Bioprosthetic leaflets made from animal tissues are used in the majority of surgical and transcatheter cardiac valve replacements. This study develops a new surgical bioprosthesis, using porcine pericardial leaflets. Porcine pericardium was obtained from genetically engineered pigs with a mutation in the GGTA-1 gene (GTKO) and fixed in 0.6% glutaraldehyde, and used to develop a new surgical valve design. The valves underwent in vitro hydrodynamic test in a pulse duplicator and high-cycled accelerated wear testing and were evaluated for acute haemodynamics and thrombogenicity in a juvenile sheep implant study for 48 h. The porcine surgical pericardial heart valves (pSPHVs) exhibited excellent hydrodynamics and reached 200 million cycles of in vitro durability, with no observable damage. Juvenile sheep implants demonstrated normal valve function with no acute thrombogenic response for either material. The pSPHV incorporates a minimalistic construction method using a tissue-to-tissue design to cover the stent. This new design is a proof of concept alternative to the use of bovine pericardium and synthetic fabric in surgical bioprosthetic heart valves.
Bibliographical noteFunding Information:
Funding This study was funded by a Medical Research Council Development Pathway Funding Scheme grant (MR/L005891/1 and MR/R006393/1). Funding support was also provided to Drs. McGregor and Byrne by an Immunobiology of Xenotransplantation Cooperative Research Grant (AI066310) from the National Institute of Allergy and Infectious Disease at the National Institute of Health, by Comprehensive Biomedical Research Centre funds from the National Institute of Health Research, from the National Institute for Health Research University College London Hospitals Biomedical Research Centre.
- Biological heart valve
- Gal knockout
- Porcine pericardium