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

35 Scopus 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.

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

Keywords

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

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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    El-Said, H. G., Hegde, S., Foerster, S., Hellenbrand, W., Kreutzer, J., Trucco, S. M., 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, 85(2), 227-233. https://doi.org/10.1002/ccd.25684