Table 2.
Thirty-day adverse events according to VARC2.
| Variables | All Patients n = 910 | Group STS ≥ 8, n = 115 (12.6%) | Group STS < 8, n = 795 (87.4%) | p |
|---|---|---|---|---|
| Device success not achieved, n (%) | 43 (4.7%) | 6 (5.2%) | 37 (4.7%) | 0.79 |
| Procedural mortality, n (%) | 3 (0.3%) | 1 (0.9%) | 2 (0.4%) | 0.77 |
| Suboptimal positioning, n (%) | 12 (1.3%) | 4 (3.5%) | 8 (1.0%) | 0.24 |
| Non-Intended performance of the prosthetic heart valve, n (%) | 30 (3.3%) | 3 (2.6%) | 27 (3.4%) | 0.89 |
| Early safety not achieved (30 days), n (%) | 87 (9.5%) | 14 (12.2%) | 73 (9.2%) | 0.30 |
| All-cause mortality, n (%) | 18 (2.0%) | 8 (7.0%) | 10 (1.2%) | 0.03 |
| Cardiovascular, n (%) | 9 (1.0%) | 4 (3.5%) | 5 (0.6%) | 0.03 |
| Non cardiovascular, n (%) | 9 (1.0%) | 4 (3.5%) | 5 (0.6%) | 0.01 |
| All stroke, n (%) | 7 (0.8%) | 2 (1.7%) | 5 (0.6%) | 0.07 |
| Life-threatening bleeding, n (%) | 14 (1.5%) | 2 (1.7%) | 12 (1.5%) | 0.97 |
| Acute Kidney Injury stage 2 or 3, n (%) | 21 (2.3%) | 3 (2.6%) | 18 (2.3%) | 0.73 |
| Coronary artery obstruction requiring intervention, n (%) | 2 (0.2%) | 0 (0%) | 2 (0.3%) | 0.65 |
| Major vascular complications, n (%) | 27 (3.0%) | 4 (3.5%) | 23 (2.9%) | 0.46 |
| Valve-related dysfunction requiring repeat procedure, n (%) | 9 (1.0%) | 5 (4.3%) | 4 (0.5%) | 0.08 |
| Clinical efficacy not achieved, n (%) | 206 (22.6%) | 61 (53.0%) | 145 (18.2%) | <0.001 |