Table 5.
Thirty-day hemodynamic performance of the THV and 30-day and long-term clinical outcomes of the patients in this study.
| Sapien XT (N = 20) | Sapien 3 (N = 36) | P-value | |
|---|---|---|---|
| Intensive care unit stay, days | 2.85 ± 4.61 | 1.17 ± 0.45 | 0.120 |
| 30-day NYHA functional class | |||
| III/IV, n (%) | 4 (20%) | 1 (3%) | 0.094 |
| 30-day MACCE, n (%) | 3 (15%) | 3 (8%) | 0.747 |
| All-cause mortality, n (%) | 0 (0%) | 0 (0%) | - |
| Cardiac mortality, n (%) | 0 (0%) | 0 (0%) | - |
| Non-fatal myocardial infarction, n (%) | 0 (0%) | 0 (0%) | - |
| Non-fatal stroke, n (%) | 1 (5%) | 0 (0%) | 0.764 |
| Other 30-day VARC-2 complications | |||
| Major vascular access complication, n (%) | 0 (0%) | 0 (0%) | - |
| Acute kidney injury, stage 3, n (%) | 0 (0%) | 0 (0%) | - |
| Permanent pacemaker implantation for CAVB, n (%) | 2 (10%) | 2 (6%) | 0.938 |
| Hemodynamics by echocardiography at 30-day | |||
| Mean gradient, mmHg | 8.69 ± 3.05 | 11.03 ± 5.04 | 0.066 |
| Aortic valve area, cm2 | 1.97 ± 0.35 | 1.82 ± 0.25 | 0.089 |
| Aortic regurgitation ≧ moderate, n (%) | 2 (10%) | 2 (6%) | 0.938 |
| Left ventricular ejection fraction, % | 55.70 ± 13.55 | 58.30 ± 11.13 | 0.451 |
| Pulmonary hypertension (PASP ≧60 mmHg), n (%) | 1 (5%) | 2 (6%) | 1 |
| Long-term cumulative MACCE, n (%) | 7 (35%) | 4 (11%) | 0.071 |
| All-cause mortality, n (%) | 3 (15%) | 0 (0%) | 0.077 |
| Cardiac mortality, n (%) | 0 (0%) | 0 (0%) | - |
| Non-fatal myocardial infarction, n (%) | 0 (0%) | 1 (3%) | 1 |
| Non-fatal stroke, n (%) | 2 (10%) | 1 (3%) | 0.596 |
| Valve failure, n (%) | 1 (5%) | 1 (3%) | 1 |
| Clinically relevant Valve thrombus, n (%) | 1 (5%) | 1 (3%) | 1 |
THV, transcatheter heart valve; NYHA, New York Heart Association; MACCE, major adverse cardiac cerebral events; VARC, valve academic research consortium; CAVB, complete atrioventricular block; PASP, pulmonary artery systolic pressure.