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腔静脉滤器插入术和“预防性”使用的趋势。

Trends in vena cava filter insertions and "prophylactic" use.

机构信息

Department of Medical Education, Icahn School of Medicine at Mount Sinai, New York, NY.

Division of Vascular Surgery, Icahn School of Medicine at Mount Sinai, New York, NY.

出版信息

J Vasc Surg Venous Lymphat Disord. 2018 Sep;6(5):592-598.e6. doi: 10.1016/j.jvsv.2018.01.018. Epub 2018 Apr 18.

DOI:10.1016/j.jvsv.2018.01.018
PMID:29678686
Abstract

BACKGROUND

Prophylactic vena cava filter (VCF) use in patients without venous thromboembolism is common practice despite ongoing controversy. Thorough analysis of the evolution of this practice is lacking. We describe trends in VCF use and identify events associated with changes in practice.

METHODS

Using the National Inpatient Sample, we conducted a retrospective observational study of U.S. adult hospitalizations from 2000 to 2014. Trends in prophylactic VCF insertion were analyzed both across the entire study population and within subgroups according to trauma status and type of concurrent surgery. Annual percentage change (APC) was calculated, and trends were analyzed using Poisson regression.

RESULTS

Among 461,904,314 adult inpatients (median [interquartile range] age, 58.1 [38.5-74.3] years; 39.6% male), the incidence of VCF insertion increased rapidly at first (from 0.19% to 0.35%; APC, 11.2%; 95% confidence interval [CI], 10.3%-12.2%; P < .001), then at a slower rate after the publication of the Prévention du Risque d'Embolie Pulmonaire par Interruption Cave 2 (PREPIC2) trial in 2005 (from 0.35% to 0.42%; APC, 4.4%; 95% CI, 2.8%-6.0%; P < .001), and it began decreasing after the 2010 Food and Drug Administration (FDA) safety alert (from 0.42% to 0.32%; APC, -5.5%; 95% CI, -6.5% to -4.6%; P < .001). The percentage of total VCFs that had a prophylactic indication increased quickly before publication of the PREPIC2 trial (APC, 19.5%; 95% CI, 17.9%-21.0%; P < .001), increased at a slower rate after publication in 2005 (APC, 4.4%; 95% CI, 2.6%-6.2%; P < .001), and dropped after the FDA safety alert, stabilizing at 18.5% for the last 3 years (APC, -0.3%; 95% CI, -2.2% to 1.7%; P = .8). Subgroups most associated with prophylactic VCF insertion were operative trauma (odds ratio [OR], 10.9; 95% CI, 10.2-11.7), orthopedic surgery (OR, 4.7; 95% CI, 4.3-5.2), and neurosurgical procedures (OR, 3.9; 95% CI, 3.6-4.2). All groups except orthopedic surgery experienced a deceleration in prophylactic VCF growth after the publication of PREPIC2. Meanwhile, the FDA safety alert was associated with a decrease in prophylactic VCF insertions for all groups except other major surgery.

CONCLUSIONS

Whereas publication of the PREPIC2 trial led to a deceleration in prophylactic VCF insertion growth, the FDA alert had a bigger impact, leading to declining rates of prophylactic VCF use. Further investigations of prophylactic insertion of VCF in trauma, orthopedic, and neurosurgical patients are needed to determine whether current levels of use are justified.

摘要

背景

尽管存在持续的争议,但在没有静脉血栓栓塞症的患者中预防性放置下腔静脉滤器(VCF)的做法仍然很常见。缺乏对此类做法演变的全面分析。我们描述了 VCF 使用的趋势,并确定了与实践变化相关的事件。

方法

使用国家住院患者样本,我们对 2000 年至 2014 年美国成年住院患者进行了回顾性观察性研究。分析了整个研究人群以及根据创伤状态和同时进行的手术类型进行分组的预防性 VCF 插入的趋势。计算了年度百分比变化(APC),并使用泊松回归分析了趋势。

结果

在 461,904,314 名成年住院患者中(中位数[四分位距]年龄为 58.1[38.5-74.3]岁;39.6%为男性),VCF 插入的发生率起初迅速增加(从 0.19%增加到 0.35%;APC,11.2%;95%置信区间[CI],10.3%-12.2%;P<0.001),然后在 2005 年 PREPIC2 试验发表后以较慢的速度增加(从 0.35%增加到 0.42%;APC,4.4%;95%CI,2.8%-6.0%;P<0.001),并且在 2010 年食品和药物管理局(FDA)安全警报后开始减少(从 0.42%减少到 0.32%;APC,-5.5%;95%CI,-6.5%至-4.6%;P<0.001)。具有预防性指征的总 VCF 百分比在 PREPIC2 试验发表前迅速增加(APC,19.5%;95%CI,17.9%-21.0%;P<0.001),发表后以较慢的速度增加(APC,4.4%;95%CI,2.6%-6.2%;P<0.001),并且在 FDA 安全警报后下降,在过去 3 年稳定在 18.5%(APC,-0.3%;95%CI,-2.2%至 1.7%;P=0.8)。与预防性 VCF 插入最相关的亚组是手术创伤(比值比[OR],10.9;95%CI,10.2-11.7)、骨科手术(OR,4.7;95%CI,4.3-5.2)和神经外科手术(OR,3.9;95%CI,3.6-4.2)。除骨科手术外,所有组在 PREPIC2 发表后预防性 VCF 生长速度均减缓。与此同时,FDA 安全警报与除其他大手术外的所有组预防性 VCF 插入量的减少有关。

结论

尽管 PREPIC2 试验的发表导致预防性 VCF 插入生长速度减缓,但 FDA 警报的影响更大,导致预防性 VCF 使用率下降。需要进一步研究创伤、骨科和神经外科患者中预防性 VCF 插入的情况,以确定目前的使用水平是否合理。

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