Characterization of Alteplase (tPA) Following Delivery Through the AngioJet Rheolytic Catheter.

Purpose: To analyze alteplase solutions following delivery through the AngioJet Xpeedior rheolytic thrombectomy device to characterize the viability of proteins exposed to high shear stress. Methods: Alteplase solutions were prepared by reconstitution in sterile water to obtain a targeted concentration of 1.0 mg/mL. A baseline control sample was obtained. The AngioJet system was modified by occluding the return line to allow collection of the dispersed fluid volume. Alteplase solutions (n = 5) were delivered through the 6-F, 120-cm Xpeedior catheter and collected. Alt samples were assayed and compared to baseline using qualitative visual inspection, ultraviolet spectrophotometry, size exclusion chromatography, and in vitro clot lysis assays. Results: Analysis of the test solutions demonstrated a mean protein recovery of 98.0%±3.5% of targeted concentration; the collected protein was fully active, as determined by clot lysis assays (specific activity ≥100%). All samples were clear and colorless. No significant fragmentation or aggregation of protein was observed. Conclusions: Alteplase solutions, when delivered through the AngioJet Xpeedior rheolytic thrombectomy device, remain stable and biologically active in vitro. Further clinical investigation is warranted using this method as a novel approach for pharmacomechanical thrombolysis. [ABSTRACT FROM AUTHOR]