In vitro effectiveness of mechanical thrombectomy devices for large vessel diameter and low-pressure fluid dynamic applications.
Academic Article
Overview
abstract
PURPOSE: To determine in vitro the efficacy of clot removal of the AngioJet (AJ; new 6-F generation), Hydrolyser (HL; 6-F), and Oasis (OS; 6-F) hydrodynamic thrombectomy devices and the Amplatz Thrombectomy Device fragmentation catheter (ATD; 8-F and new-generation 7-F) in large-diameter vessels and low-pressure fluid dynamic applications (ie, pulmonary embolism). MATERIALS AND METHODS: Thrombectomy of clots (N = 60; n = 12 for each tested device) created from 5-day-old porcine blood (16 g) was performed with the AJ (with coaxial 0.035-inch guide wire), HL, OS, and ATD in a bench-top model simulating low-pressure fluid dynamics (pulsed flow, 1,250 L/min). Tubes made of silicone (20-mm inner diameter) containing thrombus simulated a large-diameter vessel. The effluent was passed through a three-step filter system (10-1,000 micro m; pressure drop, 15 mm Hg). RESULTS: Mean thrombectomy time ranged from 83 seconds (7-F ATD) to 185 seconds (OS; P <.0001 compared to all). Remaining thrombus ranged from 5.4 g/32.7% (AJ) to 11.1 g/68.1% (HL; P <.001 compared to all). The AJ's fluid balance was 0.92, whereas the mean ratio of applied saline solution to aspirated fluid for the other devices were significantly different than isovolumetric conditions (HL, 0.64; OS, 0.59; P <.0001 compared to AJ). The AJ (0.36%), HL (0.43%), and OS (0.38%) caused the least overall emboli larger than 10 micro m; the ATD (7-F, 0.82%; 8-F, 0.74%) caused the most (P <.001 for both). CONCLUSIONS: The tested mechanical thrombectomy devices showed performance differences in thrombectomy time, efficacy of thrombus removal, and peripheral embolization rates. Based on low embolization rates for all devices tested, the experimental data indicate that the 7-F ATD and the 0.035-inch guide-wire-compatible AJ showed feasibility advantages for thrombectomy in large vessel diameter and low-pressure fluid dynamic applications.
