Biocompatibility of septal defect closure devices

Area of Science:

• Biomaterials Science
• Cardiovascular Research
• Histopathology

Background:

• Amplatzer and Cardioseal/Starflex devices are used for septal defect closure.
• Limited human data exists on the healing response to these devices.
• Previous studies focused on animal models, necessitating human correlative data.

Purpose of the Study:

• To investigate the biocompatibility and healing response of Amplatzer and Cardioseal/Starflex septal occluder devices in humans.
• To compare human healing responses with those observed in experimental animal models.
• To establish a comprehensive understanding of device-tissue integration and inflammatory reactions.

Main Methods:

• Analysis of explanted human septal occluder devices (n=12) with follow-up periods ranging from 5 days to 4 years.
• Evaluation of explanted animal devices (n=32) with follow-up periods from 4 days to 1 year.
• Histological examination of embedded specimen and scanning electron microscopy for biocompatibility assessment.

Main Results:

• Complete neoendothelialisation of all devices was achieved within 3 months post-implantation.
• Initial fibrin and blood cell deposition was organized by fibroblastic cells, transforming into mature connective tissue.
• A mild, chronic inflammatory response, characterized by lymphocytic infiltration and giant cells, was consistently observed in both human and animal explants.

Conclusions:

• Human explant analysis confirms the biocompatibility of Amplatzer and Cardioseal/Starflex devices.
• Observed healing responses, including neoendothelialisation and tissue organization, align with findings in animal studies.
• The persistent immune response suggests ongoing interaction between the device materials and host tissue.