Table 5. Long term follow-up.
| FreedomSolo (n = 77) |
Edwards Perimount (n = 77) |
p-value | |
|---|---|---|---|
| Events, % (n) | |||
| - Valve degeneration | 5.2 (4) | 0 (0) | 0.049 |
| - Thromboembolic | 1.3 (1) | 0 (0) | 0.341 |
| - Valve thrombosis | 0 (0) | 0 (0) | 0.571 |
| - Endocarditis | 5.2 (4) | 1.3 (1) | 0.211 |
| - Paravalvular leak | 2.6 (2) | 0 (0) | 0.176 |
| MACCE, % (n) | 5.2 (4) | 3.9 (3) | 0.456 |
| - Stroke | 5.2 (4) | 2.6 (2) | 0.507 |
| - Myocardial infarction | 0 (0) | 1.3 (1) | 0.281 |
| Explantation/ Re-Do, % (n) | 9.1 (7) | 1.3 (1) | 0.038 |
| - Structural valve deterioration | 5.2 (4) | 0 (0) | 0.285 |
| - Endocarditis | 3.9 (3) | 1.3 (1) | |
| Mortality, % (n) | |||
| - Survival | 79.2 (61) | 85.7 (66) | 0.397 |
| - Overall mortality | 20.8 (16) | 14.3 (11) | |
| Cause of death, % (n) | |||
| - Cardiac related | 3.9 (3) | 2.6 (2) | 0.937 |
| - Valve related | 6.5 (5) | 1.3 (1) | 0.211 |
| - Sepsis | 1.3 (1) | 1.3 (1) | 0.727 |
| - Multi organ failure | 1.3 (1) | 0 (0) | 0.420 |
| - Tumor | 3.9 (3) | 2.6 (2) | 0.937 |
| - Other | 0 (0) | 1.3 (1) | 0.197 |
| - Unknown | 3.9 (3) | 5.2 (4) | 0.780 |
MACCE: Major adverse cardiac and cerebrovascular events