Department of Paediatric and Adult Congenital Cardiology, Bordeaux University Hospital (CHU), Pessac F-33600, Bordeaux, France.
IHU Liryc, Electrophysiology and Heart Modeling Institute, Fondation Bordeaux Université, Pessac F-33600, Bordeaux, France.
J Interv Cardiol. 2020 Jun 20;2020:8413831. doi: 10.1155/2020/8413831. eCollection 2020.
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.
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.
After percutaneous ASD creation, 12 pigs were implanted with 15 mm Hyperion ( = 6) and 15 mm ASO ( = 6) devices. After 1 month ( = 3 for each device) and 3 months ( = 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.
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.
In this preclinical study, we demonstrated that Amplatzer septal occluder and Hyperion occluder were not significantly different for device healing and nickel release processes.
在慢性猪模型中，比较 Hyperion 封堵器（荷兰 Comed BV）和 Amplatzer 房间隔封堵器（ASO）（美国圣犹达医疗公司，明尼苏达州圣保罗市）的愈合过程和镍释放情况。
经皮房间隔缺损（ASD）封堵术后出现的一些长期并发症可能与装置愈合不当和镍释放增加部分相关。目前尚无不同封堵器在愈合和镍释放方面的直接比较研究。
经皮 ASD 造口术后，12 头猪被植入 15mm Hyperion（n=6）和 15mm ASO（n=6）装置。在 1 个月（每种装置各 3 个）和 3 个月（每种装置各 3 个）的随访后，进行装置取出，并通过组织病理学评估来评估愈合情况。进行系统性和组织性镍释放检测。
植入术成功率为 100%，无并发症。植入后 1 个月即可观察到装置覆盖，3 个月后几乎完全覆盖。在与 Nitinol 丝接触时观察到肉芽组织，伴有以单核炎性反应为主的炎症反应，而在与纺织纤维接触时则观察到炎症反应。无论随访时间如何，2 种装置之间在组织学分级评分或系统性镍释放方面均无统计学差异。
在这项临床前研究中，我们证明 Amplatzer 房间隔封堵器和 Hyperion 封堵器在装置愈合和镍释放过程方面没有显著差异。
