Table 5.
Outcomes by device chosen
| ASO n=1098 |
HSO n=333 |
GSO n=81 |
Other n=52 |
p | |
|---|---|---|---|---|---|
| Technical failure | 5.8% (64) | 6.9% (23) | 3.7% (3) | 1.9% (1) | 0.42 |
| Release and retrieve | 3.8% (42) | 3.6% (12) | 2.5% (2) | 0% (0) | 0.49 |
| Embolization | 1.6% (17) | 3.0% (10) | 1.2% (1) | 1.9% (1) | 0.37 |
| Malposition | 0.4% (4) | 0.3% (1) | 0.0% (0) | 0.0% (0) | 0.92 |
| Residual shunt (>3mm) | 1.8% (20) | 0.6% (2) | 0.0% (0) | 0.0% (0) | 0.19 |
| Major early adverse event | 3.7% (41) | 4.5% (15) | 1.2% (1) | 9.6% (5) | 0.10 |
| Cardiac arrest | 0.2% (2) | 0.0% (0) | 0.0% (0) | 0.0% (0) | 0.84 |
| Arrhythmia | 1.7% (19) | 2.1% (7) | 1.2% (1) | 7.7% (4) | 0.03 |
| Tamponade | 0.2% (2) | 0.0% (0) | 0.0% (0) | 0.0% (0) | 0.84 |
| Bleeding event | 0.8% (9) | 0.6% (2) | 1.2% (1) | 0.0% (0) | 0.85 |
| Transfusion | 0.4% (4) | 0.0% (0) | 0.0% (0) | 0.0% (0) | 0.64 |
| Vascular complication | 0.2% (4) | 0.1% (1) | 0.0% (0) | 1.0% (1) | 0.38 |
| Unplanned cardiac surgery | 1.0% (19) | 0.6% (4) | 0.0% (0) | 1.0% (1) | 0.53 |
| Unplanned other surgery | 0.1% (2) | 0.0% (0) | 0.0% (0) | 1.0% (1) | 0.05 |
| Subsequent cardiac catheterization |
0.4% (8) | 1.2% (8) | 0.0% (0) | 0.0% (0) | 0.12 |
| Airway event requiring intubation |
0.1% (2) | 0.0% (0) | 0.0% (0) | 0.0% (0) | 0.81 |
ASO: Amplatzer septal occluder device, GSO: Gore septal occluder device or Cardioform device, HSO: Helex septal occluder device