Table 2. Adverse events.
| Events | 0–30 days (n=50) | >30 days (n=41) |
|---|---|---|
| Death | 7 (14.0) | 4 (9.8) |
| Cardiovascular | 7 (14.0) | 4 (9.8) |
| Non-cardiovascular | 0 (0.0) | 0 (0.0) |
| Stroke | 2 (4.0) | 0 (0.0) |
| Disabling stroke | 0 (0.0) | 0 (0.0) |
| Non-disabling stroke | 2 (4.0) | 1 (2.4) |
| Myocardial infarction | 0 (0.0) | 0 (0.0) |
| Acute renal impairment, stage 3 | 5 (10.0) | 0 (0.0) |
| Major vascular complications | 0 (0.0) | 0 (0.0) |
| Major cardiac structural complication | 2 (4.0) | 0 (0.0) |
| Major bleeding | 9 (18.0) | 0 (0.0) |
| Reoperation for any reason | 5 (10.0) | 1 (2.4)† |
| Reoperation for bleeding | 5 (10.0) | 0 (0.0) |
| Reoperation for other* | 0 (0.0) | 1 (2.4)† |
| New-onset atrial fibrillation | 7 (14.0) | 2 (4.9) |
| Hemolysis | 0 (0.0) | 0 (0.0) |
| Endocarditis† | 1 (2.0) | 1 (2.4) |
| Device embolization | 0 (0.0) | 0 (0.0) |
| Device thrombosis | 0 (0.0) | 0 (0.0) |
| Cardiovascular re-hospitalization | 8 (16.0) | 13 (31.7) |
| Re-hospitalization for heart failure | 4 (8.0) | 8 (19.5) |
Data are presented as n (%). *, reoperation for wound infection at incision site; †, the endocarditis event was related to placement of a pacemaker lead.