Table 2.
Summary of polymeric heart valve development focusing on in vivo performance from their emergence in 1960 through the advent of new biostable polymers.
| Valve | Year described | Preclinical/clinical experience (position implanted) | Reason for dysfunction/failure or outcome | Ref. |
|---|---|---|---|---|
| PU bileaflet | 1960 | One human implantation resulting in death (mitral) | Arrhythmia | [39] |
| Composite silicone rubber-polyprolylene fabric trileaflet | 1975 | Clincal trials 1967–1973: 20 patient deaths associated with device failure (aortic) | Degradation, fatigue failure and thrombosis | [119,119] |
| Expanded PTFE trileaflet | 1977 | 28 dogs, 15 months, experimented with different leaflet thicknesses (tricuspid) | Leaflet stiffening, suture ring dehisence, strut entrapment | [44] |
| ABIOMED PU trileaflet | 1983, 1993 | In vitro tests revealed stenotic turbulent flow worse than a THV | Stiff leaflets, narrow orifice | [47,48,120,121] |
| PU trileaflet | 1987 | 17–21 week sheep studies (mitral) | Calcification, thrombosisstenosis and regurgitation | [49] |
| PTFE trileaflet | 1990 | 12 sheep, 8–10 weeks (tricuspid) | Leaflet stiffening, calcification and thrombosis | [52] |
| Leeds PU trileaflet valve | 1996 | In vitro hemodynamics comparison of dip casting versus film fabricated | Method of manufacture had significant effect on results | [53] |
| The advent of biostable polymers | ||||
| AorTech MDI siloxane-PU trileaflet | 2002 | 12 sheep, 6–9 months (mitral) | No evidence of degradation, thrombosis or calcification | [122] |
| PCU trileaflet | 2004 | 14 growing calves, 20 weeks (seven mitral, seven aortic) | Two AV animals died from pannus overgrowth causing severe AS; degradation and calcification observed to a greater degree in AVs but comparably less than in THVs | [85] |
| Innovia SIBS-Dacron composite trileaflet | 2010 | Six sheep (aortic) | Viscoelatic creep in SIBS, Dacron fatigue and calcification, no evidence of SIBS degradation | [102] |
Most polymeric heart valves failed after being implanted in the aortic valve position.
AS: Aortic stenosis; AV: Aortic valve; MDI: Methylenediphenyl diisocyanate; PCU: Polycarbonate urethane; PTFE: Polytetrafluoroethylene; PU: Polyurethane; THV: Tissue heart valve.