Table 3.
Summary of linearized complications rate after valve replacement with Bovine Pericardium Organic Valvular Bioprosthesis (BVP, Braile Biomédica®).
| Complications | Aortic | Mitral | ||
|---|---|---|---|---|
| Early event rate(a) (%) | Linearized late event rate(b,c) | Number of events/number of subjects | Linearized late event rate(b,c) | |
| All-cause mortality | 3.7 | 1.1 | 5.93 | 1.4 |
| Stroke | 1.97 | 0 | 0.91 | 0.45 |
| All hemorrhage | 3.5 | 0.45 | 3.41 | 0 |
| All paravalvular leak | 1.09 | 0 | 1.36 | 0 |
| Structural valve deterioration | 0 | 0 | 0.22 | 0 |
| Nonstructural valve dysfunction (NSVD)(d) | 0 | 0 | 0.91 | 0.45 |
| Explant(e) | 0.21 | 0 | 1.36 | 0.46 |
| Reintervention(e) | 0.21 | 0 | 1.13 | 0.46 |
(a)
Early events include events that occurred on or before 30 days after the procedure
(b)
Late events include events that occurred > 30 days after the procedure
(c)
Late linearized rates (percent per patient-year) were calculated by dividing the number of late events by the sum of the late patient-years of experience and expressed as a percentage
(d)
NSVD is inclusive of all paravalvular leak events; no NSVD of other etiology was observed
(e)
One outcome was due to a procedure-related event and not a valve-related event