Table 1.
Baseline characteristics
| Conventional AVR |
TAVI |
P-value of global hypothesis |
P-values of pairwise comparisons [alpha level has to be corrected by the Bonferoni–Holm–Shaffer method for multiple comparisons (6-3-3-3-2-1-rule)] |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Without CABG | With CABG | Transvascular | Transapical | H0: no differences between any procedures | H0: AVR = AVR + CABG | H0: AVR = TV TAVI | H0: AVR = TA TAVI | H0: AVR + CABG = TV TAVI | H0: AVR + CABG = TA TAVI | H0: TV TAVI = TA TAVI | |
| n | 6523 | 3462 | 2694 | 1181 | |||||||
| Mean age (years) | 68.3 ± 11.3 | 72.5 ± 8.0 | 81.1 ± 6.2 | 80.3 ± 6.1 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 |
| Female | 2543 (39.0%) | 984 (28.4%) | 1583 (58.8%) | 588 (49.8%) | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 |
| Mean BMI (kg/m2) | 28.1 ± 4.9 | 28.2 ± 4.4 | 27.0 ± 4.9 | 27.2 ± 5.0 | <0.001 | 0.011 | <0.001 | <0.001 | <0.001 | <0.001 | 0.123 |
| New York Heart Association (%) | |||||||||||
| Class I | 489 (7.5) | 197 (5.7) | 92 (3.4) | 40 (3.4) | <0.001 | 0.001 | <0.001 | <0.001 | <0.001 | 0.002 | 1.000 |
| Class II | 1977 (30.3) | 874 (25.2) | 297 (11.0) | 129 (10.9) | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 0.956 |
| Class III | 3726 (57.1) | 2168 (62.6) | 1968 (73.1) | 883 (74.8) | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 0.268 |
| Class IV | 331 (5.1) | 223 (6.4) | 337 (12.5) | 129 (10.9) | <0.001 | 0.005 | <0.001 | <0.001 | <0.001 | <0.001 | 0.180 |
| CAD | 1213 (18.6) | 3362 (97.1) | 1444 (53.6) | 663 (56.1) | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 0.151 |
| Myocardial infarction (%) | |||||||||||
| Within 21 days | 49 (0.8) | 171 (4.9) | 91 (3.4) | 22 (1.9) | <0.001 | <0.001 | <0.001 | 0.001 | 0.003 | <0.001 | 0.009 |
| 22–90 days | 46 (0.7) | 89 (2.6) | 74 (2.7) | 38 (3.2) | <0.001 | <0.001 | <0.001 | <0.001 | 0.690 | 0.256 | 0.407 |
| More than 90 days | 224 (3.4) | 290 (8.4) | 266 (9.9) | 153 (13.0) | <0.001 | <0.001 | <0.001 | <0.001 | 0.044 | <0.001 | 0.005 |
| Previous PCI (%) | 522 (8.0) | 599 (17.3) | 780 (29.0) | 348 (29.5) | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 0.759 |
| Previous cardiac surgery (%) | 612 (9.4) | 220 (6.4) | 475 (17.7) | 348 (29.6) | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 |
| Pulmonary hypertension (%) | 697 (10.8) | 380 (11.1) | 1063 (39.8) | 273 (23.4) | <0.001 | 0.635 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 |
| Insulin-dependent DM (%) | 532 (8.2) | 448 (12.9) | 359 (13.3) | 206 (17.5) | <0.001 | <0.001 | <0.001 | <0.001 | 0.675 | <0.001 | 0.001 |
| Arterial hypertension (%) | 5148 (79.5) | 2968 (86.1) | 2321 (86.4) | 1058 (90.0) | <0.001 | <0.001 | <0.001 | <0.001 | 0.737 | 0.001 | 0.002 |
| Atrial fibrillation (%) | 1039 (15.9) | 521 (15.0) | 779 (28.9) | 348 (29.5) | <0.001 | 0.259 | <0.001 | <0.001 | <0.001 | <0.001 | 0.730 |
| Obstructive lung disease (%) | |||||||||||
| On medication | 407 (6.2) | 243 (7.0) | 406 (15.1) | 166 (14.1) | <0.001 | 0.136 | <0.001 | <0.001 | <0.001 | <0.001 | 0.431 |
| Without medication | 248 (3.8) | 179 (5.2) | 126 (4.7) | 75 (6.4) | <0.001 | 0.002 | 0.055 | <0.001 | 0.407 | 0.120 | 0.033 |
| LVEF (%) | |||||||||||
| <30 | 199 (3.1) | 176 (5.1) | 250 (9.3) | 88 (7.5) | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 0.004 | 0.064 |
| 30–50 | 1381 (21.2) | 972 (28.1) | 817 (30.3) | 418 (35.4) | <0.001 | <0.001 | <0.001 | <0.001 | 0.054 | <0.001 | 0.002 |
| Decompensated heart failure (%) | |||||||||||
| Within 12 months | 1047 (16.5) | 711 (21.2) | 1159 (44.9 | 449 (39.5) | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 0.002 |
| Dialysis (%) | |||||||||||
| Acute | 94 (1.4) | 55 (1.6) | 43 (1.6) | 39 (3.3) | <0.001 | 0.603 | 0.571 | <0.001 | 1.000 | 0.001 | 0.001 |
| Chronic | 79 (1.2) | 52 (1.5) | 83 (3.1) | 54 (4.6) | <0.001 | 0.230 | <0.001 | <0.001 | <0.001 | <0.001 | 0.023 |
| Active endocarditis (%) | 216 (3.3) | 51 (1.5) | 2 (0.1 | 1 (0.1) | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 1.000 |
| Cardiogenic shock (%) | |||||||||||
| Within 48 h | 64 (1.0) | 53 (1.5) | 104 (3.9 | 22 (1.9 | <0.001 | 0.019 | <0.001 | 0.015 | <0.001 | 0.423 | 0.001 |
| Cardiopulmonary resuscitation (%) | |||||||||||
| Within 48 h | 4 (0.1) | 9 (0.3) | 5 (0.2) | 1 (0.1) | 0.050 | 0.016 | 0.134 | 0.564 | 0.601 | 0.468 | 0.674 |
| Patient on mechanical ventilation (%) | 38 (0.6) | 17 (0.5) | 72 (2.7) | 8 (0.7) | <0.001 | 0.670 | <0.001 | 0.681 | <0.001 | 0.490 | <0.001 |
| Neurologicaldysfunction (%) | 489 (7.5) | 304 (8.8) | 352 (13.1) | 174 (14.7) | <0.001 | 0.027 | <0.001 | <0.001 | <0.001 | <0.001 | 0.169 |
| Preop inotropic support (%) | 71 (1.1) | 52 (1.5) | 158 (5.9) | 18 (1.5) | <0.001 | 0.086 | <0.001 | 0.234 | <0.001 | 1.000 | <0.001 |
| Preop IABP (%) | 11 (0.2) | 17 (0.5) | 2 (0.1) | 0 (0.0) | 0.001 | 0.005 | 0.369 | 0.391 | 0.004 | 0.010 | 1.000 |
| Atherosclerotic disease (%) | 1310 (20.1) | 951 (27.5) | 735 (27.3) | 505 (42.8) | <0.001 | <0.001 | <0.001 | <0.001 | 0.863 | <0.001 | <0.001 |
| Peripheral (extremities) | 298 (4.6) | 402 (11.6) | 442 (16.4) | 335 (28.4) | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 |
| Carotid disease | 358 (5.5) | 457 (13.2) | 302 (11.2) | 209 (17.7) | <0.001 | <0.001 | <0.001 | <0.001 | 0.019 | <0.001 | <0.001 |
| Aortic aneurism | 636 (9.8) | 225 (6.5) | 90 (3.3) | 67 (5.7) | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 0.332 | 0.001 |
| Other | 216 (3.3) | 133 (3.9) | 132 (4.9) | 101 (8.6) | <0.001 | 0.169 | <0.001 | <0.001 | 0.050 | <0.001 | <0.001 |
| Intervention (%) | |||||||||||
| Elective | 5554 (85.1) | 2750 (79.4) | 2088 (77.5) | 1009 (85.4) | <0.001 | <0.001 | <0.001 | 0.824 | 0.069 | <0.001 | <0.001 |
| Urgent | 891 (13.7) | 643 (18.6) | 567 (21.0) | 167 (14.1) | <0.001 | <0.001 | <0.001 | 0.646 | 0.017 | <0.001 | <0.001 |
| Emergent | 78 (1.2) | 69 (2.0) | 39 (1.4 | 5 (0.4) | <0.001 | 0.002 | 0.357 | 0.014 | 0.117 | <0.001 | 0.005 |
BMI, body mass index; CAD, coronary artery disease; PCI, percutaneous coronary intervention; DM, diabetes mellitus; IABP, intra-aortic balloon pump.