title: Hemolysis comparison between the OmniSonics OmniWave Endovascular System and the Possis AngioJet in a porcine model.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: OmniSonics Medical Technologies, Wilmington, Massachusetts, USA. elang@bidmc.harvard.edu
authors.forename: Elvira V
authors.initials: EV
authors.lastname: Lang
authors.forename: Anne M
authors.initials: AM
authors.lastname: Kulis
authors.forename: Mario
authors.initials: M
authors.lastname: Villani
authors.forename: William
authors.initials: W
authors.lastname: Barnhart
authors.forename: Richard
authors.initials: R
authors.lastname: Balano
authors.forename: Robert
authors.initials: R
authors.lastname: Cohen
mesh_terms: D000818:Animals; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006461:Hemolysis / Q000502:physiology*; D023421:Models, Animal; D013552:Swine; D017131:Thrombectomy / Q000295:instrumentation* / Q000379:methods; D015912:Thrombolytic Therapy / Q000295:instrumentation* / Q000379:methods; D014464:Ultrasonic Therapy / Q000295:instrumentation* / Q000379:methods