From Disk Devices to Transcatheter Patches: The Evolution of Wireless Heart Defect Occlusion

Abstract

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.

Interventional treatment of patent ductus arteriosus in 2004

“…Since all wire-containing devices theoretically have potential complications related to the wires (such as fracture and vessel erosion), Sideris et al [57] have developed a wireless patch for closure of cardiovascular anomalies including PDA. The Patch device (Custom Medical Devices) is available in three sizes and composed of polyurethane foam with a double nylon thread attachment for retrieval (Fig.…”

Historical Aspects of Transcatheter Treatment of Heart Disease in Children

“…Subsequently a number of other devices were described and these include: botallooccluder [193], buttoned device [194][195][196], clamshell septal umbrella [197], Gianturco coil [198], Duct Occlud pfm [199], detachable (Cook and Flipper) Coils [200][201][202], Gianturco-Grifka vascular occlusion device (GGVOD) [203], polyvinyl alcohol (Ivalon R) foam plug [204], infant buttoned device [205,206], Amplatzer duct occluder [207,208], folding plug buttoned device [209],wireless PDA devices [210,211], reinforced duct-occlude pfm [212], Amplatzer muscular ventricular septal defect occluder [213], Amplatzer vascular plug [214], Nit-Occlud coils [215], Inoue single-branched stent graft [216], non-ferromagnetic Inconel MReye embolization coils [217], Amplatzer vascular plug with prefilled embolization coils [218], self-expanding platinum-coated Nitinol device [219], Chinese self-expandable occluder, similar to the Amplatzer occluder [220], Amplatzer Vascular Plug II [221], Cardio-O-Fix occluder [222], NitOcclud PDA-R (reverse) device [223] and perhaps, others.…”

Is interventional closure the current treatment of choice for selected patients with deficient atrial septation?

“…Some devices are still purely investigational, such as the Solysafe device developed in Gothenburg, Sweden, 24 a device from Cardia, and a non-metal Dacron patch being explored by Sideris. 25,26 In continuing my survey, I will exclude from consideration those devices constructed solely for closure of the persistent oval foramen.…”