Table 3:
Early (≤30 days) and late (>30 days) outcomes
| Early outcomes | Late outcomes | |
|---|---|---|
| N (% AEs in 1652 patients) | N (% in 2848.1 late pt-yrs) (2-side 95% CI) | |
| All deaths | 13 (0.8) | 127 (4.5) (3.7–5.3) |
| Cardiovascular deaths | 5 (0.3) | 55 (1.9) (1.5–2.5) |
| Non-cardiovascular deaths | 8 (0.5) | 70 (2.5) (1.9–3.1) |
| Valve-related reintervention | 11 (0.7) | 23 (0.8) (0.5–1.2) |
| SVD | 0 | 6 (0.2) (0.1–0.4) |
| TIA | 7 (0.4) | 13 (0.5) (0.3–0.8) |
| Disabling stroke | 7 (0.4) | 7 (0.2) (0.1–0.5) |
| Non-disabling stroke | 12 (0.7) | 12 (0.4) (0.2–0.7) |
| Thromboembolism | 2 (0.1) | 3 (0.1) (0.0–0.3) |
| Bleeding | 22 (1.3) | 17 (0.6) (0.4–0.9) |
| Intra-prosthetic regurgitation (≥2) | 3 (0.2) | 13 (0.5) (0.3–0.8) |
| PVL (≥2) | 2 (0.1) | 0 (0) |
| Intra and PVL (≥2) | 0 (0) | 0 (0) |
| Endocarditis | 0 (0) | 14 (0.5) (0.3–0.8) |
| Valve thrombosis | 0 (0) | 0 (0) |
| Myocardial infarction | 3 (0.2) | 13 (0.5) (0.3–0.8) |
| Pacemaker implant | 95 (5.7) | 48 (1.7) (1.3–2.2) |
CI: confidence interval; PVL: paravalvular leak; SVD: structural valve deterioration; TIA: transient ischaemic attack; AEs: adverse events.