Abstract

The left atrial appendage (LAA) is a small, finger-like 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.

Highlights

  • The left atrial appendage (LAA) is a small, fingerlike extension of the left atrium protruding from its lateral or inferolateral wall with a narrow junction to the venous component of the left atrium (Fig. 1a)

  • The concept of operation for the device was based on the idea that the tubes would press the LAA base, which would lead to its closure and occlude the connection between the LAA and left atrium (Fig. 2)

  • The whole unit was made monolithically using a 3D printing method with Selective Laser Sintering (SLS) technology with polyamide powder PA 2200 (PA 12), which is a biostable polymer that is used in biomedical engineering

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Summary

Introduction

The left atrial appendage (LAA) is a small, fingerlike extension of the left atrium protruding from its lateral or inferolateral wall with a narrow junction to the venous component of the left atrium (Fig. 1a) It is a remnant of the original left atrium, and in contrast to the smooth walled venous component of the left atrium, it is richly trabeculated (Fig. 1b). Patients with atrial fibrillation have a five-fold greater risk for developing ischemic stroke due to formation of blood clots in their LAAs.. Patients with atrial fibrillation have a five-fold greater risk for developing ischemic stroke due to formation of blood clots in their LAAs.30 This may occur incidentally or rapidly (within 6 h of onset of symptoms) in some cases.. Pharmacological treatments pose a risk of major bleeding, including intracranial hemorrhage. antithrombotic therapy is not recommended for some patients and may even be prohibited as a primary treatment modality in some cases. A new approach to solve the abovementioned issues would consist of obliterating the LAA, 0090-6964/20/0100-0133/0 Ó 2019 The Author(s)

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