Sentry Bioconvertible Inferior Vena Cava Filter: Study of Stages of Incorporation in an Experimental Ovine Model

Peter A Gaines, Frank D Kolodgie, Gordon Crowley, Steven Horan, Megan MacDonagh, Emily McLucas, David Rosenthal, Ashley Strong, Michael Sweet, Deepal K Panchal, Peter A Gaines, Frank D Kolodgie, Gordon Crowley, Steven Horan, Megan MacDonagh, Emily McLucas, David Rosenthal, Ashley Strong, Michael Sweet, Deepal K Panchal

Abstract

The Sentry inferior vena cava (IVC) filter is designed to provide temporary protection from pulmonary embolism (PE) and then bioconvert to become incorporated in the vessel wall, leaving a patent IVC lumen. Objective. To evaluate the performance and stages of incorporation of the Sentry IVC filter in an ovine model. Methods. Twenty-four bioconvertible devices and 1 control retrievable filter were implanted in the infrarenal IVC of 25 sheep, with extensive daily monitoring and intensive imaging. Vessels and devices were analyzed at early (≤98 days, n = 10) and late (180 ± 30 days, n = 14 study devices, 1 control) termination and necropsy time-points. Results. Deployment success was 100% with all devices confirmed in filtering configuration, there were no filter-related complications, and bioconversion was 100% at termination with vessels widely patent. By 98 days for all early-incorporation analysis animals, the stabilizing cylindrical part of the Sentry frame was incorporated in the vessel wall, and the filter arms were retracted. By 180 days for all late-incorporation analysis animals, the filter arms as well as frames were stably incorporated. Conclusions. Through 180 days, there were no filter-related complications, and the study devices were all bioconverted and stably incorporated, leaving all IVCs patent.

Figures

Figure 1
Figure 1
Sentry IVC filter in filtering (left) and bioconverted (right) configurations.
Figure 2
Figure 2
Study design.
Figure 3
Figure 3
Representative imaging for an animal from the late-incorporation analysis cohort. Left: venogram of the Sentry IVC filter on the day of implantation. Middle: X-ray of the bioconverted filter. Right: CT reconstruction showing bioconversion of the Sentry IVC filter.
Figure 4
Figure 4
IVC from an animal from the early-incorporation analysis cohort terminated at 97 days. Laparoscopic imaging at necropsy of IVC sections containing the Sentry IVC filter, showing the unobstructed patent lumen and the nearly complete incorporation of the filter frame.
Figure 5
Figure 5
Imaging of the IVC segments with the control OptEase device (terminated at 183 days). Left: preexplant digital photograph of IVC sections with the implanted control OptEase Retrievable Vena Cava Filter. Right: a transverse section stained with toluidine blue/basic fuchsin, demonstrating incorporation of the device into the wall of the IVC.
Figure 6
Figure 6
Representative images of IVC sections with the Sentry IVC filter (terminated at 184 days). Left: preexplant digital photograph of IVC sections with the implanted Sentry device. Middle: laparoscopic image of IVC filter within the IVC, demonstrating lumen patency. Right: transverse section stained with toluidine blue/basic fuchsin, demonstrating incorporation into the wall of the IVC. The green box indicates mild neointimal proliferation.
Figure 7
Figure 7
Representative high-power images from the histological analysis of the integration of the Sentry filter arms into the wall of the IVC. Left: section cut through the tips of the filter arms, stained with H&E. Right: view of residual PPDO filament material, surrounding chronic inflammatory cells adjacent to the fully incorporated tip of a filter arm (dark red box in the image at left).

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Source: PubMed

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