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Transcatheter Pulmonary Valve Replacement from Autologous Pericardium with a Self-Expandable Nitinol Stent in an Adult Sheep Model
Published on: June 8, 2022
Bioengineered human and allogeneic pulmonary valve conduits chronically implanted orthotopically in baboons:
Richard A Hopkins1, Arthur A Bert2, Stephen L Hilbert1
1Cardiac Regenerative Surgery Research Laboratories, The Ward Family Center for Congenital Heart Disease, Children's Mercy Hospital, Kansas City, Mo.
The Journal of Thoracic and Cardiovascular Surgery
|July 31, 2012
Summary
Bioengineered heart valves, decellularized and conditioned, showed excellent hemodynamics and reduced immunogenicity in baboons compared to traditional valves. These advanced scaffolds offer a promising alternative for valve replacement, maintaining native valve function.
Area of Science:
- Biomaterials Science
- Cardiovascular Surgery
- Immunology
Background:
- Heart valve replacement is a common procedure, but current prostheses can lead to dysfunction and immunogenic responses.
- Bioengineered heart valves offer a potential alternative to traditional grafts, aiming to improve long-term outcomes.
Purpose of the Study:
- To evaluate the hemodynamic performance and immunogenicity of decellularized and collagen-conditioned human and baboon heart valve scaffolds implanted in a baboon model.
- To compare the outcomes of bioengineered valves against clinically relevant cryopreserved or porcine valved conduits.
Main Methods:
- Pulmonary valve replacement in 14 baboons using either bioengineered valves (allogeneic or xenogeneic) or reference conduits.
- Serial assessment of hemodynamics (echocardiography) and immunogenicity (antibody titers, C-reactive protein) over 10 or 26 weeks.
- Statistical analysis using Kruskal-Wallis and Wilcoxon rank-sum tests to compare groups.
Main Results:
- All bioengineered valves maintained normal effective orifice area and normal transvalvular gradients, outperforming reference valves.
- Cryopreserved valves induced the most intense antibody responses; some bioengineered valves showed no human leukocyte antigen class I antibody response.
- Bioengineered human scaffolds induced class II antibodies, while C1q(+) antibodies developed in some recipients of bioengineered valves.
Conclusions:
- Valve dysfunction was linked to heightened inflammatory responses, underscoring the importance of reduced antigenicity.
- The bioengineering techniques effectively reduced the antigenicity of both human and baboon valve scaffolds.
- Bioengineered valves from both species demonstrated hemodynamic equivalence to native valves, indicating their potential as effective replacements.

