摘要:在小兒心臟外科 領域 ,右心室出口重建是複雜性先天性心臟病常見的術式之一。病人在嬰兒時期因為肺動脈狹窄接受補片擴大手術之後,常有肺動脈閉鎖不全的問題,等到病人成長到孩童或青少年時期,會因為長期肺動脈瓣逆流導致右心室擴大、功能衰竭,必須置換瓣膜。由於病人年齡小、體重輕,常無合適的瓣膜可供使用。Expanded Poly-Tetra-Fluoro-Ethylene (ePTFE) 已被證實具有良好的生物相容性(biocompatibility),其具微孔但不易溶漏的構造可防止細胞的穿透及後續的鈣化現象。我們已發展一種手縫三瓣肺動脈瓣的製作方式並獲刊登在國外心臟外科頂尖期刊(The Annals of Thoracic Surgery)中。由於製作材料簡單,翻轉手法創新獨特,我們進一步計畫將此瓣膜發展成為經導管肺動脈瓣置放術 TPVT(Transcatheter Pulmonary Valve Therapy),以走在世界的先驅。目前TPVT僅美國於2010年通過FDA使用於人體之Melody Valve,其構造為取牛之頸靜脈血管瓣膜製作,而生物性瓣膜(xenograft)無可避免地會在人體中產生鈣化及退化過程,故其公司宣稱其功效性(effectiveness)尚未證實。預計發展的 經導管肺動脈瓣置放術,以手縫ePTFE材質的瓣膜於市售覆膜支架中,以導管方式置入右心室出口,可免除病人接收開心手術的痛苦與危險。且以此材質的耐久性,應可達到超越生物瓣膜的壽命。我們預計測試覆膜支架組合於豬隻做動物實驗,並延續先前計畫(MOST 103-2314-B-002-114)一併測試流體力學。
Abstract: Right ventricular outflow tract (RVOT) reconstruction is one of the mostdistinctive procedures in the complex congenital heart surgery. Patients who had patch augmentation surgery of RVOT due to pulmonary stenosis in their infant stage often lead to pulmonary insufficiency. Long-term pulmonary valve insufficiency or regurgitation leads right ventricle dilation and right heart failure. Pulmonary valve replacement (PVR) became inevitable. Since those patients were young and small, there was no proper pulmonary valvular prosthesis available for implantation. Expanded polytetrafluoroethylene (ePTFE) has been documented with good biocompatibility and its microporous structure impedes cellular penestration and subsequent calcification. The product has been widely used as graft for systemico-pulmonary shunts and primary RVOT patch reconstruction in cyanotic congenital heart surgery. Various ePTFE valved conduits have been used but the methods and conduct processes were complicated. We have created an efficient way to make a trileaflet-valved conduit of ePTFE which has been published in renowned journal (Ann Thorac Surg 2013;96:e163–5). In the past two years, it has been implanted in 15 patients with satisfactory results in clinical follow-up by echocardiography. Because of the simple design and unique flip-over method, we intend to transform this method onto transcatheter pulmonary valve therapy (TPVT) as a pioneer study. Currently the only available transcatheter pulmonary valve in USA is the Melody® valve (Medtronic Company). It was the first FDA-approved transcatheter pulmonary valve since 2010. However, the valve was made by bovine jugular vein valve with metal frame. As we know, xenograft inevitably faces calcification and degeneration with limited lifespan. And the company claimed the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for the effectiveness of Melody valve for this use has not been demonstrated.this use has not been demonstrated. this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated. this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated. this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated. this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated. this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated.this use has not been demonstrated. In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade In this project, we planned to use a handmade ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a ePTFE composite valve to incorporate into a covered stent sycovered stent sycovered stent sycovered stent sycovered stent sycovered stent sycovered stent sy covered stent sycovered stent sycovered stent sycovered stent sycovered stent sycovered stent sycovered stent sycovered stent system by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous stem by using our previous published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will published method. Through testing and combination of the best delivery system, we will do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. Also, it will be tested do animal experiments in porcine model to establish feasibility. 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Project number: MOST 103-2314-B-002-114).