Table 3.
Baseline Demographic and Clinical Characteristics in the Propensity‐Matched Small THV Cohort
| Variable | Total population (N=278) | Evolut‐Pro/Evolut R 34 mm (N=139) | S3‐Ultra (N=139) | P value |
|---|---|---|---|---|
| General demographics | ||||
| Female sex, n (%) | 224 (80.6) | 114 (82) | 110 (79.1) | 0.650 |
| Age, y | 83 (78–87) | 83 (78–88) | 83 (77–87) | 0.423 |
| BMI, kg/m2 | 26.7 (23.8–30.9) | 26.6 (23–30.2) | 26.8 (24.4–32) | 0.114 |
| Cardiovascular risk factors and medical history | ||||
| Diabetes, n (%) | 78 (28.2) | 42 (30.4) | 36 (25.9) | 0.4 |
| Smoking, n (%) | ||||
| Ex smoker | 101 (37.3) | 57 (41.6) | 44 (32.8) | 0.209 |
| Current smoker | 4 (1.5) | 3 (2.2) | 1 (0.7) | |
| On dialysis, n (%) | 6 (2.2) | 1 (0.7) | 5 (3.6) | 0.214 |
| Creatinine, mmol/L | 79 (65–103) | 78 (65–103) | 80 (66–105) | 0.498 |
| Previous cardiac surgery, n (%) | ||||
| Isolated CABG | 20 (7.2) | 10 (7.2) | 10 (7.2) | 0.935 |
| Valvular surgery | 10 (3.6) | 6 (4.3) | 4 (2.9) | |
| CABG and valve | 2 (0.7) | 1 (0.7) | 1 (0.7) | |
| Previous BAV, n (%) | 0 | 0 | 0 | |
| Previous PCI, n (%) | 66 (23.7) | 31 (22.3) | 35 (25.2) | 0.573 |
| Previous MI, n (%) | 29 (10.5) | 16 (11.6) | 13 (9.4) | 0.542 |
| PAD, n (%) | 19 (6.8) | 12 (8.6) | 7 (5) | 0.235 |
| COPD or asthma, n (%) | 60 (21.7) | 31 (22.3) | 29 (21) | 0.098 |
| Previous CVA, n (%) | 12 (4.3) | 4 (2.8) | 8 (5.7) | 0.627 |
| Echocardiographic data | ||||
| LV function, n (%) | ||||
| Good (EF>50%) | 250 (89.9) | 122 (87.8) | 128 (92.1) | 0.430 |
| Moderate (EF=30%–49%) | 24 (8.6) | 15 (10.8) | 9 (6.5) | |
| Poor (EF<30%) | 4 (1.4) | 2 (1.4) | 2 (1.4) | |
| Mean AV gradient, mm Hg | 47.8±18.4 | 48.6±19.3 | 46.9±17.5 | 0.460 |
| Peak AV gradient, mm Hg | 76.4±28.4 | 75.8±30 | 76.9±26.9 | 0.770 |
| Mitral regurgitation, n (%) | 0.902 | |||
| None | 61 (21.9) | 29 (20.9) | 32 (23) | |
| Mild | 184 (66.2) | 94 (67.6) | 90 (64.7) | |
| Moderate | 33 (11.9) | 16 (11.5) | 17 (12.2) | |
| Severe | 0 | 0 | 0 | |
| Bicuspid aortic valve, n (%) | 1 (1.3) | 0 | 1 (2.3) | 1.0 |
| Coronary angiography | ||||
| Extent of epicardial CAD, n (%) | ||||
| Single vessel | 38 (14.2) | 17 (12.4) | 21 (16) | 0.688 |
| Two vessel | 9 (3.4) | 5 (3.6) | 4 (3.1) | |
| Three vessel | 8 (3.0) | 3 (2.2) | 5 (3.8) | |
| Significant LMS disease, n (%) | 2 (1.5) | 2 (1.5) | 0 | 0.498 |
| Computed tomography data | ||||
| Annulus perimeter, mm | 71 (68.2–74.9) | 71.1 (67.5–74.5) | 71 (67.3–74.8) | 0.769 |
| Extensive calcification of the aorta, %* | 0 | 0 | 0 | N/A |
| ECG | ||||
| Bundle‐branch block, n (%) | ||||
| None | 216 (93.1) | 114 (90.5) | 102 (96.2) | 0.190 |
| LBBB | 8 (3.4) | 6 (4.8) | 2 (1.9) | |
| RBBB | 4 (1.7) | 2 (1.6) | 2 (1.9) | |
| Preoperative heart rhythm, n (%) | ||||
| Sinus rhythm | 206 (74.1) | 105 (75.5) | 101 (72.7) | 0.034 |
| AF/flutter | 62 (22.3) | 25 (18) | 37 (26.6) | |
| Paced | 10 (3.6) | 9 (6.5) | 1 (0.7) | |
Data are given as median (interquartile range) unless otherwise indicated. 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; RBBB, right bundle‐branch block; and THV, transcatheter heart valve.
Includes calcifications of LV outflow tract and aortic annulus.