Safety evaluation of the Guardian device on the common carotid artery in sheep.
Alzheimer's dementia
Chronic implant
Common carotid artery
Dementia
Pulse pressure wave
Sheep
Journal
Heliyon
ISSN: 2405-8440
Titre abrégé: Heliyon
Pays: England
ID NLM: 101672560
Informations de publication
Date de publication:
Apr 2023
Apr 2023
Historique:
received:
22
06
2022
revised:
15
03
2023
accepted:
21
03
2023
medline:
18
4
2023
entrez:
17
4
2023
pubmed:
18
4
2023
Statut:
epublish
Résumé
Pulse pressure intensity in middle-aged adults is a risk factor for dementia. The Guardian device (The Brain Protection Company, Sydney, Australia) has been developed to reduce pulse pressure, as a potential therapy. The aim of this study was to evaluate the safety of the Guardian, a novel pulse modulation device designed to reduce the intensity of the pulse pressure that penetrates into the cerebral small vessels. The Guardian is a helix that gently wraps around the common carotid artery (CCA) to slightly change its shape, to absorb pulsatility, without lowering flow. The Guardian was implanted bilaterally on the CCAs of 10 mature sheep for chronic implant periods of 3, 6 or 8 months. The ratio of internal device diameter to outer diameter of the CCA varied from 63% to 92% (n = 20). The implant position on the vessel was marked surgically at implant. Gross pathology and histopathology of the CCA were examined at 3- and 6-months post explant. Most devices were explanted using open surgery, however minimally invasive surgical explant techniques were examined in 2 animals to assess the potential of this approach for explant in humans if required. The Guardian was successfully implanted with no adverse events, and minimally invasive explant appeared to be viable for removal. Following implant, the device was surrounded by a thin fibrous capsule, with similar pathology at 3- and 6-months. Minimal or no movement was observed. CCA sections appeared histologically normal, with no evidence of thrombosis, stenosis, fibrosis, chronic inflammatory response, or vessel degeneration. The feasibility of surgical implantation and biomaterial safety of the Guardian was confirmed over 8 months. Minimally invasive explant of the Guardian has the potential to be viable. Further work is required to demonstrate efficacy
Sections du résumé
Background
UNASSIGNED
Pulse pressure intensity in middle-aged adults is a risk factor for dementia. The Guardian device (The Brain Protection Company, Sydney, Australia) has been developed to reduce pulse pressure, as a potential therapy.
Objectives
UNASSIGNED
The aim of this study was to evaluate the safety of the Guardian, a novel pulse modulation device designed to reduce the intensity of the pulse pressure that penetrates into the cerebral small vessels. The Guardian is a helix that gently wraps around the common carotid artery (CCA) to slightly change its shape, to absorb pulsatility, without lowering flow.
Methods
UNASSIGNED
The Guardian was implanted bilaterally on the CCAs of 10 mature sheep for chronic implant periods of 3, 6 or 8 months. The ratio of internal device diameter to outer diameter of the CCA varied from 63% to 92% (n = 20). The implant position on the vessel was marked surgically at implant. Gross pathology and histopathology of the CCA were examined at 3- and 6-months post explant. Most devices were explanted using open surgery, however minimally invasive surgical explant techniques were examined in 2 animals to assess the potential of this approach for explant in humans if required.
Results
UNASSIGNED
The Guardian was successfully implanted with no adverse events, and minimally invasive explant appeared to be viable for removal. Following implant, the device was surrounded by a thin fibrous capsule, with similar pathology at 3- and 6-months. Minimal or no movement was observed. CCA sections appeared histologically normal, with no evidence of thrombosis, stenosis, fibrosis, chronic inflammatory response, or vessel degeneration.
Conclusions
UNASSIGNED
The feasibility of surgical implantation and biomaterial safety of the Guardian was confirmed over 8 months. Minimally invasive explant of the Guardian has the potential to be viable. Further work is required to demonstrate efficacy
Identifiants
pubmed: 37064446
doi: 10.1016/j.heliyon.2023.e14909
pii: S2405-8440(23)02116-3
pmc: PMC10102196
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e14909Informations de copyright
© 2023 The Authors.
Déclaration de conflit d'intérêts
The authors declare the following conflict of interests: Any potential conflicts of interest, including related consultancies, patent applications, shareholdings and funding grants. Natalie L James, Zoran Milijasevic, Anthony Ujhazy, David Huber are consultants to The Brain Protection Company (BPCo). David S Celermajer is Chief Medical Officer, Director and a shareholder of BPCo. Zoran Milijasevic, Anthony Ujhazy and David S Celermajer are named on patent applications/registrations for the Guardian device. Randi Rotne, Glenn Edwards and Kieri Jermyn were funded to conduct surgery via a contract between 10.13039/501100001769Charles Sturt University and BPCo. This research was funded by BPCo.
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