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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
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Atrial septal defect and patent foramen ovale closure- complication profile of approved Gore Occluders

Michał Piotrowski1, Julia Izabela Karpierz2, Jakub Batko1

  • 1CAROL-Cardiothoracic Anatomy Research Operative Lab, Department of Cardiovascular Surgery and Transplantology, Institute of Cardiology, Jagiellonian University Medical College, 31-008 Krakow, Poland.

Cardiovascular Revascularization Medicine : Including Molecular Interventions
|April 12, 2025
PubMed

Insights

This study analyzed Gore device complications for patent foramen ovale and atrial septal defects, finding device embolization and arrhythmias were common adverse events. No cardiac erosions were reported, but complication profiles varied by device and size.

Area of Science:

  • Cardiovascular Medicine
  • Medical Device Technology
  • Congenital Heart Disease Research

Background:

  • Patent foramen ovale and atrial septal defects are common congenital heart diseases requiring treatment.
  • Percutaneous or surgical interventions are considered for symptomatic cases.
  • Gore Cardioform and Gore Helex devices are used for closure procedures.

Purpose of the Study:

  • To investigate the post-approval complication profiles of Gore Cardioform and Gore Helex devices.
  • To analyze adverse events reported in the Manufacturer and User Facility Device Experience database.

Main Methods:

  • A retrospective analysis of the Manufacturer and User Facility Device Experience Database.
  • Inclusion of 401 reports detailing complications associated with Gore device closure of atrial septal defects.
  • Categorization of reports by specific Gore device models (Cardioform Septal Occluder, Cardioform ASD Occluder, Helex Septal Occluder).

Main Results:

  • Device problems accounted for 51.4% of complications, primarily device embolization (n=140).
  • Three deaths were reported, two linked to device embolization.
  • Other reported complications included pericardial effusion (54 cases), perforation (14 cases), and postoperative arrhythmias (80 cases), notably atrial fibrillation and heart block.

Conclusions:

  • No cardiac erosions were identified with the use of Gore devices, aligning with previous findings.
  • The complication profiles differed between the investigated Gore devices and their various sizes.
Abstract

Keywords:
ASD occlusionPFO occlusion

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