Table 1.
Clinical baseline characteristics.
| Matched Cohort Myval n = 91 N (%) or Mean ± SD |
Evolut n = 91 N (%) or Mean ± SD |
p-Value | Complete Cohort Myval n = 120 N (%) or Mean ± SD |
Evolut n = 103 N (%) or Mean ± SD |
p-Value | |
|---|---|---|---|---|---|---|
| Clinical characteristics | ||||||
| Age | 80.0 ± 6.1 | 80.5 ± 5.5 | 0.58 | 80.2 ± 6.3 | 80.5 ± 5.6 | 0.76 |
| Male | 46 (51) | 46 (51) | 1.00 | 64 (53) | 53 (51) | 0.78 |
| BMI | 28.3 ± 4.3 | 28.2 ± 4.6 | 0.91 | 28.2 ± 4.6 | 27.8 ± 4.6 | 0.49 |
| Euroscore II | 3.7 ± 3.0 | 3.5 ± 2.7 | 0.64 | 4.0 ± 2.8 | 3.5 ± 2.8 | 0.92 |
| NYHA class III or IV | 28 (31) | 42 (46) | 0.03 | 23 (38) | 44 (43) | 0.0001 |
| Diabetes Mellitus | 34 (37) | 32 (35) | 0.76 | 43 (36) | 36 (35) | 0.89 |
| Hypertension | 65 (71) | 59 (65) | 0.34 | 85 (71) | 66 (64) | 0.28 |
| Coronary artery disease | 41 (45) | 37 (41) | 0.55 | 56 (47) | 45 (44) | 0.66 |
| Previous CABG | 13 (14) | 10 (11) | 0.50 | 13 (11) | 15 (15) | 0.40 |
| Previous valve surgery | 3 (3) | 2 (2) | 0.65 | 3 (3) | 3 (3) | 0.85 |
| Chronic kidney disease | 31 (34) | 30 (33) | 0.88 | 42 (35) | 39 (38) | 0.66 |
| Cerebrovascular disease | 19 (21) | 19 (21) | 1.00 | 24 (20) | 21 (20) | 0.94 |
| Peripheral vascular disease | 12 (13) | 12 (13) | 1.00 | 17 (14) | 12 (12) | 0.58 |
| COPD | 12 (13) | 17 (19) | 0.31 | 19 (16) | 18 (17) | 0.74 |
| Atrial fibrillation | 26 (29) | 25 (27) | 0.87 | 39 (33) | 27 (26) | 0.31 |
| Prior Pacemaker | 6 (7) | 5 (5) | 0.76 | 10 (8) | 5 (5) | 0.30 |
| RBBB | 11 (12) | 8 (9) | 0.47 | 12 (10) | 12 (12) | 0.69 |
| LBBB | 7 (8) | 6 (7) | 0.77 | 11 (9) | 7 (7) | 0.52 |
| 1st-degree AVB | 8 (9) | 17 (19) | 0.05 | 12 (10) | 19 (18) | 0.07 |
| Echocardiographic measurements | ||||||
| LVEF ≤ 40% | 9 (10) | 11 (12) | 0.64 | 16 (13) | 11 (11) | 0.54 |
| AV area, cm2 | 0.76 ± 0.16 | 0.77 ± 0.22 | 0.58 | 0.77 ± 0.18 | 0.77 ± 0.24 | 0.82 |
| AV mean gradient, mmHg | 37.8 ± 13.3 | 43.8 ± 17.9 | 0.02 | 37.4 ± 13.5 | 44.1 ± 17.6 | 0.003 |
| Moderate or severe aortic regurgitation | 0 (0) | 14 (15) | NA | 0 (0) | 14 (14) | NA |
| Moderate or severe mitral regurgitation | 14 (15) | 19 (21) | 0.34 | 18 (15) | 22 (21) | 0.22 |
| MDCT measurements | ||||||
| Maximum annulus diameter, mm | 27.4 ± 3.7 | 27.1 ± 3.0 | 0.60 | 27.7 ± 3.7 | 27.2 ± 2.9 | 0.35 |
| Minimum annulus diameter, mm | 21.2 ± 2.2 | 21.0 ± 2.8 | 0.67 | 21.3 ± 2.2 | 21.1 ± 2.7 | 0.53 |
| Perimeter derived diameter, mm | 24.7 ± 2.1 | 24.5 ± 2.7 | 0.59 | 24.9 ± 2.3 | 24.6 ± 2.6 | 0.37 |
| Area derived diameter, mm | 24.1 ± 2.1 | 23.9 ± 2.7 | 0.61 | 24.3 ± 2.2 | 24.0 ± 2.6 | 0.37 |
| Moderate–severe calcified aortic valve | 45 (49) | 56 (62) | 0.10 | 58 (48) | 66 (64) | 0.02 |
Abbreviations: BMI = Body Mass Index, NYHA = New York Heart Association, CABG = Coronary Artery Bypass Grafting, COPD = Chronic Obstructive Pulmonary Disease, RBBB = Right Bundle Branch Block, LBBB = Left Bundle Branch Block, AVB = Atrioventricular Block, LVEF = Left Ventricular Ejection Fraction, AV = Aortic Valve, MDCT = Multidetector Computed Tomography.