Evaluation of Local Tissue Reaction After the Application of a 3D Printed Novel Holdfast Device for Left Atrial Appendage Exclusion

Abstract

The left atrial appendage (LAA) is a small, fingerlike extension of the left atrium and its exclusion is used as a treatment strategy to prevent ischemic stroke. Existing holdfast devices may damage the tissue, are unisized and not adjustable. A novel holdfast device for LAA exclusion devoid of these shortcomings was designed and 3D-printed using the Selective Laser Sintering (SLS) technology with polyamide powder and tested it on animal model. We selected the SLS 3D printing technology due to its wid14e availability and low production costs which could provide on-site 3D printing for specific patient. The purpose of this study was to evaluate the biocompatibility of the reported holdfast device and compare the histological results obtained for local tissue reactions to those obtained for an established grafting material. Thirty swine subdivided into two groups were examined. The LAA exclusion device was implanted and was either coated with a polyester vascular implant or not coated at all and the histological response to the device's presence was evaluated which is a standard approach to test the device biocompatibility. In all cases, complete occlusion was seen without any pathological findings during the incubation time. In both groups, the surface of the atrium under a holdfast device was smooth and shiny and had no clots. The foreign body reaction of the LAA holdfast device made of polyamide powder was insignificantly lower compared to the polyester graft. Thus, it fulfils the parameters of biocompatibility at the highest degree, and makes it suitable material for the manufacturing of LAA holdfast devices.

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“…Results showed no clots on the atrium surface, and the foreign body reaction levels were similar to that of a polyester graft. This novel device that was evaluated in the research meets the biocompatibility parameters without any issues; that is, it is a suitable device for stroke prevention (182).…”