From disk devices to transcatheter patches: the evolution of wireless heart defect occlusion.

Since 1988, we have been using double-disk devices with several device generations and improving results. Our current disk device, "The ButtonSeal Centering on Demand Device," is a multipurpose device made of stainless steel and polyurethane. It has shown high occlusion rates and no significant complications in atrial septal defects (ASDs) up to 30 mm in diameter. It can be used according to the ASD anatomy both in large, single defects (centering) and in multiple fenestrations (noncentering). The ButtonSeal shares the same limitations as other disk devices, namely, the possibility of wire-related problems and the need for significant septal rim. The development of wireless balloon-delivered devices and patches addresses these problems and limitations. Both detachable balloon devices and patches were used experimentally in animals and in feasibility studies in humans. The results showed good occlusion rates and lack of wire-related complications. Both methods required a minimal rim and occluded more defects than the disk devices. The transcatheter patch method was safer and had only one disadvantage, which was the need for 48-hour balloon support.