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Ostium Secundum Atrial Septal Defect Closure. Thomas Hoy March 24, 2004 Department of Biomedical Engineering BME 272 Senior Design . Significance of Project. Isolated secundum atrial septal defects account for ~ 7% of congenital cardiac defects.
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Ostium Secundum Atrial Septal Defect Closure Thomas Hoy March 24, 2004 Department of Biomedical Engineering BME 272 Senior Design
Significance of Project • Isolated secundum atrial septal defects account for ~ 7% of congenital cardiac defects. • CHD of significance occur in ~ 8 in 1000 live births. • If untreated can cause: • Congestive Heart Failure • Pulmonary Vascular Disease
Existing Solutions Invasive Approach Transcatheter Approach Direct suture FDA approved devices Pericardial patch Experimental devices
Problems with Existing Devices • Difficulty centering the device in larger defects [57] • Wire related problems • Wire fractures [58] • Atrial / mitral valve perforation [59] • Wire migration [60] • Difficulty in device retrieval [61] • Expense
Project Design Goals • Develop a less costly / more simplistic occlusion device • Develop a device that is easily centered on the ASD • Ensure ease use in the medical environment • Stimulate endotheliazation of the device • Increase the possible success rate in the application of the device
Design Proposal 1 • Double Balloon Catheter • Inflate across the septum • Position on the ASD • Adhere via an activated adhesive to the atrial rim on the septum • Deflate the balloon to form a thin membrane • Extract lead wire
Advantages • No wire related problems • Double balloon device requires a septal rim slightly larger than the defect [62,63] • Costs associated with the device • Spherical shape of the device is ideal for centering; however is quite bulky
Future Work • Researching heat-activated adhesives that may be used in a biological setting • Developing a preliminary model representing the theoretical aspect of the device
References • [57] Sideris EB, Leung M, Yoon JH, et al. Occlusion of large atrial septal defects with a centering buttoned device. Am Heart J 1996;131;356-359. • [58] Prieto LR, Foreman CK, Cheatham JP, Latson LA. Intermediate-term outcome of transcatheter secundum atrial septal defect closure, using the Bard Clamshell septal occluder. Am J Cardiol 1996;78:1310-1312. • [59] Silvert H, Babic M, Ensslen R. Transcatheter closure of large atrial septal defects with the Babic system. Cathet Cardiovasc Diagn 1995;36: 232-240. • [60] Rao PS, Sideris EB, Hausdorf G, et al. International experience with secundum atrial septal defect occlusion by the buttoned device. Am Heart J 1994; 128:1022-1035. • [61] Agarwal SK, Ghosh PK, Mittal PK. Failure of devices used for closure of atrial septal defects mechanisms and management. J Thorac Cardiovasc Surg 1996;112:21-26. • [62] Sideris EB, Sideris SE, Thanopoulos BD, Ehly RL, Fowlkes JP. Transvenous atrial septal defect occlusion by the buttoned device. Am J Cardiol 1990;66:1524-1526. • [63] Das GS, Voss G, Jarvis G, Wyche K, Gunther R, Wilson RF. Experimental atrial septal defect closure with a new, transcatheter, self-centering device. Circulation 1997;96(Suppl):I-3177.