eTable 1.
Explant valve necropsy observations
Valve Type | Animal ID Number | Pericardial Adhesions | Valve Conduit wall | Valve sinus wall | Valve cusps | Histologic inflammatory response score |
---|---|---|---|---|---|---|
Porcine Glutaraldehyde1 | 1 | moderately severe | stiff | stiff, thick | very stiff, thick | marked |
2 | severe | rigid | stiff, thick | stiff, thick | marked | |
Papio Cryopreserved | 3 | moderate | stiff, nodular suture line | nodules, scarring | thin | mild |
4 | severe | scarring at suture lines | stiff, thick | thick, contracted | marked | |
Human Cryopreserved | 5 | moderately severe | no scar | no scar or calcium | thin, normal | marked |
6 | moderate | no scar | stiff, thick | stiff, thickened | marked | |
Papio 10 wk implant | 7 | mild | normal | normal | thin, normal | minimal – mild |
8 | mild | normal | normal | thin, normal | minimal – mild | |
9 | mild | normal | fibrin deposits | thin, normal | minimal – mild | |
Human 10 wk implant | 10 | moderate | thickened | inflammatory adventitia | slightly thickened | marked |
11 | mild | normal | normal | thin, normal | moderate | |
12 | moderate | small nodule at STJ2 | normal to slight thickening | thin, pliable | marked | |
Human 6 mo implant | 13 | mild | normal | normal | thin, normal | moderate |
14 | mild | normal | normal | thin, normal | minimal – mild |
Porcine glutaraldehyde, papio cryopreserved and human cryopreserved valves are reference valves while papio 10 week, human 10 week and human 6 month implant valves are bioengineered valves.
Porcine glutaraldehyde valve inflammatory infiltrates were limited to the adventitia only.
STJ = sino-tubular junction.