Table 2.
Procedural characteristics and periprocedural outcomes
| Measure | N = 120 |
|---|---|
| Valve size implanted | |
| S | 25.8 (31) |
| M | 45.0 (54) |
| La | 29.2 (35) |
| Total procedure time, minutes | 48.5 [22.5] |
| Time from femoral insertion to withdrawal of delivery system, minutes | 3.0 [1.0] |
| Balloon pre-dilatation performed | 95.8 (115) |
| Maximum balloon diameter, mm | 23.0 [4.0] |
| Number of balloon inflations | |
| 1 | 93.0 (107) |
| 2 | 5.2 (6) |
| 3 | 1.7 (2) |
| Post-dilatation performed | 32.5 (39) |
| Maximum balloon diameter, mm | 23.0 [2.0] |
| Number of balloon inflations | |
| 1 | 84.6 (33) |
| 2 | 15.4 (6) |
| Procedural success | 97.5 (117) |
| Valve malpositioning (including valve migration, valve embolization, ectopic valve deployment)b | 1.7 (2) |
| Ventricular septal perforationc | 0.8 (1) |
| Coronary obstruction | 0.0 (0) |
| Cardiac tamponade | 0.0 (0) |
| MI ≤ 72 h post-procedure | 0.0 (0) |
| Life-threatening or disabling bleeding | 5.0 (6) |
| Disabling stroke | 1.7 (2) |
Values are % (n/120) or median [IQR]
MI myocardial infarction
aSize L valve was only available in the second phase of enrollment (i.e., after enrollment of the first 30 patients)
bValve-in-valve implantation of a non-study valve required due to valve dislodgement/migration (n = 1), valve embolization (n = 1)
cPerforation resultant from post-dilatation; patient was converted to open heart surgery