Table 4.
Adverse events associated with “off-label” Melody® valve implantation
| Native RVOT (n=124) | Tricuspid (n=108) | Mitral (n=51) | RVOT in children < 30kg (n=26) | |
|---|---|---|---|---|
| Procedural | ||||
| Vascular complication | - | 1 | 5 | 1 |
| Conduit tear | 1 | - | - | 5 |
| AP fistula | 1 | - | - | - |
| Guidewire perforation | - | - | 1 | 1 |
| Hemo / pneumothorax | 3 | |||
| Embolization | - | - | 5 | - |
| Complete AV block | - | 3 | 1 | - |
| Procedural mortality | - | - | 1 | 1* |
| Post-procedural | - | - | - | - |
| Stent fracture | 6 | 2 | - | 2 |
| Endocarditis | 3 | 1 | - | 2 |
| Early valve failure | 1 | 7 | - | - |
| Paravalvar leak | - | - | 2 | - |
RVOT: Right ventricular Outflow Tract;
*
Melody® valve implantation was performed in a patient on ECMO following PA laceration during a previous procedure. Mortality was not felt to be directly attributable to the Melody® implantation.