Device therapy for atrial septal defects in a multicenter cohort: Acute outcomes and adverse events

Howaida G. El-Said, Sanjeet Hegde, Susan Foerster, William Hellenbrand, Jacqueline Kreutzer, Sara M. Trucco, Ralf Holzer, Grant Burch, Ajay Mirani, Ramzi Nicolas, Diego Porras, Lisa Bergersen, John Moore

Research output: Contribution to journalArticle

32 Citations (Scopus)

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

Original languageEnglish (US)
Pages (from-to)227-233
Number of pages7
JournalCatheterization and Cardiovascular Interventions
Volume85
Issue number2
DOIs
StatePublished - Feb 1 2015

Fingerprint

Atrial Heart Septal Defects
Septal Occluder Device
Equipment and Supplies
Therapeutics
Cardiac Catheterization
Industry
Safety

Keywords

  • ASD/PDA/PFO
  • Closure
  • Complications
  • Congenital heart disease
  • Pediatric catheterization/intervention
  • Pediatric intervention
  • Pediatrics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

El-Said, H. G., Hegde, S., Foerster, S., Hellenbrand, W., Kreutzer, J., Trucco, S. M., ... Moore, J. (2015). Device therapy for atrial septal defects in a multicenter cohort: Acute outcomes and adverse events. Catheterization and Cardiovascular Interventions, 85(2), 227-233. https://doi.org/10.1002/ccd.25684

Device therapy for atrial septal defects in a multicenter cohort : Acute outcomes and adverse events. / El-Said, Howaida G.; Hegde, Sanjeet; Foerster, Susan; Hellenbrand, William; Kreutzer, Jacqueline; Trucco, Sara M.; Holzer, Ralf; Burch, Grant; Mirani, Ajay; Nicolas, Ramzi; Porras, Diego; Bergersen, Lisa; Moore, John.

In: Catheterization and Cardiovascular Interventions, Vol. 85, No. 2, 01.02.2015, p. 227-233.

Research output: Contribution to journalArticle

El-Said, HG, Hegde, S, Foerster, S, Hellenbrand, W, Kreutzer, J, Trucco, SM, Holzer, R, Burch, G, Mirani, A, Nicolas, R, Porras, D, Bergersen, L & Moore, J 2015, 'Device therapy for atrial septal defects in a multicenter cohort: Acute outcomes and adverse events', Catheterization and Cardiovascular Interventions, vol. 85, no. 2, pp. 227-233. https://doi.org/10.1002/ccd.25684
El-Said, Howaida G. ; Hegde, Sanjeet ; Foerster, Susan ; Hellenbrand, William ; Kreutzer, Jacqueline ; Trucco, Sara M. ; Holzer, Ralf ; Burch, Grant ; Mirani, Ajay ; Nicolas, Ramzi ; Porras, Diego ; Bergersen, Lisa ; Moore, John. / Device therapy for atrial septal defects in a multicenter cohort : Acute outcomes and adverse events. In: Catheterization and Cardiovascular Interventions. 2015 ; Vol. 85, No. 2. pp. 227-233.
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