Table 6.
Comparison of Adverse Events in Previous Large Series of PDA Closure
| Report | Timeframe | Subjects | Weight | Device Type | Adverse Event Rate | Major Adverse Event Rate |
|---|---|---|---|---|---|---|
| Tometzki et al1 | 1994–1995 | 71 | 16.4 | Cook coil | 4 (5.6%) | 1 (1.4%) |
| PDA coil registry10 | 1993–1995 | 523 | Gianturco coil | 151 (28.9%) | 116 (22.2%) | |
| Faella and Hijazi2 | 1996–1999 | 316 | 10.7 | ADO | 15 (4.7%) | 1 (0.3%) |
| Pass et al3 | 1999–2002 | 439 | 11 | ADO | 41 (7.1%) | 10 (2.3%) |
| Jang et al4 | 1999–2005 | 117 | 30 | ADO, Nit‐Occlud, Cook | 6 (5.1%) | 4 (3.4%) |
| Dimas et al8 | 1995–2005 | 62 | 4.6 | Gianturco coil, Gianturca‐Grifka VOD, ADO | 8 (13%) | 4 (6.5%) |
| Wang et al13 | 2002–2008 | 46 | 6.3 | ADO | 13 (28.3%) | 3 (6.5%) |
| Ghasemi et al12 | 1994–2007 | 546 | 19.9 | Gianturco coil, Flipper coil, ADO, Nit‐Occlud | 47 (8.6%) | 21 (3.8%) |
| Brunetti et al11 | 2005–2008 | 359 | 18.7 | Gianturco coils, Flipper coils, ADO, other devices | 16 (4.5%) | 8 (2.2%) |
ADO indicates Amplatzer Ductal Occluder; PDA, patent ductus arteriosus; VOD, vascular occlusion device.