Table 3.
Clinical Outcomes at 30 Days and at 12 Months
| RD-AVR (n = 107) | SAVR (n = 437) | TAVR (n = 476) | P Value | |
|---|---|---|---|---|
| 30-day outcomes | ||||
| Composite outcome of death, stroke, or rehospitalization | 3 (2.8) | 12 (2.8) | 38 (8.0) | 0.001 |
| Death | 1 (0.9) | 6 (1.4) | 13 (2.7) | 0.24 |
| Cardiac death | 1 (0.9) | 3 (0.7) | 8 (1.7) | 0.37 |
| Noncardiac death | 0 (0) | 3 (0.7) | 5 (1.1) | 0.51 |
| Stroke | 1 (0.9) | 3 (0.7) | 18 (3.8) | 0.004 |
| Disabling stroke | 0 (0) | 1 (0.2) | 7 (1.5) | 0.07 |
| Nondisabling stroke | 1 (0.9) | 2 (0.5) | 11 (2.3) | 0.05 |
| Death or stroke | 2 (1.9) | 9 (2.1) | 28 (5.9) | 0.006 |
| Rehospitalizationa | 1 (0.9) | 3 (0.7) | 13 (2.8) | 0.04 |
| Life-threatening or surgery-requiring bleeding | 6 (5.6) | 19 (4.3) | 34 (7.1) | 0.20 |
| Acute kidney injury requiring renal replacement therapy | 1 (0.9) | 14 (3.2) | 5 (1.1) | 0.05 |
| New permanent pacemaker | 3 (2.8) | 5 (1.1) | 43 (9.1) | <0.001 |
| New-onset atrial fibrillation | 32 (29.9) | 139 (31.8) | 11 (2.3) | <0.001 |
| Moderate or severe paravalvular regurgitation | 2 (1.9) | 0 (0) | 41 (8.6) | <0.001 |
| 12-month outcomes | ||||
| Primary composite outcome of death, stroke, or rehospitalization | 8 (8.0) | 39 (9.3) | 91 (20.0) | <0.001 |
| Death | 4 (4.1) | 21 (5.1) | 39 (8.7) | 0.054 |
| Cardiac death | 3 (3.1) | 12 (3.0) | 15 (3.4) | 0.91 |
| Noncardiac death | 1 (1) | 9 (2.2) | 24 (5.5) | 0.01 |
| Stroke | 1 (0.9) | 6 (1.5) | 30 (6.7) | <0.001 |
| Disabling stroke | 0 (0) | 2 (0.5) | 11 (2.4) | 0.02 |
| Nondisabling stroke | 1 (0.9) | 4 (1) | 19 (4.3) | 0.004 |
| Death or stroke | 5 (4.8) | 26 (6.2) | 60 (13.1) | <0.001 |
| Rehospitalizationa | 3 (3.3) | 14 (3.4) | 41 (9.5) | <0.001 |
| Life-threatening or surgery-requiring bleeding | 6 (5.6) | 19 (4.3) | 41 (8.8) | 0.03 |
| Acute kidney injury requiring renal replacement therapy | 2 (2.2) | 14 (3.2) | 5 (1.1) | 0.07 |
| New permanent pacemaker | 4 (3.8) | 5 (1.1) | 46 (9.8) | <0.001 |
| Moderate or severe paravalvular regurgitation | 6 (5.6) | 1 (0.2) | 51 (10.7) | <0.001 |
Values are n (%). Percentages were calculated by means of Kaplan-Meier estimates.
Abbreviations as in Table 1.
a
Valve-related or procedure-related and including heart failure.