Table I.
Clinical characteristics
| Parameter | Overall cohort (n = 50) | 1st gen DS (n = 28) | FlexNav DS (n = 22) | P-value |
|---|---|---|---|---|
| Age (mean ± SD) | 81.6 ±3.8 | 80.7 ±3.8 | 82.6 ±3.6 | 0.07 |
| Female, n (%) | 26 (52.0) | 11 (39.3) | 15 (68.2) | 0.04 |
| STS-PROM score (mean ± SD) | 5.2 ±2.8 | 5.4 ±2.2 | 4.9 ±3.3 | 0.11 |
| Hypertension, n (%) | 46 (92.0) | 25 (89.3) | 21 (95.4) | 0.42 |
| Dyslipidemia, n (%) | 30 (60.0) | 17 (60.7) | 13 (59.1) | 0.91 |
| Diabetes, n (%) | 16 (32.0) | 11 (39.3) | 5 (22.7) | 0.21 |
| BMI > 25 kg/m2, n (%) | 7 (14.0) | 4 (16.3) | 3 (13.6) | 0.95 |
| History of smoking, n (%) | 14 (28.0) | 9 (32.1) | 5 (22.7) | 0.46 |
| Heart failure, n (%) | 12 (24.0) | 8 (28.6) | 4 (18.2) | 0.39 |
| Peripheral artery disease, n (%) | 15 (30.0) | 9 (32.1) | 6 (27.3) | 0.71 |
| Atrial fibrillation, n (%) | 16 (32.0) | 7 (25.0) | 9 (40.9) | 0.23 |
| eGFR [ml/min] (mean ± SD) | 60.5 ±19.3 | 61.1 ±22.2 | 59.8 ±15.5 | 0.80 |
| Previous PCI, n (%) | 17 (34.0) | 12 (42.9) | 5 (22.7) | 0.14 |
| Previous cardiac surgery, n (%) | 6 (12.0) | 2 (7.1) | 4 (18.2) | 0.23 |
| Previous myocardial infarction, n (%) | 7 (14.0) | 4 (14.3) | 3 (13.6) | 0.95 |
| Previous stroke/TIA, n (%) | 3 (6.0) | 1 (3.6) | 2 (9.1) | 0.41 |
| Poor mobility, n (%) | 24 (48.0) | 13 (46.4) | 11 (50) | 0.80 |
| Left ventricle ejection fraction (mean ± SD) | 59.9 ±8.9 | 59.8 ±8.8 | 60.0 ±9.1 | 0.97 |
| Mean transvalvular gradient (mean ± SD) | 43.4 ±12.8 | 43.2 ±12.4 | 43.7 ±13.5 | 0.90 |
| Moderate-to-severe aortic regurgitation, n (%) | 17 (34.0) | 12 (42.9) | 5 (22.7) | 0.14 |
DS – delivery system, STS-PROM – Society of Thoracic Surgery-Predicted Risk Of Mortality, BMI – body mass index, eGFR – estimated glomerular filtration rate, PCI – percutaneous coronary intervention, TIA – transient ischemic attack.