Partial prolapse of a HELEX device associated with early frame fracture and mitral valve perforation

Abstract

One or more breaks in the wire frame of the HELEX Septal Occluder (W.L. Gore and Associates, Flaggstaff, Arizona) were identified in 5% of patients in the multicenter pivotal trial leading to FDA approval. Fractures of the perimeter frame have not previously been associated with any apparent deleterious clinical effects. We report a case in which the broken ends of wire at a frame fracture were located in a position that resulted in perforation of the anterior mitral valve leaflet. There was significant mitral regurgitation and the device was removed surgically. The possible etiologies and prevention of wire frame fractures are also discussed.

Wire‐frame integrity of patch‐like Gore devices following atrial septal defect closure

“…Consequently, we have not observed any clinical sequelae due to a WFF in the GSO device. In contrast, clinically relevant complications caused by WFFs have been occasionally identified in the HSO device . Unlike in previous studies including the HSO and the new Gore ASD occluder, the presence of WFF was not associated with predispositioning factors such as larger devices or deficient retro‐aortic rim in this cohort .…”

Experience using the new GORE® septal occluder at the margins

“…Previous reports have described the apparent safety of the earlier version of this device (the Helex ® Septal Occluder) in initial clinical evaluations , and sequential implantation has also been described []. However complications associated with the Helex device have been encountered, particularly with fracture of the frame []. The newer generation device employed in this case series has a more user‐friendly delivery system, making deployment easier and retrieval if necessary easier.…”

First experiences with the GORE® Septal Occluder in children and adults with atrial septal defects

“…However, wire frame fracture has been reported a problem with the GORE ® HELEX ® Septal Occluder, especially the larger sizes, occurring in 6.4–8.0% after 1 year . In an 8‐year‐old child a fractured wire in a GORE ® HELEX ® Septal Occluder led to perforation of the anterior mitral leaflet and surgery . With patent foramen ovale closure, the GORE ® HELEX ® Septal Occluder has a significant longer time to complete occlusion compared with the Amplatzer Septal Occluder .…”