Lang Elvira V, Kulis Anne M, Villani Mario, Barnhart William, Balano Richard, Cohen Robert
OmniSonics Medical Technologies, Wilmington, Massachusetts, USA.
J Vasc Interv Radiol. 2008 Aug;19(8):1215-21. doi: 10.1016/j.jvir.2008.04.007. Epub 2008 Jun 2.
To compare the degree of hemolysis generated during use of the ultrasound-based OmniSonics OmniWave Endovascular System and the Possis AngioJet connected to an Xpeedior-6 catheter.
Twelve 64-145-kg Yorkshire pigs were used as the model because their weight, blood volume, and vessel diameters are comparable to that of adult humans. Six pigs were treated with the OmniWave and six with the AngioJet; half of the pigs in each group were treated in the contralateral iliofemoral arteries and half in the ipsilateral iliofemoral veins. Devices were activated for 10 minutes in patent vessels to represent a worst-case scenario for hemolysis generation. Plasma-free hemoglobin (PfHgb) levels, red blood cell counts, white blood cell (WBC) counts, and platelet counts were measured before and after the procedure, and PfHgb levels were measured every 2 minutes during treatment.
The OmniWave generated significantly lower PfHgb levels than the AngioJet (average, 228 vs 1,367 mg/dL; P < .001). The location of activation (arterial vs venous) had no significant effect (P = .575). Compared with OmniWave use, AngioJet use was associated with significantly greater changes from pre- to posttreatment values in WBCs (P = .002), platelets (P = .004), and creatinine (P = .002). AngioJet use was associated with a significant postprocedure decrease in the WBC count (mean, -8,000/microl; 95% confidence interval [CI]: -3,830, -12,170; P = .004) and platelet count (mean, -72,000; 95% CI: -25,000, -120,000; P = .011). With the OmniWave device there were no significant differences between pre- and posttreatment WBC count (P = .127), platelet count (P = .493), and creatinine level (P = .317).
The OmniWave generated approximately one-sixth of the hemolysis the AngioJet created. In addition, animals treated with the AngioJet exhibited a decrease in WBC and platelet counts.
比较基于超声的OmniSonics OmniWave血管内系统和连接至Xpeedior - 6导管的Possis AngioJet在使用过程中产生的溶血程度。
选用12头体重64 - 145千克的约克夏猪作为模型，因为它们的体重、血容量和血管直径与成年人类相当。6头猪接受OmniWave治疗，6头接受AngioJet治疗；每组中一半猪在对侧髂股动脉进行治疗，另一半在同侧髂股静脉进行治疗。在通畅血管中激活设备10分钟，以代表溶血产生的最坏情况。在手术前后测量无血浆血红蛋白（PfHgb）水平、红细胞计数、白细胞（WBC）计数和血小板计数，并在治疗期间每2分钟测量一次PfHgb水平。
OmniWave产生的PfHgb水平显著低于AngioJet（平均分别为228和1367毫克/分升；P <.001）。激活位置（动脉与静脉）无显著影响（P =.575）。与使用OmniWave相比，使用AngioJet后白细胞（P =.002）、血小板（P =.004）和肌酐（P =.002）的治疗前后值变化显著更大。使用AngioJet与术后白细胞计数显著降低相关（平均为 - 8,000/微升；95%置信区间[CI]： - 3,830， - 12,170；P =.004）和血小板计数（平均为 - 72,000；95%CI： - 25,000， - 120,000；P =.011）。使用OmniWave设备时，治疗前后白细胞计数（P =.127）、血小板计数（P =.493）和肌酐水平（P =.317）无显著差异。
OmniWave产生的溶血约为AngioJet的六分之一。此外，接受AngioJet治疗的动物白细胞和血小板计数降低。
