颈动脉支架置入术远端保护装置的体外性能评估：生理解剖结构对血管阻力的影响
In vitro performance assessment of distal protection devices for carotid artery stenting: effect of physiological anatomy on vascular resistance.
作者信息
Siewiorek Gail M, Wholey Mark H, Finol Ender A
机构信息
Biomedical Engineering Department, Carnegie Mellon University, Pittsburgh, Pennsylvania 15213, USA.
出版信息
J Endovasc Ther. 2007 Oct;14(5):712-24. doi: 10.1177/152660280701400517.
PURPOSE
To assess in vitro the performance of 5 distal protection devices (DPDs) by evaluating the capture efficiency, pressure gradient, volume flow rate, and vascular resistance in the internal carotid artery (ICA).
METHODS
The time-averaged mean peak velocity in the common carotid artery and a blood-mimicking solution were used to simulate physiologICAl conditions in a silicone carotid phantom representing average human carotid artery geometry with a 70% symmetrICAl ICA stenosis. Five milligrams of dyed 200-microm nominal diameter polymer microspheres (larger than the pore size of the devices, except Spider RX, which was tested with 300-microm-diameter particles) were injected into the ICA. The percentages of particles missed after injection and lost during device retrieval were measured for the 5 devices (Spider RX, FilterWire EZ, RX Accunet, Angioguard XP, and Emboshield). The normalized pressure gradient, fraction of the volume flow rate, and vascular resistance in the ICA were calculated.
RESULTS
Spider RX captured the most particles (missing 0.06%, p<0.05) and yielded the smallest normalized pressure gradient increase (4.2%), the largest volume flow rate fraction (0.40), and the smallest vascular resistance in the ICA (272 mmHg/L x min(-1), a 5.4% increase with respect to initial conditions). Angioguard XP captured the fewest particles (missing 36.3%, p<0.05 except Emboshield) and resulted in the largest normalized pressure gradient increase (37%) in the ICA. RX Accunet produced the smallest volume flow rate fraction in the ICA (0.30) and the largest vascular resistance in the ICA (470 mmHg/ L x min(-1), an 82.2% increase). Emboshield migrated approximately 6 cm distal to the original position after particle injection. FilterWire EZ lost the fewest particles during retrieval (0.45%, p<0.05 except Accunet RX and Spider RX) and had the best overall performance with 200-microm emboli (p<0.05 except Accunet RX).
CONCLUSION
None of the devices tested completely prevented embolization. Overall, Spider RX had the best performance and is conjectured to have the best wall apposition of the devices tested. Vascular resistance should be considered a key filter design parameter for performance testing since it represents a quantitative estimation of the "slow-flow phenomenon." Our findings should be extrapolated cautiously to help interventionists choose the best device.
目的
通过评估颈内动脉（ICA）的捕获效率、压力梯度、体积流量和血管阻力，在体外测试5种远端保护装置（DPD）的性能。
方法
使用颈总动脉的时间平均平均峰值速度和模拟血液的溶液，在代表平均人体颈动脉几何形状且有70%对称性ICA狭窄的硅胶颈动脉模型中模拟生理条件。将5毫克染色的标称直径为200微米的聚合物微球（除Spider RX用300微米直径颗粒测试外，微球大于装置的孔径）注入ICA。测量了5种装置（Spider RX、FilterWire EZ、RX Accunet、Angioguard XP和Emboshield）注射后遗漏和装置回收过程中丢失的颗粒百分比。计算了ICA中的标准化压力梯度、体积流量分数和血管阻力。
结果
Spider RX捕获的颗粒最多（遗漏0.06%，p<0.05），标准化压力梯度增加最小（4.2%），体积流量分数最大（0.40），ICA中的血管阻力最小（272 mmHg/L×min⁻¹，相对于初始条件增加5.4%）。Angioguard XP捕获的颗粒最少（遗漏36.3%，除Emboshield外p<0.05），导致ICA中标准化压力梯度增加最大（37%）。RX Accunet在ICA中产生的体积流量分数最小（0.30），ICA中的血管阻力最大（470 mmHg/L×min⁻¹，增加82.2%）。Emboshield在颗粒注射后向远端迁移了约6厘米。FilterWire EZ在回收过程中丢失的颗粒最少（0.45%，除Accunet RX和Spider RX外p<0.05），对于200微米的栓子总体性能最佳（除Accunet RX外p<0.05）。
结论
所测试的装置均未完全防止栓塞。总体而言，Spider RX性能最佳，推测在所测试的装置中其与血管壁贴合最好。血管阻力应被视为性能测试的关键过滤器设计参数，因为它代表了“慢流现象”的定量估计。我们的研究结果应谨慎外推，以帮助介入医生选择最佳装置。
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