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

https://doi.org/10.1016/j.jvir.2008.04.007Get rights and content

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

References (32)

  • X. Liu et al.

    Diffusion-limited reaction of free nitric oxide with erythrocytes

    J Biol Chem

    (1998)
  • T.M. Vesely et al.

    Comparison of the AngioJet Rheolytic catheter to surgical thrombectomy for the treatment of thrombosed dialysis grafts

    J Vasc Intervent Radiol

    (1999)
  • J.S. Danetz et al.

    Pancreatitis caused by rheolytic thrombolysis: an unexpected complication

    J Vasc Intervent Radiol

    (2004)
  • C.E. Zimmermann

    Bedside manipulation of the clotted arteriovenous fistula

    Dialysis Transplant

    (1981)
  • M.R. Middlebrook et al.

    Thrombosed hemodialysis grafts: percutaneous mechanical balloon declotting versus thrombolysis

    Radiology

    (1995)
  • B.L. Dolmatch et al.

    Will iatrogenic pulmonary embolization be our pulmonary embarrassment?

    Radiology

    (1994)
  • Cited by (18)

    • Risk factors for acute kidney injury after pharmacomechanical thrombolysis for acute deep vein thrombosis

      2021, Journal of Vascular Surgery: Venous and Lymphatic Disorders
      Citation Excerpt :

      Careful consideration is required to not surpass a total thrombectomy volume of 300 mL in accordance with the instructions for use. Multiple studies have demonstrated hemolysis resulting from AngioJet therapy in animal models.7,8 This intravascular hemolysis results in acute tubular necrosis due to hemoglobinuria and, ultimately, AKI.

    • Comparison of ASPIRE Mechanical Thrombectomy Versus AngioJet Thrombectomy System in a Porcine Iliac Vein Thrombosis Model

      2017, Annals of Vascular Surgery
      Citation Excerpt :

      In this report, we compared the device performance, including thrombectomy efficacy, thrombogenicity, hemolysis, and device-associated pulmonary embolism of the AngioJet thrombectomy system and ASPIRE thrombectomy device using a porcine DVT model. The AngioJet thrombectomy catheter received the Food and Drug Administration (FDA) approval for thrombectomy application in 1999, and its utility has been widely examined in both clinical literature and animal studies.7,11,18 This device requires a console unit to generate a high-velocity fluid stream, which is delivered to the catheter to achieve the thrombectomy functionality.

    • Hemodynamic and Hematologic Effects of Histotripsy of Free-Flowing Blood: Implications for Ultrasound-Mediated Thrombolysis

      2015, Journal of Vascular and Interventional Radiology
      Citation Excerpt :

      A previous study in pigs found peak free hemoglobin of 1,367 mg/dL after 10 minutes of AngioJet therapy (14). After 10 minutes of OmniWave therapy, peak free hemoglobin was 228 mg/dL (14). After 10 minutes of histotripsy in the present study, free hemoglobin was 156 mg/dL ± 58.4 in the surviving animals.

    • Utility of Thrombectomy in Primary Percutaneous Coronary Intervention

      2013, Interventional Cardiology Clinics
      Citation Excerpt :

      Recanalization, defined as TIMI flow 2 to 3 occurred in 89% of patients.49 Currently, FDA-approved for use in thrombotic dialysis shunts, the OmniWave Endovascular System (OmniSonics Medical Technologies, Wilmington, Massachusetts) is a novel system that emits low-energy (20 kHz) ultrasonic waves from the distal 10 cm of a 0.018-in wire, resulting in cavitation of thrombus with no disruption of underlying endothelium.50 This technology may warrant further investigation in certain patient subsets, such as those with high thrombus burden during acute MI, and may one day serve a role adjunctively in acute MI.

    View all citing articles on Scopus

    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.

    View full text