TABLE 5.
Adverse events data
|
Overall cohort n = 240 |
Low tortuosity n = 88 |
High tortuosity n = 152 |
P value | |
|---|---|---|---|---|
| Myocardial infarction | 1 (0.4) | 1 (1.1) | 0 (0.0) | 0.371 |
| Vascular access complication | 52 (21.7) | 14 (15.9) | 38 (25.0) | 0.067 |
| Minor access complication | 45 (18.8) | 11 (12.5) | 34 (22.4) | 0.043 |
| Major access complication | 7 (2.9) | 3 (3.4) | 4 (2.6) | 0.507 |
| Bleeding complication | 64 (26.7) | 14 (15.9) | 50 (32.9) | 0.003 |
| Minor bleeding complication | 50 (20.8) | 11 (12.5) | 39 (25.6) | 0.007 |
| Major bleeding complication | 14 (5.8) | 3 (3.4) | 11 (7.2) | 0.176 |
| Any access or bleeding complication | 73 (30.4) | 17 (19.3) | 56 (36.8) | 0.003 |
| Neurological adverse event | 6 (2.5) | 3 (3.4) | 3 (2.0) | 0.386 |
| Acute Kidney Injury | 38 (15.8) | 10 (11.4) | 28 (18.4) | 0.102 |
| Postoperative renal replacement therapy | 6 (2.5) | 2 (2.3) | 4 (2.6) | 0.614 |
| New atrial fibrillation | 17 (7.1) | 4 (4.5) | 13 (8.6) | 0.173 |
| Conversion to open surgery | 1 (0.4) | 0 (0.0) | 1 (0.7) | 0.629 |
| Reoperation for valvular dysfunction | 1 (0.4) | 0 (0.0) | 1 (0.7) | 0.629 |
| Reoperation for bleeding/tamponade | 12 (5.0) | 2 (2.3) | 10 (6.6) | 0.115 |
| Reoperation for non‐cardiac problems | 9 (3.8) | 5 (5.7) | 4 (2.6) | 0.205 |
| Valve in valve bailout | 6 (2.5) | 3 (3.4) | 3 (2.0) | 0.395 |
| 30‐day combined safety endpoint | 208 (86.7) | 76 (86.4) | 132 (86.8) | 0.531 |
| 30‐day all‐cause mortality | 14 (5.8) | 3 (3.4) | 11 (7.2) | 0.176 |
AV, atrioventricular; other abbreviations as in Tables 1‐3.