Table 2. Procedural characteristics and outcomes.
| Overall (n=189) | Sapien XT (n=94) | Sapien 3 (n=95) | p value | |||
|---|---|---|---|---|---|---|
| Approach | 0.007 | |||||
| TF | 182 (96.3) | 87 (92.6) | 95 (100.0) | |||
| TA | 7 (3.7) | 7 (7.4) | 0 (0.0) | |||
| Room | <0.001 | |||||
| Hybrid room | 143 (75.7) | 83 (88.3) | 60 (63.2) | |||
| Cath lab | 46 (24.3) | 11 (11.7) | 35 (36.8) | |||
| Anesthesia | 0.121 | |||||
| General | 185 (97.9) | 94 (100.0) | 91 (95.8) | |||
| Conscious sedation | 4 (2.1) | 0 (0.0) | 4 (4.2) | |||
| Valve size (mm) | 0.329 | |||||
| 23 | 76 (40.2) | 37 (39.4) | 39 (41.1) | |||
| 26 | 91 (48.1) | 48 (52.1) | 42 (44.2) | |||
| 29 | 22 (11.6) | 8 (8.5) | 14 (14.7) | |||
| Device success | 178 (94.2) | 85 (90.4) | 93 (97.9) | 0.028 | ||
| Pre-dilation | 115 (60.8) | 76 (80.9) | 39 (41.1) | <0.001 | ||
| Post-dilation | 24 (12.7) | 13 (13.8) | 11 (11.6) | 0.642 | ||
| Complications | ||||||
| PPM implantation | 3 (1.6) | 2 (2.1) | 1 (1.1) | 0.621 | ||
| Cardiac tamponade | 2 (1.1) | 2 (2.1) | 0 (0.0) | 0.246 | ||
| Coronary obstruction | - | - | - | - | ||
| MI | - | - | - | - | ||
| New onset AF | 8 (4.2) | 4 (4.3) | 4 (4.2) | 1.000 | ||
| LBBB | 10 (5.3) | 5 (5.3) | 5 (5.3) | 1.000 | ||
| Transient | 6 (3.2) | 3 (3.2) | 3 (3.2) | |||
| Persistent | 4 (2.1) | 2 (2.1) | 2 (2.1) | |||
| RBBB | 3 (1.6) | 1 (1.1) | 2 (2.1) | 1.000 | ||
| Major bleeding | 2 (1.1) | 2 (2.1) | 0 (0.0) | 0.246 | ||
| Mitral injury | - | - | - | - | ||
| Aortic dissection | - | - | - | - | ||
| Annular rupture | 1 (0.5) | 1 (1.1) | 0 (0.0) | 0.497 | ||
| LV perforation | - | - | - | - | ||
| TAV-in-TAV | 4 (2.1) | 2 (2.1) | 2 (2.1) | 1.000 | ||
| Valve malposition | 3 (1.6) | 3 (3.2) | 0 (0.0) | 0.121 | ||
| Emergent operation | 2 (1.1) | 2 (2.1) | 0 (0.0) | 0.246 | ||
| Procedure time (minutes) | 92.1±56.2 | 107.7±66.7 | 77.1±38.4 | <0.001 | ||
| Hospital duration (days) | 12.1±11.2 | 13.6±13.8 | 10.5±7.4 | 0.053 | ||
Values are presented as number of patients (%) or mean±standard deviation.
AF = atrial fibrillation; LBBB = left bundle branch block; LV = left ventricular; MI = myocardial infarction; PPM = permanent pacemaker; RBBB = right bundle branch block; TA = transapical; TAV = transcatheter aortic valve; TF = transfemoral.