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

Background: Trans-catheter closure has become the treatment ofchoice for patent foramen ovale (PFO) and ostium secundum atrial septal defects(ASD). A wide variety of devices are commercially available, however, concernshave been raised about the risk of cardiac erosion associated with stiff/rigiddevices. 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 incidenceand clinical significance of WFF after GSO implantation in paediatric patients.Methods: Seventy-seven consecutive patients were enrolled. Periprocedural andfollow-up assessments included clinical, echocardiographic, and X-ray fluoroscopy examinations. Results: Mean patient age was 10.0 ± 3.9 years. In 7 patientsthe 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 for60 patients. WFF was detected in a total of 22 (35.4%) GSO devices. ThreeWFF 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 confirmedthat 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 resultin any clinical sequelae/patient harm. Residual shunt was observed in 4 patients(5%) at 24 hours following procedure. Conclusion: The GSO device is safe andeffective for PFO and ASD closure. WFF was not associated with clinical sequelaeor device instability. Device diameter strongly correlates with incidence of WFF.