Open Access

ARTICLE

Percutaneous Closure of Patent Foramen Ovale and Secundum Atrial Septal Defects with the GORE® CARDIOFORM Septal Occluder: Incidence and Implications of Device Wire Frame Fracture

by Biagio Castaldi^1,*, Giulio Cabrelle¹, Massimo Padalino², Vladimiro Vida², Ornella Milanesi¹, Giovanni Di Salvo¹

1 Department of Women’s and Children’s Health, University of Padua, Padua, Italy
2 Department of Cardio-Thoracic Sciences, University of Padua, Padua, Italy

* Corresponding Author: Biagio Castaldi. Email:

Congenital Heart Disease 2020, 15(5), 347-360. https://doi.org/10.32604/CHD.2020.012750

Received 13 July 2020; Accepted 20 August 2020; Issue published 23 September 2020

Abstract

Background: Trans-catheter closure has become the treatment of choice for patent foramen ovale (PFO) and ostium secundum atrial septal defects (ASD). A wide variety of devices are commercially available, however, concerns have been raised about the risk of cardiac erosion associated with stiff/rigid devices. The GORE® CARDIOFORM Septal Occluder (GSO) is a double-disc, soft and conformable device with no reported incidence of cardiac erosions. However, wire frame fracture (WFF) have been reported. Aim: To assess the incidence and clinical significance of WFF after GSO implantation in paediatric patients. Methods: Seventy-seven consecutive patients were enrolled. Periprocedural and follow-up assessments included clinical, echocardiographic, and X-ray fluoroscopy examinations. Results: Mean patient age was 10.0 ± 3.9 years. In 7 patients the indication was PFO closure, in 70 patients ASD closure. Mean follow-up period was 3.1 ± 1.3 years. X-ray fluoroscopy evaluations were available for 60 patients. WFF was detected in a total of 22 (35.4%) GSO devices. Three WFF compromised the outer perimeter of the device. Incidence of WFF was higher for the 30 mm GSO device (58%; p = 0.001). A multivariate analysis confirmed that the GSO device diameter (p = 0.013; F = 6.7) and stretched ASD diameter (p = 0.034; F = 4.38) were independent factors related to WFF. WFF did not result in any clinical sequelae/patient harm. Residual shunt was observed in 4 patients (5%) at 24 hours following procedure. Conclusion: The GSO device is safe and effective for PFO and ASD closure. WFF was not associated with clinical sequelae or device instability. Device diameter strongly correlates with incidence of WFF.

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