Table 2.
Procedural features at unadjusted analysis.
| Feature | Acurate | Evolut | Lotus | Portico | Sapien3 | P |
|---|---|---|---|---|---|---|
| Patients | 234 | 703 | 151 | 347 | 541 | — |
| Local anesthesia | 202 (86.3%) | 594 (84.5%) | 134 (88.7%) | 313 (90.2%) | 420 (77.6%) | <0.001 |
| Transephageal guidance | 76 (32.5%) | 10 (1.4%) | 47 (31.1%) | 128 (36.9%) | 51 (9.4%) | <0.001 |
| Femoral access | 216 (92.3%) | 612 (87.1%) | 141 (93.4%) | 303 (87.3%) | 510 (94.3%) | <0.001 |
| Percutaneous approach | 208 (88.9%) | 616 (87.6%) | 130 (86.1%) | 305 (87.9%) | 464 (85.8%) | 0.732 |
| Sheathless procedure | 5 (2.1%) | 160 (22.8%) | 4 (2.7%) | 6 (1.7%) | 26 (4.8%) | <0.001 |
| Sheath size (French) | 18.4 ± 2.1 | 15.1 ± 1.7 | 18.4 ± 1.8 | 18.4 ± 0.7 | 14.5 ± 1.7 | <0.001 |
| Embolic protection device | <0.001 | |||||
| None | 232 (99.2%) | 702 (99.9%) | 150 (99.3%) | 345 (99.4%) | 519 (95.9%) | |
| Claret | 1 (0.4%) | 1 (0.1%) | 1 (0.7%) | 2 (0.6%) | 20 (3.7%) | |
| Shimon | 1 (0.4%) | 0 | 0 | 0 | 2 (0.4%) | |
| Right ventricular pacing | 118 (50.4%) | 422 (60.0%) | 60 (39.7%) | 192 (55.3%) | 452 (83.6%) | <0.001 |
| Predilation | <0.001 | |||||
| None | 82 (35.0%) | 272 (38.7%) | 93 (61.6%) | 117 (33.7%) | 92 (17.0%) | |
| One balloon | 149 (63.7%) | 417 (59.3%) | 58 (38.4%) | 225 (64.8%) | 449 (83.0%) | |
| Two balloons | 3 (1.3%) | 14 (2.0%) | 0 | 5 (1.4%) | 0 | |
| Balloon diameter (mm) | 21.8 ± 2.9 | 20.4 ± 2.0 | 20.3 ± 1.9 | 20.7 ± 1.6 | 21.6 ± 2.0 | <0.001 |
| Balloon type | <0.001 | |||||
| Cristal | 52 (34.2%) | 19 (4.4%) | 0 | 25 (10.9%) | 7 (1.6%) | |
| Nucleus | 3 (2.0%) | 37 (8.5%) | 7 (12.1%) | 0 | 4 (0.9%) | |
| Z.Med | 24 (15.8%) | 72 (16.6%) | 23 (39.7%) | 1 (0.4%) | 4 (0.9%) | |
| Other | 73 (48.0%) | 307 (70.6%) | 28 (48.3%) | 204 (88.7%) | 434 (96.7%) | |
| Prosthesis | 0.029 | |||||
| One | 230 (98.3%) | 681 (96.9%) | 150 (99.3%) | 340 (98.0%) | 537 (99.3%) | |
| Two | 4 (1.7%) | 22 (3.1%) | 1 (0.7%) | 7 (2.0%) | 4 (0.7%) | |
| Heterogenous device | 1 (0.4%) | 0 | 0 | 0 | 0 | 0.114 |
| Device size (French) | 25.0 ± 2.1 | 28.1 ± 3.1 | 24.9 ± 2.0 | 26.4 ± 2.2 | 25.0 ± 2.4 | <0.001 |
| Pacing during implant | 71 (30.3%) | 152 (21.6%) | 16 (10.6%) | 18 (5.2%) | 501 (92.6%) | <0.001 |
| Pacing rate (bpm) | 181 ± 25 | 158 ± 36 | 145 ± 59 | 163 ± 24 | 182 ± 12 | <0.001 |
| Postdilation | 111 (47.4%) | 202 (28.7%) | 2 (1.3%) | 165 (47.6%) | 27 (5.0%) | <0.001 |
| Balloon diameter (mm) | 23.2 ± 1.9 | 24.1 ± 2.6 | 20 ± 0 | 23.9 ± 2.0 | 22.4 ± 2.1 | <0.001 |
| Balloon length (mm) | 42.1 ± 4.7 | 40.8 ± 2.4 | 40.0 ± 0 | 41.1 ± 2.9 | 40.9 ± 7.4 | 0.415 |
| Fluoroscopy time (seconds) | 22.7 ± 13.5 | 26.3 ± 16.3 | 30.0 ± 11.0 | 26.4 ± 14.1 | 21.5 ± 14.8 | <0.001 |
| Procedural time (minutes) | 120.5 ± 50.8 | 113.0 ± 51.5 | 104.5 ± 39.6 | 87.4 ± 43.1 | 113.1 ± 46.6 | <0.001 |
| Device success | 232 (99.2%) | 693 (98.6%) | 148 (98.0%) | 343 (98.9%) | 533 (98.5%) | 0.899 |
| Procedural success | 232 (99.2%) | 693 (98.6%) | 148 (99.4%) | 345 (99.4%) | 533 (98.5%) | 0.627 |
| Complications | ||||||
| Death | 1 (0.4%) | 2 (0.3%) | 3 (2.0%) | 1 (0.3%) | 6 (1.1%) | 0.085 |
| Valve migration | 5 (2.1%) | 7 (1.0%) | 0 | 0 | 1 (0.2%) | 0.007 |
| Anulus rupture | 0 | 0 | 0 | 0 | 2 (0.4%) | 0.257 |
| Surgical conversion | 0 | 1 (0.1%) | 1 (0.7%) | 2 (0.6%) | 2 (0.4%) | 0.576 |
| Coronary occlusion | 0 | 1 (0.1%) | 0 | 0 | 2 (0.4%) | 0.590 |
| Myocardial infarction | 0 | 1 (0.1%) | 0 | 0 | 1 (0.2%) | 0.873 |
| Pericardial tamponade | 1 (0.4%) | 2 (0.3%) | 3 (2.0%) | 2 (0.6%) | 8 (1.5%) | 0.069 |
| Aortic dissection | 0 | 3 (0.4%) | 0 | 3 (0.9%) | 2 (0.4%) | 0.492 |
| Major vascular complication | 7 (3.0%) | 25 (3.6%) | 5 (3.3%) | 11 (3.2%) | 21 (3.9%) | 0.969 |
| Major bleeding | 8 (3.4%) | 39 (5.6%) | 5 (3.3%) | 8 (2.3%) | 43 (8.0%) | 0.002 |