EVALUATION OF VENOUS INJURY CAUSED BY A PERCUTANEOUS MECHANICAL THROMBOLYTIC DEVICE

Purpose: To study venous injury caused by a prototype percutaneous mec hanical thrombolytic device. Methods: Simulated thrombolysis was perfo rmed using the device, or the Fogarty balloon catheter (FBC) as contro l, in the infrarenal inferior vena cava (IVC) of 40 New Zealand white rabbits. Venous injury was evaluated by cavography, Evans blue dye sta ining, and histology at 0, 1, and 6 weeks postprocedure. Results: Both devices resulted in near complete endothelial denudation acutely. No differences in reendothelialization were noted at any time in the prox imal and mid-IVC, but there was significantly greater reendothelializa tion in the distal IVC in the rabbits treated 6 weeks earlier with the device (p less than or equal to 0.004). Additionally, the inner lumin al diameter at necropsy for the 1-week rabbits treated with the FBC wa s significantly narrower in the distal and middle sections of the IVC when compared with the device (p less than or equal to 0.02 for both s egments). There was no luminal diameter difference at 0 or 6 weeks. Co nclusion: Based on a rabbit model, venous injury from the device was f ound to be similar to, and in the distal IVC less than, the routinely used FBC.