Table 2.
Crude rates of adverse events occurred during the index hospitalization in patients undergoing transcatheter or surgical aortic valve replacement.
| Outcomes | TAVR 2130 patients |
SAVR 4333 patients |
p-Value |
|---|---|---|---|
| 30-day death, (%) | 62 (2.9) | 158 (3.6) | .125 |
| Stroke, n (%) | 53 (2.5) | 165 (3.8) | .006 |
| Postop. IABP/ECMO, n (%) | 4 (0.2) | 80 (1.8) | <.0001 |
| Conversion to cardiac surgery, n (%) | 13 (0.6) | – | – |
| Coronary ostium occlusion, n (%) | 8 (0.4) | 10 (0.2) | .320 |
| Aortic annulus rupture, n (%) | 10 (0.5) | 8 (0.2) | .047 |
| Aortic dissection/rupture | 17 (0.8) | 31 (0.7) | .716 |
| Major vascular complication, n (%) | 191 (9.0) | 69 (1.6) | <.0001 |
| RBC trasfusion, n (%) | 403 (19.2) | 3010 (70.4) | <.0001 |
| RBC transfusion, mean (units) | 0.6 ± 1.7 | 3.0 ± 3.8 | <.0001 |
| RBC transfusion, >4 units | 76 (3.6) | 926 (21.7) | <.0001 |
| Resternotomy for bleeding, n (%) | 30 (1.4) | 351 (8.1) | <.0001 |
| Severe bleeding,an (%) | 116 (5.5) | 1033 (24.1) | <.0001 |
| VARC-2 bleeding events | <.0001 | ||
| Major, n (%) | 567 (26.7) | 1564 (36.2) | |
| Life-threatening, n (%) | 167 (7.9) | 2597 (60.0) | |
| KDIGO acute kidney injury grades 3,bn (%) | 21 (1.0) | 127 (3.0) | <.0001 |
| Renal replacement therapy, n (%) | 30 (1.4) | 113 (2.6) | .002 |
| Moderate-severe paravalvular regurgitation, n (%) | 79 (3.7) | 29 (0.7) | <.0001 |
| Atrial fibrillation,cn (%) | 160 (13.4) | 1645 (48.7)) | <.0001 |
| Permanent pacemaker, n (%) | 185 (8.7) | 170 (3.9) | <.0001 |
| Hospital stay, mean (days) | 5.5 ± 5.0 | 8.3 ± 6.4 | <.0001 |
Continuous variables are reported as means ± standard deviation. Categorical variables as counts and percentages. a, it refers to transfusion of more than 4 units of red blood cells and/or operation for excessive bleeding; b, it excludes patients with estimated glomerular filtration rate <15 mL/min/1.73 m2 or dialysis; c, it excludes patients with preoperative atrial fibrillation. TAVR: transcatheter aortic valve replacement; SAVR: surgical aortic valve replacement; IABP: intraaortic balloon pump; ECMO: extracorporeal membrane oxygenation; RBC: red blood cells; VARC-2: Valve Academic Research Consortium-2; KDIGO: Kidney Disease: Improving Global Outcomes.