Preclinical assessment of a modified Occlutech left atrial appendage closure device in a porcine model

Abstract Left atrial appendage (LAA) closure is being developed as an alternative for stroke prevention in patients with atrial fibrillation that cannot tolerate long-term oral anticoagulation. To assess the feasibility, safety, and performance of a novel modified Occlutech LAA closure device in a p...

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Autores principales:	Markus Reinthaler, Johannes Grosshauser, Tanja Schmidt, Juliane Unger, Ross Morgan, Friederike Zimmermann, Johannes Hartung, Claudio Seppelt, Denitsa Meteva, Wolfram Haider, Ulf Landmesser, Carsten Skurk
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/29e4836ee08347ceb7cc73c23b07c720
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spelling	oai:doaj.org-article:29e4836ee08347ceb7cc73c23b07c7202021-12-02T14:06:25ZPreclinical assessment of a modified Occlutech left atrial appendage closure device in a porcine model10.1038/s41598-021-82359-12045-2322https://doaj.org/article/29e4836ee08347ceb7cc73c23b07c7202021-02-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-82359-1https://doaj.org/toc/2045-2322Abstract Left atrial appendage (LAA) closure is being developed as an alternative for stroke prevention in patients with atrial fibrillation that cannot tolerate long-term oral anticoagulation. To assess the feasibility, safety, and performance of a novel modified Occlutech LAA closure device in a preclinical porcine model, the modified Occlutech modified Occlutech Plus LAA closure device was implanted in 12 female pigs (25–39 kg body weight) under fluoroscopic and transesophageal echocardiography (TEE) guidance. Procedural and technical success, as well as safety of LAA closure, were evaluated peri-procedurally and after 4, 8, and 12 weeks. Moreover, after 4, 8 and, 12 weeks animals were sacrificed for pathological analysis (e.g., thrombus formation, device ingrowth, endothelialization, and inflammation). All LAA closure devices were successfully implanted. On follow-up, no serious adverse events such as device-associated thrombus or translocalization/embolization were observed. A clinically non-significant pericarditis was observed in 4 animals at the time of autopsy. Endothelialization of the device was visible after 4 weeks, advanced after 8 weeks and completed after 12 weeks. Immunohistochemistry showed low amounts of inflammatory infiltration on the edges of the device. The results of this study indicate that implantation of a modified Occlutech LAA closure device is feasible with rapid endothelialization and low inflammatory infiltration in a porcine model. Human data are needed to further characterize safety and efficacy.Markus ReinthalerJohannes GrosshauserTanja SchmidtJuliane UngerRoss MorganFriederike ZimmermannJohannes HartungClaudio SeppeltDenitsa MetevaWolfram HaiderUlf LandmesserCarsten SkurkNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Markus Reinthaler Johannes Grosshauser Tanja Schmidt Juliane Unger Ross Morgan Friederike Zimmermann Johannes Hartung Claudio Seppelt Denitsa Meteva Wolfram Haider Ulf Landmesser Carsten Skurk Preclinical assessment of a modified Occlutech left atrial appendage closure device in a porcine model
description	Abstract Left atrial appendage (LAA) closure is being developed as an alternative for stroke prevention in patients with atrial fibrillation that cannot tolerate long-term oral anticoagulation. To assess the feasibility, safety, and performance of a novel modified Occlutech LAA closure device in a preclinical porcine model, the modified Occlutech modified Occlutech Plus LAA closure device was implanted in 12 female pigs (25–39 kg body weight) under fluoroscopic and transesophageal echocardiography (TEE) guidance. Procedural and technical success, as well as safety of LAA closure, were evaluated peri-procedurally and after 4, 8, and 12 weeks. Moreover, after 4, 8 and, 12 weeks animals were sacrificed for pathological analysis (e.g., thrombus formation, device ingrowth, endothelialization, and inflammation). All LAA closure devices were successfully implanted. On follow-up, no serious adverse events such as device-associated thrombus or translocalization/embolization were observed. A clinically non-significant pericarditis was observed in 4 animals at the time of autopsy. Endothelialization of the device was visible after 4 weeks, advanced after 8 weeks and completed after 12 weeks. Immunohistochemistry showed low amounts of inflammatory infiltration on the edges of the device. The results of this study indicate that implantation of a modified Occlutech LAA closure device is feasible with rapid endothelialization and low inflammatory infiltration in a porcine model. Human data are needed to further characterize safety and efficacy.
format	article
author	Markus Reinthaler Johannes Grosshauser Tanja Schmidt Juliane Unger Ross Morgan Friederike Zimmermann Johannes Hartung Claudio Seppelt Denitsa Meteva Wolfram Haider Ulf Landmesser Carsten Skurk
author_facet	Markus Reinthaler Johannes Grosshauser Tanja Schmidt Juliane Unger Ross Morgan Friederike Zimmermann Johannes Hartung Claudio Seppelt Denitsa Meteva Wolfram Haider Ulf Landmesser Carsten Skurk
author_sort	Markus Reinthaler
title	Preclinical assessment of a modified Occlutech left atrial appendage closure device in a porcine model
title_short	Preclinical assessment of a modified Occlutech left atrial appendage closure device in a porcine model
title_full	Preclinical assessment of a modified Occlutech left atrial appendage closure device in a porcine model
title_fullStr	Preclinical assessment of a modified Occlutech left atrial appendage closure device in a porcine model
title_full_unstemmed	Preclinical assessment of a modified Occlutech left atrial appendage closure device in a porcine model
title_sort	preclinical assessment of a modified occlutech left atrial appendage closure device in a porcine model
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/29e4836ee08347ceb7cc73c23b07c720
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Preclinical assessment of a modified Occlutech left atrial appendage closure device in a porcine model

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