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Echocardiographic Evaluation of Atrial Communications before Transcatheter Closure
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GORE® Cardioform ASD Occluder experience in transcatheter closure of "complex" atrial septal defects

Giuseppe Santoro1, Magdalena Cuman1, Alessandra Pizzuto1

  • 1Pediatric Cardiology and GUCH Unit, Heart Hospital "G. Pasquinucci", National Research Council-Tuscany Foundation "G. Monasterio", Massa, Italy.

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
|October 15, 2021
PubMed

Insights

The GORE® Cardioform ASD Occluder (GCO) effectively and safely closes complex atrial septal defects (ASDs) in a high percentage of patients. This transcatheter approach offers a viable solution for challenging ASD cases.

Area of Science:

  • Cardiology
  • Medical Devices
  • Interventional Cardiology

Background:

  • Transcatheter closure of atrial septal defects (ASDs) presents challenges in complex clinical and anatomical scenarios.
  • The GORE® Cardioform ASD Occluder (GCO) is a device designed for ASD closure.

Purpose of the Study:

  • To evaluate the efficacy and safety of the GORE® Cardioform ASD Occluder (GCO) for transcatheter closure of complex atrial septal defects (ASDs).

Main Methods:

  • A retrospective study involving 72 patients with significant ASDs between January 2020 and March 2021.
  • Patients were categorized into "complex" (n=36) and "simple" (n=36) ASD groups based on anatomical and clinical criteria.
  • Complex ASDs were defined by rim deficiency, large size relative to patient metrics, or multifenestrated septa.

Main Results:

  • Complex ASDs were significantly larger and associated with higher Qp/Qs ratios compared to simple ASDs.
  • Procedure and fluoroscopy times were longer for complex ASDs, with a lower procedure feasibility rate (94.4% vs. 100%) and a higher complication rate (13.9% vs. 0%).
  • Successful closure was achieved in 92% of complex ASD cases, with complete closure rates at follow-up not significantly different between groups (97.1% vs. 100%).

Conclusions:

  • Percutaneous transcatheter closure using the GCO device is an effective and safe treatment option for a high percentage of complex ASDs.
  • The GCO device demonstrates feasibility and good early outcomes in challenging ASD anatomies.
  • Despite a higher complication rate in complex cases, the overall success and closure rates are encouraging.
Abstract

Keywords:
atrial septal defectdeviceinterventional cardiac catheterization

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