Table 5.
Adverse events during follow-up
| Overall events | N = 272 |
|---|---|
| Follow-up, d, mean (SD) | 709.7 (467.2) |
| Composite death/stroke/TIA/MI | 45 (16.5) |
| Cardiovascular death | 10 (3.7) |
| Noncardiovascular death | 21 (7.7) |
| Stroke | 10 (3.7) |
| TIA | 4 (1.5) |
| Systemic embolization | 0 (0) |
| MI | 2 (0.7) |
| Major bleeding | 24 (8.8) |
| Minor bleeding | 28 (10.3) |
| Device surveillance (TEE or CTA) | 229 (84.2) |
| Device-related thrombus | 5 (1.8) |
| Peri-device leak (on TEE; N = 216), mm | |
| Any leak | 76 (35.2) |
| Minimal, < 1 | 27 (12.5) |
| Minor, 1–3 | 24 (11.1) |
| Moderate, 3–5 | 20 (9.3) |
| Severe, > 5 | 3 (1.4) |
Values are n (%), unless otherwise indicated.
CTA, computed tomography angiography; MI, myocardial infarction; SD, standardized difference; TEE, transesophageal echocardiography; TIA, transient ischemic attack.