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. How-ever, 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 fluoro-scopy 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.
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
Castaldi B.;Cabrelle G.;Padalino M.;Vida V.;Milanesi O.;Di Salvo G.
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. How-ever, 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 fluoro-scopy 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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