Table 1 Sources and characterisation of specimens for histopathological work up.
| Animal experiments (n = 32) | |||||
|---|---|---|---|---|---|
| Implant | n | Implantation times | |||
| Amplatzer | 8 (2 groups) | 4 days, 1/3/6 months | |||
| Starflex | 24 (3 groups) | 7/14 days, 1/3/6/12 months | |||
| Human specimen (n = 12) | |||||
|---|---|---|---|---|---|
| Patient | Implant | Implantation time | Indication for explantation | ||
| 1 | Amplatzer ASD | 5 days | Malpositioning | ||
| 2 | Amplatzer VSD | 2 months | Valve incompetence | ||
| 3 | Cardioseal ASD | 5 months | Recurrent transient ischaemic attacks | ||
| 4 | Amplatzer ASD | 12 months | Malpositioning | ||
| 5 | Amplatzer ASD | 15 months | Residual shunt | ||
| 6 | Starflex ASD | 21 months | Deformation/residual shunt | ||
| 7 | Amplatzer ASD | 21 months | Malpositioning | ||
| 8 | Amplatzer ASD | 24 months | Residual shunt | ||
| 9 | Cardioseal ASD | 25 months | Residual shunt | ||
| 10 | Starflex ASD (2) | 31 months | Residual shunt | ||
| 11 | Cardioseal ASD | 36 months | Arm fracture, tissue proliferation atrial surface | ||
| 12 | Starflex ASD | 48 months | Recurrent neurology, tissue proliferation atrial surface | ||
ASD, atrial septal defect; VSD, ventricular septal defect.