BIOSA bileaflet pericardial valve: experimental study in sheep model

Area of Science:

• Biomaterials Science
• Cardiovascular Surgery
• Medical Device Engineering

Background:

• BIOSA is a novel bileaflet glutaraldehyde-fixed bovine pericardial valve prosthesis designed for reduced stress and enhanced durability.
• The study aimed to evaluate the performance and tissue characteristics of the BIOSA valve in an adult sheep model.

Purpose of the Study:

• To assess the structural integrity and tissue preservation of the BIOSA valve.
• To compare the BIOSA valve's performance against the Baxter Carpentier-Edwards (Perimount) pericardial valve in an animal model.

Main Methods:

• Seven BIOSA and two Perimount pericardial bioprosthetic valves (BPs) were implanted in the tricuspid position of adult sheep.
• Explanted valves underwent gross examination, X-ray, histology, scanning electron microscopy (SEM), transmission electron microscopy (TEM), and atomic absorption spectroscopy.

Main Results:

• Early explants showed preserved collagen-elastic fibers and pericardiocytes, with comparable calcium content between BIOSA and Perimount valves.
• Late explants exhibited regular cusp pliability, coaptation, and no signs of structural deterioration, calcification, or inflammation.
• Calcium content remained low and comparable between BIOSA and Perimount valves in late explants.

Conclusions:

• The BIOSA valve demonstrated optimal tissue characteristics and structural integrity, comparable to the Perimount valve.
• No structural valve deterioration was observed in the long term within this animal model.
• The BIOSA valve shows promise as a durable bioprosthetic option.