Evidence map›Paper›PMID 31309369›Full record

ArticleAnnals of biomedical engineering2020

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

Maciej Brzeziński, Aleksandra Sejda, Rafał Pęksa, Maciej Pawlak, Kamil Bury, Zbigniew Adamiak, Maciej Kowalik, Dariusz Jagielak, Krzysztof Bartus, Mateusz K Hołda and 2 more

Abstract read
In one paragraph

Article in Annals of biomedical engineering, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Maciej BrzezińskiDepartment of Cardiac and Vascular Surgery, Medical University of Gdansk, Gdańsk, Poland.
Aleksandra SejdaDepartment of Pathomorphology, Medical University of Gdansk, Gdańsk, Poland.
Rafał PęksaDepartment of Pathomorphology, Medical University of Gdansk, Gdańsk, Poland.
Maciej PawlakDepartment of Cardiac and Vascular Surgery, Medical University of Gdansk, Gdańsk, Poland.
Kamil BuryDepartment of Cardiac and Vascular Surgery, Medical University of Gdansk, Gdańsk, Poland.
Zbigniew AdamiakDepartment of Surgery and Roentgenology, Faculty of Veterinary Medicine, University of Warmia and Mazury, Olsztyn, Poland.
Maciej KowalikDepartment of Anesthesiology and Intensive Care, Medical University of Gdansk, Gdańsk, Poland.
Dariusz JagielakDepartment of Cardiac and Vascular Surgery, Medical University of Gdansk, Gdańsk, Poland.
Krzysztof BartusDepartment of Cardiovascular Surgery and Transplantology, Jagiellonian University Medical College, Kraków, Poland.
Mateusz K HołdaHEART - Heart Embryology and Anatomy Research Team, Department of Anatomy, Jagiellonian University Medical College, Kopernika 12, 31-034, Kraków, Poland. mkh@onet.eu.ORCID http://orcid.org/0000-0001-5754-594X
Radoslaw LitwinowiczDepartment of Cardiovascular Surgery and Transplantology, Jagiellonian University Medical College, Kraków, Poland.
Jan RogowskiDepartment of Cardiac and Vascular Surgery, Medical University of Gdansk, Gdańsk, Poland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Biocompatible MaterialsProsthesis DesignAnimalsAtrial AppendageCardiac Surgical ProceduresFemaleForeign-Body ReactionMaleMaterials TestingNylonsPolyestersPrinting, Three-DimensionalSwineBiocompatible MaterialsNylonsPolyesters3D printingAtrial fibrillationCardiovascular surgeryLeft atriumStroke prevention

Identifiers

PMID31309369
PMCPMC6928093

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.