Laboratory investigation
Hemolysis Comparison between the OmniSonics OmniWave Endovascular System and the Possis AngioJet in a Porcine Model

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Purpose

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.

Materials and 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/μl; 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.

Section snippets

Procedure

Procedures were performed after receiving institutional IACUC approval in accordance with Good Laboratory Practices. The native-vessel nonthrombosed pig model was chosen because porcine weight, blood volume, and vessel diameters are comparable to that in adult humans. Twelve female Yorkshire swine with an average weight of 85.5 kg (range, 64.1–145 kg) were studied. Six were treated with the OmniWave device and six with the AngioJet connected to an Xpeedior-6 catheter (Possis). According to a

Baseline Characteristics

At baseline, animals in the OmniWave and AngioJet groups did not differ significantly from each other with regard to weight (P = .099), hematocrit level (P = .358), WBC count (P = .928), and platelet count (P = .250) (Table). Animals in the AngioJet group had a higher average baseline creatinine level (1.85 mg/dL ± 0.22 [163 μmol/L ± 19]) than those in the OmniWave group (1.53 mg/dL ± 0.18 [135 μmol/L ± 16]; P = .021), although all creatinine measurements were within the normal range for pigs

Discussion

The red cell membrane is composed of a metastable lipid bilayer. Shearing forces on the outer membrane can effect a transient opening of pores and, if they exceed a critical point, result in irreversible membrane rupture and lysis (17). Membrane deformation can be brought on by exposure to ultrasonic energy through the shearing forces of shock waves or flow effects from cavitation bubbles (as with the OmniWave) or shear stress from turbulent or steady flow through viscous and inertial fluid

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    From the 2008 SIR annual meeting.

    E.V.L., A.M.K, and R.B. are employees of OmniSonics Medical Technologies.

    W.B. is a consultant for OmniSonics Medical Technologies. M.V. is an employee of DaVinci Biomedical.

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