RHEOLYTIC THROMBECTOMY WITH USE OF THE ANGIOJET-F1O5 CATHETER - PRECLINICAL EVALUATION OF SAFETY

PURPOSE: A preclinical evaluation of the safety of the AngioJet-F105 r heolytic thrombectomy catheter. MATERIALS AND METHODS: The AngioJet-F1 05 catheter uses multiple retrograde high-speed fluid jets impinging o n a primary aspiration lumen to create a hydrodynamic recirculation vo rtex that traps and fragments adjacent thrombus, with simultaneous eva cuation of the resulting debris through the aspiration lumen, The effe ct of the AngioJet on treated vessels was evaluated in 10 canines, Vas cular integrity on histopathologic examination and endothelial coverag e on scanning electron microscopic study were examined in 15 vessel se gments treated with the AngioJet-F105 catheter, compared with four ves sel segments subjected to the Fogarty balloon maneuver, and 10 untreat ed vessel segments, The size distribution of particulate debris, upstr eam and downstream, after thrombectomy was determined in a flow-circui t model simulating the superficial femoral artery, Aliquots from the d ownstream effluent were then injected into the renal arteries of two h ealthy canines. RESULTS: The device caused only minimal focal endothel ial denudation and no significant deep injury, No significant differen ce in endothelial coverage occurred in AngioJet-treated vessel segment s compared to untreated control vessels (mean +/- standard deviation: 88.0% +/- 7.9% vs 89.7% +/- 11.6%, P = .77), Vessels treated with the Fogarty balloon pullback maneuver had significantly less residual endo thelial coverage (58.0% +/- 8.0%, P < .03), Particulate microemboli in the effluent of the flow model accounted for 12% of the initial throm bus volume (0% > 100 mu m, 99.83% less than or equal to 10 mu m). Hist opathologic evaluation of the four renal beds injected with the result ing debris demonstrated no signs of necrosis, A moderate transient inc rease in plasma-free hemoglobin occurred, with a mild corresponding de crease in hematocrit. CONCLUSIONS: The AngioJet-F105 catheter resulted in only mild and focal injury to the treated vessels, The vast majori ty of resulting particulate debris consist of microscopic particles, w ithout significant ischemic effect.