Table 2.
Procedure-related data.
| n | % | Literature*** | |
|---|---|---|---|
| Procedure time (min, mean±SD, range) | 104±31(45-186) | ||
| Echocardiography, n (%) | |||
| Transesophageal | 59/59 | 100% | |
| Success | 57/59 | 96.6% | 92% |
| (95% CI: 0.90-0.94) | |||
| Device sizes, n (%) | |||
| 5 | 7/57 | 12% | |
| 6 | 15/57 | 26% | |
| 7 | 17/57 | 30% | |
| 8 | 10/57 | 18% | |
| 10 | 5/57 | 9% | |
| 12 | 3/57 | 5% | |
| Converting to surgical repair | 2/59 | 3.4% | 80/1368 |
| (5.8%) | |||
| Clinically insignificant residual shunt | 2/59 | 3.4% | 95/1368 |
| (6.9%) | |||
| Total severe complications | 3/59 | 5.3% | 109/1368 |
| -8% | |||
| Intraoperative complications | 2/59 | 3.4% | 88/1368 |
| -6% | |||
| (95% CI: 0.028-0.071) | |||
| Significant residual shunt* | 1/59 | 1.7% | 32/1368 |
| New-onset aortic valve insufficiency* | 1/59 | 1.7% | 31/1368 |
| Complete heart block | None | 10/1368 | |
| Failure to establish a path | None | 8/1368 | |
| New-onset tricuspid valve insufficiency | None | 7/1368 | |
| Postoperative early complications | 1/57 | 1.7% | 12/1368 |
| 0.9% | |||
| Significant residual shunt | None | 0 | |
| New-onset aortic valve insufficiency | None | 0 | |
| Complete heart block | None | 5/1368 | |
| New-onset tricuspid valve insufficiency | None | 1/1368 | |
| New-onset tricuspid valve insufficiency | None | ||
| Occluder dislodgement** | 1/57 | 1.7% | 2/1368 |
| Second operation** | 1/57 | 1.7% | 4/1368 |
| Follow-up period | No major complications | 0% | 9/1368 |
iRBBB=incomplete right bundle branch block.
*
The patient's device was extracted and surgical closure was performed.
**
Same patient.
***
Hong et al.[5].