Müller-Hülsbeck Stefan, Schäfer Philipp J, Charalambous Nikolas, Schaffner Silvio R, Heller Martin, Jahnke Thomas
Department of Diagnostic and Interventional Radiology / Neuroradiology, Academic Hospitals Flensburg, Germany.
J Endovasc Ther. 2009 Apr;16(2):168-77. doi: 10.1583/08-2539.1.
To examine and compare different carotid stent designs with regard to flexibility, adaptability (adjustability), conformability (compliance) to the vessel, and scaffolding to reduce plaque prolapse and embolization.
Six stents of different design were compared (Precise, Acculink, Protégé, Xact, Wallstent, and Cristallo Ideale). Optical microscopy was used to determine exact dimensions and scaffolding of each stent. Radial force was tested using a parallel plate setup, and flexibility (torsion and bending) was measured in water at body temperature. Particle penetration simulation was performed using plastic spheres from 1.5- to 6.0-mm outer diameter.
Stent dimensions met the manufacturers' data; none of the products showed any failure during the test program. Cell sizes in the middle part of the stents ranged from 1.36 mm(2) (Wallstent) to 15.10 mm(2) (Acculink). Bending forces at 20 degrees /30 degrees ranged from 0.063 N / 0.074 N (Cristallo Ideale) to 0.890 N / 0.616 N (Xact); forces to achieve torsion at 10 degrees /15 degrees ranged from 0.032 N / 0.043 N (Acculink) to 0.905 N / 1.071 N (Xact). According to the parallel plate method, mean lowest force was measured for Xact (0.765 N), while the Wallstent had the highest force (2.136 N). Mean radial force measurements were lowest for Cristallo Ideale (9.06 N at mid part) and highest for Protégé (24.09 N). The Cristallo Ideale stent at mid part resisted penetration by all but the smallest plastic spheres (1.5-mm spheres penetrated only at 0.65 N); the Precise and Protégé stent had the highest variation in sphere penetration (1.5- to 4.0-mm spheres). Only the Acculink let 6-mm spheres penetrate.
Despite comparable stent sizes, these carotid stents showed differences in behavior due to stent design. The open-cell design displayed the greatest flexibility and adaptability to the vessel but easily allowed particle penetration due to the open structure. Closed-cell designs had low flexibility and thus low adaptability to the vessel but high resistance to particle penetration due to the closed-cell design and high scaffolding. The hybrid stent design (Cristallo Ideale) was able to combine both the flexibility of an open-cell structure and the resistance to particle penetration of closed-cell structures.
研究并比较不同颈动脉支架设计在柔韧性、适应性(可调节性)、对血管的顺应性以及减少斑块脱垂和栓塞的支架结构方面的差异。
比较六种不同设计的支架(Precise、Acculink、Protégé、Xact、Wallstent和Cristallo Ideale)。使用光学显微镜确定每个支架的精确尺寸和支架结构。使用平行板装置测试径向力,并在体温的水中测量柔韧性(扭转和弯曲)。使用外径为1.5至6.0毫米的塑料球进行颗粒穿透模拟。
支架尺寸符合制造商的数据;在测试过程中,没有任何产品出现故障。支架中部的网孔尺寸范围从1.36平方毫米(Wallstent)到15.10平方毫米(Acculink)。20度/30度时的弯曲力范围从0.063牛/0.074牛(Cristallo Ideale)到0.890牛/0.616牛(Xact);10度/15度时实现扭转的力范围从0.032牛/0.043牛(Acculink)到0.905牛/1.071牛(Xact)。根据平行板法,Xact的平均最低力为0.765牛,而Wallstent的力最高(2.136牛)。Cristallo Ideale的平均径向力测量值最低(中部为9.06牛),Protégé的最高(24.09牛)。Cristallo Ideale支架中部除最小的塑料球外(1.5毫米的球仅在0.65牛时穿透)能抵抗所有颗粒穿透;Precise和Protégé支架在球穿透方面变化最大(1.5至4.0毫米的球)。只有Acculink能让6毫米的球穿透。
尽管支架尺寸相当,但这些颈动脉支架由于设计不同而表现出差异。开放式网孔设计表现出最大的柔韧性和对血管的适应性,但由于开放结构容易导致颗粒穿透。封闭式网孔设计柔韧性低,因此对血管的适应性低,但由于封闭式网孔设计和高支架结构对颗粒穿透具有高抵抗力。混合支架设计(Cristallo Ideale)能够将开放式网孔结构的柔韧性和封闭式网孔结构对颗粒穿透的抵抗力结合起来。