Table 3. Adverse events, number of patients<sup>1</sup>.
| One year n (%) | Two years n (%) | |
| Death | 5 (16.7)a | 8 (26.7)a |
| Stroke | 1 (3.3) | 2 (6.7) |
| Myocardial infarction | 0 | 0 |
| Bleeding complications (extensive, life-threatening, or fatal)* | 6 (20.0)b | 7 (23.3) |
| Coronary complications | 3 (10.0) | 3 (10.0) |
| Device-related secondary intervention | 1 (3.3)b | 2 (6.7) |
| Device-related cardiac surgery | 0 | 0 |
| Renal failure¶ | 1 (3.3) | 1 (3.3) |
| Conduction system disturbance | 1 (3.3) | 2 (6.7) |
| Ventricular arrhythmia | 3 (10.0) | 3 (10.0) |
| 1CEC adjudicated. *Defined according to MVARC guidelines. ¶Occurrence in the first week post procedure and required haemodialysis. aNone of the deaths between 30 days and two years were cardiovascular-related. bPatient experienced bleeding after secondary intervention. | ||