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Occlusion of the LAA by the TP is feasible and effective in most patients with atrial fibrillation at high risk for embolic stroke. Angiography before placement probably affects patch adhesion and is contraindicated.

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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.

Introduction: The Transcatherer Patch (TP) is a bioabsorbale device used in the occlusion of septal defects including atrial septal defects(ASDs) and ventricular septal defects(VSDs) the last 15 years. Acute results have been described as effective occlusions with rare small residual shunts and occasional instability of the immediately release patch on the septum. Hypothesis: Long term results of successful implantations were critically examined to determine effectiveness of occlusion and the extent of septal reconstruction. Method: The records of 200 successfully implanted devices (149 ASDs, 51 VSDs) were analyzed. ASDs were of secundum type with the exception of five that were ostium primum and sinus venosus types. All VSDs were peri-membranous except for four malalignment (Fallot Tetralogy) and one muscular defect. Defect size varied from 13 to 35mm for ASDs and 4-16mm for VSDs. The TP was deployed in three versions including, temporary double balloon support (48hrs), temporary double balloon support with surgical adhesive (45min - 2hrs), and extended single balloon support with immediate release. Results: Long term results were free from deaths or serious complications including perforation, erosion, heart block, thrombus, and arrhythmia. All occlusions were effective with occasional persistence of trivial residual shunts. The septum was normalized and the patch was undetectable by echocardiography 1-2yrs after implantation. Normalization of the septum required a longer period of time with the immediate release patch. Conclusions: Long term results of the TP in septal defect occlusion were excellent. Serious complications seen with metallic devices did not occur. The TP offers a promising alternative in septal defect occlusion although further improvements must be made to eliminate rare acute problems and residual shunts. A double balloon immediately released patch could be a solution. B

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