Demonstration of proof-of-concept of StrokeShield system for complete closure and occlusion of the left atrial appendage for non-valvular atrial fibrillation therapy.

In the US, the most significant morbidity and mortality associated with non-valvular atrial fibrillation (NVAF) is embolic stroke, with 90% of thrombus originating from the left atrial appendage (LAA). Anticoagulation is the preferred treatment for the prevention of stroke in NVAF patients, but clin...

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Autores principales:	Mark S Slaughter, Gretel Monreal, Steven C Koenig, Guruprasad A Giridharan, Landon H Tompkins, Jorge H Jimenez
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/d0d2079cc2ab4300be0cd83b6ba15e11
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spelling	oai:doaj.org-article:d0d2079cc2ab4300be0cd83b6ba15e112021-12-02T20:10:16ZDemonstration of proof-of-concept of StrokeShield system for complete closure and occlusion of the left atrial appendage for non-valvular atrial fibrillation therapy.1932-620310.1371/journal.pone.0253299https://doaj.org/article/d0d2079cc2ab4300be0cd83b6ba15e112021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0253299https://doaj.org/toc/1932-6203In the US, the most significant morbidity and mortality associated with non-valvular atrial fibrillation (NVAF) is embolic stroke, with 90% of thrombus originating from the left atrial appendage (LAA). Anticoagulation is the preferred treatment for the prevention of stroke in NVAF patients, but clinical studies have demonstrated high levels of non-compliance and increased risk of bleeding or ineligibility for anticoagulation therapy, especially in the elderly population where the incidence of NVAF is highest. Alternatively, stroke may be preventing using clinically approved surgical and catheter-based devices to exclude or occlude the LAA, but these devices continue to be plagued by peri-device leaks and thrombus formation because of residual volume. To overcome these limitations, Cor Habere (Louisville, KY) and the University of Louisville are developing a LAA closure device (StrokeShield) that completely occludes and collapses the LAA to minimize the risk of stroke. The StrokeShield device is a collapsible occluder (nitinol reinforced membrane) that completely covers the LAA orifice with an expandable conical coil anchor that attaches to the myocardium. The device is designed for catheter-based delivery and expands to completely occlude the LAA orifice and collapse the LAA. The primary advantages of the StrokeShield system are a completely sealed LAA (no peri-device flow or residual space) and smooth endothelialized connection to the left atrial wall with minimal risk of cardiac bleeding and tamponade. We tested proof-of-concept of a prototype StrokeShield device in acute (n = 2) and chronic 60-day (n = 2) healthy canine models. Acute results demonstrated that the conical coil securely attached to the myocardium (5N pull-out force) and the Nitinol umbrella fully deployed and covered the LAA ostium. Results from the chronic implants demonstrated long-term feasibility of device placement with no procedural or device-related intra- or post-operative complications, secure placement and correct positioning of the device with no device migration. The device successfully occluded the LAA ostium and collapsed the LAA with no interference with the mitral valve, circumflex coronary artery, or pulmonary veins. Necropsy demonstrated no gross signs of thrombus or end-organ damage and the device was encapsulated in the LAA. Histology demonstrated mature neointima covering the device with expected foreign body inflammatory response. These early positive results will help to guide the iterative design process for the continued development of the StrokeShield system.Mark S SlaughterGretel MonrealSteven C KoenigGuruprasad A GiridharanLandon H TompkinsJorge H JimenezPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 6, p e0253299 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Mark S Slaughter Gretel Monreal Steven C Koenig Guruprasad A Giridharan Landon H Tompkins Jorge H Jimenez Demonstration of proof-of-concept of StrokeShield system for complete closure and occlusion of the left atrial appendage for non-valvular atrial fibrillation therapy.
description	In the US, the most significant morbidity and mortality associated with non-valvular atrial fibrillation (NVAF) is embolic stroke, with 90% of thrombus originating from the left atrial appendage (LAA). Anticoagulation is the preferred treatment for the prevention of stroke in NVAF patients, but clinical studies have demonstrated high levels of non-compliance and increased risk of bleeding or ineligibility for anticoagulation therapy, especially in the elderly population where the incidence of NVAF is highest. Alternatively, stroke may be preventing using clinically approved surgical and catheter-based devices to exclude or occlude the LAA, but these devices continue to be plagued by peri-device leaks and thrombus formation because of residual volume. To overcome these limitations, Cor Habere (Louisville, KY) and the University of Louisville are developing a LAA closure device (StrokeShield) that completely occludes and collapses the LAA to minimize the risk of stroke. The StrokeShield device is a collapsible occluder (nitinol reinforced membrane) that completely covers the LAA orifice with an expandable conical coil anchor that attaches to the myocardium. The device is designed for catheter-based delivery and expands to completely occlude the LAA orifice and collapse the LAA. The primary advantages of the StrokeShield system are a completely sealed LAA (no peri-device flow or residual space) and smooth endothelialized connection to the left atrial wall with minimal risk of cardiac bleeding and tamponade. We tested proof-of-concept of a prototype StrokeShield device in acute (n = 2) and chronic 60-day (n = 2) healthy canine models. Acute results demonstrated that the conical coil securely attached to the myocardium (5N pull-out force) and the Nitinol umbrella fully deployed and covered the LAA ostium. Results from the chronic implants demonstrated long-term feasibility of device placement with no procedural or device-related intra- or post-operative complications, secure placement and correct positioning of the device with no device migration. The device successfully occluded the LAA ostium and collapsed the LAA with no interference with the mitral valve, circumflex coronary artery, or pulmonary veins. Necropsy demonstrated no gross signs of thrombus or end-organ damage and the device was encapsulated in the LAA. Histology demonstrated mature neointima covering the device with expected foreign body inflammatory response. These early positive results will help to guide the iterative design process for the continued development of the StrokeShield system.
format	article
author	Mark S Slaughter Gretel Monreal Steven C Koenig Guruprasad A Giridharan Landon H Tompkins Jorge H Jimenez
author_facet	Mark S Slaughter Gretel Monreal Steven C Koenig Guruprasad A Giridharan Landon H Tompkins Jorge H Jimenez
author_sort	Mark S Slaughter
title	Demonstration of proof-of-concept of StrokeShield system for complete closure and occlusion of the left atrial appendage for non-valvular atrial fibrillation therapy.
title_short	Demonstration of proof-of-concept of StrokeShield system for complete closure and occlusion of the left atrial appendage for non-valvular atrial fibrillation therapy.
title_full	Demonstration of proof-of-concept of StrokeShield system for complete closure and occlusion of the left atrial appendage for non-valvular atrial fibrillation therapy.
title_fullStr	Demonstration of proof-of-concept of StrokeShield system for complete closure and occlusion of the left atrial appendage for non-valvular atrial fibrillation therapy.
title_full_unstemmed	Demonstration of proof-of-concept of StrokeShield system for complete closure and occlusion of the left atrial appendage for non-valvular atrial fibrillation therapy.
title_sort	demonstration of proof-of-concept of strokeshield system for complete closure and occlusion of the left atrial appendage for non-valvular atrial fibrillation therapy.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/d0d2079cc2ab4300be0cd83b6ba15e11
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Demonstration of proof-of-concept of StrokeShield system for complete closure and occlusion of the left atrial appendage for non-valvular atrial fibrillation therapy.

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