Comparison of Two Percutaneous Atrial Septal Defect Occluders for Device Healing and Nickel Release in a Chronic Porcine Model

• Main Authors: Zakaria Jalal, Younes Boudjemline, Xavier Iriart, Pierre-Emmanuel Seguela, Samantha Delmond, Virgine Loyer, David Gonthier, Olivier Bernus, Marlène Durand, Laurence Bordenave, Jean-Benoit Thambo
• Format: Article
• Language: English
• Published: Hindawi-Wiley 2020-01-01
• Series: Journal of Interventional Cardiology
• Online Access: http://dx.doi.org/10.1155/2020/8413831
• ISSN: 0896-4327; 1540-8183

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.