Increasing propensity to pursue operative closure of atrial septal defects following changes in the instructions for use of the Amplatzer Septal Occluder device: An observational study using data from the Pediatric Health Information Systems database

Abstract

Concern for device erosion following transcatheter treatment of atrial septal defects (TC-ASD) led in 2012 to a United States Food and Drug Administration panel review and changes in the instructions for use of the Amplatzer Septal Occluder (ASO) device. No studies have assessed the effect of these changes on real-world practice. To this end a multicenter observational study was performed to evaluate trends in the treatment of ASD.

Methods: A retrospective observational study was performed using data from the Pediatric Health Information Systems database of all patients with isolated ASD undergoing either TC-ASD or operative ASD closure (O-ASD) from January 1, 2007, to September 30, 2015, hypothesizing that the propensity to pursue O-ASD increased beginning in 2013.

Results: A total of 6,392 cases from 39 centers underwent ASD closure (82% TC-ASD). Adjusting for patient factors, between 2007 and 2012, the probability of pursuing O-ASD decreased (odds ratio [OR] 0.95 per year, P = .03). This trend reversed beginning in 2013, with the probability of O-ASD increasing annually (OR 1.21, P = .006). There was significant between-hospital variation in the choice between TC-ASD and O-ASD (median OR 2.79, P < .0001). The age of patients undergoing ASD closure (regardless of method) decreased over the study period (P = .04). Cost of O-ASD increased over the study period, whereas cost of TC-ASD and length of stay for both O-ASD and TC-ASD was unchanged.

Conclusions: Although TC-ASD remains the predominant method of ASD closure, the propensity to pursue O-ASD has increased significantly following changes in instructions for use for ASO. Further research is necessary to determine what effect this has on outcomes and resource utilization.