Table 1.
Baseline Demographic and Clinical Characteristics in the Total Cohort
| Variable | Total population (N=1673) | Evolut‐Pro/Evolut R 34 mm (N=917) | S3‐Ultra (N=756) | P value |
|---|---|---|---|---|
| General demographics | ||||
| Female sex, n (%) | 706 (42.2) | 385 (42) | 321 (42.5) | 0.827 |
| Age, y | 81.2±7.3 | 81.5±7.1 [914] | 80.9±7.5 [752] | 0.152 |
| BMI, kg/m2 | 26.8 (24–30.5) | 26.8 (24–30.5) [857] | 26.8 (24–30.5) [701] | 0.889 |
| Cardiovascular risk factors and medical history | ||||
| Diabetes, n (%) | 428 (26.4) | 228 (25.6) | 200 (27.4) | 0.382 |
| Smoking, n (%) | ||||
| Ex smoker | 727 (46.1) | 404 (46.2) | 323 (46) | 0.446 |
| Current smoker | 55 (3.5) | 35 (4) | 20 (2.8) | |
| On dialysis, n (%) | 26 (1.6) | 11 (1.3) | 15 (2) | 0.224 |
| Creatinine, mmol/L | 88 (71–112) | 87 (71–112) [857] | 88 (71–112) [714] | 0.654 |
| Previous cardiac surgery, n (%) | ||||
| Isolated CABG | 203 (12.6) | 114 (12.9) | 89 (12.2) | 0.871 |
| Valvular surgery | 64 (4) | 35 (4) | 29 (4) | |
| CABG and valve | 5 (0.3) | 2 (0.2) | 3 (0.4) | |
| Previous BAV, n (%) | 128 (7.9) | 76 (8.6) | 52 (7.1) | 0.268 |
| Previous PCI, n (%) | 422 (26.1) | 236 (26.6) | 186 (25.5) | 0.598 |
| Previous MI, n (%) | 194 (12.0) | 96 (10.8) | 98 (13.4) | 0.111 |
| PAD, n (%) | 168 (10.3) | 99 (11) | 69 (9.5) | 0.316 |
| COPD or asthma, n (%) | 333 (20.5) | 179 (20.1) | 154 (21.2) | 0.441 |
| Previous CVA, n (%) | 95 (5.8) | 48 (5.5) | 47 (6.5) | 0.135 |
| Preexisting PPM, n (%) | 114 (7.6) | 87 (9.9) | 27 (4.3) | <0.001 |
| Echocardiographic data | ||||
| LV function, n (%) | ||||
| Good (EF>50%) | 1203 (75.1) | 638 (73.5) | 565 (77.1) | |
| Moderate (EF=30%–49%) | 266 (16.6) | 168 (19.4) | 98 (13.4) | 0.002 |
| Poor (EF<30%) | 132 (8.2) | 62 (7.1) | 70 (9.5) | |
| Mean AV gradient, mm Hg | 44.1±17.8 | 44.5±18.5 [818] | 43.5±16.8 [622] | 0.113 |
| Peak AV gradient, mm Hg | 71.6±31.7 | 72.2±33.5 [822] | 70.8±29.2 [652] | 0.955 |
| Mitral regurgitation, n (%) | ||||
| None | 327 (22.7) | 160 (18.7) | 167 (28.5) | <0.001 |
| Mild | 823 (57.2) | 506 (59.3) | 317 (54.2) | |
| Moderate | 254 (17.7) | 168 (19.7) | 86 (14.7) | |
| Severe | 35 (2.4) | 20 (2.3) | 15 (2.6) | |
| Pulmonary artery pressure, mm Hg | 35 (27–45) | 34 (24–45) [571] | 37 (30–45) [269] | <0.001 |
| Bicuspid aortic valve, n (%) | 41 (2.4) | 29 (2.6) | 12 (1.6) | 0.534 |
| Coronary angiography | ||||
| Extent of epicardial CAD, n (%) | ||||
| Single vessel | 227 (14.2) | 109 (12.4) | 118 (16.5) | |
| Two vessel | 118 (7.4) | 43 (4.9) | 75 (10.5) | <0.001 |
| Three vessel | 58 (3.6) | 22 (2.5) | 36 (5) | |
| Significant LMS disease, n (%) | 21 (1.3) | 7 (0.8) | 14 (1.9) | 0.048 |
| Computed tomography data | ||||
| Annulus perimeter, mm | 78 (73–84) | 78.0 (73–84) [775] | 78.6 (73–84) [370] | 0.387 |
| Extensive calcification of the aorta, n (%)* | 33 (2.4) | 24 (3.3) | 9 (1.4) | 0.018 |
| ECG | ||||
| Bundle‐branch block, % | ||||
| None | 85.7 | 85.6 | 85.7 | 0.385 |
| LBBB | 5.2 | 4.6 | 5.2 | |
| RBBB | 3.6 | 3.7 | 3.6 | |
| Preoperative heart rhythm, n (%) | ||||
| Sinus rhythm | 1072 (65.7) | 587 (65.6) | 485 (65.8) | |
| AF/flutter | 470 (28.8) | 249 (27.8) | 221 (30) | 0.256 |
| Paced | 86 (5.3) | 56 (6.3) | 30 (4.1) | |
Data are given as mean±SD or median (interquartile range) unless otherwise indicated. Data in brackets are number of patients with available data. AF indicates atrial fibrillation; AV, aortic valve; BAV, balloon aortic valvuloplasty; BMI, body mass index; CABG, coronary artery bypass grafting; CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; CVA, cerebrovascular accident; EF, ejection fraction; LBBB, left bundle‐branch block; LMS, left main stem; LV, left ventricular; MI, myocardial infarction; PAD, peripheral artery disease; PCI, percutaneous coronary intervention; PPM, permanent pacemaker; and RBBB, right bundle‐branch block.
Includes calcifications of LV outflow tract and aortic annulus.