@Article{CHD.2020.012750,
AUTHOR = {Biagio Castaldi, Giulio Cabrelle, Massimo Padalino, Vladimiro Vida, Ornella Milanesi, Giovanni Di Salvo},
TITLE = {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},
JOURNAL = {Congenital Heart Disease},
VOLUME = {15},
YEAR = {2020},
NUMBER = {5},
PAGES = {347--360},
URL = {http://www.techscience.com/chd/v15n5/40255},
ISSN = {1747-0803},
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.},
DOI = {10.32604/CHD.2020.012750}
}