Table 5.
VARC-2 efficacy and safety endpoints
| Technical success (intra-procedure) | 13 (86.7) |
| Procedural mortality | 0 (0) |
| Successful leaflet traversal and laceration | 13 (86.7) |
| Successful implantation of the cerebral protection device | 15 (100) |
| Coronary obstruction/intervention at target leaflet | 1 (6.7) |
| Successful first TAVI | 15 (100) |
| Emergency surgery or reintervention related to BASILICA/TAVI | 0 (0) |
| Early safety (at 30 days) | 13 (86.7) |
| All-cause mortality | 0 (0) |
| Myocardial infarction | 0 (0) |
| Coronary obstruction requiring intervention | 1 (6.7) |
| Stroke | 0 (0) |
| Major vascular/access site complication | 1 (6.7) |
| Life-threatening bleeding (BARC type ≥ 3b) | 0 (0) |
| Acute kidney injury (AKIN stage 2 or 3) | 0 (0) |
| Cardiac tamponade | 0 (0) |
| Major cardiac structural complication | 0 (0) |
| New permanent pacemaker implantation | 0 (0) |
| Valve-related dysfunction requiring repeat procedure | 0 (0) |
| THV function at discharge | |
| Paravalvular leakage > trace | 0 (0.0) |
| Mean AV gradient, mmHg | 9.0 (5.5, 14.0) |
| Mean AV gradient > 20 mmHg | 2 (13.3) |
Values are n (%) or median (interquartile range)
AKIN Acute Kidney Injury Network, AV aortic valve, BARC Bleeding Academic Research Consortium, BASILICA bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction, TAVI transcatheter aortic valve implantation, THV transcatheter heart valve, VARC-2 Valve Academic Research Consortium-2