Table 3.
Safety outcomes
| Clinical event | 30 Days N = 120 |
1 Year N = 118 |
|---|---|---|
| VARC-2 early safety compositea | 13.3 (16) | – |
| All-cause mortality | 3.3 (4) | 11.9 (14) |
| Cardiovascular mortality | 3.3 (4) | 9.3 (11) |
| All stroke | 2.5 (3) | 2.5 (3) |
| Disabling stroke | 1.7 (2) | 1.7 (2) |
| Major vascular complications | 3.3 (4) | 3.3 (4) |
| Life-threatening/disabling bleeding | 5.0 (6) | 8.5 (10) |
| Acute kidney injury (stage 2 or 3) | 0.8 (1) | 0.8 (1) |
| Myocardial infarction > 72 h | 0.8 (1) | 0.8 (1) |
| Repeat procedure (surgery/interventional) for valve-related dysfunction | 0.0 (0) | 0.0 (0) |
| Hospitalization for valve-related symptoms or CHF | – | 4.2 (5) |
| New permanent pacemaker | 15.0 (18) | 17.8 (21) |
| New-onset atrial fibrillation or atrial flutter | 5.8 (7) | 8.5 (10) |
| Coronary obstruction requiring intervention | 0.8 (1) | 0.8 (1) |
| Prosthetic aortic valve thrombosis | 0.0 (0) | 0.0 (0) |
| Prosthetic aortic valve endocarditis | 0.0 (0) | 0.0 (0) |
Values are % (n); two patients required a valve-in-valve procedure with a non-study valve and thus are not included in the 1-year analyses
BAV balloon aortic valvuloplasty; CHF congestive heart failure
aIncludes all-cause mortality, all stroke, major vascular complications, life-threatening or disabling bleeding, acute kidney injury (Stage 2/3), repeat procedure for valve-related dysfunction, and coronary obstruction requiring intervention