Table 1.
Demographics and clinical characteristics.
| Characteristic | Portico™ DS 1
% (n) of Subjects (n = 501) |
FlexNav™ DS % (n) of Subjects (n = 500) |
Total (n = 1001) |
|---|---|---|---|
| Age (Years) | 81.7 ± 5.4 | 82.3 ± 5.3 | 82.0 ± 5.3 |
| Gender (Female) | 63.7% | 61.4% | 62.5% |
| NYHA Class | |||
| I | 2.8% | 0.8% | 1.8% |
| II | 31.9% | 37.0% | 34.5% |
| III | 58.9% | 58.6% | 58.7% |
| IV | 6.4% | 3.6% | 5.0% |
| EuroSCORE I (%) | 16.4 ± 11.1 | 14.9 ± 10.3 | 15.7 ± 10.8 |
| EuroSCORE II (%) | 4.8 ± 3.8 | 4.7 ± 4.3 | 4.8 ± 4.1 |
| STS Mortality Risk Score (%) | 4.2 ± 2.9 | 4.2 ± 2.7 | 4.2 ± 2.8 |
| Number of frailty factors contributing to the subject’s surgical risk score | |||
| 1 | 23.5% | 19.3% | 21.1% |
| 2 | 14.7% | 11.8% | 13.1% |
| 3 | 9.7% | 10.7% | 10.2% |
| 4 | 0.9% | 1.2% | 1.0% |
| Cardiac arrhythmia | 49.1% | 47.6% | 48.4% |
| Carotid artery disease | 12.6% | 10.6% | 11.6% |
| Chronic kidney disease | 27.7% | 26.0% | 26.9% |
| Dialysis | 2.9% | 1.5% | 2.2% |
| Chronic lung disease | 19.4% | 21.0% | 20.2% |
| Coronary artery disease | 57.9% | 52.4% | 55.1% |
| Diabetes | 35.1% | 36.4% | 35.8% |
| Dyslipidemia | 59.3% | 64.4% | 61.8% |
| Hematologic disorders | 10.4% | 10.8% | 10.6% |
| Hypertension | 87.8% | 86.2% | 87.0% |
| Liver disease or cirrhosis | 3.4% | 3.0% | 3.2% |
| Mitral valve disease | 61.7% | 61.0% | 61.3% |
| Myocardial infarction | 13.6% | 12.2% | 12.9% |
| Peripheral artery disease | 12.0% | 11.8% | 11.9% |
| Prior permanent pacemaker | 9.4% | 11.2% | 10.3% |
| Prior CABG | 7.4% | 8.8% | 8.1% |
| Prior PCI | 31.7% | 31.4% | 31.6% |
| Prior stroke | 10.6% | 7.6% | 9.1% |
| Prior TIA | 4.4% | 5.0% | 4.7% |
| Mean aortic valve gradient (mmHg) | 43.4 ± 14.5 | 42.2 ± 15.0 | 42.8 ± 14.7 |
| Aortic valve area (cm2) | 0.71 ± 0.2 | 0.72 ± 0.2 | 0.72 ± 0.18 |
1 First-generation Portico™ delivery system.