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

Objectives Study trends in the treatment of atrial septal defects (ASD). Background Concern for device erosion following transcatheter treatment of ASD (TC-ASD) led in 2012 to a US FDA panel review and changes in the instructions for use (IFU) of the Amplatzer Septal Occluder (ASO) device. No studies have assessed the effect of these changes on real-world practice. 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 1/1/2007 to 9/30/2015, hypothesizing that the propensity to pursue O-ASD increased beginning in 2013. Results 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 (OR: 0.95 per year, p=0.03). This trend reversed beginning in 2013, with the probability of O-ASD increasing annually (OR: 1.21, p=0.006). There was significant between-hospital variation in the choice between TC-ASD and O-ASD (median odds ratio: 2.79, p<0.0001). The age of patients undergoing ASD closure (regardless of method) decreased over the study period (p=0.04). Cost of O-ASD increased over the study period, while cost of TC-ASD and LOS for both O-ASD and TC-ASD was unchanged. Conclusion Though TC-ASD remains the predominant method of ASD closure, the propensity to pursue O-ASD has increased significantly following changes in IFU for ASO. Further research is necessary to determine what effect this has on outcomes and resource utilization.

Variation in practice patterns in device closure of atrial septal defects and patent ductus arteriosus: An analysis of data from the IMproving Pediatric and Adult Congenital Treatment (IMPACT) registry

“…Data about surgical cases, which would provide a more comprehensive view of practice in closing ASD and PDA, are not included in IMPACT®. A previous study has demonstrated that in a contemporary cohort of ASD’s treated at primary pediatric hospitals there is significant inter-hospital variability in the propensity to pursue operative or transcatheter closure of ASD after adjusting for measurable covariates 27 . Though it is conjecture, we would propose that this is also likely true for PDA.…”

“…Subjects of all ages who underwent transcatheter closure of an isolated ASD or PDA recorded in IMPACT ® between January 1, 2011 and September 30, 2015 were included in the study. Cases from hospitals with >15% incomplete data, contributing data for less than 6 months or at which less than 10 total ASD or PDA procedures were performed over the study period were excluded from analysis as described previously 21,27 . Individual cases were excluded if the ASD or PDA was not treated.…”

Transcatheter device closure of atrial septal defects

“…In analysis of data from the PHIS database, TC-ASD accounted for >80% of ASD closure procedures at US pediatric hospitals[9]. However, there was significant variation in how individual centers chose to pursue ASD closure with the range of ASD closure performed in the catheterization laboratory between 30 and nearly 100%[9]. Even after adjusting for differences in case-mix, there remained significant inter-hospital variability in the choice between O-ASD and TC-ASD[9].…”

“…TC-ASD with the current generation of devices has favorable rates of technical success and risk of adverse events when compared to operative closure of ASD (O-ASD)[3–8]. TC-ASD is the dominant technique for closing ASD; >80% of isolated ASD treated at primary pediatric hospitals in the United States are closed in the catheterization laboratory[9]. Though new devices continue to be developed, the technique for TC-ASD has remained essentially unchanged since the introduction of the Amplatzer Septal Occluder (ASO) in the early 2000’s.…”

Effect of Amplatzer Septal Occluder on Atrial Septal Defect Closure in Beagles

“…ASO is a double-disc, self-expandable, occlusion device, which is made of nickel-titanium-alloy and approved for percutaneous closure of secundum ASD by the US Food and Drug Administration in 2001. [9][10] However, the efficacy of ASO on ASD in animal such as beagles remains to be determined. The molecular architecture of ASD involves down-regulated genes related to heart atrial septum formation, cardiomyocyte proliferation, and normal electrical conduction and muscle contraction, such as HERG, Mink, Kir2.1, Kir2.3, 11 CX40 (Connexin 40) and CX43 genes.…”