Faculty Collaboration Database

Device therapy for atrial septal defects in a multicenter cohort: acute outcomes and adverse events. Catheter Cardiovasc Interv 2015 Feb 01;85(2):227-33

Date

09/27/2014

Pubmed ID

25257700

DOI

10.1002/ccd.25684

Scopus ID

2-s2.0-84922015466 (requires institutional sign-in at Scopus site)   46 Citations

Abstract

BACKGROUND: Secundum atrial septal defect (ASD) closure devices were granted approval based on industry-sponsored, prospective, nonrandomized, single device studies, demonstrating acceptable efficacy and safety in selected patients. We sought to report community practice and outcomes.

METHODS AND RESULTS: Procedure specific data was collected on cases considered for ASD closure in the congenital cardiac catheterization project on outcomes (C3PO) between February 1, 2007 and June 31, 2010. Eight centers contributed data during this time period. All adverse events (AE) were independently reviewed and classified by a five level severity scale. In 40 months (2/07-6/10), 653 of 688 ASDs were occluded with a single device using an AMPLATZER(®) Septal Occluder (ASO) in 566 (87%), GORE(®) HELEX(®) Septal Occluder (HSO) in 33 (5%), and a CardioSEAL(®) or STARFlex™ device (CSD) in 54 (8%). Most patients had an isolated ASD (93%). 85% were >2 years of age. The ASD median diameter was 12 mm [8,16] for ASO, with smaller diameters in HSO 8 mm [7,10] and CSD 8 mm [5,10] (P < 0.001). AE (n = 82) were recorded in 76 cases, 11.5% (95% CI 9.2%, 14.1%) and classified as high severity in 4.7% (95% CI 3.2%, 6.5%), with no mortality. A new conduction abnormality was detected during 15 cases and did not resolve in one. Transcatheter device retrieval was possible in 7 of 10 device embolizations. Device erosion occurred in 3 of 566, 0.5% (95% CI 0.1%, 1.5%), ASO implants.

CONCLUSION: Although device closure of ASDs is associated with low morbidity and rare mortality, ongoing assessment of device safety profiles are warranted, and registries offer opportunities to facilitate the required surveillance.

Author List

El-Said H, Hegde S, Foerster S, Hellenbrand W, Kreutzer J, Trucco SM, Holzer R, Burch G, Mirani A, Nicolas R, Porras D, Bergersen L, Moore J

Author

Susan Foerster MD Professor in the Pediatrics department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adolescent
Cardiac Catheterization
Child
Child, Preschool
Device Removal
Female
Foreign-Body Migration
Heart Septal Defects, Atrial
Humans
Infant
Male
Prospective Studies
Prosthesis Design
Prosthesis Failure
Registries
Risk Factors
Septal Occluder Device
Time Factors
Treatment Outcome
United States
Young Adult