Background—Prospective data on the medium-term safety and effectiveness of the AMPLATZER Septal Occluder in clinical practice are not available. The objective of this study was to prospectively evaluate the risk of hemodynamic compromise and obtain medium-term survival data on patients implanted with the AMPLATZER Septal Occluder for percutaneous closure of secundum atrial septal defects.Methods and Results—Subjects were enrolled prospectively at 50 US sites and followed for 2 years. Between 2008 and 2012, atrial septal defect closure with the AMPLATZER Septal Occluder was attempted in 1000 patients (aged 0.3–83.6 years, mean 21±22 years). Procedural closure occurred in 97.9%, with 1-month and 2-year closure 98.5% and 97.9%, respectively. Hemodynamic compromise occurred in 6 subjects (0.65%), because of dysrhythmia in 2, device embolization in 1, and cardiac erosion in 3. The rate of cardiac erosion was 0.3% (average 83, range 12–171 days from implant).Conclusions—Closure of atrial septal defect with the AMPLATZER Septal Occluder is safe and effective. The rate of hemodynamic compromise and cardiac erosion is rare. The risk factors for cardiac erosion after device closure are not yet clear.Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00650936.

Background The practice of coiling APCs before Fontan completion is controversial and published data are limited. We sought to compare outcomes in subjects with and without pre-Fontan coil embolization of aortopulmonary collaterals (APCs) using the Pediatric Heart Network (PHN) Fontan Cross-Sectional Study database which enrolled survivors of prior Fontan palliation. Methods We compared hospital length of stay (LOS) after Fontan in 80 subjects who underwent APC coiling with 459 subjects who did not. Secondary outcomes included post-Fontan complications and assessment of health status and ventricular performance at cross-sectional evaluation (mean 8.6±3.4 years after Fontan). Results Centers varied markedly in frequency of pre-Fontan APC coiling (range 0-30% of subjects, p<0.001). The coil group was older at Fontan (p=0.004), and more likely to have single right ventricular morphology (p=0.054) and pre-Fontan atrioventricular valve regurgitation (p=0.03). The coil group underwent Fontan surgery more recently (p<0.001), was more likely to have a prior superior cavopulmonary anastomosis (p<0.001), and more likely to undergo extracardiac Fontan connection (p<0.001) and surgical fenestration (p<0.001). In multivariable analyses, APC coiling was not associated with LOS (hazard ratio (HR) for remaining in-hospital 0.91, 95% CI 0.70-1.18, p=0.48) or postoperative complications, except more post-Fontan catheter interventions (HR 1.74, 95% CI 1.04-2.91, p=0.03), primarily additional APC coils. The groups had similar outcomes at cross-sectional evaluation. Conclusion Management of APCs before Fontan shows marked practice variation. We did not find an association between pre-Fontan coiling of APCs and shorter post-operative hospital stay or with better late outcomes. Prospective studies of this practice are needed.