title: Device therapy for atrial septal defects in a multicenter cohort: acute outcomes and adverse events.
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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pediatric Cardiology, Rady Children's Hospital, San Diego, California.
authors.forename: Howaida
authors.initials: H
authors.lastname: El-Said
authors.forename: Sanjeet
authors.initials: S
authors.lastname: Hegde
authors.forename: Susan
authors.initials: S
authors.lastname: Foerster
authors.forename: William
authors.initials: W
authors.lastname: Hellenbrand
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Kreutzer
authors.forename: Sara M
authors.initials: SM
authors.lastname: Trucco
authors.forename: Ralf
authors.initials: R
authors.lastname: Holzer
authors.forename: Grant
authors.initials: G
authors.lastname: Burch
authors.forename: Ajay
authors.initials: A
authors.lastname: Mirani
authors.forename: Ramzi
authors.initials: R
authors.lastname: Nicolas
authors.forename: Diego
authors.initials: D
authors.lastname: Porras
authors.forename: Lisa
authors.initials: L
authors.lastname: Bergersen
authors.forename: John
authors.initials: J
authors.lastname: Moore
mesh_terms: D000293:Adolescent; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D020878:Device Removal; D005260:Female; D005548:Foreign-Body Migration / Q000209:etiology / Q000628:therapy; D006344:Heart Septal Defects, Atrial / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D007223:Infant; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012042:Registries; D012307:Risk Factors; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
keywords: ASD/PDA/PFO; closure; complications; congenital heart disease; pediatric catheterization/intervention; pediatric intervention; pediatrics