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The New 3D Printed Left Atrial Appendage Closure with a Novel Holdfast Device: A Pre-Clinical Feasibility Animal Study
Abstract
Many patients undergoing cardiac surgery have risk factors for both atrial fibrillation and stroke. The left atrial appendage (LAA) is the primary site for thrombi formation. Therefore LAA occlusion devices should be tested for their ability to reduce future cerebral ischemic events in patients with high-risk of haemorrhage. The aim of this study was to evaluate the safety and feasibility of a novel left atrial appendage exclusion device with a minimally invasive introducer in a swine model. A completely novel LAA device, which is composed of two tubes connected together using a specially created bail, was designed using finite element modelling to obtain an optimal support force of 36 N at the closure line. The monolithic form of the occluder was obtained by using additive manufacturing of granular PA2200 powder with the technology of selective laser sintering SLS. Fifteen swine were included in the feasibility tests. This novel 3D printed left atrial appendage closure technique with a novel holdfast device was proven to be safe and feasible in all pigs. A benign healing process without inflammation and damage to the surrounding structures or evidence of new thrombi formation was observed. Moreover, the uncomplicated survival and full LAA exclusion in all animals demonstrate the efficacy of this novel and relatively cheap device. Further clinical evaluation and implementation studies should be performed to introduce this new technology into clinical practice.
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Authors (9)
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Maciej Brzeziński
- GUMed .
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Kamil Bury
- GUMed .
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Piotr Holak
- Uniwersytet Warmińsko-Mazurski .
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Aleksandra Sejda dr n. med
- GUMed .
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M. Pawlak
- GUMed .
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Dariusz Jagielak
- GUMed .
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Z. Adamiak
- Uniwersytet Warmińsko-Mazurski .
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Full text
- Publication version
- Accepted or Published Version
- DOI:
- Digital Object Identifier (open in new tab) 10.1371/journal.pone.0154559
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Details
- Category:
- Articles
- Type:
- artykuł w czasopiśmie wyróżnionym w JCR
- Published in:
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PLOS ONE
no. 11,
edition 5,
pages 1 - 11,
ISSN: 1932-6203 - Language:
- English
- Publication year:
- 2016
- Bibliographic description:
- Brzeziński M., Bury k., Dąbrowski L., Holak P., Sejda A., Pawlak M., Jagielak D., Adamiak Z., Rogowski J.: The New 3D Printed Left Atrial Appendage Closure with a Novel Holdfast Device: A Pre-Clinical Feasibility Animal Study// PLOS ONE. -Vol. 11, iss. 5 (2016), s.1-11
- DOI:
- Digital Object Identifier (open in new tab) 10.1371/journal.pone.0154559
- Verified by:
- Gdańsk University of Technology
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