Sharafuddin M J, Hicks M E, Jenson M L, Morris J E, Drasler W J, Wilson G J
Section of Vascular and Interventional Radiology, Mallinckrodt Institute of Radiology, Washington University Medical Center, St. Louis, MO 63110, USA.
J Vasc Interv Radiol. 1997 Nov-Dec;8(6):939-45. doi: 10.1016/s1051-0443(97)70690-0.
A preclinical evaluation of the safety of the AngioJet-F105 rheolytic thrombectomy catheter.
The AngioJet-F105 catheter uses multiple retrograde high-speed fluid jets impinging on a primary aspiration lumen to create a hydrodynamic recirculation vortex that traps and fragments adjacent thrombus, with simultaneous evacuation of the resulting debris through the aspiration lumen. The effect of the AngioJet on treated vessels was evaluated in 10 canines. Vascular integrity on histopathologic examination and endothelial coverage on scanning electron microscopic study were examined in 15 vessel segments treated with the AngioJet-F105 catheter, compared with four vessel segments subjected to the Fogarty balloon maneuver, and 10 untreated vessel segments. The size distribution of particulate debris, upstream and downstream, after thrombectomy was determined in a flow-circuit model simulating the superficial femoral artery. Aliquots from the downstream effluent were then injected into the renal arteries of two healthy canines.
The device caused only minimal focal endothelial denudation and no significant deep injury. No significant difference in endothelial coverage occurred in AngioJet-treated vessel segments compared to untreated control vessels (mean +/- standard deviation: 88.0% +/- 7.9% vs 89.7% +/- 11.6%, P = .77). Vessels treated with the Fogarty balloon pullback maneuver had significantly less residual endothelial coverage (58.0% +/- 8.0%, P < .03). Particulate microemboli in the effluent of the flow model accounted for 12% of the initial thrombus volume (0% > 100 microm, 99.83% < or = 10 microm). Histopathologic evaluation of the four renal beds injected with the resulting debris demonstrated no signs of necrosis. A moderate transient increase in plasma-free hemoglobin occurred, with a mild corresponding decrease in hematocrit.
The AngioJet-F105 catheter resulted in only mild and focal injury to the treated vessels. The vast majority of resulting particulate debris consist of microscopic particles, without significant ischemic effect.
对AngioJet-F105流变血栓切除术导管的安全性进行临床前评估。
AngioJet-F105导管利用多个逆行高速流体射流冲击主吸引腔，形成流体动力再循环涡流，捕获并破碎相邻血栓，同时通过吸引腔排出产生的碎片。在10只犬中评估了AngioJet对治疗血管的影响。对15个用AngioJet-F105导管治疗的血管段进行组织病理学检查的血管完整性和扫描电子显微镜研究的内皮覆盖情况，与4个接受Fogarty球囊操作的血管段和10个未治疗的血管段进行比较。在模拟股浅动脉的流动回路模型中确定血栓切除术后上游和下游颗粒碎片的大小分布。然后将下游流出物的等分试样注入两只健康犬的肾动脉。
该装置仅引起最小程度的局灶性内皮剥脱，无明显深度损伤。与未治疗的对照血管相比，AngioJet治疗的血管段内皮覆盖无显著差异（平均值±标准差：88.0%±7.9%对89.7%±11.6%，P = 0.77）。用Fogarty球囊回撤操作治疗的血管残余内皮覆盖明显较少（58.0%±8.0%，P < 0.03）。流动模型流出物中的颗粒微栓子占初始血栓体积的12%（0%>100微米，99.83%≤10微米）。对注入产生的碎片的四个肾床进行组织病理学评估未发现坏死迹象。血浆游离血红蛋白出现中度短暂升高，血细胞比容相应轻度下降。
AngioJet-F105导管对治疗血管仅造成轻度局灶性损伤。产生的绝大多数颗粒碎片由微观颗粒组成，无明显缺血效应。
