Frame fracture frequency and heatmap distribution during follow-up of the GORE Cardioform ASD device

Gareth J Morgan, Salvador A Rodriguez Franco, Ryan Leahy, Jess Randall, Jenny E Zablah

Objective: To evaluate the frequency and characteristics of Gore Cardioform ASD Device Frame Fractures (FF) and explore the most susceptible locations for these events.

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 directly impacting patient well-being, a significant amount of FFs have been observed in the GCA at short to medium-term follow-up.

Methods: We performed a retrospective single-center chart review of 38 patients who received a GCA in whom a 6-month fluoroscopic follow-up was performed. We assessed the number and type of fractures and devised a simple nomenclature system based on a Three-Dimensional (3D) reconstruction of the device’s fluoroscopic images. We also translated these systems to a basic fluoroscopy setting to be applied without the need of a complex 3D system.

Results: The FF incidence in our population was 40% at a 6-month follow-up. By 3D evaluation, the most common anatomical position for fractures was the anteroinferior quadrant. At the time of manuscript submission, no echocardiographic or clinical sequelae were noted in our population. Factors statistically associated with FF were the size of the defect and the size of the device implanted.

Conclusion: 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 left atrial disc was the most susceptible to FF.