Table 2.
Baseline Demographic and Clinical Characteristics in the Small Valve Cohort
| Variable | Total population (N=544) | Evolut‐Pro/Evolut R 34 mm (N=284) | S3‐Ultra (N=260) | P value |
|---|---|---|---|---|
| General demographics | ||||
| Female sex, n (%) | 440 (80.9) | 235 (82.7) | 205 (78.8) | 0.248 |
| Age, y | 81.8±7.3 | 82.4±6.4 [283] | 81±8.1 [258] | 0.029 |
| BMI, kg/m2 | 26.5 (23.4–30.2) | 26.3 (23–30.1) [268] | 26.6 (24.1– 30.7) [241] | 0.242 |
| Cardiovascular risk factors and medical history | ||||
| Diabetes, n (%) | 139 (26.2) | 75 (26.7) | 64 (25.6) | 0.529 |
| Smoking, n (%) | ||||
| Ex smoker | 186 (35.8) | 103 (37.1) | 83 (34.3) | 0.425 |
| Current smoker | 15 (2.9) | 10 (3.6) | 5 (2.1) | |
| On dialysis, n (%) | 8 (1.5) | 2 (0.7) | 6 (2.4) | 0.124 |
| Creatinine, mmol/L | 80 (65–103) | 81 (65–104) [268] | 79.5 (64.3–100) [244] | 0.735 |
| Previous cardiac surgery, n (%) | ||||
| Isolated CABG | 37 (7) | 17 (6.2) | 20 (8) | 0.882 |
| Valvular surgery | 27 (5.1) | 14 (5.1) | 13 (5.2) | |
| CABG and valve | 4 (0.8) | 2 (0.7) | 2 (0.8) | |
| Previous BAV, n (%) | 26 (4.9) | 8 (2.9) | 18 (7.2) | 0.024 |
| Previous PCI, n (%) | 121 (23.1) | 65 (23.6) | 56 (22.6) | 0.775 |
| Previous MI, n (%) | 53 (10) | 27 (9.7) | 26 (10.3) | 0.817 |
| PAD, n (%) | 39 (7.3) | 22 (7.8) | 17 (6.8) | 0.658 |
| COPD or asthma, n (%) | 111 (21) | 60 (21.5) | 51 (20.4) | 0.580 |
| Previous CVA, n (%) | 22 (4.1) | 9 (3.2) | 11 (5.2) | 0.464 |
| Echocardiographic data | ||||
| LV function, n (%) | ||||
| Good (EF>50%) | 444 (85.2) | 222 (81.9) | 222 (88.8) | 0.070 |
| Moderate (EF=30%–49%) | 61 (11.7) | 40 (14.8) | 21 (8.4) | |
| Poor (EF<30%) | 16 (3.1) | 9 (3.3) | 7 (2.8) | |
| Mean AV gradient, mm Hg | 46.9±19.3 | 46.9±19.5 [254] | 47±19.1 [218] | 0.929 |
| Peak AV gradient, mm Hg | 74.6±29.2 | 73.8±25.7 [253] | 75.5±32.6 [251] | 0.526 |
| Mitral regurgitation, n (%) | ||||
| None | 105 (21.8) | 44 (16.1) | 61 (29.3) | 0.002 |
| Mild | 282 (58.6) | 171 (62.6) | 111 (53.4) | |
| Moderate | 85 (17.7) | 55 (20.1) | 30 (14.4) | |
| Severe | 9 (1.9) | 3 (1.1) | 6 (2.9) | |
| Pulmonary artery pressure, mm Hg | 36 (29–45.8) | 36 (28–45) | 37 (30–47.5) | 0.129 |
| Bicuspid aortic valve, n (%) | 9 (1.7) | 5 (1.8) | 4 (1.7) | 0.805 |
| Coronary angiography | ||||
| Extent of epicardial CAD, n (%) | ||||
| Single vessel | 64 (12.5) | 31 (11.4) | 33 (13.7) | 0.097 |
| Two vessel | 27 (5.3) | 9 (3.3) | 18 (7.5) | |
| Three vessel | 14 (2.7) | 6 (2.2) | 8 (3.3) | |
| Significant LMS disease, n (%) | 4 (0.8) | 3 (1.1) | 1 (0.4) | 0.359 |
| Computed tomography data | ||||
| Annulus perimeter, mm | 72 (68.7–75) | 72 (68.9–75) [148] | 71 (68–75) [50] | 0.427 |
| Extensive calcification of the aorta, n (%)* | 6 (1.3) | 6 (2.4) | 0 | 0.031 |
| ECG | ||||
| Bundle‐branch block, n (%) | ||||
| None | 480 (90.6) | 244 (87.8) | 236 (93.7) | 0.112 |
| LBBB | 21 (4) | 13 (4.7) | 8 (3.2) | |
| RBBB | 13 (2.5) | 9 (3.2) | 4 (1.6) | |
| Preoperative heart rhythm, n (%) | 0.231 | |||
| Sinus rhythm | 401 (75.4) | 207 (74.2) | 194 (76.7) | |
| AF/flutter | 114 (21.4) | 59 (21.1) | 55 (21.7) | |
| Paced | 16 (3) | 12 (4.3) | 4 (1.6) | |
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; LVEF, left ventricular; MI, myocardial infarction; PAD, peripheral artery disease; PCI, percutaneous coronary intervention; and RBBB, right bundle‐branch block.
Includes calcifications of LV outflow tract and aortic annulus.