Table 3.
One-month outcomes at unadjusted analysis.
| Feature | Acurate | Evolut | Lotus | Portico | Sapien3 | P |
|---|---|---|---|---|---|---|
| Patients | 234 | 703 | 151 | 347 | 541 | — |
| Clinical outcomes | ||||||
| Major adverse event* | 60 (25.6%) | 135 (19.2%) | 24 (15.9%) | 40 (11.5%) | 131 (24.2%) | <0.001 |
| Death | 4 (1.7%) | 11 (1.6%) | 4 (2.7%) | 8 (2.3%) | 8 (1.5%) | 0.794 |
| Cardiac death | 1 (0.4%) | 4 (0.6%) | 3 (2.0%) | 2 (0.6%) | 6 (1.1%) | 0.357 |
| Surgical aortic valve replacement | 0 | 1 (0.1%) | 1 (0.7%) | 3 (0.9%) | 2 (0.4%) | 0.320 |
| Valve thrombosis | 0 | 2 (0.3%) | 0 | 0 | 1 (0.2%) | 0.742 |
| Valve degeneration | 0 | 0 | 0 | 0 | 0 | 1 |
| Endocarditis | 0 | 0 | 0 | 0 | 0 | 1 |
| Coronary occlusion | 0 | 1 (0.1%) | 0 | 0 | 2 (0.4%) | 0.590 |
| Myocardial infarction | 0 | 2 (0.3%) | 0 | 0 | 2 (0.4%) | 0.650 |
| Pericardial effusion | 12 (5.1%) | 27 (3.8%) | 6 (4.0%) | 8 (2.3%) | 46 (8.5%) | <0.001 |
| Stroke | 1 (0.4%) | 12 (1.7%) | 4 (2.7%) | 2 (0.6%) | 7 (1.3%) | 0.216 |
| Transient ischemic attack | 0 | 2 (0.3%) | 0 | 1 (0.3%) | 0 | 0.618 |
| Stroke or transient ischemic attack | 1 (0.4%) | 13 (1.9%) | 4 (2.7%) | 3 (0.9%) | 7 (1.3%) | 0.283 |
| Major vascular complication | 33 (14.1%) | 61 (8.7%) | 8 (5.3%) | 17 (4.9%) | 68 (12.6%) | <0.001 |
| Amputation | 0 | 0 | 0 | 0 | 0 | 1 |
| Major bleeeding | 10 (4.3%) | 20 (2.8%) | 7 (4.6%) | 9 (2.6%) | 27 (5.0%) | 0.218 |
| Renal failure | 26 (11.1%) | 63 (9.0%) | 9 (6.0%) | 16 (4.6%) | 47 (8.7%) | 0.035 |
| Permanent pacemaker | 13 (5.6%) | 122 (17.4%) | 35 (23.2%) | 42 (12.1%) | 72 (13.3%) | <0.001 |
| Echocardiographic outcomes | ||||||
| Left ventricular end-diastolic diameter (mm) | 45.6 ± 9.3 | 49.2 ± 10.5 | 49.6 ± 8.1 | 46.7 ± 6.9 | 49.1 ± 8.5 | 0.002 |
| Left ventricular end-systolic diameter (mm) | 32.1 ± 8.2 | 32.3 ± 10.5 | 33.2 ± 9.5 | 31.6 ± 8.0 | 32.1 ± 11.5 | 0.971 |
| Left ventricular ejection fraction (%) | 55.2 ± 9.5 | 53.3 ± 9.6 | 52.9 ± 10.4 | 54.2 ± 9.1 | 53.2 ± 9.2 | 0.051 |
| Peak aortic gradient (mm Hg) | 16.0 ± 9.5 | 15.3 ± 7.9 | 19.6 ± 14.0 | 18.2 ± 13.2 | 21.6 ± 11.5 | <0.001 |
| Mean aortic gradient (mm Hg) | 9.2 ± 0.4.4 | 8.2 ± 4.6 | 12.1 ± 5.4 | 9.4 ± 6.1 | 11.6 ± 5.1 | <0.001 |
| Aortic valve area (mm2) | 1.17 ± 0.47 | 1.43 ± 0.49 | 1.28 ± 0.37 | 1.04 ± 0.47 | 1.37 ± 0.47 | <0.001 |
| Aortic regurgitation | <0.001 | |||||
| None | 44 (20.9%) | 207 (35.3%) | 91 (67.4%) | 133 (44.5%) | 240 (50.0%) | |
| 1+ | 135 (64.0%) | 309 (52.7%) | 40 (29.6%) | 139 (46.5%) | 224 (46.7%) | |
| 2+ | 32 (15.2%) | 66 (11.3%) | 4 (3.0%) | 26 (8.7%) | 16 (3.3%) | |
| 3+ | 0 | 4 (0.7%) | 0 | 1 (0.3%) | 0 | |
| 4+ | 0 | 0 | 0 | 0 | 0 | |
| Mitral regurgitation | <0.001 | |||||
| None | 12 (5.2%) | 42 (7.0%) | 6 (4.2%) | 20 (6.0%) | 21 (4.0%) | |
| 1+ | 131 (57.2%) | 367 (61.0%) | 87 (60.4%) | 199 (59.8%) | 263 (50.3%) | |
| 2+ | 64 (28.0%) | 37 (6.2%) | 42 (29.2%) | 86 (25.8%) | 193 (36.9%) | |
| 3+ | 15 (6.6%) | 140 (23.3%) | 8 (5.6%) | 20 (6.0%) | 36 (6.9%) | |
| 4+ | 7 (3.1%) | 16 (2.7%) | 1 (0.7%) | 8 (2.4%) | 10 (1.9%) | |
| Systolic pulmonary artery pressure (mm Hg) | 36.7 ± 11.8 | 38.1 ± 15.0 | 38.2 ± 11.9 | 37.8 ± 11.0 | 35.5 ± 9.5 | 0.052 |
*Composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure.