Abstract 12288: Three-Dimensional Location and Heatmap Distribution of Frame Fractures on the GORE Cardioform ASD Device

Abstract

Objective: To evaluate the frequency and characteristics of Gore Cardioform ASD Device Frame Fractures (FF) and explore potential associations in patient and procedural practice variables. Background: The latest device approved by the FDA for atrial septal defect (ASD) closure is the GORE® Cardioform ASD occluder (GCA). Despite a very low incidence of complications having a direct impact on patient wellbeing, a significant amount of FFs have been observed in the GCA at short to medium-term follow-up, being described in almost one-third of the devices implanted during clinical trials. Methods: We performed a retrospective single-center chart review of 54 patients who received a GCA between January 2017 and December 2019, and selected 35 patients in whom a 6-month fluoroscopic follow-up was performed. We evaluated the number and type of fractures based on this fluoroscopic assessment and devised a simple nomenclature system based on three-dimensional (3D) reconstruction of the device's fluoroscopic images. We also evaluated the association between the position and number of fractures, and patient and procedural characteristics. Results: The FF incidence in our population was 42.9% at a 6-month follow-up. The factors statistically associated with FF were the size of the defect and the size of the device implanted. FFs were most frequently located in a central position in the right atrial disc. By 3D evaluation, the most common anatomical position for fractures was the anteroinferior quadrant of the right atrial disc. At the time of manuscript submission, no echocardiographic or clinical sequelae were noted in our population. Conclusions: The incidence of frame fractures in our population was higher than that observed in published literature, albeit using more intense image scrutiny than that required by other cited studies. We noted that the central portion of the anteroinferior quadrant of the right atrial disc was the most susceptible to FF and found that the defect size and the device size were the only statistically associated factors.