Table 1.
Authors (Study Period) |
#Pts | PDA Sizes* | Closure Types† | % Closure at Latest Follow-Up | Adverse Outcomes‡ |
---|---|---|---|---|---|
Uzun 199626 (not reported) |
43 | Not reported | Coil | 3 months: 86% | Major (4.7%): major embolization (2) Minor (7.0%): minor embolization (3) |
Tometzki et al. 199625 (1994–1995) |
71 | 2.0 mm (1–5 mm) |
Coil | 6 months: 98% | Major (1.4%): major embolization (1) Minor: none |
Celiker et al. 199724 (1994–1995) |
52 | 3.2 mm [1–6.5 mm] | Coil | 1 month: 94% | Major: none Minor (11.5%): minor embolization (5), Hemolysis (1) |
Thanopoulos et al. 200023 (1997–1999) |
43 | 3.9 mm (2.2–8 mm) |
ADO | 1 day: 100% | Major (2.3%): major embolization (1) Minor (2.3%): N (1) |
Galal et al. 200122 (1994–1998) |
272 | 2.55 mm [0.2–7 mm] | Coil | 6 months: 79% | Major (1.5%): major embolization (4) Minor (9.9%): minor embolization (27) |
Pass et al. 200421 (1999–2002) |
439 | 2.6 mm (0.9–11.2 mm) |
ADO | 1 year: 99% | Major (0.5%): major embolization (1), death (1) Minor (10.7%):minor embolization (1) hemolysis (7), P (7), Ar (2), N (2), B (2), Other (8) |
Wang et al. 200620 (1995–2000) |
350 | 2.7 mm ±1.2 mm | Coil ADO |
3 months: 96% | Major (0.3%): major embolization (1) Minor (8.9%): minor embolization (20), N (9), P (9), Hemolysis (2) |
Jang et al. 200719 (1999–2005) |
117 | 4 mm (3–8 mm) |
ADO BD Coil |
Overall: 97% | Major (0.9%): IE (1) Minor (7.7%): minor embolization (1) N (6), Hemolysis (2) |
Gudausky et al. 200818 (2000–2005) |
132 132 |
1.7 mm ±1.0 mm | Coil ADO |
6 months: 95% | Major (3.0%): major embolization (4) Minor: (6.8%): minor embolization (9) |
Azhar et al. 200917 (2000–2004) |
121 | 2.9 mm (1–10 mm) |
Coil ADO |
Overall: 98% | Major (1.7%): major embolization (2) Minor (16.5%): minor embolization (4), N (14), P (2) |
Children’s Hospital Boston (2005–2009) |
168 | 2.6 mm (1.0–6.0) |
Coil ADO |
Overall: 95%§ | Major: none Minor (6.6%): minor embolization (7), N (4) |
Totals ‖ | 1808 | Average 2.7 mm (0.2–11.2 mm) |
Coil BD ADO |
Overall mean: 94.0% | Overall mean adverse outcome rates: Major: total n = 18, 1.5% (95% CI: 1.1–2.1%) Minor: total n = 169, 8.0% (95% CI: 7.3–10.0%) |
Patent ductus arteriosus (PDA) sizes presented as median (min–max), mean [min–max], or mean ± standard deviation, unless otherwise specified.
Closure types: ADO, Amplatzer ductal occluder; BD, Buttoned device; Coil, Cook detachable coils.
Adverse outcomes (adverse events, AEs): Major AEs: death, device embolization requiring interventions or resulting in morbidities as defined in text, infective endocarditis (IE); Minor AEs: device embolization without major complication, aortic or left pulmonary artery narrowing requiring no intervention (N), arrhythmia (Ar), blood loss requiring transfusion (B), significant hemolysis, pseudoaneurysm, or loss of peripheral pulse (P).
Early postcatheterization echocardiograms available on 60 of 168 patients, 57 completed closed.
Overall averages listed in Totals are weighted based on number of patients in each study group. 95% confidence intervals (CI) for event frequency based on binomial estimates.
Pts, patients