TABLE 2.
Comparison of baseline characteristics and procedural data between groups.
| Patient number, n | 498 |
||
| SAPIEN 3 n = 352 |
SAPIEN 3 Ultra n = 146 |
P-value | |
| Age (years) | 80.6 ± 5.73 | 80.7 ± 5.29 | 0.864 |
| Female, n (%) | 171 (48.5%) | 81 (55.5%) | 0.324 |
| BMI (kg/m2) | 26.7 ± 5.25 | 26.3 ± 4.8 | 0.921 |
| Hypertension, n (%) | 304 (86%) | 101 (69.2%) | 0.107 |
| Diabetes, n (%) | 94 (26%) | 31 (21.2%) | 0.791 |
| Dyslipidemia, n (%) | 176 (50%) | 74 (51%) | 0.887 |
| NYHA class III or IV, n (%) | 190 (54%) | 76 (52%) | 0.789 |
| COPD, n (%) | 91 (25.8%) | 26 (17.8%) | 0.146 |
| Previous MI, n (%) | 49 (14%) | 23 (16%) | 0.546 |
| GFR (mL/min/1.73 m2) | 54.9 ± 19.85 | 52.2 ± 19.48 | 0.246 |
| Logistic Euroscore II | 4.8 ± 4.5 | 4.33 ± 4.7 | 0.2658 |
| STS score | 3.7 ± 3.5 | 3.2 ± 3.4 | 0.346 |
| AF, n (%) | 61 (17%) | 20 (14%) | 0.360 |
| RBBB at baseline, n (%) | 32 (9%) | 19 (13%) | 0.213 |
| PR interval, ms | 168 ± 38.9 | 175 ± 34.6 | 0.673 |
| QRS duration, ms | 101 ± 25.4 | 102 ± 23.8 | 0.854 |
| Moderate or severe LVOT calcium n (%) | 74 (21%) | 32 (22%) | 0.843 |
| Membranous septum length (mm) | 4.1 ± 2.4 | 4.2 ± 2.4 | 0.886 |
| Calcification (grade) | 2.35 ± 0.9 | 2.4 ± 0.94 | 0.577 |
| Annulus area (mm2) | 461 ± 85.4 | 454 ± 83 | 0.401 |
| Echocardiography data | |||
| LV ejection fraction (%) | 58.4 ± 10.9 | 60.6 ± 10.3 | 0.069 |
| Transvalvular mean aortic gradient (mmHg) | 45.6 ± 15.2 | 46.6 ± 13.5 | 0.501 |
| Transvalvular maximum aortic gradient (mmHg) | 74.3 ± 23 | 74.8 ± 20.3 | 0.933 |
| Previous medication | |||
| Beta blockers, n (%) | 182 (51%) | 61 (42%) | 0.148 |
| Calcium channel blockers, n (%) | 81 (23%) | 36 (24.7%) | 0.730 |
| Amiodarone, n (%) | 39 (11%) | 14 (9.5%) | 0.642 |
| Procedural data | |||
| Percutaneous access | |||
| Transfemoral | 331 (94%) | 140 (95.9%) | 0.819 |
| Transapical | 16 (4.5%) | 4 (2.7%) | 0.270 |
| Transaortic | 5 (1.4%) | 2 (1.4%) | 0.923 |
| Prosthesis size | |||
| 26 mm | 207 | 71 | 0.166 |
| 23 mm | 142 | 75 | 0.089 |
| 20 mm | 3 | 0 | 0.264 |
| Predilatation, n (%) | 37 (10.5%) | 16 (11%) | 0.889 |
| Postdilatation, n (%) | 33 (9.3%) | 12 (8%) | 0.696 |
| Postprocedural PR interval, ms | 185 ± 39.4 | 178 ± 35.6 | 0.784 |
| Postprocedural QRS duration, ms | 111 ± 26.3 | 110 ± 28.6 | 0.811 |
| Prosthesis implantation depth (mm) | 4.89 ± 1.57 | 4.47 ± 1.36 | 0.001 |