Abstract
Aims To investigate the healing process and nickel release of the Hyperion occluder (Comed BV, Netherlands), as compared to the Amplatzer septal occluder (ASO) (St. Jude Medical Inc., St. Paul, MN, USA) in a chronic swine model. Background Some long-term complications occurring after percutaneous atrial septal defect (ASD) closure may be partially associated with an inappropriate healing of the device and increased nickel release. There is no direct comparative study of different occluders for healing and nickel release. Methods After percutaneous ASD creation, 12 pigs were implanted with 15 mm Hyperion (n = 6) and 15 mm ASO (n = 6) devices. After 1 month (n = 3 for each device) and 3 months (n = 3 for each device) of follow-up, device explantation was performed and healing was assessed using histopathological workup. Systemic and tissular nickel release was performed. Results Implantation was successful in 100% without complications. Device coverage was observed as early as 1 month after implantation and was almost complete after 3 months. A granulation tissue with a predominantly mononuclear inflammatory reaction was observed in contact with nitinol wires while an inflammatory reaction was seen in contact with textile fibers. We found no statistically significant difference between the 2 devices whether for histological grading scores or systemic nickel release, regardless to follow-up duration. Conclusions In this preclinical study, we demonstrated that Amplatzer septal occluder and Hyperion occluder were not significantly different for device healing and nickel release processes.
Highlights
Transcatheter device occlusion of secundum atrial septal defects (ASD) has become the currently gold-standard treatment strategy for patients with suitable anatomy [1, 2].e Amplatzer septal occluder (ASO)
As for any implantable device, large animal models of ASD have been widely used throughout the historical developments of atrial septal defect closure devices, especially to study the biocompatibility of occluders with a focus on healing and neo-endothelialization processes for regulatory device approval [13,14,15,16]
We perform our tests on 2 types of devices: one recently developed occluder, the Hyperion occluder, and the ASO which was used as the «gold-standard» device. e Hyperion occluder is very similar to the ASO in terms of design
Summary
Transcatheter device occlusion of secundum atrial septal defects (ASD) has become the currently gold-standard treatment strategy for patients with suitable anatomy [1, 2]. As for any implantable device, large animal models of ASD have been widely used throughout the historical developments of atrial septal defect closure devices, especially to study the biocompatibility of occluders with a focus on healing and neo-endothelialization processes for regulatory (premarket) device approval [13,14,15,16]. According to manufacturer’s product information, this treatment has been shown to decrease nickel release in vitro These properties have not been investigated in in vivo preclinical studies so far. Us, in this study, we aimed to investigate the healing process and nickel ion release of the Hyperion septal occluder as compared to the ASO—used as a gold standard—in a chronic swine model These properties have not been investigated in in vivo preclinical studies so far. us, in this study, we aimed to investigate the healing process and nickel ion release of the Hyperion septal occluder as compared to the ASO—used as a gold standard—in a chronic swine model
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