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The Gore Septal Occluder (GSO) for Multiple Indications in Children - An Intention to Treat Analysis

Vivek Kumar1, Cameron Ward2, Robert Justo2

  • 1Queensland Paediatric Cardiac Service, Queensland Children's Hospital, Brisbane, Qld, Australia; Queensland Paediatric Cardiac Research Group, Brisbane, Qld, Australia.

Heart, Lung & Circulation
|April 27, 2021
PubMed

Insights

The Gore septal occluder (GSO) is safe and effective for pediatric atrial septal defects and Fontan fenestrations, showing high closure rates and few complications. Long-term follow-up indicates sustained efficacy with minimal residual shunting over time.

Area of Science:

  • Pediatric Cardiology
  • Interventional Cardiology
  • Medical Device Technology

Background:

  • The Gore septal occluder (GSO) is established for adult atrial septal communication closure.
  • Increasingly used in pediatric populations, the GSO's design may offer advantages.
  • This study evaluates its use in a specialized pediatric cardiac center.

Purpose of the Study:

  • To evaluate the safety and efficacy of the Gore septal occluder (GSO) in pediatric patients.
  • To assess closure rates and procedural complications associated with GSO implantation.
  • To determine the long-term outcomes of GSO use in children.

Main Methods:

  • Retrospective data review of 54 pediatric patients over six years.
  • Analysis of all intended uses of the GSO, including atrial septal defect (ASD), patent foramen ovale (PFO), and Fontan fenestration.
  • Outcome measures included successful deployment, occlusion rates at various time points, and procedural complications.

Main Results:

  • Successful GSO deployment in 92% of ASD/PFO cases and 100% of Fontan cases.
  • High complete occlusion rates: 91% at 24 hours, improving to 98% by 25.4 months.
  • Low complication rate, with transient rhythm disorder in two patients; no major complications like erosion, death, or venous access issues.

Conclusions:

  • The GSO is a safe and effective device for pediatric atrial septum and Fontan fenestration closure.
  • Early trivial residual shunts typically resolve over time, demonstrating sustained efficacy.
  • Delivery sheath size did not contribute to significant complications in this pediatric cohort.
Abstract

Keywords:
Atrial septal defectFenestrated FontanPatent foramen ovale

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