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用于经皮取出的新型可选下腔静脉滤器——栓子捕获效率的体外评估

New optional IVC filter for percutaneous retrieval--in vitro evaluation of embolus capturing efficiency.

作者信息

Günther R W, Neuerburg J, Mossdorf A, Pfeffer J, Høj A R, Mølgaard-Nielsen A, Bücker A, Schmitz-Rode T

机构信息

Klinik für Radiologische Diagnostik, Universitätsklinikum Aachen.

出版信息

Rofo. 2005 May;177(5):632-6. doi: 10.1055/s-2005-858109.

Abstract

PURPOSE

In-vitro evaluation of a new caval filter (Cook Celect Filter) developed for delayed percutaneous retrieval in comparison to the Gunther Tulip filter.

MATERIALS AND METHODS

The new Celect filter is constructed on the basis of the Tulip filter and consists of 4 primary anchoring legs and additional 8 thinner secondary wires to stabilize the filter and to guarantee adequate filtering efficiency. The filtering wires are of the same amount and equal distribution as the filtering wires of the Tulip filter. The secondary wires are arranged in such a way that percutaneous filter retrieval should be possible even if the wires are incorporated into the caval wall. In a flow model (tube size ø15-, ø22- and ø30 mm), the filter was exposed to single and multiple emboli (blood clots) of different sizes (3 x 5, 3 x 10, 5 x 10, 3 x 20, 5 x 20, 7 x 10, 7 x 20 to 10 x 24 mm) to analyse the embolus capturing efficiency under different conditions including eccentric and concentric, horizontal and vertical positions in comparison to the Tulip filter. All testing was carried out in SPSS analytic software; statistical significance was assumed for p-values < 0.05.

RESULTS

The in-vitro embolus capturing efficiency of the Celect filter proved to be equivalent to the Tulip filter. In the single-embolus test, 91.6 % of the clots were captured by the Celect filter and 87.2 % by the Tulip filter (p = 0.042). Large clots ranging from 7 x 10 to 10 x 24 mm were captured in all cases, whereas the capture rates for the 3 x 5-mm and 3 x 10-mm clots were lower. The filters captured significantly more clots in the concentric than in the eccentric location. There was no significant difference between the overall capture rates of the two filters in the multi-clot test (72.2 % vs. 75.1 %), which showed deterioration of filter function during multiple clot exposure. With the 15-mm tube, the Celect filter had a significantly higher capture rate than the Tulip filter, whereas it was lower with the ø30-mm tube. There was no significant difference between the filters in a ø22-mm tube. The pressure gradient across the filters when exposed to blood clots ranged from 4.9 - 7.4 mm Hg for the Celect filter and 5.7 - 6.8 mm Hg for the Tulip filter in the single-embolus testing. There was no significant difference in the multi-clot tests.

CONCLUSION

The new Celect filter showed similar in-vitro capture properties as the Gunther Tulip filter and deserves further in-vivo testing.

摘要

目的

对一种新开发的用于延迟经皮取出的腔静脉滤器(库克Celect滤器)与冈瑟郁金香滤器进行体外评估。

材料与方法

新型Celect滤器基于郁金香滤器构建,由4根主要锚固腿和另外8根较细的辅助金属丝组成,以稳定滤器并确保足够的过滤效率。过滤金属丝的数量和分布与郁金香滤器的过滤金属丝相同。辅助金属丝的排列方式使得即使金属丝嵌入腔静脉壁,经皮取出滤器也应是可行的。在流动模型(管径分别为ø15 -、ø22 -和ø30 mm)中,将滤器暴露于不同大小(3×5、3×10、5×10、3×20、5×20、7×10、7×20至10×24 mm)的单个和多个栓子(血凝块),以分析与郁金香滤器相比在不同条件下(包括偏心和同心、水平和垂直位置)栓子捕获效率。所有测试均在SPSS分析软件中进行;p值<0.05时认为具有统计学意义。

结果

Celect滤器的体外栓子捕获效率被证明与郁金香滤器相当。在单栓子测试中,Celect滤器捕获了91.6%的凝块,郁金香滤器捕获了87.2%(p = 0.042)。所有情况下均捕获了大小从7×10至10×24 mm的大凝块,而对于3×5 - mm和3×10 - mm的凝块捕获率较低。滤器在同心位置捕获的凝块明显多于偏心位置。在多栓子测试中,两种滤器的总体捕获率之间无显著差异(72.2%对75.1%),这表明在多次凝块暴露期间滤器功能有所下降。对于15 - mm的管,Celect滤器的捕获率明显高于郁金香滤器,而对于ø30 - mm的管则较低。在ø22 - mm的管中,两种滤器之间无显著差异。在单栓子测试中,当暴露于血凝块时,Celect滤器两端的压力梯度为4.9 - 7.4 mmHg,郁金香滤器为5.7 - 6.8 mmHg。在多栓子测试中无显著差异。

结论

新型Celect滤器在体外显示出与冈瑟郁金香滤器相似的捕获特性,值得进一步进行体内测试。

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