation rates were 97.08% (95% CI, 95.66-98.04), 82.13% (95% CI, 71.64-89.32), 0.80 (95% CI, 0.34-1.47), and 58 days (95% CI, 36.64-92.82), respectively. Secondary patency and pAVF abandonment rates where the only end points were WavelinQ and Ellipsys displayed statistically significant differences of 81.36% (95% CI, 76.15-85.65) versus 92.12% (95% CI, 87.94-94.93) and 32.54% (95% CI, 22.23-44.87) versus 11.13% (95% CI, 4.82-23.65). An IPD meta-analysis of hazard ratios for primary and secondary patency between pAVF and sAVF were 1.27 (95% CI, 0.61-2.67) and 1.25 (95% CI, 0.87-1.80), favoring sAVF. Statistically significant difference between pAVF and sAVF were solely depicted for steal syndrome relative risk of 5.91 (95% CI, 1.12-31.12) and wound infections relative risk of 4.19 (95% CI, 1.04-16.88). Plotting of pAVF smoothed hazard estimate displayed an upsurge in the probability of primary patency failure at 1 month after the intervention.

CONCLUSIONS

Although we failed to identify statistically significant differences between pAVF and sAVF regarding any of the primary end points, pAVF displayed a decreased risk for steal syndrome and wound infection. Although both the Ellipsys and WavelinQ devices displayed satisfactory secondary patency rates, Ellipsys demonstrated a statistically significant improved rate compared with WavelinQ. Additionally, and despite the borderline statistically insignificant inferior reintervention rate displayed by WavelinQ, one in three WavelinQ pAVFs resulted in abandonment. The introduction of pAVF as a treatment modality calls for standardized definition adjustment and improvement.

摘要

目的

评估经皮腔内血管动静脉瘘(pAVF)创建的短期和中期安全性和有效性。

方法

根据 PRISMA 2020 和 PRISMA 2015 个体参与者数据系统评价进行了系统搜索。获得了纳入研究的汇总数据,并对整体 pAVF 疗效以及 pAVF 与手术动静脉瘘(sAVF)的比较进行了荟萃分析。我们对比较 pAVF 和 sAVF 的研究进行了两阶段个体参与者数据荟萃分析,比较了一级和二级通畅率。主要终点包括一级通畅率、二级通畅率和功能吻合率。

结果

纳入了 18 项研究共 1863 例患者。整体 pAVF、一级通畅率、二级通畅率、功能吻合率和废弃率分别为 54.01%(95%置信区间,40.69-66.79)、87.27%(95%置信区间,81.53-91.42)、79.94%(95%置信区间,65.94-89.13)和 15.58%(95%置信区间,7.77-28.79)。整体 pAVF、技术成功率、成熟度、每人每年再干预率和平均成熟时间率分别为 97.08%(95%置信区间,95.66-98.04)、82.13%(95%置信区间,71.64-89.32)、0.80(95%置信区间,0.34-1.47)和 58 天(95%置信区间,36.64-92.82)。次级通畅率和 pAVF 废弃率是唯一的终点,WavelinQ 和 Ellipsys 的二次通畅率分别为 81.36%(95%置信区间,76.15-85.65)和 92.12%(95%置信区间,87.94-94.93),废弃率分别为 32.54%(95%置信区间,22.23-44.87)和 11.13%(95%置信区间,4.82-23.65),差异具有统计学意义。pAVF 和 sAVF 的一级和二级通畅率的危险比的个体参与者数据荟萃分析结果分别为 1.27(95%置信区间,0.61-2.67)和 1.25(95%置信区间,0.87-1.80),支持 sAVF。pAVF 和 sAVF 之间仅在盗血综合征相对风险 5.91(95%置信区间,1.12-31.12)和伤口感染相对风险 4.19(95%置信区间,1.04-16.88)方面存在统计学差异。pAVF 平滑危险估计图显示,术后 1 个月时一级通畅失败的概率上升。

结论

尽管我们未能在任何主要终点方面确定 pAVF 和 sAVF 之间存在统计学差异,但 pAVF 发生盗血综合征和伤口感染的风险较低。尽管 Ellipsys 和 WavelinQ 设备的二级通畅率均令人满意,但与 WavelinQ 相比,Ellipsys 显示出统计学上显著改善的二级通畅率。此外,尽管 WavelinQ 的再干预率略有统计学意义上的低,但三分之一的 WavelinQ pAVF 被废弃。作为一种治疗方式引入 pAVF 需要调整和改进标准化定义。

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