Abstract

To evaluate the size and quantity of downstream emboli after thrombectomy using the Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) with or without temporary filtration for extensive iliofemoral and iliocaval thrombi in an in vitro flow model. Iliocaval thrombi were simulated by clotted bovine blood in a flow model (semilucent silicone tubings, diameter 12-16 mm). Five experimental set-ups were performed 10 times each; thrombus particles and distribution were measured in the effluent. First, after retrograde insertion, mechanical thrombectomy was performed using the PTD alone. Then a modified self-expanding tulip-shaped temporary vena cava stent filter was inserted additionally at the beginning of each declotting procedure and removed immediately after the intervention without any manipulation within or at the filter itself. In a third step, the filter was filled with thrombus only. Here, two experiments were performed: Careful closure within the flow circuit without any additional fragmentation procedure and running the PTD within the filter lumen, respectively. In the final set-up, mechanical thrombectomy was performed within the thrombus-filled tubing as well as in the filter lumen. The latter was closed at the end of the procedure and both devices were removed from the flow circuit. Running the PTD in the flow circuit without filter protection led to a fragmentation of 67.9% (+/-7.14%) of the clot into particles < or =500 microm; restoration of flow was established in all cases. Additional placement of the filter safely allowed maceration of 82.9% (+/-5.59%) of the thrombus. Controlled closure of the thrombus-filled filter within the flow circuit without additional mechanical treatment broke up 75.2% (+/-10.49%), while additional mechanical thrombectomy by running the PTD within the occluded filter led to dissolution of 90.4% (+/-3.99%) of the initial clot. In the final set-up, an overall fragmentation rate of 99.6% (+/-0.44%) was achieved. The combined use of the Arrow-Trerotola PTD and a temporary vena cava stent filter proved to be effective for even large clot removal in this experimental set-up.

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