Evaluation of a spiral nitinol temporary inferior vena caval filter.

RATIONALE AND OBJECTIVES

The authors performed this study to evaluate the (a) ability of a prototype temporary inferior vena caval (IVC) filter to trap and retain emboli in an ex vivo flow circuit, (b) feasibility of filter placement and removal via a superficial vein in sheep, and (c) intermediate-term effects of the filter on the insertion vein and at the filter site.

MATERIALS AND METHODS

In an iliocaval circuit, embolus capture with the prototype filter was compared to that with a Greenfield filter. In addition, prototype filters were placed into the infrarenal IVC in six sheep. Placement via a superficial venous route was initially attempted. Inferior vena cavography was performed weekly, and filters were removed after 2, 3, or 4 weeks (n = 2 each). Two weeks after the filters were removed, vena cavograms were obtained, the animals were sacrificed, and the IVC was evaluated at pathologic examination.

RESULTS

The prototype filter captured all emboli, and the Greenfield filter captured 70%-100% of emboli. Successful placement via a superficial venous route was accomplished in only two sheep owing to small vein caliber; four filters were placed via a deep vein. Adverse events included perifilter thrombus, insertion site infection, and caudal migration. Two sheep died before filter removal owing to sepsis and anesthetic complications. The filters in the remaining four sheep were easily and successfully removed. Five sheep had stenosis at the filter site, and fibrosis with acute and chronic inflammation was seen at microscopic examination.

CONCLUSION

The prototype filter trapped emboli as well as the Greenfield filter. Insertion via a superficial route, however, is possible only if the access vein is of an adequate size.