Table 2.
Safety events
| Event | Early (≤30 d) N (%) |
Cumulative at 5 y N |
Probability event-free at 5 y % (95% CI) |
|---|---|---|---|
| All-cause mortality | 1 (1.2%) | 15 | 79.9% (70.8%-89.1%) |
| Reoperation | 0 (0%) | 2 | 97.1% (93.1%-100%) |
| Thromboembolism | 2 (2.4%) | 9 | 87.0% (78.9%-95.0%) |
| All bleeding | 1 (1.2%) | 18 | 74.6% (64.4%-84.9%) |
| Endocarditis | 0 (0%) | 2 | 96.9% (92.7%-100%) |
| Hemolysis | 0 (0%) | 0 | 100% (100%-100%) |
| Valve dysfunction | |||
| SVD | 0 (0%) | 1 | 98.7% (96.1%-100%) |
| NSVD | 0 (0%) | 2 | 97.0% (92.8%-100%) |
| Major PVL∗ | 0 (0%) | 0 | 100% (100%-100%) |
| Study valve explant | 0 (0%) | 1 | 98.6% (95.8%-100%) |
| Valve thrombosis | 0 (0%) | 1 | 98.5% (95.5%-100%) |
All events as defined by Akins and colleagues14 and as adjudicated by Clinical Events Committee. All percentages computed as % of the total number of successfully implanted patients (N = 82). One patient was omitted from further analysis due to major PVL (4+) after the heart was restarted before leaving the operating room and was deemed a technical failure; this patient was reintervened with a 27-mm Magna Mitral Ease valve. CI, Confidence interval; SVD, structural valve deterioration; NSVD, nonstructural valve dysfunction; PVL, paravalvular leak.
∗
Major PVL = paravalvular leak of any grade requiring surgical intervention or considered a serious adverse event.