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

SUBMITTER: O'Byrne ML 

PROVIDER: S-EPMC5741186 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature