Table 4 Device Success, Outcome and Safety according to VARC-2
Lotus (n = 53) | Sapien (n = 47) | p-value | |
|---|---|---|---|
Device Success (n = 54 for Lotus)a | 98.1% (53) | 91.5% (43) | 0.1809 |
Absence of procedural mortality | 100% (54) | 97.9% (46) | 0.4653 |
Correct positioning of single valve in correct anatomical position | 98.1% (53) | 97.9% (46) | 1.0000 |
Intended performance of prosthetic heart valve | 100% (54) | 95.7% (45) | 0.2141 |
Early safety at 30 days | 96.2% (51) | 89.4% (42) | 0.2486 |
All-cause mortality | 3.8% (2) | 10.6% (5) | 0.2486 |
All stroke | 9.4% (5) | 0% (0) | 0.0585 |
Life-threatening bleeding | 1.9% (1) | 10.6% (5) | 0.0965 |
Acute kidney injury stage I | 1.9% (1) | 14.9% (7) | 0.0244 |
Acute kidney injury stage II | 1.9% (1) | 0% (0) | 1.0000 |
Coronary artery obstruction requiring intervention | 0% (0) | 2.1% (1) | 0.4700 |
Major vascular complication | 1.9% (1) | 6.4% (3) | 0.4968 |
Valve-related dysfunction requiring repeat procedure | 0% (0) | 0% (0) | |
Clinical efficacy at 30 days | |||
Mortality | 3.8% (2) | 10.6% (5) | 0.2486 |
All stroke | 9.4% (5) | 0% (0) | 0.0585 |
Major stroke | 3.8% (2) | 0% (0) | 0.4968 |
Rehospitalization for valve-related symptoms | 1.9% (1) | 6.4% (3) | 0.3393 |
Valve endocarditis | 0% (0) | 0% (0) | |
Valve related dysfunction | 0% (0) | 4.3% (2) | 0.2184 |