Table 4.
Per cent-expansion area and delivery balloon volume
| SAPIEN 3 (n = 39) |
SAPIEN XT (n = 55) |
|||||
|---|---|---|---|---|---|---|
| Under-filling (n = 6) | Nominal (n = 26) | Over-filling (n = 7) | Under-filling (n = 12) | Nominal (n = 33) | Over-filling (n = 10) | |
| Overall levels | 96.0 ± 3.2 | 100.1 ± 5.0 | 107.8 ± 3.4* | 91.0 ± 4.7 | 97.5 ± 4.1** | 97.4 ± 7.2 |
| 1. THV inflow | 99.0 ± 5.2 | 104.8 ± 5.7 | 112.0 ± 1.5 | 87.7 ± 5.7 | 94.3 ± 4.2 | 96.5 ± 8.5 |
| 2. Native annulus | 95.1 ± 7.8 | 98.4 ± 5.5 | 107.0 ± 3.3 | 89.8 ± 5.2 | 95.9 ± 4.2 | 97.8 ± 6.1 |
| 3. Mid-THV | 90.9 ± 3.5 | 95.8 ± 4.8*** | 103.5 ± 4.8 | 90.2 ± 5.1 | 96.9 ± 5.0**** | 94.8 ± 7.7 |
| 4. THV outflow | 99.1 ± 3.3 | 101.5 ± 6.3 | 108.6 ± 4.7 | 96.4 ± 8.0 | 102.9 ± 6.6 | 100.4 ± 8.8 |
Values are mean ± SD.
*P < 0.001 and **P = 0.029 vs. the SAPIEN 3 nominal, ***P < 0.001 vs. the SAPIEN 3 THV-inflow, ****P = 0.0041 vs. the SAPIEN XT THV-inflow.