New Optional IVC Filter for Percutaneous Retrieval - In Vitro Evaluation of Embolus Capturing Efficiency

Abstract

In-vitro evaluation of a new caval filter (Cook Celect Filter) developed for delayed percutaneous retrieval in comparison to the Gunther Tulip filter. The new Celect filter is constructed on the basis of the Tulip filter and consists of 4 primary anchoring legs and additional 8 thinner secondary wires to stabilize the filter and to guarantee adequate filtering efficiency. The filtering wires are of the same amount and equal distribution as the filtering wires of the Tulip filter. The secondary wires are arranged in such a way that percutaneous filter retrieval should be possible even if the wires are incorporated into the caval wall. In a flow model (tube size ø15-, ø22- and ø30 mm), the filter was exposed to single and multiple emboli (blood clots) of different sizes (3 x 5, 3 x 10, 5 x 10, 3 x 20, 5 x 20, 7 x 10, 7 x 20 to 10 x 24 mm) to analyse the embolus capturing efficiency under different conditions including eccentric and concentric, horizontal and vertical positions in comparison to the Tulip filter. All testing was carried out in SPSS analytic software; statistical significance was assumed for p-values < 0.05. The in-vitro embolus capturing efficiency of the Celect filter proved to be equivalent to the Tulip filter. In the single-embolus test, 91.6 % of the clots were captured by the Celect filter and 87.2 % by the Tulip filter (p = 0.042). Large clots ranging from 7 x 10 to 10 x 24 mm were captured in all cases, whereas the capture rates for the 3 x 5-mm and 3 x 10-mm clots were lower. The filters captured significantly more clots in the concentric than in the eccentric location. There was no significant difference between the overall capture rates of the two filters in the multi-clot test (72.2 % vs. 75.1 %), which showed deterioration of filter function during multiple clot exposure. With the 15-mm tube, the Celect filter had a significantly higher capture rate than the Tulip filter, whereas it was lower with the ø30-mm tube. There was no significant difference between the filters in a ø22-mm tube. The pressure gradient across the filters when exposed to blood clots ranged from 4.9 - 7.4 mm Hg for the Celect filter and 5.7 - 6.8 mm Hg for the Tulip filter in the single-embolus testing. There was no significant difference in the multi-clot tests. The new Celect filter showed similar in-vitro capture properties as the Gunther Tulip filter and deserves further in-vivo testing.