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Multicenter midterm follow-up results using the gore septal occluder for atrial septal defect closure in pediatric

Jochen Grohmann1, Christian Wildberg1, Peter Zartner2

  • 1Department of Congenital Heart Defects and Pediatric Cardiology, Heart Center, University of Freiburg, Freiburg, Germany.

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
|December 1, 2016
PubMed

Insights

The Gore Septal Occluder (GSO) is safe and effective for closing atrial septal defects (ASD II) in pediatric patients, showing a 95.4% closure rate with minimal complications.

Area of Science:

  • Cardiology
  • Pediatric Cardiology
  • Medical Devices

Background:

  • Secundum-type atrial septal defects (ASD II) are common congenital heart conditions.
  • Device closure is an alternative to surgical repair for ASD II.
  • The Gore Septal Occluder (GSO) is a double-disc device designed for septal defect closure.

Purpose of the Study:

  • To evaluate the safety and efficacy of the Gore Septal Occluder (GSO) for device closure of ASD II in pediatric patients.
  • To assess midterm outcomes of GSO implantation in children and adolescents.
  • To determine the suitability of GSO in complex ASD anatomies, including those with deficient retro-aortic rims.

Main Methods:

  • Multicenter retrospective analysis of pediatric patients who received a GSO for ASD II.
  • Inclusion criteria required a minimum of 12 months of follow-up.
  • Data collected included patient demographics, ASD characteristics, procedural details, and clinical outcomes.

Main Results:

  • 173 pediatric patients were analyzed with a median follow-up of 20 months.
  • An overall closure rate of 95.4% was achieved, with only 4.6% experiencing small residual shunts.
  • Minor complications occurred in 5.2% during the procedure and 5.2% on follow-up, with no major adverse events reported.

Conclusions:

  • The Gore Septal Occluder (GSO) demonstrates favorable safety and efficacy for periprocedural and midterm outcomes in pediatric ASD II closure.
  • GSO is a suitable option for children and adolescents, particularly for complex defects like those with deficient retro-aortic rims or multi-fenestrated anatomy.
  • The device may be considered a first-choice option in specific challenging cases requiring extensive septal coverage.
Abstract

Keywords:
cardiac interventioncongenital heart diseasedevice closurefollow-upoccludepediatricsecundum-type atrial septal defect

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