In vitro evaluation of clot capture efficiency of an absorbable vena cava filter.

In vitro evaluation of clot capture efficiency of an absorbable vena cava filter.
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DOI:
10.1016/j.jvsv.2016.05.006
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发表时间:
2016-10
影响因子:
3.2
通讯作者:
Eggers, Mitchell D.
Eggers, Mitchell D.
中科院分区:
医学2区
文献类型:
--
作者:
Dria, Stephen J.;Eggers, Mitchell D.

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确定试验用可吸收下腔静脉滤器(IVCF)与格林菲尔德IVCF的体外凝块捕获效率(CCE)。试验用可吸收滤器和格林菲尔德滤器使用3×5至10×24 mm(直径)的聚丙烯酰胺(PAM)凝块替代物进行挑战。×长度)。使用凝块挑战过滤器,直至在二项式统计下达到5%或更低的CCE标准误差。测量了最大尺寸凝块的滤器压力梯度,从而能够计算滤器上的力。除3×10 mm凝块外,可吸收IVCF体外CCE与格林菲尔德滤器的所有凝块尺寸在统计学上相似,滤器CCE之间存在统计学显著差异(可吸收滤器:59%,格林菲尔德:31%,p=0.0001)。CCE范围从3×5凝块的平均32%到7×10 mm和更大凝块的100%。可吸收滤器与10×24 mm凝块之间的压力梯度平均为0.14 mmHg,相当于滤器上的净力为2.1×10−3 N,而格林菲尔德滤器为0.39 mmHg或5.8×10−3 N(p<0.001)。对于所有受试凝块尺寸,可吸收滤器的CCE在统计学上与格林菲尔德不锈钢滤器相似或有所改善。本研究中格林菲尔德滤器的CCE与既往研究的数据一致。鉴于格林菲尔德滤器在降低肺栓塞风险方面的有效性,当前研究表明可吸收滤器可能是后续人体试验的可行候选器械。
Determine the in-vitro clot capture efficiency (CCE) of an investigational absorbable inferior vena cava filter (IVCF) versus the Greenfield IVCF. Investigational absorbable and Greenfield filters were challenged with polyacrylamide (PAM) clot surrogates ranging from 3×5 to 10×24 mm (dia. × length) in a flow loop simulating the venous system. Filters were challenged with clots until CCE standard error of 5% or less was achieved under binomial statistics. Pressure gradients across the filters were measured for the largest size clot, enabling calculation of forces on the filter. The absorbable IVCF in-vitro CCE was statistically similar to the Greenfield filter for all clot sizes apart from the 3×10 mm clot, where there was statistically significant difference between filter CCE’s (absorbable filter: 59%, Greenfield: 31%, p=0.0001). CCE ranged from an average 32% for the 3×5 clot to 100% for 7×10 mm and larger clots for the absorbable IVCF. Pressure gradient across the absorbable filter with 10×24 mm clot averaged 0.14 mmHg, corresponding to a net force on the filter of 2.1×10−3 N, compared to 0.39 mmHg or 5.8×10−3 N (p<0.001) for the Greenfield filter. CCE of the absorbable filter was statistically similar to, or an improvement upon, the Greenfield stainless steel filter for all clot sizes tested. CCE of the Greenfield filter in this study aligned with data from previous studies. Given the efficacy of the Greenfield filter in attenuating the risk of pulmonary embolism, the current study suggests the absorbable filter may be a viable candidate for subsequent human testing.
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